IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2019-06-03

DGFT Committee Minutes

Document text

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Office of Directorate General of Foreign Trade New Delhi -0

-----------------------------------------------------------------------------Para 4.7 Decision

Minutes of the Norms Committee – 3 Meeting No. 1/82-ALC4/2019 dated 03.06.2019 (actually held on 13.06.2019) for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products falling under Chapter 29 and 30, held under the Chairmanship of Shri Satyan Sharda, Addl. DGFT in Room No.11, Udyog Bhawan, New Delhi.

Following members were present:-

(i) Shri Nirmal Kumar, Dy. Director General of Foreign Trade (ii) Shri Ajay Kumar, Assistant Director (iii) Consultant, Technical Expert Pharmaceuticals (iv) Consultant, Technical Expert Chemicals

The committee went through the minutes of earlier meeting No. 15/82-ALC4/2018 dated 14.02.2019 (actually held on 22.02.2019, 28.02.2019, 08.03.2019 and 12.03.2019) and approved the same.

MEETING NUMBER : 15/82-ALC4/2018 MEETING DATE :22.03.2019 (actually held on 29.03.2019, 11.04.2019, 18.04.2019, 26.04.2019, 02.05.2019 and 15.05.2019)

ONLINE CASES

1 Case No.:27/2/82-ALC4/2010 Party Name:ARJUN<br>CHEMICALS PVT. LTD., Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
HQ File<br>:01/82/050/01261/AM10/ RLA File<br>:04/24/040/00279/AM10/ Lic.No/Date:0410111329<br>04.02.2010 Defer Date
**Decision:**Application received from RLA,Chennai. Deferred for comments of TE.
Case No.:6/22/82-ALC4/2012 Party Name:SALVI Meet No/Date:1/82- Status:
CHEMICAL INDUSTRIES ALC4/2019 Deferred
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0310705888 Defer Date
:01/82/050/00709/AM13/ :03/95/040/00262/AM13/ 22.08.2012

Decision: The Committee considered the case as per online agenda in the presence of technical experts and 2 it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Appendix 4E with complete technical details.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

2

Case No.:238/1/82-ALC4/2019 Party Name:EXPO FINE Meet No/Date:1/82- Status:
CHEMICAL INDUSTRIES ALC4/2019 Deferred
03.06.2019
3 HQ File RLA File Lic.No/Date:2410037438 Defer Date:
:01/82/050/00144/AM20/ :24/24/040/00011/AM13/ 20.09.2012
**Decision:**Application received from RLA,Rajkot. Deferred for comments of TE.
Case No.:236/1/82-ALC4/2019 Party Name:MAITHRI Meet No/Date:1/82- Status:
LABORATORIES (P) LTD., ALC4/2019 Deferred
03.06.2019
4 HQ File<br>:01/82/050/00142/AM20/ RLA File<br>:09/24/040/00620/AM14/ Lic.No/Date:0910059454<br>28.02.2014 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.
Case No.:239/1/82-ALC4/2019 Party Name:EXPO FINE Meet No/Date:1/82- Status:
CHEMICAL INDUSTRIES ALC4/2019 Deferred
03.06.2019
5 HQ File RLA File Lic.No/Date:2410041561 Defer Date:
:01/82/050/00145/AM20/ :24/24/040/00008/AM15/ 26.08.2014
**Decision:**Application received from RLA,Rajkot. Deferred for comments of TE.
Case No.:17/1/82-ALC4/2019 Party Name:NEW ALLIANCE Meet No/Date:1/82- Status:
DYE-CHEM PVT. LTD., ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310795239
:01/82/050/00017/AM20/ :03/95/040/01096/AM15/ 10.04.2015

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 6 meeting no. 5/82-ALC4/2013 dated 30.05.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export product Qty. Sl.No. Import items Qty.
DISODIUM EDTA 1 kg 1 EDTA ACID 0.810 kg
WHITE POWDER WHITE POWDER
RA maytake appropriate action as per the decision of Norms Committee.

3

Case No.:247/1/82-ALC4/2019 Party Name:MANALI Meet No/Date:1/82- Status:
PETROCHEMICALS ALC4/2019 Approved
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0410160619
:01/82/050/00153/AM20/ :04/24/040/00240/AM15/ 02.06.2015

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 7 meeting no. 5/82-ALC4/2018 dated 25.07.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl.No. Import items Qty. Propylene Glycol USP 1 kg 1 Propylene Oxide 0.87 kg

RA may take appropriate action as per the decision of Norms Committee.

Case No.:15/1/82-ALC4/2019 Party Name:SUPRIYA Meet No/Date:1/82- Status:
LIFESCIENCE LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310798537
:01/82/050/00015/AM20/ :03/95/040/00988/AM15/ 27.08.2015

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was 8 decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

Export Product Qty. Sl.No. Import items Qty.
Methyl Cobalamin JP<br>(Mecobalamin) 1 kg 1 VITAMIN B12<br>(Cyanocobalamin) 0.95 kg

RA concerned may take further necessary action as per above decision of NC.

4

Case No.:191/13/82- Party Name:NATURAL& Meet No/Date:1/82- Status:
ALC4/2018 ESSENTIAL OILS PVT.LTD., ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0710108878
:01/82/050/01169/AM19/ :07/24/040/00226/AM16/ 13.10.2015
Case No.:191/13/82-<br>ALC4/2018 Case No.:191/13/82-<br>ALC4/2018 Party Name:NATURAL&<br>ESSENTIAL OILS PVT.LTD., Party Name:NATURAL&<br>ESSENTIAL OILS PVT.LTD., Party Name:NATURAL&<br>ESSENTIAL OILS PVT.LTD., Party Name:NATURAL&<br>ESSENTIAL OILS PVT.LTD., Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/01169/AM19/ RLA File<br>:07/24/040/00226/AM16/ Lic.No/Date:0710108878<br>13.10.2015
9 **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by<br>firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.No.<br>Import items<br>Qty.<br>CAFFEINE POWDER<br>3150 kg<br>1<br>CRUDE<br>CAFFEINE<br>(EXTRACTS OF COFFEE<br>BEANS<br>CONTAINS<br>CHOLORGENIC<br>ACIDS<br>32%)<br>POWDER<br>5200 kg<br>COFFEE<br>EXTRACTS<br>POWDER<br>3000 kg<br>2<br>CRUDE<br>CAFFEINE<br>(EXTRACTS OF COFFEE<br>BEANS<br>CONTAINS<br>CHOLORGENIC<br>ACIDS<br>32%)<br>POWDER<br>2800 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.
Export Product Qty. Sl.No. Import items Qty.
CAFFEINE POWDER 3150 kg 1 CRUDE<br>CAFFEINE<br>(EXTRACTS OF COFFEE<br>BEANS<br>CONTAINS<br>CHOLORGENIC<br>ACIDS<br>32%)<br>POWDER 5200 kg
COFFEE<br>EXTRACTS<br>POWDER 3000 kg 2 CRUDE<br>CAFFEINE<br>(EXTRACTS OF COFFEE<br>BEANS<br>CONTAINS<br>CHOLORGENIC<br>ACIDS<br>32%)<br>POWDER 2800 kg
10 <br>Case No.:16/1/82-ALC4/2019Party Name:SUPRIYA<br>LIFESCIENCE LTD<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00016/AM20/<br>RLA File<br>:03/95/040/01086/AM15/<br>Lic.No/Date:0310800300<br>18.11.2015<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by<br>firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.No.<br>Import items<br>Qty.<br>Methyl Cobalamin JP<br>(Mecobalamin)<br>1 kg<br>1<br>VITAMIN B12<br>(Cyanocobalamin)<br>0.95 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. Party Name:SUPRIYA<br>LIFESCIENCE LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
RLA File<br>:03/95/040/01086/AM15/ Lic.No/Date:0310800300<br>18.11.2015

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11 Case No.:112/20/82-<br>ALC4/2015 Case No.:112/20/82-<br>ALC4/2015 Party Name:SUPREET<br>CHEMICALS PVT.LTD. Party Name:SUPREET<br>CHEMICALS PVT.LTD. Party Name:SUPREET<br>CHEMICALS PVT.LTD. Party Name:SUPREET<br>CHEMICALS PVT.LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/01695/AM16/ RLA File<br>:03/95/040/00646/AM16/ Lic.No/Date:0310800620<br>03.12.2015
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 12/82-ALC4/2018 dated 12.12.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.No.<br>Import items<br>Qty.<br>6-NITRO-2-AMINO<br>PHENOL<br>4-SULFONIC<br>ACID<br>1 kg<br>1<br>ORTHO AMINO PHENOL<br>0.568 kg<br>RA maytake appropriate action asper the decision of Norms Committee.
Export product Qty. Sl.No. Import items Qty.
6-NITRO-2-AMINO<br>PHENOL<br>4-SULFONIC<br>ACID 1 kg 1 ORTHO AMINO PHENOL 0.568 kg
per the decision of Norms Committee.

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 12/82-ALC4/2018 dated 12.12.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as 11 per details given below or as applied by the firm, whichever is less:

Case No.:70/20/82-ALC4/2015 Party Name:SUNSHIELD Meet No/Date:1/82- Status:
CHEMICALS LTD. ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310800862
:01/82/050/01653/AM16/ :03/95/040/00598/AM16/ 10.12.2015

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 12 meeting no. 10/82-ALC4/2013 dated 22.08.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export product Qty. Sl.No. Import items Qty.
ETHOXYLATED AMINE (<br>SURFACTANT) 1 kg 1 TALLOW AMINE 0.193 kg
2 ETHYLENE OXIDE 0.741 kg
Case No.:310/10/82- Party Name:BELOOR BAYIR Meet No/Date:1/82- Status:Deferred
ALC4/2018 BIOTECH LTD, ALC4/2019
03.06.2019
HQ File RLA File Lic.No/Date:0710109255 Defer Date
:01/82/050/00597/AM19/ :07/24/040/00347/AM16/ 12.01.2016

Decision: The Committee considered the case as per online agenda in the presence of technical experts 13 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(ii) Approved composition of each export product; and (iii) Copy of Master Batch Formula of each export product.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

6

Case No.:281/12/82- Party Name:GLOBAL Meet No/Date:1/82- Status:
ALC4/2018 CALCIUM PRIVATE ALC4/2019 Deferred
LIMITED, 03.06.2019
14 HQ File RLA File Lic.No/Date:0710109416 Defer Date
:01/82/050/00908/AM19/ :07/24/040/00384/AM16/ 18.02.2016
**Decision:**Application received from RLA,Bangalore. Deferred for comments of TE.
Case No.:200/10/82- Party Name:MAHARSHI Meet No/Date:1/82- Status:
ALC4/2018 PHARMA CHEM PVT.LTD, ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0810137571
:01/82/050/00487/AM19/ :08/24/040/00459/AM16/ 31.03.2016

Decision: The Committee considered case as per agenda in the presence of the technical experts and it 15 was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

Export Product Qty. Sl.No. Import items Qty.
TRIAMCINOLONE 1 kg 1 16a ,17a ,21-trihydroxy 9b ,11b 1.05 kg
ACETONIDE BP/ USP oxidopregna 1,4-diene 3,20-dione
Case No.:203/10/82- Party Name:MAHARSHI Meet No/Date:1/82- Status:
ALC4/2018 PHARMA CHEM PVT.LTD, ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0810137909
:01/82/050/00490/AM19/ :08/24/040/00060/AM17/ 13.05.2016
16 **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied
by firm whichever is lower:
Export Product<br>Qty.<br>Sl.No.<br>Import items<br>Qty.
Dexamethasone<br>1 kg<br>1<br>16-Alpha Methyl Epoxide(8DM)<br>1.04 kg
RA concerned maytake further necessaryaction asper above decision of NC.
Case No.:43/10/82- Party Name:O C Meet No/Date:1/82- Status:
ALC4/2016 SPECIALITIES PVT.LTD. ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310805124
:01/82/050/00389/AM17/ :03/95/040/00169/AM17/ 01.06.2016

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 17 by firm whichever is lower:

Export Product Qty. Sl.No. Import items Qty.
C5 HYDROXYESTER (ETHYL -1- 1 kg 1 CYCLOPENTANONE 1.13 kg
HYDROXY CYCLOPENTANE 2 SODIUM CYANIDE 0.66 kg
CARBOXYLATE

7

Case No.:316/10/82- Party Name:ALEMBIC Meet No/Date:1/82- Status:
ALC4/2018 PHARMACEUTICALS LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:3410042371
:01/82/050/00603/AM19/ :34/24/040/00103/AM17/ 22.07.2016
Case No.:316/10/82-<br>ALC4/2018 Party Name:ALEMBIC<br>PHARMACEUTICALS LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/00603/AM19/ RLA File<br>:34/24/040/00103/AM17/ Lic.No/Date:3410042371<br>22.07.2016
18 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Table A<br>Norms for tablet<br>Product<br>Qty.<br>VALSARTAN<br>40.8 mg / 40 mg tablet<br>VALSARTAN<br>81.6 mg / 80 mg tablet<br>VALSARTAN<br>163.2 mg / 160 mg tablet<br>VALSARTAN<br>326.4 mg / 320 mg tablet<br>Table B<br>Norms for 1 kg export of Valsartan<br>Sl.No.<br>Import items<br>Qty.<br>1<br>METHYL (2S) 2 2 CYANO 1- 1-BIPEHNYL 4- YL METHYL AMINO-<br>3-METHYL BUTANOATE ETHANEDIOATE (BI PHENYL VALINE<br>OXALATE)<br>1.455 kg/kg<br>2<br>METHANOL<br>2.486 lit/kg<br>3<br>METHYLENECHLORIDE(OR DICHLOROMETHANE)<br>12.545lit/kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

Case No.:6/11/85-ALC3/2016 Party Name:GELTEC Meet No/Date:1/82- Status:
PRIVATE LIMITED ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310807611 Defer Date:
:01/85/050/00103/AM17/ :03/94/040/00502/AM17/ 06.09.2016

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 19 Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Approved composition / Drug Manufacturing Licence (DML) of each export product; (ii) Master Batch Formula of each export product; and (iii) Certificate of Analysis (COA) of Import Item No. 3.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

8

Case No.:244/1/82-ALC4/2019 Party Name:SIRMAXO Meet No/Date:1/82- Status:
CHEMICALS PVT LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310807807
:01/82/050/00150/AM20/ :03/95/040/00360/AM17/ 15.09.2016

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by 20 firm whichever is lower:

Export Product Qty. Sl.No. Import items Qty.
Povidone Iodine Topical solution USP 1 kg 1 Povidone Iodine 0.098 kg
10%(External Preparation-Antiseptics
& Disinfectents)(Available Iodine NLT
1% w/v)
Case No.:335/12/82- Party Name:MEDREICH Meet No/Date:1/82- Status:
ALC4/2018 LIMITED ALC4/2019 Deferred
03.06.2019
21 HQ File RLA File Lic.No/Date:0710110453 Defer Date
:01/82/050/00962/AM19/ :07/24/040/00216/AM17/ 23.09.2016
**Decision:**Application received from RLA,Bangalore. Deferred for comments of TE.
Case No.:148/17/82- Party Name:STERLING Meet No/Date:1/82- Status:
ALC4/2016 AUXILIARIES PVT LTD ALC4/2019 Deferred
03.06.2019
22 HQ File RLA File Lic.No/Date:0310809708 Defer Date
:01/82/050/01109/AM17/ :03/95/040/00703/AM17/ 09.12.2016
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
Case No.:158/17/82- Party Name:STERLING Meet No/Date:1/82- Status:
ALC4/2016 AUXILIARIES PVT LTD ALC4/2019 Deferred
03.06.2019
23 HQ File RLA File Lic.No/Date:0310809727 Defer Date
:01/82/050/01119/AM17/ :03/95/040/00690/AM17/ 09.12.2016
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.

9

Case No.:20/13/82- Party Name:RECKITT Meet No/Date:1/82- Status:
ALC4/2018 BENCKISER HEALTHCARE ALC4/2019 Approved
INDIA PRIVATE LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0510401413
:01/82/050/00998/AM19/ :05/24/040/00535/AM17/ 30.01.2017

Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 14/AM19, dated 14.02.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:

24

Export product Qty. Sl.<br>No. Import items Qty.<br>allowed<br>for 1<br>Number,<br>100 ml<br>bottle
Nurofen For Children 1 Number<br>(100 ml<br>bottles) 1. Ibuprofen 2.10gram
2. Tween 80(Polysorbate 80) 0.01gram
3. Glycerin 12.616<br>gram
4. Lycasin 80/55 (Maltotol) 44.52<br>gram
5. Saccharin Sodium 40/80 0.20gram
6. Citric Acid Monohydrate 0.40gram
7. Tri Sodium Citrate Dihydrate 0.509<br>gram
8. Keltrol SF Xanthan Gum 0.75 gram
9. Sodium Chloride 0.11 gram
10. Orange flavour 0.25 gram
11 Domiphen Bromide (BP) 0.01 gram
12 987 PP28mm M-LOC H&A White T/E Relevant<br>as per<br>packing<br>policy
13 DEVC,NURFN,GB,ORAL SUSPENSION<br>(Syringe)
14 Pet Bottle
15 INSR,NURFN,NN PASTIC PLUGS
16 NFC2 Percent Paper labels
17 NFC2 Percent Paper leaflets
18 NFC2 Percent Mono cartons
Note:<br>1. Above proposed norms are for the export of 1 No. 100 ml Bottle. For any other bottle size<br>exported, RA may workout the entitlement on pro-rata basis.<br>2. The firm will declare No. of Bottles exported / to be exported, of different pack size as per DML.<br>3. The firm will in future, show the quantity of export in terms of Number of Bottles and their<br>packsize.

Note:

  1. Above proposed norms are for the export of 1 No. 100 ml Bottle. For any other bottle size exported, RA may workout the entitlement on pro-rata basis.

  2. The firm will declare No. of Bottles exported / to be exported, of different pack size as per DML.

  3. The firm will in future, show the quantity of export in terms of Number of Bottles and their packsize.

10

Case No.:41/1/82- Party Name:GODAVARI Meet No/Date:1/82- Status:
ALC4/2017 DRUGS LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0910064654
:01/82/050/01395/AM17/ :09/24/040/00607/AM17/ 07.02.2017
C<br>A<br>H<br>: ase No.:41/1/82-<br>LC4/2017<br>Q File<br>01/82/050/01395/AM17/ Party Name:GODAVARI<br>DRUGS LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved<br>
RLA File<br>:09/24/040/00607/AM17/ Lic.No/Date:0910064654<br>07.02.2017
25<br>D<br>d<br>w<br>R **ecision:**The Committee considered case as per agenda in the presence of the technical experts and it was<br>ecided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm<br>hichever is lower:<br>Export Product<br>Qty.<br>Sl.No.<br>Import items<br>Qty.<br>CIPROFLOXACIN HCL/BASE<br>1 kg<br>1<br>2,4-DICHLORO-5-FLUROBENZOYL<br>CHLORIDE<br>0.879 kg<br>2<br>ETHYL 3-(N,N-DIMETHYLAMINO)<br>ACRYLATE<br>0.573 kg<br>3<br>CYCLOPROPYLAMINE<br>0.230 kg<br>4<br>TRI-N-BUTYLAMINE<br>0.050 kg<br>5<br>PIPERAZINE ANHYDROUS<br>0.450 kg<br>6<br>METHANOL<br>1.00 kg<br>A concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

Case No.:9/4/82-ALC4/2017 Party Name:O C Meet No/Date:1/82- Status:
SPECIALITIES PVT.LTD. ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310811043
:01/82/050/00017/AM18/ :03/95/040/00886/AM17/ 08.02.2017

26 Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 33/82-ALC4/2012 dated 21.03.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Qty. Sl.No. Import items Qty. N N DIISOPROPYL ETHYL AMINE 1 kg 1 DI ISOPROPYL AMINE 1.18 kg

Case No.:317/10/82- Party Name:ALEMBIC Meet No/Date:1/82- Status: ALC4/2018 PHARMACEUTICALS LTD ALC4/2019 Approved 03.06.2019 HQ File RLA File Lic.No/Date:3410042941 :01/82/050/00604/AM19/ :34/24/040/00333/AM17/ 16.02.2017

Case No.:317/10/82-<br>ALC4/2018 Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/00604/AM19/ Lic.No/Date:3410042941<br>16.02.2017
27 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-<br>hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:<br>Table A<br>Norms for tablet<br>Product<br>Qty.<br>VALSARTAN<br>40.8 mg / 40 mg tablet<br>VALSARTAN<br>81.6 mg / 80 mg tablet<br>VALSARTAN<br>163.2 mg / 160 mg tablet<br>VALSARTAN<br>326.4 mg / 320mg tablet<br>Table B<br>Norms for 1 kg export of Valsartan<br>Sl.No.<br>Import items<br>Qty.<br>1<br>Methyl (2S) 2 {[2 Cyano1 1 bipehnyl 4 yl)methyl] amino} 3 methyl butanoate ethanedioate<br>(Biphenyl valine oxalate)<br>1.455 kg/kg<br>2<br>Methanol<br>2.486 lit/kg<br>3<br>Methylene Chloride (or Dichloromethane)<br>12.545 lit/kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

11

Case No.:181/4/82- Party Name:BRILLIANT BIO Meet No/Date:1/82- Status:Approved
ALC4/2017 PHARMA PRIVATE ALC4/2019
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0910064725
:01/82/050/00189/AM18/ :09/24/040/00561/AM17/ 24.02.2017

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 6/82-ALC4/2018 dated 26.07.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: 28

Export product Qty. Sl.No. Import items Qty.
FUTVAC (FOOT AND<br>MOUTH DISEASE<br>VACCINE)<br>( 70,00,000 doses 2 ml<br>eachdose= 14,000litre) 1 Litre 1 MONTANIDE OIL ISA 0.533 kg
2 ADULT BOVINE SERUM 0.44 kiloliters<br>(440 Litres)
Case No.:54/4/82-ALC4/2017 Party Name:SUNSHIELD Meet No/Date:1/82- Status:
CHEMICALS LTD. ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310811691
:01/82/050/00062/AM18/ :03/95/040/00964/AM17/ 08.03.2017

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 29 meeting no. 4/82-ALC4/2018 dated 19.06.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export product Qty. Sl.No. Import items Qty.
CDPA<br>(CUMYLATED<br>DI PHENYL AMINE) 1 Litre 1 DI PHENYLAMINE 0.489 kg
Case No.:245/1/82-ALC4/2019 Party Name:SIRMAXO Meet No/Date:1/82- Status:
CHEMICALS PVT LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310811981
:01/82/050/00151/AM20/ :03/95/040/00970/AM17/ 20.03.2017

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 30

Export product Qty. Sl.No. Import items Qty.
Povidone Iodine Topical<br>Solution USP 10%<br>(Available Iodine NLT<br>1% w/v) 1 Litre 1 Povidone Iodine 0.098 kg

12

31 <br>Case No.:103/4/82-ALC4/2017 Party Name:RELIANCE<br>INDUSTRIES LTD.<br>RLA File<br>:03/95/040/01013/AM17/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00111/AM18/ Lic.No/Date:0310812389<br>10.04.2017
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
Case No.:340/4/82- Party Name:GODAVARI Meet No/Date:1/82- Status:
ALC4/2017 DRUGS LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0910064920
:01/82/050/00348/AM18/ :09/24/040/00694/AM17/ 13.04.2017
Case No.:340/4/82-<br>ALC4/2017<br>HQ File<br>:01/82/050/00348/AM18/ Party Name:GODAVARI<br>DRUGS LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
RLA File<br>:09/24/040/00694/AM17/ Lic.No/Date:0910064920<br>13.04.2017
32 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.No.<br>Import items<br>Qty.<br>CIPROFLOXACIN HCL/BASE<br>1 kg<br>1<br>2,4-DICHLORO-5-<br>FLUROBENZOYL<br>CHLORIDE<br>0.879 kg<br>2<br>ETHYL 3-(N,N-<br>DIMETHYLAMINO<br>ACRYLATE)<br>0.573 kg<br>3<br>CYCLOPROPYLAMINE<br>0.230 kg<br>4<br>TRI-N-BUTYLAMINE<br>0.050 kg<br>5<br>PIPERAZINE<br>ANHYDROUS<br>0.450 kg<br>6<br>METHANOL<br>1.00 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

33 Case No.:341/4/82-<br>ALC4/2017 Party Name:HONOUR LAB<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:0910064954<br>24.04.2017 Status:<br>Approved
HQ File<br>:01/82/050/00349/AM18/ RLA File<br>:09/24/040/00035/AM18/
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.No.<br>Import items<br>Qty.<br>(2S,3S,5S)-2-(2,6-Dimethyl<br>phenoxyacetyl)amino-3-hydroxy-<br>5-amino-1,6-diphenylhexane<br>1 kg<br>1<br>Ethyl bromo acetate<br>1.05 kg<br>2<br>(2S,3S,5S)-2-amino-3-<br>hydroxy-5-(t-<br>butyloxycarbonylamino)-<br>1,6-diphenylhexane<br>1.345 kg<br>3<br>Diisopropyl ether<br>1.44 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

13

34 <br>Case No.:205/4/82-ALC4/2017 Party Name:AETHER<br>INDUSTRIES LIMITED<br>RLA File<br>:52/24/040/00004/AM18/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00213/AM18/ Lic.No/Date:5210042246<br>01.05.2017 Defer Date
**Decision:**Application received from RLA,Surat. Deferred for comments of TE.
35 Case No.:59/9/82-ALC4/2017 <br>HQ File<br>:01/82/050/00786/AM18/ Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
RLA File<br>:09/24/040/00021/AM18/ Lic.No/Date:0910065008<br>04.05.2017
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.No.<br>Import items<br>Qty.<br>OLMESARTAN MEDOXOMIL<br>1 kg<br>1<br>5-[4-(BROMOMETHYL)<br>[1,1-BIPHENYL]-2-YL]-N-<br>(TRIPHENYL-METHYL)<br>TETRAZOLE<br>(BROMOMETHYL<br>BIPHENYL TRITYL<br>TETRAZOLE)<br>1.35 kg<br>2<br>4-CHLOROMETHYL-5-<br>METHYL-1,3-DIXOL-2-<br>ONE<br>0.426 kg<br>3<br>POTASSIUM<br>CARBONATE<br>(ANHYDROUS)<br>0.50 kg<br>4<br>CARBON<br>ENOANTICROMOS<br>(Activated Carbon)<br>0.039 kg<br>5<br>4-(1-HYDROXY-1-<br>METHYLETHYL)-2-<br>PROPYLIMIDAZOLE-5-<br>CARBOXYLIC ACID,<br>ETHYL ESTER<br>[IMIDAZOLE<br>DERIVATIVE]<br>0.70 kg<br>6<br>ACETONE<br>3.00 kg<br>7<br>N,N- DIMETHYL<br>ACETAMIDE<br>0.75 kg<br>8<br>METHYLENE CHLORIDE<br>2.60 kg<br>9<br>TETRAHYDROFURAN<br>1.00 kg<br>10<br>DI ISOPROPYL ETHER<br>0.80 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

14

Case No.:246/1/82-ALC4/2019 Party Name:SIRMAXO Meet No/Date:1/82- Status:
CHEMICALS PVT LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310813048
:01/82/050/00152/AM20/ :03/95/040/00081/AM18/ 04.05.2017
Case No.:246/1/82-ALC4/2019 Case No.:246/1/82-ALC4/2019 Party Name:SIRMAXO<br>CHEMICALS PVT LTD Party Name:SIRMAXO<br>CHEMICALS PVT LTD Party Name:SIRMAXO<br>CHEMICALS PVT LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/00152/AM20/ RLA File<br>:03/95/040/00081/AM18/ Lic.No/Date:0310813048<br>04.05.2017
36 <br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 6/82-ALC4/2014 dated 29.08.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.No.<br>Import items<br>Qty.<br>Povidone Iodine Topical Solution USP<br>10%<br>(Available Iodine NL T 1% w/v)<br>1 Litre<br>1<br>Povidone Iodine<br>0.098 kg<br>RA maytake appropriate action asper the decision of Norms Committee.
Export product Qty. Sl.No. Import items Qty.
Povidone Iodine Topical Solution USP<br>10%<br>(Available Iodine NL T 1% w/v) 1 Litre 1 Povidone Iodine 0.098 kg
Case No.:1/4/82-ALC4/2017 Party Name:LEE PHARMA Meet No/Date:1/82- Status:
LIMITED ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0910065019
:01/82/050/00009/AM18/ :09/24/040/00084/AM18/ 11.05.2017

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 37 by firm whichever is lower:

Export product Qty. Sl.No. Import items Qty.
2"3"-DI-O-ACETYL-5-<br>DEOXY-5"-FLUORO<br>CYTEDINE 1 kg 1 1,2,3-TRIACETYL-5-DEOXY-D-RIBOSE 1.05 kg
2 5-FLUORO CYTOSINE 0.437 kg
3 METHYLENE CHLORIDE(MDC) 2.00 kg
38 Case No.:283/12/82-<br>ALC4/2018 Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED, Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00910/AM19/ RLA File<br>:07/24/040/00053/AM18/ Lic.No/Date:0710111675<br>29.05.2017 Defer Date
**Decision:**RA, Bangalore was requested vide e-mail dated 13.03.2019 to furnish a hard copy<br>application. Application awaited from RA,Bangalore. of 4.07
39 <br>Case No.:109/12/82-<br>ALC4/2017 Party Name:VIVIMED LABS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01064/AM18/ RLA File<br>:09/24/040/00181/AM18/ Lic.No/Date:0910065247<br>06.07.2017 Defer Date
**Decision:**The firm has been requested to attend PH scheduled o n 21.06.2019.

15

Case No.:33/6/82-ALC4/2017 Party Name:GODAVARI Meet No/Date:1/82- Status:
DRUGS LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0910065287
:01/82/050/00603/AM18/ :09/24/040/00191/AM18/ 19.07.2017
Case No.:33/6/82-ALC4/2017 Party Name:GODAVARI<br>DRUGS LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/00603/AM18/ RLA File<br>:09/24/040/00191/AM18/ Lic.No/Date:0910065287<br>19.07.2017
40 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.No.<br>Import items<br>Qty.<br>CIPROFLOXACIN HCL / BASE<br>1 kg<br>1<br>2,4-DICHLORO-5-<br>FLUOROBENZOYL<br>CHLORIDE<br>0.879 kg<br>2<br>ETHYL 3-(N,N-<br>DIMETHYLAMINO)<br>ACRYLATE<br>0.573 kg<br>3<br>CYCLOPROPYLAMINE<br>0.230 kg<br>4<br>TRI-N-BUTYLAMINE<br>0.050 kg<br>5<br>PIPERAZINE<br>ANHYDROUS<br>0.450 kg<br>6<br>METHANOL<br>1.00 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

Case No.:206/13/82- Party Name:NATURAL Meet No/Date:1/82- Status:
ALC4/2018 REMEDIES PVT.LTD., ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0710111893 Defer Date
:01/82/050/01184/AM19/ :07/24/040/00307/AM17/ 20.07.2017

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 41 Meeting No. 13/82-ALC4/2018 dated 14.01.2019:

(i) Complete set of application.; (ii) Copy of DML / approved composition from Competent Authority and (iii) Complete technical details as per Appendix 4E

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

16

Case No.:520/4/82-ALC4/2017 Party Name:SUNSHIELD Meet No/Date:1/82- Status:
CHEMICALS LTD. ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310814918
:01/82/050/00528/AM18/ :03/95/040/00355/AM18/ 31.07.2017

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 8/82-ALC4/2014 dated 25.09.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as 42 per details given below or as applied by the firm, whichever is less:

Export product<br>SUN HQEE<br>(Hydroquinone<br>Ethoxylate) Qty. Sl.No. Import items Qty.
1 kg 1 Hydroquinone 0.625 kg
2 Ethylene Oxide 0.494 kg
43 Case No.:297/12/82-<br>ALC4/2018 Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED,<br>RLA File<br>:07/24/040/00129/AM18/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:0710111984<br>08.08.2017 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00924/AM19/ Defer Date
**Decision:**RA, Bangalore w<br>application. Application awaite as requested vide e-mail dated 13.03.2019 to furnish a hard<br>d from RA,Bangalore. copy of 4.07
Case No.:199/13/82- Party Name:NATURAL AND Meet No/Date:1/82- Status:
ALC4/2018 ESSENTIAL OILS PVT LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0710112040
:01/82/050/01177/AM19/ :07/24/040/00148/AM18/ 21.08.2017

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 44 by firm whichever is lower:

Export Product Qty. Sl.No. Import items Qty.
CAFFEINE 10020 kg 1 Crude Caffeine<br>(decaffeination from green<br>coffee) Purity 53.91%<br>Powder 17600 kg
COFFEE EXTRACTS 6150 kg
45 <br>Case No.:116/12/82-<br>ALC4/2017<br>P<br> <br>HQ File<br>:01/82/050/01071/AM18/<br> <br>: arty Name:VIVIMED LABS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
RLA File<br>09/24/040/00234/AM18/ Lic.No/Date:0910065373<br>23.08.2017 Defer Date
**Decision:**The firm has been requested to attend PH scheduled on 21.06.2019.

17

46 Case No.:134/12/82-<br>ALC4/2017 Party Name:VIVIMED LABS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br> <br>Lic.No/Date:0910065372<br>23.08.2017<br> Status: Deferred
<br>HQ File<br>:01/82/050/01089/AM18/ RLA File<br>:09/24/040/00233/AM18/ Defer Date
**Decision:**The firm has been requested to attend PH scheduled on 21.06.2019.
Case No.:195/13/82- Party Name:NATURAL& Meet No/Date:1/82- Status:
ALC4/2018 ESSENTIAL OILS PVT.LTD., ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0710112050
:01/82/050/01173/AM19/ :07/24/040/00150/AM18/ 23.08.2017

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 47 by firm whichever is lower:

Export Product Qty. Sl.No. Import items Qty.
CAFFEINE 10020 kg 1 Crude Caffeine (decaffeination<br>from green coffee) Purity<br>47.83% 17600 kg
COFFEE EXTRACTS 6150 kg
48 <br>Case No.:309/12/82-<br>ALC4/2018 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00936/AM19/ RLA File<br>:09/24/040/00132/AM18/ Lic.No/Date:0910065393<br>24.08.2017 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
49 <br>Case No.:131/12/82-<br>ALC4/2017 Party Name:VIVIMED LABS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01086/AM18/ RLA File<br>:09/24/040/00238/AM18/ Lic.No/Date:0910065396<br>28.08.2017 Defer Date
**Decision:**The firm has been requested to attend PH scheduled on 21.06.2019.
50 <br>Case No.:132/12/82-<br>ALC4/2017 Party Name:VIVIMED LABS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01087/AM18/ RLA File<br>:09/24/040/00235/AM18/ Lic.No/Date:0910065398<br>28.08.2017 Defer Date
**Decision:**The firm has been requested to attend PH scheduled on 21.06.2019.

18

51 <br>Case No.:141/12/82-<br>ALC4/2017 Party Name:VIVIMED LABS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01096/AM18/ RLA File<br>:09/24/040/00236/AM18/ Lic.No/Date:0910065397<br>28.08.2017 Defer Date
**Decision:**The firm has been requested to attend PH scheduled on 21.06.2019.

Case No.:138/12/82- Party Name:BRILLIANT BIO Meet No/Date:1/82- Status: ALC4/2017 PHARMA PRIVATE LIMITED ALC4/2019 Approved 03.06.2019 HQ File RLA File Lic.No/Date:0910065419 :01/82/050/01093/AM18/ :09/24/040/00267/AM18/ 31.08.2017

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 6/82-ALC4/2018 dated 26.07.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as 52 per details given below or as applied by the firm, whichever is less:

Export product Qty. Sl.No. Import items Qty.
FUTVAC (FOOT AND<br>MOUTH<br>DISEASE<br>VACCINE) <br> <br>1 Litre 1 MONTANIDE OIL ISA 0.533 kg
2 ADULT BOVINE SERUM 0.44<br>kiloliters<br>(440 Litres)
Case No.:177/12/82- Party Name:AUROBINDO Meet No/Date:1/82- Status:
ALC4/2017 PHARMA LIMITED ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0910065450 Defer Date
:01/82/050/01132/AM18/ :09/24/040/00273/AM18/ 11.09.2017

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 53 Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Import quantity does not tally with DML. Detailed working for each export item to be furnished.

(ii) Whether the quantity of Import Item No. 2 is for Diluted (1:1) or Active Compound i.e. Pot. Clavulanate.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

19

Case No.:112/12/82- Party Name:SATYA Meet No/Date:1/82- Status:
ALC4/2017 DEEPTHA ALC4/2019 Deferred
PHARMACEUTICALS LTD 03.06.2019
HQ File RLA File Lic.No/Date:0910065453 Defer Date
:01/82/050/01067/AM18/ :09/24/040/00303/AM18/ 14.09.2017

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

54 (i) Stepwise complete and balanced chemical reaction showing molecular weights of input and output materials.

(ii) % yield on molar basis for each steps . (iii) Requirement and recovery of each solvent in the process. (iv) Material balance for each step of manufacturing process. Hence, the Committee decided to issue Final Reminder to firm for submission of above information.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

55 <br>Case No.:198/4/82-ALC4/2018 Party Name:SAPTAGIR<br>CAMPHOR LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00198/AM19/ RLA File<br>:09/24/040/00293/AM18/ Lic.No/Date:0910065468<br>15.09.2017 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
56 Case No.:153/10/82-<br>ALC4/2018 Party Name:GLAND PHARMA<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00440/AM19/ RLA File<br>:09/24/040/00336/AM18/ Lic.No/Date:0910065562<br>17.10.2017 Defer Date
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 23.01.2019 has furnished its reply. Case is deferred.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 23.01.2019 has furnished its reply. Case is deferred.

57 <br>Case No.:64/10/82-<br>ALC4/2017 Party Name:MEDISPRAY<br>LABORATORIES PVT. LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00902/AM18/ RLA File<br>:03/95/040/00574/AM18/ Lic.No/Date:0310816779<br>02.11.2017 Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.

20

58 <br>Case No.:79/12/82-ALC4/2017 Party Name:CIPLA LIMITED. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01034/AM18/ RLA File<br>:03/94/040/00496/AM18/ Lic.No/Date:0310816778<br>02.11.2017 Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
Case No.:51/12/82-ALC4/2017 Party Name:D. K. PHARMA Meet No/Date:1/82- Status:
LAB ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310816992 Defer Date
:01/82/050/01006/AM18/ :03/94/040/00603/AM18/ 13.11.2017

59 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was observed that as per manufacturing process, starting raw material is DETOX FOC - 27 FISH BODY OIL CRUDE, which falls under Chapter 1504 and the licence should not be issued under para 4.07 of HBP Vol. I. Hence, it was decided to ask RLA, Mumbai to give justification for issuing licence against the import item - DETOX FOC - 27 FISH BODY OIL CRUDE.

60 Case No.:208/12/82-<br>ALC4/2017 Party Name:ATUL LIMITED, Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01163/AM18/ RLA File<br>:08/24/040/00203/AM18/ Lic.No/Date:0810141364<br>24.11.2017 Defer Date
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 14.02.2019 has furnished its reply. The case is deferred for comments of TE.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 14.02.2019 has furnished its reply. The case is deferred for comments of TE.

61 <br>Case No.:234/4/82-<br>ALC4/2018 Party Name:VIVIMED LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00234/AM19/ RLA File<br>:09/24/040/00396/AM18/ Lic.No/Date:0910065686<br>24.11.2017 Defer Date
**Decision:**The firm has been requested to attend PH scheduled on 21.06.2019.
62 <br>Case No.:236/4/82-<br>ALC4/2018 Party Name:VIVIMED LABS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00236/AM19/ RLA File<br>:09/24/040/00403/AM18/ Lic.No/Date:0910065688<br>24.11.2017 Defer Date
**Decision:**The firm has been requested to attend PH scheduled on 21.06.2019.

