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Office of Directorate General of Foreign Trade New Delhi -0

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

Minutes of the Norms Committee – 3 Meeting No. 1/82-ALC4/2020 dated 17.04.2020 (actually held on 06.05.2020) 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:

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

The committee went through the minutes of earlier meeting No. 14/82-ALC4/2019 dated 06.03.2020 dated 06.03.2020 (actually held on 19.03.2020)

ONLINE CASES

1 Case No.:969/15/82-<br>ALC4/2018 Party Name:SOMU<br>SOLVENTS PVT. LTD Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
HQ File<br>:01/82/050/02426/AM19/ RLA File<br>:07/24/040/00175/AM16/ Lic.No/Date:0710108673<br>02.09.2015 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>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.

2 Case No.:405/15/82-<br>ALC4/2018 Party Name:SHIVA<br>PHARMACHEM LTD, Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
HQ File<br>:01/82/050/01862/AM19/ RLA File<br>:34/24/040/00139/AM16/ Lic.No/Date:3410041522<br>16.09.2015 Defer Date:
**Decision:**Deferred for comments of TE.

2

Case No.:259/15/82- Party Name:CADILA Meet No/Date:1/82- Status:
ALC4/2018 PHARMACEUTICALS LTD. ALC4/2020 Withdrawn
17.04.2020
HQ File RLA File Lic.No/Date:0810136251
:01/82/050/01716/AM19/ :08/24/040/00222/AM16/ 12.10.2015

||ALC4/2018||PHARMACEUTICALS LTD.||ALC4/2020||Withdrawn| ||||||17.04.2020||| ||HQ File||RLA File||Lic.No/Date:0810136251||| ||:01/82/050/01716/AM19/||:08/24/040/00222/AM16/||12.10.2015|||

3 Decision: The firm vide its e-mail dated 24.02.2020 has enclosed a copy of Redemption Letter dated 13.05.2017 vide which Office of Addl. DGFT, Ahmedabad has issued EODC and closed the subject advance authorization.

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

Case No.:322/15/82- Party Name:HESTER Meet No/Date:1/82- Status:
ALC4/2018 BIOSCIENCES LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0810136418 Defer Date:
:01/82/050/01779/AM19/ :08/24/040/00270/AM16/ 02.11.2015

Decision: The Committee considered the case as per online agenda in the presence of technical experts 4 and it was noted that the firm still has not furnished the 4.07 application of subject Advancer Authorization as asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 21.02.2020 as per Policy Circular No. 23/2015-20 dated 15.05.2019.

Hence, it was decided to issue Final Reminder to firm with the request to furnish a copy of 4.07 application of the subject advance authorization immediately to this Directorate as per Policy Circular No. 23/2015-20, dated 15.05.2019, failing which its case will be rejected.

ish a copy of 4.07 application of the subject advance authorization immediately to this Directorate as per Policy Circular No. 23/2015-20, dated 15.05.2019, failing which its case will be rejected.

Case No.:1030/15/82- Party Name:SWATI Meet No/Date:1/82- Status:
ALC4/2018 MENTHOL & ALLIED ALC4/2020 Deferred
CHEMICALS LTD., 17.04.2020
HQ File RLA File Lic.No/Date:2910025235 Defer Date:
:01/82/050/02487/AM19/ :29/21/040/00029/AM16/ 21.12.2015

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 5 Meeting No. 7/82-ALC4/2019 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.

The requisite reply is still awaited from the firm.

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

3

Case No.:260/15/82- Party Name:VINNY Meet No/Date:1/82- Status:
ALC4/2018 HEALTHCARE PRIVATE ALC4/2020 Deferred
LIMITED 17.04.2020
HQ File RLA File Lic.No/Date:0810137198 Defer Date:
:01/82/050/01717/AM19/ :08/24/040/00386/AM16/ 12.02.2016

18**||HEALTHCARE PRIVATE||ALC4/2020||Deferred| |||LIMITED||17.04.2020||| |HQ File||RLA File||Lic.No/Date:0810137198||Defer Date:| |:01/82/050/01717/AM19/||:08/24/040/00386/AM16/||12.02.2016|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts 6 and it was noted that the firm still has not furnished the 4.07 application of subject Advancer Authorization as asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 21.02.2020 as per Policy Circular No. 23/2015-20 dated 15.05.2019.

