IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2019-07-05

DGFT Committee Minutes

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Office of Directorate General of Foreign Trade New Delhi -0

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Para 4.7 Decision

Minutes of the Norms Committee – 3 Meeting No. 3/82-ALC4/2019 dated 05.07.2019 (actually held on 05.07.2019 and 12.07.2019) 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. 2/82-ALC4/2019 dated 21.06.2019 (actually held on 21.06.2019 and 28.06.2019) and approved the same.

MEETING NUMBER : 3/82-ALC4/2019 MEETING DATE : 05.07..2019 (Actually held on 05.07.2019 and 12.07.2019)

ONLINE CASES

1 Case No.:104/23/82-<br>ALC4/2013 Party Name:PCL OIL &<br>SOLVENTS LTD., Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/01151/AM14/ RLA File<br>:05/24/040/00201/AM14/ Lic.No/Date:0510372321<br>29.11.2013
**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence<br>of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as<br>per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>PVC Plasticizer( DOP )<br>1 kg<br>1<br>Phthalic Anhydride<br>0.400 kg<br>2<br>2-Ethylhexanol (Octanol)<br>0.700 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

2

Case No.:1063/15/82- Party Name:MALLADI Meet No/Date:3/82- Status:
ALC4/2018 DRUGS & ALC4/2019 Approved
PHARMACEUTICALS 05.07.2019
LIMITED
HQ File RLA File Lic.No/Date:0410160592
:01/82/050/02520/AM19/ :04/24/040/00046/AM16/ 27.05.2015
**Decision:**The Committee considered case as **Decision:**The Committee considered case as **Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence per agenda and deliberated on the matter in the presence per agenda and deliberated on the matter in the presence per agenda and deliberated on the matter 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:
2 Export product Qty. Sl. Import items Qty.
No.
Phenylepherine Bitartrate 1 kg 1 3-Hydroxy Acetophenone 1.92 kg
2 Methanol 3.42 kg
3 L(+)Tartaric Acid 2.00 kg
4 Methyl Isobutyl Ketone Not shown in
CE certificate
5 Acetic Anhydride 1.60 kg
6 Iso Propyl Alcohol 5.17 kg
7 Caustic soda Flakes 0.46 kg
RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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.:137/14/82- Party Name:HPL ADDITIVES Meet No/Date:3/82- Status:
ALC4/2015 LIMITED(FORMERLY ALC4/2019 Approved
KNOWN HIGH POLYMER 05.07.2019
HQ File RLA File Lic.No/Date:0510395972
:01/82/050/01273/AM16/ :05/23/040/00275/AM16/ 19.10.2015

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken 3 in meeting no. 5/82-ALC4/2015 dated 25.06.2015, 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. Import items Qty.
Azodicarbonamide 1 kg Hydrazine Hydrate (100%) 0.548 kg
Technical Grade Urea 1.316 kg
RA maytake appropriate action asper the decision of Norms Committee.

3

Case No.:324/15/82- Party Name:RA CHEM Meet No/Date:3/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0910065457
:01/82/050/01781/AM19/ :09/24/040/00291/AM18/ 14.09.2017
Case No.:324/15/82- Case No.:324/15/82- Party Name:RA CHEM Party Name:RA CHEM Party Name:RA CHEM Party Name:RA CHEM Party Name:RA CHEM Party Name:RA CHEM Party Name:RA CHEM Meet No/Date:3/82- Status:
<br>ALC4/2018 <br>PHARMA LIMITED <br>ALC4/2019<br>05.07.2019 <br>Approved
HQ File<br>:01/82/050/01781/AM19/ RLA File<br>:09/24/040/00291/AM18/ Lic.No/Date:0910065457<br>14.09.2017
4 **Decision:**The Committ e considered case as per agenda and deliberated on the matt er in the presence
<br>of the technical experts and it was decided to ratify the ad-hoc input output norms under par<br>per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>2-(2,3-Dichlorophenyl)<br>Methylene<br>Hydrazine Carboximdamidine<br>1 kg<br>1<br>2,3-Dichloro Benzoyl Chloride<br>2<br>Amino Guanidine Bicarbonate<br>3<br>Cuprous Cyanide<br>4<br>Hexane <br>a 4.7 of HBP as<br>Qty.<br> <br>1.60 kg<br> <br>1.06 kg<br>0.69 kg<br>2.02 kg
Qty. Sl.<br>No. Import items Qty.
1 kg 1 2,3-Dichloro Benzoyl Chloride <br>1.60 kg
2 Amino Guanidine Bicarbonate <br>1.06 kg
3 Cuprous Cyanide 0.69 kg
4 Hexane 2.02 kg
RA concerned maytake further necessary action asper above decision of NC.
5 Case No.:44/12/82-<br>ALC4/2018 Party Name:KRISHNA<br>ANTIOXIDANTS PVT. LTD. Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved
HQ File RLA File Lic.No/Date:0310821359
<br>:01/82/050/00671/AM19/ :03/94/040/00145/AM19/ 31.05.2018
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken<br>in meeting no. 1/82-ALC4/2019 dated 03.06.2019, 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>TRI ISODECYL PHOSPHITE<br>1 kg<br>1<br>YELLOW PHOSPHORUS<br>0.065 kg<br>2<br>PHENOL<br>0.090 kg<br>3<br>ISODECYL ALCOHOL<br>0.973 kg
Export product Qty. Sl.<br>No. Import items Qty.
TRI ISODECYL PHOSPHITE 1 kg 1 YELLOW PHOSPHORUS 0.065 kg
2 PHENOL 0.090 kg
3 ISODECYL ALCOHOL 0.973 kg
RA maytake appropriate action asper the decision of Norms Committee.
6 Case No.:462/15/82-<br>ALC4/2018 Party Name:SMILAX Meet No/Date:3/82- Status:
<br>LABORATORIES LIMITED ALC4/2019<br>05.07.2019 Deferred
HQ File<br>:01/82/050/01919/AM19/ RLA File<br>:09/24/040/00223/AM19/ Lic.No/Date:0910066557<br>10.08.2018 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:462/15/82- Party Name:SMILAX Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES LIMITED ALC4/2019 Deferred
05.07.2019
6 HQ File RLA File Lic.No/Date:0910066557 Defer
:01/82/050/01919/AM19/ :09/24/040/00223/AM19/ 10.08.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.

4

Case No.:464/15/82- Party Name:MYLAN Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES LIMITED ALC4/2019 Deferred
05.07.2019
7 HQ File RLA File Lic.No/Date:0910066565 Defer
:01/82/050/01921/AM19/ :09/24/040/00175/AM19/ 13.08.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:537/15/82- Party Name:MEDWISE Meet No/Date:3/82- Status:
ALC4/2018 OVERSEAS PRIVATE ALC4/2019 Deferred
LIMITED 05.07.2019
HQ File RLA File Lic.No/Date:0810143251 Defer
:01/82/050/01994/AM19/ :08/24/040/00141/AM19/ 13.08.2018 Date:05.07.2019

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

(i) Export quantity in Nos. of tablets. (ii) DML.

Case No.:470/15/82- Party Name:JODAS EXPOIM Meet No/Date:3/82- Status:
ALC4/2018 PVT.LTD ALC4/2019 Deferred
05.07.2019
9 HQ File RLA File Lic.No/Date:0510407550 Defer
:01/82/050/01927/AM19/ :05/23/040/00232/AM19/ 20.08.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:471/15/82- Party Name:JODAS EXPOIM Meet No/Date:3/82- Status:
ALC4/2018 PVT.LTD ALC4/2019 Deferred
05.07.2019
10 HQ File RLA File Lic.No/Date:0510407551 Defer
:01/82/050/01928/AM19/ :05/23/040/00231/AM19/ 20.08.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:472/15/82- Party Name:WINTAC Meet No/Date:3/82- Status:
ALC4/2018 LIMITED, ALC4/2019 Deferred
05.07.2019
HQ File RLA File Lic.No/Date:0710113733 Defer
:01/82/050/01929/AM19/ :07/24/040/00131/AM19/ 20.08.2018 Date:05.07.2019

11 Decision: RLA, Bangalore was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07 application of subject Advance Authorization. However, the application is still awaited from RLA, Bangalore. Hence, it was decided to issue a Reminder to RLA, Bangalore for furnishing a copy of application expeditiously.

Further, the Committee considered the case as per agenda and it was decided to call for a copy of DML from the firm.

5

12 Case No.:474/15/82-<br>ALC4/2018 Party Name:MEDREICH<br>LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01931/AM19/ RLA File<br>:07/24/040/00129/AM19/ Lic.No/Date:0710113746<br>23.08.2018 Defer<br>Date:05.07.2019
<br>**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information:<br>(i)<br>Copy of DML.<br>(ii)<br>Master Batch Formula.
13 Case No.:475/15/82-<br>ALC4/2018 Party Name:WINTAC<br>LIMITED,<br>RLA File<br>:07/24/040/00098/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/01932/AM19/ Lic.No/Date:0710113754<br>24.08.2018
Decision:<br>RLA, Bangalore was requested vide e-mail dated 05.04.2019 to furnish the hard copy of<br>4.07 application of subject Advance Authorization. Application awaited from RLA, Bangalore. However,<br>the application is still awaited. Hence, it was decided to issue a Reminder to RLA, Bangalore for furnishing<br>a copyof application expeditiously.
14 <br>Case No.:35/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00249/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/01492/AM19/ Lic.No/Date:0910066604<br>29.08.2018
**Decision:**Deferred for comments of TE.
15 <br>Case No.:492/15/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01949/AM19/ RLA File<br>:09/24/040/00245/AM19/ Lic.No/Date:0910066600<br>29.08.2018 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
16 <br>Case No.:502/15/82-<br>ALC4/2018 Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01959/AM19/ RLA File<br>:09/24/040/00260/AM19/ Lic.No/Date:0910066621<br>03.09.2018 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

6

Case No.:504/15/82- Party Name:GLOBAL Meet No/Date:3/82- Status:
ALC4/2018 CALCIUM PRIVATE ALC4/2019 Approved
LIMITED, 05.07.2019
HQ File RLA File Lic.No/Date:0710113808
:01/82/050/01961/AM19/ :07/24/040/00116/AM19/ 03.09.2018

17

Decision: The Committee considered case as per agenda and deliberated on the matter 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.<br>No. Import items Qty.
MAGNESIUM ASCORBATE 1 kg 1 ASCORBIC ACID 1.1 kg
CALCIUM ASCORBATE (BP/USP) 1 kg 1 ASCORBIC ACID 0.964 kg
ZINC ASCORBATE <br>1 kg 1 ASCORBIC ACID <br>0.989 kg
SODIUM ASCORBATE (BP/EP/USP) 1 kg 1 ASCORBIC ACID 1.03 kg

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

Case No.:44/15/82- Party Name:DISCOVERY Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES PRIVATE ALC4/2019 Deferred
LIMITED 05.07.2019
18 HQ File RLA File Lic.No/Date:0910066631 Defer
:01/82/050/01501/AM19/ :09/24/040/00283/AM19/ 06.09.2018 Date:05.07.2019
**Decision:**The Committee considered the case as per agenda and it was decided to call for complete
technical details asper Appendix 4E alongwith chemistry,Molecular weight and % ofyield.
Case No.:40/15/82- Party Name:INCHEM Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES PRIVATE ALC4/2019 Deferred
LIMITED 05.07.2019
19 HQ File RLA File Lic.No/Date:0910066657 Defer
:01/82/050/01497/AM19/ :09/24/040/00230/AM19/ 11.09.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:41/15/82- Party Name:INCHEM Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES PRIVATE ALC4/2019 Deferred
LIMITED 05.07.2019
20 HQ File RLA File Lic.No/Date:0910066658 Defer
:01/82/050/01498/AM19/ :09/24/040/00261/AM19/ 11.09.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.

7

Case No.:667/15/82- Party Name:GLOBAL Meet No/Date:3/82- Status:
ALC4/2018 CALCIUM PRIVATE ALC4/2019 Approved
LIMITED 05.07.2019
HQ File RLA File Lic.No/Date:0710113844
:01/82/050/02124/AM19/ :07/24/040/00147/AM19/ 12.09.2018
**Decision:**The Committee **Decision:**The Committee considered the cases as per agenda and in the light of earlier decision considered the cases as per agenda and in the light of earlier decision considered the cases as per agenda and in the light of earlier decision considered the cases as per agenda and in the light of earlier decision considered the cases as per agenda and in the light of earlier decision
taken in meeting no. 1/82-ALC4/2019 dated 03.06.2019, 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.
MAGNESIUM CITRATE(USP/ 1 kg 1 CITRIC ACID - ANY GRADE 1.001 kg
21 NONAHYDRATE Eur.Ph/<br>ANHYDROUS Eur.Ph/ 2 MAGNESIUM CARBONATE -<br>ANY GRADE 0.730 kg
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.

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 1/82-ALC4/2019 dated 03.06.2019, 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:

Case No.:519/15/82- Party Name:SUVEN LIFE Meet No/Date:3/82- Status: Deferred
ALC4/2018 SCIENCES LIMITED ALC4/2019
05.07.2019
22 HQ File RLA File Lic.No/Date:0910066679 Defer
:01/82/050/01976/AM19/ :09/24/040/00288/AM19/ 18.09.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:538/15/82- Party Name:NAVIN Meet No/Date:3/82- Status:
ALC4/2018 FLUORINE ALC4/2019 Approved
INTERNATIONAL 05.07.2019
LIMITED
HQ File RLA File Lic.No/Date:0310823846
:01/82/050/01995/AM19/ :03/95/040/00112/AM19/ 19.09.2018

Decision: The Committee considered case as per agenda and deliberated on the matter in the 23 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.<br>No. Import items Qty.
META AMINO BENZO TRI<br>FLUORIDE (MABTF) 1 kg 1 BENZOTRIFLUORIDE<br>(BTF) 1.07 kg

8

Case No.:558/15/82- Party Meet No/Date:3/82- Status:
ALC4/2018 Name:METROPOLITAN ALC4/2019 Approved
EXIMCHEM PRIVATE LTD. 05.07.2019
HQ File RLA File Lic.No/Date:0310823899
:01/82/050/02015/AM19/ :03/95/040/00613/AM19/ 21.09.2018

Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of 24 HBP as per details below or as applied by firm whichever is lower:

Export product Qty. Sl.<br>No. Import items Qty.
CPPM (3-(2-CHLORO<br>PROPIONYLAMINO)-PROPIONIC<br>ACID METHYL ESTER 1 kg 1 BETA ALANINE 0.707 kg
2 2-CHLORO PROPIONYL<br>CHLORIDE 1.11 kg
25 Case No.:525/15/82-<br>ALC4/2018 Party Name:SHILPA<br>MEDICARE LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01982/AM19/ RLA File<br>:07/24/040/00164/AM19/ Lic.No/Date:0710113890<br>25.09.2018 Defer<br>Date:05.07.2019
**Decision:**RLA, Bangalore was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07<br>application of subject Advance Authorization. However, the application is still awaited from RLA,<br>Bangalore. Hence, it was decided to issue a Reminder to RLA, Bangalore for furnishing a hard copy of 4.07<br>application expeditiously.

Decision: RLA, Bangalore was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07 application of subject Advance Authorization. However, the application is still awaited from RLA, Bangalore. Hence, it was decided to issue a Reminder to RLA, Bangalore for furnishing a hard copy of 4.07 application expeditiously.

9

Case No.:531/15/82- Party Name:CADILA Meet No/Date:3/82- Status:
ALC4/2018 HEALTHCARE LTD ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0810143555
:01/82/050/01988/AM19/ :08/24/040/00212/AM19/ 25.09.2018
Case No.:531/15/82-<br>ALC4/2018 Party Name:CADILA<br>HEALTHCARE LTD Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br>Lic.No/Date:0810143555<br>25.09.2018 Status:<br>Approved
HQ File<br>:01/82/050/01988/AM19/ RLA File<br>:08/24/040/00212/AM19/
26 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per<br>details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>DIHYDROERGOTAMINE<br>MESYLATE<br>INJECTION<br>USP<br>1MG/ML<br>(1ML<br>VIAL)<br>(ACTIVE<br>INGREDIENT<br>:<br>DIHYDROERGOTAMINE<br>MESYLATE USP - NET WT.<br>166.66<br>GMS)<br>&<br>(PACKING<br>MATERIAL IN FINISHED FORM<br>- NET NOS. 62500)<br>166664<br>Number<br>1<br>DIHYDROERGOTAMINE<br>MESYLATE USP<br>183.33<br>gram<br>2<br>2 ML USP TYPE I AMBER<br>TREATED<br>GLASS<br>VIAL<br>(AS PER GENERAL NOTE<br>FOR<br>CHEMICAL<br>AND<br>ALLIED PRODUCTS POINT<br>NO.<br>5,<br>WASTAGE<br>ALLOWED @ 5%)<br>Relevant<br>as per<br>packing<br>policy<br>3<br>13<br>MM<br>FLUROTEC<br>RUBBER<br>STOPPER<br>(AS PER GENERAL NOTE<br>FOR<br>CHEMICAL<br>AND<br>ALLIED PRODUCTS POINT<br>NO.<br>5,<br>WASTAGE<br>ALLOWED @ 1%)<br>Relevant<br>as per<br>packing<br>policy<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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:

27 Case No.:534/15/82-<br>ALC4/2018 Party Name:YASH<br>RASAYAN & CHEMICALS Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/01991/AM19/ RLA File<br>:34/24/040/00184/AM19/ Lic.No/Date:3410044523<br>26.09.2018
**Decision:**RLA, Vadodara was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07<br>application of subject Advance Authorization. However, the application is still awaited from RLA,<br>Vadodara. Hence, it was decided to issue a Reminder to RLA, Vadodara for furnishing a hard copy of 4.07<br>application expeditiously.

Decision: RLA, Vadodara was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07 application of subject Advance Authorization. However, the application is still awaited from RLA, Vadodara. Hence, it was decided to issue a Reminder to RLA, Vadodara for furnishing a hard copy of 4.07 application expeditiously.

28 Case No.:536/15/82-<br>ALC4/2018 Party Name:YASH<br>RASAYAN & CHEMICALS Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/01993/AM19/ RLA File<br>:34/24/040/00185/AM19/ Lic.No/Date:3410044524<br>26.09.2018
**Decision:**RLA, Vadodara was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07<br>application of subject Advance Authorization. However, the application is still awaited from RLA,<br>Vadodara. Hence, it was decided to issue a Reminder to RLA, Vadodara for furnishing a hard copy of 4.07<br>application expeditiously.

Decision: RLA, Vadodara was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07 application of subject Advance Authorization. However, the application is still awaited from RLA, Vadodara. Hence, it was decided to issue a Reminder to RLA, Vadodara for furnishing a hard copy of 4.07 application expeditiously.

10

Case No.:560/15/82- Party Name:MATRIX FINE Meet No/Date:3/82- Status:
ALC4/2018 SCIENCES PVT.LTD., ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310824019
:01/82/050/02017/AM19/ :03/95/040/00488/AM19/ 26.09.2018
Case No.:560/15/82-<br>ALC4/2018 Party Name:MATRIX FINE<br>SCIENCES PVT.LTD., Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br>Lic.No/Date:0310824019<br>26.09.2018 Status:<br>Approved
HQ File<br>:01/82/050/02017/AM19/ RLA File<br>:03/95/040/00488/AM19/
29 <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 as<br>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>D Alpha Tocopherol having Net Content<br>of Fatty Acid Distillate / Deoderised<br>Distillate 727000.00 KGS<br>Methenol 99 PERCENT 222400.00 KGS<br>S Heptane 71200.00 KGS Acetone<br>29000.00 KGS<br>1 kg<br>1<br>Fatty Acid Distillate /<br>Deoderised Distillate<br>33.50 kg<br>2<br>Methenol99%<br>10.25 kg<br>3<br>S-Heptane<br>3.28 kg<br>4<br>Acetone<br>1.34 kg<br>Note:<br>1. RA will verify the documents for the export of following bye-products, at the time of<br>redemption, against the present licence viz:<br>(i)<br>Fatty Acid Distillate / Residue – 3.63 kg per kg export of D Alpha Tocopherol.<br>(ii)<br>Phytosteral – 1.09 kg per kg export of D Alpha Tecopherol.<br>2. In future, the firm shall take the export obligation for the by-products alongwith the main<br>export product – D Alpha Tocopherol.<br>RA may take appropriate action as 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. 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:

Case No.:612/15/82- Party Name:MANGALAM Meet No/Date:3/82- Status:
ALC4/2018 ORGANICS LIMITED ALC4/2019 Deferred
(FORMERLY DUJODWALA 05.07.2019
HQ File RLA File Lic.No/Date:0310824148 Defer
:01/82/050/02069/AM19/ :03/95/040/00560/AM19/ 03.10.2018 Date:05.07.2019

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

(i) Complete technical details as per Appendix 4E (ii) Catalogue of import item No. 2.

11

Case No.:543/15/82- Party Name:VIVIMED LABS Meet No/Date:3/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0910066709
:01/82/050/02000/AM19/ :09/24/040/00316/AM19/ 04.10.2018
ALC4/2018<br>LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02000/AM19/<br>RLA File<br>:09/24/040/00316/AM19/<br>Lic.No/Date:0910066709<br>04.10.2018 ALC4/2018<br>LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02000/AM19/<br>RLA File<br>:09/24/040/00316/AM19/<br>Lic.No/Date:0910066709<br>04.10.2018 ALC4/2018<br>LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02000/AM19/<br>RLA File<br>:09/24/040/00316/AM19/<br>Lic.No/Date:0910066709<br>04.10.2018 ALC4/2018<br>LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02000/AM19/<br>RLA File<br>:09/24/040/00316/AM19/<br>Lic.No/Date:0910066709<br>04.10.2018 ALC4/2018<br>LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02000/AM19/<br>RLA File<br>:09/24/040/00316/AM19/<br>Lic.No/Date:0910066709<br>04.10.2018 ALC4/2018<br>LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02000/AM19/<br>RLA File<br>:09/24/040/00316/AM19/<br>Lic.No/Date:0910066709<br>04.10.2018 ALC4/2018<br>LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02000/AM19/<br>RLA File<br>:09/24/040/00316/AM19/<br>Lic.No/Date:0910066709<br>04.10.2018
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision
taken in meeting no. 6/82-ALC4/2014 dated 29.08.2014, 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:
Export product Qty. Sl. Import items Qty.
31 No.
ROFLOX TABLETS 250 mg (10 1 1 Levofloxacin Hemihydrate 261.35 mg
PACKS) Number USP / 250 mg
tablet
ROFLOX TABLETS 500 mg (10 1 1 Levofloxacin Hemihydrate 522.70 mg
PACKS) Number USP / 500 mg
tablet
ROFLOX TABLETS 500 mg (5 1 1 Levofloxacin Hemihydrate 522.70 mg
PACKS) Number USP / 500 mg
tablet
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. 6/82-ALC4/2014 dated 29.08.2014, 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:

Case No.:562/15/82- Party Name:ORTIN Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2019 Deferred
05.07.2019
32 HQ File RLA File Lic.No/Date:0910066712 Defer
:01/82/050/02019/AM19/ :09/24/040/00302/AM19/ 04.10.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:563/15/82- Party Name:S M S Meet No/Date:3/82- Status:
ALC4/2018 PHARMACEUTICALS LTD ALC4/2019 Deferred
05.07.2019
33 HQ File RLA File Lic.No/Date:0910066714 Defer
:01/82/050/02020/AM19/ :09/24/040/00318/AM19/ 04.10.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
34 <br>Case No.:565/15/82-<br>ALC4/2018 Party Name:S M S<br>PHARMACEUTICALS LTD Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br>Lic.No/Date:0910066716<br>04.10.2018 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02022/AM19/ RLA File<br>:09/24/040/00319/AM19/ Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

12

35 Case No.:567/15/82-<br>ALC4/2018 Party Name:VERVE HUMAN<br>CARE LABORATORIES Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/02024/AM19/ RLA File<br>:61/24/040/00009/AM19/ Lic.No/Date:6110001546<br>04.10.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information from the firm:<br>(i)<br>Copyof DML alongwith approved composition of each export item.
Case No.:568/15/82- Party Name:PAB ORGANICS Meet No/Date:3/82- Status:
ALC4/2018 PVT.LTD, ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:3410044551
:01/82/050/02025/AM19/ :34/24/040/00124/AM19/ 05.10.2018

Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of 36 HBP as per details below or as applied by firm whichever is lower:

Export product Qty. Sl. Import items Qty.
No.
+/-, -3- (CARBAMOYL METHYL) - 1 kg 1 2-CYANOACETAMIDE 1.40 kg
5- METHYLHEXANOIC ACID 2 ISOVALERALDEHYDE 0.72 kg
(ISOVALERAL)
Case No.:569/15/82- Party Name:JODAS EXPOIM Meet No/Date:3/82- Status:
ALC4/2018 PVT.LTD ALC4/2019 Deferred
05.07.2019
37 HQ File RLA File Lic.No/Date:0510408024 Defer
:01/82/050/02026/AM19/ :05/23/040/00297/AM19/ 08.10.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:570/15/82- Party Name:JODAS EXPOIM Meet No/Date:3/82- Status:
ALC4/2018 PVT.LTD ALC4/2019 Deferred
05.07.2019
38 HQ File RLA File Lic.No/Date:0510408025 Defer
:01/82/050/02027/AM19/ :05/23/040/00295/AM19/ 08.10.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:572/15/82- Party Name:A.R. LIFE Meet No/Date:3/82- Status:
ALC4/2018 SCIENCES PVT LTD ALC4/2019 Deferred
05.07.2019
39 HQ File RLA File Lic.No/Date:0910066726 Defer
:01/82/050/02029/AM19/ :09/24/040/00309/AM19/ 08.10.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.

