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Office of Directorate General of Foreign Trade New Delhi -0

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Para 4.07 Decision

Minutes of the Norms Committee – 3 Meeting No. 4/82-ALC4/2020 dated 18.09.2020 (actually held on 28.09.2020) 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 in the Meeting:

Sl. No. Name&Designation Department
1 ShriShaish Kumar,Technical – 1 Consultant
2 Shri D.N. Mathur,Technical – 2 Consultant
In attendance
1 Shri Munish Kumar,Dy. DGFT DGFT
2 Shri AjayKumar,Assistant Director DGFT

The committee went through the minutes of earlier meeting No. 3/82-ALC4/2020 dated 07.08.2020 (actually held on 02.09.2020)

ONLINE CASES

Case No.:60/4/82-ALC4/2020 Party Name:HETERO LABS Meet No/Date:4/82- Status:
LTD. ALC4/2020 Deferred
18.09.2020
HQ File RLA File Lic.No/Date:0910038262
:01/82/050/01561/AM21/ :09/24/040/00092/AM10/ 17.06.2009

Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019. It was also decided to ask RLA, Hyderabad whether EODC in respect of subject Advance Authorization has been issued to firm or not.

Case No.:56/4/82-ALC4/2020 Party Name:CORAL DRUGS Meet No/Date:4/82- Status:
PVT. LTD., ALC4/2020 Deferred
18.09.2020
HQ File RLA File Lic.No/Date:0510287831
:01/82/050/01557/AM21/ :05/23/040/00006/AM12/ 08.04.2011

Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019. It was also decided to ask CLA, New Delhi whether EODC in respect of subject Advance Authorization has been issued to firm or not.

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firm as per Policy Circular No. 23/2015-20, dated 15.05.2019. It was also decided to ask CLA, New Delhi whether EODC in respect of subject Advance Authorization has been issued to firm or not.

2

Case No.:969/15/82- Party Name:SOMU Meet No/Date:4/82- Status:
ALC4/2018 SOLVENTS PVT. LTD ALC4/2020 Deferred
18.09.2020
HQ File RLA File Lic.No/Date:0710108673
:01/82/050/02426/AM19/ :07/24/040/00175/AM16/ 02.09.2015

3 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 1/82-ALC4/2020 dated 17.04.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:405/15/82- Party Name:SHIVA Meet No/Date:4/82- Status:
ALC4/2018 PHARMACHEM LTD, ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:3410041522
:01/82/050/01862/AM19/ :34/24/040/00139/AM16/ 16.09.2015

-|---|---| |ALC4/2018||PHARMACHEM LTD,||ALC4/2020||Approved| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:3410041522||| |:01/82/050/01862/AM19/||:34/24/040/00139/AM16/||16.09.2015|||

Case No.:405/15/82-<br>ALC4/2018 Party Name:SHIVA<br>PHARMACHEM LTD,<br>RLA File<br>:34/24/040/00139/AM16/ Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Approved
HQ File<br>:01/82/050/01862/AM19/ Lic.No/Date:3410041522<br>16.09.2015
4 **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was<br>decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>CYCLOPROPANE CARBONYL<br>CHLORIDE<br>APPEARANCE:<br>CLEAR<br>COLOURLESS<br>LIQUID,<br>ASSAY MIN. 99%<br>1 kg<br>1<br>CYCLOPROPANE<br>CARBOXYLIC<br>ACID<br>APPEARANCE<br>:<br>CLEAR<br>COLOURLESS LIQUID, ASSAY<br>MIN. 99%<br>0.9115 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.
Case No.:322/15/82- Party Name:HESTER Meet No/Date:4/82- Status:
ALC4/2018 BIOSCIENCES LIMITED ALC4/2020 Withdrawn
18.09.2020
HQ File RLA File Lic.No/Date:0810136418
:01/82/050/01779/AM19/ :08/24/040/00270/AM16/ 02.11.2015

|---| |ALC4/2018||BIOSCIENCES LIMITED||ALC4/2020||Withdrawn| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0810136418||| |:01/82/050/01779/AM19/||:08/24/040/00270/AM16/||02.11.2015|||

5 Decision: The firm vide letter dated 18.08.2020 has informed that they had surrendered the subject Advance Authorization in RLA, Ahmedabad and on the basis of their request, RLA, Ahmedbad had issued a Surrender Letter to them. The firm has furnished a copy of the Surrender Letter received from RLA, Ahmedabad with the request to close the case.

The Committee considered the case in the presence of technical experts and in light of above letter of firm, it was decided to withdraw the case.

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Case No.:1030/15/82- Party Name:SWATI Meet No/Date:4/82- Status:
ALC4/2018 MENTHOL & ALLIED ALC4/2020 Rejected
CHEMICALS LTD., 18.09.2020
HQ File RLA File Lic.No/Date:2910025235
:01/82/050/02487/AM19/ :29/21/040/00029/AM16/ 21.12.2015

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 7/82-ALC4/2019 6 dated 06.09.2019, followed by Reminder on 31.10.2019 and Final Reminder on 13.02.2020 :

(i) Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction and % of yield at every stage. (ii) Central Excise or GST Certificate.

Hence, the Committee decided to reject the case.

echnical details chemistry, molecular weight, stoichiometric reaction and % of yield at every stage. (ii) Central Excise or GST Certificate.**

Hence, the Committee decided to reject the case.

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

Case No.:260/15/82- Party Name:VINNY Meet No/Date:4/82- Status:
ALC4/2018 HEALTHCARE PRIVATE ALC4/2020 Rejected
LIMITED 18.09.2020
HQ File RLA File Lic.No/Date:0810137198
:01/82/050/01717/AM19/ :08/24/040/00386/AM16/ 12.02.2016

7 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

Case No.:221/15/82- Party Name:GOPINATH Meet No/Date:4/82- Status:
ALC4/2018 CHEM-TECH LTD., ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0810137649
:01/82/050/01678/AM19/ :08/24/040/00469/AM16/ 11.04.2016

-|---|---| |ALC4/2018||CHEM-TECH LTD.,||ALC4/2020||Approved| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0810137649||| |:01/82/050/01678/AM19/||:08/24/040/00469/AM16/||11.04.2016|||

Case No.:221/15/82-<br>ALC4/2018 Party Name:GOPINATH<br>CHEM-TECH LTD.,<br>RLA File<br>:08/24/040/00469/AM16/ Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Approved
HQ File<br>:01/82/050/01678/AM19/ Lic.No/Date:0810137649<br>11.04.2016
8 **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was<br>decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>4,4 Diamino Diphenyl Amine -2-<br>Sulphonic Acid ( F.C Acid )<br>1 kg<br>1<br>Para NItro Aniline<br>0.61 kg<br>2<br>Para NItro Chloro Benzene<br>0.70 kg<br>3<br>Soda Ash<br>1.80 kg<br>Note: The Committee while fixing the norms of subject Advance Authorization observed that the<br>**Standard Input Output Norms (SION) for the export product -**4,4 Diamino Diphenyl Amine -2-<br>Sulphonic Acid are published in SION at A-465 and A-468. As the norms at SION A-465 are more<br>precise,the Committee after deliberation decided to recommend deletingthe norms at SION A-468.<br>RA concerned maytake further necessaryaction asper above decision of NC.

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A-465 are more<br>precise,the Committee after deliberation decided to recommend deletingthe norms at SION A-468.<br>RA concerned maytake further necessaryaction asper above decision of NC.||||

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Case No.:274/15/82- Party Name:SHILPA Meet No/Date:4/82- Status:
ALC4/2018 MEDICARE LTD., ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0710109729
:01/82/050/01731/AM19/ :07/24/040/00034/AM17/ 27.04.2016

9 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 12/82ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

Case No.:230/15/82- Party Name:WINTAC Meet No/Date:4/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0710109922
:01/82/050/01687/AM19/ :07/24/040/00083/AM17/ 08.06.2016

|---|---|---|---| |ALC4/2018||LIMITED,||ALC4/2020||Rejected| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0710109922||| |:01/82/050/01687/AM19/||:07/24/040/00083/AM17/||08.06.2016|||

10 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

Case No.:231/15/82- Party Name:WINTAC Meet No/Date:4/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0710109921
:01/82/050/01688/AM19/ :07/24/040/00082/AM17/ 08.06.2016

11 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

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020** as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

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Case No.:501/15/82- Party Name:WINTAC Meet No/Date:4/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0710109926
:01/82/050/01958/AM19/ :07/24/040/00081/AM17/ 09.06.2016

12 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Case No.:646/15/82- Party Name:WINTAC Meet No/Date:4/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0710110596
:01/82/050/02103/AM19/ :07/24/040/00251/AM17/ 28.10.2016

13 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

Case No.:680/15/82- Party Name:WINTAC Meet No/Date:4/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0710110805
:01/82/050/02137/AM19/ :07/24/040/00282/AM17/ 16.12.2016

14 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

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Case No.:265/15/82- Party Name:ATUL LIMITED, Meet No/Date:4/82- Status:
ALC4/2018 ALC4/2020 Deferred
18.09.2020
HQ File RLA File Lic.No/Date:0810139395
:01/82/050/01722/AM19/ :08/24/040/00374/AM17/ 28.12.2016

|---|---|---|---|---|---| |ALC4/2018||||ALC4/2020||Deferred| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0810139395||| |:01/82/050/01722/AM19/||:08/24/040/00374/AM17/||28.12.2016|||

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

(i) Exact chemical name of Export Product (ii) % yield of chemical reaction (iii) Use of Methanol in manufacturing process.

Case No.:992/15/82- Party Name:WINTAC Meet No/Date:4/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0710111032
:01/82/050/02449/AM19/ :07/24/040/00353/AM17/ 27.01.2017

16 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

08.2020** as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

Case No.:995/15/82- Party Name:WINTAC Meet No/Date:4/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0710111117
:01/82/050/02452/AM19/ :07/24/040/00362/AM17/ 10.02.2017
  • 17 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

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Case No.:1002/15/82- Party Name:WINTAC Meet No/Date:4/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0710111160
:01/82/050/02459/AM19/ :07/24/040/00365/AM17/ 21.02.2017

|---|---|---|---| |ALC4/2018||LIMITED,||ALC4/2020||Rejected| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0710111160||| |:01/82/050/02459/AM19/||:07/24/040/00365/AM17/||21.02.2017|||

18 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

19 Case No.:276/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD., Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01733/AM19/ RLA File<br>:05/23/040/00561/AM17/ Lic.No/Date:0510401758<br>22.02.2017
**Decision:**The Committee considered the case as per agenda<br>Show Cause Notice vide letter dated 10.10.2019. and it was observed that the firm was issued

Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

was observed that the firm was issued||

Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

20 Case No.:55/4/82-ALC4/2020 Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01556/AM21/ RLA File<br>:03/94/040/01066/AM17/ Lic.No/Date:0310811424<br>23.02.2017
**Decision:**This case appeared for the first time before Norms Committee. The Committee noted that the<br>4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy<br>of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.<br>23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Case No.:382/4/82-ALC4/2017 Party Name:ELPPE Meet No/Date:4/82- Status:
CHEMICALS PRIVATE ALC4/2020 Withdrawn
LIMITED 18.09.2020
HQ File RLA File Lic.No/Date:0310812684
:01/82/050/00390/AM18/ :03/94/040/00036/AM18/ 24.04.2017

|---|---| ||||CHEMICALS PRIVATE||ALC4/2020||Withdrawn| ||||LIMITED||18.09.2020||| ||HQ File||RLA File||Lic.No/Date:0310812684||| ||:01/82/050/00390/AM18/||:03/94/040/00036/AM18/||24.04.2017|||

21 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020.

In view of above, the Committee decided to withdraw the case.

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22 Case No.:294/15/82-<br>ALC4/2018 Party Name:SUPREET<br>CHEMICALS PVT.LTD. Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01751/AM19/ RLA File<br>:52/24/040/00006/AM18/ Lic.No/Date:5210042249<br>02.05.2017
**Decision:**The Committee considered the case as per online agenda in the presence of technical experts<br>and it was decided to call for following information from the firm:<br>(i)<br>Recovery of other Isomer and its commercial value.

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

Case No.:289/15/82- Party Name:ATUL LIMITED, Meet No/Date:4/82- Status:
ALC4/2018 ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0810140311
:01/82/050/01746/AM19/ :08/24/040/00043/AM18/ 18.05.2017

|---|---|---|---|---|---| |ALC4/2018||||ALC4/2020||Approved| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0810140311||| |:01/82/050/01746/AM19/||:08/24/040/00043/AM18/||18.05.2017|||

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: 23

|Export Product<br>Lapox ARD 54 (Diglycidyl ether<br>of polypropylene glycol)|Qty.|Sl.<br>No.|Import items|Qty.|
|---|---|---|---|---|
||1 kg|1|Poly Propylene Glycol | PPG-425 |<br>Konix PP 400 | Wanol C 2004 |<br>Exacol PPG 425|0.7938 kg|
|||2|Epichlorohydrin|0.345 kg|
Case No.:290/15/82- Party Name:WINTAC Meet No/Date:4/82- Status: Rejected
ALC4/2018 LIMITED, ALC4/2020
18.09.2020
HQ File RLA File Lic.No/Date:0710111636
:01/82/050/01747/AM19/ :07/24/040/00052/AM18/ 23.05.2017

24 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

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3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

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Case No.:291/15/82- Party Name:WINTAC Meet No/Date:4/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0710111650
:01/82/050/01748/AM19/ :07/24/040/00056/AM18/ 24.05.2017

25 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Case No.:109/12/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status:
ALC4/2017 LIMITED ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0910065247
:01/82/050/01064/AM18/ :09/24/040/00181/AM18/ 06.07.2017

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 26 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 13.02.2020 and Final Reminder on 06.08.2020 :

ished the information on following deficiencies raised by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 13.02.2020 and Final Reminder on 06.08.2020 :

(i) Justification for low yield in the process alongwith documentary evidence. (ii) Complete set of 4.07 application.

Case No.:309/15/82- Party Name:DISCOVERY Meet No/Date:4/82- Status:
ALC4/2018 INTERMEDIATES PVT LTD. ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0910065252
:01/82/050/01766/AM19/ :09/24/040/00157/AM18/ 07.07.2017

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: 27

Export Product<br>DIPHENYLAMINOHEXANE<br>(DAH) II. Qty. Sl.<br>No. Import items Qty.
1 kg 1 L PHENYLAMINE 0.4465 kg
2 POTASSIUM CARBONATE 1.075 kg
3 BENZYL CHLORIDE 1.032 kg
4 CITRIC ACID 1.000 kg

10

Case No.:311/15/82- Party Name:ASSOCIATED Meet No/Date:4/82- Status:
ALC4/2018 DYESTUFF PVT. LTD ALC4/2020 Deferred
18.09.2020
HQ File RLA File Lic.No/Date:0810140725
:01/82/050/01768/AM19/ :08/24/040/00123/AM18/ 26.07.2017

---|---| |ALC4/2018||DYESTUFF PVT. LTD||ALC4/2020||Deferred| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0810140725||| |:01/82/050/01768/AM19/||:08/24/040/00123/AM18/||26.07.2017|||

28 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 1/82-ALC4/2020 dated 17.04.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

29 Case No.:297/12/82-<br>ALC4/2018 Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED, Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Withdrawn
<br>HQ File<br>:01/82/050/00924/AM19/ RLA File<br>:07/24/040/00129/AM18/ Lic.No/Date:0710111984<br>08.08.2017
<br>Decision:The firm vide e-mail dated 07.08.2020 has furnished a copy of EODC obtained from RLA,<br>Bangalore.<br>The Committee considered the case in the presence of technical experts and in light of above<br>e-mail,the Committee decided towithdrawthe case.
Case No.:116/12/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status:
ALC4/2017 LIMITED ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0910065373
:01/82/050/01071/AM18/ :09/24/040/00234/AM18/ 23.08.2017

-|---|---|---|---| |ALC4/2017||LIMITED||ALC4/2020||Rejected| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0910065373||| |:01/82/050/01071/AM18/||:09/24/040/00234/AM18/||23.08.2017|||

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 30 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 13.02.2020 and Final Reminder on 06.08.2020 :

(i) Justification for low yield in the process alongwith documentary evidence. (ii) Complete set of 4.07 application.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

11

Case No.:134/12/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status:
ALC4/2017 LIMITED ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0910065372
:01/82/050/01089/AM18/ :09/24/040/00233/AM18/ 23.08.2017

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 31 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 13.02.2020 and Final Reminder on 06.08.2020 :

(i) Justification for low yield in the process alongwith documentary evidence. (ii) Complete set of 4.07 application.

ed by Reminder on 13.02.2020 and Final Reminder on 06.08.2020 :

(i) Justification for low yield in the process alongwith documentary evidence. (ii) Complete set of 4.07 application.

Case No.:131/12/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status:
ALC4/2017 LIMITED ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0910065396
:01/82/050/01086/AM18/ :09/24/040/00238/AM18/ 28.08.2017

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 32 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 13.02.2020 and Final Reminder on 06.08.2020 :

(i) Justification for low yield in the process alongwith documentary evidence. (ii) Complete set of 4.07 application.

Case No.:132/12/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status:
ALC4/2017 LIMITED ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0910065398
:01/82/050/01087/AM18/ :09/24/040/00235/AM18/ 28.08.2017

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 33 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 13.02.2020 and Final Reminder on 06.08.2020 :

ished the information on following deficiencies raised by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 13.02.2020 and Final Reminder on 06.08.2020 :

(i) Justification for low yield in the process alongwith documentary evidence. (ii) Complete set of 4.07 application.

12

Case No.:141/12/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status:
ALC4/2017 LIMITED ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0910065397
:01/82/050/01096/AM18/ :09/24/040/00236/AM18/ 28.08.2017

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 34 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 13.02.2020 and Final Reminder on 06.08.2020 :

(i) Justification for low yield in the process alongwith documentary evidence. (ii) Complete set of 4.07 application.