Hence, it was decided to issue Final Reminder to firm with the request to furnish a copy of 4.07 application of the subject advance authorization immediately to this Directorate as per Policy Circular No. 23/2015-20, dated 15.05.2019, failing which its case will be rejected.

Case No.:996/15/82- Party Name:RECKITT Meet No/Date:1/82- Status:
ALC4/2018 BENCKISER ( INDIA) LTD ALC4/2020 Withdrawn
17.04.2020
HQ File RLA File Lic.No/Date:0710109433
7 :01/82/050/02453/AM19/ :07/24/040/00374/AM16/ 23.02.2016
**Decision:**The firm vide e-mail dated 26.02.2020 has informed that they have surrendered the subject
Advance Authorization.
In view of above,the Committee decided towithdrawthe case

irm vide e-mail dated 26.02.2020 has informed that they have surrendered the subject||||||| |||Advance Authorization.||||||| |||In view of above,the Committee decided towithdrawthe case|||||||

Case No.:221/15/82-<br>Party Name:GOPINATH<br>Meet No/Date:1/82- Status:
ALC4/2018<br>CHEM-TECH LTD.,<br>ALC4/2020 Deferred
17.04.2020
8 HQ File<br>:01/82/050/01678/AM19/<br>RLA File<br>:08/24/040/00469/AM16/<br>Lic.No/Date:0810137649<br>11.04.2016 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
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.

Case No.:274/15/82- Party Name:SHILPA Meet No/Date:1/82- Status:
ALC4/2018 MEDICARE LTD., ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0710109729 Defer Date:
:01/82/050/01731/AM19/ :07/24/040/00034/AM17/ 27.04.2016

|ALC4/2018||MEDICARE LTD.,||ALC4/2020||Deferred| |||||17.04.2020||| |HQ File||RLA File||Lic.No/Date:0710109729||Defer Date:| |:01/82/050/01731/AM19/||:07/24/040/00034/AM17/||27.04.2016|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts and 9 it was noted that the firm still has not furnished the 4.07 application of subject Advancer Authorization as asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 21.02.2020 as per Policy Circular No. 23/2015-20 dated 15.05.2019. Hence, it was decided to issue Final Reminder to firm with the request to furnish a copy of 4.07 application of the subject advance authorization immediately to this Directorate as per Policy Circular No. 23/2015-20, dated 15.05.2019, failing which its case will be rejected.

4

Case No.:222/15/82- Party Name:ADCOCK Meet No/Date:1/82- Status:
ALC4/2018 INGRAM LTD, ALC4/2020 Approved
17.04.2020
HQ File RLA File Lic.No/Date:0710109746
:01/82/050/01679/AM19/ :07/24/040/00015/AM17/ 02.05.2016

-|---|---|---| |ALC4/2018||INGRAM LTD,||ALC4/2020||Approved| |||||17.04.2020||| |HQ File||RLA File||Lic.No/Date:0710109746||| |:01/82/050/01679/AM19/||:07/24/040/00015/AM17/||02.05.2016|||