21

63 <br>Case No.:243/4/82-<br>ALC4/2018 Party Name:VIVIMED LABS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00243/AM19/ RLA File<br>:09/24/040/00404/AM18/ Lic.No/Date:0910065687<br>24.11.2017 Defer Date
**Decision:**The firm has been requested to attend PH scheduled on 21.06.2019.
64 <br>Case No.:232/4/82-ALC4/2018 Party Name:SATYA<br>DEEPTHA<br>PHARMACEUTICALS LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00232/AM19/ RLA File<br>:09/24/040/00421/AM18/ Lic.No/Date:0910065715<br>30.11.2017 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
65 Case No.:215/12/82-<br>ALC4/2017 Party Name:KLJ<br>PLASTICIZERS LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01170/AM18/ RLA File<br>:05/23/040/00334/AM18/ Lic.No/Date:0510404915<br>13.12.2017 Defer Date
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 12.01.2019 has furnished its reply. Case is deferred for comments of TE.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 12.01.2019 has furnished its reply. Case is deferred for comments of TE.

66 <br>Case No.:240/12/82-<br>ALC4/2017 Party Name:HERBOCHEM<br>INDUSTRIES Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01195/AM18/ RLA File<br>:06/24/040/00041/AM18/ Lic.No/Date:0610038759<br>14.12.2017 Defer Date
**Decision:**Application received from RLA,Kanpur. Deferred for comments of TE.
67 <br>Case No.:236/12/82-<br>ALC4/2017 Party Name:FRESENIUS KABI<br>ONCOLOGY LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01191/AM18/ RLA File<br>:05/23/040/00337/AM18/ Lic.No/Date:0510404950<br>15.12.2017 Defer Date
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.

22

Case No.:29/4/82- Party Name:VAKS PHARMA Meet No/Date:1/82- Status:
ALC4/2018 PVT.LTD., ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310818019 Defer Date
:01/82/050/00029/AM19/ :03/95/040/00752/AM18/ 26.12.2017

Decision: The Committee considered the case as per online agenda in the presence of technical experts 68 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) DML and (ii) Master Batch Formula

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

69 Case No.:217/12/82-<br>ALC4/2017 Party Name:TITAN<br>LABORATORIES PVT. LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01172/AM18/ RLA File<br>:03/95/040/00811/AM18/ Lic.No/Date:0310818044<br>27.12.2017 Defer Date
**Decision:**The Committee considered the case as per Agenda and it was noted that the firm vide letter<br>dated 13.03.2019 has furnished its reply. Case is deferred for comments of TE.

Decision: The Committee considered the case as per Agenda and it was noted that the firm vide letter dated 13.03.2019 has furnished its reply. Case is deferred for comments of TE.

70 Case No.:471/13/82-<br>ALC4/2018 Party Name:SWISS<br>PARENTERALS LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01449/AM19/ RLA File<br>:08/24/040/00291/AM18/ Lic.No/Date:0810141670<br>04.01.2018 Defer Date
**Decision:**The Committee considered the case as per Agenda and it was noted that the firm vide letter<br>dated 28.02.2019 has furnished its reply. Case is deferred for comments of TE.

Decision: The Committee considered the case as per Agenda and it was noted that the firm vide letter dated 28.02.2019 has furnished its reply. Case is deferred for comments of TE.

71 <br>Case No.:241/12/82-<br>ALC4/2017 Party Name:HERBOCHEM<br>INDUSTRIES Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01196/AM18/ RLA File<br>:06/24/040/00044/AM18/ Lic.No/Date:0610038783<br>10.01.2018 Defer Date
**Decision:**Application received from RLA,Kanpur. Deferred for comments of TE.
72 Case No.:12/4/82-ALC4/2018 Party Name:MELOG<br>SPECIALITY CHEMICALS<br>PVT. LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00012/AM19/ RLA File<br>:03/95/040/00810/AM18/ Lic.No/Date:0310818490<br>15.01.2018 Defer Date
**Decision:**The Committee considered the case as per Agenda and it was noted that the firm vide letter<br>dated 17.12.2018 has furnished its reply. Case is deferred for comments of TE.

Decision: The Committee considered the case as per Agenda and it was noted that the firm vide letter dated 17.12.2018 has furnished its reply. Case is deferred for comments of TE.

23

73 Case No.:128/4/82-ALC4/2018 Party Name:ALIVIRA<br>ANIMAL HEALTH LIMITED<br>RLA File<br>:03/94/040/00811/AM18/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00128/AM19/ Lic.No/Date:0310818544<br>16.01.2018 Defer Date
**Decision:**The Committee considered the case as per Agenda and it was noted that the firm vide e-mail<br>dated 30.03.2019 has furnished the DML copy. Hence,it was decided to defer the case for comments of TA.
Case No.:164/10/82- Party Name:AURORE LIFE Meet No/Date:1/82- Status: Deferred
ALC4/2018 SCIENCES PRIVATE ALC4/2019
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0910065897 Defer Date
:01/82/050/00451/AM19/ :09/24/040/00454/AM18/ 17.01.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 74 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) % yield on molar basis for each step supported by Technical Literature. (ii) Past production consumption certificate certified by Central Excise / GST Authorities.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:168/10/82- Party Name:OPTRIX Meet No/Date:1/82- Status:
ALC4/2018 LABORATORIES PRIVATE ALC4/2019 Approved
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0910065892
:01/82/050/00455/AM19/ :09/24/040/00416/AM18/ 17.01.2018
Case No.:168/10/82-<br>ALC4/2018<br> <br> <br> <br>HQ File<br>:01/82/050/00455/AM19/<br> <br> Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
RLA File<br>:09/24/040/00416/AM18/ Lic.No/Date:0910065892<br>17.01.2018
75 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.No.<br>Import items<br>Qty.<br>TEDIZOLID PHOSPHATE<br>1 kg<br>1<br>5-Bromo-2-(2-methyl-2H-1,2,3-<br>trizaol-4-yl)pyridine<br>0.746 kg<br>2<br>Bis(pinacolato)diboron<br>0.706 kg<br>3<br>Dichlorobis (di-tert-<br>butylphenylphosphine)palladium(II)<br>(CAS No34409-44-4)OR Cl2P2Pd<br>0.025 kg<br>4<br>(R)-3-(4-bromo-3-flourophenyl)-5-<br>(hydroxymethyl) oxozolidin-2-one<br>OR (R)-3-(4-bromo-3-<br>flourophenyl)-5-<br>(hydroxymethyl)oxozolidin-2-one<br>0.90 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

24

Case No.:165/10/82- Party Name:AURORE LIFE Meet No/Date:1/82- Status:
ALC4/2018 SCIENCES PRIVATE ALC4/2019 Deferred
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0910065915 Defer Date
:01/82/050/00452/AM19/ :09/24/040/00438/AM18/ 20.01.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 76 Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Stepwise yield on molar basis supported by Technical Literature. (ii) Requirement and recovery of solvents at each step.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

77 <br>Case No.:188/10/82-<br>ALC4/2018 Party Name:SATYADEVA<br>PHARMACEUTICALS PVT<br>LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00475/AM19/ RLA File<br>:09/24/040/00504/AM18/ Lic.No/Date:0910065921<br>24.01.2018 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
78 <br>Case No.:213/10/82-<br>ALC4/2018 Party Name:HETERO DRUGS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00500/AM19/ RLA File<br>:09/24/040/00548/AM18/ Lic.No/Date:0910065932<br>29.01.2018 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
79 <br>Case No.:38/13/82-<br>ALC4/2018 Party Name:RELIANCE<br>INDUSTRIES LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01016/AM19/ RLA File<br>:03/95/040/00804/AM18/ Lic.No/Date:0310818748<br>30.01.2018 Defer Date
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
80 <br>Case No.:180/10/82-<br>ALC4/2018 Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00467/AM19/ RLA File<br>:09/24/040/00539/AM18/ Lic.No/Date:0910065943<br>31.01.2018 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.

25

81 <br>Case No.:187/10/82-<br>ALC4/2018 Party Name:NISARG<br>BIOSCIENCES PVT LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00474/AM19/ RLA File<br>:09/24/040/00497/AM18/ Lic.No/Date:0910065945<br>31.01.2018 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
82 <br>Case No.:132/10/82-<br>ALC4/2018 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00419/AM19/ RLA File<br>:09/24/040/00516/AM18/ Lic.No/Date:0910065954<br>01.02.2018 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
83 <br>Case No.:130/10/82-<br>ALC4/2018 Party Name:NISARG<br>BIOSCIENCES PVT LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00417/AM19/ RLA File<br>:09/24/040/00496/AM18/ Lic.No/Date:0910065956<br>02.02.2018 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
84 Case No.:131/10/82-<br>ALC4/2018 Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00418/AM19/ RLA File<br>:09/24/040/00561/AM18/ Lic.No/Date:0910065961<br>02.02.2018 Defer Date
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

85 <br>Case No.:135/10/82-<br>ALC4/2018 Party Name:NISARG<br>BIOSCIENCES PVT LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00422/AM19/ RLA File<br>:09/24/040/00498/AM18/ Lic.No/Date:0910065963<br>02.02.2018 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
86 <br>Case No.:140/10/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00427/AM19/ RLA File<br>:09/24/040/00527/AM18/ Lic.No/Date:0910065968<br>06.02.2018 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.

26

87 <br>Case No.:249/10/82-<br>ALC4/2018 Party Name:AETHER<br>INDUSTRIES LIMITED<br>RLA File<br>:52/24/040/00054/AM18/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00536/AM19/ Lic.No/Date:5210042512<br>06.02.2018 Defer Date
**Decision:**Application received from RLA,Surat. Deferred for comments of TE.

==> picture [454 x 472] intentionally omitted <==

----- Start of picture text -----<br> Case No.:121/4/82- Party Name:GLENMARK Meet No/Date:1/82- Status:<br>ALC4/2018 PHARMACEUTICALS LTD., ALC4/2019 Approved<br>03.06.2019<br>HQ File RLA File Lic.No/Date:0310818971<br>:01/82/050/00121/AM19/ :03/94/040/00908/AM18/ 07.02.2018<br>Decision: The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export Product Qty.<br>Levonorgestrel and Ethinyl Estradiol Tablet 0.15mg/0.03mg (MARLISSA 50000.000 Packs<br>TABS) (Pack size 84 Tabs.)<br>( Net wt. of Levonorgestrel USP is 0.473 Kgs & Ethinyl Estradiol is 0.095<br>kgs)<br>Levonorgestrel and Ethinyl Estradiol Tablet 0.09mg/0.02mg (Pack size 84 45000.000 Packs<br>Tabs.)<br>( Net wt. of Levonorgestrel USP is 0.340 Kgs & Ethinyl Estradiol is 0.076<br>kgs)<br>Levonorgestrel and Ethinyl Estradiol Tablet 0.15mg/0.03mg (Pack size 273 45000.000 Packs<br>88<br>Tabs.)<br>( Net wt. of Levonorgestrel USP is 1.701 Kgs & Ethinyl Estradiol is 0.340<br>kgs)<br> Levonorgestrel and Ethinyl Estradiol 0.15mg/0.03mg Tablets & Ethinyl 50000.000 Packs<br>Estradiol 0.01mg Tablets (ASHLYNA)<br>(Pack size 182 Tabs.) ( Net wt. of Levonorgestrel USP is 1.260 Kgs &<br>Ethinyl Estradiol is 0.259 kgs)<br>Levonorgestrel and Ethinyl Estradiol 0.15mg/0.03mg Tablets & Ethinyl 75000.000 Packs<br>Estradiol 0.01mg Tablets (Pack size 91 Tabs.)<br>( Net wt. of Levonorgestrel USP is 0.945 Kgs & Ethinyl Estradiol is 0.194<br>kgs)<br> Levonorgestrel 1.5mg Tablets 150000.000 Packs<br>( Net wt. of Levonorgestrel USP is 0.225 Kgs)<br>Sl.No. Import items Qty.<br>1 Levonorgestrel USP 5.0429 kg<br>2 Ethinyl Estradiol 0.9833 kg<br>RA concerned may take further necessary action as per above decision of NC.<br>----- End of picture text -----<br>

27

Case No.:142/4/82-ALC4/2018 Party Name:HERBOCHEM Meet No/Date:1/82- Status:
INDUSTRIES ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0610038810 Defer Date
:01/82/050/00142/AM19/ :06/24/040/00047/AM18/ 07.02.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 89 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Appendix 4E with complete technical details.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

90 Case No.:166/10/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status: Deferred
<br>HQ File<br>:01/82/050/00453/AM19/ RLA File<br>:09/24/040/00528/AM18/ Lic.No/Date:0910065973<br>07.02.2018 <br>Defer Date
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:83/4/82-ALC4/2018 Party Name:SUN Meet No/Date:1/82- Status:
PHARMACEUTICAL ALC4/2019 Approved
INDUSTRIES LTD. 03.06.2019
HQ File RLA File Lic.No/Date:0510405614
:01/82/050/00083/AM19/ :05/24/040/00558/AM18/ 12.02.2018
Case No.:83/4/82-ALC4/2018 Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:0510405614<br>12.02.2018 Status:<br>Approved
HQ File<br>:01/82/050/00083/AM19/ RLA File<br>:05/24/040/00558/AM18/
91 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by<br>firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.No.<br>Import items<br>Qty.<br>Latanoprost and Timolol Maleate<br>Ophthalmic<br>Solution,<br>0.005%<br>/<br>0.5%w/v,<br>2.5ml<br>(LATOCOM)<br>Each ml contains Timolol Maleate<br>USP 6.83 mg equivalent to Timolol<br>5.0 mg (Equivalent to 426.875 Gram<br>of Bulk Drug)<br>25000.000<br>Number<br>1<br>Timolol Maleate<br>1480.40<br>gram<br>Timolol<br>Maleate<br>Long<br>Acting<br>Ophthalmic Solution 0.5%w/v, 5ml<br>(TIMOLET<br>OD)<br>Each ml contains Timolol Maleate<br>USP 6.83mg equivalent to Timolol<br>5.0<br>mg<br>(Equivalent<br>to<br>1024.500Gram of Bulk Drug)<br>30000.000<br>Number<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

28

Case No.:80/10/82- Party Name:CORAL Meet No/Date:1/82- Status:
ALC4/2018 LABORATORIES LTD., ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310819212 Defer Date
:01/82/050/00367/AM19/ :03/94/040/00938/AM18/ 16.02.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 92 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Copy of DML; and (ii) Pack size of each export product.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:272/12/82- Party Name:KOPALLE Meet No/Date:1/82- Status:
ALC4/2018 PHARMA CHEMICALS ALC4/2019 Approved
PVT.LTD., 03.06.2019
HQ File RLA File Lic.No/Date:0910065994
:01/82/050/00899/AM19/ :09/24/040/00565/AM18/ 16.02.2018
Case No.:272/12/82-<br>ALC4/2018 Party Name:KOPALLE<br>PHARMA CHEMICALS<br>PVT.LTD.,<br>RLA File<br>:09/24/040/00565/AM18/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/00899/AM19/ Lic.No/Date:0910065994<br>16.02.2018
93 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.No.<br>Import items<br>Qty.<br>PHTHALOYL AMLODIPINE<br>1 kg<br>1<br>MONO ETHANOL AMINE<br>0.272 kg<br>2<br>ETHYL-4-CHLORO ACETO<br>ACETATE<br>0.758 kg<br>3<br>ORTHO CHLORO<br>BENZYLDEHYDE<br>0.592 kg<br>4<br>METHYL ACETO ACETATE<br>1.115 kg<br>5<br>MORPHOLINE<br>0.068 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

94 <br>Case No.:82/10/82-<br>ALC4/2018 Party Name:FRESENIUS<br>KABI INDIA PRIVATE LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00369/AM19/ RLA File<br>:03/94/040/00911/AM18/ Lic.No/Date:0310819230<br>19.02.2018 Defer Date
**Decision:**The firm has been requested to attend PH scheduled on 21.06.2019.

29

95 Case No.:93/10/82-<br>ALC4/2018 Party Name:YASHO<br>INDUSTRIES PVT.LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00380/AM19/ RLA File<br>:03/95/040/01007/AM18/ Lic.No/Date:0310819263<br>20.02.2018 Defer Date
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 11.05.2019 has furnished its reply. Case is deferred.
96 <br>Case No.:47/13/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01025/AM19/ RLA File<br>:09/24/040/00587/AM18/ Lic.No/Date:0910066003<br>20.02.2018 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
Case No.:140/4/82- Party Name:RECKITT Meet No/Date:1/82- Status:
ALC4/2018 BENCKISER (INDIA) ALC4/2019 Deferred
PRIVATE LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0510405700 Defer Date
:01/82/050/00140/AM19/ :05/24/040/00592/AM18/ 21.02.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 97 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) DML

(ii) Masterbatch formula.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:141/4/82- Party Name:STERILE INDIA Meet No/Date:1/82- Status:
ALC4/2018 PRIVATE LIMITED ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0510405693 Defer Date
:01/82/050/00141/AM19/ :05/24/040/00577/AM18/ 21.02.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 98 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) complete technical details as per Appendix 4E

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

30

99<br> <br> <br> <br> <br> <br> Case No.:186/13/82-<br>ALC4/2018<br> <br> <br> <br>HQ File<br>:01/82/050/01164/AM19/<br> <br> Party Name:SONGWON<br>SPECIALTY CHEMICALS<br>INDIA PVT. LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
RLA File<br>:34/24/040/00341/AM18/ Lic.No/Date:3410043908<br>22.02.2018 Defer Date
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 22.04.2019 has furnished its reply. Case is deferred.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 22.04.2019 has furnished its reply. Case is deferred.

Case No.:87/10/82- Party Name:ATHENA DRUG Meet No/Date:1/82- Status:
ALC4/2018 DELIVERY SOLUTIONS ALC4/2019 Deferred
PRIVATE LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0310819402 Defer Date
:01/82/050/00374/AM19/ :03/94/040/00963/AM18/ 23.02.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 100 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Chemical name of import item; and

(ii) Copy of Master Batch Formula

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

101 <br>Case No.:286/4/82-<br>ALC4/2018<br>Party Name:SURVIVAL<br>TECHNOLOGIES PVT.LTD.<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Status:<br>Deferred<br>HQ File<br>:01/82/050/00286/AM19/<br>RLA File<br>:03/95/040/00993/AM18/<br>Lic.No/Date:0310819412<br>26.02.2018<br>Defer Date<br>**Decision:**The Committee considered the case as per online agenda in the presence of technical experts<br>and it was decided to call for following information from the firm:<br>(i)<br>Justification for lowyield of the chemical reaction. Party Name:SURVIVAL<br>TECHNOLOGIES PVT.LTD.<br>RLA File<br>:03/95/040/00993/AM18/ <br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
Lic.No/Date:0310819412<br>26.02.2018 <br>Defer Date

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was decided to call for following information from the firm:

102 <br>Case No.:6/4/82-ALC4/2018Party Name:SHREE<br>BANKEY BEHARI LAL<br>FLAVORS<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>HQ File<br>:01/82/050/00006/AM19/<br>RLA File<br>:05/24/040/00597/AM18/<br>Lic.No/Date:0510405729<br>27.02.2018<br>**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE. Party Name:SHREE<br>BANKEY BEHARI LAL<br>FLAVORS<br>RLA File<br>:05/24/040/00597/AM18/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
Lic.No/Date:0510405729<br>27.02.2018 <br>Defer Date

31

Case No.:269/12/82- Party Name:SATYA Meet No/Date:1/82- Status:
ALC4/2018 DEEPTHA ALC4/2019 Approved
PHARMACEUTICALS LTD 03.06.2019
HQ File RLA File Lic.No/Date:0910066024
:01/82/050/00896/AM19/ :09/24/040/00599/AM18/ 01.03.2018
Case No.:269/12/82-<br>ALC4/2018 Party Name:SATYA<br>DEEPTHA<br>PHARMACEUTICALS LTD<br>RLA File<br>:09/24/040/00599/AM18/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/00896/AM19/ Lic.No/Date:0910066024<br>01.03.2018
103 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>3R 3aS 6aR -hexabydrofuro<br>2,3-b furan-3-yl 4-nitrophenyl<br>carbonate Nitro Complex<br>1 kg<br>1<br>3aS,4S,6aR-4-oMe THF 3,4-b<br>furan 2(3H)one or 3aS-4S-6aR-<br>4-<br>METHOXYTHETRAHYDRO-<br>FURO- 3,4-b furan-2 3H one<br>lactone<br>1.093 kg<br>2<br>POTASSIUM BORO<br>HYDRIDE<br>0.55 kg<br>3<br>TETRA HYDRO FURAN<br>2.73 kg<br>4<br>DICHLORO METHANE<br>(MDC)<br>1.20 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

Case No.:275/12/82- Party Name:SATYA Meet No/Date:1/82- Status:
ALC4/2018 DEEPTHA ALC4/2019 Approved
PHARMACEUTICALS LTD 03.06.2019
HQ File RLA File Lic.No/Date:0910066023
:01/82/050/00902/AM19/ :09/24/040/00606/AM18/ 01.03.2018
Case No.:275/12/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/00902/AM19/ Party Name:SATYA<br>DEEPTHA<br>PHARMACEUTICALS LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
RLA File<br>:09/24/040/00606/AM18/ Lic.No/Date:0910066023<br>01.03.2018
104 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>(1S<br>4R)<br>4<br>[(2-AMINO-6<br>CHLORO 5 FORMAMIDO 4<br>PYRIMIDINYL) AMINO 2<br>CYCLO<br>PENTENE<br>1<br>METHANOL OR AFC OR<br>AFC Abacavir (ABV) I<br>1 kg<br>1<br>N-(2-AMINO-4,6-DICHLORO-<br>5-PYRIMIDINYL)<br>FORMAMIDE<br>0.764 kg<br>2<br>(+)-2-<br>AZABICYCLO[2.2.1]HEPT-5-<br>EN-3-ONE(VINCELACTAM)<br>1.298 kg<br>3<br>D(-)TARTARIC ACID<br>0.78 kg<br>4<br>SODIUM BOROHYDRIDE<br>0.226 kg<br>5<br>ISOPROPYL ALCOHOL<br>4.40 kg<br>6<br>METHANOL<br>1.375 kg<br>7<br>L(+)TARTARIC ACID<br>0.519kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

32

Case No.:45/10/82- Party Name:CADILA Meet No/Date:1/82- Status: Deferred
ALC4/2018 HEALTHCARE LTD ALC4/2019
03.06.2019
105 HQ File RLA File Lic.No/Date:0810142125 Defer Date
:01/82/050/00332/AM19/ :08/24/040/00342/AM18/ 08.03.2018
**Decision:**Application received from RLA,Ahmedabad. Deferred for comments of TE.
Case No.:51/10/82- Party Name:FDC LTD Meet No/Date:1/82- Status:
ALC4/2018 ALC4/2019 Deferred
03.06.2019
106 HQ File RLA File Lic.No/Date:0310819641 Defer Date
:01/82/050/00338/AM19/ :03/94/040/01017/AM18/ 08.03.2018
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
Case No.:64/10/82- Party Name:GLOBE Meet No/Date:1/82- Status:
ALC4/2018 TROTTERS PVT LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310819725
:01/82/050/00351/AM19/ :03/94/040/00961/AM18/ 12.03.2018
**Decision:**The Committee considered **Decision:**The Committee considered **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it case as per agenda in the presence of the technical experts and it case as per agenda in the presence of the technical experts and it case as per agenda in the presence of the technical experts and it
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as
applied by firm whichever is lower:
Export Product Qty. Sl. Import items Qty.
107 No.
CEFOTAXIME SODIUM 1 kg 1 CEFOTAXIME ACID 0.989kg
STERILE 2 TRIETHYLAMINE 0.178 kg
3 SODIUM 2 ETHYL HEXANOATE 0.44 kg
4 ETHYL ACETATE 2.233 kg
5 ETHYLENEDIAMINATRAACETIC 0.013 kg
ACID
6 ACTIVATED CARBON 0.014 kg
7 METHANOL 0.40 kg
RA concerned maytake further necessary action asper above decision of NC.

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

33

108 <br>Case No.:69/10/82-<br>ALC4/2018 Party Name:MEDISPRAY<br>LABORATORIES PVT.<br>LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00356/AM19/ RLA File<br>:03/95/040/01054/AM18/ Lic.No/Date:0310819735<br>12.03.2018 <br>Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
Case No.:311/10/82- Party Name:ALEMBIC Meet No/Date:1/82- Status:
ALC4/2018 PHARMACEUTICALS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:3410043955 Defer Date
:01/82/050/00598/AM19/ :34/24/040/00361/AM18/ 12.03.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 109 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) copy of Masterbatch formula for each export product

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

110 <br>Case No.:125/13/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01103/AM19/ RLA File<br>:09/24/040/00611/AM18/ Lic.No/Date:0910066054<br>12.03.2018 <br>Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
111 Case No.:72/10/82-<br>ALC4/2018 Party Name:O C<br>SPECIALITIES PVT.LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00359/AM19/ RLA File<br>:03/95/040/01114/AM18/ Lic.No/Date:0310819894<br>16.03.2018 <br>Defer Date
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 15.01.2019 has furnished its reply. Case is deferred.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 15.01.2019 has furnished its reply. Case is deferred.

112 <br>Case No.:33/13/82-<br>ALC4/2018 Party Name:VISWAAT<br>CHEMICALS LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01011/AM19/ RLA File<br>:03/95/040/01027/AM18/ Lic.No/Date:0310819857<br>16.03.2018 <br>Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.

34

Case No.:55/10/82- Party Name:BENZO CHEM Meet No/Date:1/82- Status:
ALC4/2018 INDUSTRIES PRIVATE ALC4/2019 Approved
LIMITED, 03.06.2019
HQ File RLA File Lic.No/Date:0310819905
:01/82/050/00342/AM19/ :03/94/040/00462/AM18/ 19.03.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

113

Export Product Qty. Sl. Import items Qty.
No.
2-DIMETHYLAMINO-2- 1 kg 1 PROPIOPHENONE 1.408 kg
PHENYLBUTAN-1-OL 2 SODIUM CYANIDE 0.599kg
(DAFOL) 3 PARA FORMALDEHYDE 0.528 kg
4 SODIUM BOROHYDRIDE 0.528 kg
5 TETRA HYDRO FURAN 1.00 kg
Case No.:127/13/82- Party Name:SPANSULES Meet No/Date:1/82- Status:
ALC4/2018 FORMULATIONS ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0910066066 Defer Date
:01/82/050/01105/AM19/ :09/24/040/00619/AM18/ 20.03.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 114 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Copy of DML for each export product

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:258/12/82- Party Name:SYNTHO Meet No/Date:1/82- Status:
ALC4/2018 CHIRALS PRIVATE ALC4/2019 Deferred
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0910066087 Defer Date
:01/82/050/00885/AM19/ :09/24/040/00669/AM18/ 26.03.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 115 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Details of import item and its use in the manufacturing process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

35

116 <br>Case No.:126/13/82-<br>ALC4/2018 Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01104/AM19/ RLA File<br>:09/24/040/00639/AM18/ Lic.No/Date:0910066086<br>26.03.2018 <br>Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
Case No.:37/10/82-ALC4/2018 Party Name:CADILA Meet No/Date:1/82- Status:
HEALTHCARE LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0810142248
:01/82/050/00324/AM19/ :08/24/040/00379/AM18/ 27.03.2018
Case No.:37/10/82-ALC4/2018 Case No.:37/10/82-ALC4/2018 Case No.:37/10/82-ALC4/2018 Case No.:37/10/82-ALC4/2018 Party Name:CADILA<br>HEALTHCARE LTD Party Name:CADILA<br>HEALTHCARE LTD Party Name:CADILA<br>HEALTHCARE LTD Party Name:CADILA<br>HEALTHCARE LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/00324/AM19/ RLA File<br>:08/24/040/00379/AM18/ Lic.No/Date:0810142248<br>27.03.2018
117 <br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 24/82-ALC4/2013 dated 27.03.2014, it was decided to ratify norms under Para 4.7 of HBP v1<br>as per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Norms recommended for OMEPRAZOLE DELAYED RELEASE 10 mg 20 mg and 40 mg capsule<br> <br>Sl.<br>No.<br>Import Items<br>Norms for 1 million capsule (Qty. In kg)<br>10 mg capsule<br>20 mg capsule<br>40 mg capsule<br>1<br>SUGAR SPHERES NF<br>(PHARMA-SPHERES, 710-<br>850 MICRON)<br>47.50<br>95.0<br>190.0<br>2<br>HYPROMELLOSE 3 CPS<br>2910 USP<br>4.68<br>9.36<br>18.6<br>3<br>HYPROMELLOSE<br>PHTHALATE NF<br>8.555<br>17.110<br>31.0<br>4<br>TRIETHYL CITRATE NF<br>1.285<br>2.570<br>4.65<br>5<br>2-CHLOROMETHYL-3,5<br>HYDROCHLORIDE<br>10.76<br>21.52<br>43.04<br>6<br>5-METHOXY 2-<br>MERCAPTO<br>BENZAMIDAZOLE<br>9.118<br>18.236<br>36.472<br>7<br>TALC PH.E/USP/JP<br>5.00<br>10.00<br>20.00<br>RA maytake appropriate action asper the decision of Norms Committee.
Sl.<br>No. Import Items Norms for 1 million capsule (Qty. In kg)
10 mg capsule 20 mg capsule 40 mg capsule
1 SUGAR SPHERES NF<br>(PHARMA-SPHERES, 710-<br>850 MICRON) 47.50 95.0 190.0
2 HYPROMELLOSE 3 CPS<br>2910 USP 4.68 9.36 18.6
3 HYPROMELLOSE<br>PHTHALATE NF 8.555 17.110 31.0
4 TRIETHYL CITRATE NF 1.285 2.570 4.65
5 2-CHLOROMETHYL-3,5<br>HYDROCHLORIDE 10.76 21.52 43.04
6 5-METHOXY 2-<br>MERCAPTO<br>BENZAMIDAZOLE 9.118 18.236 36.472
7 TALC PH.E/USP/JP 5.00 10.00 20.00
decision of Norms Committee.
118 Case No.:44/10/82-<br>ALC4/2018 Party Name:JUBILANT<br>GENERICS LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00331/AM19/ RLA File<br>:05/23/040/00490/AM18/ Lic.No/Date:0510406024<br>28.03.2018 <br>Defer Date
**Decision:**Application awaited from CLA, New Delhi. A Reminder is to be issued to CLA, New Delhi<br>for furnishingapplication expeditiously.

36

Case No.:320/10/82- Party Name:HETERO LABS Meet No/Date:1/82- Status:
ALC4/2018 LIMITED ALC4/2019 Deferred
03.06.2019
119 HQ File RLA File Lic.No/Date:0910066105 Defer Date
:01/82/050/00607/AM19/ :09/24/040/00666/AM18/ 28.03.2018
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
Case No.:122/12/82- Party Name:NEON Meet No/Date:1/82- Status:
ALC4/2018 LABORATORIES LTD. ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310820210 Defer Date
:01/82/050/00749/AM19/ :03/95/040/00877/AM18/ 02.04.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 120 Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) NOC applied for 360 ampule of 10 ML to Uganda, whereas the present application is for the export of 2455 Nos. , give justification for the discrepancy and

(ii) Detailed working for arriving at import quantity applied for.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:123/12/82- Party Name:NEON Meet No/Date:1/82- Status:
ALC4/2018 LABORATORIES LTD. ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310820208 Defer Date
:01/82/050/00750/AM19/ :03/95/040/00709/AM18/ 02.04.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 121 Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) NOC applied for 360 ampule of 10 ML to Uganda, whereas the present application is for the export of 2455 Nos. , give justification for the discrepancy and (ii) Detailed working for arriving at import quantity applied for.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:335/10/82- Party Name:CIPLA Meet No/Date:1/82- Status: Deferred
ALC4/2018 LIMITED. ALC4/2019
03.06.2019
122 HQ File RLA File Lic.No/Date:0310820244 Defer Date
:01/82/050/00622/AM19/ :03/94/040/01092/AM18/ 03.04.2018
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.

37

Case No.:200/13/82- Party Name:NATURAL& Meet No/Date:1/82- Status:
ALC4/2018 ESSENTIAL OILS ALC4/2019 Approved
PVT.LTD., 03.06.2019
HQ File RLA File Lic.No/Date:071011303
:01/82/050/01178/AM19/ :07/24/040/00370/AM18/ 6
03.04.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 123 applied by firm whichever is lower:

Export Product Qty. Sl.No. Import items Qty.
CAFFEINE 10020<br>kg 1 Crude Caffeine -<br>decaffeination from green<br>coffee-Purity 50.59% 17600 kg
COFFEE EXTRACTS 6150 kg
124 Case No.:5/10/82-<br>ALC4/2018 Party Name:DCM SHRIRAM<br>INDUSTRIES LTD, Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
HQ File<br>:01/82/050/00292/AM19/ RLA File<br>:05/23/040/00515/AM18/ Lic.No/Date:0510406067<br>09.04.2018 <br>Defer Date
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.
Case No.:334/10/82- Party Name:ZYTEX Meet No/Date:1/82- Status:
ALC4/2018 BIOTECH PVT. LTD. ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310820343
:01/82/050/00621/AM19/ :03/95/040/01161/AM18/ 10.04.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 125 meeting no. 1/82-ALC4/2018 dated 01.05.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export Product Qty. Sl.<br>No. Import Items
BACILLUS CEREUS (B.C.) 1 kg 1 PEPTONES
126 Case No.:261/12/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/00888/AM19/ Party Name:AKTINOS<br>HEALTHCARE PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:0910066131<br>11.04.2018 Status: Deferred
RLA File<br>:09/24/040/00668/AM18/ Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.

38

127 <br>Case No.:232/10/82-<br>ALC4/2018<br>Party Name:DEEPAK<br>NOVOCHEM<br>TECHNOLOGIES LTD<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Status:<br>Deferred<br>HQ File<br>:01/82/050/00519/AM19/<br>RLA File<br>:31/83/040/00171/AM18/<br>Lic.No/Date:3110067030<br>12.04.2018<br>Defer Date<br>**Decision:**The Committee considered the case as per Agenda and it was noted that the firm vide e-mail<br>dated 25.03.2019 has furnished its reply. The case is deferred for comments of TE. Party Name:DEEPAK<br>NOVOCHEM<br>TECHNOLOGIES LTD<br>RLA File<br>:31/83/040/00171/AM18/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
Lic.No/Date:3110067030<br>12.04.2018 Defer Date
128 <br>Case No.:156/13/82-<br>ALC4/2018<br>Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Status:<br>Deferred<br>HQ File<br>:01/82/050/01134/AM19/<br>RLA File<br>:09/24/040/00654/AM18/<br>Lic.No/Date:0910066137<br>12.04.2018<br>Defer Date<br>**Decision:**Application awaited from RLA, Hyderabad. A Reminder is to be issued to RLA, Hyderabad<br>for furnishingapplication expeditiously. Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED<br>RLA File<br>:09/24/040/00654/AM18/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
Lic.No/Date:0910066137<br>12.04.2018 Defer Date

Decision: Application awaited from RLA, Hyderabad. A Reminder is to be issued to RLA, Hyderabad for furnishing application expeditiously.

Case No.:88/10/82- Party Name:PARAGON Meet No/Date:1/82- Status:
ALC4/2018 INDUSTRIES ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0810142368 Defer Date
:01/82/050/00375/AM19/ :08/24/040/00004/AM19/ 13.04.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 129 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) GST / Central Excise certified data.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:320/13/82- Party Meet No/Date:1/82- Status: Deferred
ALC4/2018 Name:GULBRANDSEN ALC4/2019
CHEMICALS PVT LTD 03.06.2019
HQ File RLA File Lic.No/Date:3410044039 Defer Date
:01/82/050/01298/AM19/ :34/24/040/00006/AM19/ 16.04.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 130 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated -6.02.2019:

(i) complete technical details as per Appendix 4E along with Chemical reaction, molecular weight and percentage of yield on molar basis

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

39

Case No.:24/10/82- Party Name:ASCENT Meet No/Date:1/82- Status:
ALC4/2018 FINECHEM PVT. LTD., ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0810142416 Defer Date
:01/82/050/00311/AM19/ :08/24/040/00309/AM18/ 18.04.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 131 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Complete technical details as per Appendix 4E.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

132 <br>Case No.:122/13/82-<br>ALC4/2018 Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:0910066156<br>18.04.2018 Status:<br>Deferred<br> <br>Defer Date
<br>HQ File<br>:01/82/050/01100/AM19/ RLA File<br>:09/24/040/00024/AM19/
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
Case No.:333/10/82- Party Name:ZYTEX Meet No/Date:1/82- Status:
ALC4/2018 BIOTECH PVT. LTD. ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310820589
:01/82/050/00620/AM19/ :03/95/040/00051/AM19/ 23.04.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 133 meeting no. 1/82-ALC4/2018 dated 01.05.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export Product Qty. Sl.<br>No. Import Items
BACILLUS SUBTILIS DE111 1 kg 1 BIONIS YE MF

40

Case No.:153/12/82- Party Name:ETERNIS FINE Meet No/Date:1/82- Status:
ALC4/2018 CHEMICALS LIMITED, ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310820647 Defer Date
:01/82/050/00780/AM19/ :03/94/040/00055/AM19/ 25.04.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 134 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Complete technical details as per Appendix 4E.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:319/13/82- Party Name:AMI LIFE Meet No/Date:1/82- Status:
ALC4/2018 SCIENCES PRIVATE ALC4/2019 Approved
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:3410044121
:01/82/050/01297/AM19/ :34/24/040/00019/AM19/ 01.05.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 13/82-ALC4/2018 dated 14.01.2019, it was decided to ratify norms under Para 4.7 of HBP v1 135 as per details given below or as applied by the firm, whichever is less:

Export product Qty. Sl. Import items Qty.
No.
Benfotiamine 1 kg 1 Thiamine Hydrochloride 0.922 kg
Case No.:68/13/82- Party Name:NASENSE Meet No/Date:1/82- Status: Deferred
ALC4/2018 LABS PVT LTD ALC4/2019
03.06.2019
HQ File RLA File Lic.No/Date:0910066196 Defer Date
:01/82/050/01046/AM19/ :09/24/040/00018/AM19/ 04.05.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 136 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019:

(i) Complete technical details as per Appendix 4E along with Chemical reaction, molecular weight and percentage of yield on molar basis.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

41

137 <br>Case No.:121/13/82-<br>ALC4/2018 Party Name:VIVIMED LABS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01099/AM19/ RLA File<br>:09/24/040/00044/AM19/ Lic.No/Date:0910066198<br>04.05.2018 <br>Defer Date
**Decision:**The firm has been requested to attend PH scheduled on 21.06.2019.
138 <br>Case No.:225/10/82-<br>ALC4/2018 Party Name:DR J<br>PHARMACHEM PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00512/AM19/ RLA File<br>:31/83/040/00014/AM19/ Lic.No/Date:3110067038<br>07.05.2018 Defer Date
**Decision:**Application received from RLA,Pune. Deferred for comments of TE.
139 <br>Case No.:272/10/82-<br>ALC4/2018 Party Name:DORF KETAL<br>CHEMICALS INDIA<br>PRIVATE LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00559/AM19/ RLA File<br>:03/94/040/00090/AM19/ Lic.No/Date:0310820805<br>07.05.2018 Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
140 Case No.:247/10/82-<br>ALC4/2018 Party Name:GOPINATH<br>CHEM-TECH LTD., Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00534/AM19/ RLA File<br>:08/24/040/00391/AM18/ Lic.No/Date:0810142536<br>09.05.2018 Defer Date
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Ahmedabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.

141 <br>Case No.:12/13/82-ALC4/2018 Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00990/AM19/ RLA File<br>:09/24/040/00004/AM19/ Lic.No/Date:0910066208<br>09.05.2018 Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
142 <br>Case No.:107/13/82-<br>ALC4/2018 Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01085/AM19/ RLA File<br>:09/24/040/00006/AM19/ Lic.No/Date:0910066210<br>09.05.2018 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.

42

143 Case No.:250/10/82-<br>ALC4/2018 Party Name:AETHER<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date
<br>HQ File<br>:01/82/050/00537/AM19/ RLA File<br>:52/24/040/00016/AM19/ Lic.No/Date:5210042638<br>10.05.2018
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Ahmedabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.