Case No.:321/15/82- Party Name:AASHA Meet No/Date:4/82- Status:
ALC4/2018 BIOCHEM ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:1010059805
:01/82/050/01778/AM19/ :10/24/040/00018/AM18/ 31.08.2017

-|---|---|---|---| |ALC4/2018||BIOCHEM||ALC4/2020||Approved| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:1010059805||| |:01/82/050/01778/AM19/||:10/24/040/00018/AM18/||31.08.2017|||

Decision: The Committee considered case as per agenda in the presence of the technical experts and as per COA of Export Product / Import items, it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

35

Export Product<br>SQUALENE<br>99%<br>CHEMICAL NAME 2 6 10 15<br>19 23 HEXAMETHYLETRA<br>COSA 2 6 10 14 18 22<br>HEXAENE Qty. Sl.<br>No. Import items Qty.
1 kg 1 SQUALENE<br>OIL<br>80%<br>CHEMICAL NAME 2 6 10 15 19 23<br>HEXAMETHYLETRA COSA 2 6 10 14<br>18 22 HEXAENE 1.185 kg
36 Case No.:198/4/82-<br>ALC4/2018 Party Name:SAPTAGIR<br>CAMPHOR LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Approved
HQ File<br>:01/82/050/00198/AM19/ RLA File<br>:09/24/040/00293/AM18/ Lic.No/Date:0910065468<br>15.09.2017
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and taken<br>into value of By-Product, it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.<br>I 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>Camphene<br>1 kg<br>1<br>Alpha Pinene<br>1.140 kg
RA concerned maytake further necessaryaction asper above decision of NC.

Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Camphene<br>1 kg<br>1<br>Alpha Pinene<br>1.140 kg|||| ||RA concerned maytake further necessaryaction asper above decision of NC.||||

Decision: The Committee considered case as per agenda in the presence of the technical experts and taken 36 into value of By-Product, it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

13

Case No.:327/15/82- Party Name:JODAS EXPOIM Meet No/Date:4/82- Status: ALC4/2018 PVT.LTD., ALC4/2020 Deferred 18.09.2020 37 HQ File RLA File Lic.No/Date:0510404290 :01/82/050/01784/AM19/ :05/23/040/00268/AM18/ 13.10.2017

Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

38 Case No.:328/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD., Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01785/AM19/ RLA File<br>:05/23/040/00266/AM18/ Lic.No/Date:0510404285<br>13.10.2017
**Decision:**The Committee considered the case as per agenda and it was observed that the firm was issued<br>Show Cause Notice vide letter dated 10.10.2019.

Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

otice vide letter dated 10.10.2019.||||

Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

39 Case No.:329/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD., Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01786/AM19/ RLA File<br>:05/23/040/00267/AM18/ Lic.No/Date:0510404287<br>13.10.2017
**Decision:**The Committee considered the case as per agenda and it was observed that the firm was issued<br>Show Cause Notice vide letter dated 10.10.2019.

Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

40 Case No.:550/15/82-<br>ALC4/2018 Party Name:TADIMETY<br>AROMATICS PVT. LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02007/AM19/ RLA File<br>:07/24/040/00202/AM18/ Lic.No/Date:0710112366<br>08.11.2017
<br>Decision:The Committee considered the case as per online agenda in the presence of technical experts<br>and it was decided to call for following information from the firm:<br>(i)<br>Complete technical details as per Appendix 4E having complete chemistry,<br>molecular weight, percentage yield and Stoichiometric balance.

14

information from the firm:<br>(i)<br>Complete technical details as per Appendix 4E having complete chemistry,<br>molecular weight, percentage yield and Stoichiometric balance.||||

14

Case No.:236/4/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status:
ALC4/2018 LIMITED ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0910065688
:01/82/050/00236/AM19/ :09/24/040/00403/AM18/ 24.11.2017

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 41 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 13.02.2020 and Final Reminder on 06.08.2020 :

(i) Justification for low yield in the process alongwith documentary evidence. (ii) Complete set of 4.07 application.

Case No.:243/4/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status:
ALC4/2018 LIMITED ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0910065687
:01/82/050/00243/AM19/ :09/24/040/00404/AM18/ 24.11.2017

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 42 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 13.02.2020 and Final Reminder on 06.08.2020 :

ished the information on following deficiencies raised by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 13.02.2020 and Final Reminder on 06.08.2020 :

(i) Justification for low yield in the process alongwith documentary evidence. (ii) Complete set of 4.07 application.

Case No.:1021/15/82- Party Name:ANLON Meet No/Date:4/82- Status:
ALC4/2018 HEALTHCARE ALC4/2020 Deferred
PRIVATELIMITED 18.09.2020
HQ File RLA File Lic.No/Date:2410042334
:01/82/050/02478/AM19/ :24/24/040/00039/AM18/ 12.01.2018

43 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 1/82-ALC4/2020 dated 17.04.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

15

Case No.:12/4/82-ALC4/2018 Party Name:MELOG Meet No/Date:4/82- Status:
SPECIALITY CHEMICALS ALC4/2020 Approved
PVT. LTD. 18.09.2020
HQ File RLA File Lic.No/Date:0310818490
:01/82/050/00012/AM19/ :03/95/040/00810/AM18/ 15.01.2018

|---|---| |||SPECIALITY CHEMICALS||ALC4/2020||Approved| |||PVT. LTD.||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0310818490||| |:01/82/050/00012/AM19/||:03/95/040/00810/AM18/||15.01.2018|||

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as 44 applied by firm whichever is lower:

Export Product<br>T-2003 (2,2-METHYLEBIS (4,6-<br>DI-TERTIARY-<br>BUTYLPHENOL) Qty. Sl.<br>No. Import items Qty.
1 kg 1 2,4-DI-TERTIARY BUTYL PHENOL 1.02 kg
45 Case No.:165/10/82-<br>ALC4/2018 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00452/AM19/ RLA File<br>:09/24/040/00438/AM18/ Lic.No/Date:0910065915<br>20.01.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 24.08.2020 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 24.08.2020 has furnished its reply. Deferred for comments of TE.

he Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 24.08.2020 has furnished its reply. Deferred for comments of TE.

Case No.:187/10/82- Party Name:NISARG Meet No/Date:4/82- Status:
ALC4/2018 BIOSCIENCES PVT LTD ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0910065945
:01/82/050/00474/AM19/ :09/24/040/00497/AM18/ 31.01.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 46 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 8/82-ALC4/2019 dated 20.09.2019, followed by Reminder on 31.10.2019 and Final Reminder on 13.02.2020 :

(i) Exact chemical name of the export product.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

47 <br>Case No.:132/10/82-<br>ALC4/2018 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00419/AM19/ RLA File<br>:09/24/040/00516/AM18/ Lic.No/Date:0910065954<br>01.02.2018
**Decision:**Deferred for comments of TE.

16

rred**| |---|---|---|---|---| ||<br>HQ File<br>:01/82/050/00419/AM19/|RLA File<br>:09/24/040/00516/AM18/|Lic.No/Date:0910065954<br>01.02.2018|| ||**Decision:**Deferred for comments of TE.||||

16

Case No.:135/10/82- Party Name:NISARG Meet No/Date:4/82- Status:
ALC4/2018 BIOSCIENCES PVT LTD ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0910065963
:01/82/050/00422/AM19/ :09/24/040/00498/AM18/ 02.02.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 48 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 8/82-ALC4/2019 dated 20.09.2019, followed by Reminder on 31.10.2019 and Final Reminder on 13.02.2020 :

(i) Percentage yield on molar basis at every stage. (ii) Exact chemical name of the export product.

49 <br>Case No.:140/10/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00427/AM19/ RLA File<br>:09/24/040/00527/AM18/ Lic.No/Date:0910065968<br>06.02.2018
**Decision:**Deferred for comments of TE.
Case No.:142/4/82- Party Name:HERBOCHEM Meet No/Date:4/82- Status:
ALC4/2018 INDUSTRIES ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0610038810
:01/82/050/00142/AM19/ :06/24/040/00047/AM18/ 07.02.2018

--|---|---|---| |ALC4/2018||INDUSTRIES||ALC4/2020||Approved| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0610038810||| |:01/82/050/00142/AM19/||:06/24/040/00047/AM18/||07.02.2018|||

Decision: The Committee considered case as per agenda in the presence of the technical experts and with 2% wastage, it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

50

Sl. Export Product Qty. Sl. Import items Qty.
No. No.
1 MENTHOL 8928.000 kg 1 MENTHA ARVENSIS 14247.36 kg
2 DEMENTHOLISED 3960.000 kg OIL
PEPPERMINT OIL
3 CORNMINT FRACTION OR 1080.000 kg
MINT TERPENE

17

Case No.:166/10/82- Party Name:ORTIN Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0910065973
:01/82/050/00453/AM19/ :09/24/040/00528/AM18/ 07.02.2018

|---|---| |ALC4/2018||LABORATORIES LTD||ALC4/2020||Approved| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0910065973||| |:01/82/050/00453/AM19/||:09/24/040/00528/AM18/||07.02.2018|||

Case No.:166/10/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Party Name:ORTIN<br>LABORATORIES LTD Party Name:ORTIN<br>LABORATORIES LTD Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/00453/AM19/ RLA File<br>:09/24/040/00528/AM18/ Lic.No/Date:0910065973<br>07.02.2018
51 **Decision:**The Committee considered cas<br>was decided to ratify the ad-hoc input output<br>applied by firm whichever is lower:
Export Product Qty. Sl.<br>No. Import items Qty.
2S,3S,5S)-2-AMINO-3-<br>HYDROXY-5-(1-TETRA-<br>HYDRO PYRIMID-2-ONLY)-3-<br>METHYL<br>BUTANOYL)<br>AMINO-1,6-DIPHENYL<br>HEXANE-S-PYRO<br>GLUTAMATE(THP) 1 kg 1 L-PHENYLALANINE 0.473 kg
2 1,2 DIMETHOXYETHANE 6.74 kg
3 SODIUM BORO HYDRIDE 0.406 kg
4 METHANE SULPHONIC ACID 1.57 kg
5 ISOPROPYL ALCOHOL 1.27 kg
6 TRIETHANOLAMINE(99%) 1.167 kg
7 N,N-DIMETHYL ACETAMIDE 1.60 kg
8 L- VALINE 0.630 kg
9 ACRELONITRILE 0.277 kg
10 MDC 3.25 kg
11 N,N- CARBONYL DIMIDAZOLE 0.443 kg
12 AMMONIUM FORMATE 0.500 kg
13 DIMETHYL FORMAMIDE 3.945 kg
14 L-PYROGLUTAMIC ACID 0.295 kg
15 n- HEPTANE 0.450 kg
16 TETRAHYDROFURAN 2.445 kg

ZOLE|||0.443 kg| |||||12|AMMONIUM FORMATE|||0.500 kg| |||||13|DIMETHYL FORMAMIDE|||3.945 kg| |||||14|L-PYROGLUTAMIC ACID|||0.295 kg| |||||15|n- HEPTANE|||0.450 kg| |||||16|TETRAHYDROFURAN|||2.445 kg| |||||17|SODIUM AMIDE|||0.378 kg| |||||18|ACETONITRILE|||0.300 kg| |||||19|PALLADIUM 99.95%|||0.001 kg| |||||20|POTTASIUM CARBONATE|||1.50 kg| |||||21|CITRIC ACID|||2.00 kg| ||RA concerned maytake further necessaryaction asper above decision of NC.||||||||

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

52 Case No.:819/15/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/02276/AM19/ Party Name:DHANUKA<br>LABORATORIES LTD<br> <br> <br> <br>RLA File<br>:05/23/040/00440/AM18/<br> <br> Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
Lic.No/Date:0510405609<br>09.02.2018
Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.<br>1/82-ALC4/2020dated17.04.2020, followed by Reminder on07.08.2020as per Policy Circular No.<br>23/2015-20, dated 15.05.2019.<br>In view of above, the Committee decided to issueFinal Reminderto firm to furnish its 4.07<br>application,failingwhich the case will be rejected.

18

o.<br>23/2015-20, dated 15.05.2019.<br>In view of above, the Committee decided to issueFinal Reminderto firm to furnish its 4.07<br>application,failingwhich the case will be rejected.||||

18

53 Case No.:1009/15/82-<br>ALC4/2018 Party Name:TADIMETY<br>AROMATICS PVT. LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02466/AM19/ RLA File<br>:07/24/040/00305/AM18/ Lic.No/Date:0710112820<br>13.02.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 16.11.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 16.11.2019 has furnished its reply. Deferred for comments of TE.

Case No.:82/10/82-ALC4/2018 Party Name:FRESENIUS KABI Meet No/Date:4/82- Status:
INDIA PRIVATE LTD ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0310819230
:01/82/050/00369/AM19/ :03/94/040/00911/AM18/ 19.02.2018

54 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was observed that the reply furnished by the firm was not proper. Hence, the Committee decided to reject the case.

onsidered the case as per agenda in the presence of technical experts and it was observed that the reply furnished by the firm was not proper. Hence, the Committee decided to reject the case.

55 Case No.:93/10/82-<br>ALC4/2018 Party Name:YASHO<br>INDUSTRIES PVT.LTD. Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00380/AM19/ RLA File<br>:03/95/040/01007/AM18/ Lic.No/Date:0310819263<br>20.02.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 24.10.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 24.10.2019 has furnished its reply. Deferred for comments of TE.

Case No.:47/13/82- Party Name:ORTIN Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0910066003
:01/82/050/01025/AM19/ :09/24/040/00587/AM18/ 20.02.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: 56

a in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: 56

Export Product<br>(3R,3aS,6aR)-<br>Hexahydrofuro[2,3-b]furan-3-<br>ol(BIS-IV) Qty. Sl.<br>No. Import items Qty.
1 kg 1 2,3-dihydrofuran 1.05 kg
2 Triethyl amine 2.05 kg
3 Methelene dichloride 3.30 kg
4 Sodium borohydride 0.72 kg

19

57

Case No.:186/13/82- Party Name:SONGWON Meet No/Date:4/82- Status:
ALC4/2018 SPECIALTY CHEMICALS ALC4/2020 Deferred
INDIA PVT. LTD. 18.09.2020
HQ File RLA File Lic.No/Date:3410043908
:01/82/050/01164/AM19/ :34/24/040/00341/AM18/ 22.02.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was observed that the reply furnished by the firm in response to earlier issued DL was not proper. Hence, it was decided to call for following information from the firm:

(i) % yield on molar basis at every stage.

Case No.:286/4/82-ALC4/2018 Party Name:SURVIVAL Meet No/Date:4/82- Status:
TECHNOLOGIES PVT.LTD. ALC4/2020 Deferred
18.09.2020
HQ File RLA File Lic.No/Date:0310819412
:01/82/050/00286/AM19/ :03/95/040/00993/AM18/ 26.02.2018

|---|---|---|---| |||TECHNOLOGIES PVT.LTD.||ALC4/2020||Deferred| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0310819412||| |:01/82/050/00286/AM19/||:03/95/040/00993/AM18/||26.02.2018|||

58 Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was observed that the reply furnished by the firm in response to earlier issued DL was not proper. Hence, it was decided to call for following information from the firm:

(i) Production / Consumption data duly certified by GST for last one year. (ii) Use of Acetonitrile in manufacturing. (iii) Recovery of N-Hexane.

Case No.:125/13/82- Party Name:ORTIN Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0910066054
:01/82/050/01103/AM19/ :09/24/040/00611/AM18/ 12.03.2018
Case No.:125/13/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Party Name:ORTIN<br>LABORATORIES LTD Party Name:ORTIN<br>LABORATORIES LTD Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/01103/AM19/ RLA File<br>:09/24/040/00611/AM18/ Lic.No/Date:0910066054<br>12.03.2018
59 **Decision:**The Committee considered cas<br>was decided to ratify the ad-hoc input output<br>applied by firm whichever is lower:
Export Product Qty. Sl.<br>No. Import items Qty.

|| |59|**Decision:**The Committee considered cas<br>was decided to ratify the ad-hoc input output<br>applied by firm whichever is lower:|||||||| ||Export Product||Qty.|Sl.<br>No.|Import items|||Qty.| ||[2S,3S,5S]-5-t-<br>butyloxycarbonylamino-2-<br>Amino-3-hydroxy-1,6-<br>diphenylhexane<br>succinate(BDH<br>Succinic Acid RIT)||1 kg|1|1,2-dimethoxyethane(1,2-DME)|||4.74 kg| |||||2|SODIUM BORO HYDRIDE|||0.45 kg| |||||3|METHANE SULPHONIC ACID|||1.50 kg| |||||4|ISOPROPYL ALCOHOL|||2.90 kg| |||||5|TRIETHANOLAMINE|||1.167 kg| |||||6|N,N-DIMETHYL ACETAMIDE|||0.80 kg| |||||7|AMMONIUM FORMATE|||0.50 kg| |||||8|POTTASIUM CARBONATE|||0.40 kg| |||||9|Di-Tert-Butyl- Di- Carbonate|||0.60 kg| |||||10|Methylene Dichloride(MDC)|||1.34 kg| ||RA concerned maytake further necessaryaction asper above decision of NC.||||||||

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

20

Case No.:33/13/82-ALC4/2018 Party Name:VISWAAT Meet No/Date:4/82- Status:
CHEMICALS LIMITED ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0310819857
:01/82/050/01011/AM19/ :03/95/040/01027/AM18/ 16.03.2018

|---|---|---|---|---| |||CHEMICALS LIMITED||ALC4/2020||Rejected| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0310819857||| |:01/82/050/01011/AM19/||:03/95/040/01027/AM18/||16.03.2018|||

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm was asked to furnish following information asked for by NC-3 in its Meeting No. 9/82-ALC4/2019 dated 18.10.2019, followed by Reminder on 09.12.2019 and Final Reminder on 13.02.2020:

(i) Indigenous input and their quantity.

60

The firm vide e-mail dated 14.02.2020 instead of giving reply to the above query referred to the Minutes of NC-3 Meeting No. 5/82-ALC4/2019 dated 25.07.2018 vide which NC fixed norms of their Advance Authorization No. 0310808110 dated 27.09.2016.

The Committee examined the above e-mail received from firm in light of norms fixed for Advance Authorization No. 0310808110 dated 27.09.2016 vide NC-3 Meeting No. 5/82-ALC4/2019 dated 25.07.2018 and it was observed that NC while fixing the norms of Advance Authorization No. 0310808110 dated 27.09.2016 clearly mentioned that the norms allowed are for one time basis and repeat norms will be allowed.