13

40

Case No.:578/15/82- Party Name:SURVIVAL Meet No/Date:3/82- Status:
ALC4/2018 TECHNOLOGIES PVT.LTD. ALC4/2019 Deferred
05.07.2019
HQ File RLA File Lic.No/Date:0310824348 Defer
:01/82/050/02035/AM19/ :03/95/040/00679/AM19/ 10.10.2018 Date:05.07.2019

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

(i) Justification for use of 2 ml of Sodium Borohydride in reaction. (ii) Justification for low recovery of solvent.

Case No.:587/15/82- Party Name:CAMUS Meet No/Date:3/82- Status:
ALC4/2018 BIOTECH PRIVATE ALC4/2019 Approved
LIMITED 05.07.2019
HQ File RLA File Lic.No/Date:0910066735
:01/82/050/02044/AM19/ :09/24/040/00299/AM19/ 10.10.2018

Decision: The Committee considered case as per agenda and deliberated on the matter 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: 41

Export product Qty. Sl. Import items Qty.
No.
D2 AMINO BUTANOL 1 kg 1 DL-2-AMINO-1-BUTANOL 2.2642 kg
2 MONOSODIUM 0.90 kg
GLUTAMATE
3 TOLUENE 0.60 kg
Case No.:101/15/82- Party Name:O C Meet No/Date:3/82- Status:
ALC4/2018 SPECIALITIES PVT.LTD. ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310824363
:01/82/050/01558/AM19/ :03/95/040/00699/AM19/ 11.10.2018

Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of 42 HBP as per details below or as applied by firm whichever is lower:

Export product Qty. Sl. Import items Qty.
No.
METHYL-2- 1 kg 1 PROPIONIC ACID 0.911 kg
CHLOROPROPIONATE

14

43 Case No.:582/15/82-<br>ALC4/2018 Party Name:MACSON<br>PRODUCTS Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/02039/AM19/ RLA File<br>:52/24/040/00039/AM19/ Lic.No/Date:5210042796<br>11.10.2018
**Decision:**RLA, Surat was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07<br>application of subject Advance Authorization. However, the application is still awaited from RLA, Surat.<br>Hence,it was decided to issue a Reminder to RLA,Surat for furnishinga copyof application expeditiously.
44 Case No.:590/15/82-<br>ALC4/2018 Party Name:VERVE HUMAN<br>CARE LABORATORIES Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02047/AM19/ RLA File<br>:61/24/040/00011/AM19/ Lic.No/Date:6110001553<br>11.10.2018 Defer<br>Date:05.07.2019
**Decision:**RLA, Dehradun was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07<br>application of subject Advance Authorization. However, the application is still awaited from RLA,<br>Dehradun. Hence, it was decided to issue a Reminder to RLA, Dehradun for furnishing a copy of<br>application expeditiously.

Decision: RLA, Dehradun was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07 application of subject Advance Authorization. However, the application is still awaited from RLA, Dehradun. Hence, it was decided to issue a Reminder to RLA, Dehradun for furnishing a copy of application expeditiously.

45 Case No.:801/15/82-<br>ALC4/2018 Party Name:DEEPAK<br>PHENOLICS LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02258/AM19/ RLA File<br>:34/24/040/00230/AM19/ Lic.No/Date:3410044580<br>11.10.2018 Defer<br>Date:05.07.2019
**Decision:**RLA, Vadodara was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07<br>application of subject Advance Authorization. However, the application is still awaited from RLA,<br>Vadodara. Hence, it was decided to issue a Reminder to RLA, Vadodara for furnishing a copy of<br>application expeditiously.

Decision: RLA, Vadodara was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07 application of subject Advance Authorization. However, the application is still awaited from RLA, Vadodara. Hence, it was decided to issue a Reminder to RLA, Vadodara for furnishing a copy of application expeditiously.

Case No.:588/15/82- Party Name:S V LABS PVT Meet No/Date:3/82- Status:
ALC4/2018 LTD ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0910066750
:01/82/050/02045/AM19/ :09/24/040/00330/AM19/ 15.10.2018

Decision: The Committee considered case as per agenda and deliberated on the matter in the 46 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.
No.
FCE (SA) 1 kg 1 5-Flouro Cytosine 0.44 kg
RA concerned maytake further necessaryaction asper above decision of NC.

15

Case No.:589/15/82- Party Name:S V LABS PVT Meet No/Date:3/82- Status:
ALC4/2018 LTD ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0910066751
:01/82/050/02046/AM19/ :09/24/040/00339/AM19/ 15.10.2018

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

Export product Qty. Sl.<br>No. Import items Qty.
FCE (SA) 1 kg 1 5-Flouro Cytosine 0.44 kg
2 2,5-DIHYDROXY-1,4<br>DITHANE (DIOL) 0.28 kg
48 <br>Case No.:592/15/82-<br>ALC4/2018 Party Name:SRIAM LABS<br>PRIVATE LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/02049/AM19/ RLA File<br>:09/24/040/00338/AM19/ Lic.No/Date:0910066753<br>16.10.2018
**Decision:**Deferred for comments of TE.
Case No.:157/15/82- Party Name:VAKS PHARMA Meet No/Date:3/82- Status:
ALC4/2018 PVT.LTD., ALC4/2019 Deferred
05.07.2019
HQ File RLA File Lic.No/Date:0310824491 Defer
:01/82/050/01614/AM19/ :03/95/040/00732/AM19/ 17.10.2018 Date:05.07.2019

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

(i) Whether the Soft Gelatin Capsules to be exported are empty or filled. (ii) In case of Filled Capsules, complete details of each type of capsules such as weight of empty capsules, weight of finished goods, their approved composition, wastage claimed etc. is to be furnished.

16

Case No.:173/15/82- Party Name:VITAL Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES PRIVATE ALC4/2019 Approved
LIMITED 05.07.2019
HQ File RLA File Lic.No/Date:0310824503
:01/82/050/01630/AM19/ :03/95/040/00415/AM19/ 17.10.2018

Decision: The Committee considered case as per agenda and deliberated on the matter 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:

50

Export product Qty. Sl.<br>No. Import items Qty.
LUMEFANTRINE PH.I. 1 kg 1 9H FLUORENE 0.90 kg
2 PARA CHLORO<br>BENZALDEHYDE 0.3476 kg
3 METHANOL 2.19 kg
4 METHYLENE DICHLORIDE 1.38 kg
51 <br>Case No.:174/15/82-<br>ALC4/2018 Party Name:VITAL<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/01631/AM19/ RLA File<br>:03/95/040/00527/AM19/ Lic.No/Date:0310824501<br>17.10.2018
**Decision:**Deferred for comments of TE.
52 <br>Case No.:178/15/82-<br>ALC4/2018 Party Name:VITAL<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01635/AM19/ RLA File<br>:03/95/040/00548/AM19/ Lic.No/Date:0310824502<br>17.10.2018 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

17

Case No.:175/15/82- Party Name:VITAL Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES PRIVATE ALC4/2019 Approved
LIMITED 05.07.2019
HQ File RLA File Lic.No/Date:0310824604
:01/82/050/01632/AM19/ :03/95/040/00547/AM19/ 23.10.2018

Decision: The Committee considered case as per agenda and deliberated on the matter 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

Export product Qty. Sl. Import items Qty.
No.
YOHIMBINE HYDROCHLORIDE 1 kg 1 YOHIMBINE BARK 100.0 kg
BP/EP/USP (CONTAINING YOHIMBINE
CONTENT MAXIMUM 1 -
1.2%)
Case No.:169/15/82- Party Name:WOCKHARDT Meet No/Date:3/82- Status:
ALC4/2018 LIMITED ALC4/2019 Deferred
05.07.2019
54 HQ File RLA File Lic.No/Date:0310824651 Defer
:01/82/050/01626/AM19/ :03/95/040/00755/AM19/ 24.10.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:595/15/82- Party Name:SHODHANA Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0910066758
:01/82/050/02052/AM19/ :09/24/040/00343/AM19/ 24.10.2018

Decision: The Committee considered case as per agenda and deliberated on the matter 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: 55

Export product Qty. Sl. Import items Qty.
No.
4-Hydroxy Carbazole 1 kg 1 Resorcinol 2.31 kg
Raw Material
2 Phenyl Hydrazine HCL 2.50 kg
RawMaterial

18

Case No.:596/15/82- Party Name:AUROBINDO Meet No/Date:3/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0910066761
:01/82/050/02053/AM19/ :09/24/040/00346/AM19/ 25.10.2018
Case No.:596/15/82- Case No.:596/15/82- Party Name:AUROBINDO Party Name:AUROBINDO Party Name:AUROBINDO Party Name:AUROBINDO Meet No/Date:3/82- Status: Status: Status:
<br>ALC4/2018 <br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00346/AM19/ <br>ALC4/2019<br>05.07.2019 <br>Approved
HQ File Lic.No/Date:0910066761
<br>:01/82/050/02053/AM19/ <br>25.10.2018
**Decision:**The Co mmittee considered case as per agenda and deliberated on the matter in the
<br>presence of the technical experts and it wa<br>HBP as per details below or as applied by<br>Export product<br>Qty.<br>SultamicillinTosylate<br>1 kg <br>s decided to ratify the ad-hoc input output norms<br>firm whichever is lower: <br>under para 4.7 of<br>Qty.<br>0.6049 kg
Export product Qty. Sl. No. Import items Qty.
SultamicillinTosylate 1 kg 1 Iodomethyl Sulbactam 0.6049 kg
2 6-Amino Penicillanic Acid (6-APA) 0.418 kg
3 Methyl Acetoacetate (MAA) 0.366 kg
56 4 D(-) Alph<br>Base) a Phenyl Glycine Base (PG 0.3301 kg
5 Potassium Carbonate (Anhydrous) 0.1873 kg
6 Activated<br>Enoanticr Carbon (Carbon<br>omos) 00487 k
. g
7 Penicillin G Amidase (Particle size 1.00 gram
<br>250 - 500 micron, Creamish to Brown<br>regularly shaped beads)<br>or (Immobilized Acylase Enzyme)<br>Xinase
8 Dimethylformamide (D M F) 2.522 kg
9 Isopropyl Alcohol (IPA) 0.390 kg
10 Methanol (Methyl Alcohol) 0.620 kg
11 Toluene 0.258kg
RA concerned maytake further necessary action asper above decision of NC.
57 Case No.:597/15/82- Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:3/82- Status:<br>Deferred
<br>ALC4/2018 ALC4/2019<br>05.07.2019
<br>HQ File<br>:01/82/050/02054/AM19/ RLA File<br>:09/24/040/00345/AM19/ Lic.No/Date:0910066762<br>25.10.2018 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

Decision: The Committee considered case as per agenda and deliberated on the matter 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.:597/15/82- Party Name:AUROBINDO Meet No/Date:3/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2019 Deferred
05.07.2019
57 HQ File RLA File Lic.No/Date:0910066762 Defer
:01/82/050/02054/AM19/ :09/24/040/00345/AM19/ 25.10.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:599/15/82- Party Name:LITMUS Meet No/Date:3/82- Status:
ALC4/2018 ORGANICS P. LTD. ALC4/2019 Deferred
05.07.2019
HQ File RLA File Lic.No/Date:0310824684 Defer
:01/82/050/02056/AM19/ :03/95/040/00747/AM19/ 25.10.2018 Date:05.07.2019

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

(i) Stepwise yield of reaction. (ii) Calculation Sheet to arrive at the quantity of raw material asked on the basis of chemistry, molecular weight and % of yield.

19

Case No.:107/15/82- Party Name:POSY Meet No/Date:3/82- Status:
ALC4/2018 PHARMACHEM PVT. LTD. ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0810143768
:01/82/050/01564/AM19/ :08/24/040/00229/AM19/ 26.10.2018

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. 15/82-ALC4/2018 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 59 per details below or as applied by firm whichever is lower:

Exportproduct<br>SODIUM CITRATE BP/USP Qty. Sl. No. Import items Qty.
1 kg 1 CITRIC ACID<br>MONOHYDRATE 0.421 kg
2. CAUSTIC SODA FLAKES /<br>PEARLS 0.736 kg
Case No.:163/15/82- Party Name:NAPROD LIFE Meet No/Date:3/82- Status:
ALC4/2018 SCIENCES PVT. LTD. ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310824723
:01/82/050/01620/AM19/ :03/95/040/00766/AM19/ 26.10.2018

Decision: The Committee considered case as per agenda and deliberated on the matter 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 60 details below or as applied by firm whichever is lower:

Export product Qty. Sl.<br>No. Import items Qty.
L-Asparaginase<br>for<br>Injection<br>10000IU<br>(<br>net<br>contain<br>of<br>L-<br>Asparaginase 0.652Kgs ) 7500<br>vials 1 L-Asparaginase 0.700 kg

20

Case No.:600/15/82- Party Name:CADILA Meet No/Date:3/82- Status:
ALC4/2018 HEALTHCARE LTD ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0810143760
:01/82/050/02057/AM19/ :08/24/040/00233/AM19/ 26.10.2018
Case No.:600/15/82-<br>ALC4/2018 Party Name:CADILA<br>HEALTHCARE LTD<br>RLA File<br>:08/24/040/00233/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/02057/AM19/ Lic.No/Date:0810143760<br>26.10.2018
61 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the<br>presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of<br>HBP as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty. / 1.2<br>gm tablet<br>MESALAMINE DELAYED<br>RELEASE TABLETS 1.2<br>GRAM<br>(ACTIVE INGREDIENT :<br>MESALAMINE USP - NEW<br>WT. 112723.06 KGS)<br>1 Number<br>1<br>MESALAMINE USP<br>1.224 gm<br>2<br>MAGNESIUM STEARATE<br>PH.E/NF/JP<br>0.013 gm<br>3<br>SODIUM STARCH<br>GLYCOLATE NF/JP<br>0.012 gm<br>4<br>HYPEROMELLOSE 15 CPS<br>USP<br>0.030 gm<br>5<br>TRIETHYL CITRATE NF<br>0.015 gm<br>6<br>TALC PH.E/USP/JP<br>0.011 gm<br>7<br>ISOPROPYL ALCOHOL USP<br>0.50 gm<br>8<br>MICROCRYSTALLINE<br>CELLULOSE NF/PH.E<br>(AVICEL PH200)<br>0.0140 gm<br>9<br>METHACRYLIC ACID AND<br>METHYL METHACRYLATE<br>COPOLYMER NF<br>0.0345 gm<br>10<br>METHACRYLIC ACID<br>COPOLYMER NF<br>(EUDRAGIT L 100)<br>0.0185 gm<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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:

62 <br>Case No.:602/15/82-<br>ALC4/2018 Party Name:GLAND<br>PHARMA LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02059/AM19/ RLA File<br>:09/24/040/00229/AM19/ Lic.No/Date:0910066775<br>26.10.2018 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
63 <br>Case No.:603/15/82-<br>ALC4/2018 Party Name:THERAPIVA<br>PRIVATE LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02060/AM19/ RLA File<br>:09/24/040/00359/AM19/ Lic.No/Date:0910066778<br>26.10.2018 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

21

64 <br>Case No.:604/15/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02061/AM19/ RLA File<br>:09/24/040/00347/AM19/ Lic.No/Date:0910066780<br>26.10.2018 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
65 <br>Case No.:605/15/82-<br>ALC4/2018 Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02062/AM19/ RLA File<br>:09/24/040/00354/AM19/ Lic.No/Date:0910066781<br>26.10.2018 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
66 Case No.:608/15/82-<br>ALC4/2018 Party Name:MACSON<br>PRODUCTS Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/02065/AM19/ RLA File<br>:52/24/040/00058/AM19/ Lic.No/Date:5210042821<br>26.10.2018
**Decision:**RLA, Surat was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07<br>application of subject Advance Authorization. However, the application is still awaited from RLA,<br>Bangalore. Hence, it was decided to issue a Reminder to RLA, Surat for furnishing a copy of application<br>expeditiously.

Case No.:162/15/82- Party Name:VITAL Meet No/Date:3/82- Status: ALC4/2018 LABORATORIES PRIVATE ALC4/2019 Approved LIMITED 05.07.2019 HQ File RLA File Lic.No/Date:0310824779 :01/82/050/01619/AM19/ :03/95/040/00751/AM19/ 29.10.2018

Decision: The Committee considered case as per agenda and deliberated on the matter 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: 67

Export product Qty. Sl.<br>No. Import items Qty.
LUMEFANTRINE PH.I. 1 kg 1 9H FLUORENE 0.90 kg
2 PARA CHLORO BENZALDEHYDE 0.3476 kg
3 METHANOL 2.19 kg
4 METHYLENE DICHLORIDE 1.38 kg

22

Case No.:164/15/82- Party Name:VN CREATIVE Meet No/Date:3/82- Status:
ALC4/2018 CHEMICALS PRIVATE ALC4/2019 Deferred
LIMITED 05.07.2019
HQ File RLA File Lic.No/Date:0310824780 Defer
:01/82/050/01621/AM19/ :03/95/040/00692/AM19/ 29.10.2018 Date:05.07.2019

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

(i) Complete technical details as per Appendix 4E with chemistry, molecular weight and % of yield.

Case No.:607/15/82- Party Name:CADILA Meet No/Date:3/82- Status:
ALC4/2018 HEALTHCARE LTD ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0810143774
:01/82/050/02064/AM19/ :08/24/040/00188/AM19/ 29.10.2018
Case No.:607/15/82-<br>ALC4/2018 Party Name:CADILA<br>HEALTHCARE LTD<br>RLA File<br>:08/24/040/00188/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/02064/AM19/ Lic.No/Date:0810143774<br>29.10.2018
69 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the<br>presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of<br>HBP as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>VALSARTAN TABLETS 40 MG<br>(ACTIVE INGREDIENT :<br>VALSARTAN PH EUR - NET WT.<br>35.977 KGS)<br>1 Number<br>1<br>VALSARTAN PH EUR<br>40.8 mg/<br>40 mg<br>tablet<br>VALSARTAN TABLETS 80 MG<br>(ACTIVE INGREDIENT :<br>VALSARTAN PH EUR - NET WT.<br>203.941 KGS)<br>1 Number<br>1<br>VALSARTAN PH EUR<br>81.60 mg/<br>80 mg<br>tablet<br>VALSARTAN TABLETS 160 MG<br>(ACTIVE INGREDIENT :<br>VALSARTAN PH EUR - NET WT.<br>407.884 KGS)<br>1 Number<br>1<br>VALSARTAN PH EUR<br>163.20<br>mg/ 160<br>mg tablet<br>VALSARTAN &<br>HYDROCHLOROTHIAZIDE<br>TABLETS 80/12.5 MG<br>(ACTIVE INGREDIENT :<br>VALSARTAN PH EUR - NET WT.<br>134.955)<br>1 Number<br>1<br>VALSARTAN PH EUR<br>81.60 mg/<br>80 mg<br>tablet<br>VALSARTAN &<br>HYDROCHLOROTHIAZIDE<br>TABLETS 160/12.5 MG<br>(ACTIVE INGREDIENT :<br>VALSARTAN PH EUR - NET WT.<br>479.888)<br>1 Number<br>1<br>VALSARTAN PH EUR<br>163.20<br>mg/ 160<br>mg tablet<br>VALSARTAN &<br>HYDROCHLOROTHIAZIDE<br>TABLETS 160/25 MG<br>(ACTIVE INGREDIENT :<br>VALSARTAN PH EUR - NET WT.<br>269.899KGS)<br>1 Number<br>1<br>VALSARTAN PH EUR<br>163.20<br>mg/ 160<br>mg tablet<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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:

23

Case No.:76/15/82- Party Name:BLISS GVS Meet No/Date:3/82- Status:
ALC4/2018 PHARMA LTD. ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310824793
:01/82/050/01533/AM19/ :03/94/040/00687/AM19/ 30.10.2018
Decision: Decision: The Committee considered case as per agenda and deliberated on the matter in the The Committee considered case as per agenda and deliberated on the matter in the The Committee considered case as per agenda and deliberated on the matter in the The Committee considered case as per agenda and deliberated on the matter in the The Committee considered case as per agenda and deliberated on the matter in the The Committee considered case as per agenda and deliberated on the matter in the The Committee considered case as per agenda and deliberated on the matter 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:
70 Export product Qty. Sl.<br>No. Import items Qty.
BG-CLIND Clindamycin<br>Vaginal 784300.00 1 CLINDAMYCIN 80 kg
Suppositories 100<br>Mg Number PHOSPHATE
( Net Contain clindamycin phosphate
78.43 Kgs.)
VAGID-CL Clindamycin<br>and 98000.00 1 CLINDAMYCIN 10 kg
Clotrimazole Vaginal Suppositories Number PHOSPHATE
( Net Contain clindamycin phosphate
9.8 Kgs.)
RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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.:610/15/82- Party Name:JODAS EXPOIM Meet No/Date:3/82- Status:
ALC4/2018 PVT.LTD ALC4/2019 Deferred
05.07.2019
71 HQ File RLA File Lic.No/Date:0510408268 Defer
:01/82/050/02067/AM19/ :05/23/040/00334/AM19/ 30.10.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:611/15/82- Party Name:OPTRIX Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES PRIVATE ALC4/2019 Approved
LIMITED 05.07.2019
HQ File RLA File Lic.No/Date:0910066796
:01/82/050/02068/AM19/ :09/24/040/00331/AM19/ 01.11.2018
Decision: Decision: The Committee considered the cases as per agenda and in the light of earlier decision The Committee considered the cases as per agenda and in the light of earlier decision The Committee considered the cases as per agenda and in the light of earlier decision The Committee considered the cases as per agenda and in the light of earlier decision The Committee considered the cases as per agenda and in the light of earlier decision
taken in meeting no. 1/82-ALC4/2019 dated 03.06.2019, 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 items Qty.
72 Product No.
TEDIZOLID 1 kg 1 5-Bromo-2-(2-Methyl-2H-Tetrazol-5-Yl)-Pyridine 0.746 kg
PHOSPHATE 2 (R)-3-(4-Bromo-3-fluorophenyl)-5- 0.90 kg
(hydroxymethyl)oxazolidin-2-one
3 Dichlorobis(di-tert-butylphenylphosphine)palladium(II) 0.025 kg
4 Bis(pinacolato)diboron 0.706 kg
5 1,1- Not Shown
Bis(diphenylphosphino)ferrocene]dichloropalladium(II) in the
chemistry
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. 1/82-ALC4/2019 dated 03.06.2019, 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:

24

Case No.:193/15/82- Party Name:RUMIT LIFE Meet No/Date:3/82- Status:
ALC4/2018 CARE ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310824914
:01/82/050/01650/AM19/ :03/95/040/00736/AM19/ 05.11.2018
Case No.:193/15/82-<br>ALC4/2018 Case No.:193/15/82-<br>ALC4/2018 Party Name:RUMIT LIFE<br>CARE Party Name:RUMIT LIFE<br>CARE Party Name:RUMIT LIFE<br>CARE Party Name:RUMIT LIFE<br>CARE Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/01650/AM19/ RLA File<br>:03/95/040/00736/AM19/ Lic.No/Date:0310824914<br>05.11.2018
73 <br>**Decision:**The Committee considered case as per agenda and deliberated on<br>presence of the technical experts and it was decided to ratify the ad-hoc input output norms<br>HBP as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>BETAMETHASONE<br>DIPROPIONATE<br>1 kg<br>1<br>BETAMETHASONE 17<br>PROPIONATE<br>RA concerned maytake further necessaryaction asper above decision of NC. the matter in the<br>under para 4.7 of<br>Qty.<br>0.94 kg
Export product Qty. Sl.<br>No. Import items Qty.
BETAMETHASONE<br>DIPROPIONATE 1 kg 1 BETAMETHASONE 17<br>PROPIONATE 0.94 kg
74 <br>Case No.:198/15/82-<br>ALC4/2018 Party Name:RUMIT<br>LIFECARE Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/01655/AM19/ RLA File<br>:03/95/040/00737/AM19/ Lic.No/Date:0310824932<br>06.11.2018
**Decision:**Deferred for comments of TE.
Case No.:613/15/82- Party Name:MELOG Meet No/Date:3/82- Status:
ALC4/2018 SPECIALITY CHEMICALS ALC4/2019 Approved
PVT. LTD. 05.07.2019
HQ File RLA File Lic.No/Date:0310824922
:01/82/050/02070/AM19/ :03/95/040/00775/AM19/ 06.11.2018