144 Case No.:196/12/82-<br>ALC4/2018 Party Name:SHREE<br>BANKEY BEHARI LAL<br>FLAVORS Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00823/AM19/ RLA File<br>:05/24/040/00067/AM19/ Lic.No/Date:0510406412<br>10.05.2018 <br>Defer Date
**Decision:**The Committee considered the case as per Agenda and it was noted that the firm vide letter<br>dated 23.04.2019 has furnished its reply. The case is deferred for comments of TE.
Case No.:93/12/82- Party Name:GLENMARK Meet No/Date:1/82- Status:
ALC4/2018 PHARMACEUTICALS ALC4/2019 Deferred
LTD., 03.06.2019
HQ File RLA File Lic.No/Date:0310820963 Defer Date
:01/82/050/00720/AM19/ :03/94/040/00104/AM19/ 14.05.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 145 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 12/82-ALC4/2018 dated 14.01.2019:

(i) DML showing the composition of all the three export products

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

146 <br>Case No.:203/12/82-<br>ALC4/2018 Party Name:THEON<br>PHARMACEUTICALS LTD., Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00830/AM19/ RLA File<br>:22/24/040/00015/AM19/ Lic.No/Date:2210015902<br>14.05.2018 Defer Date
**Decision:**Application received from RLA,Chandigarh. Deferred for comments of TE.

43

Case No.:69/13/82-ALC4/2018 Party Name:PORUS Meet No/Date:1/82- Status:
LABORATORIES PRIVATE ALC4/2019 Deferred
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0910066234 Defer Date
:01/82/050/01047/AM19/ :09/24/040/00002/AM19/ 15.05.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 147 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019:

(i) Appendix 4E showing Stoichiometry balance, molecular weight and percentage of yield at every stage

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

148 <br>Case No.:120/13/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01098/AM19/ RLA File<br>:09/24/040/00614/AM18/ Lic.No/Date:0910066236<br>15.05.2018 <br>Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
Case No.:327/10/82- Party Name:MANGALAM Meet No/Date:1/82- Status:
ALC4/2018 DRUGS & ORGANICS ALC4/2019 Approved
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0310821020
:01/82/050/00614/AM19/ :03/95/040/00119/AM19/ 16.05.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 7/82-ALC4/2018 dated 24.08.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as 149 per details given below or as applied by the firm, whichever is less:

Export product Qty. Sl. Import items Qty.
No.
DI HYDRO ARTEMISININ 1 kg 1 ARTEMISININ 1.00 kg
2 SODIUM BOROHYDRIDE 0.20 kg

44

Case No.:244/10/82- Party Name:MELOG Meet No/Date:1/82- Status:
ALC4/2018 SPECIALITY CHEMICALS ALC4/2019 Deferred
PVT. LTD. 03.06.2019
HQ File RLA File Lic.No/Date:0310821042
:01/82/050/00531/AM19/ :03/95/040/00023/AM19/ 17.05.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 1/82-ALC4/2014 dated 10.04.2014, it was decided to ratify norms under Para 4.7 of HBP v1

as per details given below or as applied by the firm, whichever is less:

150

Qty. Sl.<br>No. Import items Qty.
1 kg 1 2 METHYL RESORCINOL 1.140 kg
2 CYANURIC CHLORIDE 0.479 kg
3 SULFOLENE 1.80 kg
Case No.:38/12/82-ALC4/2018 Party Name:CIPLA LIMITED. Meet No/Date:1/82- Status:
ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310821052 Defer Date
:01/82/050/00665/AM19/ :03/94/040/00122/AM19/ 17.05.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 151 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) No. of Metered Doses of Actuation in the 100 ml pack. (ii) Master Batch Formula

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:179/12/82- Party Name:MALWA Meet No/Date:1/82- Status:
ALC4/2018 OXYGEN & INDUSTRIAL ALC4/2019 Deferred
GASES PVT.LTD., 03.06.2019
HQ File RLA File Lic.No/Date:5610005414 Defer Date
:01/82/050/00806/AM19/ :56/24/040/00008/AM19/ 17.05.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 152 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Percentage of yield and (ii) Stoichiometric balance

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

45

Case No.:189/12/82- Party Name:MALWA Meet No/Date:1/82- Status:
ALC4/2018 OXYGEN & INDUSTRIAL ALC4/2019 Deferred
GASES PVT.LTD., 03.06.2019
HQ File RLA File Lic.No/Date:5610005415 Defer Date
:01/82/050/00816/AM19/ :56/24/040/00009/AM19/ 17.05.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 153 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Percentage of yield and (ii) Stoichiometric balance

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:194/13/82- Party Name:NATURAL AND Meet No/Date:1/82- Status:
ALC4/2018 ESSENTIAL OILS PVT LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0710113301
:01/82/050/01172/AM19/ :07/24/040/00042/AM19/ 17.05.2018

154

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

Export Product Qty. Sl.No. Import items Qty.
Natural Caffeine<br>anhydrous 98.5% 11175 kg 1 NATURAL CRUDE<br>CAFFEINE (Natural<br>Crude Caffeine Less than<br>or Equal to 83 percent<br>purity) 13261.897 kg
155 <br>Case No.:18/13/82-ALC4/2018 Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED<br>RLA File<br>:09/24/040/00067/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00996/AM19/ Lic.No/Date:0910066242<br>18.05.2018 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.

46

156 Case No.:168/12/82-<br> Party<br>Name:MANGALAMORGAN<br>ICS LIMITED FORMERLY<br>DUJODWALA PRODU <br> Meet<br> No/Date:1/82-<br> Stat us: Deferred
ALC4/2018
<br>HQ File<br>:01/82/050/00795/AM19<br>/<br>RLA File<br>:03/95/040/01140/AM18/<br>Lic.No/Date:0310821107<br>21.05.2018<br>**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE. RLA File<br>:03/95/040/01140/AM18/ Lic.No/Date:0310821107<br>21.05.2018 Defer Date
Case No.:192/12/82- Party Name:SUN Meet No/Date:1/82- Status:
ALC4/2018 PHARMACEUTICAL ALC4/2019 Deferred
INDUSTRIES LTD. 03.06.2019
HQ File RLA File Lic.No/Date:0510406538 Defer Date
:01/82/050/00819/AM19/ :05/24/040/00087/AM19/ 21.05.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 157 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Copy of Mater Batch Formula showing net content of inputs and wastages claimed.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:216/10/82- Party Name:DEEPAK Meet No/Date:1/82- Status:
ALC4/2018 NOVOCHEM ALC4/2019 Deferred
TECHNOLOGIES LTD 03.06.2019
HQ File RLA File Lic.No/Date:3110067060 Defer Date
:01/82/050/00503/AM19/ :31/83/040/00005/AM19/ 23.05.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 158 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Complete technical details as per Appendix 4E (ii) Exact chemical name of the export product.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:190/12/82- Party Name:SUN Meet No/Date:1/82- Status:
ALC4/2018 PHARMACEUTICAL ALC4/2019 Deferred
INDUSTRIES LTD. 03.06.2019
159 HQ File RLA File Lic.No/Date:0510406572 Defer Date
:01/82/050/00817/AM19/ :05/24/040/00098/AM19/ 23.05.2018
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.

47

Case No.:105/13/82- Party Name:NAGARJUNA Meet No/Date:1/82- Status:
ALC4/2018 AGRICHEM LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0910066269 Defer Date
:01/82/050/01083/AM19/ :09/24/040/00085/AM19/ 24.05.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 160 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) complete technical details as per Appendix 4E showing Stoichiometry balance, molecular weight and percentage of yield at every stage and (ii) Use of import item No. 2, 3 and 4 are not indicated in the manufacturing process

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:106/13/82- Party Name:PORUS Meet No/Date:1/82- Status:
ALC4/2018 LABORATORIES PVT LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0910066268 Defer Date
:01/82/050/01084/AM19/ :09/24/040/00089/AM19/ 24.05.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 161 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Percentage of yield. (ii) Calculation sheet showing quantity of Sulphuric Acid and Nitrate Acid

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:194/12/82- Party Name:JUBILANT Meet No/Date:1/82- Status:
ALC4/2018 GENERICS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0510406614 Defer Date
:01/82/050/00821/AM19/ :05/23/040/00087/AM19/ 25.05.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 162 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Copy of Master Batch Formula.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

48

163 Case No.:114/12/82-<br>ALC4/2018<br>Party<br>Name:STERLINGAUXILIAR<br>IES PVT LTD<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Status: Deferred<br>HQ File<br>:01/82/050/00741/AM19<br>/<br>RLA File<br>:03/95/040/00875/AM18/<br>Lic.No/Date:031082125<br>5<br>28.05.2018<br>Defer Date<br>**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE. Party<br>Name:STERLINGAUXILIAR<br>IES PVT LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status: Deferred
RLA File<br>:03/95/040/00875/AM18/ Lic.No/Date:031082125<br>5<br>28.05.2018 Defer Date
Case No.:237/1/82-ALC4/2019 Party Name:COVALENT Meet No/Date:1/82- Status:
LABORATORIES PRIVATE ALC4/2019 Approved
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0910066283
:01/82/050/00143/AM20/ :09/24/040/00671/AM18/ 29.05.2018
Case No.:237/1/82-ALC4/2019 Case No.:237/1/82-ALC4/2019 Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/00143/AM20/ RLA File<br>:09/24/040/00671/AM18/ Lic.No/Date:0910066283<br>29.05.2018
164 **Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 14/82-ALC4/2018 dated 14.02.2019, it was decided to ratify norms under Para 4.7 of HBP v1<br>as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.No.<br>Import items<br>Qty.<br>Cefuroxime<br>Axetil<br>Amorphous<br>1 kg<br>1<br>D-7-AMINO CEPHALOSPORANIC<br>ACID (D-7-ACA)<br>0.752 kg<br>2<br>Cholorosulphonyl Isocynate<br>0.53 kg<br>3<br>(Z)-2-Methoxy Imino (Furyl-2-YL)<br>Acetic Acid Ammonium Salt (SMIA)<br>0.700 kg<br>4<br>Dimethyl Acetamide<br>1.94 kg<br>5<br>Methylene Chloride<br>2.87 kg<br>6<br>Acetone<br>0.175 kg<br>7<br>Methanol<br>3.05 kg<br>8<br>Activated Carbon<br>0.100 kg<br>RA maytake appropriate action asper the decision of Norms Committee.
Export product Qty. Sl.No. Import items Qty.
Cefuroxime<br>Axetil<br>Amorphous 1 kg 1 D-7-AMINO CEPHALOSPORANIC<br>ACID (D-7-ACA) 0.752 kg
2 Cholorosulphonyl Isocynate 0.53 kg
3 (Z)-2-Methoxy Imino (Furyl-2-YL)<br>Acetic Acid Ammonium Salt (SMIA) 0.700 kg
4 Dimethyl Acetamide 1.94 kg
5 Methylene Chloride 2.87 kg
6 Acetone 0.175 kg
7 Methanol 3.05 kg
8 Activated Carbon 0.100 kg
per the decision of Norms Committee.
165 Case No.:293/10/82-<br>ALC4/2018 Party Name:SATYADEVA<br>PHARMACEUTICALS PVT<br>LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
HQ File<br>:01/82/050/00580/AM19/ RLA File<br>:09/24/040/00102/AM19/ Lic.No/Date:0910066289<br>31.05.2018 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
166 Case No.:39/13/82-ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
HQ File<br>:01/82/050/01017/AM19/ RLA File<br>:09/24/040/00082/AM19/ Lic.No/Date:0910066291<br>01.06.2018 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.

49

167 Case No.:40/13/82-ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
HQ File<br>:01/82/050/01018/AM19/ RLA File<br>:09/24/040/00083/AM19/ Lic.No/Date:0910066292<br>01.06.2018 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
168 Case No.:267/10/82-<br>ALC4/2018 Party Name:GLENMARK<br>PHARMACEUTICALS LTD., Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
HQ File<br>:01/82/050/00554/AM19/ RLA File<br>:03/94/040/00190/AM19/ Lic.No/Date:0310821416<br>04.06.2018 Defer Date
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:196/13/82- Party Name:NATURAL AND Meet No/Date:1/82- Status:
ALC4/2018 ESSENTIAL OILS PVT LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:071011339
:01/82/050/01174/AM19/ :07/24/040/00059/AM19/ 9
06.06.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 169 applied by firm whichever is lower:

Export Product Qty. Sl.No. Import items Qty.
CAFFEINE 10020<br>kg 1 Crude Caffeine -<br>decaffeination from green<br>coffee-Purity 53.02% 17600 kg
COFFEE EXTRACTS 6200 kg

50

Case No.:197/13/82- Party Name:NATURAL AND Meet No/Date:1/82- Status:
ALC4/2018 ESSENTIAL OILS PVT LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0710113400
:01/82/050/01175/AM19/ :07/24/040/00060/AM19/ 06.06.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 170 applied by firm whichever is lower:

Export Product Qty. Sl.No. Import items Qty.<br>17600 kg
CAFFEINE 10020<br>kg 1 Crude Caffeine -<br>decaffeination from green<br>coffee-Purity 51.96%
COFFEE EXTRACTS 6150 kg
171 <br>Case No.:244/12/82-<br>ALC4/2018 Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00871/AM19/ RLA File<br>:05/24/040/00137/AM19/ Lic.No/Date:0510406779<br>07.06.2018 Defer Date
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.
Case No.:295/12/82- Party Name:VERVE HUMAN Meet No/Date:1/82- Status:
ALC4/2018 CARE LABORATORIES ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:6110001511 Defer Date
:01/82/050/00922/AM19/ :61/24/040/00003/AM19/ 07.06.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 172 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Copy of DML showing Approved Composition of each export product.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

173 <br>Case No.:277/10/82-<br>ALC4/2018 Party Name:CIPLA<br>LIMITED. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00564/AM19/ RLA File<br>:03/94/040/00208/AM19/ Lic.No/Date:0310821558<br>08.06.2018 <br>Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.

51

Case No.:279/10/82- Party Name:J.B. Meet No/Date:1/82- Status: ALC4/2018 CHEMICALS & ALC4/2019 Deferred PHARMACEUTICALS 03.06.2019 LIMITED 174 HQ File RLA File Lic.No/Date:0310821556 Defer Date :01/82/050/00566/AM19/ :03/94/040/00207/AM19/ 08.06.2018

Decision: Application received from RLA, Mumbai. Deferred for comments of TE.

175 <br>Case No.:81/12/82-ALC4/2018 Party Name:KOPRAN<br>RESEARCH<br>LABORATORIES LTD.<br>RLA File<br>:03/94/040/00194/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00708/AM19/ Lic.No/Date:0310821554<br>08.06.2018 Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.

Case No.:222/12/82- Party Name:DHANUKA Meet No/Date:1/82- Status: ALC4/2018 LABORATORIES LTD ALC4/2019 Approved 03.06.2019 HQ File RLA File Lic.No/Date:0510406803 :01/82/050/00849/AM19/ :05/23/040/00109/AM19/ 08.06.2018

Case No.:222/12/82-<br>ALC4/2018 Party Name:DHANUKA<br>LABORATORIES LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/00849/AM19/ RLA File<br>:05/23/040/00109/AM19/ Lic.No/Date:0510406803<br>08.06.2018
176 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>CEFDINIR USP/BP/IP/JP/EP<br>POWDER<br>1 kg<br>1<br>7-Phenylacetamideo -3-<br>Chloromethyl Cephalosporanic<br>Acid Para Methoxy Benzyl Ester<br>(GCLE)<br>2.263 kg<br>2<br>TRIPHENYL PHOSPHINE<br>1.234 kg<br>3<br>SODIUM IODIDE<br>0.11 kg<br>4<br>PHENOL<br>2.42 kg<br>5<br>METHYLENE CHLORIDE<br>12.76 kg<br>6<br>TETRA HYDRO FURAN(THF)<br>2.55 kg<br>7<br>METHANOL<br>4.25 kg<br>8<br>FORMALDEHYDE<br>2.74 kg<br>9<br>CAEM<br>1.397 kg<br>10<br>TRIETHYLAMINE<br>0.155 kg<br>11<br>n-BUTYL ACETATE<br>1.49 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

52

177 <br>Case No.:59/13/82-<br>ALC4/2018<br> <br> <br>HQ File<br>:01/82/050/01037/AM19/<br> <br> Party Name:VIVIMED LABS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
RLA File<br>:09/24/040/00106/AM19/ Lic.No/Date:0910066318<br>11.06.2018 Defer Date
**Decision:**The firm has been requested to attend PH scheduled on 21.06.2019.
178 <br>Case No.:62/13/82-ALC4/2018 Party Name:SATYA<br>DEEPTHA<br>PHARMACEUTICALS<br>LIMITED<br>RLA File<br>:09/24/040/00110/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01040/AM19/ Lic.No/Date:0910066325<br>11.06.2018 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
Case No.:63/13/82- Party Name:SATYA Meet No/Date:1/82- Status:
ALC4/2018 DEEPTHA ALC4/2019 Approved
PHARMACEUTICALS 03.06.2019
LIMITED
HQ File RLA File Lic.No/Date:0910066327
:01/82/050/01041/AM19/ :09/24/040/00111/AM19/ 11.06.2018
Case No.:63/13/82-<br>ALC4/2018 Party Name:SATYA<br>DEEPTHA<br>PHARMACEUTICALS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/01041/AM19/ RLA File<br>:09/24/040/00111/AM19/ Lic.No/Date:0910066327<br>11.06.2018
179 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>ABC-I (or) Abacavir Sulfate<br>(ABC)<br>I<br>(SA)<br>or<br>(1S,4R)-4-[(2-Amino-6-<br>Chloro-9H-Purin-yl)-2-<br>Cyclopentene-1-methanol<br>1 kg<br>1<br>N-(2-AMINO-4,6-DICHLORO-<br>5-PYRIMIDINYL)<br>FORMAMIDE<br>0.764 kg<br>2<br>(+)-2-<br>AZABICYCLO[2.2.1]HEPT-5-<br>EN-3-ONE(VINCELACTAM)<br>1.298 kg<br>3<br>D(-)TARTARIC ACID<br>0.78 kg<br>4<br>SODIUM BOROHYDRIDE<br>0.226 kg<br>5<br>ISOPROPYL ALCOHOL<br>4.40 kg<br>6<br>TRIETHYL ORTHO FORMATE<br>1.375 kg<br>7<br>L(+)TARTARIC ACID<br>0.519kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

53

Case No.:55/12/82-ALC4/2018 Party Name:SURVIVAL Meet No/Date:1/82- Status:
TECHNOLOGIES PVT.LTD. ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310821614 Defer Date
:01/82/050/00682/AM19/ :03/95/040/00220/AM19/ 12.06.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 180 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Justification for low yield and (ii) Percentage recovery of solvents.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:223/12/82- Party Name:CADILA Meet No/Date:1/82- Status:
ALC4/2018 HEALTHCARE LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0810142808
:01/82/050/00850/AM19/ :08/24/040/00076/AM19/ 12.06.2018
Case No.:223/12/82-<br>ALC4/2018 Case No.:223/12/82-<br>ALC4/2018 Party Name:CADILA<br>HEALTHCARE LTD<br> <br> <br> Party Name:CADILA<br>HEALTHCARE LTD<br> <br> <br> Party Name:CADILA<br>HEALTHCARE LTD<br> <br> <br> Party Name:CADILA<br>HEALTHCARE LTD<br> <br> <br> Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>S<br>A Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>S<br>A tatus:<br>pproved tatus:<br>pproved
HQ File<br>:01/82/050/00850/AM19/ RLA File<br>:08/24/040/00076/AM19/<br> <br> Lic.No/Date:0810142808<br>12.06.2018
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>Import items<br>Qty.
Export Product Qty. Sl. Import items Qty.
181 No.
PAROXETINE HCL 1 kg 1 PIPERIDINE ALCOHOL [(-)<br> 0.81 kg
ALCOHO<br>METHYL-<br>METHYL-<br>PHENYL) ] OR (-TRANS-1-N-<br>3-HYDROXY<br>4-(4-FLUORO<br>PIPERIDINE
2 <br>SESAMOL <br> 0. 55 kg
3 DIMETHY L SULFOXIDE 1. 916 kg
4 ISOPROPYL ALCOHOL(IPA) 2.523 kg
5 METHANOL 1.367 kg
6<br>ACETONE<br>RA concerned maytake further necessaryaction asper above decision of NC. 6 ACETONE 4.95 kg

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

182 <br>Case No.:56/12/82-ALC4/2018Party Name:SANJIVANI<br>PARANTERAL LIMITED<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>HQ File<br>:01/82/050/00683/AM19/<br>RLA File<br>:03/95/040/00227/AM19/<br>Lic.No/Date:0310821651<br>13.06.2018<br>**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE. Party Name:SANJIVANI<br>PARANTERAL LIMITED<br>RLA File<br>:03/95/040/00227/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date
Lic.No/Date:0310821651<br>13.06.2018

54

Case No.:209/12/82- Party Name:SHREE BANKEY Meet No/Date:1/82- Status:
ALC4/2018 BEHARI LAL AROMATICS ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0510406899 Defer Date
:01/82/050/00836/AM19/ :05/24/040/00117/AM19/ 18.06.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 183 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) COA of import item from foreign supplier..

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:273/10/82- Party Name:DORF-KETAL Meet No/Date:1/82- Status:
ALC4/2018 CHEMICALS INDIA ALC4/2019 Deferred
PVT.LTD. 03.06.2019
HQ File RLA File Lic.No/Date:0310821762 Defer Date
:01/82/050/00560/AM19/ :03/94/040/00224/AM19/ 19.06.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 184 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Complete technical details as per Appendix 4 E and (ii) Exact Chemical name of export product.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:278/10/82- Party Name:DORF-KETAL Meet No/Date:1/82- Status:
ALC4/2018 CHEMICALS INDIA ALC4/2019 Deferred
PVT.LTD. 03.06.2019
HQ File RLA File Lic.No/Date:0310821761 Defer Date
:01/82/050/00565/AM19/ :03/94/040/00223/AM19/ 19.06.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 185 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Complete technical details as per Appendix 4 E and

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:208/12/82- Party Name:STRIDES Meet No/Date:1/82- Status:
ALC4/2018 SHASUN LIMITED ALC4/2019 Deferred
03.06.2019
186 HQ File RLA File Lic.No/Date:0410164428 Defer Date
:01/82/050/00835/AM19/ :04/24/040/00063/AM19/ 21.06.2018
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.

55

Case No.:175/12/82- Party Name:NECTAR Meet No/Date:1/82- Status:
ALC4/2018 LIFESCIENCES LIMITED ALC4/2019 Deferred
03.06.2019
187 HQ File<br>:01/82/050/00802/AM19/ RLA File<br>:22/24/040/00028/AM19/ Lic.No/Date:2210015928<br>22.06.2018 Defer Date
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:35/13/82- Party Name:VIVIMED Meet No/Date:1/82- Status: Deferred
ALC4/2018 LABS LIMITED ALC4/2019
03.06.2019
188 HQ File RLA File Lic.No/Date:0910066375 Defer Date
:01/82/050/01013/AM19/ :09/24/040/00136/AM19/ 22.06.2018
**Decision:**The firm has been requested to attend PH scheduled on 21.06.2019.
Case No.:71/13/82- Party Name:VIVIMED LABS Meet No/Date:1/82- Status:
ALC4/2018 LIMITED ALC4/2019 Deferred
03.06.2019
189 HQ File RLA File Lic.No/Date:0910066374 Defer Date
:01/82/050/01049/AM19/ :09/24/040/00134/AM19/ 22.06.2018
**Decision:**The firm has been requested to attend PH scheduled on 21.06.2019.
Case No.:76/13/82- Party Name:VIVIMED LABS Meet No/Date:1/82- Status:
ALC4/2018 LIMITED ALC4/2019 Deferred
03.06.2019
190 HQ File RLA File Lic.No/Date:0910066376 Defer Date
:01/82/050/01054/AM19/ :09/24/040/00135/AM19/ 22.06.2018
**Decision:**The firm has been requested to attend PH scheduled on 21.06.2019.
Case No.:214/13/82- Party Name:FOURRTS Meet No/Date:1/82- Status:
ALC4/2018 (INDIA) LABORATORIES P ALC4/2019 Deferred
LTD 03.06.2019
191 HQ File RLA File Lic.No/Date:0410164438 Defer Date
:01/82/050/01192/AM19/ :04/24/040/00036/AM19/ 22.06.2018
**Decision:**Application received from RLA,Chennai. Deferred for comments of TE.
Case No.:274/10/82- Party Name:MELOG Meet No/Date:1/82- Status:
ALC4/2018 SPECIALITY CHEMICALS ALC4/2019 Deferred
PVT. LTD. 03.06.2019
192 HQ File RLA File Lic.No/Date:0310821895 Defer Date
:01/82/050/00561/AM19/ :03/95/040/00235/AM19/ 25.06.2018
**Decision:**The Committee considered the case as per Agenda and it was noted that the firm vide letter
dated 13.05.2019 has furnished its reply. The case is deferred for comments of TE.

56

Case No.:185/13/82- Party Name:SPC LIFE Meet No/Date:1/82- Status:
193 <br> <br>ALC4/2018 <br>SCIENCES PVT. LTD. <br>ALC4/2019<br>03.06.2019 <br>Deferred<br>Defer Date
<br>HQ File RLA File Lic.No/Date:3410044282
<br>:01/82/050/01163/AM19/ <br>:34/24/040/00109/AM19/ <br>26.06.2018
**Decision:**Application receive d from RLA,Vadodara. Deferred for comments of TE.

Case No.:275/10/82- Party Name:GLENMARK Meet No/Date:1/82- Status: ALC4/2018 PHARMACEUTICALS LTD., ALC4/2019 Approved 03.06.2019 HQ File RLA File Lic.No/Date:0310821966 :01/82/050/00562/AM19/ :03/94/040/00258/AM19/ 27.06.2018

Case No.:275/10/82- Case No.:275/10/82- Party Name:GLENMARK<br> Party Name:GLENMARK<br> Party Name:GLENMARK<br> Party Name:GLENMARK<br> Party Name:GLENMARK<br> Party Name:GLENMARK<br> Meet No/Date:1/82-<br>S Meet No/Date:1/82-<br>S tatus: tatus:
<br>ALC4/2018<br>HQ File <br>PHARMACEUTICALS LTD.,<br> <br> <br> <br>RLA File<br> <br>ALC4/2019<br>03.06.2019<br> <br>A<br>Lic.No/Date:0310821966<br>27.06.2018 <br>pproved
<br>:01/82/050/00562/AM19/ <br>:03/94/040/00258/AM19/<br> <br>
**Decision:**The Committee consid ered case as per agenda in the pr esence of the technical expe rts and it was
<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by<br>firm whichever is lower:
Qty.
Export Product Qty. Sl.No. Import items Qty.
Calcipotrene Ointment 60gm<br>Taro (Calcitrene Ointment U<br>0.005%)<br>( Pack Size 60m) (Net Wt <br>SP<br>f 30000.000<br>Packs 1 Calcipotriol<br>Anhydrous 2.2 664 kg
g .<br>Calcipotriol Anhydrous is 0.0<br>Kgs.) <br>90
194 CALCITRENE OINTMENT<br>0.005% 10X5 GM (Calcitrene<br>Ointment USP 0.005%)<br>(Pack Size 5gm) (Net Wt. of 75000.000<br>Packs
Calcipotriol Anhydrous is 0.188<br>Kgs.)
CALCITRENE OINTMENT<br>0.005% 60 GM (Calcitrene<br>Ointment USP 0.005%)<br>( Pack Size 60gm) (Net Wt. of<br>Calcipotriol Anhydrous is 0.084<br>Kgs.) 2800<br>Packs .000<br>
Calcipotriene Ointment 120gm<br>li i 75000<br>Packs .000<br>
Taro (Cactrene Ontment USP<br>0.005%)<br>( Pack Size 120gm) (Net Wt of
.<br>Calcipotriol Anhydrous is 0.450<br>Kgs.)<br>Calcitrene Ointment 120gm Taro<br>(Calcitrene Ointment USP<br>0.005%) (Pack Size 120gm)<br>(Net Wt. of Calcipotriol<br>Anhydrous is 0.270 Kgs.)<br>45000.000<br>Packs<br>Calcipotriene Cream 0.005%<br>60gm (Calcitrene Cream USP<br>0.005%)<br>( Pack Size 60gm) (Net Wt. of<br>Calcipotriol Anhydrous is 0.240<br>Kgs.)<br>80000.000<br>Packs<br>RA concerned maytake further necessaryaction asper .<br>Calcipotriol Anhydrous is 0.450<br>Kgs.)
Calcitrene Ointment 120gm Taro<br>(Calcitrene Ointment USP<br>0.005%) (Pack Size 120gm)<br>(Net Wt. of Calcipotriol<br>Anhydrous is 0.270 Kgs.) 45000.000<br>Packs
Calcipotriene Cream 0.005%<br>60gm (Calcitrene Cream USP<br>0.005%)<br>( Pack Size 60gm) (Net Wt. of<br>Calcipotriol Anhydrous is 0.240<br>Kgs.) 80000.000<br>Packs
above decision of NC.

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

57

Case No.:117/13/82- Party Name:ORTIN Meet No/Date:1/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2019 Deferred
03.06.2019
195 HQ File RLA File Lic.No/Date:0910066395 Defer Date
:01/82/050/01095/AM19/ :09/24/040/00150/AM19/ 27.06.2018
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
Case No.:211/12/82- Party Name:HELLO PAINTS Meet No/Date:1/82- Status:
ALC4/2018 (P) LTD ALC4/2019 Deferred
03.06.2019
196 HQ File RLA File Lic.No/Date:0510406995 Defer Date
:01/82/050/00838/AM19/ :05/23/040/00136/AM19/ 28.06.2018
**Decision:**Application received from CLA, New Delhi. Deferred for comments of TE.
Case No.:213/12/82- Party Name:STRIDES Meet No/Date:1/82- Status:
ALC4/2018 SHASUN LIMITED ALC4/2019 Deferred
03.06.2019
197 HQ File RLA File Lic.No/Date:0410164455 Defer Date
:01/82/050/00840/AM19/ :04/24/040/00075/AM19/ 29.06.2018
**Decision:**Application received from RLA,Chennai. Deferred for comments of TE.
Case No.:214/12/82- Party Name:HPL ADDITIVES Meet No/Date:1/82- Status:
ALC4/2018 LIMITED(FORMERLY ALC4/2019 Deferred
KNOWN HIGH POLYMER 03.06.2019
198 HQ File RLA File Lic.No/Date:0510407023 Defer Date
:01/82/050/00841/AM19/ :05/23/040/00024/AM19/ 29.06.2018
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.
Case No.:221/12/82- Party Name:IOL CHEMICALS Meet No/Date:1/82- Status:
ALC4/2018 AND PHARMACEUTICALS ALC4/2019 Deferred
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:3010104375 Defer Date
:01/82/050/00848/AM19/ :30/24/040/00017/AM19/ 29.06.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 199 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Complete technical details as per Appendix 4E and (ii) Production Consumption data duly certified by CA.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

58

Case No.:260/13/82- Party Name:GLENMARK Meet No/Date:1/82- Status:
ALC4/2018 PHARMACEUTICALS LTD., ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310822054
:01/82/050/01238/AM19/ :03/94/040/00271/AM19/ 29.06.2018
Case No.:260/13/82-<br>ALC4/2018 Party Name:GLENMARK<br>PHARMACEUTICALS LTD., Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/01238/AM19/ RLA File<br>:03/94/040/00271/AM19/ Lic.No/Date:0310822054<br>29.06.2018
200 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.No.<br>Import items<br>Qty.<br>Hydrocortison Butyrate<br>Cream - Lipophilic 0.1%<br>45gm<br>( Net. wt. of Hydrocortisone<br>Butyarte Micronized USP is<br>11.2500 Kgs.)<br>250000.000<br>Packs<br>1<br>Hydrocortisone Butyarte<br>Micronized USP<br>20.655 kg<br>Hydrocortison Butyrate<br>Cream - Lipophilic 0.1%<br>60gm<br>( Net. wt. of Hydrocortisone<br>Butyarte Micronized USP is<br>9.000 Kgs.)<br>15000.000<br>Packs<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

Case No.:37/13/82- Party Meet No/Date:1/82- Status:
ALC4/2018 Name:SIDDHARTHCARBOCHEM ALC4/2019 Approved
PRODUCTS LTD. 03.06.2019
HQ File RLA File :03/95/040/00250/AM19/ Lic.No/Date:0310822057
:01/82/050/01015/AM19/ 02.07.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 13/82-ALC4/2018 dated 14.01 .2019, it was decided to ratify norms under Para 4.7 of HBP v1 201 as per details given below or as applied by the firm, whichever is less:

Export Product Qty. Sl.No. Import items Qty.
METHYL SALICYLATE<br>(MIN. 99%) (PHENOL<br>FREE) 1 kg 1. SALICYLIC<br>ACID 1.1715 kg
2 METHANOL Not allowed as firm has<br>procured domestically
202 <br>Case No.:298/13/82-<br>ALC4/2018 Party Name:GLENMARK<br>PHARMACEUTICALS LTD.,<br>RLA File<br>:03/94/040/00274/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:0310822084<br>02.07.2018 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01276/AM19/ Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.

59

Case No.:241/13/82- Party Name:CLARIANT Meet No/Date:1/82- Status:
ALC4/2018 CHEMICALS [INDIA] LTD. ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822143 Defer Date
:01/82/050/01219/AM19/ :03/94/040/00291/AM19/ 05.07.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 203 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019:

(i) Complete chemical reaction showing molecular weight ; and (ii) Percentage of yield on molar basis.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:63/12/82- Party Name:MERCK Meet No/Date:1/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310822153
:01/82/050/00690/AM19/ :03/95/040/00326/AM19/ 06.07.2018
Case No.:63/12/82-<br>ALC4/2018 Party Name:MERCK<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/00690/AM19/ RLA File<br>:03/95/040/00326/AM19/ Lic.No/Date:0310822153<br>06.07.2018
204 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Thiamine Disulfide<br>1 kg<br>1<br>Thiamine HCL<br>1.4199kg<br>2<br>Sodium Hydroxide Pellets<br>0.4605 kg<br>3<br>Potassium Hexacyanoferate III<br>GR<br>0.0022 kg<br>4<br>Hydrochloric Acid Fuming37%<br>0.3356 kg<br>5<br>Hydrogen Peroxide Solution 35%<br>extrapure<br>0.2157 kg<br>6<br>Acetone<br>0.6023 Litre<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

60

Case No.:174/12/82- Party Name:SHREE GANESH Meet No/Date:1/82- Status:
ALC4/2018 VYAPAR UDYOG ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310822156
:01/82/050/00801/AM19/ :03/95/040/00303/AM19/ 06.07.2018
Case No.:174/12/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/00801/AM19/ Party Name:SHREE GANESH<br>VYAPAR UDYOG Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
RLA File<br>:03/95/040/00303/AM19/ Lic.No/Date:0310822156<br>06.07.2018
205 <br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 13/82-ALC4/2018 dated 14.01.2019, it was decided to ratify norms under Para 4.7 of HBP v1<br>as per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl.No.<br>Import items<br>Qty.<br>REGENERATED METHYL<br>METHACRYLATE MONOMER<br>(CRUDE/BLACK).<br>NET CONTENT:1)ACRYLIC<br>STRIP/REGRIND/LUMPS<br>(ITC(HS) CODE 39031990,<br>39069090,39209999) :1,00,000.000<br>KILOGRAM<br>1 kg<br>1<br>ACRYLIC<br>STRIP/REGRIND/LUMPS/<br>(ITC(HS) CODE 39031990,<br>39069090,39209999).<br>1.10 kg<br>RA maytake appropriate action asper the decision of Norms Committee.

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 13/82-ALC4/2018 dated 14.01.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

206 <br>Case No.:249/13/82-<br>ALC4/2018 Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED<br>RLA File<br>:03/94/040/00298/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01227/AM19/ Lic.No/Date:0310822175<br>06.07.2018 Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
207 <br>Case No.:247/12/82-<br>ALC4/2018 Party Name:MOREPEN<br>LABORATORIES LTD.,<br>RLA File<br>:05/24/040/00203/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00874/AM19/ Lic.No/Date:0510407132<br>09.07.2018 Defer Date
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.
208 <br>Case No.:250/13/82-<br>ALC4/2018 Party Name:BDR<br>PHARMACEUTICALS<br>INTERNATIONAL PVT. LTD.<br>RLA File<br>:03/94/040/00285/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01228/AM19/ Lic.No/Date:0310822211<br>10.07.2018 Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.

61

Case No.:96/12/82-ALC4/2018 Party Name:STERLING Meet No/Date:1/82- Status:
AUXILIARIES PVT LTD ALC4/2019 Deferred
03.06.2019
209 HQ File RLA File Lic.No/Date:0310822247 Defer Date
:01/82/050/00723/AM19/ :03/95/040/00332/AM19/ 11.07.2018
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
Case No.:93/13/82-ALC4/2018 Party Name:PORUS Meet No/Date:1/82- Status:
LABORATORIES PVT LTD ALC4/2019 Deferred
03.06.2019
210 HQ File RLA File Lic.No/Date:0910066447 Defer Date
:01/82/050/01071/AM19/ :09/24/040/00172/AM19/ 12.07.2018
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
Case No.:311/13/82- Party Name:GULBRANDSEN Meet No/Date:1/82- Status:
ALC4/2018 CHEMICALS PVT LTD ALC4/2019 Deferred
03.06.2019
211 HQ File RLA File Lic.No/Date:3410044328 Defer Date
:01/82/050/01289/AM19/ :34/24/040/00139/AM19/ 12.07.2018
**Decision:**Application received from RLA,Vadodara. Deferred for comments of TE.
Case No.:91/13/82-ALC4/2018 Party Name:SUVEN LIFE Meet No/Date:1/82- Status:
SCIENCES LIMITED ALC4/2019 Deferred
03.06.2019
212 HQ File RLA File Lic.No/Date:0910066455 Defer Date
:01/82/050/01069/AM19/ :09/24/040/00177/AM19/ 13.07.2018
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
Case No.:98/13/82- Party Name:SUVEN LIFE Meet No/Date:1/82- Status:
ALC4/2018 SCIENCES LIMITED ALC4/2019 Deferred
03.06.2019
213 HQ File RLA File Lic.No/Date:0910066454 Defer Date
:01/82/050/01076/AM19/ :09/24/040/00176/AM19/ 13.07.2018
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
Case No.:100/13/82- Party Name:RA CHEM Meet No/Date:1/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2019 Deferred
03.06.2019
214 HQ File RLA File Lic.No/Date:0910066457 Defer Date
:01/82/050/01078/AM19/ :09/24/040/00188/AM19/ 13.07.2018
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.

62

Case No.:102/13/82- Party Name:SATYA Meet No/Date:1/82- Status:
ALC4/2018 DEEPTHA ALC4/2019 Deferred
PHARMACEUTICALS 03.06.2019
215 LIMITED
HQ File RLA File Lic.No/Date:0910066456 Defer Date
:01/82/050/01080/AM19/ :09/24/040/00184/AM19/ 13.07.2018
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
Case No.:237/10/82- Party Name:CLEAN SCIENCE Meet No/Date:1/82- Status:
ALC4/2018 AND TECHNOLOGY ALC4/2019 Deferred
PVT.LTD. 03.06.2019
216 HQ File RLA File Lic.No/Date:3110067115 Defer Date
:01/82/050/00524/AM19/ :31/83/040/00050/AM19/ 16.07.2018
**Decision:**Application received from RLA,Pune. Deferred for comments of TE.
Case No.:189/13/82- Party Name:YASH RASAYAN Meet No/Date:1/82- Status:
ALC4/2018 & CHEMICALS ALC4/2019 Deferred
03.06.2019
217 HQ File RLA File Lic.No/Date:3410044333 Defer Date
:01/82/050/01167/AM19/ :34/24/040/00114/AM19/ 16.07.2018
**Decision:**Application received from RLA,Vadodara. Deferred for comments of TE.
Case No.:297/13/82- Party Name:GLENMARK Meet No/Date:1/82- Status:
ALC4/2018 PHARMACEUTICALS LTD., ALC4/2019 Deferred
03.06.2019
218 HQ File RLA File Lic.No/Date:0310822322 Defer Date
:01/82/050/01275/AM19/ :03/94/040/00309/AM19/ 16.07.2018
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
Case No.:99/12/82- Party Name:YASHO Meet No/Date:1/82- Status:
ALC4/2018 INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
219 HQ File RLA File Lic.No/Date:0310822345 Defer Date
:01/82/050/00726/AM19/ :03/95/040/00349/AM19/ 17.07.2018
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
220 <br>Case No.:300/13/82-<br>ALC4/2018 Party Name:ATHENA DRUG<br>DELIVERY SOLUTIONS<br>PRIVATE LIMITED<br>RLA File<br>:03/94/040/00312/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date
<br>HQ File<br>:01/82/050/01278/AM19/ Lic.No/Date:0310822337<br>17.07.2018
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.