In view of above, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

for one time basis and repeat norms will be allowed.**

In view of above, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

Case No.:127/13/82- Party Name:SPANSULES Meet No/Date:4/82- Status:
ALC4/2018 FORMULATIONS ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0910066066
:01/82/050/01105/AM19/ :09/24/040/00619/AM18/ 20.03.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

61

Sl. No.<br>1<br>2 Export Product Qty. Sl.<br>No. Import items Qty.
Ascorbic Acid 85% SR Pellets 7.070 MT 1 Ascorbic Acid 6.07 MT
Ascorbic<br>Acid<br>and<br>other<br>multivitamin Pellets (containing not<br>less than 50% Ascorbic Acid) 30.000 MT 2 Ascorbic Acid 15.00 MT

21

5% SR Pellets|7.070 MT|1|Ascorbic Acid|6.07 MT| ||Ascorbic<br>Acid<br>and<br>other<br>multivitamin Pellets (containing not<br>less than 50% Ascorbic Acid)|30.000 MT|2|Ascorbic Acid|15.00 MT|

21

62 Case No.:258/12/82-<br>ALC4/2018 Party Name:SYNTHO<br>CHIRALS PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Approved
HQ File<br>:01/82/050/00885/AM19/ RLA File<br>:09/24/040/00669/AM18/ Lic.No/Date:0910066087<br>26.03.2018
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>(1R,2R)-2-amino-6-(4-nitrophenyl)-1-<br>Phenylhex-5-yn-1-ol hydrochloride<br>400 kg<br>1<br>KRED,<br>RVT-901<br>(Enzyme)<br>5000.000 gram
RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as 62 applied by firm whichever is lower:

in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as 62 applied by firm whichever is lower:

Case No.:126/13/82- Party Name:OPTRIX Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES PRIVATE ALC4/2020 Approved
LIMITED 18.09.2020
HQ File RLA File Lic.No/Date:0910066086
:01/82/050/01104/AM19/ :09/24/040/00639/AM18/ 26.03.2018
Case No.:126/13/82-<br>ALC4/2018 Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Approved
HQ File<br>:01/82/050/01104/AM19/ RLA File<br>:09/24/040/00639/AM18/ Lic.No/Date:0910066086<br>26.03.2018
63 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>EMPAGLIFLOZIN IH<br>1 kg<br>1<br>(1S)-1 5-Anhydro-1-C-[4-chloro -3-[[4-[[(3S)-<br>tetrahydro-3-<br>furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol<br>tetraacetate<br>OR<br>(1S)-1<br>5-Anhydro-1-C-[4-chloro<br>-3-[[4-<br>[[(3S)-tetrahydro-3-<br>furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol<br>1.525 kg<br>RA concerned may take further necessary action as per above decision of NC.

ydro-1-C-[4-chloro<br>-3-[[4-<br>[[(3S)-tetrahydro-3-<br>furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol<br>1.525 kg<br>RA concerned may take further necessary action as per above decision of NC.||||

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

22

Case No.:5/10/82- Party Name:DCM SHRIRAM Meet No/Date:4/82- Status:
ALC4/2018 INDUSTRIES LTD, ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0510406067
:01/82/050/00292/AM19/ :05/23/040/00515/AM18/ 09.04.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 64 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 8/82-ALC4/2019 dated 20.09.2019, followed by Reminder on 31.10.2019 and Final Reminder on 13.02.2020 :

(i) Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction and % of yield on molar basis at every stage.

0.2019** and Final Reminder on 13.02.2020 :

(i) Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction and % of yield on molar basis at every stage.

65 Case No.:1014/15/82-<br>ALC4/2018 Party Name:TADIMETY<br>AROMATICS PVT. LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02471/AM19/ RLA File<br>:07/24/040/00361/AM18/ Lic.No/Date:0710113089<br>10.04.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 16.11.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 16.11.2019 has furnished its reply. Deferred for comments of TE.

66 Case No.:261/12/82-<br>ALC4/2018 Party Name:AKTINOS<br>HEALTHCARE PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
HQ File<br>:01/82/050/00888/AM19/ RLA File<br>:09/24/040/00668/AM18/ Lic.No/Date:0910066131<br>11.04.2018
<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 from the firm:<br>(i)<br>Whether export item is physical blending of two compounds as mentioned in<br>**export description.

cal experts and it<br>was decided to call for following information from the firm:<br>(i)<br>Whether export item is physical blending of two compounds as mentioned in<br>export description. If no, please give the chemical name of the export item.<br>(ii)<br>Molecular weight of export item and its chemical structure.<br>(iii)<br>Use of D-(-) Threo compound in the final step.||||

23

Case No.:156/13/82- Party Name:SMS Meet No/Date:4/82- Status:
ALC4/2018 LIFESCIENCES INDIA ALC4/2020 Approved
LIMITED 18.09.2020
HQ File RLA File Lic.No/Date:0910066137
:01/82/050/01134/AM19/ :09/24/040/00654/AM18/ 12.04.2018
Case No.:156/13/82-<br>ALC4/2018 Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/01134/AM19/ RLA File<br>:09/24/040/00654/AM18/ Lic.No/Date:0910066137<br>12.04.2018
67 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.

||| |67|<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>(3R,<br>3aS,<br>6aR)<br>-<br>HEXA<br>HYDRO FURO - [2, 3-b] -<br>FURAN - 3 - YL - 4 - NITRO<br>PHENYL<br>CARBONATE<br>(DARUNAVIR-IV)<br>Intermediate of Darunavir<br>1 kg 1<br>BIS IV (HEXA HYDRO FURO [2,3-B]<br>FURAN-3-OL)<br>1.61 kg<br>2<br>METHYLENE DI CHLORIDE<br>5.32 kg<br>RA concerned may take further necessary action as per above decision of NC.|||||||| ||<br>Export Product||Qty.|Sl.<br>No.|Import items|||Qty.| ||(3R,<br>3aS,<br>6aR)<br>-<br>HEXA<br>HYDRO FURO - [2, 3-b] -<br>FURAN - 3 - YL - 4 - NITRO<br>PHENYL<br>CARBONATE<br>(DARUNAVIR-IV)<br>Intermediate of Darunavir||1 kg|1|BIS IV (HEXA HYDRO FURO [2,3-B]<br>FURAN-3-OL)|||1.61 kg| |||||2|METHYLENE DI CHLORIDE|||5.32 kg| ||RA concerned may take further necessary|||action as|per above decision of NC.||||

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

enda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

68 <br>Case No.:26/15/82-ALC4/2018 Party Name:GLAND<br>CHEMICALS PVT LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01483/AM19/ RLA File<br>:09/24/040/00008/AM19/ Lic.No/Date:0910066148<br>17.04.2018
**Decision:**Deferred for comments of TE.
Case No.:122/13/82- Party Name:SUVEN LIFE Meet No/Date:4/82- Status:
ALC4/2018 SCIENCES LIMITED ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0910066156
:01/82/050/01100/AM19/ :09/24/040/00024/AM19/ 18.04.2018
Case No.:122/13/82-<br>ALC4/2018 Party Name:SUVEN LIFE<br>SCIENCES LIMITED Party Name:SUVEN LIFE<br>SCIENCES LIMITED Party Name:SUVEN LIFE<br>SCIENCES LIMITED Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/01100/AM19/ RLA File<br>:09/24/040/00024/AM19/ Lic.No/Date:0910066156<br>18.04.2018
69 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was<br>decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.

||| |69|<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was<br>decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1-(2-FLUORO-6-<br>(TRIFLUOROMETHYL)BENZYL)-<br>5-IODO-6-METHYLPYRIMIDINE-<br>2,4 (1H,3H)-DIONE<br>1 kg<br>1<br>3-FLUORO<br>BENZOTRIFLUORIDE<br>1.011 kg<br>2<br>DIMETHYL FORMAMIDE<br>0.472 kg<br>3<br>TETRAHYDROFURAN<br>0.80 kg<br>4<br>METHYL-1-t-BUTYLETHER<br>(MTBE)<br>0.255 kg<br>5<br>IODINE MONOCHLORIDE<br>0.411 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.|||||||| ||<br>Export Product||Qty.|Sl.<br>No.|Import items|||Qty.| ||1-(2-FLUORO-6-<br>(TRIFLUOROMETHYL)BENZYL)-<br>5-IODO-6-METHYLPYRIMIDINE-<br>2,4 (1H,3H)-DIONE||1 kg|1|3-FLUORO<br>BENZOTRIFLUORIDE|||1.011 kg| |||||2|DIMETHYL FORMAMIDE|||0.472 kg| |||||3|TETRAHYDROFURAN|||0.80 kg| |||||4|METHYL-1-t-BUTYLETHER<br>(MTBE)|||0.255 kg| |||||5|IODINE MONOCHLORIDE|||0.411 kg| ||RA concerned maytake further necessaryaction asper above decision of NC.||||||||

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

24

in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

24

Case No.:6/15/82-ALC4/2018 Party Name:AUROBINDO Meet No/Date:4/82- Status:
PHARMA LIMITED ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0910066157
:01/82/050/01463/AM19/ :09/24/040/00015/AM19/ 18.04.2018
Case No.:6/15/82-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:4/82-<br>ALC4/2020<br>18.09.2020<br>Lic.No/Date:0910066157<br>18.04.2018 Status:<br>Approved
HQ File<br>:01/82/050/01463/AM19/ RLA File<br>:09/24/040/00015/AM19/
70 **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.

/|||||| |70|**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Clindamycin Palmitate<br>Hydrochloride<br>1 kg<br>1<br>Clindamycin Hydrochloride<br>1.06 kg<br>2<br>Sulfolane Anhydrous<br>0.31 kg<br>3<br>Pyridine<br>0.18 kg<br>4<br>Acetone<br>2.10 kg<br>5<br>Acetonitrile<br>3.00 kg<br>6<br>Cyclohexane(Benzene free)<br>0.57 kg<br>7<br>Methanol(Methyl Alcohol)<br>0.13 kg<br>8<br>Methylene Chloride(MDC)<br>2.06 kg<br>RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl.<br>No.|Import items||Qty.| ||Clindamycin Palmitate<br>Hydrochloride||1 kg|1|Clindamycin Hydrochloride||1.06 kg| |||||2|Sulfolane Anhydrous||0.31 kg| |||||3|Pyridine||0.18 kg| |||||4|Acetone||2.10 kg| |||||5|Acetonitrile||3.00 kg| |||||6|Cyclohexane(Benzene free)||0.57 kg| |||||7|Methanol(Methyl Alcohol)||0.13 kg| |||||8|Methylene Chloride(MDC)||2.06 kg| ||RA concerned may take further necessary action as||||per above decision of NC.|||

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

enda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

Case No.:153/12/82- Party Name:ETERNIS FINE Meet No/Date:4/82- Status:
ALC4/2018 CHEMICALS LIMITED, ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0310820647
:01/82/050/00780/AM19/ :03/94/040/00055/AM19/ 25.04.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: 71

Export Product Qty. Sl.<br>No. Import items Qty.
1-[1,6-dimethyl-4-(4-methylpent-<br>3-enyl)-3-cyclohexen-1-yl]ethan-<br>1-one 1 kg 1 METHYL ETHYL KETONE(MEK) 0.4732 kg
2 MYRCENE 0.7265kg

25

Case No.:121/13/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status:
ALC4/2018 LIMITED ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0910066198
:01/82/050/01099/AM19/ :09/24/040/00044/AM19/ 04.05.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 72 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 13.02.2020 and Final Reminder on 06.08.2020 :

ished the information on following deficiencies raised by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 13.02.2020 and Final Reminder on 06.08.2020 :

(i) Justification for low yield in the process alongwith documentary evidence. (ii) Complete set of 4.07 application.

Case No.:225/10/82- Party Name:DR J Meet No/Date:4/82- Status:
ALC4/2018 PHARMACHEM PRIVATE ALC4/2020 Approved
LIMITED 18.09.2020
HQ File RLA File Lic.No/Date:3110067038
:01/82/050/00512/AM19/ :31/83/040/00014/AM19/ 07.05.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: 73

Export Product<br>POTASSIUM BENZOATE Qty. Sl.<br>No. Import items Qty.
1 kg 1 BENZENE CARBOXYLIC ACID<br>FINE POWDER 0.80 kg
2 CAUSTIC POTASH FLAKES 0.368 kg
Case No.:107/13/82- Party Name:OPTRIX Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES PRIVATE ALC4/2020 Deferred
LIMITED 18.09.2020
HQ File RLA File Lic.No/Date:0910066210
:01/82/050/01085/AM19/ :09/24/040/00006/AM19/ 09.05.2018

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

006/AM19/||09.05.2018|||

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

(i) Import item does not match with details given in Appendix 4E. Please clarify it.

26

Case No.:250/10/82- Party Name:AETHER Meet No/Date:4/82- Status:
ALC4/2018 INDUSTRIES LIMITED ALC4/2020 Deferred
18.09.2020
HQ File RLA File Lic.No/Date:5210042638
:01/82/050/00537/AM19/ :52/24/040/00016/AM19/ 10.05.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it 75 was decided to call for following information from the firm:

(i) Molecular weight of each raw material and finished product. (ii) Use of import item No. 2 (Sodium Tert Butoxide) in reaction and import item No. 5 (Tetrahydrofuran). (iii) % yield of reaction with stoichiometric balance. (iv) Recovery of solvents.

Case No.:366/15/82- Party Name:WINTAC Meet No/Date:4/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0710113260
:01/82/050/01823/AM19/ :07/24/040/00008/AM19/ 10.05.2018

|---|---|---|---| |ALC4/2018||LIMITED,||ALC4/2020||Rejected| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0710113260||| |:01/82/050/01823/AM19/||:07/24/040/00008/AM19/||10.05.2018|||

76 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

Case No.:120/13/82- Party Name:ORTIN Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0910066236
:01/82/050/01098/AM19/ :09/24/040/00614/AM18/ 15.05.2018

|---|---| |ALC4/2018||LABORATORIES LTD||ALC4/2020||Approved| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0910066236||| |:01/82/050/01098/AM19/||:09/24/040/00614/AM18/||15.05.2018|||

Case No.:120/13/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Party Name:ORTIN<br>LABORATORIES LTD Party Name:ORTIN<br>LABORATORIES LTD Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br>Lic.No/Date:0910066236<br>15.05.2018 Status:<br>Approved
HQ File<br>:01/82/050/01098/AM19/ RLA File<br>:09/24/040/00614/AM18/
77 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>[2S,3S,5S]-5-t-<br>butyloxycarbonylamino-2-<br>Amino-3-hydroxy-1,6-<br>diphenylhexane<br>succinate(BDH<br>Succinic Acid RIT)<br>1 kg<br>1<br>1,2-dimethoxyethane(1,2-DME)<br>4.74 kg<br>2<br>SODIUM BORO HYDRIDE<br>0.45 kg<br>3<br>METHANE SULPHONIC ACID<br>1.50 kg<br>4<br>ISOPROPYL ALCOHOL<br>2.90 kg<br>5<br>TRIETHANOLAMINE<br>1.167 kg<br>6<br>N,N-DIMETHYL ACETAMIDE<br>0.80 kg<br>7<br>AMMONIUM FORMATE<br>0.500 kg<br>8<br>POTTASIUM CARBONATE<br>0.40 kg<br>9<br>Di-Tert-Butyl- Di- Carbonate<br>0.60 kg<br>10<br>Methylene Dichloride(MDC)<br>1.34 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

M CARBONATE<br>0.40 kg<br>9<br>Di-Tert-Butyl- Di- Carbonate<br>0.60 kg<br>10<br>Methylene Dichloride(MDC)<br>1.34 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.||||||| ||Export Product||Qty.|Sl.<br>No.|Import items||Qty.| ||<br>[2S,3S,5S]-5-t-<br>butyloxycarbonylamino-2-<br>Amino-3-hydroxy-1,6-<br>diphenylhexane<br>succinate(BDH<br>Succinic Acid RIT)||1 kg|1|1,2-dimethoxyethane(1,2-DME)||4.74 kg| |||||2|SODIUM BORO HYDRIDE||0.45 kg| |||||3|METHANE SULPHONIC ACID||1.50 kg| |||||4|ISOPROPYL ALCOHOL||2.90 kg| |||||5|TRIETHANOLAMINE||1.167 kg| |||||6|N,N-DIMETHYL ACETAMIDE||0.80 kg| |||||7|AMMONIUM FORMATE||0.500 kg| |||||8|POTTASIUM CARBONATE||0.40 kg| |||||9|Di-Tert-Butyl- Di- Carbonate||0.60 kg| |||||10|Methylene Dichloride(MDC)||1.34 kg| ||RA concerned maytake further necessaryaction as||||per above decision of NC.|||

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

27

78 <br>Case No.:18/13/82-ALC4/2018 Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00996/AM19/ RLA File<br>:09/24/040/00067/AM19/ Lic.No/Date:0910066242<br>18.05.2018
**Decision:**Deferred for comments of TE.

Deferred*| |---|---|---|---|---| ||<br>HQ File<br>:01/82/050/00996/AM19/|RLA File<br>:09/24/040/00067/AM19/|Lic.No/Date:0910066242<br>18.05.2018|| ||**Decision:**Deferred for comments of TE.||||

Case No.:168/12/82- Party Name:MANGALAM Meet No/Date:4/82- Status:
ALC4/2018 ORGANICS LIMITED ALC4/2020 Deferred
FORMERLY DUJODWALA 18.09.2020
PRODU
HQ File RLA File Lic.No/Date:0310821107
:01/82/050/00795/AM19/ :03/95/040/01140/AM18/ 21.05.2018

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm was asked to furnish following information asked for by NC-3 in its Meeting No. 8/82-ALC4/2019 dated 20.09.2019 , followed by Reminder on 31.10.2019 and Final Reminder on 79 13.02.2020 :

(i) Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction and % of yield at every stage.

However, the firm vide e-mail dated 23.09.2020 has stated that due to Covid - 19, staff of its Mumbai office is not regular. Hence it will not be able to submit the documents on time. Accordingly, the firm has requested to grant 30 days time for submission of information / documents.

The Committee considered the above request of firm and it was decided to grant 30 days time to firm to furnish its reply.

equested to grant 30 days time for submission of information / documents.

The Committee considered the above request of firm and it was decided to grant 30 days time to firm to furnish its reply.

80 Case No.:373/15/82-<br>ALC4/2018 Party Name:TADIMETY<br>AROMATICS PVT. LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01830/AM19/ RLA File<br>:07/24/040/00046/AM19/ Lic.No/Date:0710113330<br>25.05.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 16.11.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 16.11.2019 has furnished its reply. Deferred for comments of TE.