Decision: The Committee considered case as per agenda and deliberated on the matter in the 75 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.
4,4-BIPHENOL 1 kg 1 2,6-DI-TERT-BUTYLPHENOL 1.129 kg
2 METHANOL 0.30kg
76 <br>Case No.:614/15/82-<br>ALC4/2018 Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02071/AM19/ RLA File<br>:09/24/040/00360/AM19/ Lic.No/Date:0910066814<br>08.11.2018 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

25

77 <br>Case No.:111/15/82-<br>ALC4/2018 Party Name:PUNJAB<br>CHEMICALS AND CROP<br>PROTECTION LTD Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01568/AM19/ RLA File<br>:03/95/040/00709/AM19/ Lic.No/Date:0310824946<br>12.11.2018 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
78 <br>Case No.:616/15/82-<br>ALC4/2018 Party Name:VIVIMED LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02073/AM19/ RLA File<br>:09/24/040/00387/AM19/ Lic.No/Date:0910066821<br>12.11.2018 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
79 <br>Case No.:87/15/82-<br>ALC4/2018 Party Name:DEEPAK<br>NITRITE LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01544/AM19/ RLA File<br>:34/24/040/00267/AM19/ Lic.No/Date:3410044685<br>13.11.2018 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:115/15/82- Party Name:WOCKHARDT Meet No/Date:3/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310824984
:01/82/050/01572/AM19/ :03/95/040/00780/AM19/ 13.11.2018
Case No.:115/15/82-<br>ALC4/2018 Party Name:WOCKHARDT<br>LIMITED<br>RLA File<br>:03/95/040/00780/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/01572/AM19/ Lic.No/Date:0310824984<br>13.11.2018
80 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per<br>details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>FOSPHENYTOIN SODIUM INJECTION<br>USP 75 MG/ML 2ML VIAL (25 VIAL<br>PACK) EACH 2ML VIAL CONTAINS<br>FOSPHENYTOIN SODIUM USP 150 MG<br>(Total 139550 Vials and Total Net Content<br>of Fosphenytoin Sodium USP upto 22.502<br>KGS)<br>1 vial<br>1<br>FOSPHENYTOIN<br>SODIUM USP<br>165mg/2 ml<br>injection<br>FOSPHENYTOIN SODIUM INJECTION<br>USP 75 MG/ML 10ML VIAL (10 VIAL<br>PACK) EACH 10ML VIAL CONTAINS<br>FOSPHENYTOIN SODIUM USP 750 MG<br>(Total 28580 Vials and Total Net Content of<br>Fosphenytoin Sodium USP upto 22.506<br>KGS)<br>1 vial<br>1<br>FOSPHENYTOIN<br>SODIUM USP<br>825 mg/10 ml<br>injection<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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:

26

81 <br>Case No.:634/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02091/AM19/ RLA File<br>:09/24/040/00376/AM19/ Lic.No/Date:0910066832<br>13.11.2018 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:656/15/82- Party Name:HONOUR LAB Meet No/Date:3/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0910066835
:01/82/050/02113/AM19/ :09/24/040/00369/AM19/ 13.11.2018

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. 15/82-ALC4/2018 , dated 22.03.2019, 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: 82

Export Product Qty. Sl. Import items Qty.
No.
(1R, 2S, 5R)-2-Isopropyl-5- 1 kg 1 N,N-Dimethyl Formamide(DMF) 0.25 kg
methylcyclohexyl (2R, 5S)-5- 2 Hexamethyl disilazane 0.708 kg
(4-amino-2-oxopyrimidin- 3 Cytosine 0.434 kg
1(2H)-yl)-1,3-oxathiolane-2-<br>carboxylate 4 Triphosgene 0.500 kg
Case No.:619/15/82- Party Name:SUVEN LIFE Meet No/Date:3/82- Status:
ALC4/2018 SCIENCES LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0910066842
:01/82/050/02076/AM19/ :09/24/040/00372/AM19/ 14.11.2018

Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of 83 HBP as per details below or as applied by firm whichever is lower:

Export product Qty. Sl. Import items Qty.
No.
(2-CHLORO-5-IODO PHENYL)- 1 kg 1 ISO PROPYL ALCOHOL 2.00 kg
(4-FLUORO PHENYL)- (IPA)
METHANONE 2 FLUORO BENZENE 2.498 kg

27

Case No.:621/15/82- Party Name:PORUS Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES PRIVATE ALC4/2019 Approved
LIMITED 05.07.2019
HQ File RLA File Lic.No/Date:0910066847
:01/82/050/02078/AM19/ :09/24/040/00390/AM19/ 14.11.2018
Case No.:621/15/82-<br>ALC4/2018 Party Name:PORUS<br>LABORATORIES PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00390/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/02078/AM19/ Lic.No/Date:0910066847<br>14.11.2018
84 <br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>9/82-ALC4/2018<br>, dated 18.09.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>BISIMIDE<br>1 kg<br>1<br>BISPHENOL A<br>0.75 kg<br>2<br>HEXAETHYLGUANIDINIUM<br>CHLORIDE(HegCL(Catalyst)<br>0.13 kg<br>3<br>N METHYL PHTHALIMIDE<br>3.2 kg<br>4<br>METHANOL<br>1.00 kg<br>5<br>TOLUENE<br>2.00 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

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. 9/82-ALC4/2018 , dated 18.09.2018, 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:

85 <br>Case No.:622/15/82-<br>ALC4/2018 Party Name:GLAND<br>PHARMA LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02079/AM19/ RLA File<br>:09/24/040/00373/AM19/ Lic.No/Date:0910066848<br>14.11.2018 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
86 Case No.:623/15/82-<br>ALC4/2018 Party Name:VINS<br>BIOPRODUCTS LTD` Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/02080/AM19/ RLA File<br>:09/24/040/00363/AM19/ Lic.No/Date:0910066851<br>14.11.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to forward a copyof application to DBT for obtainingits comments.

28

Case No.:624/15/82- Party Name:MERCK Meet No/Date:3/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310825036
:01/82/050/02081/AM19/ :03/95/040/00817/AM19/ 14.11.2018
Case No.:624/15/82-<br>ALC4/2018 Case No.:624/15/82-<br>ALC4/2018 Case No.:624/15/82-<br>ALC4/2018 Case No.:624/15/82-<br>ALC4/2018 Party Name:MERCK<br>LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/02081/AM19/ RLA File<br>:03/95/040/00817/AM19/ Lic.No/Date:0310825036<br>14.11.2018
87 <br>**Decision:**The Committee considered the cases as per agenda and in the light<br>taken in meeting no. 1/82-ALC4/2019 dated 03.06.2019, it was decided to ratify norms<br>HBP v1 as per details given below or as applied by the firm, whichever is less:<br>Export<br>Product<br>Qty.<br>Sl.No.<br>Import items<br> <br>Thiamine<br>Disulfide<br>1 kg<br>1<br>Thiamine HCL<br><br>2<br>Sodium Hydroxide Pellets<br> <br>3<br>Potassium Hexacyanoferate III GR<br> <br>4<br>Hydrochloric Acid Fuming37%<br> <br>5<br>Hydrogen Peroxide Solution 35% extrapure<br> <br>6<br>Acetone<br> <br>RA maytake appropriate action asper the decision of Norms Committee. of earlier decision<br>under Para 4.7 of<br>Qty.<br>1.4199kg<br>0.4605 kg<br>0.0022 kg<br>0.3356 kg<br>0.2157 kg<br>0.6023litres
Export<br>Product Qty. Sl.No. <br>Import items Qty.
Thiamine<br>Disulfide 1 kg 1 Thiamine HCL 1.4199kg
2 Sodium Hydroxide Pellets 0.4605 kg
3 Potassium Hexacyanoferate III GR 0.0022 kg
4 Hydrochloric Acid Fuming37% 0.3356 kg
5 Hydrogen Peroxide Solution 35% extrapure 0.2157 kg
6 Acetone 0.6023litres
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. 1/82-ALC4/2019 dated 03.06.2019, 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:

Case No.:84/15/82- Party Name:DEEPAK Meet No/Date:3/82- Status:
ALC4/2018 NITRITE LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:3410044702
:01/82/050/01541/AM19/ :34/24/040/00257/AM19/ 15.11.2018

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. 15/82-ALC4/2018 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 88 per details below or as applied by firm whichever is lower:

Export product Qty. Sl.<br>No. Import items Qty.
2- ETHYL HEXYL<br>NITRATE 1 kg 1 2-ETHYL HEXANOL 0.748 kg
2 NITRIC ACID Not allowed
3 SULPHURIC ACID Not allowed
4 SODA ASH Not allowed

29

89 <br>Case No.:627/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br> <br><br>Lic.No/Date:0910066853<br>15.11.2018<br> <br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/02084/AM19/ RLA File<br>:09/24/040/00382/AM19/ Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
90 <br>Case No.:630/15/82-<br>ALC4/2018 Party Name:VIVIN DRUGS &<br>PHARMACEUTICALS<br>LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br> <br><br>Lic.No/Date:0910066856<br>15.11.2018<br> <br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/02087/AM19/ RLA File<br>:09/24/040/00391/AM19/ Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
91 Case No.:631/15/82-<br>ALC4/2018 Party Name:VIVIN DRUGS &<br>PHARMACEUTICALS<br>LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02088/AM19/ RLA File<br>:09/24/040/00392/AM19/ Lic.No/Date:0910066857<br>15.11.2018 Defer<br>Date:05.07.2019
**Decision:**RLA, Hyderabad was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07<br>application of subject Advance Authorization. However, the application is still awaited from RLA,<br>Hyderabad. Hence, it was decided to issue a Reminder to RLA, Hyderabad for furnishing a copy of<br>application expeditiously.

Case No.:105/15/82- Party Name:SAGA Meet No/Date:3/82- Status: ALC4/2018 LABORATORIES ALC4/2019 Approved 05.07.2019 HQ File RLA File Lic.No/Date:0810143909 :01/82/050/01562/AM19/ :08/24/040/00261/AM19/ 16.11.2018

Decision: The Committee considered case as per agenda and deliberated on the matter 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:

92

Export product Qty. Sl.<br>No. Import items Qty.
DIFLAH 500 (DIOSMIN AND<br>HESPERIDIN TABLETS 500 mg<br>PACK OF 30 TABLETS) (NET<br>QTY 250.005 KGS) 16667.000<br>Packs(Each<br>pack<br>contains 30<br>tablets) 1 DIOSMIN+HESPERIDIN 9:<br>MICRONIZED<br>POLICY CIRCULAR 9 DTD<br>30.06.2003 1<br> <br>255.00 kg

30

Case No.:643/15/82- Party Name:DHANUKA Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0510408442
:01/82/050/02100/AM19/ :05/23/040/00347/AM19/ 16.11.2018
<br> <br> <br> Case No.:643/15/82-<br>ALC4/2018<br> <br> Party Name:DHANUKA Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:
LABORATORIES LTD Approved
HQ File<br>:01/82/050/02100/AM19/<br> <br> RLA File<br>:05/23/040/00347/AM19/ Lic.No/Date:0510408442<br>16.11.2018
93<br> <br> <br> <br> **Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>10/82-ALC4/2018<br>, dated 16.10.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.No.<br>Import items<br>Qty.<br>7-AVNA<br>/7AVCA<br>1 kg<br>1.<br>7-Phenylacetamideo -3-<br>2.672 kg
Export product Qty. Sl.No. Import items Qty.
7-AVNA<br>/7AVCA 1 kg 1. 7-Phenylacetamideo -3- 2.672 kg
POWDER Chloromethyl Cephalosporanic Acid<br>Para Methoxybenzyl Ester (GCLE)<br>
2. Metha nol 8.00 kg
3. n-Buty l Acetate 5.06 kg
4 Methy lene Chloride 12.66 kg
5 Tih l hhi 126 k
rpe ny pospne . g
6 Pheno l 0.933 kg
RA concerned maytake further necessaryaction asper
above d ecision of NC.

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. 10/82-ALC4/2018 , dated 16.10.2018, 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:

Case No.:644/15/82- Party Name:DHANUKA Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0510408436
:01/82/050/02101/AM19/ :05/23/040/00345/AM19/ 16.11.2018
Decision: Decision: Decision: The Committee considered the case as The Committee considered the case as The Committee considered the case as The Committee considered the case as The Committee considered the case as per agenda in the presence of Technical Experts and per agenda in the presence of Technical Experts and per agenda in the presence of Technical Experts and per agenda in the presence of Technical Experts and per agenda in the presence of Technical Experts and
in the<br>light of<br>earlier decision taken<br>by NC<br>in<br>its<br>Meeting No. 10/82-ALC4/2018
, dated 16.10.2018, 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:
94 Export product Qty. Sl.No. Import items Qty.
7-AVNA /7AVCA 1 kg 1. 7-Phenylacetamideo -3- 2.672 kg
POWDER Chloromethyl Cephalosporanic Acid
Para Methoxybenzyl Ester (GCLE)
2. Methanol 8.00 kg
3. n-Butyl Acetate 5.06 kg
4 Methylene Chloride 12.66 kg
5 Triphenyl phosphine 1.26 kg
6 Phenol 0.933 kg
RA concerned maytake further necessaryaction asper above decision of NC.

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. 10/82-ALC4/2018 , dated 16.10.2018, 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:

31

Case No.:645/15/82- Party Name:DHANUKA Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0510408439
:01/82/050/02102/AM19/ :05/23/040/00346/AM19/ 16.11.2018
Case No.:645/15/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/02102/AM19/ Party Name:DHANUKA<br>LABORATORIES LTD<br>RLA File<br>:05/23/040/00346/AM19/ Party Name:DHANUKA<br>LABORATORIES LTD<br>RLA File<br>:05/23/040/00346/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br>Lic.No/Date:0510408439<br>16.11.2018 Status:<br>Approved Status:<br>Approved
95 <br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>10/82-ALC4/2018<br>, dated 16.10.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>7-AVNA<br>/7AVCA<br>POWDER<br>1 kg<br>1.<br>7-Phenylacetamideo -3-Chloromethyl<br>Cephalosporanic Acid Para<br>Methoxybenzyl Ester (GCLE)<br>2.672 kg<br>2.<br>Methanol<br>8.00 kg<br>3.<br>n-Butyl Acetate<br>5.06 kg<br>4<br>Methylene Chloride<br>12.66 kg<br>5<br>Triphenyl phosphine<br>1.26 kg<br>6<br>Phenol<br>0.933 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.
96 Case No.:2/15/82-ALC4/2018 Party Name:DEEPAK<br>NITRITE LIMITED<br>RLA File<br>:34/24/040/00254/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/01459/AM19/ Lic.No/Date:3410044710<br>20.11.2018
<br>**Decision:**The Committee considered the case as per agenda and it was decided to call for following<br>information from the firm:<br>(i)<br>Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction<br>and % ofyield at everystage.
97 Case No.:85/15/82-<br>ALC4/2018 Party Name:DEEPAK<br>NITRITE LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01542/AM19/ RLA File<br>:34/24/040/00255/AM19/ Lic.No/Date:3410044711<br>20.11.2018 Defer<br>Date:05.07.2019
<br>**Decision:**The Committee considered the case as per agenda and it was decided to call for following<br>information from the firm:<br>(i) Complete 4E with all technical details including chemistry, molecular weight, stoichiometric<br>reaction and % ofyield at everystage.

32

98 <br>Case No.:86/15/82-<br>ALC4/2018<br> <br> <br>HQ File<br>:01/82/050/01543/AM19/<br> <br> Party Name:DEEPAK<br>NITRITE LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status: Deferred
RLA File<br>:34/24/040/00256/AM19/ Lic.No/Date:3410044712<br>20.11.2018 Defer<br>Date:05.07.2019
<br>**Decision:**The Committee considered the case as per agenda and it was decided to call for following<br>information from the firm:<br>(i)<br>Complete 4E with all technical details including chemistry, molecular weight,<br>stoichiometric reaction and % ofyield at everystage.
Case No.:110/15/82- Party Name:PRACHI Meet No/Date:3/82- Status:
ALC4/2018 PHARMACEUTICALS PVT ALC4/2019 Approved
LTD 05.07.2019
HQ File RLA File Lic.No/Date:0310825158
:01/82/050/01567/AM19/ :03/95/040/00848/AM19/ 20.11.2018

Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of 99 HBP as per details below or as applied by firm whichever is lower:

Export product Qty. Sl.<br>No. Import items Qty.
THIAMINE HYDRO CHLORIDE 1 kg 1 THIAMINE<br>MONONITRATE 1.02 kg
Case No.:155/15/82- Party Name:UNIMAX Meet No/Date:3/82- Status:
ALC4/2018 CHEMICALS PVT LTD. ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:031082515
:01/82/050/01612/AM19/ :03/95/040/00839/AM19/ 2
20.11.2018

Decision: The Committee considered case as per agenda and deliberated on the matter in the 100 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.
Erythromycin Phosphate 1 kg 1 Erythromycin Thiocyanate<br>Tech. Spec.: Erythromycin<br>Thiocyanate 0.84 kg<br>Activity

33

Case No.:638/15/82- Party Name:AUROBINDO Meet No/Date:3/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2019 Deferred
05.07.2019
101 HQ File RLA File Lic.No/Date:0910066874 Defer
:01/82/050/02095/AM19/ :09/24/040/00386/AM19/ 20.11.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:639/15/82- Party Name:CADILA Meet No/Date:3/82- Status:
ALC4/2018 HEALTHCARE LTD ALC4/2019 Deferred
05.07.2019
102 HQ File RLA File Lic.No/Date:0810143923 Defer
:01/82/050/02096/AM19/ :08/24/040/00187/AM19/ 20.11.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:640/15/82- Party Name:AETHER Meet No/Date:3/82- Status:
ALC4/2018 INDUSTRIES LIMITED ALC4/2019 Deferred
05.07.2019
103 HQ File RLA File Lic.No/Date:5210042834 Defer
:01/82/050/02097/AM19/ :52/24/040/00064/AM19/ 20.11.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:641/15/82- Party Name:HONEST BIO- Meet No/Date:3/82- Status: Deferred
ALC4/2018 VET PVT. LTD ALC4/2019
05.07.2019
104 HQ File RLA File Lic.No/Date:0810143924 Defer
:01/82/050/02098/AM19/ :08/24/040/00268/AM19/ 20.11.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.

34

Case No.:648/15/82- Party Name:CADILA Meet No/Date:3/82- Status:
ALC4/2018 HEALTHCARE LTD ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0810143957
:01/82/050/02105/AM19/ :08/24/040/00203/AM19/ 26.11.2018

Decision: The Committee considered case as per agenda and deliberated on the matter 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

LEFLUNOMIDE TABLETS USP 10 MG

(ACTIVE INGREDIENT : LEFLUNOMIDE USP - NET WT. 20.869 KGS)

105 LEFLUNOMIDE TABLETS USP 20 MG

(ACTIVE INGREDIENT : LEFLUNOMIDE USP - NET WT. 119.993 KGS)

S.NO.<br>1<br>2<br>3 Import Items<br>LEFLUNOMIDE USP<br>LACTOSE MONOHYDRATE NF/PH.E<br>(PHARMATOSE 200M)<br>CORN STARCH NF(MAIZE STARCH B) For export of 1 No.Tablet<br>(Quantity in mg / tablet)<br>10 mg / tablet<br>20 mg / tablet<br>10.2 mg<br>20.40 mg<br>92.75 mg<br>82.75 mg<br>30.00 mg<br>30.00 mg

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

106 <br>Case No.:649/15/82-<br>ALC4/2018 Party Name:GLOBE<br>TROTTERS PVT LTD Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02106/AM19/ RLA File<br>:03/94/040/00713/AM19/ Lic.No/Date:0310825212<br>26.11.2018 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

35

Case No.:653/15/82- Party Name:LUPIN Meet No/Date:3/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:031082524
:01/82/050/02110/AM19/ :03/95/040/00814/AM19/ 7
27.11.2018
ALC4/2018<br>LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02110/AM19/<br>RLA File<br>:03/95/040/00814/AM19/<br>Lic.No/Date:031082524<br>7<br>27.11.2018 ALC4/2018<br>LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02110/AM19/<br>RLA File<br>:03/95/040/00814/AM19/<br>Lic.No/Date:031082524<br>7<br>27.11.2018 ALC4/2018<br>LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02110/AM19/<br>RLA File<br>:03/95/040/00814/AM19/<br>Lic.No/Date:031082524<br>7<br>27.11.2018 ALC4/2018<br>LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02110/AM19/<br>RLA File<br>:03/95/040/00814/AM19/<br>Lic.No/Date:031082524<br>7<br>27.11.2018 ALC4/2018<br>LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02110/AM19/<br>RLA File<br>:03/95/040/00814/AM19/<br>Lic.No/Date:031082524<br>7<br>27.11.2018 ALC4/2018<br>LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02110/AM19/<br>RLA File<br>:03/95/040/00814/AM19/<br>Lic.No/Date:031082524<br>7<br>27.11.2018 ALC4/2018<br>LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02110/AM19/<br>RLA File<br>:03/95/040/00814/AM19/<br>Lic.No/Date:031082524<br>7<br>27.11.2018
**Decision:**The Committee considered case as per agenda and deliberated on the matter 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.
No.
DOXYCYCLINE FOR ORAL 1 Number 1 DOXYCYCLINE 319.32 mg / 60
SUSPENSION 25MG/5ML - MONOHYDRATE ML Bottle
107 60ML<br>(NET WT45.00 KGS, WT OF (MICRONIZED)
DRUG : 55.80 KGS)
DOXYCYCLINE CAPS USP 1 Number 2 DOXYCYCLINE 51.7 mg / 50 mg
50MG MONOHYDRATE tablet
(NET WT. 100.00 KGS , WT OF (MICRONIZED)
DRUGS : 114.00 KGS)
DOXYCYCLINE CAPS USP 1 Number 3 DOXYCYCLINE 77.55 mg / 75 mg
75MG MONOHYDRATE tablet
(NET WT.105.00 KGS, WT OF (MICRONIZED)
DRUGS : 119.70 KGS)
DOXYCYCLINE CAPS USP 1 Number 4 DOXYCYCLINE 103.4 mg / 100
100MG MONOHYDRATE mg tablet
(NET WT. 1300.00 KGS, WT OF (MICRONIZED)
DRUG : 1482.00 KGS)
RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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.:657/15/82- Party Name:BDR Meet No/Date:3/82- Status:
ALC4/2018 PHARMACEUTICALS ALC4/2019 Approved
INTERNATIONAL PVT. 05.07.2019
LTD.
HQ File RLA File Lic.No/Date:031082525
:01/82/050/02114/AM19/ :03/94/040/00739/AM19/ 4
28.11.2018

Decision: The Committee considered case as per agenda and deliberated on the matter in the 108 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.<br> Import items Qty.
No.
Colistimethate Sodium for<br>Injection BP 1 Million<br>InternationalUnits pervial 10ml 1 Number 1 Colistimethate Sodium for<br>Injection BP 96.63 mg/<br>vial

36

Case No.:658/15/82- Party Name:ATHENA DRUG <br>Meet No/Date:3/82- Status:
109 <br>ALC4/2018 <br>DELIVERY SOLUTIONS<br>PRIVATE LIMITED<br>RLA File <br> <br>ALC4/2019<br>05.07.2019 <br>Deferred<br> <br>Defer
HQ File Lic.No/Date:0310825255
<br> <br>:01/82/050/02115/AM19/ <br>:03/94/040/00744/AM19/ <br>28.11.2018 <br> <br>Date:05.07.2019
<br>**Decision:**The Committee co nsidered the case as per agenda and it was decided to call for following
<br>information:<br>(i)<br>Export description does not tally with DML.
Case No.:659/15/82- Party Name:AUROBINDO Meet No/Date:3/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2019 Deferred
05.07.2019
110 HQ File RLA File Lic.No/Date:0910066905 Defer
:01/82/050/02116/AM19/ :09/24/040/00410/AM19/ 28.11.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:664/15/82- Party Meet No/Date:3/82- Status:
ALC4/2018 Name:SMILAX LABORATORIES ALC4/2019 Deferred
LIMITED 05.07.2019
111 HQ File RLA File :09/24/040/00358/AM19/ Lic.No/Date:0910066 Defer
:01/82/050/02121/AM1 915 Date:05.07.2019
9/ 28.11.2018
**Decision:**Deferred for comments of TE.
Case No.:669/15/82- Party Name:VERVE Meet No/Date:3/82- Status:
ALC4/2018 HUMAN CARE ALC4/2019 Deferred
LABORATORIES 05.07.2019
HQ File RLA File Lic.No/Date:6110001560 Defer
:01/82/050/02126/AM19/ :61/24/040/00012/AM19/ 28.11.2018 Date:05.07.2019

112 Decision: The Committee considered the case as per agenda and it was decided to call for following information:

(i) Copy of Drug Manufacturing Licence showing approved composition for export item exclusively.

Case No.:670/15/82- Party Name:VERVE Meet No/Date:3/82- Status:
ALC4/2018 HUMAN CARE ALC4/2019 Deferred
LABORATORIES 05.07.2019
113 HQ File RLA File Lic.No/Date:6110001561 Defer
:01/82/050/02127/AM19/ :61/24/040/00013/AM19/ 28.11.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.