ALC4/2018<br>INGRAM LTD,<br>ALC4/2020<br>17.04.2020<br>Approved<br>HQ File<br>:01/82/050/01679/AM19/<br>RLA File<br>:07/24/040/00015/AM17/<br>Lic.No/Date:0710109746<br>02.05.2016 ALC4/2018<br>INGRAM LTD,<br>ALC4/2020<br>17.04.2020<br>Approved<br>HQ File<br>:01/82/050/01679/AM19/<br>RLA File<br>:07/24/040/00015/AM17/<br>Lic.No/Date:0710109746<br>02.05.2016 ALC4/2018<br>INGRAM LTD,<br>ALC4/2020<br>17.04.2020<br>Approved<br>HQ File<br>:01/82/050/01679/AM19/<br>RLA File<br>:07/24/040/00015/AM17/<br>Lic.No/Date:0710109746<br>02.05.2016 ALC4/2018<br>INGRAM LTD,<br>ALC4/2020<br>17.04.2020<br>Approved<br>HQ File<br>:01/82/050/01679/AM19/<br>RLA File<br>:07/24/040/00015/AM17/<br>Lic.No/Date:0710109746<br>02.05.2016 ALC4/2018<br>INGRAM LTD,<br>ALC4/2020<br>17.04.2020<br>Approved<br>HQ File<br>:01/82/050/01679/AM19/<br>RLA File<br>:07/24/040/00015/AM17/<br>Lic.No/Date:0710109746<br>02.05.2016 ALC4/2018<br>INGRAM LTD,<br>ALC4/2020<br>17.04.2020<br>Approved<br>HQ File<br>:01/82/050/01679/AM19/<br>RLA File<br>:07/24/040/00015/AM17/<br>Lic.No/Date:0710109746<br>02.05.2016
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied

nsidered case as per agenda in the presence of the technical experts and it|||||| |||was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied|||||| |||by firm whichever is lower:|||||| |||Export Product|Qty.|Sl.|Import items|Qty.|| |||||No.|||| |||ACURATE<br>TABS<br>-|25347.000 kg|1|PARACETAMOL|22950.000 kg|| |10||Paracetamol<br>450mg+Doxylamine|||GRANULES DC 83S<br>(KRISOPAP - 83S)||| |||Succinate 5mg+Caffeine||2|DOXYLAMINE|255.000 kg|| |||30mg|||SUCCINATE USP /Ph. Eur||| |||+Codeine<br>Phosphate|||Grade||| |||10mg+Colour<br>Quinoline||3|CAFFEINE ANHYDROUS|1530.000 kg|| |||Yellow 2Mg Tablets (Para|||BP2010/USP/EP/PH.EUR/BP||| |||-22500.000+Doxy-<br>250.000+Caffeine-||4|CODEINE PHOSPHATE<br>BP/USP/EP/PH.EUR|510.000 kg|| |||1500.000+Codeine-<br>500.000+Colour-||5|COLOUR QUINOLINE<br>YELLOW CI 47005|102.000 kg|| |||100.000Kgs)(No.<br>of<br>Tablets 50000000)|||(SPECTRACOL)||| |||RA concerned maytake further|necessaryaction|asper above decision of NC.||||

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

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

Case No.:286/15/82- Party Name:MOREPEN Party Name:MOREPEN Meet No/Date:1/82- Status:
ALC4/2018 LABORATORIES LTD., ALC4/2020 Approved
17.04.2020
HQ File RLA File Lic.No/Date:0510398453
:01/82/050/01743/AM19/ :05/24/040/00060/AM17/ 11.05.2016
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in
meeting no. 18/82-ALC4/2014 dated
18.02.2015, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied
by the firm, whichever is less:
Export product<br>SITAGLIPTIN<br>PHOSPHATE Qty.<br>Sl. No.<br>1 k<br>1 Import items<br>( R )-3-((tert-butoxycarbonyl)amino)-<br>4-(2,4,5-trifluorophenyl)butanoic acid Qty.<br>1.00 kg/kg
MONOHYDRATE (SG04)
2 3-(trifluoromethyl)-5,6,7,8-tetrahydro-<br>[1,2,4]triazolo[4,3-a]pyrazine 0.80 kg/kg
hydrochloride
3 N-Hydroxybenzotriazole(HOBT) 0.50 kg/kg
4 Methanol 3.65 lit/kg
5 Isopropyl alcohol 6.10 lit/kg
6 Methylene Dichloride 15.25 lt/kg
RA concerned maytake further necessaryaction asper above decision of NC.