63

Case No.:87/13/82- Party Name:VIVIMED LIFE Meet No/Date:1/82- Status:
ALC4/2018 SCIENCES PRIVATE ALC4/2019 Deferred
LIMITED 03.06.2019
221 HQ File RLA File Lic.No/Date:0910066481 Defer Date
:01/82/050/01065/AM19/ :09/24/040/00148/AM19/ 19.07.2018
**Decision:**The firm has been requested to attend PH scheduled on 21.06.2019.
Case No.:255/12/82- Party Name:ESKAG PHARMA Meet No/Date:1/82- Status:
ALC4/2018 PRIVATE LIMITED, ALC4/2019 Deferred
03.06.2019
222 HQ File RLA File Lic.No/Date:0210208597 Defer Date
:01/82/050/00882/AM19/ :02/24/040/00064/AM19/ 20.07.2018
**Decision:**Application received from RLA,Kolkata. Deferred for comments of TE.
Case No.:263/13/82- Party Name:J.B. CHEMICALS Meet No/Date:1/82- Status:
ALC4/2018 & PHARMACEUTICALS ALC4/2019 Deferred
LIMITED 03.06.2019
223 HQ File RLA File Lic.No/Date:0310822486 Defer Date
:01/82/050/01241/AM19/ :03/94/040/00341/AM19/ 20.07.2018
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
Case No.:238/13/82- Party Name:CIPLA LIMITED. Meet No/Date:1/82- Status:
ALC4/2018 ALC4/2019 Deferred
03.06.2019
224 HQ File RLA File Lic.No/Date:0310822521 Defer Date
:01/82/050/01216/AM19/ :03/94/040/00330/AM19/ 23.07.2018
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
Case No.:248/13/82- Party Name:FDC LTD Meet No/Date:1/82- Status:
ALC4/2018 ALC4/2019 Deferred
03.06.2019
225 HQ File RLA File Lic.No/Date:0310822498 Defer Date
:01/82/050/01226/AM19/ :03/94/040/00323/AM19/ 23.07.2018
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
Case No.:78/12/82-ALC4/2018 Party Name:NAPROD LIFE Meet No/Date:1/82- Status:
SCIENCES PVT. LTD. ALC4/2019 Deferred
03.06.2019
226 HQ File RLA File Lic.No/Date:0310822552 Defer Date
:01/82/050/00705/AM19/ :03/95/040/00394/AM19/ 24.07.2018
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.

64

227 <br>Case No.:34/13/82-ALC4/2018Party Name:NITIKA<br>PHARMACEUTICAL<br>SPECIALITIES PVT. LTD.<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>HQ File<br>:01/82/050/01012/AM19/<br>RLA File<br>:50/24/040/00013/AM19/<br>Lic.No/Date:5010002462<br>24.07.2018<br>**Decision:**Application received from RLA,Nagpur. Deferred for comments of TE. Status:<br>Deferred<br>Defer Date
228 <br>Case No.:78/13/82-ALC4/2018Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>HQ File<br>:01/82/050/01056/AM19/<br>RLA File<br>:09/24/040/00205/AM19/<br>Lic.No/Date:0910066505<br>24.07.2018<br>**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE. Status:<br>Deferred<br>Defer Date
229 <br>Case No.:245/13/82-<br>ALC4/2018<br>Party Name:GLENMARK<br>PHARMACEUTICALS LTD<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>HQ File<br>:01/82/050/01223/AM19/<br>RLA File<br>:03/94/040/00361/AM19/<br>Lic.No/Date:0310822600<br>25.07.2018<br>**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE. Status:<br>Deferred<br>Defer Date
230 <br>Case No.:323/13/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/01301/AM19/ Party Name:ALEMBIC<br>PHARMACEUTICALS LTD<br>RLA File<br>:34/24/040/00140/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:3410044364<br>25.07.2018 Status:<br>Deferred<br> <br>Defer Date
**Decision:**Application received from RLA,Vadodara. Deferred for comments of TE.

65

Case No.:246/13/82- Party Name:GLENMARK Meet No/Date:1/82- Status:
ALC4/2018 PHARMACEUTICALS ALC4/2019 Approved
LTD., 03.06.2019
HQ File RLA File Lic.No/Date:0310822665
:01/82/050/01224/AM19/ :03/94/040/00380/AM19/ 27.07.2018
Case No.:246/13/82-<br>ALC4/2018 Party Name:GLENMARK<br>PHARMACEUTICALS<br>LTD., Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/01224/AM19/ RLA File<br>:03/94/040/00380/AM19/ Lic.No/Date:0310822665<br>27.07.2018
231 **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Sl. No.<br>Export Product<br>Qty.<br>1<br>FLUCORT N SKIN CREAM (Pack Size 15 gms) (<br>Net Wt.of FLUOCINOLONE ACETONIDE BP is<br>1.210 Kgs<br>.& NEOMYCIN SULPHATE BP is 24.200 Kgs)<br>322660.000 Packs<br>2<br>FLUCORT SKIN CREAM (Pack Size 15 gms)<br>( Net Wt.of FLUOCINOLONE ACETONIDE BP is<br>1.210 Kgs.)<br>322660.000 Packs<br>3<br>FLUCORT SKIN CREAM(Pack Size 10 gms)<br>( Net Wt.of FLUOCINOLONE ACETONIDE BP is<br>0.605 Kgs.)<br>242000.000 Packs<br>4<br>FLUCORT SKIN CREAM (Pack Size 5 gms) ( Net<br>Wt.of FLUOCINOLONE ACETONIDE BP is 1.210<br>Kgs.)<br>968000.000 Packs<br>5<br>FLUOCINOLONE CREAM (TDR) ET (Pack Size 10<br>gms) ( Net Wt.of FLUOCINOLONE ACETONIDE<br>BP is 0.242 Kgs.)<br>96800.000 Packs<br>6<br>CYNOZET CREAM 0.025% (Pack Size 5 gms) ( Net<br>Wt.of FLUOCINOLONE ACETONIDE BP is 0.242<br>Kgs.)<br>193600.000<br>7<br>CYNOZET CREAM 0.025%(Pack Size 15 gms) ( Net<br>Wt.of FLUOCINOLONE ACETONIDE BP is 0.242<br>Kgs.)<br>64532.000 Packs<br>8<br>SUPRICORT CREAM (Pack Size 5 gms) ( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.)<br>580800.000 Packs<br>9<br>SUPRICORT CREAM (Pack Size 15 gms) ( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.)<br>193596.000 Packs<br>10<br>SUPRICORT CREAM (Pack Size 250 gms) ( Net<br>Wt.of FLUOCINOLONE ACETONIDE BP is 0.242<br>Kgs.)<br>3872.000 Packs<br>11<br>SUPRICORT N CREAM (Pack Size 5 gms)<br>( Net Wt.of FLUOCINOLONE ACETONIDE BP is<br>0.242 Kgs.& NEOMYCIN SULPHATE BP is 4.840<br>Kgs)<br>193600.000 Packs<br>12<br>SUPRICORT N CREAM (USP) (Pack Size 15 gms) (<br>Net Wt.of FLUOCINOLONE ACETONIDE BP is<br>0.242 Kgs.<br>& NEOMYCIN SULPHATE BP is 4.840 Kgs)<br>64532.000 Packs

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

66

13<br>Flucort C Cream (Pack Size 15 gms) ( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.095 Kgs)<br>63332.000 Packs<br>14<br>FLUCORT C OINTMENT (Pack Size 15 gms) ( Net<br>Wt.of FLUOCINOLONE ACETONIDE BP is 0.605<br>Kgs.)<br>161330.000 Packs<br>15<br>GLENCORT GEL 5GM ( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.452 Kgs.)<br>361600.000 Packs<br>16<br>GLENCORT GEL 30GM ( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.484 Kgs.)<br>64535.000 Packs<br>17<br>FLUCORT MZ SKIN OINTMENT (Pack Size 15<br>gms) ( Net Wt.of FLUOCINOLONE ACETONIDE<br>BP is 0.145 Kgs.)<br>96798.000 Packs<br>Sl. No.<br>Import items<br>Qty.<br>1<br>FLUOCINOLONE ACETONIDE BP<br>9.0984 kg<br>2<br>NEOMYCIN SULPHATE BP<br>34.5576 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

67

Case No.:283/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822656 Defer Date
:01/82/050/01261/AM19/ :03/94/040/00198/AM19/ 27.07.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 232 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis

(ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:284/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822657 Defer Date
:01/82/050/01262/AM19/ :03/94/040/00197/AM19/ 27.07.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 233 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:285/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822659 Defer Date
:01/82/050/01263/AM19/ :03/94/040/00160/AM19/ 27.07.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 234 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

68

Case No.:286/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822660 Defer Date
:01/82/050/01264/AM19/ :03/94/040/00126/AM19/ 27.07.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 235 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:288/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822658 Defer Date
:01/82/050/01266/AM19/ :03/94/040/00193/AM19/ 27.07.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 236 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

237 <br>Case No.:324/13/82-<br>ALC4/2018 Party Name:GULBRANDSEN<br>CHEMICALS PVT LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01302/AM19/ RLA File<br>:34/24/040/00150/AM19/ Lic.No/Date:3410044367<br>27.07.2018 Defer Date
**Decision:**Application received from RLA,Vadodara. Deferred for comments of TE.

69

Case No.:240/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822704 Defer Date
:01/82/050/01218/AM19/ :03/94/040/00142/AM19/ 30.07.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 238 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:242/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822702 Defer Date
:01/82/050/01220/AM19/ :03/94/040/00109/AM19/ 30.07.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 239 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:243/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822700 Defer Date
:01/82/050/01221/AM19/ :03/94/040/00196/AM19/ 30.07.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 240 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

70

241 <br>Case No.:239/13/82-<br>ALC4/2018 Party Name:KEVA<br>FRAGRANCES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01217/AM19/ RLA File<br>:03/94/040/00390/AM19/ Lic.No/Date:0310822723<br>31.07.2018 Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
Case No.:271/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822732 Defer Date
:01/82/050/01249/AM19/ :03/94/040/00162/AM19/ 31.07.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 242 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:272/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822731 Defer Date
:01/82/050/01250/AM19/ :03/94/040/00192/AM19/ 31.07.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 243 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

71

Case No.:273/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822729 Defer Date
:01/82/050/01251/AM19/ :03/94/040/00141/AM19/ 31.07.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 244 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:282/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822734 Defer Date
:01/82/050/01260/AM19/ :03/94/040/00158/AM19/ 31.07.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 245 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

72

Case No.:221/13/82- Party Name:ASTRAL Meet No/Date:1/82- Status:
ALC4/2018 STERITECH PVT. LTD. ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:3410044381
:01/82/050/01199/AM19/ :34/24/040/00115/AM19/ 01.08.2018
Case No.:221/13/82-<br>ALC4/2018 Party Name:ASTRAL<br>STERITECH PVT. LTD. Party Name:ASTRAL<br>STERITECH PVT. LTD. Party Name:ASTRAL<br>STERITECH PVT. LTD. Party Name:ASTRAL<br>STERITECH PVT. LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/01199/AM19/ RLA File<br>:34/24/040/00115/AM19/ Lic.No/Date:3410044381<br>01.08.2018
246 **Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 10/AM19 dated 13.11.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per<br>details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>CEFTAZIDIME FOR<br>INJECTION USP 1000 mg, 10<br>ml<br>vail (Each vial contains sterile<br>ceftazidime pentahydrate USP eq<br>to ceftazidime 1000mg)<br>1 No.<br>1.<br>Ceftazidime for Injection<br>(mix with Sodium Carbonate)<br>1.281 gm<br>RA maytake appropriate action asper the decision of Norms Committee.
Qty. Sl.<br>No. Import items Qty.
1 No. 1. Ceftazidime for Injection<br>(mix with Sodium Carbonate) 1.281 gm
Norms Committee.
Case No.:19/12/82- Party Name:JODAS EXPOIM Meet No/Date:1/82- Status:
ALC4/2018 PVT.LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:051040742
:01/82/050/00646/AM19/ :05/23/040/00214/AM19/ 1
02.08.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

247

Export Product Qty. Sl.<br>No. Import items Qty.
Eptifibatide Injection 2mg/ml<br>(10ml fill)Export Product Net<br>Weight - 0.4133 Kilogram.<br>Import<br>&<br>Export<br>to<br>be<br>governed<br>as<br>per<br>Policy<br>Circular<br>no.<br>9<br>dated<br>30.06.2003 as amended 20661.000<br>Number 1 EPTIFIBATIDE<br>Relevant Bulk Drug. 1.7563 kg
Eptifibatide<br>Injection<br>75mg/100mL<br>(0.75mg/mL)<br>Export Product Net Weight -<br>1.240<br>Kilogram.<br>Import<br>&<br>Export<br>to<br>be<br>governed<br>as<br>per<br>Policy<br>Circular<br>no.<br>9<br>dated<br>30.06.2003 as amended 16529.000<br>Number

73

248 <br>Case No.:296/12/82-<br>ALC4/2018 Party Name:VERVE HUMAN<br>CARE LABORATORIES Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00923/AM19/ RLA File<br>:61/24/040/00004/AM19/ Lic.No/Date:6110001530<br>02.08.2018 Defer Date
**Decision:**Application received from RLA,Dehradun. Deferred for comments of TE.
249 <br>Case No.:265/13/82-<br>ALC4/2018 Party Name:ADISHANK<br>CHEMICALS PVT.LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01243/AM19/ RLA File<br>:03/94/040/00178/AM19/ Lic.No/Date:0310822825<br>02.08.2018 Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
Case No.:276/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822799 Defer Date
:01/82/050/01254/AM19/ :03/94/040/00392/AM19/ 02.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 250 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:277/13/82- Party Name:ARCH Meet No/Date:1/82- Status: Deferred
ALC4/2018 PHARMALABS LTD ALC4/2019
03.06.2019
HQ File RLA File Lic.No/Date:0310822798 Defer Date
:01/82/050/01255/AM19/ :03/94/040/00394/AM19/ 02.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 251 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

74

Case No.:278/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822797 Defer Date
:01/82/050/01256/AM19/ :03/94/040/00391/AM19/ 02.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 252 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:279/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822800 Defer Date
:01/82/050/01257/AM19/ :03/94/040/00393/AM19/ 02.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 253 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

75

Case No.:280/13/82- Party Name:GLENMARK Meet No/Date:1/82- Status:
ALC4/2018 PHARMACEUTICALS LTD., ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310822789
:01/82/050/01258/AM19/ :03/94/040/00368/AM19/ 02.08.2018
Case No.:280/13/82-<br>ALC4/2018 Party Name:GLENMARK<br>PHARMACEUTICALS LTD., Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/01258/AM19/ RLA File<br>:03/94/040/00368/AM19/ Lic.No/Date:0310822789<br>02.08.2018
254 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Omeprazole DR Capsules USP<br>10mg (Pack size 30 tabs) ( Net<br>wt. of SUGAR SPHERES<br>USP-NF(850-1000) is 144.000<br>Kgs)<br>120000.000<br>1<br>SUGAR SPHERES<br>USP-NF(850-1000<br>57907.20 kg<br>Omeprazole DR Capsules<br>USP 10mg (Pack size 100 tabs)<br>( Net wt. of SUGAR<br>SPHERES USP-NF(850-1000)<br>is 259.200 Kgs)<br>64800.000<br>Omeprazole DR Capsules<br>USP 20mg (Pack size 30 tabs)(<br>Net wt. of SUGAR SPHERES<br>USP-NF(850-1000) is 432.000<br>Kgs)<br>180000.000<br>Omeprazole DR Capsules USP<br>20mg (Pack size 100 tabs)( Net<br>wt. of SUGAR SPHERES<br>USP-NF(850-1000) is<br>1728.000 Kgs)<br>216000.000<br>Omeprazole DR Capsules USP<br>20mg (Pack size 1000 tabs)(<br>Net wt. of SUGAR SPHERES<br>USP-NF(850-1000) is<br>20664.000 Kgs)<br>258300.000<br>Omeprazole DR Capsules USP<br>40mg (Pack size 30 tabs)( Net<br>wt. of SUGAR SPHERES<br>USP-NF(850-1000) is 816.600<br>Kgs)<br>320000.000<br>Omeprazole DR Capsules USP<br>40mg (Pack size 90 tabs) ( Net<br>wt. of SUGAR SPHERES<br>USP-NF(850-1000) is<br>5712.010 Kgs)<br>746668.000

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

76

Omeprazole DR Capsules USP 192000.000 40mg (Pack size 100 tabs)( Net wt. of SUGAR SPHERES USP-NF(850-1000) is 1632.000 Kgs) Omeprazole DR Capsules 312000.000 USP 40mg (Pack size 1000 tabs) ( Net wt. of SUGAR SPHERES USP-NF(850-1000) is 26520.000 Kgs)

Case No.:281/13/82- Party Name:GLENMARK Meet No/Date:1/82- Status:
ALC4/2018 PHARMACEUTICALS ALC4/2019 Approved
LTD., 03.06.2019
HQ File RLA File Lic.No/Date:0310822791
:01/82/050/01259/AM19/ :03/94/040/00373/AM19/ 02.08.2018
Omeprazole DR Capsules USP<br>40mg (Pack size 100 tabs)( Net Omeprazole DR Capsules USP<br>40mg (Pack size 100 tabs)( Net Omeprazole DR Capsules USP<br>40mg (Pack size 100 tabs)( Net 192000.000 192000.000 192000.000 192000.000
<br>wt. of SUGAR SPHERES<br>USP-NF(850-1000) is<br>1632.000 Kgs)
Omeprazole DR Capsules<br> 312000.000
USP 40mg (Pack size 1000<br>tabs) ( Net wt. of SUGAR<br>SPHERES USP-NF(850-1000)<br>is 26520.000 Kgs)
RA dk fh
i dii f NC
concerne maytae urter necessary cton sper a ove ecson o .
<br>
Case No.:281/13/82-<br>ALC4/2018<br> <br> <br> arty Name:GLENMARK<br>PHARMACEUTICALS<br>LTD., Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/01259/AM19/<br> <br> RLA File<br>:03/94/040/00373/AM19/ L<br>0 ic.No/Date:0310822791<br>2.08.2018
nsidered the cases as per agenda a<br>.06.2018, it was decided to ratify<br>d b the firm whichever is less: ision taken in<br>BP v1 as per
**Decision:**The Committee co<br>meeting no. 03/AM19 dated 05<br>details given below or as applie nd in the light of earlier dec<br>norms under Para 4.7 of H
y ,
Sl. Export Product Qty. Import items Qty.
No.
1 Clobetasol Propionate Cream<br> 1 Number CLOBETASOL<br> 7.65 mg / 15 gm/pack
255 USP 0.05% (Pack Siz<br>(Net Weight of Clobe<br>Propionate USP (Mic<br>1.125 Kgs) e 15gm)<br>tasol<br>ronized) PR<br>US<br>(MI PIONATE<br>P<br>CRONIZED)
2 <br>Clobetasol Propionat<br>USP 0.05% (Pack siz e Cream<br>e 30gm) 1 Number CL<br>PR OBETASOL<br>OPIONATE 15.30 mg /<br>gm/pack 30
(Net Weight of Clobetasol<br>Propionate USP<br> USP<br>(MICRONIZED)
(Micronized)1.125 Kgs)
3 Clobetasol Propionate Cream<br>USP 0.05% (Pack size 45 gm)<br>(Net Weight of Clobetasol<br>Propionate USP (Micronized)<br>0.675 Kgs) 1 Number CLOBETASOL<br>PROPIONATE<br>USP<br>(MICRONIZED) 22.95 mg / 45<br>gm/pack
4 Clobetasol Propionate Cream<br>USP 0.05% (Pack size 60gm)<br>(Net Weight of Clobetasol<br>Propionate USP (Micronized)<br>2.250 Kgs) 1 Number CLOBETASOL<br>PROPIONATE<br>USP<br>(MICRONIZED) 30.60 mg / 60<br>gm/pack
5 Clobetasol Propionate Ointment<br>USP 0.05% (Pack size 15gm)<br>(Net Weight of Clobetasol<br>Propionate USP (Micronized)<br>0.225 Kgs) 1 Number CLOBETASOL<br>PROPIONATE<br>USP<br>(MICRONIZED) 7.65 mg / 15 gm/pack
6 Clobetasol Propionate Ointment<br>USP 0.05% (Pack size 30gm)<br>(Net Weight of Clobetasol<br>Propionate USP (Micronized)<br>1.125 Kgs) 1 Number CLOBETASOL<br>PROPIONATE<br>USP<br>(MICRONIZED) 15.30 mg / 30<br>gm/pack

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 03/AM19 dated 05.06.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

77

7<br>Clobetasol Propionate Ointment<br>USP 0.05% (Pack size 45gm)<br>(Net Weight of Clobetasol<br>Propionate USP (Micronized)<br>0.675 Kgs)<br>1 Number<br>CLOBETASOL<br>PROPIONATE<br>USP<br>(MICRONIZED)<br>22.95 mg / 45<br>gm/pack<br>8<br>Clobetasol Propionate Ointment<br>USP 0.05% (Pack size 60gm)<br>(Net Weight of Clobetasol<br>Propionate USP (Micronized)<br>2.250 Kgs)<br>1 Number<br>CLOBETASOL<br>PROPIONATE<br>USP<br>(MICRONIZED)<br>30.60 mg / 60<br>gm/pack<br>9<br>Clobetasol Propionate Spray<br>0.05% (Pack size 59ml)<br>(Net Weight of Clobetasol<br>Propionate USP (Micronized)<br>0.885 Kgs)<br>1 Number<br>CLOBETASOL<br>PROPIONATE<br>USP<br>(MICRONIZED)<br>30.09 mg/ 59 ml pack<br>10<br>Clobetasol Propionate Spray<br>0.05% (Pack size 125ml)<br>(Net Weight of Clobetasol<br>Propionate USP (Micronized)<br>4.688 Kgs)<br>1 Number<br>CLOBETASOL<br>PROPIONATE<br>USP<br>(MICRONIZED)<br>63.75 mg/ 125 ml<br>pack<br>11<br>Clobetasol Prop. Top Sol USP,<br>0.05% 25ml<br>(Net Weight of Clobetasol<br>Propionate USP (Micronized)<br>0.750 Kgs)<br>1 Number<br>CLOBETASOL<br>PROPIONATE<br>USP<br>(MICRONIZED)<br>12.75 mg/25 ml pack<br>12<br>Clobetasol Prop. Top Sol USP,<br>0.05% 50ml<br>(Net Weight of Clobetasol<br>Propionate USP (Micronized)<br>1.000 Kgs)<br>1 Number<br>CLOBETASOL<br>PROPIONATE<br>USP<br>(MICRONIZED)<br>25.50 mg / 50 ml pack<br>13<br>Clobetasol Pro Shampoo, 0.05 %<br>118ml<br>(Net Weight of Clobetasol<br>Propionate USP (Micronized)<br>2.360Kgs)<br>1 Number<br>CLOBETASOL<br>PROPIONATE<br>USP<br>(MICRONIZED)<br>60.18 mg / 118 ml<br>pack<br>RA maytake appropriate action asper the decision of Norms Committee.
256 <br>Case No.:77/13/82-ALC4/2018 <br>Case No.:77/13/82-ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01055/AM19/ RLA File<br>:09/24/040/00211/AM19/ Lic.No/Date:0910066546<br>03.08.2018 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
257 <br>Case No.:141/13/82-<br>ALC4/2018 Party Name:RELIANCE<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status: Deferred
<br>HQ File<br>:01/82/050/01119/AM19/ RLA File<br>:03/95/040/00342/AM19/ Lic.No/Date:0310822835<br>03.08.2018 <br>Defer Date
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.

78

258 <br>Case No.:266/13/82-<br>ALC4/2018 Party Name:DORF-KETAL<br>CHEMICALS INDIA<br>PVT.LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01244/AM19/ RLA File<br>:03/94/040/00399/AM19/ Lic.No/Date:0310822847<br>03.08.2018 Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
259 <br>Case No.:267/13/82-<br>ALC4/2018 Party Name:DORF-KETAL<br>CHEMICALS INDIA<br>PVT.LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01245/AM19/ RLA File<br>:03/94/040/00400/AM19/ Lic.No/Date:0310822848<br>03.08.2018 Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
260 <br>Case No.:25/13/82-ALC4/2018 Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01003/AM19/ RLA File<br>:05/24/040/00266/AM19/ Lic.No/Date:0510407451<br>06.08.2018 Defer Date
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.
261 <br>Case No.:293/13/82-<br>ALC4/2018 Party Name:BLISS GVS<br>PHARMA LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01271/AM19/ RLA File<br>:03/94/040/00416/AM19/ Lic.No/Date:0310822858<br>06.08.2018 Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
262 <br>Case No.:11/13/82-<br>ALC4/2018 Party Name:SRI<br>VYJAYANTHI LABS PVT<br>LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00989/AM19/ RLA File<br>:26/24/040/00007/AM19/ Lic.No/Date:2610012846<br>07.08.2018 <br>Defer Date
**Decision:**Application received from RLA. Deferred for comments of TE.

79

Case No.:289/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822880 Defer Date
:01/82/050/01267/AM19/ :03/94/040/00404/AM19/ 07.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 263 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:290/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822878 Defer Date
:01/82/050/01268/AM19/ :03/94/040/00401/AM19/ 07.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 264 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:291/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822882 Defer Date
:01/82/050/01269/AM19/ :03/94/040/00407/AM19/ 07.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 265 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

80

Case No.:292/13/82- Party Name:GLENMARK Meet No/Date:1/82- Status:
ALC4/2018 PHARMACEUTICALS LTD., ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310822872
:01/82/050/01270/AM19/ :03/94/040/00411/AM19/ 07.08.2018
Case No.:292/13/82-<br>ALC4/2018 Case No.:292/13/82-<br>ALC4/2018 Party Name:GLENMARK<br>PHARMACEUTICALS LTD., <br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 <br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/01270/AM19/ RLA File<br>:03/94/040/00411/AM19/ Lic.No/Date:0310822872<br>07.08.2018
266 Decision:The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 8/AM19 dated 31.08.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per<br>details given below or as applied by the firm, whichever is less:<br>Sl.<br>No.<br>Export Item<br>Norms for 1 No. Tablet of<br>import item<br>Norethindrone<br>Acetate<br>Ethinyl<br>Estradiol<br>1.<br>Norethindrone Acetate & Ethinyl Estradiol Tabs. 0.5 & 0.0025<br>mg<br>(Fem HRT) (Pack Size 84 Tabs.) ( Net Wt. of Norethindrone<br>Acetate is 7.350 Kgs.)<br>0.51 mg<br>0.00255 mg<br>2.<br>Norethindrone Acetate & Ethinyl Estradiol Tabs. 1mg & 0.005mg<br>(Fem HRT) (Pack Size 84 Tabs.)<br>(Net Wt. of Norethindrone Acetate is 12.600 Kgs.)<br>1.02 mg<br>0.0051 mg<br>3.<br>Norethindrone Acetate & Ethinyl Estradiol Tabs. 1 & 0.02 mg<br>(Loestrin 21 1/20) (Pack Size 63 Tabs.)<br>(Net Wt. of Norethindrone Acetate is9.450 Kgs.)<br>0.1.02 mg<br>0.0204 mg<br>4.<br>Norethindrone Acetate Tab. USP 5mg (NETA) (Pack Size 30<br>Tabs.)<br>(Net Wt. of Norethindrone Acetate is 0.375 Kgs.)<br>5.10 mg<br>Nil<br>5.<br>Norethindrone Acetate Tab. USP 5mg (NETA) (Pack Size 90<br>Tabs.)<br>(Net Wt. of Norethindrone Acetate is 1.125 Kgs.)<br>5.10 mg<br>Nil<br>6.<br>Norethindrone Acetate Tab. USP 5mg (Pack Size 50 Tabs.)<br>(Net Wt. of Norethindrone Acetate is 0.625 Kgs.)<br>5.10 mg<br>Nil<br>7.<br>Norethindrone Acetate & Ethinyl Estradiol Tabs. 1mg & 0.005mg<br>US (Fem HRT) (Pack Size 90 Tabs.)<br>(Net Wt. of Norethindrone Acetate is 0.225 Kgs.)<br>1.02 mg<br>0.0051 mg<br>Norethindrone Acetate&EE Tab 1.0/0.02mg<br>( Net Wt. ofNorethindrone Acetate is 1.575 Kgs.)<br>8.<br>Norethindrone Acetate&EE Tab 1.0/0.02mg<br>Nor ACE& EE Tabs & Fe Fumarate (21/7 Regimen) / Hailey FE<br>1/20(Net Wt. of Norethindrone Acetate is 0.945 Kgs.)<br>1.02 mg<br>0.0204 mg<br>9.<br>Minastrin24Fe<br>(Norethindrone Acetate and Ethinyl Estradiol Chewable Tablets,<br>1 mg/0.02 mg and Ferrous Fumarate Tablets USP, 75 mg) ( Net<br>Wt. of Norethindrone Acetate is 3.600 Kgs.)<br>1.02 mg<br>0.0204 mg<br>10.<br>Norethindrone/EE Tablets [21] (Loestrin (r) 1.5/30)<br>(Microgestin 21 1.5/30) (Pack Size 63 Tabs.) ( Net Wt. of<br>Norethindrone Acetate is 4.725 Kgs.)<br>1.53 mg<br>0.0306 mg<br>11<br>Norethindrone/EE/Fe Tablets [21/7] (Loestrin (r) Fe 1.5/30)<br>(Microgestin Fe) (Pack Size 84 Tabs.) ( Net Wt. of Norethindrone<br>Acetate is 4.725 Kgs.)<br>1.53 mg<br>0.0306 mg<br>12<br>Norethindrone Acetate EE & FE Fumarate (Loestrin 24FE) 28x3<br>(Pack Size 84 Tabs.) ( Net Wt. of Norethindrone Acetate is 3.600<br>Kgs.)<br>1.02 mg<br>0.0204 mg<br>RA maytake appropriate action asper the decision of Norms Committee.
Sl.<br>No. Export Item Norms for 1 No. Tablet of<br>import item
Norethindrone<br>Acetate Ethinyl<br>Estradiol
1. Norethindrone Acetate & Ethinyl Estradiol Tabs. 0.5 & 0.0025<br>mg<br>(Fem HRT) (Pack Size 84 Tabs.) ( Net Wt. of Norethindrone<br>Acetate is 7.350 Kgs.) 0.51 mg 0.00255 mg
2. Norethindrone Acetate & Ethinyl Estradiol Tabs. 1mg & 0.005mg<br>(Fem HRT) (Pack Size 84 Tabs.)<br>(Net Wt. of Norethindrone Acetate is 12.600 Kgs.) 1.02 mg 0.0051 mg
3. Norethindrone Acetate & Ethinyl Estradiol Tabs. 1 & 0.02 mg<br>(Loestrin 21 1/20) (Pack Size 63 Tabs.)<br>(Net Wt. of Norethindrone Acetate is9.450 Kgs.) 0.1.02 mg 0.0204 mg
4. Norethindrone Acetate Tab. USP 5mg (NETA) (Pack Size 30<br>Tabs.)<br>(Net Wt. of Norethindrone Acetate is 0.375 Kgs.) 5.10 mg Nil
5. Norethindrone Acetate Tab. USP 5mg (NETA) (Pack Size 90<br>Tabs.)<br>(Net Wt. of Norethindrone Acetate is 1.125 Kgs.) 5.10 mg Nil
6. Norethindrone Acetate Tab. USP 5mg (Pack Size 50 Tabs.)<br>(Net Wt. of Norethindrone Acetate is 0.625 Kgs.) 5.10 mg Nil
7. Norethindrone Acetate & Ethinyl Estradiol Tabs. 1mg & 0.005mg<br>US (Fem HRT) (Pack Size 90 Tabs.)<br>(Net Wt. of Norethindrone Acetate is 0.225 Kgs.) 1.02 mg 0.0051 mg
Norethindrone Acetate&EE Tab 1.0/0.02mg<br>( Net Wt. ofNorethindrone Acetate is 1.575 Kgs.)
8. Norethindrone Acetate&EE Tab 1.0/0.02mg<br>Nor ACE& EE Tabs & Fe Fumarate (21/7 Regimen) / Hailey FE<br>1/20(Net Wt. of Norethindrone Acetate is 0.945 Kgs.) 1.02 mg 0.0204 mg
9. Minastrin24Fe<br>(Norethindrone Acetate and Ethinyl Estradiol Chewable Tablets,<br>1 mg/0.02 mg and Ferrous Fumarate Tablets USP, 75 mg) ( Net<br>Wt. of Norethindrone Acetate is 3.600 Kgs.) 1.02 mg 0.0204 mg
10. Norethindrone/EE Tablets [21] (Loestrin (r) 1.5/30)<br>(Microgestin 21 1.5/30) (Pack Size 63 Tabs.) ( Net Wt. of<br>Norethindrone Acetate is 4.725 Kgs.) 1.53 mg 0.0306 mg
11 Norethindrone/EE/Fe Tablets [21/7] (Loestrin (r) Fe 1.5/30)<br>(Microgestin Fe) (Pack Size 84 Tabs.) ( Net Wt. of Norethindrone<br>Acetate is 4.725 Kgs.) 1.53 mg 0.0306 mg
12 Norethindrone Acetate EE & FE Fumarate (Loestrin 24FE) 28x3<br>(Pack Size 84 Tabs.) ( Net Wt. of Norethindrone Acetate is 3.600<br>Kgs.) 1.02 mg 0.0204 mg
RA maytake appropriate action asper the decision of Norms Committee.

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 8/AM19 dated 31.08.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

81

Case No.:295/13/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/01273/AM19/ Party Name:ARCH<br>PHARMALABS LTD<br>RLA File<br>:03/94/040/00402/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:0310822879<br>07.08.2018 Status:<br>Deferred<br>Defer Date

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 267 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:296/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822877 Defer Date
:01/82/050/01274/AM19/ :03/94/040/00101/AM19/ 07.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 268 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

82

Case No.:301/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310822876 Defer Date
:01/82/050/01279/AM19/ :03/94/040/00106/AM19/ 07.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 269 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

270 <br>Case No.:172/13/82-<br>ALC4/2018 Party Name:TIDE<br>INDUSTRIES Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01150/AM19/ RLA File<br>:34/24/040/00094/AM19/ Lic.No/Date:3410044399<br>08.08.2018 Defer Date
**Decision:**Application received from RLA,Vadodara. Deferred for comments of TE.
Case No.:294/13/82- Party Name:KRISHNA Meet No/Date:1/82- Status:
ALC4/2018 ANTIOXIDANTS PVT. LTD. ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310822933
:01/82/050/01272/AM19/ :03/94/040/00364/AM19/ 08.08.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 14/82-ALC4/2018 dated 14.02.2019, it was decided to ratify norms under Para 4.7 of HBP v1 271 as per details given below or as applied by the firm, whichever is less:

Export product Qty. Sl.<br>No. Import items Qty.
TRI ISODECYL<br>PHOSPHITE 1 kg 1 YELLOW PHOSPHORUS 0.065 kg
2 PHENOL 0.090 kg
3 ISODECYL ALCOHOL 0.973 kg

83

272 <br>Case No.:134/13/82-<br>ALC4/2018 Party Name:YASHO<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01112/AM19/ RLA File<br>:03/95/040/00445/AM19/ Lic.No/Date:0310822942<br>09.08.2018 Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
Case No.:173/13/82- Party Name:SHIVA Meet No/Date:1/82- Status:
ALC4/2018 PHARMACHEM LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:3410044409
:01/82/050/01151/AM19/ :34/24/040/00147/AM19/ 09.08.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 282-ALC4/2018 dated 16.05.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as 273 per details given below or as applied by the firm, whichever is less:

Export Product Qty. Sl.No. Import items Qty.
2-ETHYL HEXANOYL<br>CHLORIDE kg 1 2-ETHYL<br>HEXANOICACID 0.952 kg
274 <br>Case No.:234/13/82-<br>ALC4/2018 Party Name:LASENOR INDIA<br>PRIVATE LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01212/AM19/ RLA File<br>:50/24/040/00015/AM19/ Lic.No/Date:5010002465<br>09.08.2018 Defer Date
**Decision:**Application received from RLA,Nagpur. Deferred for comments of TE.
275 <br>Case No.:133/13/82-<br>ALC4/2018 Party Name:RUBICON<br>RESEARCH PVT. LTD., Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01111/AM19/ RLA File<br>:03/95/040/00417/AM19/ Lic.No/Date:0310822983<br>10.08.2018 Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.

84

Case No.:146/13/82- Party Name:SIDDHARTH Meet No/Date:1/82- Status:
ALC4/2018 CARBOCHEM PRODUCTS ALC4/2019 Approved
LTD. 03.06.2019
HQ File RLA File Lic.No/Date:0310823016
:01/82/050/01124/AM19/ :03/95/040/00462/AM19/ 13.08.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 13/82-ALC4/2018 dated 14.01.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

276

Export Product Qty. Sl.No. Import items Qty.
METHYL SALICYLATE 1 kg 1. SALICYLIC ACID 1.1715 kg
(MIN. 99%) (PHENOL
FREE) 2 METHANOL Not allowed as firm
has procured
domestically
277 Case No.:305/13/82-<br>ALC4/2018<br> <br> <br> Party Name:J.B.<br>CHEMICALS &<br>PHARMACEUTICALS<br>LIMITED M<br>A<br> eet No/Date:1/82-<br>LC4/2019<br> Sta<br>De tus:<br>ferred
<br> <br> <br> <br> 03 .06.2019
<br>
HQ File<br>:01/82/050/01283/AM19/<br> <br>: RLA File<br>03/94/040/00418/AM19/ Lic.No/Date:0310823011<br>13.08.2018 <br>Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
Case No.:128/13/82- Party Name:SUNSHIELD Meet No/Date:1/82- Status:
ALC4/2018 CHEMICALS LTD. ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310823049
:01/82/050/01106/AM19/ :03/95/040/00473/AM19/ 14.08.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 8/82-ALC4/2014 dated 25.09.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as 278 per details given below or as applied by the firm, whichever is less:

Export product Qty. Sl.No. Import items Qty.
SUN HQEE 1 kg 1 Hydroquinone 0.625 kg
(Hydroquinone 2 Ethylene Oxide 0.494 kg
Ethoxylate)

85

Case No.:306/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310823058 Defer Date
:01/82/050/01284/AM19/ :03/94/040/00446/AM19/ 14.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 279 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:307/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310823050 Defer Date
:01/82/050/01285/AM19/ :03/94/040/00439/AM19/ 14.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 280 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:380/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310823052 Defer Date
:01/82/050/01358/AM19/ :03/94/040/00440/AM19/ 14.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 281 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

282 Case No.:381/13/82-

Status:

Party Name:ARCH

Meet No/Date:1/82-

86

ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310823037 Defer Date
:01/82/050/01359/AM19/ :03/94/040/00431/AM19/ 14.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:383/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310823055 Defer Date
:01/82/050/01361/AM19/ :03/94/040/00444/AM19/ 14.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 283 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:401/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310823046 Defer Date
:01/82/050/01379/AM19/ :03/94/040/00438/AM19/ 14.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 284 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

87

Case No.:402/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310823044 Defer Date
:01/82/050/01380/AM19/ :03/94/040/00436/AM19/ 14.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 285 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:403/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310823045 Defer Date
:01/82/050/01381/AM19/ :03/94/040/00437/AM19/ 14.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 286 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:409/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310823062 Defer Date
:01/82/050/01387/AM19/ :03/94/040/00445/AM19/ 14.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 287 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

88

Case No.:410/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310823066 Defer Date
:01/82/050/01388/AM19/ :03/94/040/00443/AM19/ 14.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 288 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:411/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310823060 Defer Date
:01/82/050/01389/AM19/ :03/94/040/00442/AM19/ 14.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 289 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:413/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310823048 Defer Date
:01/82/050/01391/AM19/ :03/94/040/00441/AM19/ 14.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 290 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

89

Case No.:89/13/82-ALC4/2018 Party Name:SUVEN LIFE Meet No/Date:1/82- Status:
SCIENCES LIMITED ALC4/2019 Deferred
03.06.2019
291 HQ File RLA File Lic.No/Date:0910066569 Defer Date
:01/82/050/01067/AM19/ :09/24/040/00227/AM19/ 16.08.2018
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
Case No.:198/13/82- Party Name:NATURAL AND Meet No/Date:1/82- Status:
ALC4/2018 ESSENTIAL OILS PVT LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:071011372
:01/82/050/01176/AM19/ :07/24/040/00128/AM19/ 6
17.08.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it 292 was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

Export Product Qty. Sl.No. Import items Qty.
CAFFEINE 10020 kg 1 Crude Caffeine 17600 kg
COFFEE EXTRACTS 6150 kg (decaffeination from green
coffee)Purity53.69%
Case No.:151/13/82- Party Name:STERLING Meet No/Date:1/82- Status:
ALC4/2018 AUXILIARIES PVT LTD ALC4/2019 Deferred
03.06.2019
293 HQ File RLA File Lic.No/Date:0310823127 Defer Date
:01/82/050/01129/AM19/ :03/95/040/00489/AM19/ 20.08.2018
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
Case No.:326/13/82- Party Name:BALAJI AMINES Meet No/Date:1/82- Status:
ALC4/2018 LIMITED ALC4/2019 Deferred
03.06.2019
294 HQ File RLA File Lic.No/Date:3110067147 Defer Date
:01/82/050/01304/AM19/ :31/83/040/00082/AM19/ 20.08.2018
**Decision:**Application received from RLA,Pune. Deferred for comments of TE.