37

114 <br>Case No.:671/15/82-<br>ALC4/2018 Party Name:VERVE<br>HUMAN CARE<br>LABORATORIES Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02128/AM19/ RLA File<br>:61/24/040/00014/AM19/ Lic.No/Date:6110001562<br>28.11.2018 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
115 <br>Case No.:672/15/82-<br>ALC4/2018 Party Name:VERVE<br>HUMAN CARE<br>LABORATORIES Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02129/AM19/ RLA File<br>:61/24/040/00015/AM19/ Lic.No/Date:6110001563<br>28.11.2018 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
116 <br>Case No.:673/15/82-<br>ALC4/2018 Party Name:VERVE<br>HUMAN CARE<br>LABORATORIES Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02130/AM19/ RLA File<br>:61/24/040/00018/AM19/ Lic.No/Date:6110001564<br>28.11.2018 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
117 <br>Case No.:674/15/82-<br>ALC4/2018 Party Name:VERVE<br>HUMAN CARE<br>LABORATORIES Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02131/AM19/ RLA File<br>:61/24/040/00017/AM19/ Lic.No/Date:6110001565<br>28.11.2018 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
118 <br>Case No.:675/15/82-<br>ALC4/2018 Party Name:VERVE<br>HUMAN CARE<br>LABORATORIES Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02132/AM19/ RLA File<br>:61/24/040/00016/AM19/ Lic.No/Date:6110001566<br>28.11.2018 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
119 <br>Case No.:210/15/82-<br>ALC4/2018 Party Name:VENUS<br>REMEDIES LTD., Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01667/AM19/ RLA File<br>:22/24/040/00064/AM19/ Lic.No/Date:2210016020<br>29.11.2018 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

38

120 Case No.:668/15/82-<br>ALC4/2018 Party Name:CADILA<br>HEALTHCARE LTD Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
HQ File<br>:01/82/050/02125/AM19/ RLA File<br>:08/24/040/00264/AM19/ Lic.No/Date:0810143988<br>29.11.2018
**Decision:**Deferred for comments of TE.
121 Case No.:689/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
HQ File<br>:01/82/050/02146/AM19/ RLA File<br>:09/24/040/00421/AM19/ Lic.No/Date:0910066921<br>29.11.2018
**Decision:**Deferred for comments of TE.
Case No.:838/15/82- Party Name:IND SWIFT Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:221001601
:01/82/050/02295/AM19/ :22/24/040/00065/AM19/ 9
29.11.2018
Case No.:838/15/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/02295/AM19/ Party Name:IND SWIFT<br>LABORATORIES LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved
RLA File<br>:22/24/040/00065/AM19/ Lic.No/Date:221001601<br>9<br>29.11.2018
122 **Decision:**The Committee considered case as per agenda and deliberated on the matter in the<br>presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7<br>of HBP as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Clopidogrel Hydrogen Sulphate<br>1 kg<br>1<br>DL-2-Chloro Phenyl Glycine<br>1.00 kg<br>2<br>Methanol<br>4.87 kg<br>3<br>Methylene Chloride<br>2.03 kg<br>4<br>L(+) Tartaric Acid<br>0.667 kg<br>5<br>Acetone<br>0.34 kg<br>6<br>Thiophene-2-Ethanol<br>0.60 kg<br>7<br>Toluene<br>1.11 kg<br>8<br>Isopropyl Alcohol<br>0.99 kg<br>9<br>Para Toluene Sulfonyl<br>Chloride<br>1.029 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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:

39

Case No.:144/15/82- Party Name:USV PRIVATE Meet No/Date:3/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310825333
:01/82/050/01601/AM19/ :03/95/040/00897/AM19/ 30.11.2018
Case No.:144/15/82-<br>ALC4/2018 Party Name:USV PRIVATE<br>LIMITED Party Name:USV PRIVATE<br>LIMITED Party Name:USV PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br>Lic.No/Date:0310825333<br>30.11.2018 Status:<br>Approved
HQ File<br>:01/82/050/01601/AM19/ RLA File<br>:03/95/040/00897/AM19/
123 **Decision:**The Committee considered case as per agenda and deliberated on<br>presence of the technical experts and it was decided to ratify the ad-hoc input output nor<br>of HBP as per details below or as applied by firm whichever is lower: the matter in the<br>ms under para 4.7
Export product Qty. Sl. No. Import items Qty.
<br>Propafenone Hydrochloride<br>Extended Release Capsules<br>USP 225 MG<br>(6,999 Bottles x 60 Per<br>Bottles = 4,19,940<br>Capsules) ( Net Content<br>Weight=94.487 Kgs) 6999.000<br>Bottles(Each<br>bottle<br>contains 60<br>tablets) 1 Propafenone Hydrochloride 268.04 kg
Propafenone Hydrochloride<br>Extended Release Capsules<br>USP 425 MG<br>(6,600 Bottles x 60 Per<br>Bottles = 3,96,000<br>Capsules) ( Net Content<br>Weight=168.300 Kgs) 6600.000<br>Bottles(Each<br>bottle<br>contains 60<br>tablets)
RA concerned maytake further necessaryaction asper above decision of NC.
124 Case No.:683/15/82-<br>ALC4/2018 Party Name:NEON<br>LABORATORIES LTD. Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br>Lic.No/Date:0310825329<br>30.11.2018 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02140/AM19/ RLA File<br>:03/95/040/00873/AM19/ Defer<br>Date:05.07.2019
**Decision:**RLA, Mumbai was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07<br>application of subject Advance Authorization. However, the application is still awaited from RLA,<br>Mumbai. Hence, it was decided to issue a Reminder to RLA, Mumbai for furnishing a copy of<br>application expeditiously.

Decision: RLA, Mumbai was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07 application of subject Advance Authorization. However, the application is still awaited from RLA, Mumbai. Hence, it was decided to issue a Reminder to RLA, Mumbai for furnishing a copy of application expeditiously.

125 <br>Case No.:684/15/82-<br>ALC4/2018 Party Name:GLAND<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00419/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/02141/AM19/ Lic.No/Date:0910066930<br>03.12.2018
**Decision:**Deferred for comments of TE.

40

Case No.:685/15/82- Party Name:GLAND Meet No/Date:3/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2019 Deferred
05.07.2019
126 HQ File RLA File Lic.No/Date:0910066931 Defer
:01/82/050/02142/AM19/ :09/24/040/00420/AM19/ 03.12.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:686/15/82- Party Name:GENESYS Meet No/Date:3/82- Status:
ALC4/2018 BIOLOGICS PRIVATE ALC4/2019 Deferred
LIMITED 05.07.2019
127 HQ File RLA File Lic.No/Date:0910066932 Defer
:01/82/050/02143/AM19/ :09/24/040/00427/AM19/ 03.12.2018 Date:05.07.2019
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it
was decided to forward a copyof application to DBT for obtainingits comments.
Case No.:687/15/82- Party Name:EAGLE Meet No/Date:3/82- Status:
ALC4/2018 CHEMICAL WORKS ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310825360
:01/82/050/02144/AM19/ :03/94/040/00685/AM19/ 03.12.2018
ALC4/2018<br>CHEMICAL WORKS<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02144/AM19/<br>RLA File<br>:03/94/040/00685/AM19/<br>Lic.No/Date:0310825360<br>03.12.2018 ALC4/2018<br>CHEMICAL WORKS<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02144/AM19/<br>RLA File<br>:03/94/040/00685/AM19/<br>Lic.No/Date:0310825360<br>03.12.2018 ALC4/2018<br>CHEMICAL WORKS<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02144/AM19/<br>RLA File<br>:03/94/040/00685/AM19/<br>Lic.No/Date:0310825360<br>03.12.2018
**Decision:**The Committee considered case as per agenda and as per earlier decision taken by NC in
128 its 13/82-ALC4/2018 meeting dated 14.01.2019, it was decided to ratify the ad-hoc input<br>under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- output norms
Export product<br>Qty.<br>Sl. Import items Qty.
No.
CALCIUM OROTATE<br>1 kg<br>1 OROTIC ACID 1.059 kg
DIHYDRATE
RA concerned maytake further necessaryaction asper above decision of NC
Case No.:688/15/82- Party Name:JODAS EXPOIM Meet No/Date:3/82- Status:
ALC4/2018 PVT.LTD ALC4/2019 Deferred
05.07.2019
129 HQ File RLA File Lic.No/Date:0510408748 Defer
:01/82/050/02145/AM19/ :05/23/040/00385/AM19/ 04.12.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:691/15/82- Party Name:ORTIN Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2019 Deferred
05.07.2019
130 HQ File RLA File Lic.No/Date:0910066937 Defer
:01/82/050/02148/AM19/ :09/24/040/00423/AM19/ 04.12.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.

41

Case No.:754/15/82- Party Name:CLARIANT Meet No/Date:3/82- Status:
ALC4/2018 INDIA LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310825405
:01/82/050/02211/AM19/ :03/94/040/00766/AM19/ 04.12.2018
Case No.:754/15/82-<br>ALC4/2018 Case No.:754/15/82-<br>ALC4/2018 Party Name:CLARIANT<br>INDIA LIMITED Party Name:CLARIANT<br>INDIA LIMITED Party Name:CLARIANT<br>INDIA LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/02211/AM19/ RLA File<br>:03/94/040/00766/AM19/ Lic.No/Date:0310825405<br>04.12.2018
**Decision:**The Committee considered case as per agenda and as per earlier decision taken by NC in<br>its 6/82-ALC4/2014 meeting dated 29.08.2014, it was decided to ratify the ad-hoc input output norms<br>under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-
131 <br>Exportproduct<br>EHT (ETHYL<br> Qty. Sl. No. Import items Qty.
1 kg 1. PARA NITRO BENZOIC ACID(PNBA) 1.034 kg
HEXYL TRIAZONE)<br>/ ETONE 2. PERCHLORO ETHYLENE(PCE) 0.606 kg
3. METHANOL 2.940 kg
4. 2 ETHYL HE XANOL 0.882 kg
5. ACETO NITR ILE 1.30 kg
6. XYLENE(OR THO XYLENE) 1.00 kg
7. CYANURIC C HLORIDE 0.640 kg
RA concerned maytake further necessaryaction asper above decision of NC
132 <br>Case No.:103/15/82-<br>ALC4/2018 Party Name:STERLING<br>AXILIARIES PVT LTD Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Dfd
U eerre
<br>
HQ File<br>:01/82/050/01560/AM19/ RLA File<br>:03/95/040/00851/AM19/ Lic.No/Date:0310825462<br>05.12.2018 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:140/15/82- Party Name:YASHO Meet No/Date:3/82- Status:
ALC4/2018 INDUSTRIES LIMITED ALC4/2019 Deferred
05.07.2019
133 HQ File RLA File Lic.No/Date:0310825441 Defer
:01/82/050/01597/AM19/ :03/95/040/00911/AM19/ 05.12.2018 Date:05.07.2019
**Decision:**The Committee considered the case as per agenda and it was decided to call Appendix 4E
havingcomplete technical details like chemistry,% ofyield at each stepand molecular weight.
Case No.:692/15/82- Party Name:ORTIN Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2019 Deferred
05.07.2019
134 HQ File RLA File Lic.No/Date:0910066938 Defer
:01/82/050/02149/AM19/ :09/24/040/00424/AM19/ 05.12.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.

42

Case No.:694/15/82- Party Name:AUROBINDO Meet No/Date:3/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0910066942
:01/82/050/02151/AM19/ :09/24/040/00430/AM19/ 05.12.2018
Case No.:694/15/82-<br>ALC4/2018<br> <br> <br>HQ File<br>:01/82/050/02151/AM19/<br> <br> Case No.:694/15/82-<br>ALC4/2018<br> <br> <br>HQ File<br>:01/82/050/02151/AM19/<br> <br> Case No.:694/15/82-<br>ALC4/2018<br> <br> <br>HQ File<br>:01/82/050/02151/AM19/<br> <br> Party Name:AUROBINDO<br>PHARMA LIMITED Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved Status:<br>Approved
RLA File<br>:09/24/040/00430/AM19/ Lic.No/Date:0910066942<br>05.12.2018
135 **Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>15/82-ALC4/2018<br>, dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.<br>FINASTERIDE<br>1 kg<br>1<br>Azaandrostane carboxamide (Androst-4-aza-3-<br>one-17Beta-N-Tert-Butyl Carboxamide)<br>1.7647 kg<br>2<br>Bis (Trimethylsilyl) trifluoroacetamide (BSTFA)<br>1.47 kg<br>3<br>2,3-Dichloro-5,6-dicyano-1,4-benzoquinone<br>(DDQ)<br>0.86 kg<br>4<br>Activated Carbon (Carbon Enoanticromos)<br>0.012 kg<br>5<br>Methanol (Methyl Alcohol)<br>4.66 kg<br>6<br>Methylene chloride (MDC)<br>7.50 kg<br>7<br>Tetrahydrofuran (THF)<br>3.00 kg<br>8<br>Toluene<br>4.84 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.
Export Product Qty. Sl.<br>No. Import Items Qty.
FINASTERIDE 1 kg 1 Azaandrostane carboxamide (Androst-4-aza-3-<br>one-17Beta-N-Tert-Butyl Carboxamide) 1.7647 kg
2 Bis (Trimethylsilyl) trifluoroacetamide (BSTFA) 1.47 kg
3 2,3-Dichloro-5,6-dicyano-1,4-benzoquinone<br>(DDQ) 0.86 kg
4 Activated Carbon (Carbon Enoanticromos) 0.012 kg
5 Methanol (Methyl Alcohol) 4.66 kg
6 Methylene chloride (MDC) 7.50 kg
7 Tetrahydrofuran (THF) 3.00 kg
8 Toluene 4.84 kg
necessaryaction asper above decision of NC.
Case No.:695/15/82- Party Name:AUROBINDO Meet No/Date:3/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0910066943
:01/82/050/02152/AM19/ :09/24/040/00435/AM19/ 05.12.2018
Case No.:695/15/82-<br>ALC4/2018<br> <br> <br>HQ File<br>:01/82/050/02152/AM19/<br> <br> Case No.:695/15/82-<br>ALC4/2018<br> <br> <br>HQ File<br>:01/82/050/02152/AM19/<br> <br> Party Name:AUROBINDO<br>PHARMA LIMITED Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved Status:<br>Approved
RLA File<br>:09/24/040/00435/AM19/ Lic.No/Date:0910066943<br>05.12.2018
136 **Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>15/82-ALC4/2018<br>, dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:
Export product Qty. Sl.<br>No. Import items Qty.
SILODOSIN 1 kg 1 (R)-Amine Tartrate<br>or [5-[(2R)-2-Aminopropyl]-1-[3-<br>(Benzoyloxy)Propyl)-2,3-Dihydro-1H-Indole-7-<br>Carbonitrile(2R,3R)-2,3-Dihydroxybutanedioate] 2.50 kg
2 Acetonitrile 2.65 kg
3 Dimethyl Sulfoxide 2.65 kg
4 Cyclohexane 0.54 kg
5 Isopropyl Acetate 4.95 kg
6 Methanol (Methyl Alcohol) 6.58 kg
7 Methylene Chloride (MDC) 6.00 kg
8 Potassium Carbonate (Anhydrous) 0.67 kg
9 TFEP Ethyl Mesylate<br>or [2-[2-(2,2,2-Trifluoroethoxy)Phenoxy]Ethyl<br>Methanesulfonate] 1.53 kg
RA concerned maytake further necessaryaction asper above decision of NC.

43

137 <br>Case No.:696/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02153/AM19/ RLA File<br>:09/24/040/00436/AM19/ Lic.No/Date:0910066944<br>05.12.2018 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
138 Case No.:744/15/82-<br>ALC4/2018 Party Name:LUPIN LIMITED<br>RLA File<br>:03/95/040/00876/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/02201/AM19/ Lic.No/Date:0310825438<br>05.12.2018
**Decision:**RLA, Mumbai was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07<br>application of subject Advance Authorization. However, the application is still awaited from RLA,<br>Mumbai. Hence, it was decided to issue a Reminder to RLA, Mumbai for furnishing a copy of<br>application expeditiously.
139 Case No.:773/15/82-<br>ALC4/2018 Party Name:LUPIN<br>LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02230/AM19/ RLA File<br>:03/95/040/00902/AM19/ Lic.No/Date:0310825460<br>05.12.2018 Defer<br>Date:05.07.2019
**Decision:**RLA, Mumbai was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07<br>application of subject Advance Authorization. However, the application is still awaited from RLA,<br>Mumbai. Hence, it was decided to issue a Reminder to RLA, Mumbai for furnishing a copy of<br>application expeditiously.

Decision: RLA, Mumbai was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07 application of subject Advance Authorization. However, the application is still awaited from RLA, Mumbai. Hence, it was decided to issue a Reminder to RLA, Mumbai for furnishing a copy of application expeditiously.

140 <br>Case No.:186/15/82-<br>ALC4/2018 Party Name:WOCKHARDT<br>LIMITED<br>RLA File<br>:03/95/040/00900/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/01643/AM19/ Lic.No/Date:0310825487<br>06.12.2018
**Decision:**Deferred for comments of TE.
141 <br>Case No.:698/15/82-<br>ALC4/2018 Party Name:VISION DRUGS<br>PVT LTD Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02155/AM19/ RLA File<br>:09/24/040/00412/AM19/ Lic.No/Date:0910066949<br>06.12.2018 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

44

Case No.:699/15/82- Party Name:CRYSTAL Meet No/Date:3/82- Status:
ALC4/2018 QUINONE PVT LTD ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0810144041
:01/82/050/02156/AM19/ :08/24/040/00296/AM19/ 06.12.2018

Decision: The Committee considered case as per agenda and deliberated on the matter 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: 142

Export product Qty. Sl. Import items Qty.
No.
2-CHLORO-1,4- 1 kg 1 PARADIMETHOXYBENZE 0.88 kg
DIMETHOXYBENZENE NE [1,4
DIMETHOXYBENZENE
(PDMB)]
Case No.:700/15/82- Party Name:J.B. Meet No/Date:3/82- Status:
ALC4/2018 CHEMICALS & ALC4/2019 Deferred
PHARMACEUTICALS 05.07.2019
143 LIMITED
HQ File RLA File Lic.No/Date:0310825472 Defer
:01/82/050/02157/AM19/ :03/94/040/00748/AM19/ 06.12.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:702/15/82- Party Name:GLOBAL Meet No/Date:3/82- Status:
ALC4/2018 CALCIUM PRIVATE ALC4/2019 Approved
LIMITED 05.07.2019
HQ File RLA File Lic.No/Date:0710114247
:01/82/050/02159/AM19/ :07/24/040/00212/AM19/ 06.12.2018
**Decision:**The Committee considered the case as **Decision:**The Committee considered the case as **Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and per agenda in the presence of Technical Experts and per agenda in the presence of Technical Experts and
in<br>the<br>light<br>of<br>earlier<br>decision taken<br>by NC<br>in<br>its<br>Meeting<br>No. <br>15/82-ALC4/2018
, dated 22.03.2019, 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:
144 Export product Qty. <br>Sl. No. Import items Qty.
CALCIUM GLUCONATE (EP 1 kg 1 CALCIUM GLUCONATE- 1.09 kg
FOR INJECTION/JP/USP) ORAL GRADE
CALCIUM 1 kg 1 CALCIUM GLUCONATE- 0.946 kg
BOROGLUCONATE ORAL GRADE
CALCIUM GLUBIONATE 1 kg 1 CALCIUM GLUCONATE- 0.430 kg
(FOR INJECTION) ORAL GRADE
RA concerned maytake further necessary action asper above decision of NC.

45

Case No.:149/15/82- Party Name:POLYGEL Meet No/Date:3/82- Status:
ALC4/2018 INDUSTRIES PVT.LTD ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310825534
:01/82/050/01606/AM19/ :03/95/040/00906/AM19/ 07.12.2018
Case No.:149/15/82-<br>ALC4/2018 Case No.:149/15/82-<br>ALC4/2018 Party Name:POLYGEL<br>INDUSTRIES PVT.LTD<br> <br> <br> Party Name:POLYGEL<br>INDUSTRIES PVT.LTD<br> <br> <br> Party Name:POLYGEL<br>INDUSTRIES PVT.LTD<br> <br> <br> Party Name:POLYGEL<br>INDUSTRIES PVT.LTD<br> <br> <br> Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/01606/AM19/ RLA File<br>:03/95/040/00906/AM19/<br> <br> Lic.No/Date:0310825534<br>07.12.2018
145 **Decision:**The Committee considered case as per agenda and deliberated on<br>presence of the technical experts and it was decided to ratify the ad-hoc input output<br>4.7 of HBP as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>ISO PROPYL BUTYL TITANATE<br>(PURETI TPT 15B)<br>1 kg<br>1<br>TETRA ISO PROPYL<br>TITANATE<br>2<br>TETRA NORMAL<br>BUTYL TITANATE<br>RA concerned maytake further necessaryaction asper above decision of NC. the matter in the<br>norms under para<br>Qty.<br>0.8405 kg<br>0.1795 kg
Export product Qty. Sl.<br>No. Import items Qty.
ISO PROPYL BUTYL TITANATE<br>(PURETI TPT 15B) 1 kg 1 TETRA ISO PROPYL<br>TITANATE 0.8405 kg
2 TETRA NORMAL<br>BUTYL TITANATE 0.1795 kg
action a sper above decision of NC.
146 <br>Case No.:185/15/82-<br>ALC4/2018 Party Name:YASHO<br>INDUSTRIES LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br>Lic.No/Date:0310825514<br>07.12.2018 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01642/AM19/ RLA File<br>:03/95/040/00925/AM19/ <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
147 <br>Case No.:88/15/82-<br>ALC4/2018 Party Name:J.B.<br>CHEMICALS &<br>PHARMACEUTICALS<br>LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br>Lic.No/Date:0310825559<br>10.12.2018 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01545/AM19/ RLA File<br>:03/94/040/00774/AM19/ <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
148 <br>Case No.:703/15/82-<br>ALC4/2018 Party Name:SRINI<br>PHARMACEUTICALS<br>PRIVATE LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br>Lic.No/Date:0910066958<br>10.12.2018 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02160/AM19/ RLA File<br>:09/24/040/00413/AM19/ <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

46

Case No.:704/15/82- Party Name:CLEAN Meet No/Date:3/82- Status: ALC4/2018 SCIENCE AND ALC4/2019 Approved TECHNOLOGY PVT.LTD. 05.07.2019 HQ File RLA File Lic.No/Date:3110067248 :01/82/050/02161/AM19/ :31/83/040/00133/AM19/ 10.12.2018 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. 7/82-ALC4/2018 , dated 24.08.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 149 per details below or as applied by firm whichever is lower:

Export product Qty. Sl.No. Import items Qty.
Guaiacol 1 kg 1 Anisole Purity 93% Max. 1.17 kg
2 Hydrogen Peroxide Purity 60% 0.687 kg
3 Acetone (Solvent) 0.14 kg
150 <br>Case No.:706/15/82-<br>ALC4/2018 Party Name:J.B.<br>CHEMICALS &<br>PHARMACEUTICALS<br>LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02163/AM19/ RLA File<br>:03/94/040/00773/AM19/ Lic.No/Date:0310825552<br>10.12.2018 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
151 Case No.:715/15/82-<br>ALC4/2018 Party Name:MALLADI<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02172/AM19/ RLA File<br>:04/24/040/00143/AM19/ Lic.No/Date:0410164962<br>10.12.2018 Defer<br>Date:05.07.2019
**Decision:**RLA, Chennai was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07<br>application of subject Advance Authorization. However, the application is still awaited from RLA,<br>Chennai. Hence, it was decided to issue a Reminder to RLA, Chennai for furnishing a copy of application<br>expeditiously.

Decision: RLA, Chennai was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07 application of subject Advance Authorization. However, the application is still awaited from RLA, Chennai. Hence, it was decided to issue a Reminder to RLA, Chennai for furnishing a copy of application expeditiously.

152 <br>Case No.:139/15/82-<br>ALC4/2018 Party Name:RUBICON<br>RESEARCH PRIVATE<br>LIMITED<br>RLA File<br>:03/95/040/00889/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/01596/AM19/ Lic.No/Date:0310825587<br>11.12.2018
**Decision:**Deferred for comments of TE.