28

Case No.:39/13/82- Party Name:ORTIN Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0910066291
:01/82/050/01017/AM19/ :09/24/040/00082/AM19/ 01.06.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as 81 applied by firm whichever is lower:

a in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as 81 applied by firm whichever is lower:

Export Product<br>(3R,3aS,6aR)-Hexahydrofuro[2,3-b]furan-3-<br>ol(BIS-IV) Qty. Sl.<br>No. Import items Qty.
1 kg 1 2,3-dihydrofuran 1.05 kg
2 Sodium borohydride 0.72 kg
Case No.:376/15/82- Party Name:GRANULES Meet No/Date:4/82- Status: Rejected
ALC4/2018 INDIA LIMITED ALC4/2020
18.09.2020
HQ File RLA File Lic.No/Date:0910066295
:01/82/050/01833/AM19/ :09/24/040/00099/AM19/ 04.06.2018

82 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

83 Case No.:378/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD<br>RLA File<br>:05/23/040/00080/AM19/ Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01835/AM19/ Lic.No/Date:0510406733<br>05.06.2018
**Decision:**The Committee considered the case as per agenda and it was observed that the firm was issued<br>Show Cause Notice vide letter dated 10.10.2019.

o/Date:0510406733<br>05.06.2018|| ||**Decision:**The Committee considered the case as per agenda and it was observed that the firm was issued<br>Show Cause Notice vide letter dated 10.10.2019.||||

Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

84 Case No.:379/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD<br>RLA File<br>:05/23/040/00070/AM19/ Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01836/AM19/ Lic.No/Date:0510406734<br>05.06.2018
**Decision:**The Committee considered the case as per agenda and it was observed that the firm was issued<br>Show Cause Notice vide letter dated 10.10.2019.
85 Case No.:380/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD<br>RLA File<br>:05/23/040/00022/AM19/ Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01837/AM19/ Lic.No/Date:0510406736<br>05.06.2018
**Decision:**The Committee considered the case as per agenda and it was observed that the firm was issued<br>Show Cause Notice vide letter dated 10.10.2019.

29

Case No.:279/10/82- Party Name:J.B. CHEMICALS Meet No/Date:4/82- Status:
ALC4/2018 & PHARMACEUTICALS ALC4/2020 Approved
LIMITED 18.09.2020
HQ File RLA File Lic.No/Date:0310821556
:01/82/050/00566/AM19/ :03/94/040/00207/AM19/ 08.06.2018

| |ALC4/2018||& PHARMACEUTICALS||ALC4/2020||Approved| |||LIMITED||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0310821556||| |:01/82/050/00566/AM19/||:03/94/040/00207/AM19/||08.06.2018|||

Case No.:279/10/82-<br>ALC4/2018 Case No.:279/10/82-<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 <br>Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br>Lic.No/Date:0310821556<br>08.06.2018 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/00566/AM19/ RLA File<br>:03/94/040/00207/AM19/
86 **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:
Sl.<br>No, Export Product Qty. Sl.<br>No. Import items Qty.
1 Benzydamine Hydrochloride and<br>Cetylpyridinium Chloride Anti-<br>Inflammatory<br>and Antiseptic Lozenges Sugar<br>Free and all other flavours.

xport Product||Qty.|Sl.<br>No.|Import items||Qty.| ||1|Benzydamine Hydrochloride and<br>Cetylpyridinium Chloride Anti-<br>Inflammatory<br>and Antiseptic Lozenges Sugar<br>Free and all other flavours. Each<br>Lozenge contains (i) Benzydamine<br>Hydrochloride 3 mg (ii)<br>Cetylpyridinium Chloride 1.33 mg<br>(iii) Isomalt ST-M 2700.54 mg.<br>Net content (i) 49.394 Kgs (ii)<br>21.898 Kgs(iii)44463.116 Kgs.||1 Number<br>Lozenges|1|Benzydamine<br>Hydrochloride||3.06 mg| ||||||2|Cetylpyridinium Chloride||1.357 mg| ||||||3|Isomalt ST-M||2700.54 mg| ||2|Cetylpyridinium Chloride and<br>Bromhexine Hydrochloride<br>Antiseptic Lozenges Sugar Free<br>and all other flavours. Each<br>Lozenge contains (i)<br>Cetylpyridinium Chloride 1.33 mg<br>(ii) Isomalt ST-M - 2700.54 mg.<br>Net content (i) 7.299 Kgs (ii)<br>14821.039 Kgs.||1 Number<br>Lozenges|4|Cetylpyridinium Chloride||1.357 mg| ||||||5|Isomalt ST-M||2700.54 mg| ||3|Cetylpyridinium Chloride and<br>Benzydamine Hydrochloride<br>Antiseptic Lozenges Sugar Free.<br>Each Lozenge contains (i)<br>Cetylpyridinium Chloride 1 mg (ii)<br>Isomalt ST-M - 2700.54 mg. Net<br>Content (i) 7.299 Kgs (ii)<br>19711.998 Kgs.||1 Number<br>Lozenges|6|Cetylpyridinium Chloride||1.02 mg| ||||||7|Isomalt ST-M||2700.54 mg| ||4|Zecuf Herbal Cough Lozenges<br>Sugar Free<br>Each Lozenge contains Isomalt ST-<br>M - 2700.54 mg. Net content<br>5929.695 Kgs.||1 Number<br>Lozenges|8|Isomalt ST-M||2700.54 mg| ||RA concerned maytake further necessaryaction asper above decision of NC.||||||||

30

somalt ST-<br>M - 2700.54 mg. Net content<br>5929.695 Kgs.||1 Number<br>Lozenges|8|Isomalt ST-M||2700.54 mg| ||RA concerned maytake further necessaryaction asper above decision of NC.||||||||

30

Case No.:81/12/82- Party Name:KOPRAN Meet No/Date:4/82- Status:
ALC4/2018 RESEARCH ALC4/2020 Approved
LABORATORIES LTD. 18.09.2020
HQ File RLA File Lic.No/Date:0310821554
:01/82/050/00708/AM19/ :03/94/040/00194/AM19/ 08.06.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as 87 applied by firm whichever is lower:

Export Product<br>LYMECYCLINE Qty. Sl.<br>No. Import items Qty.
1 kg 1 TETRACYCLINE HYDROCHLORIDE 0.91 kg
2 L-LYSINE MONO HYDROCHLORIDE 0.33 kg
88 <br>Case No.:60/15/82-ALC4/2018 Party Name:ALPHAMED<br>FORMULATIONS P LTD. Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01517/AM19/ RLA File<br>:09/24/040/00075/AM19/ Lic.No/Date:0910066310<br>08.06.2018
**Decision:**Deferred for comments of TE.

Deferred*| |---|---|---|---|---| ||<br>HQ File<br>:01/82/050/01517/AM19/|RLA File<br>:09/24/040/00075/AM19/|Lic.No/Date:0910066310<br>08.06.2018|| ||**Decision:**Deferred for comments of TE.||||

89 Case No.:383/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01840/AM19/ RLA File<br>:05/23/040/00121/AM19/ Lic.No/Date:0510406800<br>08.06.2018
**Decision:**The Committee considered the case as per agenda and it was observed that the firm was issued<br>Show Cause Notice vide letter dated 10.10.2019.

Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

90 Case No.:385/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01842/AM19/ RLA File<br>:05/23/040/00501/AM18/ Lic.No/Date:0510406802<br>08.06.2018
**Decision:**The Committee considered the case as per agenda and it was observed that the firm was issued<br>Show Cause Notice vide letter dated 10.10.2019.

Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

31

vide letter dated 10.10.2019.||||

Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

31

Case No.:59/13/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status:
ALC4/2018 LIMITED ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0910066318
:01/82/050/01037/AM19/ :09/24/040/00106/AM19/ 11.06.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 91 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 13.02.2020 and Final Reminder on 06.08.2020 :

(i) Justification for low yield in the process alongwith documentary evidence. (ii) Complete set of 4.07 application.

Case No.:35/13/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status:
ALC4/2018 LIMITED ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0910066375
:01/82/050/01013/AM19/ :09/24/040/00136/AM19/ 22.06.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 92 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 13.02.2020 and Final Reminder on 06.08.2020 :

ished the information on following deficiencies raised by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 13.02.2020 and Final Reminder on 06.08.2020 :

(i) Justification for low yield in the process alongwith documentary evidence. (ii) Complete set of 4.07 application.

Case No.:71/13/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status:
ALC4/2018 LIMITED ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0910066374
:01/82/050/01049/AM19/ :09/24/040/00134/AM19/ 22.06.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 93 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 13.02.2020 and Final Reminder on 06.08.2020 :

(i) Justification for low yield in the process alongwith documentary evidence. (ii) Complete set of 4.07 application.

32

Case No.:76/13/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status:
ALC4/2018 LIMITED ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0910066376
:01/82/050/01054/AM19/ :09/24/040/00135/AM19/ 22.06.2018

-|---|---|---|---| |ALC4/2018||LIMITED||ALC4/2020||Rejected| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0910066376||| |:01/82/050/01054/AM19/||:09/24/040/00135/AM19/||22.06.2018|||

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 94 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 13.02.2020 and Final Reminder on 06.08.2020 :

(i) Justification for low yield in the process alongwith documentary evidence. (ii) Complete set of 4.07 application.

Case No.:274/10/82- Party Name:MELOG Meet No/Date:4/82- Status:
ALC4/2018 SPECIALITY CHEMICALS ALC4/2020 Approved
PVT. LTD. 18.09.2020
HQ File RLA File Lic.No/Date:0310821895
:01/82/050/00561/AM19/ :03/95/040/00235/AM19/ 25.06.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as 95 applied by firm whichever is lower:

Export Product Qty. Sl. Import items Qty.
No.
T-2003 (2,2-METHYLEBIS) (4,6- 1 kg 1 2,4-DI-TERTIARY BUTYLPHENOL 1.07 kg
DI-TERTIARY-BUTYLPHENOL)
RA concerned maytake further necessaryaction asper above decision of NC.

33

||| ||T-2003 (2,2-METHYLEBIS) (4,6-|1 kg|1|2,4-DI-TERTIARY BUTYLPHENOL|1.07 kg| ||DI-TERTIARY-BUTYLPHENOL)||||| |RA concerned maytake further necessaryaction asper above decision of NC.||||||

33

Case No.:185/13/82- Party Name:SPC LIFE Meet No/Date:4/82- Status:
ALC4/2018 SCIENCES PVT. LTD. ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:3410044282
:01/82/050/01163/AM19/ :34/24/040/00109/AM19/ 26.06.2018
Case No.:185/13/82-<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:4/82-<br>ALC4/2020<br>18.09.2020<br>Lic.No/Date:3410044282<br>26.06.2018 Status:<br>Approved
HQ File<br>:01/82/050/01163/AM19/ RLA File<br>:34/24/040/00109/AM19/
96 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.

||| |96|<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>2-N-BUTYL BENZOFURAN.<br>CLEAR LIQUID.<br>1 kg<br>1<br>METHYL-2-BROMO HEXANOATE.<br>CLEAR COLOURLESS LIQUID.<br>2.316 kg<br>2<br>SALICYLALDEHYDE<br>CLEAR COLOURLESS TO LIGHT<br>BROWN LIQUID.<br>1.35 kg<br>3<br>POTASSIUM CARBONATE.<br>WHITE CRYSTALLINE POWDER.<br>1.00 kg<br>4<br>DI METHYL FORMAMIDE.<br>CLEAR COLOURLESS LIQUID.<br>1.00 kg<br>5<br>TOLUNE.<br>CLEAR COLOURLESS LIQUID.<br>1.00 kg<br>RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl.<br>No.|Import items||Qty.| ||<br>2-N-BUTYL BENZOFURAN.<br>CLEAR LIQUID.||1 kg|1|METHYL-2-BROMO HEXANOATE.<br>CLEAR COLOURLESS LIQUID.||2.316 kg| |||||2|SALICYLALDEHYDE<br>CLEAR COLOURLESS TO LIGHT<br>BROWN LIQUID.||1.35 kg| |||||3|POTASSIUM CARBONATE.<br>WHITE CRYSTALLINE POWDER.||1.00 kg| |||||4|DI METHYL FORMAMIDE.<br>CLEAR COLOURLESS LIQUID.||1.00 kg| |||||5|TOLUNE.<br>CLEAR COLOURLESS LIQUID.||1.00 kg| ||RA concerned may take further necessary action as||||per above decision of NC.|||

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

enda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

Case No.:117/13/82- Party Name:ORTIN Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0910066395
:01/82/050/01095/AM19/ :09/24/040/00150/AM19/ 27.06.2018
Case No.:117/13/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Party Name:ORTIN<br>LABORATORIES LTD Party Name:ORTIN<br>LABORATORIES LTD Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br>Lic.No/Date:0910066395<br>27.06.2018 Status:<br>Approved
HQ File<br>:01/82/050/01095/AM19/ RLA File<br>:09/24/040/00150/AM19/
97 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.

||| |97|<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>[2S,3S,5S]-5-t-<br>butyloxycarbonylamino-2-<br>Amino-3-hydroxy-1,6-<br>diphenylhexane<br>succinate(BDH<br>Succinic Acid RIT)<br>1 kg<br>1<br>1,2-dimethoxyethane(1,2-DME)<br>4.74 kg<br>2<br>SODIUM BORO HYDRIDE<br>0.45 kg<br>3<br>METHANE SULPHONIC ACID<br>1.50 kg<br>4<br>TRIETHANOLAMINE<br>1.167 kg<br>5<br>Di-Tert-Butyl- Di- Carbonate<br>0.60 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.||||||| ||<br>Export Product||Qty.|Sl.<br>No.|Import items||Qty.| ||[2S,3S,5S]-5-t-<br>butyloxycarbonylamino-2-<br>Amino-3-hydroxy-1,6-<br>diphenylhexane<br>succinate(BDH<br>Succinic Acid RIT)||1 kg|1|1,2-dimethoxyethane(1,2-DME)||4.74 kg| |||||2|SODIUM BORO HYDRIDE||0.45 kg| |||||3|METHANE SULPHONIC ACID||1.50 kg| |||||4|TRIETHANOLAMINE||1.167 kg| |||||5|Di-Tert-Butyl- Di- Carbonate||0.60 kg| ||RA concerned maytake further necessaryaction as||||per above decision of NC.|||

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

34

in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

34

98 Case No.:12/15/82-ALC4/2018 Case No.:12/15/82-ALC4/2018 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
HQ File<br>:01/82/050/01469/AM19/ RLA File<br>:09/24/040/00113/AM19/ Lic.No/Date:0910066403<br>28.06.2018
**Decision:**Deferred for comments of TE.
99 Case No.:221/12/82-<br>ALC4/2018 Party Name:IOL<br>CHEMICALS AND<br>PHARMACEUTICALS<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
HQ File<br>:01/82/050/00848/AM19/ RLA File<br>:30/24/040/00017/AM19/ Lic.No/Date:3010104375<br>29.06.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 28.06.2019 has furnished its reply. Deferred for comments of TE.

e considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 28.06.2019 has furnished its reply. Deferred for comments of TE.|||||||

100 <br>Case No.:417/15/82-<br>ALC4/2018<br>Party Name:JODAS<br>EXPOIM PVT.LTD<br>Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br>Status: Deferred<br>HQ File<br>:01/82/050/01874/AM19/<br>RLA File<br>:05/23/040/00167/AM19/<br>Lic.No/Date:0510407069<br>04.07.2018<br>**Decision:**The Committee considered the case as per agenda and it was observed that the firm was issued<br>Show Cause Notice vide letter dated 10.10.2019. Party Name:JODAS<br>EXPOIM PVT.LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status: Deferred
RLA File<br>:05/23/040/00167/AM19/ Lic.No/Date:0510407069<br>04.07.2018

35

Case No.:418/15/82- Party Name:JODAS Meet No/Date:4/82- Status: Deferred ALC4/2018 EXPOIM PVT.LTD ALC4/2020 18.09.2020 101 HQ File RLA File Lic.No/Date:0510407077 :01/82/050/01875/AM19/ :05/23/040/00163/AM19/ 04.07.2018

Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

/AM19/ :05/23/040/00163/AM19/ 04.07.2018

Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

102 Case No.:419/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01876/AM19/ RLA File<br>:05/23/040/00164/AM19/ Lic.No/Date:0510407078<br>04.07.2018
**Decision:**The Committee considered the case as per agenda and it was observed that<br>issued Show Cause Notice vide letter dated 10.10.2019. the firm was

Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

103 <br>Case No.:389/15/82-<br>ALC4/2018 <br>Case No.:389/15/82-<br>ALC4/2018 Party Name:ATUL LIMITED, Party Name:ATUL LIMITED, Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01846/AM19/ RLA File<br>:08/24/040/00030/AM19/ Lic.No/Date:0810142955<br>04.07.2018
**Decision:**Deferred for comments of TE.
104 Case No.:617/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD <br>Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02074/AM19/ RLA File<br>:05/23/040/00166/AM19/ Lic.No/Date:0510407070<br>04.07.2018

||<br>Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020||Status:<br>Deferred|| ||<br>HQ File<br>:01/82/050/02074/AM19/|RLA File<br>:05/23/040/00166/AM19/||Lic.No/Date:0510407070<br>04.07.2018|||| ||**Decision:**The Committee considered the case as per agenda and it was observed<br>issued Show Cause Notice vide letter dated 10.10.2019.|||||that the firm was||

105 Case No.:96/12/82-<br>ALC4/2018 Party Name:STERLING<br>AUXILIARIES PVT LTD<br>RLA File<br>:03/95/040/00332/AM19/ Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00723/AM19/ Lic.No/Date:0310822247<br>11.07.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 31.10.2019 has furnished its reply. Deferred for comments of TE.

36

106 <br>Case No.:46/15/82-ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00181/AM19/ Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01503/AM19/ Lic.No/Date:0910066442<br>11.07.2018
**Decision:**Deferred for comments of TE.
Case No.:100/13/82- Party Name:RA CHEM Meet No/Date:4/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0910066457
:01/82/050/01078/AM19/ :09/24/040/00188/AM19/ 13.07.2018

--|---|---| |ALC4/2018||PHARMA LIMITED||ALC4/2020||Approved| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0910066457||| |:01/82/050/01078/AM19/||:09/24/040/00188/AM19/||13.07.2018|||

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or 107 as applied by firm whichever is lower:

Export Product Qty. Sl. Import items Qty.
No.
FENOFIBRIC ACID DR 200.000 kg 1 FENOFIBRATO DE COLINE 76.700 kg
PELLETS 29% (Choline Fenofibrate)
108 <br>Case No.:189/13/82-<br>ALC4/2018<br> <br> <br>HQ File<br>:01/82/050/01167/AM19/<br> <br>: Party Name:YASH<br>RASAYAN & CHEMICALS Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
RLA File<br>34/24/040/00114/AM19/ Lic.No/Date:3410044333<br>16.07.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 11.09.2020 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 11.09.2020 has furnished its reply. Deferred for comments of TE.

he Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 11.09.2020 has furnished its reply. Deferred for comments of TE.