g|| |||4|Methanol|||3.65 lit/kg|| |||5|Isopropyl alcohol|||6.10 lit/kg|| |||6|Methylene Dichloride|||15.25 lt/kg|| ||RA concerned maytake further necessaryaction asper above decision of NC.|||||||

Case No.:286/15/82- Party Name:MOREPEN Party Name:MOREPEN Meet No/Date:1/82- Status:
ALC4/2018 LABORATORIES LTD., ALC4/2020 Approved
17.04.2020
HQ File RLA File Lic.No/Date:0510398453
:01/82/050/01743/AM19/ :05/24/040/00060/AM17/ 11.05.2016
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in
meeting no. 18/82-ALC4/2014 dated
18.02.2015, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied
by the firm, whichever is less:
Export product<br>SITAGLIPTIN<br>PHOSPHATE Qty.<br>Sl. No.<br>1 k<br>1 Import items<br>( R )-3-((tert-butoxycarbonyl)amino)-<br>4-(2,4,5-trifluorophenyl)butanoic acid Qty.<br>1.00 kg/kg
MONOHYDRATE (SG04)
2 3-(trifluoromethyl)-5,6,7,8-tetrahydro-<br>[1,2,4]triazolo[4,3-a]pyrazine 0.80 kg/kg
hydrochloride
3 N-Hydroxybenzotriazole(HOBT) 0.50 kg/kg
4 Methanol 3.65 lit/kg
5 Isopropyl alcohol 6.10 lit/kg
6 Methylene Dichloride 15.25 lt/kg
RA concerned maytake further necessaryaction asper above decision of NC.

5

|||4|Methanol|||3.65 lit/kg|| |||5|Isopropyl alcohol|||6.10 lit/kg|| |||6|Methylene Dichloride|||15.25 lt/kg|| ||RA concerned maytake further necessaryaction asper above decision of NC.|||||||

5

Case No.:230/15/82- Party Name:WINTAC Meet No/Date:1/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0710109922 Defer Date:
:01/82/050/01687/AM19/ :07/24/040/00083/AM17/ 08.06.2016

Decision: The Committee considered the case as per online agenda in the presence of technical experts 12 and it was noted that the firm still has not furnished the 4.07 application of subject Advancer Authorization as asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020 , followed by Reminder on 21.02.2020 as per Policy Circular No. 23/2015-20 dated 15.05.2019.

Hence, it was decided to issue Final Reminder to firm with the request to furnish a copy of 4.07 application of the subject advance authorization immediately to this Directorate as per Policy Circular No. 23/2015-20, dated 15.05.2019, failing which its case will be rejected.

Case No.:231/15/82- Party Name:WINTAC Meet No/Date:1/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0710109921 Defer Date:
:01/82/050/01688/AM19/ :07/24/040/00082/AM17/ 08.06.2016

-|---| |ALC4/2018||LIMITED,||ALC4/2020||Deferred| |||||17.04.2020||| |HQ File||RLA File||Lic.No/Date:0710109921||Defer Date:| |:01/82/050/01688/AM19/||:07/24/040/00082/AM17/||08.06.2016|||

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

Hence, it was decided to issue Final Reminder to firm with the request to furnish a copy of 4.07 application of the subject advance authorization immediately to this Directorate as per Policy Circular No. 23/2015-20, dated 15.05.2019, failing which its case will be rejected.

Case No.:501/15/82- Party Name:WINTAC Meet No/Date:1/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0710109926 Defer Date:
:01/82/050/01958/AM19/ :07/24/040/00081/AM17/ 09.06.2016

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

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

Hence, it was decided to issue Final Reminder to firm with the request to furnish a copy of 4.07 application of the subject advance authorization immediately to this Directorate as per Policy Circular No. 23/2015-20, dated 15.05.2019, failing which its case will be rejected.