47

153<br> <br> <br> <br>:<br> Case No.:711/15/82-<br>ALC4/2018 Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
HQ File<br>01/82/050/02168/AM19/ RLA File<br>:09/24/040/00441/AM19/ Lic.No/Date:0910066959<br>11.12.2018
**Decision:**Deferred for comments of TE.
Case No.:712/15/82- Party Name:DELTA Meet No/Date:3/82- Status:
ALC4/2018 FINOCHEM PVT.LTD. ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:031082561
:01/82/050/02169/AM19/ :03/94/040/00740/AM19/ 1
11.12.2018

Decision: The Committee considered case as per agenda and deliberated on the matter in the 154 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.
No.
N Octyl Bromide ( 1-Bromo Octane) 1 kg 1 N Octanol ( N Octyl Alcohol) 0.744 kg
2 Liquid Bromine 0.460 kg
155<br> <br> <br> <br>:<br> <br>t<br> <br> <br> Case No.:100/15/82-<br>ALC4/2018 Party Name:PANACEA<br>BIOTEC LTD., Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved<br>
HQ File<br>01/82/050/01557/AM19/ RLA File<br>:05/24/040/00499/AM19/ Lic.No/Date:0510408880<br>12.12.2018
**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>he technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as<br>per details below or as applied by firm whichever is lower (on one time basis):<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>ALPHADOL CAPSULES (EACH<br>SOFT GELATIN CAPSULE<br>CONTAINS: ALFACALCIDOL<br>0.25 MCG.)<br>2700000 Capsules<br>1<br>ALFACALCIDOL<br>1.785<br>gram<br>ALPHADOL-CA CAPSULES<br>(EACH SOFT GELATIN<br>CAPSULE CONTAINS:<br>ALFACALCIDOL 0.25 mcg &<br>CALCIUM CARBONATE 500mg<br>EQUIVALENT TO<br>ELEMENTAL CALCIUM 200<br>mg)<br>2400000 Capsules<br>The Committee allowed the above norms on one time basis and no repeat norms is allowed.<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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 (on one time basis):

48

156 <br>Case No.:106/15/82-<br>ALC4/2018<br> <br> <br> <br>HQ File<br>:01/82/050/01563/AM19/<br> <br> Party Name:SONGWON<br>SPECIALTY CHEMICALS<br>INDIA PVT. LTD. Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
RLA File<br>:34/24/040/00294/AM19/ Lic.No/Date:3410044750<br>12.12.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for complete technical details asper Appendix 4E from the firm.
157 <br>Case No.:152/15/82-<br>ALC4/2018<br> <br> <br> <br>HQ File<br>:01/82/050/01609/AM19/<br> <br>: Party Name:PRASOL<br>CHEMICALS PRIVATE<br>LIMITED<br>RLA File<br>03/95/040/00948/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br>Lic.No/Date:0310825623<br>12.12.2018 Status:<br>Deferred
Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:189/15/82- Party Name:TATA Meet No/Date:3/82- Status:
ALC4/2018 CHEMICALS LIMITED ALC4/2019 Deferred
05.07.2019
HQ File RLA File Lic.No/Date:0310825645 Defer
:01/82/050/01646/AM19/ :03/95/040/00901/AM19/ 13.12.2018 Date:05.07.2019

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

(i) Use of item of export. (ii) Complete 4E with technical details. (iii) Calculation Sheet to arrive at the quantity of raw material asked. (iv) Past Production Consumption Data duly certified by CE.

Case No.:716/15/82- Party Name:JUBILANT LIFE Meet No/Date:3/82- Status:
ALC4/2018 SCIENCES LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0510408887
:01/82/050/02173/AM19/ :05/23/040/00243/AM19/ 13.12.2018
Case No.:716/15/82-<br>ALC4/2018 Party Name:JUBILANT LIFE<br>SCIENCES LIMITED<br>RLA File<br>:05/23/040/00243/AM19/ Party Name:JUBILANT LIFE<br>SCIENCES LIMITED<br>RLA File<br>:05/23/040/00243/AM19/ Party Name:JUBILANT LIFE<br>SCIENCES LIMITED<br>RLA File<br>:05/23/040/00243/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/02173/AM19/ Lic.No/Date:0510408887<br>13.12.2018
159 **Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 15/82-ALC4/2018 dated 22.03.2019, 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:
Export product Qty. Sl.No. Import items Qty.
<br>Beta Picoline 1 kg 1 Denatured Ethyl Alcohol 1.121 kg
2 Propionaldehyde 0.057 kg
3 Methanol 0.76 kg
4 Ammonia 0.82 kg
5 Alumino Silicate Catalyst 0.007 kg
Piperidine (Min Purity 99%) 1 kg 1 Ruthenium Alumina Catalyst<br>(Ruthenium 5 %) 0.00196 kg
2 Alumina Silicate Catalyst 0.01896 kg
3 Denatured Ethyl Alcohol 2.242 kg
4 Propionaldehyde No details
5 Methanol 1.441 kg
RA maytake appropriate action asper the decision of Norms Committee.

49

Case No.:720/15/82- Party Name:CADILA Meet No/Date:3/82- Status:
ALC4/2018 HEALTHCARE LTD ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0810144085
:01/82/050/02177/AM19/ :08/24/040/00276/AM19/ 13.12.2018

Decision: The Committee considered case as per agenda and deliberated on the matter 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. AZELASTINE HYDROCHLORIDE NASAL SPRAY 137 MCG (30 ML BOTTLE) 1103453.000 (EACH ML CONTAIN 1 MG OF AZELASTINE HYDROCHLORIDE) Number (ACTIVE INGREDIENT : AZELASTINE HYDROCHLORI DE - NET WT. 33.104 KGS) & (PACKING MATERIAL IN FINISHED FORM - NET NOS. 1103453) 160 AZELASTINE HYDROCHLORIDE NASAL SPRAY 205.5 MCG (30 ML 293767.000 BOTTLE) (EACH ML CONTAIN 1.5 MG OF AZELASTINE HYDROCHLORIDE) Number (ACTIVE INGREDIENT : AZELASTINE HYDROCHLORIDE - NET WT. 13.220 - KGS) & (PACKING MATERIAL IN FINISHED FORM NET NOS. 293767) Sl. Import items Qty. No. 1 AZELASTINE HYDROCHLORIDE 47.254 kg 2 30 CC HDPE 18 MM BOTTLE NS Relevant as per packing (AS PER GENERAL POLICY FOR PACKING MATERIAL policy WASTAGE ALLOWED @ 1%) 3 PUMP/ACTUATOR/CLIP Relevant as per packing (AS PER GENERAL POLICY FOR PACKING MATERIAL policy WASTAGE ALLOWED @ 1%)

161 Case No.:721/15/82-<br>ALC4/2018 Party Name:VERVE<br>HUMAN CARE<br>LABORATORIES Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02178/AM19/ RLA File<br>:61/24/040/00020/AM19/ Lic.No/Date:6110001570<br>13.12.2018 <br>Defer<br>Date:05.07.2019
**Decision:**RLA, Dehradun was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07<br>application of subject Advance Authorization. However, the application is still awaited from RLA,<br>Dehradun. Hence, it was decided to issue a Reminder to RLA, Dehradun for furnishing a copy of<br>application expeditiously.

50

Case No.:131/15/82- Party Name:STERLING Meet No/Date:3/82- Status:
ALC4/2018 AUXILIARIES PVT LTD ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310825740
:01/82/050/01588/AM19/ :03/95/040/00959/AM19/ 18.12.2018
Case No.:131/15/82-<br>ALC4/2018 Party Name:STERLING<br>AUXILIARIES PVT LTD Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br>Lic.No/Date:0310825740<br>18.12.2018 Status:<br>Approved
HQ File<br>:01/82/050/01588/AM19/ RLA File<br>:03/95/040/00959/AM19/
162 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the<br>presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7<br>of HBP as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>STERO DIPA 99<br>(Diisopropanolamine)<br>1 kg<br>1<br>DIISOPROPANOLAMINE 99<br>0.98 kg<br>STERO DIPA 85<br>(DIISOPROPANOLAMINE)<br>1 kg<br>1<br>DIISOPROPANOLAMINE 99<br>0.95 kg<br>STEROQUAT 80 (MG)<br>(Benzalkonium Chloride)<br>1 kg<br>1<br>FARMIN DM 2465 (Alkyl Dimethyl<br>Amine)<br>0.5886kg<br>STEROQUAT 50<br>(Benzalkonium Chloride<br>50%)<br>1 kg<br>1<br>FARMIN DM 2465 (Alkyl Dimethyl<br>Amine)<br>0.325 kg<br>BPR81242 (Imidazoline<br>based formulatedproduct)<br>1 kg<br>1<br>Tall Oil fatty Acid (TOFA)<br>0.696 kg<br>2<br>DiethyleneTriamine (DETA)<br>0.1285kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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.:724/15/82- Party Name:DHANUKA Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0510408950
:01/82/050/02181/AM19/ :05/23/040/00399/AM19/ 18.12.2018
Case No.:724/15/82-<br>ALC4/2018 Party Name:DHANUKA<br>LABORATORIES LTD Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/02181/AM19/ RLA File<br>:05/23/040/00399/AM19/ Lic.No/Date:0510408950<br>18.12.2018
163 <br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 1/82-ALC4/2019 dated 03.06.2019, 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.<br>No.<br>Import items<br>Qty.<br>CEFDINIR USP/BP/IP/JP/EP<br>POWDER<br>1 kg<br>1<br>7-Phenylacetamideo<br>-3-<br>Chloromethyl<br>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>1.49kg<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. 1/82-ALC4/2019 dated 03.06.2019, 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:

51

Case No.:725/15/82- Party Name:MELOG Meet No/Date:3/82- Status:
ALC4/2018 SPECIALITY CHEMICALS ALC4/2019 Approved
PVT. LTD. 05.07.2019
HQ File RLA File Lic.No/Date:0310825718
:01/82/050/02182/AM19/ :03/95/040/00947/AM19/ 18.12.2018
Case No.:725/15/82-<br>ALC4/2018 Party Name:MELOG<br>SPECIALITY CHEMICALS<br>PVT. LTD. Party Name:MELOG<br>SPECIALITY CHEMICALS<br>PVT. LTD. Party Name:MELOG<br>SPECIALITY CHEMICALS<br>PVT. LTD. Party Name:MELOG<br>SPECIALITY CHEMICALS<br>PVT. LTD. Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/02182/AM19/ RLA File<br>:03/95/040/00947/AM19/ Lic.No/Date:0310825718<br>18.12.2018
164 <br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 1/82-ALC4/2019 dated 03.06.2019, 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.<br>No.<br>Import items<br>Qty.<br>MR-3 (2,4,6-TRI[(2,4-<br>DIHYDROXY 3<br>METHYL)PHENYL]1,3,5-<br>TRIAZINE<br>1 kg<br>1<br>2 METHYL RESORCINOL<br>1.140 kg<br>2<br>CYANURIC CHLORIDE<br>0.479 kg<br>3<br>SULFOLENE<br>1.80 kg<br>RA maytake appropriate action asper the decision of Norms Committee.
<br>Export product Qty. Sl.<br>No. Import items Qty.
MR-3 (2,4,6-TRI[(2,4-<br>DIHYDROXY 3<br>METHYL)PHENYL]1,3,5-<br>TRIAZINE 1 kg 1 2 METHYL RESORCINOL 1.140 kg
2 CYANURIC CHLORIDE 0.479 kg
3 SULFOLENE 1.80 kg
RA maytake appropriate action asper the decision of Norms Committee.
165 <br>Case No.:726/15/82-<br>ALC4/2018 Party Name:NATCO<br>PHARMA LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02183/AM19/ RLA File<br>:09/24/040/00417/AM19/ Lic.No/Date:0910066973<br>18.12.2018 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
166 <br>Case No.:727/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02184/AM19/ RLA File<br>:09/24/040/00443/AM19/ Lic.No/Date:0910066974<br>18.12.2018 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

52

Case No.:728/15/82- Party Name:AUROBINDO Meet No/Date:3/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0910066975
:01/82/050/02185/AM19/ :09/24/040/00442/AM19/ 18.12.2018
Case No.:728/15/82-<br>ALC4/2018 Case No.:728/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Party Name:AUROBINDO<br>PHARMA LIMITED Party Name:AUROBINDO<br>PHARMA LIMITED Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/02185/AM19/ RLA File<br>:09/24/040/00442/AM19/ Lic.No/Date:0910066975<br>18.12.2018
167 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as<br>per details below or as applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>DOLUTEGRAVIR SODIUM<br>1 kg<br>1<br>(R)-3-Amino-1-butanol (or) (R)-3-<br>Amino-butan-1-ol<br>0.395 kg<br>2<br>2,4 -Difluoro benzylamine<br>0.47 kg<br>3<br>Acetonitrile<br>1.57 kg<br>4<br>Activated<br>Carbon<br>(Carbon<br>Enoanticromos)<br>0.100 kg<br>5<br>Dimethyl Oxalate<br>1.677 kg<br>6<br>Isopropyl Alcohol<br>1.71 kg<br>7<br>Lithiumhydroxide Monohydrate<br>0.355 kg<br>8<br>Methanesulfonic Acid<br>0.122 kg<br>9<br>Methanol(Methyl Alcohol)<br>2.63 kg<br>10<br>Methyl 4-Chloroacetoacetate (or)<br>Methyl 4-Chloro-3-Oxo-Butanoate<br>1.245 kg<br>11<br>Methylene Chloride<br>3.29kg<br>12<br>Pivaloyl Chloride<br>0.38 kg<br>13<br>Tetrahydrofuran<br>1.70 kg<br>14<br>Triethylamine<br>0.367 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.
Export Product Qty. Sl.<br>No. Import items Qty.
DOLUTEGRAVIR SODIUM 1 kg 1 (R)-3-Amino-1-butanol (or) (R)-3-<br>Amino-butan-1-ol 0.395 kg
2 2,4 -Difluoro benzylamine 0.47 kg
3 Acetonitrile 1.57 kg
4 Activated<br>Carbon<br>(Carbon<br>Enoanticromos) 0.100 kg
5 Dimethyl Oxalate 1.677 kg
6 Isopropyl Alcohol 1.71 kg
7 Lithiumhydroxide Monohydrate 0.355 kg
8 Methanesulfonic Acid 0.122 kg
9 Methanol(Methyl Alcohol) 2.63 kg
10 Methyl 4-Chloroacetoacetate (or)<br>Methyl 4-Chloro-3-Oxo-Butanoate 1.245 kg
11 Methylene Chloride 3.29kg
12 Pivaloyl Chloride 0.38 kg
13 Tetrahydrofuran 1.70 kg
14 Triethylamine 0.367 kg

53

Case No.:729/15/82- Party Name:AUROBINDO Meet No/Date:3/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0910066976
:01/82/050/02186/AM19/ :09/24/040/00458/AM19/ 18.12.2018
Case No.:729/15/82-<br>ALC4/2018 Case No.:729/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Party Name:AUROBINDO<br>PHARMA LIMITED Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/02186/AM19/ RLA File<br>:09/24/040/00458/AM19/ Lic.No/Date:09100669<br>18.12.2018 76
**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 22.03.02019, 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:
168 <br> Qty.
Export product Qty. Sl.<br>No. Import item s Qty.
TENOFOVIR<br>DISOPROXIL FUMARAT E 1 kg 1. (R)-PMPA- Pure (PMPA) 0.769 kg
2. Chlorometh yl Isopropyl Carbonate 1.3527 kg
3. Triethylamine 0.4477 kg
4. N-Methyl-2-Pyrrolidone 1.4878 kg
5. Activated Carbon (Carbon<br>Enoanticromos) 0.016 kg
6. Isopropyl Acetate 1.62 kg
7. Isopropyl Alcohol 2.85 kg
8. Methylene Chloride (MDC) 4.32 kg
9 Tl 026 k
RA maytake appropriate action a . ouene . g
sper the decision of Norms Committee.
Case No.:730/15/82- Party Name:PERKIN Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0910066977
:01/82/050/02187/AM19/ :09/24/040/00444/AM19/ 18.12.2018
Case No.:730/15/82-<br>ALC4/2018 Case No.:730/15/82-<br>ALC4/2018 Party Name:PERKIN<br>LABORATORIES Party Name:PERKIN<br>LABORATORIES Party Name:PERKIN<br>LABORATORIES Party Name:PERKIN<br>LABORATORIES Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/02187/AM19/ RLA File<br>:09/24/040/00444/AM19/ Lic.No/Date:0910066977<br>18.12.2018
**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical exerts and it was decided to ratif the ad-hoc inut outut norms under ara 47 of HBP as
169 <br>p y<br>per details below or as applied by firm whichever is lower:<br> <br>Export product<br>Qty.<br>Sl.<br>No.<br>Bromo Ketorolac<br>1500.000 kg<br>1 p p<br> p .<br>Qty.<br>1185.000 kg
Export product Qty. Sl. Import items Qty.
No.
Bromo Ketorolac 1500.000 kg 1 Pyrrole 1185.000 kg
(OR) 5-Benzoyl, 3bromo-2,3-<br>Dihydro,1-H pyrrolizine-1-<br>carboxylic acid 2 Isopropenyl Acetate 1350.000 kg
3 Dimethyl sulphoxide 2565.000 kg
4 DMF 2295.000 kg
5 Potassium Carbonate 6240.000 kg
6 Di-ethyl malonate 3435.000 kg
RA maytake appropriate action asper the decision of Norms Committee.

Decision: The Committee considered case as per agenda and deliberated on the matter 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:

54

Case No.:732/15/82- Party Name:ASHISH LIFE Meet No/Date:3/82- Status:
ALC4/2018 SCIENCE PVT.LTD. ALC4/2019 Deferred
05.07.2019
170 HQ File RLA File Lic.No/Date:0310825741 Defer
:01/82/050/02189/AM19/ :03/94/040/00719/AM19/ 18.12.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:733/15/82- Party Name:S V LABS PVT Meet No/Date:3/82- Status:
ALC4/2018 LTD ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0910066978
:01/82/050/02190/AM19/ :09/24/040/00469/AM19/ 18.12.2018
**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of **Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of **Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of **Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of **Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of **Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of **Decision:**The Committee considered case as per agenda and deliberated on the matter 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:<br>
Export product Qty. Sl. Import items Qty.
171 No.
Cyclohexyl Ester (CEI) 1500.000 kg 1 Glyoxyalic acid (50%) 0.743 kg
2 2,5 Dihydroxy-1,4 Dithiane 0.325 kg
(Diol)
3 Triphosgene 0.40 kg
4 Cytosine 0.412 kg
5 METHYLENE CHLORIDE 2.63 kg
STABILIZED WITH
AMYLENE 50 PPM(MDC)
6 L-Menthol 0.751 kg
RA maytake appropriate action asper the decision of Norms Committee.

Decision: The Committee considered case as per agenda and deliberated on the matter 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.:735/15/82- Party Name:CIPLA Meet No/Date:3/82- Status:
ALC4/2018 LIMITED. ALC4/2019 Deferred
05.07.2019
172 HQ File RLA File Lic.No/Date:0310825758 Defer
:01/82/050/02192/AM19/ :03/94/040/00753/AM19/ 18.12.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:736/15/82- Party Name:AMI Meet No/Date:3/82- Status:
ALC4/2018 ORGANICS LIMITED ALC4/2019 Deferred
05.07.2019
173 HQ File RLA File Lic.No/Date:5210042870 Defer
:01/82/050/02193/AM19/ :52/24/040/00068/AM19/ 18.12.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.

55

Case No.:99/15/82- Party Name:SUN Meet No/Date:3/82- Status:
ALC4/2018 PHARMACEUTICAL ALC4/2019 Deferred
INDUSTRIES LTD. 05.07.2019
174 HQ File RLA File Lic.No/Date:0510408988 Defer
:01/82/050/01556/AM19/ :05/24/040/00503/AM19/ 19.12.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:738/15/82- Party Name:VIVIMED LABS Meet No/Date:3/82- Status:
ALC4/2018 LIMITED ALC4/2019 Deferred
05.07.2019
175 HQ File RLA File Lic.No/Date:0910066983 Defer
:01/82/050/02195/AM19/ :09/24/040/00460/AM19/ 19.12.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:739/15/82- Party Name:BALAJI AMINES Meet No/Date:3/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:3110067257
:01/82/050/02196/AM19/ :31/83/040/00131/AM19/ 19.12.2018

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: 176

Export product Qty. Sl. No. Import items Qty.
N-METHYL-2- 1 kg 1 METHANOL 0.370 kg
PYRROLIDONE 2 AMMONIA ANHYDROUS 0.160 kg
3 1,4 BUTANEDIOL 1.044 kg
4 METHYLAMINE CATALYST 0.00080 kg
5 GBL CATALYST 0.00075 kg

56

Case No.:740/15/82- Party Name:AARTI DRUGS Meet No/Date:3/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310825780
:01/82/050/02197/AM19/ :03/94/040/00772/AM19/ 19.12.2018
Case No.:740/15/82-<br>ALC4/2018 Party Name:AARTI DRUGS<br>LIMITED<br>RLA File<br>:03/94/040/00772/AM19/ Party Name:AARTI DRUGS<br>LIMITED<br>RLA File<br>:03/94/040/00772/AM19/ Party Name:AARTI DRUGS<br>LIMITED<br>RLA File<br>:03/94/040/00772/AM19/ Party Name:AARTI DRUGS<br>LIMITED<br>RLA File<br>:03/94/040/00772/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/02197/AM19/ Lic.No/Date:0310825780<br>19.12.2018
177 **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 Qty. Sl.<br>No. Import items Qty.
Ciprofloxacin Hydrochloride 1 kg 1 Ethyl 3 Cyclopropylamino-2(2,4<br>Dichloro-5 Fluorobenzoyl)<br>Acrylate 1.294 kg
2 Caustic Soda Flakes 0.35 kg
3 Sulpuric Acid (98%) Not importable
4 Toluene 0.123 kg
5 Anhydrous Piperazine 0.39 kg
RA maytake appropriate action as per the decision of Norms Committee.
178 <br>Case No.:1025/15/82-<br>ALC4/2018<br> <br> <br> <br>HQ File<br>:01/82/050/02482/AM19/<br> <br> Party Name:ANLON<br>HEALTHCARE<br>PRIVATELIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
RLA File<br>:24/24/040/00044/AM19/ Lic.No/Date:2410042604<br>19.12.2018 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:209/15/82- Party Name:NECTAR Meet No/Date:3/82- Status:
ALC4/2018 LIFESCIENCES LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:2210016040
:01/82/050/01666/AM19/ :22/24/040/00041/AM19/ 20.12.2018

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:

179

Export product Qty. Sl.<br>No. Import items Qty.
Cefuroxime<br>Axetil<br>Amorphous 1 kg 1 Desacetyl-7-Amino Cephalosporanic Acid (D-<br>7-ACA) 0.752 kg
2 Ethyl acetate 3.56 kg
3 Methanol 0.59 kg
4 Syn-Methoxyimino Furanyl Acetic Acid<br>Ammonium Salt (SMIA) 0.70 kg
5 Activated Carbon 0.100 kg
6 Methylene Chloride 2.18 kg
7 Acetonitrile 0.93 kg
8 Chlorosulphonyl Isocyanate 0.53 kg
9 Acetone 1.67 kg
10 N,N-Dimethyl Acetamide 1.06 kg
11 Cyclohexane 0.87kg

57

Case No.:742/15/82-<br>Party Name:BEST VALUE Meet No/Date:3/82- Status:
ALC4/2018<br>CHEM PVT. LTD. ALC4/2019 Deferred
05.07.2019
HQ File<br>RLA File Lic.No/Date:3410044774 Defer
180 :01/82/050/02199/AM19/<br>:34/24/040/00295/AM19/ 20.12.2018 Date:05.07.2019
Decision:<br>RLA, Vadodara was requested vide e-mail dated 05.04.2019 to furnish the hard copy of
4.07 application of subject Advance Authorization. Application awaited from RLA, Vadodara. However,
the application is still awaited. Hence, it was decided to issue a Reminder to RLA, Vadodara for furnishing
a copyof application expeditiously.

Decision: RLA, Vadodara was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07 application of subject Advance Authorization. Application awaited from RLA, Vadodara. However, the application is still awaited. Hence, it was decided to issue a Reminder to RLA, Vadodara for furnishing a copy of application expeditiously.

Case No.:743/15/82- Party Name:SHUBHLAXMI Meet No/Date:3/82- Status:
ALC4/2018 INDUSTRIES ALC4/2019 Deferred
05.07.2019
HQ File RLA File Lic.No/Date:0810144119 Defer
181 :01/82/050/02200/AM19/ :08/24/040/00267/AM19/ 20.12.2018 Date:05.07.2019
Decision:<br>RLA, Ahmedabad was requested vide e-mail dated 05.04.2019 to furnish the hard copy
of 4.07 application of subject Advance Authorization. Application awaited from RLA, Ahmedabad.
However, the application is still awaited. Hence, it was decided to issue a Reminder to RLA, Ahmedabad
for furnishinga copyof application expeditiously.

Decision: RLA, Ahmedabad was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07 application of subject Advance Authorization. Application awaited from RLA, Ahmedabad. However, the application is still awaited. Hence, it was decided to issue a Reminder to RLA, Ahmedabad for furnishing a copy of application expeditiously.