90

Case No.:370/13/82- Party Name:GLENMARK Meet No/Date:1/82- Status:
ALC4/2018 PHARMACEUTICALS LTD., ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310823140
:01/82/050/01348/AM19/ :03/94/040/00448/AM19/ 20.08.2018
Case No.:370/13/82-<br>ALC4/2018 Party Name:GLENMARK<br>PHARMACEUTICALS LTD., <br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:0310823140<br>20.08.2018 Status:<br>Approved<br>
HQ File<br>:01/82/050/01348/AM19/ RLA File<br>:03/94/040/00448/AM19/
295 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.No.<br>Import items<br>Qty.<br>Drospirenone and Ethinyl<br>Estradiol Tablets<br>(YASMIN)<br>3 mg / 0.03 mg (Pack 3 x<br>28s) (Net wt of<br>Drospirenone is 47.250<br>Kgs)<br>250000.000<br>Packs<br>1<br>Drospirenone<br>101.0718 kg<br>Drospirenone and Ethinyl<br>Estradiol Tablets (YAZ) (<br>Pack 3 x 28s) 3 mg / 0.02<br>mg<br>(Net wt of Drospirenone is<br>51.840Kgs)<br>240000.000<br>Packs<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

Case No.:130/13/82- Party Name:PRO-LIFE BIO- Meet No/Date:1/82- Status:
ALC4/2018 CHEMICAL INDUSTRIES ALC4/2019 Approved
(P)LTD. 03.06.2019
HQ File RLA File Lic.No/Date:0310823271
:01/82/050/01108/AM19/ :03/95/040/00470/AM19/ 24.08.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it 296 was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

Export Product Qty. Sl.No. Import items Qty.<br>1.234 kg
1-METHYLAMINO-4-BROMO<br>ANTHRAQUINONE 1 kg 1 1-<br>NITROANTHRAQUINONE
297 <br>Case No.:142/13/82-<br>ALC4/2018 Party Name:PALADIN<br>PAINTS AND CHEMICALS<br>PVT. LTD.,<br>RLA File<br>:03/95/040/00456/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01120/AM19/ Lic.No/Date:0310823254<br>24.08.2018 Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.

91

Case No.:149/13/82- Party Name:RELIANCE Meet No/Date:1/82- Status:
ALC4/2018 INDUSTRIES LTD. ALC4/2019 Deferred
03.06.2019
298 HQ File RLA File Lic.No/Date:0310823249 Defer Date
:01/82/050/01127/AM19/ :03/95/040/00423/AM19/ 24.08.2018
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
Case No.:209/13/82- Party Name:DEEPAK Meet No/Date:1/82- Status:
ALC4/2018 NOVOCHEM ALC4/2019 Deferred
TECHNOLOGIES LTD 03.06.2019
299 HQ File RLA File Lic.No/Date:3110067162 Defer Date
:01/82/050/01187/AM19/ :31/83/040/00081/AM19/ 24.08.2018
**Decision:**Application received from RLA,Pune. Deferred for comments of TE.
Case No.:86/13/82-ALC4/2018 Party Name:RAKSHIT Meet No/Date:1/82- Status:
PHARMACEUTICALS LTD ALC4/2019 Deferred
03.06.2019
300 HQ File RLA File Lic.No/Date:0910066593 Defer Date
:01/82/050/01064/AM19/ :09/24/040/00239/AM19/ 27.08.2018
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
Case No.:150/13/82- Party Name:STERLING Party Name:STERLING Party Name:STERLING Meet No/Date:1/82- Meet No/Date:1/82- Meet No/Date:1/82- Status: Status: Status:
ALC4/2018 AUXILIARIES PVT LTD ALC4/2019 Deferred
03.06.2019
301 HQ File RLA File Lic.No/Date:0310823301 Defer Date
:01/82/050/01128/AM19/ :03/95/040/00413/AM19/ 27.08.2018
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
Case No.:164/13/82- Party Name:SARNA Meet No/Date:1/82- Status:
ALC4/2018 CHEMICALS PVT LTD ALC4/2019 Deferred
03.06.2019
302 HQ File RLA File Lic.No/Date:5210042742 Defer Date
:01/82/050/01142/AM19/ :52/24/040/00044/AM19/ 27.08.2018
**Decision:**Application received from RLA,Surat. Deferred for comments of TE.

92

Case No.:165/13/82- Party Name:SARNA Meet No/Date:1/82- Status:
ALC4/2018 CHEMICALS PVT LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:5210042743
:01/82/050/01143/AM19/ :52/24/040/00046/AM19/ 27.08.2018
Case No.:165/13/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/01143/AM19/ Party Name:SARNA<br>CHEMICALS PVT LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:5210042743<br>27.08.2018 Status:<br>Approved<br>
RLA File<br>:52/24/040/00046/AM19/
303 **Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 10/82-ALC4/2018 dated 16.10.2018, it was decided to ratify norms under Para 4.7 of HBP v1<br>as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>2-HYDROXY 4-<br>METHOXY<br>BENZALDEHYDE /<br>MOSAL / DCPC / SR 119<br>1 kg<br>1<br>RESORCINOL<br>1.83 kg<br>2<br>ETHYLENE DICHLORIDE<br>0.972 kg<br>3<br>DIMETHYL FORMAMIDE<br>1.378 kg<br>4<br>ACETONE<br>1.000 kg<br>5<br>POTASSIUM CARBONATE<br>0.972 kg<br>RA maytake appropriate action asper the decision of Norms Committee.

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 10/82-ALC4/2018 dated 16.10.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

304 Case No.:148/13/82-<br>ALC4/2018<br> <br>I<br>HQ File<br>:01/82/050/01126/AM19/<br> <br>: Party Name:RELIANCE<br>NDUSTRIES LTD.<br>RLA File<br>03/95/040/00406/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br> <br><br>Lic.No/Date:0310823341<br>28.08.2018<br> Status:<br>Deferred
Defer Date
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
305 Case No.:368/13/82-<br>ALC4/2018 Party Name:DANOPHARM<br>CHEMICALS PRIVATE LTD.<br>RLA File<br>:03/94/040/00340/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
HQ File<br>:01/82/050/01346/AM19/ Lic.No/Date:0310823354<br>28.08.2018 Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
306 Case No.:369/13/82-<br>ALC4/2018 Party Name:DANOPHARM<br>CHEMICALS PRIVATE LTD.<br>RLA File<br>:03/94/040/00413/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
HQ File<br>:01/82/050/01347/AM19/ Lic.No/Date:0310823358<br>28.08.2018 Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.

93

Case No.:436/13/82- Party Name:MAHIMA LIFE Meet No/Date:1/82- Status:
ALC4/2018 SCIENCES PVT.LTD. ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0510407628
:01/82/050/01414/AM19/ :05/24/040/00307/AM19/ 28.08.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 14/82-ALC4/2014 dated 14.02.2019, it was decided to ratify norms under Para 4.7 of HBP v1 307 as per details given below or as applied by the firm, whichever is less:

Export product<br>TRIAMCINOLONE<br>ACETONIDE MICRONISED Qty.<br>99 kg Sl.<br>No.<br>1 Import items<br>TRIAMCINOLONE ACETONIDE Qty.<br>99 kg
308 <br>Case No.:85/13/82-ALC4/2018Party Name:S V LABS PVT<br>LTD<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>HQ File<br>:01/82/050/01063/AM19/<br>RLA File<br>:09/24/040/00246/AM19/<br>Lic.No/Date:0910066602<br>29.08.2018<br>**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE. Status:<br>Deferred<br>Defer Date
309 <br>Case No.:147/13/82-<br>ALC4/2018 Party Name:NAPROD LIFE<br>SCIENCES PVT. LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01125/AM19/ RLA File<br>:03/95/040/00537/AM19/ Lic.No/Date:0310823401<br>29.08.2018 Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
310 <br>Case No.:84/13/82-ALC4/2018 Party Name:SRINI<br>PHARMACEUTICALS<br>PRIVATE LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01062/AM19/ RLA File<br>:09/24/040/00251/AM19/ Lic.No/Date:0910066620<br>03.09.2018 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.

94

Case No.:88/13/82-ALC4/2018 Party Name:SATYADEVA Meet No/Date:1/82- Status:
PHARMACEUTICALS PVT ALC4/2019 Deferred
LTD 03.06.2019
311 HQ File RLA File Lic.No/Date:0910066623 Defer Date
:01/82/050/01066/AM19/ :09/24/040/00247/AM19/ 03.09.2018
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
Case No.:230/13/82- Party Name:KAIRAV Meet No/Date:1/82- Status:
ALC4/2018 CHEMOFARBE INDUSTRIES ALC4/2019 Deferred
LTD. 03.06.2019
312 HQ File RLA File Lic.No/Date:0310823513 Defer Date
:01/82/050/01208/AM19/ :03/94/040/00403/AM19/ 04.09.2018
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
313 Case No.:138/13/82-<br>ALC4/2018 P<br>I arty Name:RELIANCE<br>NDUSTRIES LTD. Me<br>AL<br>03.0 et No/Date:1/82-<br>C4/2019 Statu s: Deferred
6.2019
<br>HQ File R LA File Lic. No/Date:0310823558 <br>Defe r Date
:01/82/050/01116/AM19/ :0 3/95/040/00515/AM19/ 05.09.2018
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
Case No.:435/13/82- Party Name:DCM SHRIRAM Meet No/Date:1/82- Status:
ALC4/2018 INDUSTRIES LTD, ALC4/2019 Deferred
03.06.2019
314 HQ File RLA File Lic.No/Date:0510407689 Defer Date
:01/82/050/01413/AM19/ :05/23/040/00242/AM19/ 05.09.2018
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.
Case No.:227/13/82- Party Name:GLENMARK Meet No/Date:1/82- Status:
ALC4/2018 PHARMACEUTICALS LTD., ALC4/2019 Deferred
03.06.2019
315 HQ File RLA File Lic.No/Date:0310823648 Defer Date
:01/82/050/01205/AM19/ :03/94/040/00518/AM19/ 07.09.2018
**Decision:**Application received from RLA,Pune. Deferred for comments of TE.
Case No.:429/13/82- Party Name:CADILA Meet No/Date:1/82- Status:
ALC4/2018 HEALTHCARE LTD ALC4/2019 Deferred
03.06.2019
316 HQ File RLA File Lic.No/Date:0810143413 Defer Date
:01/82/050/01407/AM19/ :08/24/040/00131/AM19/ 07.09.2018
**Decision:**Application received from RLA,Ahmedabad. Deferred for comments of TE.

95

317 <br>Case No.:94/13/82-<br>ALC4/2018 Party Name:VIVIMED LABS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01072/AM19/ RLA File<br>:09/24/040/00273/AM19/ Lic.No/Date:0910066645<br>10.09.2018 <br>Defer Date
**Decision:**The firm has been requested to attend PH scheduled on 21.06.2019.
318 <br>Case No.:108/13/82-<br>ALC4/2018 Party Name:SHREE BANKEY<br>BEHARI LAL FLAVORS Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01086/AM19/ RLA File<br>:05/24/040/00324/AM19/ Lic.No/Date:0510407757<br>12.09.2018 Defer Date
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.
319 <br>Case No.:180/13/82-<br>ALC4/2018 Party Name:SARNA<br>CHEMICALS PVT LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01158/AM19/ RLA File<br>:52/24/040/00050/AM19/ Lic.No/Date:5210042764<br>14.09.2018 <br>Defer Date
**Decision:**Application received from RLA,Surat. Deferred for comments of TE.
Case No.:395/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310823783 Defer Date
:01/82/050/01373/AM19/ :03/94/040/00435/AM19/ 17.09.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 320 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

321 <br>Case No.:400/13/82-<br>ALC4/2018 Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01378/AM19/ RLA File<br>:03/94/040/00504/AM19/ Lic.No/Date:0310823779<br>17.09.2018 Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.

96

Case No.:399/13/82- Party Name:AARTI DRUGS Meet No/Date:1/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310823810
:01/82/050/01377/AM19/ :03/94/040/00506/AM19/ 18.09.2018
Case No.:399/13/82-<br>ALC4/2018 Party Name:AARTI DRUGS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/01377/AM19/ RLA File<br>:03/94/040/00506/AM19/ Lic.No/Date:0310823810<br>18.09.2018
322 **Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 10/82-ALC4/2014 dated 16.10.2018, it was decided to ratify norms under Para 4.7 of HBP v1<br>as per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.<br>Norfloxacin<br>1 kg<br>1.<br>2,4 Dichloro-5-Fluoro<br>Acetophenone(DCFA)<br>0.877<br>2.<br>Dimethyl Carbonate<br>0.789<br>3.<br>Sodium Hydride<br>0.289<br>4.<br>Toluene<br>0.800<br>5.<br>Acetic Acid<br>0.289<br>6.<br>Dimethyl Sulphate<br>0.670<br>7<br>Dimethyl Formamide<br>0.385<br>8<br>Mono Ethyl Amine (70%)<br>0.439<br>9<br>Caustic Flakes<br>0.410<br>10<br>Sulfuric Acid<br>Not importable<br>item<br>11<br>Methanol<br>0.150<br>RA maytake appropriate action asper the decision of Norms Committee.

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 10/82-ALC4/2014 dated 16.10.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

323 Case No.:176/13/82-<br>ALC4/2018 Party Name:VOVANTIS<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
HQ File<br>:01/82/050/01154/AM19/ RLA File<br>:34/24/040/00145/AM19/ Lic.No/Date:3410044518<br>26.09.2018 <br>Defer Date
**Decision:**Application received from RLA,Vadodara. Deferred for comments of TE.
324 Case No.:213/13/82-<br>ALC4/2018 Party Name:DEEPAK<br>NOVOCHEM<br>TECHNOLOGIES LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
HQ File<br>:01/82/050/01191/AM19/ RLA File<br>:31/83/040/00094/AM19/ Lic.No/Date:3110067177<br>26.09.2018 <br>Defer Date
**Decision:**Application received from RLA,Pune. Deferred for comments of TE.

97

325 <br>Case No.:365/13/82-<br>ALC4/2018 Party Name:ELPPE<br>CHEMICALS PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01343/AM19/ RLA File<br>:03/94/040/00551/AM19/ Lic.No/Date:0310823993<br>26.09.2018 Defer Date
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
326 Case No.:439/13/82-<br>ALC4/2018 Party Name:JUBILANT<br>GENERICS LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01417/AM19/ RLA File<br>:05/23/040/00272/AM19/ Lic.No/Date:0510407887<br>26.09.2018 Defer Date
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from CLA,New Delhi.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.

Case No.:57/13/82-ALC4/2018 Party Name:RECKITT Meet No/Date:1/82- Status:
BENCKISER HEALTHCARE ALC4/2019 Approved
INDIA PRIVATE LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0510407915
:01/82/050/01035/AM19/ :05/24/040/00359/AM19/ 27.09.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 14/82-ALC4/2018 dated 14.02.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

327

Export product Qty. Sl.<br>No. Import items
Cepacol Extra<br>Strength Lozenges<br>Cherry (2350 MG<br>PER TABLET) 1 Number<br>tablet<br>(Lozenges) 1 Isomalt ST-M
2 Lycasin 80/55 (Maltitol)
3 D&C red no. 33
4 FD&C Red no. 40
5 Benzocaine USP
6 Wild Cherry Flavour TAK
7 Cherry Bark FL NAT
8 Intensate Cool Flavour<br>TAK052848
328 <br>Case No.:447/13/82-<br>ALC4/2018 Party Name:AETHER<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01425/AM19/ RLA File<br>:52/24/040/00031/AM19/ Lic.No/Date:5210042774<br>27.09.2018 Defer Date
**Decision:**Application received from RLA,Surat. Deferred for comments of TE.

98

329 <br>Case No.:450/13/82-<br>ALC4/2018 Party Name:AETHER<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01428/AM19/ RLA File<br>:52/24/040/00048/AM19/ Lic.No/Date:5210042776<br>27.09.2018 Defer Date
**Decision:**Application received from RLA,Surat. Deferred for comments of TE.
Case No.:394/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824073 Defer Date
:01/82/050/01372/AM19/ :03/94/040/00571/AM19/ 28.09.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 330 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:404/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824071 Defer Date
:01/82/050/01382/AM19/ :03/94/040/00564/AM19/ 28.09.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 331 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

99

Case No.:405/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824072 Defer Date
:01/82/050/01383/AM19/ :03/94/040/00568/AM19/ 28.09.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 332 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:406/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824068 Defer Date
:01/82/050/01384/AM19/ :03/94/040/00569/AM19/ 28.09.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 333 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

334 Case No.:407/13/82-<br>ALC4/2018 Party Name:ARCH<br>PHARMALABS LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
HQ File<br>:01/82/050/01385/AM19/ RLA File<br>:03/94/040/00567/AM19/ Lic.No/Date:0310824070<br>28.09.2018 Defer Date
<br>**Decision:**The Committee considered the case as per online agenda in the presence of technical experts<br>and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its<br>Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:<br>(i)<br>Stepwise complete and balanced chemical reaction showing<br>Molecular weight and Percentage of yield on molar basis<br>(ii)<br>Reaction and Recovery of solvent at each stage<br>(iii)<br>Material of balance for the entire process.<br>In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which<br>the case will be rejected.

100

Case No.:414/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824069 Defer Date
:01/82/050/01392/AM19/ :03/94/040/00565/AM19/ 28.09.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 335 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:328/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824112 Defer Date
:01/82/050/01306/AM19/ :03/94/040/00574/AM19/ 01.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 336 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:329/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824092 Defer Date
:01/82/050/01307/AM19/ :03/94/040/00587/AM19/ 01.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 337 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

101

Case No.:330/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824113 Defer Date
:01/82/050/01308/AM19/ :03/94/040/00581/AM19/ 01.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 338 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:346/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824115 Defer Date
:01/82/050/01324/AM19/ :03/94/040/00590/AM19/ 01.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 339 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:348/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824131 Defer Date
:01/82/050/01326/AM19/ :03/94/040/00588/AM19/ 01.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 340 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

102

Case No.:349/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824095 Defer Date
:01/82/050/01327/AM19/ :03/94/040/00591/AM19/ 01.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 341 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:350/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824086 Defer Date
:01/82/050/01328/AM19/ :03/94/040/00585/AM19/ 01.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 342 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:352/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824088 Defer Date
:01/82/050/01330/AM19/ :03/94/040/00603/AM19/ 01.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 343 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

103

Case No.:353/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824101 Defer Date
:01/82/050/01331/AM19/ :03/94/040/00576/AM19/ 01.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 344 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:354/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824087 Defer Date
:01/82/050/01332/AM19/ :03/94/040/00592/AM19/ 01.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 345 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:355/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824097 Defer Date
:01/82/050/01333/AM19/ :03/94/040/00602/AM19/ 01.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 346 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

104

Case No.:391/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824121 Defer Date
:01/82/050/01369/AM19/ :03/94/040/00583/AM19/ 01.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 347 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:392/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824119 Defer Date
:01/82/050/01370/AM19/ :03/94/040/00580/AM19/ 01.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 348 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:393/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824116 Defer Date
:01/82/050/01371/AM19/ :03/94/040/00573/AM19/ 01.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 349 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

105

Case No.:415/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824128 Defer Date
:01/82/050/01393/AM19/ :03/94/040/00579/AM19/ 01.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 350 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:416/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824108 Defer Date
:01/82/050/01394/AM19/ :03/94/040/00577/AM19/ 01.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 351 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing
Molecular weight and Percentage of yield on molar basis
(ii) Reaction and Recovery of solvent at each stage
(iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:417/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824118 Defer Date
:01/82/050/01395/AM19/ :03/94/040/00578/AM19/ 01.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 352 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

106

Case No.:418/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824130 Defer Date
:01/82/050/01396/AM19/ :03/94/040/00586/AM19/ 01.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 353 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:419/13/82- Party Name:ARCH Meet No/Date:1/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Deferred
03.06.2019
HQ File RLA File Lic.No/Date:0310824123 Defer Date
:01/82/050/01397/AM19/ :03/94/040/00575/AM19/ 01.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 354 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 and e-mail dated 06.02.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

355 <br>Case No.:112/13/82-<br>ALC4/2018 Party Name:VARAHI<br>PHARMA PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01090/AM19/ RLA File<br>:66/24/040/00004/AM19/ Lic.No/Date:6610000013<br>03.10.2018 Defer Date
**Decision:**Application received from RLA. Deferred for comments of TE.
356 <br>Case No.:52/13/82-ALC4/2018 Party Name:S V LABS PVT<br>LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01030/AM19/ RLA File<br>:09/24/040/00301/AM19/ Lic.No/Date:0910066711<br>04.10.2018 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.

107

357 <br>Case No.:56/13/82-ALC4/2018 Party Name:S M S<br>PHARMACEUTICALS LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01034/AM19/ RLA File<br>:09/24/040/00321/AM19/ Lic.No/Date:0910066717<br>04.10.2018 Defer Date
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
358 <br>Case No.:442/13/82-<br>ALC4/2018 Party Name:MOREPEN<br>LABORATORIES LTD., Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01420/AM19/ RLA File<br>:05/24/040/00367/AM19/ Lic.No/Date:0510407973<br>04.10.2018 Defer Date
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.
359 <br>Case No.:454/13/82-<br>ALC4/2018 Party Name:IND-SWIFT<br>LABORATORIES LTD., Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01432/AM19/ RLA File<br>:22/24/040/00058/AM19/ Lic.No/Date:2210015989<br>05.10.2018 Defer Date
**Decision:**Application received from RLA,Chandigarh. Deferred for comments of TE.
360 <br>Case No.:438/13/82-<br>ALC4/2018 Party Name:HPL ADDITIVES<br>LIMITED(FORMERLY<br>KNOWN HIGH POLYMER Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01416/AM19/ RLA File<br>:05/23/040/00284/AM19/ Lic.No/Date:0510408013<br>08.10.2018 Defer Date
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.
Case No.:331/13/82- Party Name:AVA Meet No/Date:1/82- Status:
ALC4/2018 CHEMICALS PVT.LTD., ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310824321
:01/82/050/01309/AM19/ :03/94/040/00609/AM19/ 09.10.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 12/82-ALC4/2018 dated 12.12..2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: 361

Export product Qty. Sl. Import items Qty.
No.
DISODIUM MAGNESIUM 1 kg 1 ETHYLENE DIAMINE TETRA 0.700 kg
EDTA Content (6.0 + / – 0.5%) as ACETIC ACID
Mg

108

362 <br>Case No.:224/13/82-<br>ALC4/2018<br>Party Name:ASTRAL<br>STERITECH PVT. LTD.<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>HQ File<br>:01/82/050/01202/AM19/<br>RLA File<br>:34/24/040/00225/AM19/<br>Lic.No/Date:3410044573<br>10.10.2018<br>**Decision:**Application received from RLA,Vadodara. Deferred for comments of TE. Status:<br>Deferred<br>Defer Date
363 <br>Case No.:168/13/82-<br>ALC4/2018<br>Party Name:SONGWON<br>SPECIALTY CHEMICALS<br>INDIA PVT. LTD.<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>HQ File<br>:01/82/050/01146/AM19/<br>RLA File<br>:34/24/040/00232/AM19/<br>Lic.No/Date:3410044578<br>11.10.2018<br>**Decision:**Application received from RLA, Vadodara. Deferred for comments of TE. Status:<br>Deferred<br> <br>Defer Date
364 <br>Case No.:169/13/82-<br>ALC4/2018<br>Party Name:SPC LIFE<br>SCIENCES PVT. LTD.<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>HQ File<br>:01/82/050/01147/AM19/<br>RLA File<br>:34/24/040/00211/AM19/<br>Lic.No/Date:3410044586<br>12.10.2018<br>**Decision:**Application received from RLA,Vadodara. Deferred for comments of TE. Status:<br>Deferred<br>Defer Date
Case No.:177/13/82- Party Name:SONGWON Meet No/Date:1/82- Status:
ALC4/2018 SPECIALTY CHEMICALS ALC4/2019 Approved
INDIA PVT. LTD. 03.06.2019
HQ File RLA File Lic.No/Date:3410044585
:01/82/050/01155/AM19/ :34/24/040/00169/AM19/ 12.10.2018
Case No.:177/13/82-<br>ALC4/2018 Party Name:SONGWON<br>SPECIALTY CHEMICALS<br>INDIA PVT. LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/01155/AM19/ RLA File<br>:34/24/040/00169/AM19/ Lic.No/Date:3410044585<br>12.10.2018
365 <br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 13/82-ALC4/2018 dated 14.01.2019, it was decided to ratify norms under Para 4.7 of HBP v1<br>as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>EDOT (3,4 - Ethylenedioxythiophene)<br>(Other Organo-Sulphur Compnds)<br>1 kg<br>1<br>Dimethyl 2,2 -<br>thiobisacetate<br>0.566 kg<br>2<br>Dimethyl oxalate<br>1.30 kg<br>3<br>Sodium Methoxide Solution<br>30% (Sodium Methylate)<br>4.39 kg<br>4<br>Dimethylformamide<br>0.329 kg<br>5<br>1,2-Dichloroethane<br>1.76 kg<br>6<br>Sulfolane<br>0.4186 kg<br>7<br>Sodium Sulphide<br>Not shown<br>in the<br>process,<br>hence not<br>allowed.

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 13/82-ALC4/2018 dated 14.01.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

109

Case No.:192/13/82- Party Name:NATURAL Meet No/Date:1/82- Status:
ALC4/2018 AND ESSENTIAL OILS ALC4/2019 Approved
PVT LTD 03.06.2019
HQ File RLA File Lic.No/Date:0710114044
:01/82/050/01170/AM19/ :07/24/040/00183/AM19/ 24.10.2018
Case No.:192/13/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/01170/AM19/ Party Name:NATURAL<br>AND ESSENTIAL OILS<br>PVT LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
RLA File<br>:07/24/040/00183/AM19/ Lic.No/Date:0710114044<br>24.10.2018
366 **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.No.<br>Import items<br>Qty.<br>CAFFEINE<br>9600 kg<br>1<br>Crude<br>Caffeine<br>(decaffeination from green<br>coffee)Purity51.78%<br>17600 kg<br>COFFEE<br>EXTRACTS<br>6150 kg<br>CAFFEINE<br>9600 kg<br>1<br>Crude<br>Caffeine<br>(decaffeination from green<br>coffee)Purity53.49%<br>17600 kg<br>COFFEE EXTRACTS<br>6250 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

367 Case No.:322/13/82-<br>ALC4/2018 Party Name:ANLON<br>HEALTHCARE<br>PRIVATELIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:2410042548<br>24.10.2018 Status:<br>Deferred
HQ File<br>:01/82/050/01300/AM19/ RLA File<br>:24/24/040/00033/AM19/ Defer Date
**Decision:**Application received from RLA,Chandigarh. Deferred for comments of TE.
368 Case No.:424/13/82-<br>ALC4/2018 Party Name:DEEPAK<br>NITRITE LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date
HQ File<br>:01/82/050/01402/AM19/ RLA File<br>:34/24/040/00144/AM19/ Lic.No/Date:3410044635<br>25.10.2018
**Decision:**Application received from RLA,Vadodara. Deferred for comments of TE.
369 Case No.:426/13/82-<br>ALC4/2018 Party Name:DEEPAK<br>NITRITE LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date
HQ File<br>:01/82/050/01404/AM19/ RLA File<br>:34/24/040/00208/AM19/ Lic.No/Date:3410044636<br>25.10.2018
**Decision:**Application received from RLA,Vadodara. Deferred for comments of TE.

110

Case No.:453/13/82- Party Name:HESTER Meet No/Date:1/82- Status:
ALC4/2018 BIOSCIENCES LIMITED ALC4/2019 Deferred
03.06.2019
370 HQ File RLA File Lic.No/Date:0810143739 Defer Date
:01/82/050/01431/AM19/ :08/24/040/00231/AM19/ 25.10.2018
**Decision:**Application received from RLA, Ahmedabad. It was decided to forward a copy of application
to DBT for its comments.

Decision: Application received from RLA, Ahmedabad. It was decided to forward a copy of application to DBT for its comments.

Case No.:232/13/82- Party Name:DEEPAK Meet No/Date:1/82- Status:
ALC4/2018 NOVOCHEM ALC4/2019 Deferred
TECHNOLOGIES LTD 03.06.2019
371 HQ File RLA File Lic.No/Date:3110067218 Defer Date
:01/82/050/01210/AM19/ :31/83/040/00114/AM19/ 29.10.2018
**Decision:**Application received from RLA,Pune. Deferred for comments of TE.
Case No.:356/13/82- Party Name:AARTI DRUGS Meet No/Date:1/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310824757
:01/82/050/01334/AM19/ :03/94/040/00217/AM19/ 29.10.2018
Case No.:356/13/82-<br>ALC4/2018 Case No.:356/13/82-<br>ALC4/2018 Party Name:AARTI DRUGS<br>LIMITED Party Name:AARTI DRUGS<br>LIMITED Party Name:AARTI DRUGS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br> <br> Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br> <br> Status:<br>Approved
HQ File<br>:01/82/050/01334/AM19/ RLA File<br>:03/94/040/00217/AM19/ Lic.No/Date:0310824757<br>29.10.2018
**Decision:**The Committee considered the cases as per agenda and in the light of earlier dec ision taken in
<br>meeting no. 19/82-ALC4/2013 dated 02.01.2014, it was decided to ratify norms under Para 4.7 of HBP v1<br>as per details given below or as applied by the firm, whichever is less:
372 <br>Exportproduct<br>DICLOFENAC<br>
Qty. Sl.No. Import items Qty.
1 kg 1. ACETIC ACID 1.25 k g
<br>SODIUM 2. METHANOL 1.00 k g
3. 2,6 DICHLOROP HENOL 1.521 kg
4. TOLUENE 1.995 kg
5 POTASSIUM CARBONATE 100
. .g
6. ANILINE 1.198 kg
7 0795 k
. SODIUM METH XIDE . g
8. SODIUM HYDR OXIDE FLAKES 0.285 kg
9. ISOPROPYL AL COHOL 2.040 kg
DIMETHYL FOR 0.469
10. MAMIDE kg
RA maytake appropriate action asper the decision of Norms Committee.

111

Case No.:183/13/82- Party Name:PHAROSE Meet No/Date:1/82- Status:
ALC4/2018 REMEDIES LTD. ALC4/2019 Deferred
03.06.2019
373 HQ File RLA File Lic.No/Date:3010104485 Defer Date
:01/82/050/01161/AM19/ :30/24/040/00032/AM19/ 31.10.2018
**Decision:**Application received from RLA,Ludhiana. Deferred for comments of TE.
Case No.:363/13/82- Party Name:CIPLA LIMITED. Meet No/Date:1/82- Status:
ALC4/2018 ALC4/2019 Deferred
03.06.2019
374 HQ File RLA File Lic.No/Date:0310824906 Defer Date
:01/82/050/01341/AM19/ :03/94/040/00699/AM19/ 05.11.2018
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
Case No.:193/13/82- Party Name:NATURAL& Meet No/Date:1/82- Status:
ALC4/2018 ESSENTIAL OILS ALC4/2019 Approved
PVT.LTD., 03.06.2019
HQ File RLA File Lic.No/Date:0710114100
:01/82/050/01171/AM19/ :07/24/040/00197/AM19/ 06.11.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 375 applied by firm whichever is lower:

Export Product Qty. Sl.No. Import items Qty.
CAFFEINE 10020 kg 1 Crude Caffeine 17600 kg
COFFEE EXTRACTS 6200 kg (decaffeination from green
coffee)Purity48.83%
Case No.:362/13/82- Party Name:AARTI DRUGS Meet No/Date:1/82- Status:
ALC4/2018 LIMITED ALC4/2019 Deferred
03.06.2019
376 HQ File RLA File Lic.No/Date:0310824929 Defer Date
:01/82/050/01340/AM19/ :03/94/040/00683/AM19/ 06.11.2018
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.

112

377 Case No.:351/13/82-<br>ALC4/2018 Party Name:AARTI DRUGS<br>LIMITED<br>RLA File Meet No/Date:1/82-<br>ALC4/2019 Status:<br>Deferred<br>Defer Date
03.06.2019
<br>HQ File Lic.No/Date:0310824972
:01/82/050/01329/AM19/ :03/94/040/00682/AM19/ 12.11.2018
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
Case No.:241/1/82- Party Name:HONOUR LAB Meet No/Date:1/82- Status:
ALC4/2019 LIMITED ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0910066836
:01/82/050/00147/AM20/ :09/24/040/00368/AM19/ 13.11.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 378 applied by firm whichever is lower:

Export Product Qty. Sl.No. Import items Qty.
(2R,5S)-5-(4-amino-5-fluoro-2- 1 kg 1 5-Fluoro Cytosine 0.44 kg
oxo-2H-pyrimidin-1-yl)- 2 Hexamethyl Disilazane 0.53 kg
[1,3]oxathiolane-2-carboxylic 3 Methane Sulfonic Acid 0.007 kg
acid(1R,2S,5R)-menthylester
Case No.:427/13/82- Party Name:GULBRANDSEN Meet No/Date:1/82- Status:
ALC4/2018 CHEMICALS PVT LTD ALC4/2019 Deferred
03.06.2019
379 HQ File RLA File Lic.No/Date:3410044694 Defer Date
:01/82/050/01405/AM19/ :34/24/040/00264/AM19/ 14.11.2018
**Decision:**Application received from RLA,Pune. Deferred for comments of TE.
Case No.:461/13/82- Party Name:JUBILANT Meet No/Date:1/82- Status:
ALC4/2018 GENERICS LTD ALC4/2019 Deferred
03.06.2019
380 HQ File<br>:01/82/050/01439/AM19/ RLA File<br>:05/23/040/00353/AM19/ Lic.No/Date:0510408451<br>19.11.2018 Defer Date
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from CLA,New Delhi.

113

381 <br>Case No.:463/13/82-<br>ALC4/2018 Party Name:INDIA GLYCOLS<br>LTD., Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01441/AM19/ RLA File<br>:05/23/040/00359/AM19/ Lic.No/Date:0510408634<br>26.11.2018 Defer Date
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.
382 Case No.:242/1/82-ALC4/2019 Party Name:MALWA<br>OXYGEN & INDUSTRIAL<br>GASES PVT.LTD., Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00148/AM20/ RLA File<br>:56/24/040/00028/AM19/ Lic.No/Date:5610005519<br>29.11.2018 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Bhopal.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bhopal.

383 Case No.:466/13/82-<br>ALC4/2018 Party Name:DCM SHRIRAM<br>INDUSTRIES LTD, Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01444/AM19/ RLA File<br>:05/23/040/00376/AM19/ Lic.No/Date:0510408809<br>06.12.2018 Defer Date
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from CLA,New Delhi.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.

384 Case No.:240/1/82-ALC4/2019 Party Name:BENZO CHEM<br>INDUSTRIES PRIVATE<br>LIMITED,<br>RLA File<br>:03/94/040/00756/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br> <br><br>Lic.No/Date:0310825931<br>26.12.2018<br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/00146/AM20/ Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

385 <br>Case No.:144/1/82-ALC4/2019 Party Name:VIRCHOW<br>BIOTECH PV T LTD., Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02539/AM19/ RLA File<br>:09/24/040/00484/AM19/ Lic.No/Date:0910067053<br>09.01.2019 Defer Date:
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.

114

Case No.:190/1/82-ALC4/2019 Party Name:MICRO LABS Meet No/Date:1/82- Status:
LTD ALC4/2019 Deferred
03.06.2019
386 HQ File<br>:01/82/050/02585/AM19/ RLA File<br>:07/24/040/00283/AM19/ Lic.No/Date:0710114616<br>04.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Bangalore.
Case No.:191/1/82-ALC4/2019 Party Name:GLOBAL Meet No/Date:1/82- Status:
CALCIUM PRIVATE ALC4/2019 Deferred
LIMITED 03.06.2019
387 HQ File<br>:01/82/050/02586/AM19/ RLA File<br>:07/24/040/00282/AM19/ Lic.No/Date:0710114617<br>04.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Bangalore.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bangalore.

Case No:201/1/82-ALC4/2019 Part Name:ALEOR Meet No/Date:1/82- Status:
388 <br>. y<br>DERMACEUTICALS<br>LIMITED <br>ALC4/2019<br>03.06.2019 <br>Deferred<br>Defer Date:
<br>HQ File RLA File<br>:34/24/040/00370/AM19/ Lic.No/Date:3410044950<br>05.03.2019
<br>:01/82/050/02596/AM19/
**Decision:**Alication receive d from RLAVadodara Deferred for comments of TE
pp ,. .
Case No.:192/1/82-ALC4/2019 Party Name:CLEAN SCIENCE Meet No/Date:1/82- Status:
AND TECHNOLOGY ALC4/2019 Deferred
PVT.LTD. 03.06.2019
389 HQ File<br>:01/82/050/02587/AM19/ RLA File<br>:31/83/040/00182/AM19/ Lic.No/Date:3110067342<br>05.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Pune.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Pune.

Case No.:143/1/82-ALC4/2019 Party Name:TINA ORGANICS Meet No/Date:1/82- Status:
PRIVATE LIMITED ALC4/2019 Deferred
03.06.2019
390 HQ File<br>:01/82/050/02538/AM19/ RLA File<br>:05/24/040/00695/AM19/ Lic.No/Date:0510409855<br>06.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from CLA,New Delhi.