6

Case No.:234/15/82- Party Name:R L FINE CHEM Meet No/Date:1/82- Status:
ALC4/2018 ALC4/2020 Approved
17.04.2020
HQ File RLA File Lic.No/Date:0710109991
:01/82/050/01691/AM19/ :07/24/040/00057/AM17/ 23.06.2016

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 3/82-ALC4/2018 dated 15 05.06.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

the firm, whichever is less:
Export Product Qty. Sl. No. Import items Qty.
TRIMIPRAMINE<br>MESYLATE<br>IHT 1 kg 1 1 BROMO 3 CHLORO 2<br>METHYL PROPANE 0.53 kg
2 IMINODIBENZYL 0.72 kg

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

ty.| |TRIMIPRAMINE<br>MESYLATE<br>IHT|1 kg|1|1 BROMO 3 CHLORO 2<br>METHYL PROPANE|0.53 kg| |||2|IMINODIBENZYL|0.72 kg|

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

16 Case No.:179/6/82-ALC4/2019 Party Name:CIPLA LIMITED.<br>RLA File<br>:03/94/040/00257/AM17/ Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Withdrawn
<br>HQ File<br>:01/82/050/00405/AM20/ Lic.No/Date:0310805901<br>04.07.2016
Decision:The firm vide e-mail dated 29.01.2020 has informed that they have surrendered the subject<br>Advance Authorization.<br>In view of above,the Committee decided towithdrawthe case.
Case No.:646/15/82- Party Name:WINTAC Meet No/Date:1/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0710110596 Defer Date:
:01/82/050/02103/AM19/ :07/24/040/00251/AM17/ 28.10.2016

Decision: The Committee considered the case as per online agenda in the presence of technical experts 17 and it was noted that the firm still has not furnished the 4.07 application of subject Advancer Authorization as asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 21.02.2020 as per Policy Circular No. 23/2015-20 dated 15.05.2019.

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

Hence, it was decided to issue Final Reminder to firm with the request to furnish a copy of 4.07 application of the subject advance authorization immediately to this Directorate as per Policy Circular No. 23/2015-20, dated 15.05.2019, failing which its case will be rejected.

7

Case No.:680/15/82- Party Name:WINTAC Meet No/Date:1/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0710110805 Defer Date:
:01/82/050/02137/AM19/ :07/24/040/00282/AM17/ 16.12.2016

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

Hence, it was decided to issue Final Reminder to firm with the request to furnish a copy of 4.07 application of the subject advance authorization immediately to this Directorate as per Policy Circular No. 23/2015-20, dated 15.05.2019, failing which its case will be rejected.

ish a copy of 4.07 application of the subject advance authorization immediately to this Directorate as per Policy Circular No. 23/2015-20, dated 15.05.2019, failing which its case will be rejected.

Case No.:265/15/82- Party Name:ATUL LIMITED, Meet No/Date:1/82- Status:
ALC4/2018 ALC4/2020 Deferred
17.04.2020
19 HQ File RLA File Lic.No/Date:0810139395 Defer Date:
:01/82/050/01722/AM19/ :08/24/040/00374/AM17/ 28.12.2016
**Decision:**Deferred for comments of TE.
Case No.:992/15/82- Party Name:WINTAC Meet No/Date:1/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0710111032 Defer Date:
:01/82/050/02449/AM19/ :07/24/040/00353/AM17/ 27.01.2017

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

Hence, it was decided to issue Final Reminder to firm with the request to furnish a copy of 4.07 application of the subject advance authorization immediately to this Directorate as per Policy Circular No. 23/2015-20, dated 15.05.2019, failing which its case will be rejected.

ish a copy of 4.07 application of the subject advance authorization immediately to this Directorate as per Policy Circular No. 23/2015-20, dated 15.05.2019, failing which its case will be rejected.

Case No.:995/15/82- Party Name:WINTAC Meet No/Date:1/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0710111117 Defer Date:
:01/82/050/02452/AM19/ :07/24/040/00362/AM17/ 10.02.2017

Decision: The Committee considered the case as per online agenda in the presence of technical experts 21 and it was noted that the firm still has not furnished the 4.07 application of subject Advancer Authorization as asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 21.02.2020 as per Policy Circular No. 23/2015-20 dated 15.05.2019.