Case No.:745/15/82- Party Name:CIPLA Meet No/Date:3/82- Status:
ALC4/2018 LIMITED. ALC4/2019 Deferred
05.07.2019
182 HQ File RLA File Lic.No/Date:0310825817 Defer
:01/82/050/02202/AM19/ :03/94/040/00782/AM19/ 20.12.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:747/15/82- Party Name:BLISS GVS Meet No/Date:3/82- Status:
ALC4/2018 PHARMA LTD. ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310825821
:01/82/050/02204/AM19/ :03/94/040/00765/AM19/ 20.12.2018
ALC4/2018<br>PHARMA LTD.<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02204/AM19/<br>RLA File<br>:03/94/040/00765/AM19/<br>Lic.No/Date:0310825821<br>20.12.2018 ALC4/2018<br>PHARMA LTD.<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02204/AM19/<br>RLA File<br>:03/94/040/00765/AM19/<br>Lic.No/Date:0310825821<br>20.12.2018 ALC4/2018<br>PHARMA LTD.<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02204/AM19/<br>RLA File<br>:03/94/040/00765/AM19/<br>Lic.No/Date:0310825821<br>20.12.2018 ALC4/2018<br>PHARMA LTD.<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02204/AM19/<br>RLA File<br>:03/94/040/00765/AM19/<br>Lic.No/Date:0310825821<br>20.12.2018 ALC4/2018<br>PHARMA LTD.<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02204/AM19/<br>RLA File<br>:03/94/040/00765/AM19/<br>Lic.No/Date:0310825821<br>20.12.2018 ALC4/2018<br>PHARMA LTD.<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02204/AM19/<br>RLA File<br>:03/94/040/00765/AM19/<br>Lic.No/Date:0310825821<br>20.12.2018 ALC4/2018<br>PHARMA LTD.<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02204/AM19/<br>RLA File<br>:03/94/040/00765/AM19/<br>Lic.No/Date:0310825821<br>20.12.2018 ALC4/2018<br>PHARMA LTD.<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02204/AM19/<br>RLA File<br>:03/94/040/00765/AM19/<br>Lic.No/Date:0310825821<br>20.12.2018
**Decision:**The Committee considered case as per agenda and deliberated on the matter 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<br> by firm whichever is lower:
Export product Qty. Sl. Import items Qty.
No.
183 Gsunate-50/<br>Artesunatesuppositories Malavan-50<br>50<br>mg 117660.000<br>Number 1 Artesunate 6.000 kg
( Net Contain clindamycin phosphate
5.883 Kgs.)
Gsunate-100/Malavan-100 117650.000 2 Artesunate 12.000 kg
Artesunatesuppositories 100<br>mg Number
( Net Contain clindamycin phosphate
11.765 Kgs.)
Gsunate-200/ Malavan200 34315.000 3 Artesunate 7.000 kg
Artesunatesuppositories 200<br>mg Number
( Net Contain clindamycin phosphate
6.863 Kgs.)
RA maytake appropriate action asper the decision of Norms Committee.

Decision: The Committee considered case as per agenda and deliberated on the matter 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:

58

184 Case No.:748/15/82-<br>ALC4/2018<br>Party Name:SPANSULES<br>FORMULATIONS<br>Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br>Status:<br>Deferred<br>HQ File<br>:01/82/050/02205/AM19/<br>RLA File<br>:09/24/040/00418/AM19/<br>Lic.No/Date:0910066987<br>20.12.2018<br>Defer<br>Date:05.07.2019<br>**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for DML from the firm.
Case No.:749/15/82- Party Name:SRINI Meet No/Date:3/82- Status:
ALC4/2018 PHARMACEUTICALS ALC4/2019 Approved
PRIVATE LIMITED 05.07.2019
HQ File RLA File Lic.No/Date:091006698
:01/82/050/02206/AM19/ :09/24/040/00464/AM19/ 9
20.12.2018
Case No.:749/15/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/02206/AM19/ Party Name:SRINI<br>PHARMACEUTICALS<br>PRIVATE LIMITED<br>RLA File<br>:09/24/040/00464/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br>Lic.No/Date:091006698<br>9<br>20.12.2018 Status:<br>Approved
185 **Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence<br>of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP<br>as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>FLUVOXAMINE<br>MALEATE<br>1 kg<br>1<br>1-CHLORO-4-METHOXY BUTANE<br>1.01 kg<br>2<br>4-(TRIFLUORO<br>METHYL)<br>BENZONITRILE<br>0.93 kg<br>3<br>TETRA HYDROFURAN<br>1.9845 kg<br>4<br>2-CHLOROETHYLAMINE HCL<br>0.48 kg<br>5<br>SODIUM HYDROXIDE MICRO<br>PEARLS<br>1.313 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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:

186 Case No.:752/15/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/02209/AM19/ Party Name:ATUL<br>LIMITED,<br>RLA File<br>:08/24/040/00303/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br>Lic.No/Date:0810144142<br>21.12.2018 Status: Deferred<br> <br>Defer<br>Date:05.07.2019
Decision:<br>RLA, Ahmedabad was requested vide e-mail dated 05.04.2019 to furnish the hard copy<br>of 4.07 application of subject Advance Authorization. Application awaited from RLA, Ahmedabad.<br>However, the application is still awaited. Hence, it was decided to issue a Reminder to RLA, Ahmedabad<br>for furnishinga copyof application expeditiously.

59

Case No.:753/15/82- Party Name:AARTI DRUGS Meet No/Date:3/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310825880
:01/82/050/02210/AM19/ :03/94/040/00800/AM19/ 21.12.2018
Case No.:753/15/82-<br>ALC4/2018 Party Name:AARTI DRUGS<br>LIMITED<br>RLA File<br>:03/94/040/00800/AM19/ Party Name:AARTI DRUGS<br>LIMITED<br>RLA File<br>:03/94/040/00800/AM19/ Party Name:AARTI DRUGS<br>LIMITED<br>RLA File<br>:03/94/040/00800/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/02210/AM19/ Lic.No/Date:0310825880<br>21.12.2018
187 **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 Qty. Sl.<br>No. Import items Qty.
Ciprofloxacin Hydrochloride 1 kg 1 Ethyl 3 Cyclopropylamino-2(2,4<br>Dichloro-5 Fluorobenzoyl) Acrylate 1.294 kg
2 Caustic Soda Flakes 0.35 kg
3 Sulpuric Acid (98%) Not<br>importable
4 Toluene 0.123 kg
5 Anhydrous Piperazine 0.39 kg
RA maytake appropriate action asper the decision of Norms Committee.
Case No.:126/15/82- Party Name:POLYGEL Meet No/Date:3/82- Status:
ALC4/2018 INDUSTRIES PVT.LTD ALC4/2019 Deferred
05.07.2019
HQ File RLA File Lic.No/Date:0310825887 Defer
:01/82/050/01583/AM19/ :03/95/040/00969/AM19/ 24.12.2018 Date:05.07.2019

188 Decision: The Committee considered the case as per agenda in the presence of technical experts, it was decided to call for following information:

(i) Exact chemical name of import item No. 2 (ii) Catalogue of import item No. 2.

60

Case No.:758/15/82- Party Name:OPTRIX Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES PRIVATE ALC4/2019 Approved
LIMITED 05.07.2019
HQ File RLA File Lic.No/Date:0910066997
:01/82/050/02215/AM19/ :09/24/040/00472/AM19/ 24.12.2018
**Decision:**The Committee considered case as per agenda and deliberated on the matter in **Decision:**The Committee considered case as per agenda and deliberated on the matter in **Decision:**The Committee considered case as per agenda and deliberated on the matter in **Decision:**The Committee considered case as per agenda and deliberated on the matter in **Decision:**The Committee considered case as per agenda and deliberated on the matter 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.
No.
189 TEDIZOLID PHOSPHATE 1 kg 1 5-Bromo-2-(2-Methyl-2H-Tetrazol-5- 0.746 kg
Yl)-Pyridine
2 (R)-3-(4-Bromo-3-fluorophenyl)-5- 0.90 kg
(hydroxymethyl)oxazolidin-2-one
3 Dichlorobis(di-tert- 0.025 kg
butylphenylphosphine)palladium(II)
4 Bis(pinacolato)diboron 0.706 kg
5 1,1-Bis (diphenylphosphino) Not shown
ferrocene]dichloropalladium(II) in the
process
RA maytake appropriate action as per the decision of Norms Committee.
Case No.:925/15/82- Party Name:OPTRIX Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES PRIVATE ALC4/2019 Deferred
LIMITED 05.07.2019
190 HQ File RLA File Lic.No/Date:0910066998 Defer
:01/82/050/02382/AM19/ :09/24/040/00470/AM19/ 24.12.2018 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:761/15/82- Party Name:CADILA Meet No/Date:3/82- Status:
ALC4/2018 HEALTHCARE LTD ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0810144172
:01/82/050/02218/AM19/ :08/24/040/00310/AM19/ 26.12.2018

Decision: The Committee considered case as per agenda and deliberated on the matter 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 191 per details below or as applied by firm whichever is lower:

Export product Qty. Sl. Import items Qty.
No.
2-chloromethyl-4-Methyl 1 kg 1 2-amino Acetophenone 0.99 kg
Quinazoline(CD 605 BS) 2 Methyl Cyclohexane 1.954 kg

192 Case No.:762/15/82-

Status:

Meet No/Date:3/82-

Party Name:HPL

61

ALC4/2018<br>HQ File<br>:01/82/050/02219/AM19/ ADDITIVES<br>LIMITED(FORMERLY<br>KNOWN HIGH POLYMER ADDITIVES<br>LIMITED(FORMERLY<br>KNOWN HIGH POLYMER ADDITIVES<br>LIMITED(FORMERLY<br>KNOWN HIGH POLYMER ADDITIVES<br>LIMITED(FORMERLY<br>KNOWN HIGH POLYMER ALC4/2019<br>05.07.2019 ALC4/2019<br>05.07.2019 Deferred<br> <br>Defer<br>Date:05.07.2019 Deferred<br> <br>Defer<br>Date:05.07.2019 Deferred<br> <br>Defer<br>Date:05.07.2019
RLA File<br>:05/23/040/00403/AM19/ Lic.No/Date:0510409068<br>26.12.2018
**Decision:**Deferred for comments of TE.
193 Case No.:766/15/82-<br>ALC4/2018 Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00471/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/02223/AM19/ Lic.No/Date:0910067002<br>27.12.2018
<br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as<br>per details below or as applied by firm whichever is lower:
Export product Qty. Sl.<br>No. Import items Qty.
Eplerenone 1 kg 1 (7A,17A)-17-Hydroxy-3-oxo-pregna-<br>4,9(11)-diene-7,21-dicarboxylic acid g-<br>lactonemethylester 1.42 kg
RA maytake appropriate action as per the decision of Norms Committee.
194 <br>Case No.:767/15/82-<br>ALC4/2018<br> <br> <br>HQ File<br>:01/82/050/02224/AM19/<br> <br> Party Name:CIPLA<br>LIMITED. Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br>Lic.No/Date:0310825972<br>27.12.2018 Status:<br>Deferred
RLA File<br>:03/94/040/00826/AM19/ Defer<br>Date:05.07.2019
Decision:<br>Deferred for c omments of TE.
Case No.:116/15/82- Party Name:O C Meet No/Date:3/82- Status:
ALC4/2018 SPECIALITIES PVT.LTD. ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310826001
:01/82/050/01573/AM19/ :03/95/040/01022/AM19/ 28.12.2018

Decision: The Committee considered case as per agenda and deliberated on the matter 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 195 per details below or as applied by firm whichever is lower:

Export product Qty. Sl. Import items Qty.
No.
2,6 DICHLORO BENZOYL 1 kg 1 2,6 DICHLORO BENZALDEHYDE 0.927 kg
CHLORIDE

62

Case No.:770/15/82- Party Name:J.B. CHEMICALS Meet No/Date:3/82- Status:
ALC4/2018 & PHARMACEUTICALS ALC4/2019 Approved
LIMITED 05.07.2019
HQ File RLA File Lic.No/Date:0310826011
:01/82/050/02227/AM19/ :03/94/040/00818/AM19/ 28.12.2018
Case No.:770/15/82-<br>ALC4/2018 Case No.:770/15/82-<br>ALC4/2018 Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/02227/AM19/ RLA File<br>:03/94/040/00818/AM19/ Lic.No/Date:0310826<br>28.12.2018 011
**Decision:**The Committee c<br>the technical experts and it wa<br>per details below or as applied onsidered case as per agenda a<br>s decided to ratify the ad-hoc<br>by firm whichever is lower: nd deliberated on the matte<br>input output norms under r in the presence of<br>para 4.7 of HBP as
Export product Qty. Sl.<br>No. Import items Qty.
Rinza sip with Vitamin C<br>(Flavours Orange/ Lemon/<br>Black Currant/ Other<br>flavours)<br>& Rinza Sip (Flavours<br>Orange/ Lemon/ Black<br>currant/ Cranberry/ Honey<br>Lemon/ Other flavours). 30303050.000<br>Number<br>Sachet 1 Caffeine Anhydrous Powder 918.18 kg
196 <br>Each sachet of 5gm contains<br>Caffeine Anhydrous Powder<br>
30mg. Net content of<br>Caffeine Anhydrous Powder<br>909.09 Kgs.
Rinza Tablet Each tablet 35772360000 2 Caff ine Anhydrous Powder 109463 kg
.<br>Contains Caffeine<br>Anhydrous Powder 30 mg, .<br>Number<br>Tablet .
3 Para cetamol IP/BP 18243.90 kg
and Paracetamol BP 500 mg.<br>Net Content of Caffeine<br>Anhydrous Powder -<br>1073.17 Kgs and<br>Paracetamol IP/ BP-<br>17886.18 Kgs
Rinza Sip for Children<br>(Flavours Rasp berry/ other<br>flavours). Each sachet of<br>3gm contains Paracetamol<br>IP/BP - 280mg.<br> 46932250.000<br>Number<br>Tablet 4 Paracetamol IP/BP 13272.44 kg
Net content-13141.03 Kgs.
RA matake aroriate action aser the decision of Norms Committee
y ppp p .
197 Case No.:771/15/82- PartyName:AUROBINDO Meet No/Date:3/82- Status:

Status:

197 Case No.:771/15/82-

Party Name:AUROBINDO

Meet No/Date:3/82-

63

ALC4/2018 PHARMA LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0910067005
:01/82/050/02228/AM19/ :09/24/040/00448/AM19/ 31.12.2018

Decision: The Committee considered case as per agenda and deliberated on the matter 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.
No.
AMOXICILLIN TRIHYDRATE 1 kg 1 6-APA (6-Amino Penicillanic 0.55 kg
Condition: The firm shall have to Acid)
complete the EO within 12 (Pre-import Condition imposed)
months from the date of clearance 2 Methyl D-(-)-4-Hydroxy- 0.477 kg
of each import consignment of Phenylglycinate (OR) D-(-)-4-
Sl.No.1 of the Import List as per hydroxyphenylglycine Methyl
Appendix 4J read with PN Ester [PHPG Ester]
No.62/24.03.2017 3 Penicillin G Amidase (Particle size 0.0017 kg
250 - 500 micron, Creamish to
Brown regularly shaped beads)
198 <br>Case No.:772/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00445/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/02229/AM19/ Lic.No/Date:0910067006<br>31.12.2018
**Decision:**Deferred for comments of TE.
199 <br>Case No.:775/15/82-<br>ALC4/2018 Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br>Lic.No/Date:0910067014<br>31.12.2018 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02232/AM19/ RLA File<br>:09/24/040/00482/AM19/ Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

Status:

200 Case No.:779/15/82-

Party Name:BALAJI AMINES Meet No/Date:3/82-

64

ALC4/2018 LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:3110067272
:01/82/050/02236/AM19/ :31/83/040/00129/AM19/ 31.12.2018

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:

Export product Qty. Sl. No. Import items Qty.
N-METHYL-2- 1 kg 1 METHANOL 0.370 kg
PYRROLIDONE 2 AMMONIA ANHYDROUS 0.160 kg
3 1,4 BUTANEDIOL 1.044 kg
4 METHYLAMINE CATALYST 0.00080 kg
5 GBL CATALYST 0.00075 kg
Case No.:780/15/82- Party Name:BALAJI AMINES Meet No/Date:3/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:3110067273
:01/82/050/02237/AM19/ :31/83/040/00148/AM19/ 31.12.2018

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

Export product Qty. Sl. No. Import items Qty.
GAMMA BUTYROLACONE 1 kg 1 1,4 BUTANEDIOL 1.16 kg
2 GBL CATAYLYST 0.001 kg
Case No.:781/15/82- Party Name:BALAJI AMINES Meet No/Date:3/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:3110067274
:01/82/050/02238/AM19/ :31/83/040/00149/AM19/ 31.12.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 1/82-ALC4/2019 dated 03.06.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as 202 per details given below or as applied by the firm, whichever is less:

Export product Qty. Sl. No. Import items Qty.
N-ETHYL-2- 1 kg 1 GAMMA BUTYROLACTONE 0.72 kg
PYRROLIDONE 2 MONOETHYLAMINE 70% 0.533 kg
SOLUTION

65

Case No.:119/15/82-<br>Party Name:THINQ PHARMA<br>Meet No/Date:3/82- Case No.:119/15/82-<br>Party Name:THINQ PHARMA<br>Meet No/Date:3/82- Status:
ALC4/2018<br>CRO LIMITED<br>ALC4/2019 Approved
05.07.2019
HQ File<br>RLA File Lic.No/Date:0310826050
:01/82/050/01576/AM19/<br>:03/95/040/00872/AM19/<br>01.01.2019
**Decision:**The Committee considered case as per agenda and deliberated on the matter 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<br>Qty. Sl.<br>Import items Qty.
No.
G-101 (All Trans Retinoic Acid,1-<br>1 kg 1<br>Tretinoin (All Trans Retinoic 1.00 kg
Hydroxy-3,3-dimethyl-2-Butanone Acid)
Ester) 2<br>1-Chloropinacolone 0.469 kg
3<br>Cesium Carbonate 1.135 kg
RA maytake appropriate action asper the decision of Norms Committee.

Decision: The Committee considered case as per agenda and deliberated on the matter 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: 203

Case No.:784/15/82- Party Name:SMS Meet No/Date:3/82- Status:
ALC4/2018 LIFESCIENCES INDIA ALC4/2019 Deferred
LIMITED 05.07.2019
HQ File RLA File Lic.No/Date:0910067021 Defer
204 :01/82/050/02241/AM19/ :09/24/040/00490/AM19/ 01.01.2019 Date:05.07.2019
Decision:<br>RLA, Hyderabad was requested vide e-mail dated 05.04.2019 to furnish the hard copy of
4.07 application of subject Advance Authorization. Application awaited from RLA, Hyderabad. However,
the application is still awaited. Hence, it was decided to issue a Reminder to RLA, Hyderabad for
furnishinga copyof application expeditiously.

Decision: RLA, Hyderabad was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07 application of subject Advance Authorization. Application awaited from RLA, Hyderabad. However, the application is still awaited. Hence, it was decided to issue a Reminder to RLA, Hyderabad for furnishing a copy of application expeditiously.

Case No.:785/15/82- Party Name:LUPIN LIMITED Meet No/Date:3/82- Status:
ALC4/2018 ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310826058
:01/82/050/02242/AM19/ :03/95/040/01003/AM19/ 01.01.2019
ALC4/2018<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02242/AM19/<br>RLA File<br>:03/95/040/01003/AM19/<br>Lic.No/Date:0310826058<br>01.01.2019 ALC4/2018<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02242/AM19/<br>RLA File<br>:03/95/040/01003/AM19/<br>Lic.No/Date:0310826058<br>01.01.2019 ALC4/2018<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02242/AM19/<br>RLA File<br>:03/95/040/01003/AM19/<br>Lic.No/Date:0310826058<br>01.01.2019 ALC4/2018<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02242/AM19/<br>RLA File<br>:03/95/040/01003/AM19/<br>Lic.No/Date:0310826058<br>01.01.2019 ALC4/2018<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02242/AM19/<br>RLA File<br>:03/95/040/01003/AM19/<br>Lic.No/Date:0310826058<br>01.01.2019 ALC4/2018<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02242/AM19/<br>RLA File<br>:03/95/040/01003/AM19/<br>Lic.No/Date:0310826058<br>01.01.2019
**Decision:**The Committee considered case as per agenda and deliberated on the matter 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:
205 Export product Qty. Sl. Import items Qty.
No.
BIPERIDEN 1 Number 1 BIPERIDEN 1.02 mg/tablet
HYDROCHLORIDE 1MG HYDROCHLORIDE
TABLETS
(NET WT. 50.40 KGS,
WEIGHT OF DRUG : 52.42
KGS)
RA maytake appropriate action asper the decision of Norms Committee.

66

Case No.:843/15/82- Party Name:IPCA Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310826061
:01/82/050/02300/AM19/ :03/94/040/00825/AM19/ 01.01.2019
ALC4/2018<br>LABORATORIES LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02300/AM19/<br>RLA File<br>:03/94/040/00825/AM19/<br>Lic.No/Date:0310826061<br>01.01.2019 ALC4/2018<br>LABORATORIES LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02300/AM19/<br>RLA File<br>:03/94/040/00825/AM19/<br>Lic.No/Date:0310826061<br>01.01.2019 ALC4/2018<br>LABORATORIES LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02300/AM19/<br>RLA File<br>:03/94/040/00825/AM19/<br>Lic.No/Date:0310826061<br>01.01.2019 ALC4/2018<br>LABORATORIES LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02300/AM19/<br>RLA File<br>:03/94/040/00825/AM19/<br>Lic.No/Date:0310826061<br>01.01.2019 ALC4/2018<br>LABORATORIES LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02300/AM19/<br>RLA File<br>:03/94/040/00825/AM19/<br>Lic.No/Date:0310826061<br>01.01.2019 ALC4/2018<br>LABORATORIES LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02300/AM19/<br>RLA File<br>:03/94/040/00825/AM19/<br>Lic.No/Date:0310826061<br>01.01.2019 ALC4/2018<br>LABORATORIES LIMITED<br>ALC4/2019<br>05.07.2019<br>Approved<br>HQ File<br>:01/82/050/02300/AM19/<br>RLA File<br>:03/94/040/00825/AM19/<br>Lic.No/Date:0310826061<br>01.01.2019
**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:
206 Export product Qty. Sl. Import Items Qty.
No.
Lumefantrine 1 kg 1. a(Dibutylamine Methyl) 2,7-Dichloro-4-Fluoren 0.8693 kg
Methanol[DBA]/2,7-Dichloro-A-
(Dibutylamino)Methyl-9H-Fluorene-4-Methanol
2. P-Chlorobenzyldehyde 0.3477 kg
3. Acetone 0.604 kg
4. Methanol 0.600 kg
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. 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:

Case No.:788/15/82- Party Name:MANKIND Meet No/Date:3/82- Status:
ALC4/2018 PHARMA LTD ALC4/2019 Deferred
05.07.2019
207 HQ File RLA File Lic.No/Date:0510409149 Defer
:01/82/050/02245/AM19/ :05/24/040/00552/AM19/ 02.01.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:789/15/82- Party Name:POSY Meet No/Date:3/82- Status:
ALC4/2018 PHARMACHEM PVT. LTD. ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0810144202
:01/82/050/02246/AM19/ :08/24/040/00253/AM19/ 02.01.2019

208

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 product Qty. Sl. Import Items Qty.
No.
SODIUM 1 kg 1. CITRIC ACID MONOHYDRATE 0.421 kg
CITRATE BP /<br>USP 2. CAUSTIC SODA FLAKES / PEARLS 0.736 kg

67

Case No.:792/15/82-<br>ALC4/2018 Party Name:BIOLOGICAL E<br>LTD Meet No/Date:3/82-<br>ALC4/2019 Status:<br>Deferred
209 <br>RLA File<br>:09/24/040/00479/AM19/ <br>05.07.2019 <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/02249/AM19/ Lic.No/Date:0910067026<br>03.01.2019
**Decision:**A copy of applicat<br>DBT. ion has been forwarded to DBT on 17.07.2019. Deferred for comments of
Case No.:794/15/82- Party Name:BDR Meet No/Date:3/82- Status:
ALC4/2018 PHARMACEUTICALS ALC4/2019 Deferred
INTERNATIONAL PVT. 05.07.2019
210 LTD.
HQ File RLA File Lic.No/Date:0310826132 Defer
:01/82/050/02251/AM19/ :03/94/040/00836/AM19/ 03.01.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:796/15/82- Party Meet No/Date:3/82- Status:
ALC4/2018 Name:D.K.BIOPHARMA ALC4/2019 Deferred
PRIVATE LIMITED 05.07.2019
211 HQ File RLA File Lic.No/Date:0310826158 Defer
:01/82/050/02253/AM19/ :03/94/040/00842/AM19/ 04.01.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:798/15/82- Party Name:NEULAND Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2019 Deferred
05.07.2019
212 HQ File RLA File Lic.No/Date:0910067032 Defer
:01/82/050/02255/AM19/ :09/24/040/00488/AM19/ 04.01.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:1072/15/82- Party Name:MALLADI Meet No/Date:3/82- Status:
ALC4/2018 DRUGS & ALC4/2019 Deferred
PHARMACEUTICALS 05.07.2019
213 LIMITED
HQ File RLA File Lic.No/Date:0410165065 Defer
:01/82/050/02529/AM19/ :04/24/040/00218/AM19/ 04.01.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:109/15/82- Party Name:U SQUARE Meet No/Date:3/82- Status:
ALC4/2018 LIFESCIENCE PRIVATE ALC4/2019 Deferred
LIMITED 05.07.2019
214 HQ File RLA File Lic.No/Date:0810144243 Defer
:01/82/050/01566/AM19/ :08/24/040/00329/AM19/ 07.01.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.