115

Case No.:193/1/82-ALC4/2019 Party Name:GLOBAL Meet No/Date:1/82- Status:
CALCIUM PRIVATE ALC4/2019 Approved
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0710114623
:01/82/050/02588/AM19/ :07/24/040/00281/AM19/ 06.03.2019
Case No.:193/1/82-ALC4/2019Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/02588/AM19/<br>RLA File<br>:07/24/040/00281/AM19/<br>Lic.No/Date:0710114623<br>06.03.2019 Case No.:193/1/82-ALC4/2019Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/02588/AM19/<br>RLA File<br>:07/24/040/00281/AM19/<br>Lic.No/Date:0710114623<br>06.03.2019 Case No.:193/1/82-ALC4/2019Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/02588/AM19/<br>RLA File<br>:07/24/040/00281/AM19/<br>Lic.No/Date:0710114623<br>06.03.2019 Case No.:193/1/82-ALC4/2019Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/02588/AM19/<br>RLA File<br>:07/24/040/00281/AM19/<br>Lic.No/Date:0710114623<br>06.03.2019 Case No.:193/1/82-ALC4/2019Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/02588/AM19/<br>RLA File<br>:07/24/040/00281/AM19/<br>Lic.No/Date:0710114623<br>06.03.2019 Case No.:193/1/82-ALC4/2019Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/02588/AM19/<br>RLA File<br>:07/24/040/00281/AM19/<br>Lic.No/Date:0710114623<br>06.03.2019 Case No.:193/1/82-ALC4/2019Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/02588/AM19/<br>RLA File<br>:07/24/040/00281/AM19/<br>Lic.No/Date:0710114623<br>06.03.2019
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in
meeting no. 4/82-ALC4/2018 dated 19.06.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as
per details given below or as applied by the firm, whichever is less:
Exportproduct Qty. Sl. No. Import items Qty.
MAGNESIUM 1 kg 1 CITRIC ACID - ANY GRADE 1.001 kg
391 CITRATE(USP/<br>NONHYDRATE Eur.Ph/ 2 MAGNESIUM CARBONATE -<br>ANY GRADE 0.730 kg
ANHYDROUS Eur.Ph/
DODECAHYDRATE Eur.Ph)
CALCIUM CITRATE(USP) 1 kg 1 CITRIC ACID - ANY GRADE 0.816 kg
2 CALCIUM CARBONATE 0.708 kg
ZINC CITRATE(USP) 1 kg 1 CITRIC ACID - ANY GRADE 0.880 kg
POTASSIUM CITRATE(BP/ 1 kg 1 CITRIC ACID - ANY GRADE 0.859 kg
Eur.Ph/ USP)
RA maytake appropriate action asper the decision of Norms Committee.
Case No.:194/1/82-ALC4/2019 Party Name:SARNA Meet No/Date:1/82- Status:
CHEMICALS PVT LTD ALC4/2019 Deferred
03.06.2019
392 HQ File<br>:01/82/050/02589/AM19/ RLA File<br>:52/24/040/00090/AM19/ Lic.No/Date:5210042986<br>06.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Surat.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Surat.

Case No.:142/1/82-ALC4/2019 Party Name:AVA Meet No/Date:1/82- Status:
CHEMICALS PVT.LTD., ALC4/2019 Deferred
03.06.2019
393 HQ File<br>:01/82/050/02537/AM19/ RLA File<br>:03/94/040/01029/AM19/ Lic.No/Date:0310827515<br>07.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

116

394 Case No.:145/1/82-ALC4/2019 Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/02540/AM19/ RLA File<br>:03/94/040/01066/AM19/ Lic.No/Date:0310827513<br>07.03.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

395 Case No.:174/1/82-ALC4/2019 Party Name:BIOLOGICAL E<br>LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/02569/AM19/ RLA File<br>:09/24/040/00588/AM19/ Lic.No/Date:0910067245<br>07.03.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:195/1/82-ALC4/2019 Party Name:THEON Meet No/Date:1/82- Status: PHARMACEUTICALS LTD., ALC4/2019 Approved 03.06.2019 HQ File RLA File Lic.No/Date:2210016106 :01/82/050/02590/AM19/ :22/24/040/00095/AM19/ 07.03.2019

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 14/82-ALC4/2018 dated 14.02.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

396

Export product Export product Qty. Sl. Import items Qty.
No.
Sitagliptin Tablets 100mg 1 Number 1 Sitagliptin Phosphate Monohydrate 131.05 mg
Each firm coated tablet Tablet USP
contains Sitagliptin 2 Microcrystalline cellulose 32.30 mg
Phosphate Monohydrate 3 ISO PROPYL ALCOHOL 149.11 mg
eq. to Sitagliptin Excipients 4 METHYLENE DICHLORIDE 70.00 mg

117

Case No.:202/1/82- Party Name:AMI LIFE Meet No/Date:1/82- Status:
ALC4/2019 SCIENCES PRIVATE ALC4/2019 Approved
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:3410044955
:01/82/050/02597/AM19/ :34/24/040/00372/AM19/ 07.03.2019

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 14/82-ALC4/2018 dated 14.02.2019, it was decided to ratify norms under Para 4.7 of HBP v1 397 as per details given below or as applied by the firm, whichever is less:

Export product Qty. Sl. Import items Qty.
No.
Benfotiamine 1 kg 1 ThiamineHydrochloride 0.922 kg
Case No.:203/1/82- Party Name:AMI LIFE Meet No/Date:1/82- Status:
ALC4/2019 SCIENCES PRIVATE ALC4/2019 Approved
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:3410044956
:01/82/050/02598/AM19/ :34/24/040/00374/AM19/ 07.03.2019

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 398 meeting no. 14/82-ALC4/2018 dated 14.02.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export product Qty. Sl. Import items Qty.
No.
Benfotiamine 1 kg 1 Thiamine Hydrochloride 0.922 kg
Case No.:146/1/82- Party Name:RELIANCE Meet No/Date:1/82- Status:
ALC4/2019 INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
399 HQ File RLA File Lic.No/Date:0310827531 Defer Date:
:01/82/050/02541/AM19/ :03/95/040/01074/AM19/ 08.03.2019
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.

118

Case No.:147/1/82- Party Name:AVA Meet No/Date:1/82- Status:
ALC4/2019 CHEMICALS PVT.LTD., ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310827545
:01/82/050/02542/AM19/ :03/94/040/01056/AM19/ 08.03.2019
Case No.:147/1/82-<br>ALC4/2019 Party Name:AVA<br>CHEMICALS PVT.LTD.,<br> <br> <br> Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved<br>
HQ File<br>:01/82/050/02542/AM19/ RLA File<br>:03/94/040/01056/AM19/<br> <br> Lic.No/Date:0310827545<br>08.03.2019
400 <br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 13/82-ALC4/2018 dated 14.01.2019, it was decided to ratify norms under Para 4.7 of HBP v1<br>as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>EDTA Tetrasodium<br>1 kg<br>1<br>ETHYLENE DIAMINE TETRA<br>ACETIC ACID<br>0.75 kg<br>RA maytake appropriate action asper the decision of Norms Committee.
Case No.:148/1/82-ALC4/2019 Party Name:ORTIN Meet No/Date:1/82- Status:
LABORATORIES LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0910067248
:01/82/050/02543/AM19/ :09/24/040/00596/AM19/ 08.03.2019

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 14/82-ALC4/2018 dated 14.02.2019, it was decided to ratify norms under Para 4.7 of HBP v1 401 as per details given below or as applied by the firm, whichever is less:

Export product Qty. Sl. Import items Qty.
No.
-((5-Thiazolyl)-(4- 1 kg 1 5-Hydroxymethyl Thiazole 0.513 kg
nitrophenyl)carbonate, (NCT)
402 Case No.:149/1/82-ALC4/2019 Party Name:SRIAM LABS<br>PRIVATE LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02544/AM19/ RLA File<br>:09/24/040/00604/AM19/ Lic.No/Date:0910067252<br>11.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

119

403 Case No.:150/1/82-ALC4/2019 Party Name:ALKALI METALS<br>LTD.,<br>RLA File<br>:09/24/040/00561/AM19/ <br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
HQ File<br>:01/82/050/02545/AM19/ Lic.No/Date:0910067258<br>11.03.2019
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
Case No.:151/1/82- Party Name:KOPRAN Meet No/Date:1/82- Status:
ALC4/2019 RESEARCH ALC4/2019 Approved
LABORATORIES LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0310827587
:01/82/050/02546/AM19/ :03/94/040/01063/AM19/ 11.03.2019

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 13/82-ALC4/2018 dated 14.01.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

404

Qty. Sl.<br>No. Import items Qty.
1 kg 1 CEFEPIME HCL (NON-<br>STERILE) 0.655 kg
2 ACETONE 1.816 kg
3 L-ARGININE 0.37 kg
4 ISO PROPYL ALCOHOL 0.392 kg
5 PACKING MATERIAL:ALU.<br>CANISTER(10KG)/ALUMINIU<br>M BOTTLE ANODIZED<br>2M(20L000T.8020XY)(ONE<br>SET CONT.ONE<br>CAN./ALU.BOTL.ANO. Relevant as<br>per packing<br>policy
Case No.:152/1/82-ALC4/2019 Party Name:BENZO CHEM Meet No/Date:1/82- Status:
INDUSTRIES PRIVATE ALC4/2019 Deferred
LIMITED, 03.06.2019
HQ File<br>:01/82/050/02547/AM19/ RLA File<br>:03/94/040/00854/AM19/ Lic.No/Date:0310827603<br>11.03.2019 Defer Date:

405

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

120

Case No.:196/1/82-ALC4/2019 Party Name:BALAJI AMINES Meet No/Date:1/82- Status:
LIMITED ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:3110067348
:01/82/050/02591/AM19/ :31/83/040/00190/AM19/ 11.03.2019

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 10/82-ALC4/2018 dated 16.10.2018, it was decided to ratify norms under Para 4.7 of HBP v1 406 as per details given below or as applied by the firm, whichever is less:

Exportproduct Qty. Sl.No. Import items Qty.
N-ETHYL-2- 1 kg 1 GAMMA 0.72 kg
PYRROLIDONE BUTYROLACTONE
2 MONOETHYLAMINE 0.533 kg
70% SOLUTION
Case No.:153/1/82-ALC4/2019 Party Name:COVALENT Meet No/Date:1/82- Status:
LABORATORIES PRIVATE ALC4/2019 Approved
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0910067260
:01/82/050/02548/AM19/ :09/24/040/00610/AM19/ 12.03.2019
Case No.:153/1/82-ALC4/2019 Case No.:153/1/82-ALC4/2019 Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/02548/AM19/ RLA File<br>:09/24/040/00610/AM19/ Lic.No/Date:0910067260<br>12.03.2019
407 **Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 12/82-ALC4/2018 dated 12.12.2018, it was decided to ratify norms under Para 4.7 of HBP v1<br>as per details given below or as applied by the firm, whichever is less:
Export product Qty. Sl.<br>No. Import items Qty.
Cefixime 1 kg 1 7-Phenylacetamideo-3-Chloromethyl<br>Cephalosporonic Acid Para<br>Methoxybenzyl Ester (GCLE) 1.4219 kg
2 Triphenyl Phosphine 0.775 kg
3 Activated Carbon 0.05 kg
4 Dimethyl Formamide 2.80 kg
5 Methylene Chloride 10.00 kg
6 Mica Ester 0.82 kg
RA maytake appropriate action asper the decision of Norms Committee.

121

Case No.:154/1/82-ALC4/2019 Party Name:COVALENT Meet No/Date:1/82- Status:
LABORATORIES PRIVATE ALC4/2019 Approved
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0910067261
:01/82/050/02549/AM19/ :09/24/040/00608/AM19/ 12.03.2019
**Decision:**The Committee considered **Decision:**The Committee considered **Decision:**The Committee considered **Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in the cases as per agenda and in the light of earlier decision taken in the cases as per agenda and in the light of earlier decision taken in the cases as per agenda and in the light of earlier decision taken in
meeting no. 15/82-ALC4/2018 dated 22.03.2019, it was decided to ratify norms under Para 4.7 of HBP v1
as per details given below or as applied by the firm, whichever is less:
Export product Qty. Sl. Import items Qty.
No.
408 Cefuroxime Axetil 1 kg 1 D-7-AMINO CEPHALOSPORANIC 0.752 kg
Amorphous ACID (D-7-ACA)
2 Cholorosulphonyl Isocynate 0.530 kg
3 (Z)-2-Methoxy Imino (Furyl-2-YL) Acetic 0.700 kg
Acid Ammonium Salt (SMIA)
4 Dimethyl Acetamide 0.850 kg
5 Methylene Chloride 5.000 kg
6 Acetone 3.800 kg
7 Methanol 1.300 kg
8 Activated Carbon 0.100 kg
RA maytake appropriate action asper the decision of Norms Committee.
Case No.:155/1/82-ALC4/2019 Case No.:155/1/82-ALC4/2019 Case No.:155/1/82-ALC4/2019 Case No.:155/1/82-ALC4/2019 Case No.:155/1/82-ALC4/2019 Party Name:COVALENT<br>Meet No/Date:1/82- Status:
LABORATORIES PRIVATE<br>ALC4/2019 Approved
LIMITED<br>03.06.2019
HQ File RLA File<br>Lic.No/Date:0910067262
:01/82/050/02550/AM19/ :09/24/040/00609/AM19/<br>12.03.2019
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in
meeting no. 15/82-ALC4/2018 dated 22.03.2019, it was decided to ratify norms under Para 4.7 of HBP v1
as per details given below or as applied by the firm, whichever is less:
Export Qty Sl. Import Item Name. Qty.
Product No.
Cefdinir 1kg 1 7-Phenylacetamideo-3-Chloromethyl Cephalosporonic 2.263 kg
Acid Para Methoxybenzyl Ester (GCLE)
2 ethyl-(Z)-2-hydroxylamino-2-(2-aminthiazole-4-y) 1.397 kg
acetate (EHATA)
3 Methylene Chloride 14.87 kg
4 Tetra Hydro Furan 2.06 kg
5 Methanol 4.12 kg
6 Activated Carbon 0.055kg
RA may take appropriate action as per the decision of Norms Committee.
Case No.:155/1/82-ALC4/2019 Case No.:155/1/82-ALC4/2019 Case No.:155/1/82-ALC4/2019 Case No.:155/1/82-ALC4/2019 Case No.:155/1/82-ALC4/2019 Party Name:COVALENT<br>Meet No/Date:1/82- Status:
LABORATORIES PRIVATE<br>ALC4/2019 Approved
LIMITED<br>03.06.2019
HQ File RLA File<br>Lic.No/Date:0910067262
:01/82/050/02550/AM19/ :09/24/040/00609/AM19/<br>12.03.2019
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in
meeting no. 15/82-ALC4/2018 dated 22.03.2019, it was decided to ratify norms under Para 4.7 of HBP v1
as per details given below or as applied by the firm, whichever is less:
Export Qty Sl. Import Item Name. Qty.
Product No.
Cefdinir 1kg 1 7-Phenylacetamideo-3-Chloromethyl Cephalosporonic 2.263 kg
Acid Para Methoxybenzyl Ester (GCLE)
2 ethyl-(Z)-2-hydroxylamino-2-(2-aminthiazole-4-y) 1.397 kg
acetate (EHATA)
3 Methylene Chloride 14.87 kg
4 Tetra Hydro Furan 2.06 kg
5 Methanol 4.12 kg
6 Activated Carbon 0.055kg
RA may take appropriate action as per the decision of Norms Committee.

122

410 <br>Case No.:156/1/82-ALC4/2019 Party Name:NEOGEN<br>CHEMICALS LIMITED<br>RLA File<br>:03/95/040/01222/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/02551/AM19/ Lic.No/Date:0310827621<br>12.03.2019
**Decision:**Application received from RLA,Pune. Deferred for comments of TE.
Case No.:157/1/82- Party Name:SIDDHARTH Meet No/Date:1/82- Status:
ALC4/2019 CARBOCHEM PRODUCTS ALC4/2019 Approved
LTD. 03.06.2019
HQ File RLA File Lic.No/Date:0310827624
:01/82/050/02552/AM19/ :03/95/040/01289/AM19/ 12.03.2019

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 411 meeting no. 13/82-ALC4/2018 dated 14.01 .2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export Product Qty. Sl.No. Import items Qty.
METHYL SALICYLATE<br>(MIN.99%) (PHENOL FREE) 1 kg 1. SALICYLIC ACID 1.1715 kg
412 <br>Case No.:158/1/82-<br>ALC4/2019 Party Name:RELIANCE<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02553/AM19/ RLA File<br>:03/95/040/01102/AM19/ Lic.No/Date:0310827628<br>12.03.2019 Defer Date:
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
413 Case No.:159/1/82-ALC4/2019 Party Name:EMMENNAR<br>PHARMA PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00600/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/02554/AM19/ Lic.No/Date:0910067264<br>12.03.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

123

Case No.:160/1/82-ALC4/2019 Party Name:ASHISH LIFE Meet No/Date:1/82- Status:
SCIENCE PVT.LTD. ALC4/2019 Deferred
03.06.2019
414 HQ File<br>:01/82/050/02555/AM19/ RLA File<br>:03/94/040/00693/AM19/ Lic.No/Date:0310827639<br>12.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:161/1/82-ALC4/2019 Party Name:OPTRIX Meet No/Date:1/82- Status:
LABORATORIES PRIVATE ALC4/2019 Deferred
LIMITED 03.06.2019
415 HQ File RLA File Lic.No/Date:0910067270 Defer Date:
:01/82/050/02556/AM19/ :09/24/040/00621/AM19/ 13.03.2019
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
Case No.:162/1/82- Party Name:SHREE JAYA Meet No/Date:1/82- Status:
ALC4/2019 LABORATORIES PVT LTD. ALC4/2019 Deferred
03.06.2019
416 HQ File<br>:01/82/050/02557/AM19/ RLA File<br>:09/24/040/00611/AM19/ Lic.No/Date:0910067271<br>13.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:163/1/82- Party Name:SUNSHIELD Meet No/Date:1/82- Status:
ALC4/2019 CHEMICALS LTD. ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310827658
:01/82/050/02558/AM19/ :03/95/040/01312/AM19/ 13.03.2019

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 8/82-ALC4/2014 dated 25.09.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as 417 per details given below or as applied by the firm, whichever is less:

Export product Qty. Sl.No. Import items Qty.
SUN HQEE 1 kg 1 Hydroquinone 0.625 kg
(Hydroquinone<br>Ethoxylate) 2 Ethylene Oxide 0.494 kg

124

Case No.:164/1/82- Party Name:RELIANCE Meet No/Date:1/82- Status:
ALC4/2019 INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
418 HQ File RLA File Lic.No/Date:0310827666 Defer Date:
:01/82/050/02559/AM19/ :03/95/040/01064/AM19/ 13.03.2019
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
Case No.:165/1/82- Party Name:RELIANCE Meet No/Date:1/82- Status:
ALC4/2019 INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
419 HQ File RLA File Lic.No/Date:0310827671 Defer Date:
:01/82/050/02560/AM19/ :03/95/040/01096/AM19/ 13.03.2019
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
Case No.:166/1/82-ALC4/2019 Party Name:ENAL DRUGS Meet No/Date:1/82- Status:
PVT LTD., ALC4/2019 Deferred
03.06.2019
420 HQ File<br>:01/82/050/02561/AM19/ RLA File<br>:09/24/040/00614/AM19/ Lic.No/Date:0910067274<br>13.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:167/1/82-ALC4/2019 Party Name:AURORE LIFE Meet No/Date:1/82- Status:
SCIENCES PRIVATE ALC4/2019 Deferred
LIMITED 03.06.2019
421 HQ File<br>:01/82/050/02562/AM19/ RLA File<br>:09/24/040/00612/AM19/ Lic.No/Date:0910067275<br>13.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:168/1/82- Party Name:NEOGEN Meet No/Date:1/82- Status:
ALC4/2019 CHEMICALS LIMITED ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310827684
:01/82/050/02563/AM19/ :03/95/040/00232/AM18/ 13.03.2019

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 422 applied by firm whichever is lower:

Export Product Qty. Sl.No. Import items Qty.
BENZOYL BROMIDE 1 kg 1 BENZOYL ALCOHOL 0.845 kg
2 HYDROBROMIC ACID 1.45 kg
48%

125

Case No.:169/1/82- Party Name:RUSAN Meet No/Date:1/82- Status:
ALC4/2019 PHARMA LTD. ALC4/2019 Deferred
03.06.2019
423 HQ File<br>:01/82/050/02564/AM19/ RLA File<br>:03/95/040/01315/AM19/ Lic.No/Date:0310827685<br>13.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:170/1/82-ALC4/2019 Party Name:J.B. CHEMICALS Meet No/Date:1/82- Status:
& PHARMACEUTICALS ALC4/2019 Deferred
LIMITED 03.06.2019
424 HQ File<br>:01/82/050/02565/AM19/ RLA File<br>:03/94/040/01071/AM19/ Lic.No/Date:0310827686<br>13.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:197/1/82- Party Name:STERILE INDIA Meet No/Date:1/82- Status:
ALC4/2019 PRIVATE LIMITED ALC4/2019 Deferred
03.06.2019
425 HQ File<br>:01/82/050/02592/AM19/ RLA File<br>:33/24/040/00019/AM19/ Lic.No/Date:3310030518<br>13.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Pune.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Pune.

Case No.:171/1/82-ALC4/2019 Party Name:MALLADI Meet No/Date:1/82- Status: DRUGS & ALC4/2019 Deferred PHARMACEUTICALS 03.06.2019 LIMITED 426 HQ File RLA File Lic.No/Date:0410165319 Defer Date: :01/82/050/02566/AM19/ :04/24/040/00243/AM19/ 14.03.2019

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Chennai.

Case No.:172/1/82- Party Name:RELIANCE Meet No/Date:1/82- Status:
ALC4/2019 INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
427 HQ File RLA File Lic.No/Date:0310827697 Defer Date:
:01/82/050/02567/AM19/ :03/95/040/01063/AM19/ 14.03.2019
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.

126

428 <br>Case No.:173/1/82-<br>ALC4/2019 Party Name:RELIANCE<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:0310827699<br>14.03.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02568/AM19/ RLA File<br>:03/95/040/01076/AM19/ Defer Date:
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
429 <br>Case No.:175/1/82-ALC4/2019 Party Name:MALLADI<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02570/AM19/ RLA File<br>:04/24/040/00244/AM19/ Lic.No/Date:0410165324<br>14.03.2019 Defer Date:
**Decision:**Application received from RLA,Chennai. Deferred for comments of TE.
430 <br>Case No.:198/1/82-ALC4/2019 Party Name:LABORATE<br>PHARMACEUTICAL INDIA<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/02593/AM19/ RLA File<br>:33/24/040/00020/AM19/ Lic.No/Date:3310030519<br>14.03.2019
**Decision:**Application received from RLA,Pune. Deferred for comments of TE.
431 Case No.:204/1/82-ALC4/2019 Party Name:DEEPAK<br>PHENOLICS LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/02599/AM19/ RLA File<br>:34/24/040/00353/AM19/ Lic.No/Date:3410044969<br>14.03.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Vadodara.

127

Case No.:176/1/82- Party Name:DIVIS Meet No/Date:1/82- Status:
ALC4/2019 LABORATORIES LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0910067281
:01/82/050/02571/AM19/ :09/24/040/00587/AM19/ 15.03.2019

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 432

Export Product Qty. Sl.No. Import items Qty.
NAPROXEN 1 kg 1 DL-NAPROXEN 1.17 kg
2 N-OCTYL-D-<br>GLUCAMINE 0.0882 kg
3 METHANOL 2.02 kg
4 ACETIC ACID 0.54 kg
5 TOLUENE 0.84 kg
433 <br>Case No.:177/1/82-<br>ALC4/2019 Party Name:RELIANCE<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:0310827733<br>15.03.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02572/AM19/ RLA File<br>:03/95/040/01062/AM19/ Defer Date:
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
434 Case No.:178/1/82-ALC4/2019 Party Name:VIJAYASRI<br>ORGANICS LTD<br>RLA File<br>:09/24/040/00560/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/02573/AM19/ Lic.No/Date:0910067282<br>15.03.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

128

Case No.:199/1/82- Party Name:NATURAL& Meet No/Date:1/82- Status:
ALC4/2019 ESSENTIAL OILS ALC4/2019 Approved
PVT.LTD., 03.06.2019
HQ File RLA File Lic.No/Date:0710114663
:01/82/050/02594/AM19/ :07/24/040/00295/AM19/ 15.03.2019
Decision: Decision: The Committee considered case as per agenda in the presence of the technical experts and it The Committee considered case as per agenda in the presence of the technical experts and it The Committee considered case as per agenda in the presence of the technical experts and it The Committee considered case as per agenda in the presence of the technical experts and it The Committee considered case as per agenda in the presence of the technical experts and it The Committee considered case as per agenda in the presence of the technical experts and it
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as
applied by firm whichever is lower:
Sl. No. Export Product Qty. Sl.N Import items Qty.
o.
1 Caffeine 10100.000 kg 1 Crude Caffeine 17600.000 kg
(decaffeination from
2 Coffee Extracts 6100.000 kg green coffee)Purity
53.12%
Crude Caffeine
435 (decaffeination from
green coffee)Purity
53.72%
3 Caffeine 10200.000 kg 2 Crude Caffeine 17600.000 kg
(decaffeination from
4 Coffee Extracts 6200.000 kg green coffee)Purity
50.71%
Crude Caffeine
(decaffeination from
green coffee)Purity
53.12%
5 Caffeine 9200.000 kg 3 Crude Caffeine 16300.000 kg
(decaffeination from
6 Coffee Extracts 6000.000 kg green coffee)Purity
53.72%
RA concerned maytake further necessaryaction asper above decision of NC.
Case No.:179/1/82-ALC4/2019 Party Name:SHANKUS Meet No/Date:1/82- Status:
PHARMACEUTICALS ALC4/2019 Deferred
03.06.2019
436 HQ File RLA File Lic.No/Date:0810144782 Defer Date:
:01/82/050/02574/AM19/ :08/24/040/00430/AM19/ 18.03.2019
**Decision:**Application received from RLA,Ahmedabad. Deferred for comments of TE.
Case No.:180/1/82-ALC4/2019 Party Name:VINDHYA Meet No/Date:1/82- Status:
ORGANICS PVT LTD ALC4/2019 Deferred
03.06.2019
437 HQ File<br>:01/82/050/02575/AM19/ RLA File<br>:09/24/040/00628/AM19/ Lic.No/Date:0910067284<br>18.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

129

438 Case No.:181/1/82-ALC4/2019 Party Name:DINAKARA LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/02576/AM19/ RLA File<br>:09/24/040/00571/AM19/ Lic.No/Date:0910067285<br>18.03.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

439 Case No.:182/1/82-ALC4/2019 Party Name:ORIENTAL<br>AROMATICS LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/02577/AM19/ RLA File<br>:03/95/040/01319/AM19/ Lic.No/Date:0310827770<br>18.03.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

440 <br>Case No.:183/1/82-<br>ALC4/2019 Party Name:RELIANCE<br>INDUSTRIES LIMITED<br>RLA File<br>:03/95/040/01095/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br> <br><br>Lic.No/Date:0310827773<br>18.03.2019<br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/02578/AM19/ Defer Date:
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
441 <br>Case No.:184/1/82-ALC4/2019 Party Name:KLJ<br>PLASTICIZERS LIMITED. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:0510409975<br>19.03.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02579/AM19/ RLA File<br>:05/23/040/00562/AM19/ Defer Date:
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.
442 Case No.:185/1/82-ALC4/2019 Party Name:MANGALAM<br>ORGANICS LIMITED<br>(FORMERLY DUJODWALA Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/02580/AM19/ RLA File<br>:03/95/040/00899/AM19/ Lic.No/Date:0310827775<br>19.03.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

130

Case No.:186/1/82- Party Name:INCHEM Meet No/Date:1/82- Status:
ALC4/2019 LABORATORIES PRIVATE ALC4/2019 Approved
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0910067296
:01/82/050/02581/AM19/ :09/24/040/00528/AM19/ 19.03.2019

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 443 applied by firm whichever is lower:

Sl. No. Export Product Qty. Sl.No. Import items Qty.
1 Ractopamine Hcl 1 kg 1 Amino acetonitrile hcl 0.85 kg
2 4 - ( 4 - Hydorxy phenyl<br>)-2 - butanone 0.70 kg
444 <br>Case No.:187/1/82-ALC4/2019 Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00619/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/02582/AM19/ Lic.No/Date:0910067297<br>19.03.2019
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
445 Case No.:188/1/82-ALC4/2019 Party Name:VASUDHA<br>PHARMA CHEM LTD<br>RLA File<br>:09/24/040/00629/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/02583/AM19/ Lic.No/Date:0910067299<br>19.03.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

446 Case No.:189/1/82-ALC4/2019 Party Name:DR. REDDYS<br>LABORATORIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:0910067300<br>19.03.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02584/AM19/ RLA File<br>:09/24/040/00626/AM19/ Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

131

Case No.:200/1/82-ALC4/2019 Party Name:AETHER Meet No/Date:1/82- Status:
INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
447 HQ File<br>:01/82/050/02595/AM19/ RLA File<br>:52/24/040/00085/AM19/ Lic.No/Date:5210043000<br>19.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Surat.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Surat.

Case No.:205/1/82-ALC4/2019 Party Name:ALEOR Meet No/Date:1/82- Status:
DERMACEUTICALS ALC4/2019 Deferred
LIMITED 03.06.2019
448 HQ File<br>:01/82/050/02600/AM19/ RLA File<br>:34/24/040/00396/AM19/ Lic.No/Date:3410044985<br>19.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Vadodara.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Vadodara.

Case No.:206/1/82-ALC4/2019 Party Name:ALEOR Meet No/Date:1/82- Status:
DERMACEUTICALS ALC4/2019 Deferred
LIMITED 03.06.2019
449 HQ File<br>:01/82/050/02601/AM19/ RLA File<br>:34/24/040/00397/AM19/ Lic.No/Date:3410044986<br>19.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Vadodara.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Vadodara.

Case No.:207/1/82-ALC4/2019 Party Name:ELPPE Meet No/Date:1/82- Status:
CHEMICALS PRIVATE ALC4/2019 Deferred
LIMITED 03.06.2019
450 HQ File<br>:01/82/050/02602/AM19/ RLA File<br>:03/94/040/01100/AM19/ Lic.No/Date:0310827824<br>20.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:208/1/82-ALC4/2019 Party Name:DR. ACHARYA Meet No/Date:1/82- Status:
LABORATORIES PVT. LTD., ALC4/2019 Deferred
03.06.2019
451 HQ File<br>:01/82/050/02603/AM19/ RLA File<br>:03/94/040/01091/AM19/ Lic.No/Date:0310827825<br>20.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

132

Case No.:209/1/82-ALC4/2019 Party Name:V.D.H. Meet No/Date:1/82- Status:
ORGANICS PVT. LTD ALC4/2019 Deferred
03.06.2019
452 HQ File RLA File Lic.No/Date:0510410009 Defer Date:
:01/82/050/02604/AM19/ :05/24/040/00722/AM19/ 20.03.2019
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.
Case No.:210/1/82-ALC4/2019 Party Name:V.D.H. Meet No/Date:1/82- Status:
ORGANICS PVT. LTD ALC4/2019 Deferred
03.06.2019
453 HQ File RLA File Lic.No/Date:0510410010 Defer Date:
:01/82/050/02605/AM19/ :05/24/040/00721/AM19/ 20.03.2019
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.
Case No.:211/1/82-ALC4/2019 Party Name:PORUS Meet No/Date:1/82- Status:
LABORATORIES PVT LTD ALC4/2019 Deferred
03.06.2019
454 HQ File<br>:01/82/050/02606/AM19/ RLA File<br>:09/24/040/00633/AM19/ Lic.No/Date:0910067303<br>20.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.
Case No.:212/1/82-ALC4/2019 Party Name:LUPIN LIMITED Meet No/Date:1/82- Status:
ALC4/2019 Deferred
03.06.2019
455 HQ File RLA File Lic.No/Date:0310827848 Defer Date:
:01/82/050/02607/AM19/ :03/95/040/01323/AM19/ 20.03.2019
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
Case No.:214/1/82-ALC4/2019 Party Name:DEEPAK Meet No/Date:1/82- Status:
PHENOLICS LIMITED ALC4/2019 Deferred
03.06.2019
456 HQ File<br>:01/82/050/02609/AM19/ RLA File<br>:34/24/040/00327/AM19/ Lic.No/Date:3410044990<br>20.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Vadodara.

133

457 <br>Case No.:213/1/82-ALC4/2019 Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02608/AM19/ RLA File<br>:09/24/040/00635/AM19/ Lic.No/Date:0910067312<br>21.03.2019 Defer Date:
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
458 Case No.:215/1/82-ALC4/2019 Party Name:BEST VALUE<br>CHEM PVT. LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02610/AM19/ RLA File<br>:34/24/040/00389/AM19/ Lic.No/Date:3410044991<br>22.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Vadodara.
459 Case No.:216/1/82-ALC4/2019 Party Name:BEST VALUE<br>CHEM PVT. LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02611/AM19/ RLA File<br>:34/24/040/00390/AM19/ Lic.No/Date:3410044992<br>22.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Vadodara.
460 Case No.:217/1/82-ALC4/2019 Party Name:PRACHI<br>PHARMACEUTICALS PVT<br>LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02612/AM19/ RLA File<br>:03/95/040/01344/AM19/ Lic.No/Date:0310827870<br>22.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.
461 Case No.:218/1/82-ALC4/2019 Party Name:PRACHI<br>PHARMACEUTICALS PVT<br>LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02613/AM19/ RLA File<br>:03/95/040/01345/AM19/ Lic.No/Date:0310827871<br>22.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

134

462 Case No.:220/1/82-ALC4/2019 Party Name:AETHER<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02615/AM19/ RLA File<br>:52/24/040/00097/AM19/ Lic.No/Date:5210043009<br>25.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Surat.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Surat.

463 Case No.:222/1/82-ALC4/2019 Party Name:ANLON<br>HEALTHCARE<br>PRIVATELIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02617/AM19/ RLA File<br>:24/24/040/00062/AM19/ Lic.No/Date:2410042706<br>25.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Rajkot.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Rajkot.

464 Case No.:223/1/82-ALC4/2019 Party Name:ANLON<br>HEALTHCARE<br>PRIVATELIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02618/AM19/ RLA File<br>:24/24/040/00063/AM19/ Lic.No/Date:2410042707<br>25.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Rajkot.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Rajkot.

465 Case No.:219/1/82-ALC4/2019 Party Name:GLENMARK<br>PHARMACEUTICALS LTD., Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02614/AM19/ RLA File<br>:03/94/040/01122/AM19/ Lic.No/Date:0310827889<br>26.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

135

Case No.:221/1/82- Party Name:ENALTEC LABS Meet No/Date:1/82- Status:
ALC4/2019 PVT LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310827892
:01/82/050/02616/AM19/ :03/94/040/01114/AM19/ 26.03.2019
**Decision:**The Committee considered **Decision:**The Committee considered **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it case as per agenda in the presence of the technical experts and it case as per agenda in the presence of the technical experts and it case as per agenda in the presence of the technical experts and it case as per agenda in the presence of the technical experts and it
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as
applied by firm whichever is lower:
466 Export Product Qty. Sl.No. Import items Qty.
ROSUVASTATIN 1 kg 1 6-[(1E)-2-[4-(4- 1.425 kg
CALCIUM (R-10 ROUTE) FLUOROPHENYL)-6- (1-
METHYLETHYL)-2-[METHYL
(METHYLSULFONYL)AMINO]
-5-PYRIMIDINYL] ETHENYL]-
2,2-DIMETHY L-1,3-
DIOXANE-4-ACETIC ACID
1,1-DIMETHYLETHYL ESTER
RA concerned maytake further necessary action asper above decision of NC.
Case No.:224/1/82-ALC4/2019 Party Name:SAINOR Meet No/Date:1/82- Status:
LABORATORIES PVT LTD ALC4/2019 Deferred
03.06.2019
467 HQ File<br>:01/82/050/02619/AM19/ RLA File<br>:09/24/040/00647/AM19/ Lic.No/Date:0910067319<br>26.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:225/1/82-ALC4/2019 Party Name:SAINOR<br> Meet No/Date:1/82-<br> Status:<br>
468 LABORATORIES PVT LTD ALC4/2019<br>03.06.2019 Deferred<br>Defer Date:
<br>HQ File<br> RLA File<br>:09/24/040/00646/AM19/ Lic.No/Date:0910067320<br>26.03.2019
:01/82/050/02620/AM19/
**Decision:**The Committee<br> noted that the 4.07 application<br> of subject Advance Autho<br> rization is not<br>
available. Hence, it was decided to call for a copy of 4.07 applic<br>from RLA,Hyderabad. ation of the subject advance authorization

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

469 <br>Case No.:226/1/82-ALC4/2019 Party Name:BRAWN<br>BIOTECH LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/02621/AM19/ RLA File<br>:05/23/040/00567/AM19/ Lic.No/Date:0510410051<br>26.03.2019
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.

136

Case No.:227/1/82-ALC4/2019 Party Name:GULBRANDSEN Meet No/Date:1/82- Status:
CHEMICALS PVT LTD ALC4/2019 Deferred
03.06.2019
470 HQ File RLA File Lic.No/Date:3410044999 Defer Date:
:01/82/050/02622/AM19/ :34/24/040/00392/AM19/ 26.03.2019
**Decision:**Application received from RLA,Vadodara. Deferred for comments of TE.
Case No.:228/1/82-ALC4/2019 Party Name:SPC LIFE Meet No/Date:1/82- Status:
SCIENCES PVT. LTD. ALC4/2019 Deferred
03.06.2019
471 HQ File<br>:01/82/050/02623/AM19/ RLA File<br>:34/24/040/00331/AM19/ Lic.No/Date:3410045001<br>26.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Vadodara.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Vadodara.

Case No.:243/1/82-ALC4/2019 Party Name:CHEMCON Meet No/Date:1/82- Status:
SPECIALITY CHEMICALS ALC4/2019 Deferred
PVT LTD 03.06.2019
472 HQ File<br>:01/82/050/00149/AM20/ RLA File<br>:34/24/040/00391/AM19/ Lic.No/Date:3410045000<br>26.03.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Vadodara.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Vadodara.

Case No.:229/1/82- Party Name:ABBOTT Meet No/Date:1/82- Status: ALC4/2019 HEALTH CARE PRIVATE ALC4/2019 Approved LIMITED 03.06.2019 HQ File RLA File Lic.No/Date:0310827953 :01/82/050/02624/AM19/ :03/94/040/01095/AM19/ 27.03.2019 Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

ALC4/2019<br>HEALTH CARE PRIVATE<br>LIMITED<br>ALC4/2019<br>03.06.2019<br>Approved<br>HQ File<br>:01/82/050/02624/AM19/<br>RLA File<br>:03/94/040/01095/AM19/<br>Lic.No/Date:0310827953<br>27.03.2019 ALC4/2019<br>HEALTH CARE PRIVATE<br>LIMITED<br>ALC4/2019<br>03.06.2019<br>Approved<br>HQ File<br>:01/82/050/02624/AM19/<br>RLA File<br>:03/94/040/01095/AM19/<br>Lic.No/Date:0310827953<br>27.03.2019 ALC4/2019<br>HEALTH CARE PRIVATE<br>LIMITED<br>ALC4/2019<br>03.06.2019<br>Approved<br>HQ File<br>:01/82/050/02624/AM19/<br>RLA File<br>:03/94/040/01095/AM19/<br>Lic.No/Date:0310827953<br>27.03.2019 ALC4/2019<br>HEALTH CARE PRIVATE<br>LIMITED<br>ALC4/2019<br>03.06.2019<br>Approved<br>HQ File<br>:01/82/050/02624/AM19/<br>RLA File<br>:03/94/040/01095/AM19/<br>Lic.No/Date:0310827953<br>27.03.2019 ALC4/2019<br>HEALTH CARE PRIVATE<br>LIMITED<br>ALC4/2019<br>03.06.2019<br>Approved<br>HQ File<br>:01/82/050/02624/AM19/<br>RLA File<br>:03/94/040/01095/AM19/<br>Lic.No/Date:0310827953<br>27.03.2019 ALC4/2019<br>HEALTH CARE PRIVATE<br>LIMITED<br>ALC4/2019<br>03.06.2019<br>Approved<br>HQ File<br>:01/82/050/02624/AM19/<br>RLA File<br>:03/94/040/01095/AM19/<br>Lic.No/Date:0310827953<br>27.03.2019 ALC4/2019<br>HEALTH CARE PRIVATE<br>LIMITED<br>ALC4/2019<br>03.06.2019<br>Approved<br>HQ File<br>:01/82/050/02624/AM19/<br>RLA File<br>:03/94/040/01095/AM19/<br>Lic.No/Date:0310827953<br>27.03.2019
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as
applied by firm whichever is lower:
Export Product Qty. Sl.No. Import items Qty.
473 Fenofibrate Bulk Granulate 1 kg 1 Fenofibrate Micronized 0.320 kg
IH/Ph.Eur
2 Hypromellose (2910, 3 cps) 0.0633
Ph. Eur
3 Docusate Sodium Ph.Eur 0.0062 kg
4 Sucrose Ph.Eur 0.3124 kg
5 Sodium Lauril Sulfate 0.0216 kg
Ph.Eur
6 Lactose Monohydrate 0.2804 kg
Ph.Eur
RA concerned maytake further necessaryaction asper above decision of NC.