109 Case No.:432/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD<br>RLA File<br>:05/23/040/00183/AM19/ Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01889/AM19/ Lic.No/Date:0510407217<br>17.07.2018
**Decision:**The Committee considered the case as per agenda and it was observed that the firm was issued<br>Show Cause Notice vide letter dated 10.10.2019.

37

Case No.:444/15/82- Party Name:OPTIMUS Meet No/Date:4/82- Status:
ALC4/2018 DRUGS PRIVATE LIMITED ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0910066488
:01/82/050/01901/AM19/ :09/24/040/00193/AM19/ 19.07.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020 , followed by Reminder on 18.03.2020 and Final Reminder on 06.08.2020 :

110

(i) Complete and balanced chemical reactions with % yield on molar basis for each step. (ii) Technical justification alongwith catalogue for LYOPHILIZED ENZYME POWDER. (iii) End-use of the export product.

e and balanced chemical reactions with % yield on molar basis for each step. (ii) Technical justification alongwith catalogue for LYOPHILIZED ENZYME POWDER. (iii) End-use of the export product.**

Case No.:448/15/82- Party Name:AUROBINDO Meet No/Date:4/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2020 Deferred
18.09.2020
HQ File RLA File Lic.No/Date:0910066511
:01/82/050/01905/AM19/ :09/24/040/00200/AM19/ 24.07.2018

111

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 11.09.2020 has furnished its reply.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 1/82-ALC4/2020 dated 17.04.2020 , followed by Reminder on 23.09.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

cy Circular No. 23/2015-20, dated 15.05.2019.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

112 Case No.:239/13/82-<br>ALC4/2018 Party Name:KEVA<br>FRAGRANCES PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01217/AM19/ RLA File<br>:03/94/040/00390/AM19/ Lic.No/Date:0310822723<br>31.07.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 21.09.2020 has furnished its reply.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 21.09.2020 has furnished its reply.

38

Case No.:460/15/82- Party Name:WINTAC Meet No/Date:4/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0710113686
:01/82/050/01917/AM19/ :07/24/040/00087/AM19/ 06.08.2018
  • 113 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

114 Case No.:172/13/82-<br>ALC4/2018 Party Name:TIDE<br>INDUSTRIES Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01150/AM19/ RLA File<br>:34/24/040/00094/AM19/ Lic.No/Date:3410044399<br>08.08.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 01.11.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 01.11.2019 has furnished its reply. Deferred for comments of TE.

Case No.:134/13/82- Party Name:YASHO Meet No/Date:4/82- Status:
ALC4/2018 INDUSTRIES LIMITED ALC4/2020 Deferred
18.09.2020
HQ File RLA File Lic.No/Date:0310822942
:01/82/050/01112/AM19/ :03/95/040/00445/AM19/ 09.08.2018

115 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was observed that the reply furnished by the firm vide letter dated 24.10.2019 was not proper.

In view of above, the Committee decided to call for following information from the firm:

(i) Chemical reaction with stoichiometric balance.

firm vide letter dated 24.10.2019 was not proper.

In view of above, the Committee decided to call for following information from the firm:

(i) Chemical reaction with stoichiometric balance.

116 Case No.:326/13/82-<br>ALC4/2018 Party Name:BALAJI<br>AMINES LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01304/AM19/ RLA File<br>:31/83/040/00082/AM19/ Lic.No/Date:3110067147<br>20.08.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 26.11.2019 has furnished its reply. Deferred for comments of TE.

39

Case No.:470/15/82- Party Name:JODAS EXPOIM Meet No/Date:4/82- Status: ALC4/2018 PVT.LTD ALC4/2020 Deferred 18.09.2020 117 HQ File RLA File Lic.No/Date:0510407550 :01/82/050/01927/AM19/ :05/23/040/00232/AM19/ 20.08.2018

Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

Case No.:471/15/82- Party Name:JODAS EXPOIM Meet No/Date:4/82- Status: ALC4/2018 PVT.LTD ALC4/2020 Deferred 18.09.2020 118 HQ File RLA File Lic.No/Date:0510407551 :01/82/050/01928/AM19/ :05/23/040/00231/AM19/ 20.08.2018

Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

/AM19/ :05/23/040/00231/AM19/ 20.08.2018

Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

Case No.:472/15/82- Party Name:WINTAC Meet No/Date:4/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0710113733
:01/82/050/01929/AM19/ :07/24/040/00131/AM19/ 20.08.2018

119 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

|120|Case No.:142/13/82-<br>ALC4/2018|Party Name:PALADIN<br>PAINTS AND CHEMICALS<br>PVT.

20** and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

120 Case No.:142/13/82-<br>ALC4/2018 Party Name:PALADIN<br>PAINTS AND CHEMICALS<br>PVT. LTD., Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Rejected
HQ File<br>:01/82/050/01120/AM19/ RLA File<br>:03/95/040/00456/AM19/ Lic.No/Date:0310823254<br>24.08.2018
<br>Decision:The Committee considered the case as per Agenda and it was noted that the firm still has not<br>furnished the information on following deficiencies raised by NC-3 in its Meeting No.9/82-ALC4/2019<br>dated 18.10.2019,followed by Reminder on09.12.2019and Final Reminder on18.03.2020:<br>(i)<br>Complete 4E with all technical details i.e chemistry, molecular weight,<br>stoichiometric reaction and % of yield on molar basis at every stage.<br>Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

40

Case No.:209/13/82- Party Name:DEEPAK Meet No/Date:4/82- Status:
ALC4/2018 NOVOCHEM ALC4/2020 Rejected
TECHNOLOGIES LTD 18.09.2020
HQ File RLA File Lic.No/Date:3110067162
:01/82/050/01187/AM19/ :31/83/040/00081/AM19/ 24.08.2018

| |ALC4/2018||NOVOCHEM||ALC4/2020||Rejected| |||TECHNOLOGIES LTD||18.09.2020||| |HQ File||RLA File||Lic.No/Date:3110067162||| |:01/82/050/01187/AM19/||:31/83/040/00081/AM19/||24.08.2018|||

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 9/82-ALC4/2019 121 dated 18.10.2019, followed by Reminder on 09.12.2019 and Final Reminder on 19.03.2020 :

(i) Catalogue of OCP. (ii) Certificate of Analysis (CoA) of OCP. (iii) Percentage yield on molar basis.

Case No.:475/15/82- Party Name:WINTAC Meet No/Date:4/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Rejected
18.09.2020
HQ File RLA File Lic.No/Date:0710113754
:01/82/050/01932/AM19/ :07/24/040/00098/AM19/ 24.08.2018

122 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 21.02.2020 and Final Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

123 Case No.:368/13/82-<br>ALC4/2018 Party Name:DANOPHARM<br>CHEMICALS PRIVATE LTD. Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01346/AM19/ RLA File<br>:03/94/040/00340/AM19/ Lic.No/Date:0310823354<br>28.08.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 28.11.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 28.11.2019 has furnished its reply. Deferred for comments of TE.

124 Case No.:369/13/82-<br>ALC4/2018 Party Name:DANOPHARM<br>CHEMICALS PRIVATE<br>LTD. Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01347/AM19/ RLA File<br>:03/94/040/00413/AM19/ Lic.No/Date:0310823358<br>28.08.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 28.11.2019 has furnished its reply. Deferred for comments of TE.

ttee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 28.11.2019 has furnished its reply. Deferred for comments of TE.||||

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 28.11.2019 has furnished its reply. Deferred for comments of TE.

41

Case No.:35/15/82- Party Name:AUROBINDO Meet No/Date:4/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0910066604
:01/82/050/01492/AM19/ :09/24/040/00249/AM19/ 29.08.2018
Case No.:35/15/82-<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:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/01492/AM19/ RLA File<br>:09/24/040/00249/AM19/ Lic.No/Date:0910066604<br>29.08.2018
125 **Decision:**The Committee considered case as<br>was decided to ratify the ad-hoc input output nor<br>as applied by firm whichever is lower: per agenda in the presence of the technical experts and it<br>ms under para 4.07 of HBP Vol.

case as<br>was decided to ratify the ad-hoc input output nor<br>as applied by firm whichever is lower:||||per agenda in the presence of the technical experts and it<br>ms under para 4.07 of HBP Vol. I as per details below or|||| ||Export Product||Qty.|Sl.<br>No.|Import items|||Qty.| ||ROSUVASTATIN CALCIUM||1 kg|1|Pyrimidine carboxaldehyde|||1.26 kg| |||||2|Activated Carbon(Carbon Enoanticromos)|||0.100 kg| |||||3|Diisopropyl Azodicarboxylate(DIAD)|||1.128 kg| |||||4|Isopropyl alcohol(IPA)|||2.15 kg| |||||5|Methanol(Methyl Alcohol)|||9.93 kg| |||||6|Methylene chloride(MDC)|||4.81 kg| |||||7|Potassium carbonate(Anhydrous)|||0.35 kg| |||||8|(4R-Cis)-6-[(Acetyloxy)Methyl]-2,2-<br>Dimethyl-1,3-Dioxane-4-Acetic Acid 1,1-<br>Dimethylethyl Ester|||1.53 kg| |||||9|Tetrahydrofuran(THF)|||11.80 kg| |||||10|Triphenylphosphine(TPP)|||1.464 kg| ||RA concerned may take further necessary|||action a|s per above decision of NC.||||

Case No.:492/15/82- Party Name:ORTIN Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0910066600
:01/82/050/01949/AM19/ :09/24/040/00245/AM19/ 29.08.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or 126 as applied by firm whichever is lower:

in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or 126 as applied by firm whichever is lower:

Export Product Qty. Sl.<br>No. Import items Qty.
(3R,3aS,6aR)-Hexahydrofuro[2,3-<br>b]furan-3-ol(BIS-IV) 1 kg 1 2,3-dihydrofuran 1.05 kg
2 Sodium borohydride 0.72 kg
127 Case No.:84/13/82-ALC4/2018 Party Name:SRINI<br>PHARMACEUTICALS<br>PRIVATE LIMITED<br>RLA File<br>:09/24/040/00251/AM19/ Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br> <br><br>Lic.No/Date:0910066620<br>03.09.2018 Status:<br>Deferred
HQ File<br>:01/82/050/01062/AM19/
**Decision:**Deferred for comments of TE.

42

128 <br>Case No.:502/15/82-<br>ALC4/2018 Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br>Lic.No/Date:0910066621<br>03.09.2018 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01959/AM19/ RLA File<br>:09/24/040/00260/AM19/
**Decision:**Deferred for comments of TE.
129 <br>Case No.:435/13/82-<br>ALC4/2018 Party Name:DCM SHRIRAM<br>INDUSTRIES LTD, Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br>Lic.No/Date:0510407689<br>05.09.2018 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01413/AM19/ RLA File<br>:05/23/040/00242/AM19/
**Decision:**Deferred for comments of TE.

0<br>Lic.No/Date:0510407689<br>05.09.2018|Status:<br>Deferred| ||<br>HQ File<br>:01/82/050/01413/AM19/|RLA File<br>:05/23/040/00242/AM19/||| ||**Decision:**Deferred for comments of TE.||||

130 Case No.:44/15/82-<br>ALC4/2018 Party Name:DISCOVERY<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01501/AM19/ RLA File<br>:09/24/040/00283/AM19/ Lic.No/Date:0910066631<br>06.09.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 23.09.2020 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 23.09.2020 has furnished its reply. Deferred for comments of TE.

Case No.:429/13/82- Party Name:CADILA Meet No/Date:4/82- Status:
ALC4/2018 HEALTHCARE LTD ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0810143413
:01/82/050/01407/AM19/ :08/24/040/00131/AM19/ 07.09.2018

--|---|---| |ALC4/2018||HEALTHCARE LTD||ALC4/2020||Approved| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0810143413||| |:01/82/050/01407/AM19/||:08/24/040/00131/AM19/||07.09.2018|||

Case No.:429/13/82-<br>ALC4/2018 Case No.:429/13/82-<br>ALC4/2018 Case No.:429/13/82-<br>ALC4/2018 Party Name:CADILA<br>HEALTHCARE LTD Party Name:CADILA<br>HEALTHCARE LTD Party Name:CADILA<br>HEALTHCARE LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br> <br><br>Lic.No/Date:0810143413<br>07.09.2018 Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br> <br><br>Lic.No/Date:0810143413<br>07.09.2018 Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br> <br><br>Lic.No/Date:0810143413<br>07.09.2018 Status:<br>Approved
HQ File<br>:01/82/050/01407/AM19/ RLA File<br>:08/24/040/00131/AM19/
131 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or<br>as applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.

to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or<br>as applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed in mg for 1 Number<br>Tablet<br>12.5mg<br>25.0mg<br>50.0mg<br>PROMETHAZINE<br>HYDROCHLORIDE<br>TABLETS USP 12.5<br>MG / 25 MG / 50<br>MG Tablet<br>1<br>Number<br>Tablet<br>1<br>PROMETHAZINE<br>HYDROCHLORIDE<br>USP<br>12.75<br>mg<br>25.50 mg<br>51.0 mg<br>2<br>HYDROXY<br>PROPYL<br>CELLULOSE (LOW<br>SUBSTITUT)<br>2.00 mg<br>4.00 mg<br>8.00 mg<br>3<br>HYDROXYPROPYL<br>CELLULOSE<br>NF<br>(KLUCEL LF)<br>4.00 mg<br>8.00 mg<br>16.00 mg<br>4<br>LACTOSE<br>MONOHYDRATE<br>NF/PH.EU<br>81.00<br>mg<br>162.00<br>mg<br>324.00<br>mg<br>5<br>MAGNESIUM<br>STEARATE<br>PH.E/NF/JP<br>0.50 mg<br>1.00 mg<br>2.00 mg<br>RA concerned maytake further necessaryaction asper above decision of NC.|||||||||| |||Export Product|Qty.||Sl.<br>No.|Import Items||Qty. allowed in mg for 1 Number<br>Tablet||| |||||||||12.5mg|25.0mg|50.0mg| |||PROMETHAZINE<br>HYDROCHLORIDE<br>TABLETS USP 12.5<br>MG / 25 MG / 50<br>MG Tablet|1<br>Number<br>Tablet||1|PROMETHAZINE<br>HYDROCHLORIDE<br>USP||12.75<br>mg|25.50 mg|51.0 mg| ||||||2|HYDROXY<br>PROPYL<br>CELLULOSE (LOW<br>SUBSTITUT)||2.00 mg|4.00 mg|8.00 mg| ||||||3|HYDROXYPROPYL<br>CELLULOSE<br>NF<br>(KLUCEL LF)||4.00 mg|8.00 mg|16.00 mg| ||||||4|LACTOSE<br>MONOHYDRATE<br>NF/PH.EU||81.00<br>mg|162.00<br>mg|324.00<br>mg| ||||||5|MAGNESIUM<br>STEARATE<br>PH.E/NF/JP||0.50 mg|1.00 mg|2.00 mg| ||||||||||||

43

4.00 mg|8.00 mg|16.00 mg| ||||||4|LACTOSE<br>MONOHYDRATE<br>NF/PH.EU||81.00<br>mg|162.00<br>mg|324.00<br>mg| ||||||5|MAGNESIUM<br>STEARATE<br>PH.E/NF/JP||0.50 mg|1.00 mg|2.00 mg| ||||||||||||

43

Case No.:40/15/82- Party Name:INCHEM Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES PRIVATE ALC4/2020 Approved
LIMITED 18.09.2020
HQ File RLA File Lic.No/Date:0910066657
:01/82/050/01497/AM19/ :09/24/040/00230/AM19/ 11.09.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or 132 as applied by firm whichever is lower:

Export Product Qty. Sl. Import items Qty.
No.
4 Amino 3,5 Di chloroalpha ( trimethyl 1 kg 1 4 – Nitroacetophenone 1.32 kg
)methyl amino ) methyl benzene methanol
hcl(Clenbuterol HCL)
Case No.:41/15/82- Party Name:INCHEM Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES PRIVATE ALC4/2020 Approved
LIMITED 18.09.2020
HQ File RLA File Lic.No/Date:0910066658
:01/82/050/01498/AM19/ :09/24/040/00261/AM19/ 11.09.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or 133 as applied by firm whichever is lower:

in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or 133 as applied by firm whichever is lower:

Export Product Export Product Qty. Sl. Import items Qty.
No.
4 Amino 3,5 Di chloroalpha ( trimethyl 1 kg 1 4-Amino aceto phenone 1.32 kg
)methyl amino <br>)<br>methyl benzene
methanol hcl(Clenbuterol HCL)
Case No.:17/7/82-ALC4/2019 Party Name:GLOBAL Meet No/Date:4/82- Status:
CALCIUM PRIVATE ALC4/2020 Deferred
LIMITED 18.09.2020
134 HQ File RLA File Lic.No/Date:0710113843
:01/82/050/00512/AM20/ :07/24/040/00144/AM19/ 12.09.2018
**Decision:**Deferred for comments of TE.
Case No.:400/13/82- Party Name:J.B. Meet No/Date:4/82- Status:
ALC4/2018 CHEMICALS & ALC4/2020 Deferred
PHARMACEUTICALS 18.09.2020
135 LIMITED
HQ File RLA File Lic.No/Date:0310823779
:01/82/050/01378/AM19/ :03/94/040/00504/AM19/ 17.09.2018
**Decision:**Deferred for comments of TE.