68

Case No.:202/15/82- Party Name:SUN Meet No/Date:3/82- Status:
ALC4/2018 PHARMACEUTICAL ALC4/2019 Deferred
INDUSTRIES LTD. 05.07.2019
215 HQ File RLA File Lic.No/Date:0510409204 Defer
:01/82/050/01659/AM19/ :05/24/040/00554/AM19/ 07.01.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:800/15/82- Party Name:LUPIN LIMITED Meet No/Date:3/82- Status:
ALC4/2018 ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310826190
:01/82/050/02257/AM19/ :03/95/040/01047/AM19/ 07.01.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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: 216

Export product Qty. Sl. Import items Qty.
No.
BIPERIDEN HYDROCHLORIDE 1 Number 1 BIPERIDEN 1.02 mg/tablet
1MG TABLETS HYDROCHLORIDE
(NET WT. 35.00 KGS, WEIGHT OF
DRUG : 36.40 KGS)
Case No.:201/15/82- Party Name:RECKITT Meet No/Date:3/82- Status:
ALC4/2018 BENCKISER (INDIA) ALC4/2019 Deferred
PRIVATE LIMITED 05.07.2019
217 HQ File RLA File Lic.No/Date:0510409279 Defer
:01/82/050/01658/AM19/ :05/24/040/00572/AM19/ 09.01.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:805/15/82- Party Name:DEEPAK Meet No/Date:3/82- Status:
ALC4/2018 NOVOCHEM ALC4/2019 Deferred
TECHNOLOGIES LTD 05.07.2019
218 HQ File RLA File Lic.No/Date:3110067278 Defer
:01/82/050/02262/AM19/ :31/83/040/00157/AM19/ 09.01.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:123/15/82- Party Name:REYAANSH Meet No/Date:3/82- Status:
ALC4/2018 HEALTHCARE ALC4/2019 Deferred
05.07.2019
219 HQ File RLA File Lic.No/Date:0310826282 Defer
:01/82/050/01580/AM19/ :03/95/040/01019/AM19/ 10.01.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.

69

Case No.:807/15/82- Party Name:PAB Meet No/Date:3/82- Status:
ALC4/2018 ORGANICS PVT.LTD, ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:341004481
:01/82/050/02264/AM19/ :34/24/040/00234/AM19/ 1
10.01.2019

Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 220 4.7 of HBP as per details below or as applied by firm whichever is lower:

Export product Qty. Sl.<br>No. Import items Qty.
(+) -3- (CARBAMOYLMETHYL) -<br>5- METHYLHEXANOIC ACID 1 kg 1 2-CYANOACETAMIDE 1.40 kg
2 ISOVALERALDEHYDE<br>(ISOVALERAL) 0.72 kg
Case No.:808/15/82- Party Name:ADISHANK Meet No/Date:3/82- Status:
ALC4/2018 CHEMICALS PVT.LTD. ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310826300
:01/82/050/02265/AM19/ :03/94/040/00659/AM19/ 10.01.2019

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

Export product<br>DI<br>PHENYL<br>ISO<br>DECYL<br>PHOSPHITE(DPDP) Qty. Sl.<br>No. Import Items Qty.
1 kg 1. Phenol 0.557 kg
2. 2 -Propyl Heptanol 0.386 kg
222 <br>Case No.:809/15/82-<br>ALC4/2018 Party Name:ATUL<br>LIMITED, Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br>Lic.No/Date:0810144289<br>10.01.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/02266/AM19/ RLA File<br>:08/24/040/00327/AM19/
**Decision:**Deferred for comments of TE.
223 <br>Case No.:811/15/82-<br>ALC4/2018 Party Name:ATUL<br>LIMITED, Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br>Lic.No/Date:0810144290<br>10.01.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/02268/AM19/ RLA File<br>:08/24/040/00328/AM19/
**Decision:**Deferred for comments of TE.

70

Case No.:812/15/82- Party Name:BALAJI Meet No/Date:3/82- Status:
ALC4/2018 AMINES LIMITED ALC4/2019 Deferred
05.07.2019
224 HQ File RLA File Lic.No/Date:3110067279 Defer
:01/82/050/02269/AM19/ :31/83/040/00158/AM19/ 10.01.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:815/15/82- Party Name:ELPPE Meet No/Date:3/82- Status:
ALC4/2018 CHEMICALS PRIVATE ALC4/2019 Deferred
LIMITED 05.07.2019
225 HQ File RLA File Lic.No/Date:0310826358 Defer
:01/82/050/02272/AM19/ :03/94/040/00889/AM19/ 14.01.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:817/15/82- Party Name:HEMA DYE Meet No/Date:3/82- Status:
ALC4/2018 CHEM PVT. LTD. ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310826383
:01/82/050/02274/AM19/ :03/94/040/00830/AM19/ 15.01.2019

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 5/82-ALC4/2018 dated 25.07..2018 and 14/AM19 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: 226

Export product Qty. Sl. Import items Qty.
No.
C- HYDROCHINONDIMETHETH 1 kg 1 PARADIMETHOXYBENZENE 0.875 kg
ER D (CEA) (2 CHLORO,1,4 (PDMB)
DIMETHOXY BENZENE) (HYDROQUINONEDIMETHYL
ETHER ) (HQDME) (DMB-
1,4DIMETHOXYBENZENE)

71

Case No.:820/15/82- Party Name:AURORE LIFE Meet No/Date:3/82- Status:
ALC4/2018 SCIENCES PRIVATE ALC4/2019 Deferred
LIMITED 05.07.2019
227 HQ File RLA File Lic.No/Date:0910067061 Defer
:01/82/050/02277/AM19/ :09/24/040/00508/AM19/ 16.01.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:823/15/82- Party Name:BRAWN Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2019 Deferred
05.07.2019
228 HQ File RLA File Lic.No/Date:0510409352 Defer
:01/82/050/02280/AM19/ :05/23/040/00441/AM19/ 16.01.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:1026/15/82- Party Name:ANLON Meet No/Date:3/82- Status:
ALC4/2018 HEALTHCARE ALC4/2019 Deferred
PRIVATELIMITED 05.07.2019
229 HQ File RLA File Lic.No/Date:2410042628 Defer
:01/82/050/02483/AM19/ :24/24/040/00049/AM19/ 16.01.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:825/15/82- Party Name:BRAWN Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0510409373
:01/82/050/02282/AM19/ :05/23/040/00467/AM19/ 17.01.2019
**Decision:**The Committee **Decision:**The Committee considered the cases considered the cases as per agenda and in the light of earlier decision taken in as per agenda and in the light of earlier decision taken in 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:
230 Export product Qty. Sl. Import items Qty.
No.
CIPROFLOXACIN One 500 1. CIPROFLOXACIN 555.0 mg/500
TABLETS 500MG mg tablet HYDROCHLORIDE USP mg Tablets
(OFF WHITE (FAINTLY YELLOWISH TO
ELONGATED, LIGHT YELLOW
BICONVEX, FLIM CRYSTALS)
COATED TABLET,
SCORED ON ONE SIDE)
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. 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:

72

Case No.:828/15/82- Party Name:ADISHANK Meet No/Date:3/82- Status:
ALC4/2018 CHEMICALS PVT.LTD. ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310826440
:01/82/050/02285/AM19/ :03/94/040/00865/AM19/ 17.01.2019

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

Export product Qty. Sl. Import Items Qty.
No.
DI<br>PHENYL ISO DECYL PHOSPHITE 1 kg 1. Phenol 0.557 kg
(DPDP) 2. 2 -Propyl Heptanol 0.386 kg
232 <br>Case No.:829/15/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/02286/AM19/ Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
RLA File<br>:09/24/040/00499/AM19/ Lic.No/Date:0910067071<br>18.01.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
233 <br>Case No.:830/15/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/02287/AM19/ Party Name:R CHEM<br>(SOMANAHALLI)<br>PVT.LTD, Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
RLA File<br>:09/24/040/00516/AM19/ Lic.No/Date:0910067074<br>18.01.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:831/15/82- Party Name:BENZO CHEM Meet No/Date:3/82- Status:
ALC4/2018 INDUSTRIES PRIVATE ALC4/2019 Approved
LIMITED, 05.07.2019
HQ File RLA File Lic.No/Date:0310826458
:01/82/050/02288/AM19/ :03/94/040/00853/AM19/ 18.01.2019

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 1/82-ALC4/2019 dated 03.06.2019, 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:

234

Export Product Qty. Sl.<br>No. Import items Qty.
2-DIMETHYLAMINO-2-<br>PHENYLBUTAN-1-OL<br>(DAFOL) 1 kg 1 PROPIOPHENONE 1.408 kg
2 SODIUM CYANIDE 0.599kg
3 PARA FORMALDEHYDE 0.528 kg
4 SODIUM BOROHYDRIDE 0.528 kg
5 TETRA HYDRO FURAN(THF) 1.00 kg

73

Case No.:832/15/82- Party Name:BENZO CHEM Meet No/Date:3/82- Status:
ALC4/2018 INDUSTRIES PRIVATE ALC4/2019 Approved
LIMITED, 05.07.2019
HQ File RLA File Lic.No/Date:0310826462
:01/82/050/02289/AM19/ :03/94/040/00837/AM19/ 18.01.2019

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 1/82-ALC4/2019 dated 03.06.2019, 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:

235

Export Product Qty. Sl.<br>No. Import items Qty.
2-DIMETHYLAMINO-2-<br>PHENYLBUTAN-1-OL<br>(DAFOL) 1 kg 1 PROPIOPHENONE 1.408 kg
2 SODIUM CYANIDE 0.599kg
3 PARA FORMALDEHYDE 0.528 kg
4 SODIUM BOROHYDRIDE 0.528 kg
5 TETRA HYDRO FURAN(THF) 1.00 kg
Case No.:835/15/82- Party Name:CADILA Meet No/Date:3/82- Status:
ALC4/2018 HEALTHCARE LTD ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0810144365
:01/82/050/02292/AM19/ :08/24/040/00315/AM19/ 22.01.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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: 236

Export product Qty. Sl.<br>No. Import items Qty.
DIOSMIN TABLETS 600 MG<br>(ACTIVE INGREDIENT :<br>DIOSMIN PH EUR - NET WT.<br>500.220KGS) 833700<br>Number 1 DIOSMIN PH EUR 510.224 kg
237 Case No.:837/15/82-<br>ALC4/2018 Party Name:DANOPHARM<br>CHEMICALS PRIVATE<br>LTD. Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
HQ File<br>:01/82/050/02294/AM19/ RLA File<br>:03/94/040/00886/AM19/ Lic.No/Date:0310826539<br>22.01.2019 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

74

238 <br>Case No.:869/15/82-<br>ALC4/2018 Party Name:ALKALI<br>METALS LTD., Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02326/AM19/ RLA File<br>:09/24/040/00495/AM19/ Lic.No/Date:0910067104<br>23.01.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
239 <br>Case No.:842/15/82-<br>ALC4/2018 Party Name:S.M. HERBALS<br>PVT.LTD. Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02299/AM19/ RLA File<br>:05/24/040/00602/AM19/ Lic.No/Date:0510409465<br>24.01.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
240 <br>Case No.:212/15/82-<br>ALC4/2018 Party Name:VENUS<br>REMEDIES LTD., Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01669/AM19/ RLA File<br>:22/24/040/00079/AM19/ Lic.No/Date:2210016070<br>25.01.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
241 <br>Case No.:844/15/82-<br>ALC4/2018 Party Name:KLJ<br>PLASTICIZERS LIMITED. Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02301/AM19/ RLA File<br>:05/23/040/00475/AM19/ Lic.No/Date:0510409477<br>25.01.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
242 <br>Case No.:845/15/82-<br>ALC4/2018 Party Name:J.B.<br>CHEMICALS &<br>PHARMACEUTICALS<br>LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
HQ File<br>:01/82/050/02302/AM19/ RLA File<br>:03/94/040/00925/AM19/ Lic.No/Date:0310826640<br>25.01.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
243 Case No.:847/15/82-<br>ALC4/2018 Party Name:LIRICON<br>TRADING Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02304/AM19/ RLA File<br>:03/95/040/01055/AM19/ Lic.No/Date:0310826653<br>25.01.2019 <br>Defer<br>Date:05.07.2019
Decision:<br>RLA, Mumbai was requested vide e-mail dated 05.04.2019 to furnish the hard copy of<br>4.07 application of subject Advance Authorization. Application awaited from RLA, Mumbai. However,<br>the application is still awaited. Hence, it was decided to issue a Reminder to RLA, Mumbai for furnishing<br>a copyof application expeditiously.

75

244 Case No.:848/15/82-<br>ALC4/2018 Party Name:VIVIMED LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02305/AM19/ RLA File<br>:09/24/040/00505/AM19/ Lic.No/Date:0910067112<br>28.01.2019 Defer<br>Date:05.07.2019
Decision:<br>RLA, Hyderabad was requested vide e-mail dated 05.04.2019 to furnish the hard copy of<br>4.07 application of subject Advance Authorization. Application awaited from RLA, Hyderabad. However,<br>the application is still awaited. Hence, it was decided to issue a Reminder to RLA, Hyderabad for<br>furnishinga copyof application expeditiously.
245 Case No.:851/15/82-<br>ALC4/2018 Party Name:SI GROUP -<br>INDIA PRIVATE LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02308/AM19/ RLA File<br>:03/95/040/01108/AM19/ Lic.No/Date:0310826724<br>30.01.2019 Defer<br>Date:05.07.2019
Decision:<br>RLA, Bangalore was requested vide e-mail dated 05.04.2019 to furnish the hard copy of<br>4.07 application of subject Advance Authorization. Application awaited from RLA, Bangalore. However,<br>the application is still awaited. Hence, it was decided to issue a Reminder to RLA, Bangalore for<br>furnishinga copyof application expeditiously.
246 <br>Case No.:853/15/82-<br>ALC4/2018 Party Name:ALPHAMED<br>FORMULATIONS P LTD.<br>RLA File<br>:09/24/040/00511/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/02310/AM19/ Lic.No/Date:0910067120<br>31.01.2019
**Decision:**Deferred for comments of TE.
Case No.:854/15/82- Party Name:SAI RAM Meet No/Date:3/82- Status:
ALC4/2018 CHEMICALS ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:2610012873
:01/82/050/02311/AM19/ :26/24/040/00016/AM19/ 31.01.2019

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:

247

Export product Qty. Sl. Import items Qty.
No.
(4R-CIS)-1,1-DIMETHYLETHYL-6- 1 kg 1 (4R-CIS)-1,1-DIMETHYLETHYL- 1.01 kg
(2-AMINOMETHYL-2,2- 6-CYANOMETHYL-2,2-
DIMETHYL-1,3-DIOXANE-4- DIMETHYL-1,3-DIOXANE-4-
ACETATE (AMINO KETAL) ACETATE

76

248 <br>Case No.:855/15/82-<br>ALC4/2018<br> <br> <br> <br>HQ File<br>:01/82/050/02312/AM19/<br> <br> Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
RLA File<br>:09/24/040/00542/AM19/ Lic.No/Date:0910067122<br>31.01.2019 <br>Defer<br>Date:05.07.2019
Decision:<br>RLA, Hyderabad was requested vide e-mail dated 05.04.2019 to furnish the hard copy of<br>4.07 application of subject Advance Authorization. Application awaited from RLA, Hyderabad. However,<br>the application is still awaited. Hence, it was decided to issue a Reminder to RLA, Hyderabad for<br>furnishinga copyof application expeditiously.

Decision: RLA, Hyderabad was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07 application of subject Advance Authorization. Application awaited from RLA, Hyderabad. However, the application is still awaited. Hence, it was decided to issue a Reminder to RLA, Hyderabad for furnishing a copy of application expeditiously.

Case No.:856/15/82- Party Name:TATVA Meet No/Date:3/82- Status:
ALC4/2018 CHINTAN PHARMA CHEM ALC4/2019 Approved
PVT LTD 05.07.2019
HQ File RLA File Lic.No/Date:3410044856
:01/82/050/02313/AM19/ :34/24/040/00308/AM19/ 31.01.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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: 249

Export product Qty. Sl.<br>No. Import items Qty.
METHYL TRIPHENYL<br>PHOSPHONIUM BROMIDE<br>CAS No. 1779-49-3, ASSAY NLT<br>98% 1 kg 1 TRIPHENYL PHOSPHINE<br>CAS NO: 603-35-0 ASSAY<br>NLT 98% 0.78 kg
Case No.:858/15/82- Party Name:MANGALAM Meet No/Date:3/82- Status:
ALC4/2018 DRUGS & ORGANICS ALC4/2019 Approved
LIMITED 05.07.2019
HQ File RLA File Lic.No/Date:0310826762
:01/82/050/02315/AM19/ :03/95/040/01138/AM19/ 01.02.2019

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 1/82-ALC4/2019 dated 03.06.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as 250 per details given below or as applied by the firm, whichever is less:

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

77

Case No.:860/15/82- Party Name:DORF-KETAL Meet No/Date:3/82- Status:
ALC4/2018 CHEMICALS INDIA ALC4/2019 Approved
PVT.LTD. 05.07.2019
HQ File RLA File Lic.No/Date:0310826778
:01/82/050/02317/AM19/ :03/94/040/00894/AM19/ 01.02.2019
Case No.:860/15/82-<br>ALC4/2018 Party Name:DORF-KETAL<br>CHEMICALS INDIA<br>PVT.LTD.<br>RLA File<br>:03/94/040/00894/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br>Lic.No/Date:0310826778<br>01.02.2019 Status:<br>Approved<br>
HQ File<br>:01/82/050/02317/AM19/
251 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as<br>per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>3,5 Xylenol (3-5-Dimethylphenol)<br>1 kg<br>1<br>ISOPHORONE<br>1.49 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.
252 <br>Case No.:861/15/82-<br>ALC4/2018 Party Name:INNOVARE<br>LABS PRIVATE LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02318/AM19/ RLA File<br>:09/24/040/00535/AM19/ Lic.No/Date:0910067125<br>01.02.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
253 <br>Case No.:863/15/82-<br>ALC4/2018 Party Name:JAYANT AGRO<br>ORGANICS LTD.,<br> <br> <br> <br>RLA File<br>:03/94/040/00948/AM19/<br> <br> Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br> <br><br>Lic.No/Date:0310826798<br>04.02.2019<br> <br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/02320/AM19/ Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
254 <br>Case No.:864/15/82-<br>ALC4/2018 Party Name:J.B.<br>CHEMICALS &<br>PHARMACEUTICALS<br>LIMITED<br> <br> <br> <br>RLA File<br>:03/94/040/00944/AM19/<br> <br> Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br> <br><br>Lic.No/Date:0310826799<br>04.02.2019<br> <br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/02321/AM19/ Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

78

Case No.:865/15/82- Party Name:FDC LTD Meet No/Date:3/82- Status:
ALC4/2018 ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310826803
:01/82/050/02322/AM19/ :03/94/040/00950/AM19/ 04.02.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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 255 per details below or as applied by firm whichever is lower:

Export product Qty. Sl.<br>No. Import items Qty.
OFLOXACIN OPTHALMIC<br>SOL 0.3% 5ML 1800000.000 Vial 1 OFLOXACIN 27.54 kg
Case No.:870/15/82- Party Name:SHREE Meet No/Date:3/82- Status:
ALC4/2018 BANKEY BEHARI LAL ALC4/2019 Deferred
FLAVORS 05.07.2019
256 HQ File RLA File Lic.No/Date:0510409585 Defer
:01/82/050/02327/AM19/ :05/24/040/00623/AM19/ 05.02.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:873/15/82- Party Name:CADILA Meet No/Date:3/82- Status:
ALC4/2018 HEALTHCARE LTD ALC4/2019 Deferred
05.07.2019
257 HQ File RLA File Lic.No/Date:0810144496 Defer
:01/82/050/02330/AM19/ :08/24/040/00379/AM19/ 05.02.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:874/15/82- Party Name:CADILA Meet No/Date:3/82- Status:
ALC4/2018 HEALTHCARE LTD ALC4/2019 Deferred
05.07.2019
258 HQ File RLA File Lic.No/Date:0810144497 Defer
:01/82/050/02331/AM19/ :08/24/040/00372/AM19/ 05.02.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:875/15/82- Party Name:CADILA Meet No/Date:3/82- Status:
ALC4/2018 HEALTHCARE LTD ALC4/2019 Deferred
05.07.2019
259 HQ File RLA File Lic.No/Date:0810144498 Defer
:01/82/050/02332/AM19/ :08/24/040/00381/AM19/ 05.02.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.

79

Case No.:876/15/82- Party Name:MOREPEN Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES LTD., ALC4/2019 Deferred
05.07.2019
260 HQ File RLA File Lic.No/Date:0510409596 Defer
:01/82/050/02333/AM19/ :05/24/040/00634/AM19/ 05.02.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:1027/15/82- Party Name:ANLON Meet No/Date:3/82- Status:
ALC4/2018 HEALTHCARE ALC4/2019 Deferred
PRIVATELIMITED 05.07.2019
261 HQ File RLA File Lic.No/Date:2410042653 Defer
:01/82/050/02484/AM19/ :24/24/040/00053/AM19/ 05.02.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:877/15/82- Party Name:PANACEA Meet No/Date:3/82- Status:
ALC4/2018 BIOTEC LTD., ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0510409606
:01/82/050/02334/AM19/ :05/24/040/00642/AM19/ 06.02.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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: 262

Export product Qty. Sl. Import items Qty.
No.
ALPHADOL CAPSULES (EACH 4500000 Capsules 1 ALFACALCIDOL 1.575
SOFT GELATIN CAPSULE gram
CONTAINS: ALFACALCIDOL
0.25 MCG)

The Committee allowed the above norms on one time basis and no repeat norms is allowed. RA concerned may take further necessary action as per above decision of NC.

Case No.:879/15/82- Party Name:SAGA Meet No/Date:3/82- Status: Approved
ALC4/2018 LABORATORIES ALC4/2019
05.07.2019
HQ File RLA File Lic.No/Date:081014452
:01/82/050/02336/AM19/ :08/24/040/00368/AM19/ 1
06.02.2019

Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of 263 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.
No.
DIFLAH 500 (Diosmin and 3100000 1 DIOSMIN + HESPERIDIN 1581.00 kg
Hesperidin Tablets 500mg) Number 9:1

80

264 <br>Case No.:880/15/82-<br>ALC4/2018 Party Name:DEEPAK<br>NOVOCHEM<br>TECHNOLOGIES LTD Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02337/AM19/ RLA File<br>:31/83/040/00162/AM19/ Lic.No/Date:3110067309<br>06.02.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
265 Case No.:881/15/82-<br>ALC4/2018 Party Name:SHILPA<br>MEDICARE LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02338/AM19/ RLA File<br>:07/24/040/00263/AM19/ Lic.No/Date:0710114519<br>07.02.2019 <br>Defer<br>Date:05.07.2019
Decision:<br>RLA, Bangalore was requested vide e-mail dated 05.04.2019 to furnish the hard copy of<br>4.07 application of subject Advance Authorization. Application awaited from RLA, Bangalore. However,<br>the application is still awaited. Hence, it was decided to issue a Reminder to RLA, Bangalore for<br>furnishinga copyof application expeditiously.
Case No.:882/15/82- Party Name:SURVIVAL Meet No/Date:3/82- Status:
ALC4/2018 TECHNOLOGIES PVT.LTD. ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310826900
:01/82/050/02339/AM19/ :03/95/040/01150/AM19/ 07.02.2019

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 266 meeting no. 2/82-ALC4/2018 dated 16.05.2018, 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. Import items Qty.
4-HYDROXY BENZYL ALCOHOL 1 kg 4-HYDROXY BENZALDEHYDE 1.35 kg
SODIUM BOROHYDRIDE 0.207 kg
267 Case No.:883/15/82-<br>ALC4/2018 Party Name:MAHESHRAJ<br>CHEMICALS PVT.LTD Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02340/AM19/ RLA File<br>:08/24/040/00374/AM19/ Lic.No/Date:0810144562<br>08.02.2019 <br>Defer<br>Date:05.07.2019
Decision:<br>RLA, Ahmedabad was requested vide e-mail dated 05.04.2019 to furnish the hard copy<br>of 4.07 application of subject Advance Authorization. Application awaited from RLA, Ahmedabad.<br>However, the application is still awaited. Hence, it was decided to issue a Reminder to RLA, Ahmedabad<br>for furnishinga copyof application expeditiously.

Decision: RLA, Ahmedabad was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07 application of subject Advance Authorization. Application awaited from RLA, Ahmedabad. However, the application is still awaited. Hence, it was decided to issue a Reminder to RLA, Ahmedabad for furnishing a copy of application expeditiously.