137

474 Case No.:230/1/82-ALC4/2019 Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:0310827966<br>28.03.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02625/AM19/ RLA File<br>:03/94/040/01077/AM19/ Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

475 Case No.:231/1/82-ALC4/2019 Party Name:INCHEM<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/02626/AM19/ RLA File<br>:09/24/040/00639/AM19/ Lic.No/Date:0910067335<br>28.03.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

476 Case No.:232/1/82-ALC4/2019 Party Name:NAVIN<br>FLUORINE<br>INTERNATIONAL LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:0310827981<br>28.03.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02627/AM19/ RLA File<br>:03/95/040/01210/AM19/ Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

477 <br>Case No.:233/1/82-ALC4/2019 Party Name:EMCURE<br>PHARMACEUTICALS LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/02628/AM19/ RLA File<br>:31/83/040/00193/AM19/ Lic.No/Date:3110067352<br>28.03.2019
**Decision:**Application received from RLA,Pune. Deferred for comments of TE.
478 Case No.:234/1/82-ALC4/2019 Party Name:NEOGEN<br>CHEMICALS LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/02629/AM19/ RLA File<br>:03/95/040/00788/AM18/ Lic.No/Date:0310828002<br>28.03.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

138

479 Case No.:235/1/82-ALC4/2019 Party Name:SHREE GANESH<br>REMEDIES LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
HQ File<br>:01/82/050/02630/AM19/ RLA File<br>:34/24/040/00399/AM19/ Lic.No/Date:3410045006<br>28.03.2019
**Decision:**Application received from RLA,Vadodara. Deferred for comments of TE.
Case No.:1/1/82-ALC4/2019 Party Name:ADCOCK Meet No/Date:1/82- Status:
INGRAM LTD, ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0710114722
:01/82/050/00001/AM20/ :07/24/040/00303/AM19/ 28.03.2019
Case No.:1/1/82-ALC4/2019 Party Name:ADCOCK<br>INGRAM LTD, Party Name:ADCOCK<br>INGRAM LTD, Party Name:ADCOCK<br>INGRAM LTD, Party Name:ADCOCK<br>INGRAM LTD, Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:0710114722<br>28.03.2019 Status:<br>Approved
HQ File<br>:01/82/050/00001/AM20/ RLA File<br>:07/24/040/00303/AM19/
480 **Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in<br>the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018, dated 22.03.2019, it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:
Exportproduct Qty. Sl.No. Import items Qty.
SYNDOL TABLETS -<br>(Paracetamol 450mg + Caffeine<br>30mg +<br>Doxylamine Succinate 5mg +<br>Codeine Phosphate 10mg Colour<br>Yellow 14037-1.632mg) (Para -<br>13500.000+Caff -900.000+<br>Doxy-150.000+Codeine -<br>300.000 Colour Yellow 14037-<br>48.960 KGS) (No. of Tablets<br>30000000) BP/EP/USP/PH.EUR 1<br>million<br>tablets 1. DOXYLAMINE SUCCINATE<br>USP /Ph. Eur Grade 5.10 kg
2. CODIENE PHOSPHATE BP /<br>EP / USP / PH.EUR 10.2 kg
3. COLOUR YELLOW 14037 IH 1.632 kg
**62/0-**ADCO DOL TABLETS -<br>(Paracetamol 450mg+Codeine<br>Phosphate 10mg+Caffeine<br>45mg+<br>Doxylamine Succinate<br>5mg+Colour Yellow Lake-<br>4.56mg+ Colour Yellow WS-<br>2.43mg)(Para-<br>45000.000+Codeine-<br>1000.000+Caff-4500.000+Doxy-<br>500.000 Colour Yellow Lake-<br>456.000 Colour Yellow WS-<br>243.000 KGS)(No. of Tablets<br>100000000)BP/EP/USP/PH.EUR 1<br>million<br>tablets 1. DOXYLAMINE SUCCINATE<br>USP /Ph. Eur Grade 5.10 kg
2. CODIENE PHOSPHATE BP /<br>EP / USP / PH.EUR 10.2 kg
3. COLOUR YELLOW 14037 IH 2.43 kg
4. COLOUR QUINOLINE<br>YELLOW WS (SPECTRACOL) 4.56 kg
RA concerned maytake further necessaryaction asper above decision of NC.

139

481 <br>Case No.:2/1/82-ALC4/2019 Party Name:AMI ORGANICS<br>LIMITED<br>RLA File<br>:52/24/040/00102/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/00002/AM20/ Lic.No/Date:5210043013<br>29.03.2019
**Decision:**Application received from RLA,Surat. Deferred for comments of TE.
482 Case No.:3/1/82-ALC4/2019 Party Name:DORF-KETAL<br>CHEMICALS INDIA<br>PVT.LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:0310828018<br>29.03.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00003/AM20/ RLA File<br>:03/94/040/01102/AM19/ Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

483 Case No.:4/1/82-ALC4/2019 Party Name:DORF-KETAL<br>CHEMICALS INDIA<br>PVT.LTD.<br>RLA File<br>:03/94/040/01101/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/00004/AM20/ Lic.No/Date:0310828030<br>29.03.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:5/1/82-ALC4/2019 Party Name:NEOGEN Meet No/Date:1/82- Status:
CHEMICALS LIMITED ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:0310828033
:01/82/050/00005/AM20/ :03/95/040/00983/AM17/ 29.03.2019

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 484 applied by firm whichever is lower:

Export Product Qty. Sl.No. Import items Qty.
1,4 DIBROMOBUTANE 1 kg 1 TETRAHYDROFURAN 0.412 kg
2 HYDROBROMIC ACID<br>48% 1.929 kg

140

485 Case No.:6/1/82-ALC4/2019 Party Name:SOMU ORGAN<br> O Meet No/Date:1/82-<br> Status:<br>
CHEM PVT.LTD.,<br> ALC4/2019<br>03.06.2019 Deferred<br>
<br>HQ File<br>:01/82/050/00006/AM20/ RLA File<br>:07/24/040/00308/AM19/ Lic.No/Date:0710114735<br>01.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>
from RLA,Bangalore.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bangalore.

Case No.:7/1/82-ALC4/2019 Party Name:SAGA Meet No/Date:1/82- Status:
LABORATORIES ALC4/2019 Deferred
03.06.2019
486 HQ File<br>:01/82/050/00007/AM20/ RLA File<br>:08/24/040/00444/AM19/ Lic.No/Date:0810144895<br>02.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Ahmedabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.

Case No.:8/1/82-ALC4/2019 Party Name:KOPRAN Meet No/Date:1/82- Status:
RESEARCH ALC4/2019 Deferred
LABORATORIES LIMITED 03.06.2019
487 HQ File<br>:01/82/050/00008/AM20/ RLA File<br>:03/94/040/01064/AM19/ Lic.No/Date:0310828072<br>02.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:13/1/82-ALC4/2019 Party Name:DEEPAK Meet No/Date:1/82- Status:
NOVOCHEM ALC4/2019 Deferred
TECHNOLOGIES LTD 03.06.2019
488 HQ File RLA File Lic.No/Date:3110067362 Defer Date:
:01/82/050/00013/AM20/ :31/83/040/00296/AM19/ 02.04.2019
**Decision:**Application received from RLA,Pune. Deferred for comments of TE.
Case No.:18/1/82-ALC4/2019 Party Name:VERGO Meet No/Date:1/82- Status:
PHARMA RESEARCH ALC4/2019 Deferred
LABORATORIES PVT. LTD., 03.06.2019
489 HQ File<br>:01/82/050/00018/AM20/ RLA File<br>:03/95/040/01239/AM19/ Lic.No/Date:0310828109<br>02.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

141

490 Case No.:19/1/82-ALC4/2019 Party Name:VERGO<br>PHARMA RESEARCH<br>LABORATORIES PVT. LTD.,<br>RLA File<br>:03/95/040/01240/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
HQ File<br>:01/82/050/00019/AM20/ Lic.No/Date:0310828110<br>02.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

491 Case No.:21/1/82-ALC4/2019 Party Name:CIPLA LIMITED. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
HQ File<br>:01/82/050/00021/AM20/ RLA File<br>:03/94/040/00963/AM19/ Lic.No/Date:0310828102<br>02.04.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

492 Case No.:23/1/82-ALC4/2019 Party Name:HUBERGROUP<br>INDIA PRIVATE LIMITED. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
HQ File<br>:01/82/050/00023/AM20/ RLA File<br>:03/94/040/01143/AM19/ Lic.No/Date:0310828106<br>02.04.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

493 Case No.:24/1/82-<br>ALC4/2019<br>Party<br>Name:SMILAX LABORATORIES<br>LIMITED<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Status:<br>Deferred<br>HQ File<br>:01/82/050/00024/AM20/<br>RLA File :09/24/040/00651/AM19/ Lic.No/Date:09100673<br>57<br>02.04.2019<br>Defer Date:<br>**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad. Party<br>Name:SMILAX LABORATORIES<br>LIMITED <br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
RLA File :09/24/040/00651/AM19/ Lic.No/Date:09100673<br>57<br>02.04.2019 Defer Date:

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

494 Case No.:10/1/82-ALC4/2019 Party Name:VIVIN DRUGS &<br>PHARMACEUTICALS<br>LIMITED<br>RLA File<br>:09/24/040/00593/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
HQ File<br>:01/82/050/00010/AM20/ Lic.No/Date:0910067362<br>03.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

142

Case No.:11/1/82-ALC4/2019 Party Name:VASUDHA Meet No/Date:1/82- Status:
PHARMA CHEM LTD ALC4/2019 Deferred
03.06.2019
495 HQ File<br>:01/82/050/00011/AM20/ RLA File<br>:09/24/040/00620/AM19/ Lic.No/Date:0910067361<br>03.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:22/1/82-ALC4/2019 Party Name:CIPLA LIMITED. Meet No/Date:1/82- Status:
ALC4/2019 Deferred
03.06.2019
496 HQ File<br>:01/82/050/00022/AM20/ RLA File<br>:03/94/040/01142/AM19/ Lic.No/Date:0310828142<br>03.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:26/1/82-ALC4/2019 Party Name:PACT LABS Meet No/Date:1/82- Status:
P.LTD. ALC4/2019 Deferred
03.06.2019
497 HQ File RLA File Lic.No/Date:3110067368 Defer Date:
:01/82/050/00026/AM20/ :31/83/040/00001/AM20/ 03.04.2019
**Decision:**Application received from RLA,Pune. Deferred for comments of TE.
Case No.:12/1/82-ALC4/2019 Party Name:SUVEN LIFE Meet No/Date:1/82- Status:
SCIENCES LIMITED ALC4/2019 Deferred
03.06.2019
498 HQ File<br>:01/82/050/00012/AM20/ RLA File<br>:09/24/040/00661/AM19/ Lic.No/Date:0910067365<br>04.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.
Case No.:14/1/82-ALC4/2019 Party Name:CLEAN SCIENCE Meet No/Date:1/82- Status:
AND TECHNOLOGY ALC4/2019 Deferred
PVT.LTD. 03.06.2019
499 HQ File RLA File Lic.No/Date:3110067371 Defer Date:
:01/82/050/00014/AM20/ :31/83/040/00299/AM19/ 04.04.2019
**Decision:**Application received from RLA,Pune. Deferred for comments of TE.

143

500 <br>Case No.:9/1/82-ALC4/2019 Party Name:BRAWN<br>LABORATORIES LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00009/AM20/ RLA File<br>:05/23/040/00580/AM19/ Lic.No/Date:0510410163<br>05.04.2019 Defer Date:
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.
501 Case No.:20/1/82-ALC4/2019 Party Name:THINQ<br>PHARMA-CRO LIMITED<br>RLA File<br>:03/95/040/01366/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br> <br><br>Lic.No/Date:0310828192<br>05.04.2019<br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/00020/AM20/ Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.
502 Case No.:25/1/82-ALC4/2019 Party Name:SAINOR<br>LABORATORIES PVT LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00025/AM20/ RLA File<br>:09/24/040/00659/AM19/ Lic.No/Date:0910067371<br>05.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.
503 <br>Case No.:27/1/82-ALC4/2019 Party Name:CLEAN SCIENCE<br>AND TECHNOLOGY<br>PVT.LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00027/AM20/ RLA File<br>:31/83/040/00168/AM19/ Lic.No/Date:3110067373<br>05.04.2019 Defer Date:
**Decision:**Application received from RLA,Pune. Deferred for comments of TE.
504 <br>Case No.:28/1/82-ALC4/2019 Party Name:RAJASTHAN<br>ANTIBIOTICS LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00028/AM20/ RLA File<br>:05/24/040/00744/AM19/ Lic.No/Date:0510410174<br>08.04.2019 Defer Date:
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.

144

Case No.:29/1/82-ALC4/2019 Party Name:RAJASTHAN Meet No/Date:1/82- Status:
ANTIBIOTICS LTD ALC4/2019 Deferred
03.06.2019
505 HQ File<br>:01/82/050/00029/AM20/ RLA File<br>:05/24/040/00684/AM19/ Lic.No/Date:0510410175<br>08.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from CLA,New Delhi.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.

Case No.:30/1/82-ALC4/2019 Party Name:RAJASTHAN Meet No/Date:1/82- Status:
ANTIBIOTICS LTD ALC4/2019 Deferred
03.06.2019
506 HQ File RLA File Lic.No/Date:0510410176 Defer Date:
:01/82/050/00030/AM20/ :05/24/040/00675/AM19/ 08.04.2019
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.
Case No.:31/1/82-ALC4/2019 Party Name:RELIANCE Meet No/Date:1/82- Status:
INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
507 HQ File RLA File Lic.No/Date:0310828216 Defer Date:
:01/82/050/00031/AM20/ :03/95/040/01133/AM19/ 08.04.2019
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
508 <br>Case No.:32/1/82-ALC4/2019 Party Name:RELIANCE<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00032/AM20/ RLA File<br>:03/95/040/01144/AM19/ Lic.No/Date:0310828218<br>08.04.2019 Defer Date:
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
509 <br>Case No.:33/1/82-ALC4/2019 Party Name:RELIANCE<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00033/AM20/ RLA File<br>:03/95/040/01178/AM19/ Lic.No/Date:0310828219<br>08.04.2019 Defer Date:
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
510 Case No.:34/1/82-ALC4/2019 Party Name:JUBILANT LIFE<br>SCIENCES LIMITED<br>RLA File<br>:05/23/040/00566/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/00034/AM20/ Lic.No/Date:0510410180<br>09.04.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from CLA,New Delhi.

145

Case No.:35/1/82-ALC4/2019 Party Name:BALAJI AMINES Meet No/Date:1/82- Status:
LIMITED ALC4/2019 Deferred
03.06.2019
511 HQ File<br>:01/82/050/00035/AM20/ RLA File<br>:31/83/040/00295/AM19/ Lic.No/Date:3110067375<br>09.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Pune.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Pune.

Case No.:36/1/82-ALC4/2019 Party Name:PI INDUSTRIES Meet No/Date:1/82- Status:
LTD ALC4/2019 Approved
03.06.2019
HQ File RLA File Lic.No/Date:1310049251
:01/82/050/00036/AM20/ :13/24/040/00141/AM20/ 10.04.2019

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 512 applied by firm whichever is lower:

Export Product Qty. Sl.No. Import items Qty.
2-CHLORO-4-FLUORO-5- 1 kg 1 2-Chloro-4-Fluoro Toluene 0.615 kg
NITROBENZOTRICHLORIDE
(CFN)
Case No.:37/1/82-ALC4/2019 Party Name:CADILA Meet No/Date:1/82- Status:
HEALTHCARE LTD ALC4/2019 Deferred
03.06.2019
513 HQ File<br>:01/82/050/00037/AM20/ RLA File<br>:08/24/040/00449/AM19/ Lic.No/Date:0810144979<br>10.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Ahmedabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.

Case No.:38/1/82-ALC4/2019 Party Name:CADILA Meet No/Date:1/82- Status:
HEALTHCARE LTD ALC4/2019 Deferred
03.06.2019
514 HQ File<br>:01/82/050/00038/AM20/ RLA File<br>:08/24/040/00448/AM19/ Lic.No/Date:0810144980<br>10.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Ahmedabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.

146

Case No.:39/1/82-ALC4/2019 Party Name:TIDE Meet No/Date:1/82- Status:
INDUSTRIES ALC4/2019 Deferred
03.06.2019
515 HQ File<br>:01/82/050/00039/AM20/ RLA File<br>:34/24/040/00009/AM20/ Lic.No/Date:3410045044<br>11.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Vadodara.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Vadodara.

Case No.:40/1/82-ALC4/2019 Party Name:NATURAL& Meet No/Date:1/82- Status:
ESSENTIAL OILS ALC4/2019 Approved
PVT.LTD., 03.06.2019
HQ File RLA File Lic.No/Date:0710114778
:01/82/050/00040/AM20/ :07/24/040/00005/AM20/ 15.04.2019
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as
applied by firm whichever is lower:
Export Product Qty. Sl.No. Import items Qty.
516 Caffeine 9800.000 kg 1 Crude Caffeine 17600.000
(decaffeination from green kg
Coffee Extracts 6100.000 kg coffee)Purity 50.86%
Caffeine 10200.000 kg 2 Crude Caffeine 17600.000
(decaffeination from green kg
coffee)Purity 50.86%
Coffee Extracts 5500.000 kg
RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

Case No.:41/1/82-ALC4/2019 Party Name:ORTIN Meet No/Date:1/82- Status:
LABORATORIES LTD ALC4/2019 Deferred
03.06.2019
517 HQ File<br>:01/82/050/00041/AM20/ RLA File<br>:09/24/040/00650/AM19/ Lic.No/Date:0910067389<br>15.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:42/1/82-ALC4/2019 Party Name:JODAS EXPOIM Meet No/Date:1/82- Status:
PVT.LTD ALC4/2019 Deferred
03.06.2019
518 HQ File<br>:01/82/050/00042/AM20/ RLA File<br>:05/23/040/00015/AM20/ Lic.No/Date:0510410233<br>15.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from CLA,New Delhi.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.

147

519 Case No.:43/1/82-ALC4/2019 Party Name:HEMA DYE<br>CHEM PVT. LTD.<br>RLA File<br>:03/94/040/01141/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/00043/AM20/ Lic.No/Date:0310828400<br>16.04.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

520 <br>Case No.:45/1/82-ALC4/2019 Party Name:RELIANCE<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br> <br><br>Lic.No/Date:0310828373<br>16.04.2019<br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/00045/AM20/ RLA File<br>:03/95/040/01180/AM19/ Defer Date:
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
521 <br>Case No.:46/1/82-ALC4/2019 Party Name:RELIANCE<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br> <br><br>Lic.No/Date:0310828374<br>16.04.2019<br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/00046/AM20/ RLA File<br>:03/95/040/01202/AM19/ Defer Date:
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
522 <br>Case No.:47/1/82-ALC4/2019 <br>HQ File<br>:01/82/050/00047/AM20/ Party Name:SYMBIOSIS<br>PHARMACEUTICALS.PRIVATE<br>LIMITED. <br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br> <br>Defer<br>Date:
RLA File<br>:33/24/040/00002/AM20/ Lic.No/Date:3310030527<br>16.04.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Panipat.
523 Case No.:44/1/82-ALC4/2019 Party Name:ALIVIRA<br>ANIMAL HEALTH LIMITED<br>RLA File<br>:03/94/040/00017/AM20/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/00044/AM20/ Lic.No/Date:0310828406<br>18.04.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

148

Case No.:48/1/82-ALC4/2019 Party Name:COVALENT Meet No/Date:1/82- Status:
LABORATORIES PRIVATE ALC4/2019 Approved
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0910067393
:01/82/050/00048/AM20/ :09/24/040/00018/AM20/ 23.04.2019
Case No.:48/1/82-ALC4/2019 Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019 Status:<br>Approved
03.06.2019
HQ File RLA File Lic.No/Date:0910067393
:01/82/050/00048/AM20/ :09/24/040/00018/AM20/ 23.04.2019
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 12/82-ALC4/2018 dated 12.12.2018, it was decided to ratify norms under Para 4.7 of HBP v1<br>
as per details given below or a s applied by the firm, whichever is less:
524 <br>Export product Q ty. Sl<br>N .<br>o. Import items Qty.
Cefixime 1 kg 1 7-Phenylacetami deo-3-Chloromethyl 1.4219 kg
<br>Cephalosporonic<br>Methoxybenzyl <br> <br>Acid<br>Para<br>Ester (GCLE)
2 Triphenyl Phosphine 0.775 kg
3 Activated Carbon 0.05 kg
4 Dimethyl Forma mide 2.80 kg
5 Methylene Chlor ide 10.00 kg
6 0.82 kg
Mica Ester .g
Citt
R A maytake appropriate action as per the de ii f
cson o orms o mee.
Case No.:49/1/82-ALC4/2019 Party Name:COVALENT<br>LABORATORIES PRIVATE<br> Meet No/Date:1/82-<br>ALC4/2019<br> Status:<br>Deferred
525 LIMITED<br>RLA File<br>:09/24/040/00020/AM20/ 03.06.2019 Defer Date:
<br>HQ File<br>:01/82/050/00049/AM20/ Lic.No/Date:091006<br>23.04.2019 7394
**Decision:**The Committe<br>available. Hence, it was decid<br> e noted that the 4.07 applicati<br>ed to call for a copy of 4.07 ap on of subject Advance A<br>plication of the subject ad uthorization is not<br>vance authorization
from RLA,Hyderabad.
526 Case No.:50/1/82-ALC4/2019 Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00050/AM20/ RLA File<br>:09/24/040/00019/AM20/ Lic.No/Date:0910067395<br>23.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

149

Case No.:51/1/82-ALC4/2019 Party Name:COVALENT Meet No/Date:1/82- Status:
LABORATORIES PRIVATE ALC4/2019 Approved
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0910067396
:01/82/050/00051/AM20/ :09/24/040/00021/AM20/ 23.04.2019
Case No.:51/1/82-ALC4/2019 Case No.:51/1/82-ALC4/2019 Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br> <br> <br>Lic.No/Date:0910067396<br>23.04.2019 Status:<br>Approved
HQ File<br>:01/82/050/00051/AM20/ RLA File<br>:09/24/040/00021/AM20/
527 <br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 14/82-ALC4/2018 dated 14.02.2019, it was decided to ratify norms under Para 4.7 of HBP v1<br>as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.No.<br>Import items<br>Qty.<br>Cefuroxime<br>Axetil<br>Amorphous<br>1 kg<br>1<br>D-7-AMINO CEPHALOSPORANIC<br>ACID (D-7-ACA)<br>0.752 kg<br>2<br>Cholorosulphonyl Isocynate<br>0.53 kg<br>3<br>(Z)-2-Methoxy Imino (Furyl-2-YL)<br>Acetic Acid Ammonium Salt (SMIA)<br>0.700 kg<br>4<br>Dimethyl Acetamide<br>1.94 kg<br>5<br>Methylene Chloride<br>2.87 kg<br>6<br>Acetone<br>0.175 kg<br>7<br>Methanol<br>3.05 kg<br>8<br>Activated Carbon<br>0.100 kg<br>RA maytake appropriate action asper the decision of Norms Committee.
Export product Qty. Sl.No. Import items Qty.
Cefuroxime<br>Axetil<br>Amorphous 1 kg 1 D-7-AMINO CEPHALOSPORANIC<br>ACID (D-7-ACA) 0.752 kg
2 Cholorosulphonyl Isocynate 0.53 kg
3 (Z)-2-Methoxy Imino (Furyl-2-YL)<br>Acetic Acid Ammonium Salt (SMIA) 0.700 kg
4 Dimethyl Acetamide 1.94 kg
5 Methylene Chloride 2.87 kg
6 Acetone 0.175 kg
7 Methanol 3.05 kg
8 Activated Carbon 0.100 kg
per the decision of Norms Committee.
528 <br>Case No.:52/1/82-ALC4/2019 Party Name:RELIANCE<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br> <br><br>Lic.No/Date:0310828486<br>23.04.2019<br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/00052/AM20/ RLA File<br>:03/95/040/01201/AM19/ Defer Date:
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
529 <br>Case No.:53/1/82-ALC4/2019 Party Name:RELIANCE<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br> <br><br>Lic.No/Date:0310828489<br>23.04.2019<br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/00053/AM20/ RLA File<br>:03/95/040/01179/AM19/ Defer Date:
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
530 Case No.:54/1/82-ALC4/2019 Party Name:ALTA<br>LABORATORIES LTD.<br>RLA File<br>:03/94/040/00060/AM20/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/00054/AM20/ Lic.No/Date:0310828483<br>23.04.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

150

531 Case No.:55/1/82-ALC4/2019 Party Name:ALTA<br>LABORATORIES LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00055/AM20/ RLA File<br>:03/94/040/00058/AM20/ Lic.No/Date:0310828485<br>23.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

532 <br>Case No.:56/1/82-ALC4/2019 Party Name:ALTA<br>LABORATORIES LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00056/AM20/ RLA File<br>:03/94/040/00059/AM20/ Lic.No/Date:0310828504<br>23.04.2019 Defer Date:
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
533 Case No.:57/1/82-ALC4/2019 Party Name:AVA<br>CHEMICALS PVT.LTD., Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00057/AM20/ RLA File<br>:03/94/040/00044/AM20/ Lic.No/Date:0310828516<br>23.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.
534 <br>Case No.:58/1/82-ALC4/2019 Party Name:AVA<br>CHEMICALS PVT.LTD., Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00058/AM20/ RLA File<br>:03/94/040/00043/AM20/ Lic.No/Date:0310828518<br>23.04.2019 Defer Date:
**Decision:**Application received from RLA,Mumbai. Deferred f or comments of TE.
535 <br>Case No.:59/1/82-ALC4/2019 Party Name:LUPIN LIMITED<br>RLA File<br>:03/95/040/01322/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br> <br><br>Lic.No/Date:0310828484<br>23.04.2019<br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/00059/AM20/ Defer Date:
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.

151

536 <br>Case No.:60/1/82-ALC4/2019 Party Name:MANKIND<br>PHARMA LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00060/AM20/ RLA File<br>:05/24/040/00024/AM20/ Lic.No/Date:0510410328<br>23.04.2019 Defer Date:
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.
537 <br>Case No.:61/1/82-ALC4/2019 Party Name:KUMAR<br>ORGANIC PRODCTS Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br> <br><br>Lic.No/Date:0710114795<br>24.04.2019<br> Status:<br>Deferred
U<br>LIMITED,<br>RLA File<br>:07/24/040/00008/AM20/
<br>HQ File<br>:01/82/050/00061/AM20/ Defer Date:
**Decision:**Application received from RLA,Bangalore. Deferred for comments of TE.
538 <br>Case No.:62/1/82-ALC4/2019 Party Name:KEVA<br>FRAGRANCES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00062/AM20/ RLA File<br>:03/94/040/00052/AM20/ Lic.No/Date:0310828561<br>24.04.2019 Defer Date:
**Decision:**Application received from RLA,Pune. Deferred for comments of TE.
539 Case No.:63/1/82-ALC4/2019 Party Name:CLEAN SCIENCE<br>AND TECHNOLOGY<br>PVT.LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00063/AM20/ RLA File<br>:31/83/040/00004/AM20/ Lic.No/Date:3110067389<br>24.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Pune.
540 Case No.:64/1/82-ALC4/2019 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00064/AM20/ RLA File<br>:09/24/040/00594/AM19/ Lic.No/Date:0910067402<br>24.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

152

541 <br>Case No.:65/1/82-ALC4/2019 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00065/AM20/ RLA File<br>:09/24/040/00008/AM20/ Lic.No/Date:0910067403<br>24.04.2019 Defer Date:
**Decision:**Application received from RLA,Pune. Deferred for comments of TE.
542 Case No.:66/1/82-ALC4/2019 Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00066/AM20/ RLA File<br>:09/24/040/00013/AM20/ Lic.No/Date:0910067405<br>24.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.
543 Case No.:67/1/82-ALC4/2019 Party Name:AUROBINDO<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00025/AM20/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br> <br><br>Lic.No/Date:0910067414<br>24.04.2019<br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/00067/AM20/ Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.
544 Case No.:75/1/82-ALC4/2019 Party Name:LABORATE<br>PHARMACEUTICAL INDIA<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00075/AM20/ RLA File<br>:33/24/040/00003/AM20/ Lic.No/Date:3310030529<br>24.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Panipat.
545 <br>Case No.:82/1/82-ALC4/2019 Party Name:MEDREICH<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00082/AM20/ RLA File<br>:07/24/040/00009/AM20/ Lic.No/Date:0710114798<br>24.04.2019 Defer Date:
**Decision:**Application received from RLA,Bangalore. Deferred for comments of TE.

153

546 Case No.:68/1/82-ALC4/2019 Party Name:SRF LIMITED<br>RLA File<br>:05/24/040/00438/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/00068/AM20/ Lic.No/Date:0510410372<br>25.04.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from CLA,New Delhi.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.

547 Case No.:69/1/82-ALC4/2019 Party Name:SAVLA<br>CHEMICALS LIMITED<br>RLA File<br>:03/95/040/00053/AM20/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/00069/AM20/ Lic.No/Date:0310828605<br>25.04.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

548 <br>Case No.:70/1/82-ALC4/2019 Party Name:RELIANCE<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00070/AM20/ RLA File<br>:03/95/040/01265/AM19/ Lic.No/Date:0310828615<br>25.04.2019 Defer Date:
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
549 <br>Case No.:71/1/82-ALC4/2019 Party Name:RELIANCE<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00071/AM20/ RLA File<br>:03/95/040/01205/AM19/ Lic.No/Date:0310828616<br>25.04.2019 Defer Date:
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
550 <br>Case No.:72/1/82-ALC4/2019 Party Name:RELIANCE<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00072/AM20/ RLA File<br>:03/95/040/01247/AM19/ Lic.No/Date:0310828617<br>25.04.2019 Defer Date:
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.

154

Case No.:73/1/82-ALC4/2019 Party Name:RELIANCE Meet No/Date:1/82- Status:
INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
551 HQ File RLA File Lic.No/Date:0310828620 Defer Date:
:01/82/050/00073/AM20/ :03/95/040/01261/AM19/ 25.04.2019
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
Case No.:74/1/82-ALC4/2019 Party Name:SUN Meet No/Date:1/82- Status:
PHARMACEUTICAL ALC4/2019 Deferred
INDUSTRIES LTD. 03.06.2019
552 HQ File<br>:01/82/050/00074/AM20/ RLA File<br>:05/24/040/00029/AM20/ Lic.No/Date:0510410387<br>26.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from CLA,New Delhi.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.

Case No.:76/1/82-ALC4/2019 Party Name:VERVE HUMAN Meet No/Date:1/82- Status:
CARE LABORATORIES ALC4/2019 Deferred
03.06.2019
553 HQ File<br>:01/82/050/00076/AM20/ RLA File<br>:05/24/040/00001/AM20/ Lic.No/Date:0510410398<br>26.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from CLA,New Delhi.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.

Case No.:77/1/82-ALC4/2019 Party Name:RELIANCE Meet No/Date:1/82- Status:
INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
554 HQ File RLA File Lic.No/Date:0310828623 Defer Date:
:01/82/050/00077/AM20/ :03/95/040/01260/AM19/ 26.04.2019
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
Case No.:78/1/82-ALC4/2019 Party Name:RELIANCE Meet No/Date:1/82- Status:
INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
555 HQ File RLA File Lic.No/Date:0310828624 Defer Date:
:01/82/050/00078/AM20/ :03/95/040/01231/AM19/ 26.04.2019
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.

155

556 Case No.:79/1/82-ALC4/2019 Party Name:AVA<br>CHEMICALS PVT.LTD.,<br>RLA File<br>:03/94/040/00045/AM20/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00079/AM20/ Lic.No/Date:0310828628<br>26.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

557 Case No.:80/1/82-ALC4/2019 Party Name:AVA<br>CHEMICALS PVT.LTD.,<br>RLA File<br>:03/94/040/00046/AM20/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00080/AM20/ Lic.No/Date:0310828629<br>26.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:81/1/82-ALC4/2019 Party Name:SIDDHARTH Meet No/Date:1/82- Status:
CARBOCHEM PRODUCTS ALC4/2019 Approved
LTD. 03.06.2019
HQ File RLA File Lic.No/Date:0310828654
:01/82/050/00081/AM20/ :03/95/040/00050/AM20/ 26.04.2019

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 558 meeting no. 13/82-ALC4/2018 dated 14.01 .2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export Product Qty. Sl.No. Import items Qty.
METHYL SALICYLATE<br>(MIN.99%) (PHENOL FREE) 1 kg 1. SALICYLIC ACID 1.1715 kg

156

559 Case No.:83/1/82-ALC4/2019 Party Name:CAPLIN POINT<br>LABORATORIES LIMITED<br>RLA File<br>:04/24/040/00019/AM20/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/00083/AM20/ Lic.No/Date:0410165522<br>29.04.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Chennai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Chennai.

560 Case No.:84/1/82-ALC4/2019 Party Name:SHIVA<br>PHARMACHEM LTD<br>RLA File<br>:34/24/040/00032/AM20/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/00084/AM20/ Lic.No/Date:3410045091<br>29.04.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Vadodara.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Vadodara.

561 <br>Case No.:85/1/82-ALC4/2019 Party Name:ASCENT<br>FINECHEM PVT. LTD.,<br>RLA File<br>:08/24/040/00026/AM20/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/00085/AM20/ Lic.No/Date:0810145127<br>30.04.2019
**Decision:**Application received from RLA,Ahmedabad. Deferred for comments of TE.
562 <br>Case No.:87/1/82-ALC4/2019 Party Name:S V LABS PVT<br>LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:0910067427<br>30.04.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00087/AM20/ RLA File<br>:09/24/040/00032/AM20/ Defer Date:
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
563 <br>Case No.:90/1/82-ALC4/2019 Party Name:RELIANCE<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br> <br><br>Lic.No/Date:0310828691<br>30.04.2019<br> Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br> <br><br>Lic.No/Date:0310828691<br>30.04.2019<br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/00090/AM20/ RLA File<br>:03/95/040/01081/AM19/ Defer Date:
**Decision:**The Committee decided to refer the case to Special C ommittee for further consideration.
564 <br>Case No.:94/1/82-ALC4/2019 <br> <br>HQ File<br>:01/82/050/00094/AM20/<br> <br> Party Name:RAJASTHAN<br>ANTIBIOTICS LTD<br> <br> <br>0<br>RLA File<br>:05/24/040/00023/AM20/<br> <br>3 Meet No/Date:1/82-<br>ALC4/2019<br>3.06.2019 Status:<br>Deferred
Lic.No/Date:0510410426<br>0.04.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from CLA,New Delhi.

157

Case No.:95/1/82-ALC4/2019 Party Name:RECKITT Meet No/Date:1/82- Status:
BENCKISER HEALTHCARE ALC4/2019 Approved
INDIA PRIVATE LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:0510410425
:01/82/050/00095/AM20/ :05/24/040/00055/AM20/ 30.04.2019
Case No.:95/1/82-ALC4/2019 Party Name:RECKITT<br>BENCKISER HEALTHCARE<br>INDIA PRIVATE LIMITED <br> <br> <br>0 Meet No/Date:1/82-<br>ALC4/2019<br>3.06.2019 Status:<br>Approved<br> tatus:<br>pproved
HQ File<br>:01/82/050/00095/AM20/ RLA File<br>:05/24/040/00055/AM20/ Lic.No/Date:0510410425<br>30.04.2019
**Decision:**The Committee considered the case as per agenda<br> in the presence of Technical Experts and in<br>
the light of earlier decision taken by NC in its Meeting No. 14/AM19, dated 14.02.2019, it was decided to<br>ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm<br>hih i l
wcever s ower: Qty.<br>allowed for
Export product Qty. Sl.<br>No. Import items Qty.<br>allowed for
1 Number,<br>100 ml<br>
565 bottle
Nurofen For Children 1 Number<br>(100 ml<br>bottles) 1. Ibuprofen 2.10gram
2. Tween 80(Polysorbate 80) 0.01gram
3. Glycerine 12.616<br>gram
4. Lycasin 80/55 (Maltotol) 44.52 gram
5. Saccharin Sodium 40/80 0.20gram
6. Citric Acid Monohydrate 0.40gram
7. Tri Sodium Citrate Dihydrate 0.509 gram
8. Xanthan Gum 0.75 gram
9. Sodium Chloride 0.11 gram
10. Orange flavour 0.25 gram
11 Domiphen Bromide (BP) 0.01 gram
12 987 PP28mm M-LOC H&A White T/E Relevant as<br>per packing<br>policy
13 DEVC,NURFN,GB,ORAL<br>SUSPENSION (Syringe)
14 Pet Bottle
15 INSR,NURFN,NN PASTIC PLUGS
16 NFC 2 PERCENT Paper labels
17 <br>NFC 2 PERCENT Paper leaflets
18 NFC 2 PERCENT Mono cartons
Note:<br>1. Above proposed norms are for the export of 1 No. 100 ml Bottle. For any other bottle size<br>exported, RA may workout the entitlement on pro-rata basis.<br>2. The firm will declare No. of Bottles exported / to be exported, of different pack size as per DML.<br>3. The firm will in future, show the quantity of export in terms of Number of Bottles and their<br>packsize.

Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 14/AM19, dated 14.02.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:

158

566 <br>Case No.:86/1/82-ALC4/2019 Party Name:ASCENT<br>FINECHEM PVT. LTD., Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/00086/AM20/ RLA File<br>:08/24/040/00005/AM20/ Lic.No/Date:0810145144<br>01.05.2019
**Decision:**Application received from RLA,Ahmedabad. Deferred for comments of TE.
567 Case No.:88/1/82-ALC4/2019 Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/00088/AM20/ RLA File<br>:09/24/040/00037/AM20/ Lic.No/Date:0910067429<br>01.05.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.
568 <br>Case No.:89/1/82-ALC4/2019 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/00089/AM20/ RLA File<br>:09/24/040/00617/AM19/ Lic.No/Date:0910067431<br>01.05.2019
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
569 <br>Case No.:91/1/82-ALC4/2019 Party Name:RELIANCE<br>INDUSTRIES LIMITED<br>RLA File<br>:03/95/040/01303/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br> <br><br>Lic.No/Date:0310828714<br>01.05.2019<br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/00091/AM20/ Defer Date:
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
570 <br>Case No.:92/1/82-ALC4/2019 Party Name:RELIANCE<br>INDUSTRIES LIMITED<br>RLA File<br>:03/95/040/01286/AM19/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br> <br><br>Lic.No/Date:0310828732<br>01.05.2019<br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/00092/AM20/ Defer Date:
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.