44

136 <br>Case No.:519/15/82-<br>ALC4/2018<br>Party Name:SUVEN LIFE<br>SCIENCES LIMITED<br>HQ File<br>:01/82/050/01976/AM19/<br>RLA File<br>:09/24/040/00288/AM19/<br>**Decision:**Deferred for comments of TE. Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br>Lic.No/Date:0910066679<br>18.09.2018 Status:<br>Deferred<br>

40/00288/AM19/<br>**Decision:**Deferred for comments of TE.|Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br>Lic.No/Date:0910066679<br>18.09.2018|Status:<br>Deferred<br>| |---|---|---|---|

Case No.:525/15/82- Party Name:SHILPA Meet No/Date:4/82- Status:
ALC4/2018 MEDICARE LIMITED ALC4/2020 Deferred
18.09.2020
HQ File RLA File Lic.No/Date:0710113890
:01/82/050/01982/AM19/ :07/24/040/00164/AM19/ 25.09.2018

137 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 1/82-ALC4/2020 dated 17.04.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

138 Case No.:176/13/82-<br>ALC4/2018 Party Name:VOVANTIS<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01154/AM19/ RLA File<br>:34/24/040/00145/AM19/ Lic.No/Date:3410044518<br>26.09.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 03.04.2020 has furnished its reply. Deferred for comments of TE.

ttee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 03.04.2020 has furnished its reply. Deferred for comments of TE.||||

139 Case No.:213/13/82-<br>ALC4/2018 Party Name:DEEPAK<br>NOVOCHEM<br>TECHNOLOGIES LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Rejected
HQ File<br>:01/82/050/01191/AM19/ RLA File<br>:31/83/040/00094/AM19/ Lic.No/Date:3110067177<br>26.09.2018
<br>Decision:The Committee considered the case as per Agenda and it was noted that the firm still has not<br>furnished the information on following deficiencies raised by NC-3 in its Meeting No.9/82-ALC4/2019<br>dated 18.10.2019,followed by Reminder on09.12.2019and Final Reminder on19.03.2020:<br>(i)<br>Exact chemical name of the export product<br>Hence, the Committee decided torejectthe case.<br>RA concerned maytake further necessaryaction asper above decision of NC.

45

140 <br>Case No.:534/15/82-<br>ALC4/2018 Party Name:YASH RASAYAN<br>& CHEMICALS<br>RLA File<br>:34/24/040/00184/AM19/ <br>Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br>Lic.No/Date:3410044523<br>26.09.2018 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01991/AM19/
**Decision:**Deferred for comments of TE.

br>18.09.2020<br>Lic.No/Date:3410044523<br>26.09.2018|Status:<br>Deferred| |---|---|---|---|---| ||<br>HQ File<br>:01/82/050/01991/AM19/|||| ||**Decision:**Deferred for comments of TE.||||

141 <br>Case No.:536/15/82-<br>ALC4/2018 Party Name:YASH RASAYAN<br>& CHEMICALS Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<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:**Deferred for comments of TE.
142 <br>Case No.:112/13/82-<br>ALC4/2018 Party Name:VARAHI<br>PHARMA PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01090/AM19/ RLA File<br>:66/24/040/00004/AM19/ Lic.No/Date:6610000013<br>03.10.2018
**Decision:**Deferred for comments of TE.
143 Case No.:612/15/82-<br>ALC4/2018 Party Name:MANGALAM<br>ORGANICS LIMITED<br>(FORMERLY DUJODWALA Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02069/AM19/ RLA File<br>:03/95/040/00560/AM19/ Lic.No/Date:0310824148<br>03.10.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 04.11.2019 has furnished its reply. Deferred for comments of TE.

46

considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 04.11.2019 has furnished its reply. Deferred for comments of TE.||||

46

Case No.:52/13/82- Party Name:S V LABS PVT Meet No/Date:4/82- Status:
ALC4/2018 LTD ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0910066711
:01/82/050/01030/AM19/ :09/24/040/00301/AM19/ 04.10.2018
Case No.:52/13/82-<br>ALC4/2018 Case No.:52/13/82-<br>ALC4/2018 Party Name:S V LABS PVT<br>LTD Party Name:S V LABS PVT<br>LTD Party Name:S V LABS PVT<br>LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Approved<br> Status:<br>Approved<br>
HQ File<br>:01/82/050/01030/AM19/ RLA File<br>:09/24/040/00301/AM19/ Lic.No/Date:0910066711<br>04.10.2018
144 **Decision:**The Committee considered case<br>was decided to ratify the ad-hoc input output<br>as applied by firm whichever is lower: as per agenda in the presence of the technical experts and it<br>norms under para 4.07 of HBP Vol. I as per details below or
Export Product Qty. Sl.<br>No. Import items Qty.
FCE (SA) 1 kg 1 5- Flouro Cytosine 0.44 kg
2 Glyoxyllic acid(50 %) 0.62 kg
3 2,5-DIHYDROXY-1,4 DITHANE(DIOL) 0.28 kg
4 HEXAMETHYL DISILAZANE(HMDS) 0.29 kg
5 Triphosgene 0.40 kg
6 Methylene Dichloride(MDC) 3.00 kg
RA concerned may take further necessary action as per above decision of NC.

HEXAMETHYL DISILAZANE(HMDS)|||0.29 kg| |||||5|Triphosgene|||0.40 kg| |||||6|Methylene Dichloride(MDC)|||3.00 kg| ||RA concerned may take further necessary action as per above decision of NC.||||||||

Case No.:562/15/82- Party Name:ORTIN Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0910066712
:01/82/050/02019/AM19/ :09/24/040/00302/AM19/ 04.10.2018
Case No.:562/15/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Party Name:ORTIN<br>LABORATORIES LTD Party Name:ORTIN<br>LABORATORIES LTD Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Approved
HQ File<br>:01/82/050/02019/AM19/ RLA File<br>:09/24/040/00302/AM19/ Lic.No/Date:0910066712<br>04.10.2018
145 **Decision:**The Committee considered case as per agenda in<br>was decided to ratify the ad-hoc input output norms under para<br>as applied by firm whichever is lower:
Export Product Qty. Sl.<br>No. Import items Qty.
2S,3S,5S)-2-AMINO-3-<br>HYDROXY-5-(1-TETRA-<br>HYDRO PYRIMID-2-ONLY)-<br>3-METHYL<br>BUTANOYL)<br>AMINO-1,6-DIPHENYL<br>HEXANE-S-PYRO<br>GLUTAMATE(THP) 1 kg 1 L-PHENYLALANINE 0.473 kg
2 1,2 DIMETHOXYETHANE 6.74 kg
3 SODIUM BORO HYDRIDE 0.406 kg
4 METHANE SULPHONIC ACID 1.57 kg
5 L- VALINE 0.630 kg
6 N,N- CARBONYL DIMIDAZOLE 0.443 kg
7 L-PYROGLUTAMIC ACID 0.295 kg

and all technical details starting from OCP**<br>50.<br>Hence, the Committee decided torejectthe case.<br>RA concerned maytake further necessaryaction asper above decision of NC.||||

53

169 <br>Case No.:183/13/82-<br>ALC4/2018 Party Name:PHAROSE<br>REMEDIES LTD.<br>RLA File<br>:30/24/040/00032/AM19/ Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br>Lic.No/Date:3010104485<br>31.10.2018 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01161/AM19/
**Decision:**Deferred for comments of TE.
Case No.:614/15/82- Party Name:SUVEN LIFE Meet No/Date:4/82- Status:
ALC4/2018 SCIENCES LIMITED ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0910066814
:01/82/050/02071/AM19/ :09/24/040/00360/AM19/ 08.11.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it 170 was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

Export Product<br>2-CHLORO-5-IODOBENZOIC ACID Qty. Sl.<br>No. Import items Qty.
1 kg 1 ETHYL ANTHRANILATE 0.764 kg

ils below or as applied by firm whichever is lower:

Export Product<br>2-CHLORO-5-IODOBENZOIC ACID Qty. Sl.<br>No. Import items Qty.
1 kg 1 ETHYL ANTHRANILATE 0.764 kg
171 <br>Case No.:111/15/82-<br>ALC4/2018 Party Name:PUNJAB<br>CHEMICALS AND CROP<br>PROTECTION LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br>Lic.No/Date:0310824946<br>12.11.2018 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01568/AM19/ RLA File<br>:03/95/040/00709/AM19/
**Decision:**Deferred for comments of TE.

54

Case No.:616/15/82- Party Name:VIVIMED LIFE Meet No/Date:4/82- Status:
ALC4/2018 SCIENCES PRIVATE ALC4/2020 Approved
LIMITED 18.09.2020
HQ File RLA File Lic.No/Date:0910066821
:01/82/050/02073/AM19/ :09/24/040/00387/AM19/ 12.11.2018
Case No.:616/15/82-<br>ALC4/2018 Party Name:VIVIMED LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Approved
HQ File<br>:01/82/050/02073/AM19/ RLA File<br>:09/24/040/00387/AM19/ Lic.No/Date:0910066821<br>12.11.2018
172 **Decision:**The Committee considered the case as per agenda in the presence of Technical Experts in<br>light<br>of<br>the<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>3/82-ALC4/2020<br>, dated 07.08.2020 for advance authorization No. 0910067741 dated 03.07.2019, it was decided to ratify<br>the ad-hoc input output norms under para 4.07 of HBP Vol.

Meeting<br>No.<br>3/82-ALC4/2020<br>, dated 07.08.2020 for advance authorization No. 0910067741 dated 03.07.2019, it was decided to ratify<br>the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm<br>whichever is lower:<br>Sl.<br>No<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>Amlodipine Besylate Tablets<br>USP - 2.5Mg - 500 s<br>75000000<br>Number<br>1<br>Amlodipine<br>Besylate<br>260.25 kg<br>2<br>Anhydrous<br>dibasic<br>calcium Phospahte (A-<br>TAB)<br>900.00 kg<br>3<br>Microcrystalline<br>Cellulose<br>6002.25 kg<br>4<br>Sodium Starch Glycolate<br>150.00 kg<br>5<br>Colloidal<br>Silicon<br>Dioxide(Aerosil 200)<br>37.50 kg<br>6<br>Stearic Acid (Hystrene<br>5016 FG)<br>112.50 kg<br>7<br>Magnesium Stearate<br>37.50 kg<br>2<br>Amlodipine Besylate Tablets<br>USP - 5 Mg - 1000 s<br>180000000<br>Number<br>1<br>Amlodipine Besylate<br>1167.54 kg<br>2<br>Anhydrous<br>dibasic<br>calcium Phospahte (A-<br>TAB)<br>4039.20 kg<br>3<br>Microcrystalline<br>Cellulose<br>26938.56 kg<br>4<br>Sodium Starch Glycolate<br>673.20 kg<br>5<br>Colloidal<br>Silicon<br>Dioxide(Aerosil 200)<br>168.30 kg<br>6<br>Stearic Acid (Hystrene<br>5016 FG)<br>504.90 kg<br>7<br>Magnesium Stearate<br>168.30 kg<br>3<br>Amlodipine Besylate Tablets<br>USP - 10Mg - 1000 s<br>135000000<br>Number<br>1<br>Amlodipine<br>Besylate<br>1167.54 kg<br>2<br>Anhydrous<br>dibasic<br>calcium Phospahte (A-<br>TAB)<br>4039.20 kg<br>3<br>Microcrystalline<br>Cellulose<br>26938.56 kg<br>4<br>Sodium Starch Glycolate<br>673.20 kg<br>5<br>Colloidal<br>Silicon<br>Dioxi

ydrous<br>dibasic<br>calcium Phospahte (A-<br>TAB)<br>4039.20 kg<br>3<br>Microcrystalline<br>Cellulose<br>26938.56 kg<br>4<br>Sodium Starch Glycolate<br>673.20 kg<br>5<br>Colloidal<br>Silicon<br>Dioxide(Aerosil 200)<br>168.30 kg<br>6<br>Stearic Acid (Hystrene<br>5016 FG)<br>504.90 kg<br>7<br>Magnesium Stearate<br>168.30 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 in light of the earlier decision taken by NC in its Meeting No. 3/82-ALC4/2020 , dated 07.08.2020 for advance authorization No. 0910067741 dated 03.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

55

173 Case No.:87/15/82-ALC4/2018 Party Name:DEEPAK<br>NITRITE LIMITED Meet No/Date:4/82-<br>ALC4/2020 Status:<br>Deferred
<br>HQ File 18.09.2020
RLA File Lic.No/Date:3410044685
:01/82/050/01544/AM19/<br>:34/24/040/00267/AM19/<br>13.11.2018<br>**Decision:**The Committee considered the case as per agenda in the presence of technical<br> :34/24/040/00267/AM19/ 13.11.2018
experts and it<br>
was noted that the firm vide e-mail dated 03.09.2020 has furnished its reply. Deferred for comments of TE.

sence of technical<br>|:34/24/040/00267/AM19/|13.11.2018|| |||||experts and it<br>| ||was noted that the firm vide e-mail dated 03.09.2020 has furnished its reply. Deferred for comments of TE.||||

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 03.09.2020 has furnished its reply. Deferred for comments of TE.

Case No.:623/15/82- Party Name:VINS Meet No/Date:4/82- Status:
ALC4/2018 BIOPRODUCTS LTD` ALC4/2020 Deferred
18.09.2020
HQ File RLA File Lic.No/Date:0910066851
174 :01/82/050/02080/AM19/ :09/24/040/00363/AM19/ 14.11.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it
was noted that the firm vide e-mail dated 26.03.2020 has furnished its reply. It was decided to forward a
copy of 4.07 application alongwith a copy of reply received from firm to Department of Biotechnology for
obtainingtheir comments.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 26.03.2020 has furnished its reply. It was decided to forward a copy of 4.07 application alongwith a copy of reply received from firm to Department of Biotechnology for obtaining their comments.

ed 26.03.2020 has furnished its reply. It was decided to forward a copy of 4.07 application alongwith a copy of reply received from firm to Department of Biotechnology for obtaining their comments.

Case No.:627/15/82- Party Name:AUROBINDO Meet No/Date:4/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2020 Deferred
18.09.2020
175 HQ File RLA File Lic.No/Date:0910066853
:01/82/050/02084/AM19/ :09/24/040/00382/AM19/ 15.11.2018
**Decision:**Deferred for comments of TE.
Case No.:630/15/82- Party Name:VIVIN DRUGS & Meet No/Date:4/82- Status:
ALC4/2018 PHARMACEUTICALS ALC4/2020 Deferred
LIMITED 18.09.2020
176 HQ File RLA File Lic.No/Date:0910066856
:01/82/050/02087/AM19/ :09/24/040/00391/AM19/ 15.11.2018
**Decision:**Deferred for comments of TE.
177 <br>Case No.:2/15/82-ALC4/2018 <br>HQ File Party Name:DEEPAK<br>NITRITE LIMITED Meet No/Date:4/82-<br>ALC4/2020 Status:<br>Deferred
<br>18.09.2020
RLA File LicNo/Date:3410044710
<br> <br>:01/82/050/01459/AM19/<br> <br>:34/24/040/00254/AM19/<br>.<br>20.11.2018<br>**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 13.08.2020 has furnished its reply. Deferred for comments of TE. <br>:34/24/040/00254/AM19/ .<br>20.11.2018

56

e of technical experts and it<br>was noted that the firm vide e-mail dated 13.08.2020 has furnished its reply. Deferred for comments of TE.|<br>:34/24/040/00254/AM19/|.<br>20.11.2018|| ||||||

56

178 Case No.:85/15/82-ALC4/2018 Party Name:DEEPAK<br>NITRITE LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 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
**Decision:**The Committee considered the case as per agenda i<br> n the presence of technical<br> experts and it<br>
was noted that the firm vide e-mail dated 13.08.2020 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 13.08.2020 has furnished its reply. Deferred for comments of TE.

Case No.:86/15/82-ALC4/2018Party Name:DEEPAK Meet No/Date:4/82- Status:
NITRITE LIMITED ALC4/2020 Deferred
18.09.2020
179 HQ File<br>RLA File Lic.No/Date:3410044712
:01/82/050/01543/AM19/<br>:34/24/040/00256/AM19/ 20.11.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it
was noted that the firm vide e-mail dated 13.08.2020 has furnished its reply. Deferred for comments of TE.

considered the case as per agenda in the presence of technical|||experts and it|| |||was noted that the firm vide e-mail dated 13.08.2020 has furnished its reply. Deferred for comments of TE.|||||

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 13.08.2020 has furnished its reply. Deferred for comments of TE.

Case No.:638/15/82- Party Name:AUROBINDO Meet No/Date:4/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2020 Deferred
18.09.2020
180 HQ File RLA File Lic.No/Date:0910066874
:01/82/050/02095/AM19/ :09/24/040/00386/AM19/ 20.11.2018
**Decision:**Deferred for comments of TE.
Case No.:639/15/82- Party Name:CADILA Meet No/Date:4/82- Status:
ALC4/2018 HEALTHCARE LTD ALC4/2020 Deferred
18.09.2020
181 HQ File RLA File Lic.No/Date:0810143923
:01/82/050/02096/AM19/ :08/24/040/00187/AM19/ 20.11.2018
**Decision:**Deferred for comments of TE.

rred**| |||||||18.09.2020||| |181||HQ File||RLA File||Lic.No/Date:0810143923||| |||:01/82/050/02096/AM19/||:08/24/040/00187/AM19/||20.11.2018||| |||**Decision:**Deferred for comments of TE.|||||||

Case No.:463/13/82- Party Name:INDIA GLYCOLS Meet No/Date:4/82- Status:
ALC4/2018 LTD., ALC4/2020 Deferred
18.09.2020
182 HQ File RLA File Lic.No/Date:0510408634
:01/82/050/01441/AM19/ :05/23/040/00359/AM19/ 26.11.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it
was noted that the firm vide letter dated 28.09.2020 has furnished its reply. Deferred for comments of TE.

57

183 <br>Case No.:649/15/82-<br>ALC4/2018 Party Name:GLOBE<br>TROTTERS PVT LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 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
**Decision:**Deferred for comments of TE.
184 <br>Case No.:659/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02116/AM19/ RLA File<br>:09/24/040/00410/AM19/ Lic.No/Date:0910066905<br>28.11.2018
**Decision:**Deferred for comments of TE.

Deferred*| |---|---|---|---|---| ||<br>HQ File<br>:01/82/050/02116/AM19/|RLA File<br>:09/24/040/00410/AM19/|Lic.No/Date:0910066905<br>28.11.2018|| ||**Decision:**Deferred for comments of TE.||||

185 <br>Case No.:664/15/82-<br>ALC4/2018<br>Party<br>Name:SMILAX LABORATORI<br>ES LIMITED<br>HQ File<br>:01/82/050/02121/AM19/<br>RLA File<br>:09/24/040/00358/AM19/<br>**Decision:**Deferred for comments of TE. Party<br>Name:SMILAX LABORATORI<br>ES LIMITED Party<br>Name:SMILAX LABORATORI<br>ES LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred Status:<br>Deferred
RLA File<br>:09/24/040/00358/AM19/ Lic.No/Date:0910066915<br>28.11.2018
186 Case No.:669/15/82-<br>ALC4/2018 Party Name:VERVE HUMAN<br>CARE LABORATORIES Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02126/AM19/ RLA File<br>:61/24/040/00012/AM19/ Lic.No/Date:6110001560<br>28.11.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 09.08.2019 has furnished its reply. Deferred for comments of TE.

e considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 09.08.2019 has furnished its reply. Deferred for comments of TE.|||||||

187 <br>Case No.:670/15/82-<br>ALC4/2018 Party Name:VERVE HUMAN<br>CARE LABORATORIES Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02127/AM19/ RLA File<br>:61/24/040/00013/AM19/ Lic.No/Date:6110001561<br>28.11.2018
**Decision:**Deferred for comments of TE.
188 <br>Case No.:671/15/82-<br>ALC4/2018 Party Name:VERVE HUMAN<br>CARE LABORATORIES Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 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
**Decision:**Deferred for comments of TE.