81

Case No.:885/15/82- Party Name:ORTIN Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2019 Deferred
05.07.2019
268 HQ File RLA File Lic.No/Date:0910067148 Defer
:01/82/050/02342/AM19/ :09/24/040/00538/AM19/ 08.02.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:887/15/82- Party Name:ENAL DRUGS Meet No/Date:3/82- Status:
ALC4/2018 PVT LTD., ALC4/2019 Deferred
05.07.2019
269 HQ File RLA File Lic.No/Date:0910067153 Defer
:01/82/050/02344/AM19/ :09/24/040/00543/AM19/ 08.02.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:888/15/82- Party Name:ASTRAL Meet No/Date:3/82- Status:
ALC4/2018 STERITECH PVT. LTD. ALC4/2019 Deferred
05.07.2019
270 HQ File RLA File Lic.No/Date:3410044867 Defer
:01/82/050/02345/AM19/ :34/24/040/00333/AM19/ 08.02.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:891/15/82- Party Name:GELTEC Meet No/Date:3/82- Status: Deferred
ALC4/2018 PRIVATE LIMITED ALC4/2019
05.07.2019
271 HQ File RLA File Lic.No/Date:0310826970 Defer
:01/82/050/02348/AM19/ :03/94/040/00970/AM19/ 11.02.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:892/15/82- Party Name:J.B. Meet No/Date:3/82- Status:
ALC4/2018 CHEMICALS & ALC4/2019 Deferred
PHARMACEUTICALS 05.07.2019
272 LIMITED
HQ File RLA File Lic.No/Date:0310826971 Defer
:01/82/050/02349/AM19/ :03/94/040/00978/AM19/ 11.02.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
273 Case No.:894/15/82-<br>ALC4/2018 Party Name:DEEPAK<br>PHENOLICS LIMITED Meet No/Date:3/82-<br>ALC4/2019 Status:<br>Deferred
<br> <br>05.07.2019
<br>HQ File RLA File LicNo/Date:3410044883 <br>Defer
<br>:01/82/050/02351/AM19/ <br>:34/24/040/00328/AM19/ .<br>12.02.2019 <br> <br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

82

274 <br>Case No.:899/15/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/02356/AM19/ Party Name:ATUL<br>LIMITED,<br> <br> <br> Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br> <br>Lic.No/Date:0810144581<br>12.02.2019<br> <br> Status: Deferred
RLA File<br>:08/24/040/00371/AM19/<br> <br> Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
275 <br>Case No.:896/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02353/AM19/ RLA File<br>:09/24/040/00555/AM19/ Lic.No/Date:0910067168<br>13.02.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
276 <br>Case No.:897/15/82-<br>ALC4/2018 Party Name:SATYADEVA<br>PHARMACEUTICALS PVT<br>LTD Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02354/AM19/ RLA File<br>:09/24/040/00551/AM19/ Lic.No/Date:0910067170<br>13.02.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
277 Case No.:898/15/82-<br>ALC4/2018 Party Name:DR. REDDYS<br>LABORATORIES LIMITED<br>RLA File<br>:09/24/040/00558/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/02355/AM19/ Lic.No/Date:0910067171<br>13.02.2019
**Decision:**RLA, Hyderabad was requested vide e-mail dated 05.04.2019 to furnish the hard copy of 4.07<br>application of subject Advance Authorization. Application awaited from RLA, Hyderabad. However, the<br>application is still awaited. Hence, it was decided to issue a Reminder to RLA, Hyderabad for furnishing a<br>copyof application expeditiously.
Case No.:900/15/82- Party Name:ENCEE Meet No/Date:3/82- Status:
ALC4/2018 AROMATICS PVT. LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:3210078858
:01/82/050/02357/AM19/ :32/24/040/00056/AM19/ 13.02.2019

Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of 278 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. Enamber / Kephalis / Tetrambrone 1 kg 1 Triethyl Orthoformate 2.400 kg

83

279 Case No.:901/15/82-<br>ALC4/2018 Party Name:KUMAR<br>ORGANIC PRODUCTS<br>LIMITED,<br>RLA File<br>:07/24/040/00244/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/02358/AM19/ Lic.No/Date:0710114543<br>13.02.2019
**Decision:**RLA, Ahmedabad was requested vide e-mail dated 05.04.2019 to furnish the hard copy of<br>4.07 application of subject Advance Authorization. Application awaited from RLA, Ahmedabad.<br>However, the application is still awaited. Hence, it was decided to issue a Reminder to RLA, Ahmedabad<br>for furnishinga copyof application expeditiously.
280 <br>Case No.:902/15/82-<br>ALC4/2018 Party Name:INNOVARE<br>LABS PRIVATE LIMITED<br>RLA File<br>:09/24/040/00549/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/02359/AM19/ Lic.No/Date:0910067173<br>14.02.2019
**Decision:**Deferred for comments of TE.
281 <br>Case No.:903/15/82-<br>ALC4/2018 Party Name:MATRIX FINE<br>SCIENCES PVT.LTD.,<br>RLA File<br>:03/95/040/01113/AM19/ Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:05.07.2019
<br>HQ File<br>:01/82/050/02360/AM19/ Lic.No/Date:0310827030<br>14.02.2019
**Decision:**Deferred for comments of TE.
282 <br>Case No.:905/15/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/02362/AM19/ Party Name:JODAS<br>EXPOIM PVT.LTD<br> <br> <br> Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br> <br>Lic.No/Date:0510409675<br>15.02.2019<br> <br> Status: Deferred
RLA File<br>:05/23/040/00508/AM19/<br> <br> Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
283 <br>Case No.:906/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02363/AM19/ RLA File<br>:05/23/040/00507/AM19/ Lic.No/Date:0510409676<br>15.02.2019 Defer<br>Date:22.03.2019
**Decision:**Deferred for comments of TE.
284 <br>Case No.:907/15/82-<br>ALC4/2018 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02364/AM19/ RLA File<br>:09/24/040/00515/AM19/ Lic.No/Date:0910067181<br>15.02.2019 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

84

285 <br>Case No.:911/15/82-<br>ALC4/2018 Party Name:YASHO<br>INDUSTRIES LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02368/AM19/ RLA File<br>:03/95/040/01195/AM19/ Lic.No/Date:0310827118<br>19.02.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
286 <br>Case No.:916/15/82-<br>ALC4/2018 Party Name:OPTIMUS<br>DRUGS PRIVATE LIMITED <br>Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02373/AM19/ RLA File<br>:09/24/040/00569/AM19/ Lic.No/Date:0910067192<br>20.02.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
287 <br>Case No.:919/15/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02376/AM19/ RLA File<br>:09/24/040/00573/AM19/ Lic.No/Date:0910067198<br>21.02.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:921/15/82- Party Name:SHREE JAYA Meet No/Date:3/82- Status:
ALC4/2018 LABORATORIES PVT LTD. ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0910067202
:01/82/050/02378/AM19/ :09/24/040/00411/AM19/ 21.02.2019
Case No.:921/15/82-<br>ALC4/2018 Case No.:921/15/82-<br>ALC4/2018 Party Name:SHREE JAYA<br>LABORATORIES PVT LTD. Party Name:SHREE JAYA<br>LABORATORIES PVT LTD. Party Name:SHREE JAYA<br>LABORATORIES PVT LTD. Party Name:SHREE JAYA<br>LABORATORIES PVT LTD. <br>Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/02378/AM19/ RLA File<br>:09/24/040/00411/AM19/ Lic.No/Date:0910067202<br>21.02.2019
288 <br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 5/82-ALC4/2015 dated 25.06.2015, it w as 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-CHLOROMETHYL-4-<br>METHOXY-3,5-<br>DIMETHYL<br>PYRIDINE<br>HCL<br>1 kg<br>1<br>3,5 LUTIDINE<br>1.04 kg<br>2<br>HYDROGEN PEROXIDE<br>1.13 kg<br>3<br>CHLOROFORM<br>5.20 kg<br>4<br>AMMONIUM PER SULPHATE<br>1.80 kg<br>5<br>THIONYL CHLORIDE<br>0.80 kg<br>RA maytake appropriate action asper the decision of Norms Committee.
Export product Qty. Sl.<br>No. Import items Qty.
2-CHLOROMETHYL-4-<br>METHOXY-3,5-<br>DIMETHYL<br>PYRIDINE<br>HCL 1 kg 1 3,5 LUTIDINE 1.04 kg
2 HYDROGEN PEROXIDE 1.13 kg
3 CHLOROFORM 5.20 kg
4 AMMONIUM PER SULPHATE 1.80 kg
5 THIONYL CHLORIDE 0.80 kg
per the decision of Norms Committee.
289 <br>Case No.:922/15/82-<br>ALC4/2018 Party Name:GLOBE<br>TROTTERS PVT LTD Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02379/AM19/ RLA File<br>:03/94/040/01015/AM19/ Lic.No/Date:0310827201<br>21.02.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

85

Case No.:923/15/82- Party Name:ETERNIS FINE Meet No/Date:3/82- Status:
ALC4/2018 CHEMICALS LIMITED, ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310827203
:01/82/050/02380/AM19/ :03/94/040/01000/AM19/ 21.02.2019

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: 290

Export product Qty. Sl. Import items Qty.
No.
COUMARIN 1 kg 1 SALICYLALDEHYDE 1.09 kg
2 ACETIC ANHYDRIDE Not Allowed
3 METHANOL NotAllowed

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

291 <br>Case No.:924/15/82-<br>ALC4/2018 Party Name:INDO AMINES<br>LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02381/AM19/ RLA File<br>:03/94/040/00984/AM19/ Lic.No/Date:0310827206<br>21.02.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
292 <br>Case No.:927/15/82-<br>ALC4/2018 Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02384/AM19/ RLA File<br>:09/24/040/00580/AM19/ Lic.No/Date:0910067211<br>22.02.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
293 <br>Case No.:929/15/82-<br>ALC4/2018 Party Name:THINQ<br>PHARMA-CRO LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02386/AM19/ RLA File<br>:03/95/040/01186/AM19/ Lic.No/Date:0310827227<br>22.02.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
294 <br>Case No.:931/15/82-<br>ALC4/2018 Party Name:MEHK<br>CHEMICALS PVT. LTD. Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02388/AM19/ RLA File<br>:03/95/040/01227/AM19/ Lic.No/Date:0310827242<br>22.02.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

86

295 <br>Case No.:932/15/82-<br>ALC4/2018 Party Name:MEHK<br>CHEMICALS PVT. LTD. Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02389/AM19/ RLA File<br>:03/95/040/01209/AM19/ Lic.No/Date:0310827243<br>22.02.2019 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:934/15/82- Party Name:ASTRAL Meet No/Date:3/82- Status:
ALC4/2018 STERITECH PVT. LTD. ALC4/2019 Deferred
05.07.2019
HQ File RLA File Lic.No/Date:3410044929 Defer
:01/82/050/02391/AM19/ :34/24/040/00356/AM19/ 22.02.2019 Date:05.07.2019

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

(i) Dose of injection (ii) DML. (iii) Size of vial.

Case No.:935/15/82- Party Name:ASTRAL Meet No/Date:3/82- Status:
ALC4/2018 STERITECH PVT. LTD. ALC4/2019 Deferred
05.07.2019
HQ File RLA File Lic.No/Date:3410044930 Defer
:01/82/050/02392/AM19/ :34/24/040/00355/AM19/ 22.02.2019 Date:05.07.2019

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

(i) Dose of injection (ii) DML. (iii) Size of vial.

298 <br>Case No.:936/15/82-<br>ALC4/2018 Party Name:VISION DRUGS<br>PVT LTD Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02393/AM19/ RLA File<br>:09/24/040/00575/AM19/ Lic.No/Date:0910067217<br>25.02.2019 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
299 <br>Case No.:941/15/82-<br>ALC4/2018 Party Name:AMANTA<br>HEALTHCARE LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02398/AM19/ RLA File<br>:08/24/040/00405/AM19/ Lic.No/Date:0810144674<br>25.02.2019 Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

87

300 <br>Case No.:1033/15/82-<br>ALC4/2018 Party Name:SRIAM LABS<br>PRIVATE LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02490/AM19/ RLA File<br>:09/24/040/00591/AM19/ Lic.No/Date:0910067219<br>26.02.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
301 <br>Case No.:1051/15/82-<br>ALC4/2018 Party Name:YASHO<br>INDUSTRIES LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02508/AM19/ RLA File<br>:03/95/040/01264/AM19/ Lic.No/Date:0310827302<br>26.02.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:1037/15/82- Party Name:GLAND Meet No/Date:3/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0910067223
:01/82/050/02494/AM19/ :09/24/040/00497/AM19/ 27.02.2019

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. 2/82-ALC4/2019 , dated 21.06.2019, 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:

Export Product : 1. Adenosine Injection Prefilled Syringe 3mg/ml, 2ml in a PFS 302 2. Adenosine Injection Prefilled Syringe 3mg/ml, 4ml in a PFS

Sl. Quantity Quantity
No. Import Item Name. 3mg/ml, 2ml in a 3mg/ml, 4ml in a
PFS PFS
1 Adenosine USP 0.0066 gm/ vial 0.0132 gm/ vial
2 Barrel Syringes Glass Relevant, as per Relevant, as per
3 V-OVS 10.6 Tip Caps packing policy packing policy
4 Plunger Stoppers
5 Plunger Rods
A concerned maytake further necessaryaction asper above decision of NC.
303 <br>Case No.:1038/15/82-<br>ALC4/2018 Party Name:GLAND<br>PHARMA LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019<br>Lic.No/Date:0910067224<br>27.02.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02495/AM19/ RLA File<br>:09/24/040/00530/AM19/ Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

88

304 <br>Case No.:1039/15/82-<br>ALC4/2018 Party Name:GLAND<br>PHARMA LIMITED Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02496/AM19/ RLA File<br>:09/24/040/00491/AM19/ Lic.No/Date:0910067225<br>27.02.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
305 <br>Case No.:1041/15/82-<br>ALC4/2018 Party Name:WEXFORD<br>LABORATORIES P LTD Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02498/AM19/ RLA File<br>:07/24/040/00276/AM19/ Lic.No/Date:0710114597<br>27.02.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:1048/15/82- Party Name:SPC LIFE Meet No/Date:3/82- Status:
ALC4/2018 SCIENCES PVT. LTD. ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:3410044936
:01/82/050/02505/AM19/ :34/24/040/00347/AM19/ 27.02.2019
Case No.:1048/15/82-<br>ALC4/2018 Party Name:SPC LIFE<br>SCIENCES PVT. LTD. Party Name:SPC LIFE<br>SCIENCES PVT. LTD. Party Name:SPC LIFE<br>SCIENCES PVT. LTD. Party Name:SPC LIFE<br>SCIENCES PVT. LTD. Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/02505/AM19/ RLA File<br>:34/24/040/00347/AM19/ Lic.No/Date:3410044936<br>27.02.2019
306 <br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>13/82-ALC4/2018<br>, dated 14.01.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:
<br>Export product Qty. Sl. No. Import items Qty.
CHLOROHEXAN-2-ONE 1 kg 1 1-BROMO 3-CHLORO PROPANE.<br>CLEAR LIQUID. <br>2.05 kg
2 METHYL<br>ACETO<br>ACETATE.<br>CLEAR COLOURLESS TO LIGHT<br>YELLOW LIQUID <br> <br>1.65 kg
3 SODIUM<br>METHOXIDE.<br>WHITE POWDER <br>1.25 kg
RA concerned maytake further necessaryaction asper above decision of NC.

89

Case No.:1052/15/82- Party Name:AVA Meet No/Date:3/82- Status:
ALC4/2018 CHEMICALS PVT.LTD., ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310827339
:01/82/050/02509/AM19/ :03/94/040/00933/AM19/ 27.02.2019

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. 1/82-ALC4/2019 307 , dated 03.06.2019, 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:

Export product Qty. Sl. Import items Qty.
No.
EDTA Tetrasodium 1 kg 1 ETHYLENE DIAMINE TETRA 0.75 kg
ACETIC ACID
Case No.:1042/15/82- Party Name:BALAJI AMINES Meet No/Date:3/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:3110067338
:01/82/050/02499/AM19/ :31/83/040/00184/AM19/ 28.02.2019

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

Export product Qty. Sl. No. Import items Qty.
GAMMA BUTYROLACONE 1 kg 1 1,4 BUTANEDIOL 1.016 kg
2 GBL CATAYLYST 0.001 kg
309 <br>Case No.:1044/15/82-<br>ALC4/2018 Party Name:CADILA<br>HEALTHCARE LTD Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02501/AM19/ RLA File<br>:08/24/040/00412/AM19/ Lic.No/Date:0810144716<br>28.02.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
310 <br>Case No.:1045/15/82-<br>ALC4/2018 Party Name:SAVA<br>HEALTHCARE LTD. Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02502/AM19/ RLA File<br>:31/83/040/00183/AM19/ Lic.No/Date:3110067341<br>01.03.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.

90

311 Case No.:1046/15/82-<br>ALC4/2018 Party Name:BIOLOGICAL E<br>LTD Meet No/Date:3/82-<br>ALC4/2019 Status:<br>Deferred
05.07.2019
<br>HQ File RLA File Lic.No/Date:0910067234 <br>Defer
:01/82/050/02503/AM19/ :09/24/040/00536/AM19/ 01.03.2019 Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:1055/15/82- Party Name:NEOGEN Meet No/Date:3/82- Status:
ALC4/2018 CHEMICALS LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310827406
:01/82/050/02512/AM19/ :03/95/040/01248/AM19/ 01.03.2019

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: 312

Export product Qty. Sl. No. Import items Qty.
ETHYL-2- 1 kg 1 N-BUTYRIC ACID 0.743 kg
BROMOBUTYRATE 2 HYDROBROMIC ACID 48% 1.425 kg
3 HYDROGEN PEROXIDE 50% 0.3618 kg
4 ETHANOL 0.2948 kg
Case No.:1056/15/82- Party Name:NEOGEN Meet No/Date:3/82- Status:
ALC4/2018 CHEMICALS LIMITED ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310827408
:01/82/050/02513/AM19/ :03/95/040/01249/AM19/ 01.03.2019

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: 313

Export product Qty. Sl. No. Import items Qty.
ETHYL-2- 1 kg 1 N-BUTYRIC ACID 0.743 kg
BROMOBUTYRATE 2 HYDROBROMIC ACID 48% 1.425 kg
3 HYDROGEN PEROXIDE 50% 0.3618 kg
4 ETHANOL 0.2948 kg

91

314 <br>Case No.:1057/15/82-<br>ALC4/2018 Party Name:CIPLA<br>LIMITED. Meet No/Date:3/82-<br>ALC4/2019<br>05.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02514/AM19/ RLA File<br>:03/94/040/01019/AM19/ Lic.No/Date:0310827414<br>01.03.2019 <br>Defer<br>Date:05.07.2019
**Decision:**Deferred for comments of TE.
Case No.:1058/15/82- Party Name:ZYTEX Meet No/Date:3/82- Status:
ALC4/2018 BIOTECH PVT. LTD. ALC4/2019 Approved
05.07.2019
HQ File RLA File Lic.No/Date:0310827415
:01/82/050/02515/AM19/ :03/95/040/01267/AM19/ 01.03.2019

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 1/82-ALC4/2019 dated 03.06.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as 315 per details given below or as applied by the firm, whichever is less:

Export Product Qty. Sl. Import Items Qty.
No.
BACILLUS CEREUS 1 kg 1 PEPTONES(FNI 103) 2.1 kg
RA maytake appropriate action asper the decision of Norms Committee.

92

MANUAL CASES

Case No. B-1
Meeting No. 3/AM20
Date 05.07.2019
Firm’s Name M/s Glenmark Pharmaceuticals Limited, Mumbai
HQ F. No. 01/82/050/01239/AM19/DES-III<br>01/82/050/01232/AM19/DES-III
RLA F. No. 03/94/040/00275/AM19<br>03/94/040/00310/AM19
Advance Authorization No. and Date 0310822074 dated 02.07.2018<br>0310822310 dated 16.07.2018
Subject Request of M/s Glenmark Pharmaceuticals Limited, Mumbai<br>for correction in the quantity of import item fixed against<br>Export Product No. 4 for Advance Authorization Nos.<br>0310822074 dated 02.07.2018 and 0310822310 dated 16.07.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to revise the norms of Export Product No. 4 as under:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>4<br>Supiroban 50gm Ointment (Pack<br>Size 50gms) ( Net Wt. of Mupirocin<br>USP is 55.000 Kgs.)<br>1 pack<br>1<br>Mupirocin USP<br>1.02 gm/50<br>gm pack<br>Rest of the earlier Minutes would remain the same.<br>RA may take appropriate action as per the decision of Norms Committee.

93

Case No. B-2
Meeting No. 3/AM20
Date 05.07.2019
Firm’s Name M/s Glenmark Pharmaceuticals Limited, Mumbai
HQ F. No. 01/82/050/01282/AM19/DES-III<br>01/82/050/01350/AM19/DES-III
RLA F. No. 03/94/040/00303/AM19<br>03/94/040/00449/AM19
Advance Authorization No. and<br>Date 0310822335 dated 17.07.2018<br>0310823141 dated 20.08.2018
Subject Request of M/s Glenmark Pharmaceuticals Limited, Mumbai for<br>correction in the quantity of import item fixed against Export<br>Product No. 1 for Advance Authorization Nos. 0310822335 dated<br>17.07.2018 and 0310823141 dated 20.08.2018
Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to revise the norms of Export Product No. 1 as under:<br>Sl.<br>No.<br>Export Product<br>Export<br>Qty.<br>Import Product<br>Quantity Allowed in kg<br>1<br>Lamotrigine Tablets CD 25mg<br>(Pack size 100 Tabs.) Net Wt.<br>of Lamotrigine is 54.250 Kgs.)<br>packs<br>Lamotrigine<br>25.50 mg/ 25 mg tablet<br>Rest of the earlier Minutes would remain the same.<br>RA may take appropriate action as per the decision of Norms Committee.

94

Case No. Case No. B-3 B-3 B-3 B-3 B-3
Meeting No. 3/AM20
Date 05.07.2019
Firm’s Name M/s Glenmark Pharmaceuticals Ltd., Mumbai
HQ F. No. 01/82/050/01222/AM19/DES-III
RLA F. No. 03/94/040/00360/AM19
Advance Authorization No. and Date 0310822541 dated 24.07.2018
Subject Request of M/s Glenmark Pharmaceuticals Limited, Mumbai for<br>correction in the norms fixed for Export Product No. 5 against<br>Advance<br>Authorization<br>No.<br>0310822541<br>Date: 24.07.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it was<br>decided to revise the norms of Export Product No. 5 as under:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>5<br>Estradiol Vaginal Cream 0.01%<br>42.5 gm (Net Wt. of Estradiol<br>Hemihydrate USP is 42.500 gm.)<br>1 No.<br>pack<br>1<br>Estradiol<br>Hemihydrate<br>USP<br>4.335 mg / pack<br>Rest of the earlier Minutes would remain the same.<br>RA may take appropriate action as per the decision of Norms Committee.
Sl.<br>No. Export product Qty. Sl.<br>No. Import items Qty.
5 Estradiol Vaginal Cream 0.01%<br>42.5 gm (Net Wt. of Estradiol<br>Hemihydrate USP is 42.500 gm.) 1 No.<br>pack 1 Estradiol<br>Hemihydrate<br>USP 4.335 mg / pack
Rest of the earlier Minutes would remain the same.<br>RA may take appropriate action as per the decision of Norms Committee.
Case No. Case No. B-4 B-4 B-4
Meeting No. 3/AM20
Date 05.07.2019
Firm’s Name M/s Glenmark Pharmaceuticals Ltd., Mumbai
HQ F. No. 01/82/050/01270/AM19/DES-III
RLA F. No. 03/94/040/00411/AM19
Advance Authorization No. and Date 0310822872 dated 07.08.2018
Subject Request of M/s Glenmark Pharmaceuticals Limited, Mumbai for<br>correction in the norms fixed for Export Product No. 3 and 8<br>against Advance Authorization No. 0310822872 dated 07.08.2018
Decision:The Committee considered the case as per agenda in the presence of technical experts and it was<br>decided to revise the norms as under:<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 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<br>HRT)<br>(Pack<br>Size<br>84<br>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<br>21<br>1/20)<br>(Pack<br>Size<br>63<br>Tabs.)<br>( Net Wt. ofNorethindrone Acetate is 9.450 Kgs.)<br>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
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 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<br>HRT)<br>(Pack<br>Size<br>84<br>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<br>21<br>1/20)<br>(Pack<br>Size<br>63<br>Tabs.)<br>( Net Wt. ofNorethindrone Acetate is 9.450 Kgs.) 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

95

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<br>(Fem<br>HRT)<br>(Pack<br>Size<br>90<br>Tabs.)<br>(Net Wt. of Norethindrone Acetate is 0.225 Kgs.) 1.02 mg 0.0051 mg
8 Norethindrone<br>Acetate&EE<br>Tab<br>1.0/0.02mg<br>( Net Wt. ofNorethindrone Acetate is 1.575 Kgs.) 1.02 mg 0.0204 mg
9. Norethindrone<br>Acetate&EE<br>Tab<br>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
10. Minastrin24Fe<br>(Norethindrone Acetate and Ethinyl Estradiol Chewable Tablets, 1<br>mg/0.02 mg and Ferrous Fumarate Tablets USP, 75 mg) ( Net Wt.<br>of Norethindrone Acetate is 3.600 Kgs.) 1.02 mg 0.0204 mg
11. Norethindrone/EE<br>Tablets<br>[21]<br>(Loestrin<br>(r)<br>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
12 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
13 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 may take appropriate action as per the decision of Norms Committee.

Meeting ended with thanks to Chair.


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