159

571 <br>Case No.:93/1/82-ALC4/2019 Party Name:ALCON<br>BIOSCIENCES PRIVATE<br>LIMITED<br>RLA File<br>:03/94/040/00082/AM20/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00093/AM20/ Lic.No/Date:0310828700<br>01.05.2019 Defer Date:
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
572 <br>Case No.:96/1/82-ALC4/2019 Party Name:CLEAN SCIENCE<br>AND TECHNOLOGY<br>PVT.LTD.<br>RLA File<br>:31/83/040/00012/AM20/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00096/AM20/ Lic.No/Date:3110067403<br>01.05.2019 Defer Date:
**Decision:**Application received from RLA,Pune. Deferred for comments of TE.
573 <br>Case No.:97/1/82-ALC4/2019 Party Name:CLEAN SCIENCE<br>AND TECHNOLOGY<br>PVT.LTD.<br>RLA File<br>:31/83/040/00013/AM20/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00097/AM20/ Lic.No/Date:3110067404<br>01.05.2019 Defer Date:
**Decision:**Application received from RLA,Pune. Deferred for comments of TE.
Case No.:104/1/82- Party Name:AMI LIFE Meet No/Date:1/82- Status:
ALC4/2019 SCIENCES PRIVATE ALC4/2019 Approved
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:3410045104
:01/82/050/00104/AM20/ :34/24/040/00043/AM20/ 01.05.2019
Case No.:104/1/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00104/AM20/ Party Name:AMI LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Approved
RLA File<br>:34/24/040/00043/AM20/ Lic.No/Date:3410045104<br>01.05.2019
574 <br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 13/82-ALC4/2018 dated 14.01.2019, it was decided to ratify norms under Para 4.7 of HBP v1<br>as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Benfotiamine<br>1 kg<br>1<br>Thiamine Hydrochloride<br>0.922 kg<br>RA maytake appropriate action asper the decision of Norms Committee.

160

Case No.:105/1/82- Party Name:AMI LIFE Meet No/Date:1/82- Status:
ALC4/2019 SCIENCES PRIVATE ALC4/2019 Approved
LIMITED 03.06.2019
HQ File RLA File Lic.No/Date:3410045105
:01/82/050/00105/AM20/ :34/24/040/00044/AM20/ 01.05.2019
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in **Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in **Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in
575 meeting no. 13/82-ALC4/2018 dated 14.01.2019, it was decided to ratify norms under Para 4.7 of HBP v1
as per details given below or as applied by the firm, whichever is less:
Export product<br>Qty.<br>Sl.<br>Import items Qty.
No.
Benfotiamine<br>1 kg<br>1<br>Thiamine Hydrochloride 0.922 kg
RA maytake appropriate action asper the decision of Norms Committee.
Case No.:98/1/82-ALC4/2019 Party Name:VISION DRUGS Meet No/Date:1/82- Status:
PVT LTD ALC4/2019 Deferred
03.06.2019
576 HQ File RLA File Lic.No/Date:0910067433 Defer Date:
:01/82/050/00098/AM20/ :09/24/040/00592/AM19/ 02.05.2019
**Decision:**Application received from RLA,Hyderabad. Deferred for comments of TE.
Case No.:99/1/82-ALC4/2019 Party Name:DIVIS Meet No/Date:1/82- Status:
PHARMACEUTICALS ALC4/2019 Deferred
PRIVATE LIMITED 03.06.2019
577 HQ File<br>:01/82/050/00099/AM20/ RLA File<br>:09/24/040/00009/AM20/ Lic.No/Date:0910067437<br>02.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.
Case No.:102/1/82- Party Name:SV Meet No/Date:1/82- Status:
ALC4/2019 PLASTOCHEM PVT.LTD. ALC4/2019 Deferred
03.06.2019
578 HQ File<br>:01/82/050/00102/AM20/ RLA File<br>:31/83/040/00006/AM20/ Lic.No/Date:3110067406<br>02.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Pune.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Pune.

161

Case No.:103/1/82- Party Name:SV Meet No/Date:1/82- Status:
ALC4/2019 PLASTOCHEM PVT.LTD. ALC4/2019 Deferred
03.06.2019
579 HQ File<br>:01/82/050/00103/AM20/ RLA File<br>:31/83/040/00005/AM20/ Lic.No/Date:3110067407<br>02.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Pune.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Pune.

Case No.:100/1/82- Party Name:ETERNIS FINE Meet No/Date:1/82- Status:
ALC4/2019 CHEMICALS LIMITED, ALC4/2019 Deferred
03.06.2019
580 HQ File<br>:01/82/050/00100/AM20/ RLA File<br>:03/94/040/00029/AM20/ Lic.No/Date:0310828779<br>03.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:101/1/82- Party Name:JODAS EXPOIM Meet No/Date:1/82- Status:
ALC4/2019 PVT.LTD ALC4/2019 Deferred
03.06.2019
581 HQ File<br>:01/82/050/00101/AM20/ RLA File<br>:05/23/040/00048/AM20/ Lic.No/Date:0510410475<br>03.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from CLA,New Delhi.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.

Case No.:120/1/82- Party Name:RELIANCE Meet No/Date:1/82- Status:
ALC4/2019 INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
582 HQ File RLA File Lic.No/Date:0310828788 Defer Date:
:01/82/050/00120/AM20/ :03/95/040/01206/AM19/ 06.05.2019
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
Case No.:110/1/82- Party Name:COVALENT Meet No/Date:1/82- Status:
ALC4/2019 LABORATORIES PRIVATE ALC4/2019 Deferred
LIMITED 03.06.2019
583 HQ File<br>:01/82/050/00110/AM20/ RLA File<br>:09/24/040/00031/AM20/ Lic.No/Date:0910067448<br>07.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

162

584 <br>Case No.:121/1/82-<br>ALC4/2019<br>Party Name:RELIANCE<br>INDUSTRIES LIMITED<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Status:<br>Deferred<br>HQ File<br>:01/82/050/00121/AM20/<br>RLA File<br>:03/95/040/01347/AM19/<br>Lic.No/Date:0310828807<br>07.05.2019<br>Defer Date:<br>**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
585 <br>Case No.:135/1/82-<br>ALC4/2019<br>Party Name:SV<br>PLASTOCHEM PVT.LTD.<br>Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Status:<br>Deferred<br>HQ File<br>:01/82/050/00135/AM20/<br>RLA File<br>:31/83/040/00087/AM19/<br>Lic.No/Date:3110067409<br>07.05.2019<br>Defer Date:<br>**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Pune.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Pune.

586 <br>Case No.:136/1/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00136/AM20/ Party Name:SV<br>PLASTOCHEM PVT.LTD.<br>RLA File<br>:31/83/040/00113/AM18/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:3110067410<br>07.05.2019 Status:<br>Deferred<br>Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Pune.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Pune.

587 Case No.:106/1/82-<br>ALC4/2019 Party Name:PRACHEM<br>LABORATORIES Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:0810145205<br>08.05.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00106/AM20/ RLA File<br>:08/24/040/00003/AM20/ Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Ahmedabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.

588 Case No.:107/1/82-<br>ALC4/2019 Party Name:SHANKUS<br>PHARMACEUTICALS Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:0810145203<br>08.05.2019 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/00107/AM20/ RLA File<br>:08/24/040/00040/AM20/
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Ahmedabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.

163

Case No.:108/1/82- Party Name:SYNNAT Meet No/Date:1/82- Status:
ALC4/2019 PHARMA PRIVATE ALC4/2019 Deferred
LIMITED 03.06.2019
589 HQ File<br>:01/82/050/00108/AM20/ RLA File<br>:02/24/040/00009/AM20/ Lic.No/Date:0210209153<br>08.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Kolkata.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Kolkata.

Case No.:111/1/82- Party Name:SAINOR Meet No/Date:1/82- Status:
ALC4/2019 LABORATORIES PVT LTD ALC4/2019 Deferred
03.06.2019
590 HQ File<br>:01/82/050/00111/AM20/ RLA File<br>:09/24/040/00057/AM20/ Lic.No/Date:0910067455<br>08.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:119/1/82- Party Name:GLENMARK Meet No/Date:1/82- Status:
ALC4/2019 PHARMACEUTICALS LTD., ALC4/2019 Deferred
03.06.2019
591 HQ File<br>:01/82/050/00119/AM20/ RLA File<br>:03/94/040/00065/AM20/ Lic.No/Date:0310828859<br>08.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:122/1/82- Party Name:RELIANCE Meet No/Date:1/82- Status:
ALC4/2019 INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
592 HQ File RLA File Lic.No/Date:0310828851 Defer Date:
:01/82/050/00122/AM20/ :03/95/040/01302/AM19/ 08.05.2019
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
Case No.:123/1/82- Party Name:RELIANCE Meet No/Date:1/82- Status:
ALC4/2019 INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
593 HQ File RLA File Lic.No/Date:0310828852 Defer Date:
:01/82/050/00123/AM20/ :03/95/040/01316/AM19/ 08.05.2019
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.

164

594 <br>Case No.:124/1/82-<br>ALC4/2019 Party Name:RELIANCE<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00124/AM20/ RLA File<br>:03/95/040/01381/AM19/ Lic.No/Date:0310828864<br>08.05.2019 Defer Date:
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
595 <br>Case No.:125/1/82-<br>ALC4/2019 Party Name:RELIANCE<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00125/AM20/ RLA File<br>:03/95/040/00023/AM20/ Lic.No/Date:0310828866<br>08.05.2019 Defer Date:
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
596 Case No.:129/1/82-<br>ALC4/2019 Party Name:N S CHEMICALS Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00129/AM20/ RLA File<br>:03/95/040/00012/AM20/ Lic.No/Date:0310828854<br>08.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

597 Case No.:113/1/82-<br>ALC4/2019 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00113/AM20/ RLA File<br>:09/24/040/00011/AM20/ Lic.No/Date:0910067466<br>09.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

598 Case No.:117/1/82-<br>ALC4/2019 Party Name:ADISHANK<br>CHEMICALS PVT.LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00117/AM20/ RLA File<br>:03/94/040/00006/AM20/ Lic.No/Date:0310828912<br>09.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

165

Case No.:118/1/82- Party Name:CIPLA LIMITED. Meet No/Date:1/82- Status:
ALC4/2019 ALC4/2019 Deferred
03.06.2019
599 HQ File<br>:01/82/050/00118/AM20/ RLA File<br>:03/94/040/00081/AM20/ Lic.No/Date:0310828889<br>09.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:130/1/82- Party Name:GLOBE Meet No/Date:1/82- Status:
ALC4/2019 TROTTERS PVT LTD ALC4/2019 Deferred
03.06.2019
600 HQ File<br>:01/82/050/00130/AM20/ RLA File<br>:03/94/040/00106/AM20/ Lic.No/Date:0310828909<br>09.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:131/1/82- Party Name:ZIM Meet No/Date:1/82- Status:
ALC4/2019 LABORATORIES LIMITED ALC4/2019 Deferred
03.06.2019
601 HQ File<br>:01/82/050/00131/AM20/ RLA File<br>:03/95/040/00121/AM20/ Lic.No/Date:0310828917<br>09.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:140/1/82- Party Name:MALWA Meet No/Date:1/82- Status:
ALC4/2019 OXYGEN & INDUSTRIAL ALC4/2019 Deferred
GASES PVT.LTD., 03.06.2019
602 HQ File<br>:01/82/050/00140/AM20/ RLA File<br>:56/24/040/00035/AM19/ Lic.No/Date:5610005605<br>09.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Bhopal.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bhopal.

Case No.:141/1/82- Party Name:MALWA Meet No/Date:1/82- Status:
ALC4/2019 OXYGEN & INDUSTRIAL ALC4/2019 Deferred
GASES PVT.LTD., 03.06.2019
603 HQ File<br>:01/82/050/00141/AM20/ RLA File<br>:56/24/040/00034/AM19/ Lic.No/Date:5610005606<br>09.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Bhopal.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bhopal.

166

Case No.:274/1/82- Party Name:STYRAX LIFE Meet No/Date:1/82- Status:
ALC4/2019 SCIENCES PRIVATE ALC4/2019 Deferred
LIMITED 03.06.2019
604 HQ File<br>:01/82/050/00180/AM20/ RLA File<br>:26/24/040/00003/AM20/ Lic.No/Date:2610012877<br>09.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Kanpur.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Kanpur.

Case No.:109/1/82- Party Name:SAURAV Meet No/Date:1/82- Status:
ALC4/2019 CHEMICALS LIMITED ALC4/2019 Deferred
03.06.2019
605 HQ File<br>:01/82/050/00109/AM20/ RLA File<br>:22/24/040/00011/AM20/ Lic.No/Date:2210016146<br>10.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Chandigarh.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Chandigarh.

Case No.:114/1/82- Party Name:GLAND Meet No/Date:1/82- Status:
ALC4/2019 PHARMA LIMITED ALC4/2019 Deferred
03.06.2019
606 HQ File<br>:01/82/050/00114/AM20/ RLA File<br>:09/24/040/00040/AM20/ Lic.No/Date:0910067489<br>10.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:115/1/82- Party Name:GLAND Meet No/Date:1/82- Status:
ALC4/2019 PHARMA LIMITED ALC4/2019 Deferred
03.06.2019
607 HQ File<br>:01/82/050/00115/AM20/ RLA File<br>:09/24/040/00041/AM20/ Lic.No/Date:0910067490<br>10.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:116/1/82- Party Name:ZENITH Meet No/Date:1/82- Status:
ALC4/2019 DYEINTERMEDIATES ALC4/2019 Deferred
LIMITED 03.06.2019
608 HQ File<br>:01/82/050/00116/AM20/ RLA File<br>:03/95/040/00016/AM20/ Lic.No/Date:0310828945<br>10.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

167

Case No.:126/1/82- Party Name:RELIANCE Meet No/Date:1/82- Status:
ALC4/2019 INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
609 HQ File RLA File Lic.No/Date:0310828947 Defer Date:
:01/82/050/00126/AM20/ :03/95/040/01378/AM19/ 10.05.2019
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
Case No.:127/1/82- Party Name:RELIANCE Meet No/Date:1/82- Status:
ALC4/2019 INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
610 HQ File RLA File Lic.No/Date:0310828948 Defer Date:
:01/82/050/00127/AM20/ :03/95/040/00011/AM20/ 10.05.2019
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
Case No.:128/1/82- Party Name:RELIANCE Meet No/Date:1/82- Status:
ALC4/2019 INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
611 HQ File RLA File Lic.No/Date:0310828949 Defer Date:
:01/82/050/00128/AM20/ :03/95/040/00009/AM20/ 10.05.2019
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
Case No.:134/1/82- Party Name:STERILE INDIA Meet No/Date:1/82- Status:
ALC4/2019 PRIVATE LIMITED ALC4/2019 Deferred
03.06.2019
612 HQ File<br>:01/82/050/00134/AM20/ RLA File<br>:33/24/040/00004/AM20/ Lic.No/Date:3310030540<br>10.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Panipat.
Case No.:137/1/82- Party Name:ANLON Meet No/Date:1/82- Status:
ALC4/2019 HEALTHCARE ALC4/2019 Deferred
PRIVATELIMITED 03.06.2019
613 HQ File<br>:01/82/050/00137/AM20/ RLA File<br>:24/24/040/00004/AM20/ Lic.No/Date:2410042746<br>10.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Rajkot.

168

Case No.:138/1/82- Party Name:ANLON Meet No/Date:1/82- Status:
ALC4/2019 HEALTHCARE ALC4/2019 Deferred
PRIVATELIMITED 03.06.2019
614 HQ File<br>:01/82/050/00138/AM20/ RLA File<br>:24/24/040/00005/AM20/ Lic.No/Date:2410042747<br>10.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Rajkot.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Rajkot.

Case No.:139/1/82- Party Name:MAMTA Meet No/Date:1/82- Status:
ALC4/2019 POLYCOATS ALC4/2019 Deferred
03.06.2019
615 HQ File<br>:01/82/050/00139/AM20/ RLA File<br>:34/24/040/00048/AM20/ Lic.No/Date:3410045130<br>10.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Vadoara.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Vadoara.

Case No.:112/1/82- Party Name:LANTECH Meet No/Date:1/82- Status:
ALC4/2019 PHARMACEUTICALS ALC4/2019 Deferred
LIMITED 03.06.2019
616 HQ File<br>:01/82/050/00112/AM20/ RLA File<br>:09/24/040/00067/AM20/ Lic.No/Date:0910067504<br>13.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:132/1/82- Party Name:GLENMARK Meet No/Date:1/82- Status:
ALC4/2019 LIFE SCIENCES LIMITED ALC4/2019 Deferred
03.06.2019
617 HQ File<br>:01/82/050/00132/AM20/ RLA File<br>:03/94/040/00105/AM20/ Lic.No/Date:0310828961<br>13.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:133/1/82- Party Name:GLENMARK Meet No/Date:1/82- Status:
ALC4/2019 LIFE SCIENCES LIMITED ALC4/2019 Deferred
03.06.2019
618 HQ File<br>:01/82/050/00133/AM20/ RLA File<br>:03/94/040/00104/AM20/ Lic.No/Date:0310828962<br>13.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

169

Case No.:250/1/82- Party Name:GLAND Meet No/Date:1/82- Status:
ALC4/2019 PHARMA LIMITED ALC4/2019 Deferred
03.06.2019
619 HQ File<br>:01/82/050/00156/AM20/ RLA File<br>:09/24/040/00042/AM20/ Lic.No/Date:0910067505<br>13.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:255/1/82- Party Name:J.B. CHEMICALS Meet No/Date:1/82- Status:
ALC4/2019 & PHARMACEUTICALS ALC4/2019 Deferred
LIMITED 03.06.2019
620 HQ File<br>:01/82/050/00161/AM20/ RLA File<br>:03/94/040/00107/AM20/ Lic.No/Date:0310828984<br>13.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:258/1/82- Party Name:RELIANCE Meet No/Date:1/82- Status:
ALC4/2019 INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
621 HQ File RLA File Lic.No/Date:0310828978 Defer Date:
:01/82/050/00164/AM20/ :03/95/040/01370/AM19/ 13.05.2019
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
Case No.:259/1/82- Party Name:RELIANCE Meet No/Date:1/82- Status:
ALC4/2019 INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
622 HQ File RLA File Lic.No/Date:0310828979 Defer Date:
:01/82/050/00165/AM20/ :03/95/040/01348/AM19/ 13.05.2019
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
Case No.:248/1/82- Party Name:COVALENT Meet No/Date:1/82- Status:
ALC4/2019 LABORATORIES PRIVATE ALC4/2019 Deferred
LIMITED 03.06.2019
623 HQ File<br>:01/82/050/00154/AM20/ RLA File<br>:09/24/040/00047/AM20/ Lic.No/Date:0910067509<br>14.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

170

Case No.:251/1/82- Party Name:GLAND Meet No/Date:1/82- Status:
ALC4/2019 PHARMA LIMITED ALC4/2019 Deferred
03.06.2019
624 HQ File<br>:01/82/050/00157/AM20/ RLA File<br>:09/24/040/00043/AM20/ Lic.No/Date:0910067519<br>14.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:260/1/82- Party Name:RELIANCE Meet No/Date:1/82- Status:
ALC4/2019 INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
625 HQ File RLA File Lic.No/Date:0310829020 Defer Date:
:01/82/050/00166/AM20/ :03/95/040/01362/AM19/ 14.05.2019
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.
Case No.:261/1/82- Party Name:SANDHYA Meet No/Date:1/82- Status:
ALC4/2019 ORGANIC CHEMICALS ALC4/2019 Deferred
PVT.LTD. 03.06.2019
626 HQ File<br>:01/82/050/00167/AM20/ RLA File<br>:03/95/040/01388/AM19/ Lic.No/Date:0310828995<br>14.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:262/1/82- Party Name:SANDHYA Meet No/Date:1/82- Status:
ALC4/2019 ORGANIC CHEMICALS ALC4/2019 Deferred
PVT.LTD. 03.06.2019
627 HQ File<br>:01/82/050/00168/AM20/ RLA File<br>:03/95/040/01387/AM19/ Lic.No/Date:0310828997<br>14.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:263/1/82- Party Name:JUBILANT LIFE Meet No/Date:1/82- Status:
ALC4/2019 SCIENCES LIMITED ALC4/2019 Deferred
03.06.2019
628 HQ File<br>:01/82/050/00169/AM20/ RLA File<br>:05/23/040/00018/AM20/ Lic.No/Date:0510410573<br>14.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from CLA,New Delhi.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.

171

629 Case No.:264/1/82-<br>ALC4/2019 Party Name:JUBILANT LIFE<br>SCIENCES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00170/AM20/ RLA File<br>:05/23/040/00530/AM19/ Lic.No/Date:0510410582<br>14.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from CLA,New Delhi.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.

630 Case No.:265/1/82-<br>ALC4/2019 Party Name:PANACEA<br>BIOTEC LTD., Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00171/AM20/ RLA File<br>:05/24/040/00086/AM20/ Lic.No/Date:0510410569<br>14.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from CLA,New Delhi.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.

631 Case No.:266/1/82-<br>ALC4/2019 Party Name:SENTISS<br>PHARMA PVT.LTD. Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00172/AM20/ RLA File<br>:05/24/040/00060/AM20/ Lic.No/Date:0510410568<br>14.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from CLA,New Delhi.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.

632 Case No.:249/1/82-<br>ALC4/2019 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00071/AM20/ Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br> <br><br>Lic.No/Date:0910067527<br>15.05.2019<br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/00155/AM20/ Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

633 Case No.:252/1/82-<br>ALC4/2019 Party Name:GLAND<br>PHARMA LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00158/AM20/ RLA File<br>:09/24/040/00069/AM20/ Lic.No/Date:0910067532<br>15.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

172

634 Case No.:253/1/82-<br>ALC4/2019 Party Name:GLAND<br>PHARMA LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00159/AM20/ RLA File<br>:09/24/040/00068/AM20/ Lic.No/Date:0910067533<br>15.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:254/1/82- Party Name:AMITEX AGRO Meet No/Date:1/82- Status:
ALC4/2019 PRODUCT PVT LTD ALC4/2019 Deferred
03.06.2019
635 HQ File<br>:01/82/050/00160/AM20/ RLA File<br>:03/94/040/00102/AM20/ Lic.No/Date:0310829061<br>15.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:267/1/82- Party Name:CLEAN SCIENCE Meet No/Date:1/82- Status:
ALC4/2019 AND TECHNOLOGY ALC4/2019 Deferred
PVT.LTD. 03.06.2019
636 HQ File<br>:01/82/050/00173/AM20/ RLA File<br>:31/83/040/00017/AM20/ Lic.No/Date:3110067419<br>15.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Pune.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Pune.

Case No.:256/1/82- Party Name:J.B. CHEMICALS Meet No/Date:1/82- Status:
ALC4/2019 & PHARMACEUTICALS ALC4/2019 Deferred
LIMITED 03.06.2019
637 HQ File<br>:01/82/050/00162/AM20/ RLA File<br>:03/94/040/00072/AM20/ Lic.No/Date:0310829068<br>16.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:257/1/82- Party Name:J.B. CHEMICALS Meet No/Date:1/82- Status:
ALC4/2019 & PHARMACEUTICALS ALC4/2019 Deferred
LIMITED 03.06.2019
638 HQ File<br>:01/82/050/00163/AM20/ RLA File<br>:03/94/040/00115/AM20/ Lic.No/Date:0310829085<br>16.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

173

Case No.:268/1/82- Party Name:CLEAN SCIENCE Meet No/Date:1/82- Status:
ALC4/2019 AND TECHNOLOGY ALC4/2019 Deferred
PVT.LTD. 03.06.2019
639 HQ File<br>:01/82/050/00174/AM20/ RLA File<br>:31/83/040/00019/AM20/ Lic.No/Date:3110067424<br>16.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Pune.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Pune.

Case No.:269/1/82- Party Name:CLEAN SCIENCE Meet No/Date:1/82- Status:
ALC4/2019 AND TECHNOLOGY ALC4/2019 Deferred
PVT.LTD. 03.06.2019
640 HQ File<br>:01/82/050/00175/AM20/ RLA File<br>:31/83/040/00021/AM20/ Lic.No/Date:3110067425<br>16.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Pune.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Pune.

Case No.:270/1/82- Party Name:VISION DRUGS Meet No/Date:1/82- Status:
ALC4/2019 PVT LTD ALC4/2019 Deferred
03.06.2019
641 HQ File<br>:01/82/050/00176/AM20/ RLA File<br>:09/24/040/00048/AM20/ Lic.No/Date:0910067541<br>17.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:271/1/82- Party Name:ORCH Meet No/Date:1/82- Status:
ALC4/2019 LABORATORIES INDIA PVT ALC4/2019 Deferred
LTD 03.06.2019
642 HQ File<br>:01/82/050/00177/AM20/ RLA File<br>:09/24/040/00039/AM20/ Lic.No/Date:0910067543<br>17.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

643 Case No.:276/1/82-<br>ALC4/2019 Party Name:PIRAMAL<br>ENTERPRISES LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019<br>Lic.No/Date:0310829108<br>17.05.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00182/AM20/ RLA File<br>:03/95/040/00143/AM20/ Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

174

Case No.:272/1/82- Party Name:GLAND Meet No/Date:1/82- Status:
ALC4/2019 PHARMA LIMITED ALC4/2019 Deferred
03.06.2019
644 HQ File<br>:01/82/050/00178/AM20/ RLA File<br>:09/24/040/00077/AM20/ Lic.No/Date:0910067546<br>20.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:273/1/82- Party Name:GLAND Meet No/Date:1/82- Status: ALC4/2019 PHARMA LIMITED ALC4/2019 Deferred 03.06.2019 HQ File RLA File Lic.No/Date:0910067548 Defer Date: 645 :01/82/050/00179/AM20/ :09/24/040/00076/AM20/ 20.05.2019

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:275/1/82- Party Name:SUNSHIELD Meet No/Date:1/82- Status:
ALC4/2019 CHEMICALS LTD. ALC4/2019 Deferred
03.06.2019
646 HQ File<br>:01/82/050/00181/AM20/ RLA File<br>:03/95/040/00149/AM20/ Lic.No/Date:0310829140<br>20.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:277/1/82- Party Name:CADILA Meet No/Date:1/82- Status:
ALC4/2019 HEALTHCARE LTD ALC4/2019 Deferred
03.06.2019
647 HQ File<br>:01/82/050/00183/AM20/ RLA File<br>:08/24/040/00053/AM20/ Lic.No/Date:0810145319<br>21.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Ahmedabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.

Case No.:290/1/82- Party Name:GLENMARK Meet No/Date:1/82- Status:
ALC4/2019 LIFE SCIENCES LIMITED ALC4/2019 Deferred
03.06.2019
648 HQ File<br>:01/82/050/00196/AM20/ RLA File<br>:03/94/040/00113/AM20/ Lic.No/Date:0310829156<br>21.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

175

Case No.:291/1/82- Party Name:GLENMARK Meet No/Date:1/82- Status:
ALC4/2019 LIFE SCIENCES LIMITED ALC4/2019 Deferred
03.06.2019
649 HQ File<br>:01/82/050/00197/AM20/ RLA File<br>:03/94/040/00112/AM20/ Lic.No/Date:0310829157<br>21.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:293/1/82- Party Name:PRISM Meet No/Date:1/82- Status:
ALC4/2019 INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
650 HQ File<br>:01/82/050/00199/AM20/ RLA File<br>:34/24/040/00052/AM20/ Lic.No/Date:3410045164<br>21.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Vadodara.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Vadodara.

Case No.:278/1/82- Party Name:S V LABS PVT Meet No/Date:1/82- Status:
ALC4/2019 LTD ALC4/2019 Deferred
03.06.2019
651 HQ File<br>:01/82/050/00184/AM20/ RLA File<br>:09/24/040/00079/AM20/ Lic.No/Date:0910067560<br>22.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:279/1/82- Party Name:SMILAX Meet No/Date:1/82- Status:
ALC4/2019 LABORATORIES LIMITED ALC4/2019 Deferred
03.06.2019
652 HQ File<br>:01/82/050/00185/AM20/ RLA File<br>:09/24/040/00082/AM20/ Lic.No/Date:0910067559<br>22.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:280/1/82- Party Name:SMS Meet No/Date:1/82- Status:
ALC4/2019 LIFESCIENCES INDIA ALC4/2019 Deferred
LIMITED 03.06.2019
653 HQ File<br>:01/82/050/00186/AM20/ RLA File<br>:09/24/040/00084/AM20/ Lic.No/Date:0910067561<br>22.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

176

Case No.:281/1/82- Party Name:MERCK Meet No/Date:1/82- Status:
ALC4/2019 LIMITED ALC4/2019 Deferred
03.06.2019
654 HQ File<br>:01/82/050/00187/AM20/ RLA File<br>:03/95/040/00154/AM20/ Lic.No/Date:0310829201<br>22.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:282/1/82- Party Name:J.B. CHEMICALS Meet No/Date:1/82- Status:
ALC4/2019 & PHARMACEUTICALS ALC4/2019 Deferred
LIMITED 03.06.2019
655 HQ File<br>:01/82/050/00188/AM20/ RLA File<br>:03/94/040/00120/AM20/ Lic.No/Date:0310829196<br>22.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:283/1/82- Party Name:SALVI Meet No/Date:1/82- Status:
ALC4/2019 CHEMICAL INDUSTRIES ALC4/2019 Deferred
LIMITED 03.06.2019
656 HQ File<br>:01/82/050/00189/AM20/ RLA File<br>:03/95/040/00158/AM20/ Lic.No/Date:0310829176<br>22.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:284/1/82- Party Name:SALVI Meet No/Date:1/82- Status:
ALC4/2019 CHEMICAL INDUSTRIES ALC4/2019 Deferred
LIMITED 03.06.2019
657 HQ File<br>:01/82/050/00190/AM20/ RLA File<br>:03/95/040/00156/AM20/ Lic.No/Date:0310829177<br>22.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

177

658 Case No.:285/1/82-<br>ALC4/2019 Party Name:SALVI<br>CHEMICAL INDUSTRIES<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00191/AM20/ RLA File<br>:03/95/040/00157/AM20/ Lic.No/Date:0310829190<br>22.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

659 Case No.:286/1/82-<br>ALC4/2019 Party Name:SALVI<br>CHEMICAL INDUSTRIES<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00192/AM20/ RLA File<br>:03/95/040/00160/AM20/ Lic.No/Date:0310829199<br>22.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

660 Case No.:287/1/82-<br>ALC4/2019 Party Name:SALVI<br>CHEMICAL INDUSTRIES<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00193/AM20/ RLA File<br>:03/95/040/00161/AM20/ Lic.No/Date:0310829200<br>22.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

661 Case No.:288/1/82-<br>ALC4/2019 Party Name:SALVI<br>CHEMICAL INDUSTRIES<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00194/AM20/ RLA File<br>:03/95/040/00159/AM20/ Lic.No/Date:0310829205<br>22.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

662 Case No.:289/1/82-<br>ALC4/2019 Party Name:SANDHYA<br>ORGANIC CHEMICALS<br>PRIVATE LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00195/AM20/ RLA File<br>:03/95/040/00133/AM20/ Lic.No/Date:0310829197<br>22.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

178

Case No.:292/1/82- Party Name:ASIATIC DRUGS Meet No/Date:1/82- Status:
ALC4/2019 &PHARMACEUTICALS ALC4/2019 Deferred
PVT. LTD. 03.06.2019
663 HQ File<br>:01/82/050/00198/AM20/ RLA File<br>:05/23/040/00043/AM20/ Lic.No/Date:0510410660<br>22.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from CLA,New Delhi.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.

Case No.:296/1/82- Party Name:ADCOCK Meet No/Date:1/82- Status:
ALC4/2019 INGRAM LTD, ALC4/2019 Deferred
03.06.2019
664 HQ File<br>:01/82/050/00202/AM20/ RLA File<br>:07/24/040/00035/AM20/ Lic.No/Date:0710114945<br>23.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Bangalore.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bangalore.

Case No.:294/1/82- Party Name:CADILA Meet No/Date:1/82- Status:
ALC4/2019 HEALTHCARE LTD ALC4/2019 Deferred
03.06.2019
665 HQ File RLA File Lic.No/Date:0810145358 Defer Date:
:01/82/050/00200/AM20/ :08/24/040/00072/AM20/ 24.05.2019
**Decision:**Application received from RLA,Ahmedabad. Deferred for comments of TE.
Case No.:295/1/82- Party Name:CADILA Meet No/Date:1/82- Status:
ALC4/2019 HEALTHCARE LTD ALC4/2019 Deferred
03.06.2019
666 HQ File<br>:01/82/050/00201/AM20/ RLA File<br>:08/24/040/00061/AM20/ Lic.No/Date:0810145359<br>24.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Ahmedabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.

Case No.:297/1/82- Party Name:ADCOCK Meet No/Date:1/82- Status:
ALC4/2019 INGRAM LTD, ALC4/2019 Deferred
03.06.2019
667 HQ File<br>:01/82/050/00203/AM20/ RLA File<br>:07/24/040/00034/AM20/ Lic.No/Date:0710114948<br>24.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Bangalore.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bangalore.

179

Case No.:298/1/82- Party Name:ADCOCK Meet No/Date:1/82- Status:
ALC4/2019 INGRAM LTD, ALC4/2019 Deferred
03.06.2019
668 HQ File RLA File Lic.No/Date:0710114950 Defer Date:
:01/82/050/00204/AM20/ :07/24/040/00036/AM20/ 24.05.2019
**Decision:**Application received from RLA,Bangalore. Deferred for comments of TE.
Case No.:299/1/82- Party Name:RUBICON Meet No/Date:1/82- Status:
ALC4/2019 RESEARCH PVT. LTD., ALC4/2019 Deferred
03.06.2019
669 HQ File<br>:01/82/050/00205/AM20/ RLA File<br>:03/95/040/00103/AM20/ Lic.No/Date:0310829246<br>24.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:300/1/82- Party Name:GLENMARK Meet No/Date:1/82- Status:
ALC4/2019 LIFE SCIENCES LIMITED ALC4/2019 Deferred
03.06.2019
670 HQ File RLA File Lic.No/Date:0310829263 Defer Date:
:01/82/050/00206/AM20/ :03/94/040/00133/AM20/ 27.05.2019
**Decision:**Application received from RLA,Mumbai. Deferred for comments of TE.
Case No.:301/1/82- Party Name:GLENMARK Meet No/Date:1/82- Status:
ALC4/2019 LIFE SCIENCES LIMITED ALC4/2019 Deferred
03.06.2019
671 HQ File<br>:01/82/050/00207/AM20/ RLA File<br>:03/94/040/00134/AM20/ Lic.No/Date:0310829265<br>27.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:302/1/82- Party Name:BRAWN Meet No/Date:1/82- Status:
ALC4/2019 LABORATORIES LTD ALC4/2019 Deferred
03.06.2019
672 HQ File RLA File Lic.No/Date:0510410722 Defer Date:
:01/82/050/00208/AM20/ :05/23/040/00088/AM20/ 27.05.2019
**Decision:**Application received from CLA,New Delhi. Deferred for comments of TE.

180

Case No.:303/1/82- Party Name:CLEAN SCIENCE Meet No/Date:1/82- Status:
ALC4/2019 AND TECHNOLOGY ALC4/2019 Deferred
PVT.LTD. 03.06.2019
673 HQ File<br>:01/82/050/00209/AM20/ RLA File<br>:31/83/040/00032/AM20/ Lic.No/Date:3110067429<br>28.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Pune.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Pune.

Case No.:304/1/82- Party Name:VERGO Meet No/Date:1/82- Status:
ALC4/2019 PHARMA RESEARCH ALC4/2019 Deferred
LABORATORIES PVT. LTD., 03.06.2019
674 HQ File<br>:01/82/050/00210/AM20/ RLA File<br>:03/95/040/00182/AM20/ Lic.No/Date:0310829291<br>28.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:305/1/82- Party Name:RUMIT Meet No/Date:1/82- Status:
ALC4/2019 CHEMISYNTH PRIVATE ALC4/2019 Deferred
LIMITED 03.06.2019
675 HQ File<br>:01/82/050/00211/AM20/ RLA File<br>:03/95/040/00196/AM20/ Lic.No/Date:0310829292<br>28.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:306/1/82- Party Name:VERGO Meet No/Date:1/82- Status:
ALC4/2019 PHARMA RESEARCH ALC4/2019 Deferred
LABORATORIES PVT. LTD., 03.06.2019
676 HQ File<br>:01/82/050/00212/AM20/ RLA File<br>:03/95/040/00183/AM20/ Lic.No/Date:0310829293<br>28.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:307/1/82- Party Name:ATUL LIMITED, Meet No/Date:1/82- Status:
ALC4/2019 ALC4/2019 Deferred
03.06.2019
677 HQ File<br>:01/82/050/00213/AM20/ RLA File<br>:08/24/040/00073/AM20/ Lic.No/Date:0810145379<br>28.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Ahmedabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.

181

Case No.:308/1/82- Party Name:ATUL LIMITED, Meet No/Date:1/82- Status:
ALC4/2019 ALC4/2019 Deferred
03.06.2019
678 HQ File<br>:01/82/050/00214/AM20/ RLA File<br>:08/24/040/00074/AM20/ Lic.No/Date:0810145380<br>28.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Ahmedabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.

Case No.:311/1/82- Party Name:GLAND Meet No/Date:1/82- Status:
ALC4/2019 PHARMA LIMITED ALC4/2019 Deferred
03.06.2019
679 HQ File<br>:01/82/050/00217/AM20/ RLA File<br>:09/24/040/00090/AM20/ Lic.No/Date:0910067595<br>28.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

Case No.:312/1/82- Party Name:MEDREICH Meet No/Date:1/82- Status:
ALC4/2019 LIMITED ALC4/2019 Deferred
03.06.2019
680 HQ File RLA File Lic.No/Date:0710114969 Defer Date:
:01/82/050/00218/AM20/ :07/24/040/00027/AM20/ 28.05.2019
**Decision:**Application received from RLA,Bangalore. Deferred for comments of TE.
Case No.:309/1/82- Party Name:ASHISH LIFE Meet No/Date:1/82- Status:
ALC4/2019 SCIENCE PVT.LTD. ALC4/2019 Deferred
03.06.2019
681 HQ File<br>:01/82/050/00215/AM20/ RLA File<br>:03/94/040/00130/AM20/ Lic.No/Date:0310829306<br>29.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

Case No.:310/1/82- Party Name:YASHO Meet No/Date:1/82- Status:
ALC4/2019 INDUSTRIES LIMITED ALC4/2019 Deferred
03.06.2019
682 HQ File<br>:01/82/050/00216/AM20/ RLA File<br>:03/95/040/00188/AM20/ Lic.No/Date:0310829319<br>29.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

182

683 Case No.:313/1/82-<br>ALC4/2019 Party Name:GLAND<br>PHARMA LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00219/AM20/ RLA File<br>:09/24/040/00094/AM20/ Lic.No/Date:0910067596<br>29.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

684 Case No.:314/1/82-<br>ALC4/2019 Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00220/AM20/ RLA File<br>:07/24/040/00048/AM20/ Lic.No/Date:0710114983<br>29.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Bangalore.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bangalore.

685 Case No.:315/1/82-<br>ALC4/2019 Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00221/AM20/ RLA File<br>:07/24/040/00049/AM20/ Lic.No/Date:0710114984<br>29.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Bangalore.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bangalore.

686 Case No.:316/1/82-<br>ALC4/2019 Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00222/AM20/ RLA File<br>:09/24/040/00091/AM20/ Lic.No/Date:0910067597<br>30.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

687 Case No.:317/1/82-<br>ALC4/2019 Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00223/AM20/ RLA File<br>:09/24/040/00092/AM20/ Lic.No/Date:0910067598<br>30.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

183

688 Case No.:318/1/82-<br>ALC4/2019 Party Name:PORUS<br>LABORATORIES PVT LTD Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00224/AM20/ RLA File<br>:09/24/040/00085/AM20/ Lic.No/Date:0910067601<br>30.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.

689 Case No.:319/1/82-<br>ALC4/2019 Party Name:RAVESHIA<br>ORGANICS LLP Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00225/AM20/ RLA File<br>:03/95/040/00204/AM20/ Lic.No/Date:0310829355<br>30.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.

690 Case No.:320/1/82-<br>ALC4/2019 Party Name:DEEPAK<br>PHENOLICS LIMITED Meet No/Date:1/82-<br>ALC4/2019<br>03.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00226/AM20/ RLA File<br>:34/24/040/00036/AM20/ Lic.No/Date:3410045179<br>30.05.2019 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Vadodara.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Vadodara.

Meeting ended with thanks to Chair.


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