58

189 <br>Case No.:672/15/82-<br>ALC4/2018 Party Name:VERVE HUMAN<br>CARE LABORATORIES Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 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
**Decision:**Deferred for comments of TE.

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|| ||**Decision:**Deferred for comments of TE.||||

190 <br>Case No.:673/15/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/02130/AM19/ Party Name:VERVE HUMAN<br>CARE LABORATORIES<br> <br> <br> <br>RLA File<br>:61/24/040/00018/AM19/<br> <br> Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
Lic.No/Date:6110001564<br>28.11.2018
**Decision:**Deferred for comments of TE.
191 <br>Case No.:674/15/82-<br>ALC4/2018 Party Name:VERVE HUMAN<br>CARE LABORATORIES Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 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
**Decision:**Deferred for comments of TE.
192 <br>Case No.:675/15/82-<br>ALC4/2018 Party Name:VERVE HUMAN<br>CARE LABORATORIES Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 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
**Decision:**Deferred for comments of TE.

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|| ||**Decision:**Deferred for comments of TE.||||

193 <br>Case No.:668/15/82-<br>ALC4/2018 Party Name:CADILA<br>HEALTHCARE LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>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.
194 <br>Case No.:689/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>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.

59

195 <br>Case No.:684/15/82-<br>ALC4/2018 Party Name:GLAND<br>PHARMA LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02141/AM19/ RLA File<br>:09/24/040/00419/AM19/ Lic.No/Date:0910066930<br>03.12.2018
**Decision:**Deferred for comments of TE.
196 <br>Case No.:685/15/82-<br>ALC4/2018 Party Name:GLAND<br>PHARMA LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02142/AM19/ RLA File<br>:09/24/040/00420/AM19/ Lic.No/Date:0910066931<br>03.12.2018
**Decision:**Deferred for comments of TE.

Deferred*| |---|---|---|---|---| ||<br>HQ File<br>:01/82/050/02142/AM19/|RLA File<br>:09/24/040/00420/AM19/|Lic.No/Date:0910066931<br>03.12.2018|| ||**Decision:**Deferred for comments of TE.||||

197 Case No.:688/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD<br>RLA File<br>:05/23/040/00385/AM19/ Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br>Lic.No/Date:0510408748<br>04.12.2018 Status:<br>Deferred<br>
<br>HQ File<br>:01/82/050/02145/AM19/
**Decision:**The Committee considered the case as per agenda and it was observed tha<br>issued Show Cause Notice vide letter dated 10.10.2019. t the firm was

Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

198 <br>Case No.:103/15/82-<br>ALC4/2018 Party Name:STERLING<br>AUXILIARIES PVT LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<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
**Decision:**Deferred for comments of TE.
Case No.:692/15/82- Party Name:ORTIN Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0910066938
:01/82/050/02149/AM19/ :09/24/040/00424/AM19/ 05.12.2018

|---|---| |ALC4/2018||LABORATORIES LTD||ALC4/2020||Approved| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0910066938||| |:01/82/050/02149/AM19/||:09/24/040/00424/AM19/||05.12.2018|||

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or 199 as applied by firm whichever is lower:

Export Product<br>(3R,3aS,6aR)-Hexahydrofuro[2,3-<br>b]furan-3-ol(BIS-IV) Qty. Sl.<br>No. Import items<br> Qty.
1 kg 1 2,3-dihydrofuran<br> 1.05 kg
2 Sodium borohydride<br> 0.72 kg

60

200 Case No.:696/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00436/AM19/ Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br> <br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/02153/AM19/ Lic.No/Date:0910066944<br>05.12.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 19.10.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 19.10.2019 has furnished its reply. Deferred for comments of TE.

he Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 19.10.2019 has furnished its reply. Deferred for comments of TE.

Case No.:773/15/82- Party Name:LUPIN LIMITED Meet No/Date:4/82- Status:
ALC4/2018 ALC4/2020 Deferred
18.09.2020
HQ File RLA File Lic.No/Date:0310825460
:01/82/050/02230/AM19/ :03/95/040/00902/AM19/ 05.12.2018

201 Decision: The firm vide e-mail dated 07.08.2020 has informed that its application for subject Advance Authorization falls under under para 4.18 of HBP Vol. I (Non-Infringing Process) and hence they should be exempted from approval of NC.

The Committee considered the request of firm and it was decided to verify the same from RLA, Mumbai.

202 <br>Case No.:466/13/82-<br>ALC4/2018 Party Name:DCM SHRIRAM<br>INDUSTRIES LTD, Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01444/AM19/ RLA File<br>:05/23/040/00376/AM19/ Lic.No/Date:0510408809<br>06.12.2018
**Decision:**Deferred for comments of TE.
203 <br>Case No.:698/15/82-<br>ALC4/2018 Party Name:VISION DRUGS<br>PVT LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 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
**Decision:**Deferred for comments of TE.

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|| ||**Decision:**Deferred for comments of TE.||||

204 Case No.:700/15/82-<br>ALC4/2018 Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED<br>RLA File<br>:03/94/040/00748/AM19/ Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br>Lic.No/Date:0310825472<br>06.12.2018 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02157/AM19/
Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to call for following information from the firm:<br>(i)<br>Copy of DML for both export items.

61

205 Case No.:185/15/82-<br>ALC4/2018 Party Name:YASHO<br>INDUSTRIES LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01642/AM19/ RLA File<br>:03/95/040/00925/AM19/ Lic.No/Date:0310825514<br>07.12.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 24.10.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 24.10.2019 has furnished its reply. Deferred for comments of TE.

he Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 24.10.2019 has furnished its reply. Deferred for comments of TE.

206 <br>Case No.:88/15/82-<br>ALC4/2018 Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED<br>RLA File<br>:03/94/040/00774/AM19/ Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br> <br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/01545/AM19/ Lic.No/Date:0310825559<br>10.12.2018
**Decision:**Deferred for comments of TE.
207 <br>Case No.:715/15/82-<br>ALC4/2018 Party Name:MALLADI<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 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
**Decision:**Deferred for comments of TE.
208 <br>Case No.:139/15/82-<br>ALC4/2018 Party Name:RUBICON<br>RESEARCH PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01596/AM19/ RLA File<br>:03/95/040/00889/AM19/ Lic.No/Date:0310825587<br>11.12.2018
**Decision:**Deferred for comments of TE.

.2020|Status:<br>Deferred| ||<br>HQ File<br>:01/82/050/01596/AM19/|RLA File<br>:03/95/040/00889/AM19/|Lic.No/Date:0310825587<br>11.12.2018|| ||**Decision:**Deferred for comments of TE.||||

209 <br>Case No.:711/15/82-<br>ALC4/2018 Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>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.

62

210 Case No.:106/15/82-<br>ALC4/2018 Party Name:SONGWON<br>SPECIALTY CHEMICALS<br>INDIA PVT. LTD. Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01563/AM19/ 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 noted that the firm vide e-mail dated 02.03.2020 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 02.03.2020 has furnished its reply. Deferred for comments of TE.

he Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 02.03.2020 has furnished its reply. Deferred for comments of TE.

211 <br>Case No.:721/15/82-<br>ALC4/2018 Party Name:VERVE HUMAN<br>CARE LABORATORIES Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 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
**Decision:**Deferred for comments of TE.
212 <br>Case No.:726/15/82-<br>ALC4/2018 Party Name:NATCO<br>PHARMA LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 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
**Decision:**Deferred for comments of TE.
213 <br>Case No.:727/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status: 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
**Decision:**Deferred for comments of TE.

63

Case No.:735/15/82- Party Name:CIPLA LIMITED. Meet No/Date:4/82- Status:
ALC4/2018 ALC4/2020 Deferred
18.09.2020
HQ File RLA File Lic.No/Date:0310825758
:01/82/050/02192/AM19/ :03/94/040/00753/AM19/ 18.12.2018
**Decision:**Deferred for comments of TE.

020||Deferred| |||||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0310825758||| |:01/82/050/02192/AM19/||:03/94/040/00753/AM19/||18.12.2018||| |**Decision:**Deferred for comments of TE.|||||||

Case No.:736/15/82- Party Name:AMI ORGANICS Meet No/Date:4/82- Status:
ALC4/2018 LIMITED ALC4/2020 Deferred
18.09.2020
215 HQ File RLA File Lic.No/Date:5210042870
:01/82/050/02193/AM19/ :52/24/040/00068/AM19/ 18.12.2018
**Decision:**Deferred for comments of TE.
Case No.:99/15/82-ALC4/2018 Party Name:SUN Meet No/Date:4/82- Status:
PHARMACEUTICAL ALC4/2020 Deferred
INDUSTRIES LTD. 18.09.2020
216 HQ File RLA File Lic.No/Date:0510408988
:01/82/050/01556/AM19/ :05/24/040/00503/AM19/ 19.12.2018
**Decision:**Deferred for comments of TE.
Case No.:738/15/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status:
ALC4/2018 LIMITED ALC4/2020 Deferred
18.09.2020
217 HQ File RLA File Lic.No/Date:0910066983
:01/82/050/02195/AM19/ :09/24/040/00460/AM19/ 19.12.2018
**Decision:**Deferred for comments of TE.

rred**| |||||||18.09.2020||| |217||HQ File||RLA File||Lic.No/Date:0910066983||| |||:01/82/050/02195/AM19/||:09/24/040/00460/AM19/||19.12.2018||| |||**Decision:**Deferred for comments of TE.|||||||

Case No.:1025/15/82- Party Name:ANLON Meet No/Date:4/82- Status:
ALC4/2018 HEALTHCARE ALC4/2020 Deferred
PRIVATELIMITED 18.09.2020
HQ File RLA File Lic.No/Date:2410042604
:01/82/050/02482/AM19/ :24/24/040/00044/AM19/ 19.12.2018

218 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 chemical reaction, molecular weight and % yield on molar basis for each step of manufacturing process.

64

Case No.:742/15/82- Party Name:BEST VALUE Meet No/Date:4/82- Status:
ALC4/2018 CHEM PVT. LTD. ALC4/2020 Deferred
18.09.2020
HQ File RLA File Lic.No/Date:3410044774
:01/82/050/02199/AM19/ :34/24/040/00295/AM19/ 20.12.2018

Decision: The firm vide e-mail dated 29.01.2020 informed that they had applied for issuance of Advance Authorization under para 4.07 A (self declaration and self ratification) in view of its becoming AEO status holder, but while issuing the subject Advance Authorization, RA inadvertently indicated Advance Licence issued under para 4.7 of HBP 2015-20, for which they had requested RLA,Vadodara to amend the 219 condition sheet of advance authorization to para 4.07 A of HBP Vol. I.

indicated Advance Licence issued under para 4.7 of HBP 2015-20, for which they had requested RLA,Vadodara to amend the 219 condition sheet of advance authorization to para 4.07 A of HBP Vol. I.

RLA, Vadodara was requested vide e-mail dated 23.03.2020 to check and verify whether the subject advance authorization was issued under para 4.07A of HBP Vol. I – Self ratification scheme and whether the firm should be exempted from the approval of NC for the said advance authorization.

The requisite reply is still awaited from RLA, Vadodara.

In view of above, the Committee decided to again issue a Reminder to RLA, Vadodara to check and verify whether the subject advance authorization was issued under para 4.07A of HBP Vol. I – Self ratification scheme.

Case No.:743/15/82- Party Name:SHUBHLAXMI Meet No/Date:4/82- Status:
ALC4/2018 INDUSTRIES ALC4/2020 Deferred
18.09.2020
HQ File RLA File Lic.No/Date:0810144119
:01/82/050/02200/AM19/ :08/24/040/00267/AM19/ 20.12.2018

220 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 1/82-ALC4/2020 dated 17.04.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

cy Circular No. 23/2015-20, dated 15.05.2019.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:748/15/82- Party Name:SPANSULES Meet No/Date:4/82- Status:
ALC4/2018 FORMULATIONS ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0910066987
:01/82/050/02205/AM19/ :09/24/040/00418/AM19/ 20.12.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it 221 was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

Export Product<br>Ascorbic Acid 85% SR Pellets Qty. Sl.<br>No. Import items Qty.
1 kg 1 Ascorbic Acid(Vitamin C) 0.8585 kg

65

222 <br>Case No.:752/15/82-<br>ALC4/2018 Party Name:ATUL LIMITED,<br>RLA File<br>:08/24/040/00303/AM19/ Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br>Lic.No/Date:0810144142<br>21.12.2018 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02209/AM19/
**Decision:**Deferred for comments of TE.

br>18.09.2020<br>Lic.No/Date:0810144142<br>21.12.2018|Status:<br>Deferred| |---|---|---|---|---| ||<br>HQ File<br>:01/82/050/02209/AM19/|||| ||**Decision:**Deferred for comments of TE.||||

223 <br>Case No.:925/15/82-<br>ALC4/2018 Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02382/AM19/ RLA File<br>:09/24/040/00470/AM19/ Lic.No/Date:0910066998<br>24.12.2018
**Decision:**Deferred for comments of TE.
224 <br>Case No.:772/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02229/AM19/ RLA File<br>:09/24/040/00445/AM19/ Lic.No/Date:0910067006<br>31.12.2018
**Decision:**Deferred for comments of TE.
225 <br>Case No.:775/15/82-<br>ALC4/2018 Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02232/AM19/ RLA File<br>:09/24/040/00482/AM19/ Lic.No/Date:0910067014<br>31.12.2018
**Decision:**Deferred for comments of TE.

Deferred*| |---|---|---|---|---| ||<br>HQ File<br>:01/82/050/02232/AM19/|RLA File<br>:09/24/040/00482/AM19/|Lic.No/Date:0910067014<br>31.12.2018|| ||**Decision:**Deferred for comments of TE.||||

226 Case No.:788/15/82-<br>ALC4/2018 Party Name:MANKIND<br>PHARMA LTD<br>RLA File<br>:05/24/040/00552/AM19/ Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br>Lic.No/Date:0510409149<br>02.01.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02245/AM19/
Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to call for following information from the firm:<br>(i)<br>Copy of DML for three export items.

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

227 <br>Case No.:1072/15/82-<br>ALC4/2018 Party Name:MALLADI<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
HQ File<br>:01/82/050/02529/AM19/ RLA File<br>:04/24/040/00218/AM19/ Lic.No/Date:0410165065<br>04.01.2019
**Decision:**Deferred for comments of TE.

66

Case No.:109/15/82- Party Name:U SQUARE Meet No/Date:4/82- Status:
ALC4/2018 LIFESCIENCE PRIVATE ALC4/2020 Approved
LIMITED 18.09.2020
HQ File RLA File Lic.No/Date:0810144243
:01/82/050/01566/AM19/ :08/24/040/00329/AM19/ 07.01.2019

|ALC4/2018||LIFESCIENCE PRIVATE||ALC4/2020||Approved| |||LIMITED||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0810144243||| |:01/82/050/01566/AM19/||:08/24/040/00329/AM19/||07.01.2019|||

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or 228 as applied by firm whichever is lower:

Export Product Qty. Sl. Import items Qty.
No.
CLINDAMYCIN 1 Number 1 CLINDAMYCIN PHOSPHATE 831.13 mg
INJECTION 600MG / 4 ML USP
Case No.:805/15/82- Party Name:DEEPAK Meet No/Date:4/82- Status:
ALC4/2018 NOVOCHEM ALC4/2020 Rejected
TECHNOLOGIES LTD 18.09.2020
HQ File RLA File Lic.No/Date:3110067278
:01/82/050/02262/AM19/ :31/83/040/00157/AM19/ 09.01.2019

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 9/82-ALC4/2019 229 dated 18.10.2019, followed by Reminder on 09.12.2019 and Final Reminder on 19.03.2020 :

(i) Catalogue of OCP. (ii) Certificate of Analysis (CoA) of OCP. (iii) Percentage yield on molar basis.

2019,** followed by Reminder on 09.12.2019 and Final Reminder on 19.03.2020 :

(i) Catalogue of OCP. (ii) Certificate of Analysis (CoA) of OCP. (iii) Percentage yield on molar basis.

Case No.:123/15/82- Party Name:REYAANSH Meet No/Date:4/82- Status:
ALC4/2018 HEALTHCARE ALC4/2020 Deferred
18.09.2020
230 HQ File RLA File Lic.No/Date:0310826282
:01/82/050/01580/AM19/ :03/95/040/01019/AM19/ 10.01.2019
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it
was noted that the firm vide e-mail dated 25.03.2020 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 25.03.2020 has furnished its reply. Deferred for comments of TE.

Case No.:811/15/82- Party Name:ATUL LIMITED, Meet No/Date:4/82- Status:
ALC4/2018 ALC4/2020 Deferred
18.09.2020
231 HQ File RLA File Lic.No/Date:0810144290
:01/82/050/02268/AM19/ :08/24/040/00328/AM19/ 10.01.2019
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it
was noted that the firm vide e-mail dated 11.11.2019 has furnished its reply. Deferred for comments of TE.

67

d the case as per agenda in the presence of technical|||||experts and it|| |||was noted that the firm vide e-mail dated 11.11.2019 has furnished its reply. Deferred for comments of TE.|||||||

67

232 Case No.:812/15/82-<br>ALC4/2018 Party Name:BALAJI AMINES<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02269/AM19/ RLA File<br>:31/83/040/00158/AM19/ Lic.No/Date:3110067279<br>10.01.2019
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 13.12.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 13.12.2019 has furnished its reply. Deferred for comments of TE.

Case No.:847/15/82- Party Name:LIRICON Meet No/Date:4/82- Status:
ALC4/2018 TRADING ALC4/2020 Deferred
18.09.2020
HQ File RLA File Lic.No/Date:0310826653
:01/82/050/02304/AM19/ :03/95/040/01055/AM19/ 25.01.2019

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

(i) Information given in the description of Export Product appears to be incorrect and also the import quantity is not matching with the export product. Please clarify it.

n from the firm:

(i) Information given in the description of Export Product appears to be incorrect and also the import quantity is not matching with the export product. Please clarify it.

234 Case No.:51/4/82-ALC4/2020 Party Name:SIRMAXO<br>CHEMICALS PVT LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01552/AM21/ RLA File<br>:03/95/040/00252/AM20/ Lic.No/Date:0310829902<br>25.06.2019
**Decision:**This case appeared for the first time before Norms Committee. The Committee noted that the<br>4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy<br>of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.<br>23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

n is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

235 Case No.:89/4/82-ALC4/2020 Party Name:SPANSULES<br>FORMULATIONS Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01590/AM21/ RLA File<br>:09/24/040/00202/AM20/ Lic.No/Date:0910067792<br>17.07.2019
**Decision:**This case appeared for the first time before Norms Committee. The Committee noted that the<br>4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy<br>of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.<br>23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

68

not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

68

236 Case No.:96/4/82-ALC4/2020 Party Name:SRINI<br>PHARMACEUTICALS<br>PRIVATE LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01597/AM21/ RLA File<br>:09/24/040/00642/AM19/ Lic.No/Date:0910067796<br>19.07.2019
**Decision:**This case appeared for the first time before Norms Committee. The Committee noted that the<br>4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy<br>of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.<br>23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

n is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

237 <br>Case No.:49/4/82-ALC4/2020 Party Name:SI GROUP -<br>INDIA PRIVATE LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01550/AM21/ RLA File<br>:03/95/040/00390/AM20/ Lic.No/Date:0310830654<br>29.07.2019
**Decision:**This case appeared for the first time before Norms Committee. Deferred for comments of TE.
Case No.:90/4/82-ALC4/2020 Party Name:HETERO DRUGS Meet No/Date:4/82- Status:
LIMITED ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:0910068010
:01/82/050/01591/AM21/ :09/24/040/00303/AM20/ 20.09.2019

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or 238 as applied by firm whichever is lower:

Export Product<br>FAMCICLOVIR Qty. Sl.<br>No. Import items<br> Qty.
1 kg 1 2-AMINO-6-CHLORO PURINE<br> 1.11 kg
2 SODIUM BORO HYDRIDE<br> 0.83 kg
3 N,N-Dimethyl formamide<br> 4.00 kg
MCICLOVIR Qty. Sl.<br>No. Import items<br> Qty.
1 kg 1 2-AMINO-6-CHLORO PURINE<br> 1.11 kg
2 SODIUM BORO HYDRIDE<br> 0.83 kg
3 N,N-Dimethyl formamide<br> 4.00 kg
239 Case No.:91/4/82-ALC4/2020 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01592/AM21/ RLA File<br>:09/24/040/00328/AM20/ Lic.No/Date:0910068021<br>23.09.2019
**Decision:**This case appeared for the first time before Norms Committee. The Committee noted that the<br>4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy<br>of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.<br>23/2015-20,dated 15.05.2019.

69

240 <br>Case No.:47/4/82-ALC4/2020 Party Name:CIPLA LIMITED. Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01548/AM21/ RLA File<br>:03/94/040/00528/AM20/ Lic.No/Date:0310832045<br>07.10.2019
**Decision:**This case appeared for the first time before Norms Committee. Deferred for comments of TE.

1548/AM21/|RLA File<br>:03/94/040/00528/AM20/|Lic.No/Date:0310832045<br>07.10.2019|| ||**Decision:**This case appeared for the first time before Norms Committee. Deferred for comments of TE.||||

241 <br>Case No.:48/4/82-ALC4/2020 Party Name:CIPLA LIMITED. Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01549/AM21/ RLA File<br>:03/94/040/00591/AM20/ Lic.No/Date:0310832572<br>04.11.2019
**Decision:**This case appeared for the first time before Norms Committee. Deferred for comments of TE.
Case No.:97/4/82-ALC4/2020 Party Name:PHALANX LABS Meet No/Date:4/82- Status:
PRIVATE LIMITED ALC4/2020 Approved
18.09.2020
HQ File RLA File Lic.No/Date:2610012885
:01/82/050/01598/AM21/ :26/24/040/00011/AM20/ 15.11.2019

Decision: The Committee considered the case as per agenda in the presence of Technical Experts in light of the earlier decision taken by NC in its Meeting No. 10/82-ALC4/2019 242 , dated 29.11.2019 for advance authorization No. 0910068087 dated 15.10.2019, it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: Export product Qty. Sl. Import items Qty. No. LEVETIRACETAM 1 kg 1 (S)+2 AMINO BUTYRAMIDE HCL 0.95 kg RA concerned may take further necessary action as per above decision of NC.

whichever is lower: Export product Qty. Sl. Import items Qty. No. LEVETIRACETAM 1 kg 1 (S)+2 AMINO BUTYRAMIDE HCL 0.95 kg RA concerned may take further necessary action as per above decision of NC.

243 <br>Case No.:92/4/82-ALC4/2020 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01593/AM21/ RLA File<br>:09/24/040/00449/AM20/ Lic.No/Date:0910068271<br>10.12.2019
**Decision:**This case appeared for the first time before Norms Committee. Deferred for comments of TE.

70

Case No.:93/4/82-ALC4/2020 Party Name:SREEPATHI Meet No/Date:4/82- Status:
PHARMACEUTICALS LTD ALC4/2020 Deferred
18.09.2020
244 HQ File RLA File Lic.No/Date:0910068349
:01/82/050/01594/AM21/ :09/24/040/00502/AM20/ 09.01.2020
**Decision:**This case appeared for the first time before Norms Committee. Deferred for comments of TE.
Case No.:94/4/82-ALC4/2020 Party Name:DIVIS Meet No/Date:4/82- Status:
LABORATORIES LTD ALC4/2020 Deferred
18.09.2020
245 HQ File RLA File Lic.No/Date:0910068355
:01/82/050/01595/AM21/ :09/24/040/00509/AM20/ 09.01.2020
**Decision:**This case appeared for the first time before Norms Committee. Deferred for comments of TE.

e:0910068355||| |||:01/82/050/01595/AM21/||:09/24/040/00509/AM20/||09.01.2020||| |||**Decision:**This case appeared for the first time before Norms Committee. Deferred for comments of TE.|||||||

Case No.:99/4/82-ALC4/2020 Party Name:MICRO LABS Meet No/Date:4/82- Status:
LTD ALC4/2020 Deferred
246 HQ File RLA File 18.09.2020<br>Lic.No/Date:0710116065
:01/82/050/01600/AM21/ :07/24/040/00254/AM20/ 24.01.2020
**Decision:**This case appeared for the first time before Norms Committee. Deferred for comments of TE.
Case No.:50/4/82-ALC4/2020 Party Name:MAGNOLIA Meet No/Date:4/82- Status:
LIMITED. ALC4/2020 Deferred
18.09.2020
247 HQ File RLA File Lic.No/Date:0310834718
:01/82/050/01551/AM21/ :03/95/040/01071/AM20/ 07.02.2020
**Decision:**This case appeared for the first time before Norms Committee. Deferred for comments of TE.
Case No.:53/4/82-ALC4/2020 Party Name:KOPRAN Meet No/Date:4/82- Status:
RESEARCH ALC4/2020 Approved
LABORATORIES LIMITED 18.09.2020
HQ File RLA File Lic.No/Date:0310835023
:01/82/050/01554/AM21/ :03/94/040/00915/AM20/ 24.02.2020

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or 248 as applied by firm whichever is lower:

in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or 248 as applied by firm whichever is lower:

Export Product Qty. Sl. Import items Qty.
No.
CLARITHROMYCIN GRANULES 43% 1 kg 1 CLARITHROMYCIN 0.434 kg
2 ACETONE 1.00 kg

71

Case No.:95/4/82-ALC4/2020 Party Name:LANTECH Meet No/Date:4/82- Status:
PHARMACEUTICALS ALC4/2020 Approved
LIMITED 18.09.2020
HQ File RLA File Lic.No/Date:0910068511
:01/82/050/01596/AM21/ :09/24/040/00580/AM20/ 25.02.2020
Case No.:95/4/82-ALC4/2020 Party Name:LANTECH<br>PHARMACEUTICALS<br>LIMITED Party Name:LANTECH<br>PHARMACEUTICALS<br>LIMITED Party Name:LANTECH<br>PHARMACEUTICALS<br>LIMITED Party Name:LANTECH<br>PHARMACEUTICALS<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Approved
HQ File<br>:01/82/050/01596/AM21/ RLA File<br>:09/24/040/00580/AM20/ Lic.No/Date:0910068511<br>25.02.2020
249 **Decision:**The Committee considered case a<br>was decided to ratify the ad-hoc input output n<br>as applied by firm whichever is lower:
Export Product Qty. Sl.<br>No. Import items Qty.
(2R,5S)-5-(4-Amino-5-fluoro-2-oxo-<br>2H-pyrimidin-1-yl)-[1,3]oxathiolane-<br>2-carboxylic<br>acid<br>(1R,2S,5R)-<br>menthyl ester 1 kg 1 Menthol(L-Menthol) 0.61 kg
2 Glyoxalic acid(50%) 0.68 kg
3 Cyclohexane 0.61 kg

<br>2H-pyrimidin-1-yl)-[1,3]oxathiolane-<br>2-carboxylic<br>acid<br>(1R,2S,5R)-<br>menthyl ester||1 kg|1|Menthol(L-Menthol)||0.61 kg| |||||2|Glyoxalic acid(50%)||0.68 kg| |||||3|Cyclohexane||0.61 kg| |||||4|2,5-Dihydroxy-1,4-dithiane||0.28 kg| |||||5|Toluene||0.41 kg| |||||6|Hexanes||1.01 kg| |||||7|Triethylamine||0.13 kg| |||||8|Triphosgene||0.42 kg| |||||9|5-Fluoro cytosine||0.49 kg| |||||10|Hexamethyldisilazane||0.53 kg| |||||11|Methylene dichloride||1.87 kg| |||||12|Methyl tert-butyl ether||3.39 kg| |||||13|Methanol||0.93 kg| ||RA concerned maytake further necessaryaction asper above decision of NC.|||||||

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

Case No.:52/4/82-ALC4/2020 Party Name:KOPRAN Meet No/Date:4/82- Status:
RESEARCH ALC4/2020 Approved
LABORATORIES LIMITED 18.09.2020
HQ File RLA File Lic.No/Date:0310835123
:01/82/050/01553/AM21/ :03/94/040/00909/AM20/ 28.02.2020

-|---|---| |||RESEARCH||ALC4/2020||Approved| |||LABORATORIES LIMITED||18.09.2020||| |HQ File||RLA File||Lic.No/Date:0310835123||| |:01/82/050/01553/AM21/||:03/94/040/00909/AM20/||28.02.2020|||

Case No.:52/4/82-ALC4/2020 Case No.:52/4/82-ALC4/2020 Case No.:52/4/82-ALC4/2020 Case No.:52/4/82-ALC4/2020 Party Name:KOPRAN<br>RESEARCH<br>LABORATORIES LIMITED Party Name:KOPRAN<br>RESEARCH<br>LABORATORIES LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br>Lic.No/Date:0310835123<br>28.02.2020 Status:<br>Approved<br>
HQ File<br>:01/82/050/01553/AM21/ RLA File<br>:03/94/040/00909/AM20/
250 **Decision:**The Committee considered the case as per agenda in the presence of Technical Experts in light<br>of<br>the<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 for advance authorization No. 0310811464 dated 27.02.2017, it was decided to ratify the<br>ad-hoc input output norms under para 4.07 of HBP Vol.

eeting<br>No.<br>15/82-ALC4/2018<br>, dated 22.03.2019 for advance authorization No. 0310811464 dated 27.02.2017, it was decided to ratify the<br>ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm<br>whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>STERILE<br>CEFTRIAXONE<br>SODIUM<br>1 kg<br>1<br>CEFTRIAXONE SODIUM (NON-STERILE)<br>1.04 kg<br>2<br>ACETONE<br>1.72 kg<br>3<br>Pack.Mat.-<br>Alu.Can.(10kg)/Alu.Botl.Ano.2M(20L000T.8020XY)<br>(One set cont.One Can./Alu.Botl.Ano.+In Lid+Out<br>Lid)<br>Relevant as<br>per packing<br>policy<br>RA concerned maytake further necessaryaction asper above decision of NC.|||||||| |||Export product|Qty.|Sl.<br>No.||Import items||Qty.| |||STERILE<br>CEFTRIAXONE<br>SODIUM|1 kg|1||CEFTRIAXONE SODIUM (NON-STERILE)||1.04 kg| |||||2||ACETONE||1.72 kg| |||||3||Pack.Mat.-<br>Alu.Can.(10kg)/Alu.Botl.Ano.2M(20L000T.8020XY)<br>(One set cont.One Can./Alu.Botl.Ano.+In Lid+Out<br>Lid)||<br>Relevant as<br>per packing<br>policy| ||||||||||

72

|1.72 kg| |||||3||Pack.Mat.-<br>Alu.Can.(10kg)/Alu.Botl.Ano.2M(20L000T.8020XY)<br>(One set cont.One Can./Alu.Botl.Ano.+In Lid+Out<br>Lid)||<br>Relevant as<br>per packing<br>policy| ||||||||||

72

251 Case No.:98/4/82-ALC4/2020 Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD.<br>RLA File<br>:05/24/040/00742/AM20/ Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020<br>Lic.No/Date:0510413763<br>02.03.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01599/AM21/
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

252 <br>Case No.:54/4/82-ALC4/2020 Party Name:ZENITH<br>DYEINTERMEDIATES<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01555/AM21/ RLA File<br>:03/95/040/01130/AM20/ Lic.No/Date:0310835403<br>16.03.2020
**Decision:**This case appeared for the first time before Norms Committee. Deferred for comments of TE.

1555/AM21/|RLA File<br>:03/95/040/01130/AM20/|Lic.No/Date:0310835403<br>16.03.2020|| ||**Decision:**This case appeared for the first time before Norms Committee. Deferred for comments of TE.||||

253 <br>Case No.:1/4/82-ALC4/2020 Party Name:PHAROSE<br>REMEDIES LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01502/AM21/ RLA File<br>:18/24/040/00004/AM21/ Lic.No/Date:1810004355<br>24.07.2020
**Decision:**This case appeared for the first time before Norms Committee. Deferred for comments of TE.
254 Case No.:6/4/82-ALC4/2020 Party Name:SYNNAT<br>PHARMA PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01507/AM21/ RLA File<br>:02/24/040/00050/AM21/ Lic.No/Date:0210210010<br>27.07.2020
**Decision:**This case appeared for the first time before Norms Committee. The Committee noted that the<br>4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy<br>of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.<br>23/2015-20,dated 15.05.2019.

vailable. Hence, it was decided to call for a copy<br>of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.<br>23/2015-20,dated 15.05.2019.||||

Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

255 Case No.:2/4/82-ALC4/2020 Party Name:USV PRIVATE<br>LIMITED (FORMERLY USV<br>LIMITED) Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01503/AM21/ RLA File<br>:03/95/040/00235/AM21/ Lic.No/Date:0310837435<br>28.07.2020
**Decision:**This case appeared for the first time before Norms Committee. The Committee noted that the<br>4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy<br>of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.<br>23/2015-20,dated 15.05.2019.

73

ble. Hence, it was decided to call for a copy<br>of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.<br>23/2015-20,dated 15.05.2019.||||

73

Case No.:3/4/82-ALC4/2020 Party Name:SAFECON Meet No/Date:4/82- Status:
LIFESCIENCES ALC4/2020 Deferred
18.09.2020
HQ File RLA File Lic.No/Date:0610039560
256 :01/82/050/01504/AM21/ :06/24/040/00092/AM20/ 28.07.2020
**Decision:**This case appeared for the first time before Norms Committee. The Committee noted that the
4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy
of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.
23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

n is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Case No.:4/4/82-ALC4/2020 Party Name:STERILE INDIA Meet No/Date:4/82- Status:
PRIVATE LIMITED ALC4/2020 Deferred
18.09.2020
HQ File RLA File Lic.No/Date:0510414761
257 :01/82/050/01505/AM21/ :05/24/040/00196/AM21/ 28.07.2020
**Decision:**This case appeared for the first time before Norms Committee. The Committee noted that the
4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy
of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.
23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

n is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Case No.:5/4/82-ALC4/2020 Party Name:S.M. HERBALS Meet No/Date:4/82- Status:
PRIVATE LIMITED ALC4/2020 Deferred
18.09.2020
HQ File RLA File Lic.No/Date:0510414764
258 :01/82/050/01506/AM21/ :05/24/040/00146/AM21/ 28.07.2020
**Decision:**This case appeared for the first time before Norms Committee. The Committee noted that the
4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy
of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.
23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

n is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Case No.:7/4/82-ALC4/2020 Party Name:ALPHAMED Meet No/Date:4/82- Status:
FORMULATIONS P LTD. ALC4/2020 Deferred
18.09.2020
HQ File RLA File Lic.No/Date:0910068998
259 :01/82/050/01508/AM21/ :09/24/040/00160/AM21/ 28.07.2020
**Decision:**This case appeared for the first time before Norms Committee. The Committee noted that the
4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy
of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.
23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

74

not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

74

260 Case No.:8/4/82-ALC4/2020 Party Name:STYRAX LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01509/AM21/ RLA File<br>:09/24/040/00167/AM21/ Lic.No/Date:0910069002<br>28.07.2020
**Decision:**This case appeared for the first time before Norms Committee. The Committee noted that the<br>4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy<br>of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.<br>23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

n is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

261 <br>Case No.:9/4/82-ALC4/2020 Party Name:GLENMARK<br>PHARMACEUTICALS LTD Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01510/AM21/ RLA File<br>:03/94/040/00301/AM21/ Lic.No/Date:0310837490<br>29.07.2020
**Decision:**This case appeared for the first time before Norms Committee. Deferred for comments of TE.
262 Case No.:10/4/82-ALC4/2020 Party Name:KUSUMA<br>PHARMA Meet No/Date:4/82-<br>ALC4/2020<br>18.09.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01511/AM21/ RLA File<br>:03/94/040/00198/AM21/ Lic.No/Date:0310837494<br>29.07.2020
**Decision:**This case appeared for the first time before Norms Committee. The Committee noted that the<br>4.07 application of subject A

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