Hence, it was decided to issue Final Reminder to firm with the request to furnish a copy of 4.07 application of the subject advance authorization immediately to this Directorate as per Policy Circular No. 23/2015-20, dated 15.05.2019, failing which its case will be rejected.

8

Case No.:1002/15/82- Party Name:WINTAC Meet No/Date:1/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0710111160 Defer Date:
:01/82/050/02459/AM19/ :07/24/040/00365/AM17/ 21.02.2017

-|---| |ALC4/2018||LIMITED,||ALC4/2020||Deferred| |||||17.04.2020||| |HQ File||RLA File||Lic.No/Date:0710111160||Defer Date:| |:01/82/050/02459/AM19/||:07/24/040/00365/AM17/||21.02.2017|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts 22 and it was noted that the firm still has not furnished the 4.07 application of subject Advancer Authorization as asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 21.02.2020 as per Policy Circular No. 23/2015-20 dated 15.05.2019.

Hence, it was decided to issue Final Reminder to firm with the request to furnish a copy of 4.07 application of the subject advance authorization immediately to this Directorate as per Policy Circular No. 23/2015-20, dated 15.05.2019, failing which its case will be rejected.

23 Case No.:276/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD., Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020<br>Lic.No/Date:0510401758<br>22.02.2017 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/01733/AM19/ RLA File<br>:05/23/040/00561/AM17/
**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.

t<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.

Case No.:382/4/82-ALC4/2017 Party Name:ELPPE Meet No/Date:1/82- Status:
CHEMICALS PRIVATE ALC4/2020 Deferred
LIMITED 17.04.2020
HQ File RLA File Lic.No/Date:0310812684 Defer Date:
:01/82/050/00390/AM18/ :03/94/040/00036/AM18/ 24.04.2017

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 24 Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 11.06.2020 :

(i) Justification for low yield, that is 72% and 56% with supporting data. (ii) Production – Consumption data for the last two years duly certified by GST authority.

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

9

he last two years duly certified by GST authority.**

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

9

Case No.:294/15/82- Party Name:SUPREET Meet No/Date:1/82- Status:
ALC4/2018 CHEMICALS PVT.LTD. ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:5210042249 Defer Date:
:01/82/050/01751/AM19/ :52/24/040/00006/AM18/ 02.05.2017

Decision: The Committee considered the case as per online agenda in the presence of technical experts 25 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 13.02.2020 :

(i) Recovery of By-Product i.e. Para Amino Phenol and its commercial value.

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

Case No.:282/15/82- Party Name:MSN Meet No/Date:1/82- Status:
ALC4/2018 PHARMACHEM PRIVATE ALC4/2020 Approved
LIMITED 17.04.2020
HQ File RLA File Lic.No/Date:0910065021
:01/82/050/01739/AM19/ :09/24/040/00067/AM18/ 11.05.2017

|ALC4/2018||PHARMACHEM PRIVATE||ALC4/2020||Approved| |||LIMITED||17.04.2020||| |HQ File||RLA File||Lic.No/Date:0910065021||| |:01/82/050/01739/AM19/||:09/24/040/00067/AM18/||11.05.2017|||

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 4/82-ALC4/2018 dated 19.06.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: 26

applied by the firm, whichever is less:
Export Product Qty. Sl. No Import Product Qty.
Oseltamivir Phosphate 1 kg 1. Shikimic acid 1.66 kg
2. 2,2 -DimethoxyPropane 1.58 kg
3 3 - Pentanone 5.57 kg
4 Triethylsilane 0.90 kg
5 Triethylamine 1.00 kg
6 Trifluoromethane Sulfonic acid 0.100 kg

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

27 Case No.:289/15/82-<br>ALC4/2018 Party Name:ATUL LIMITED, Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020<br>Lic.No/Date:0810140311<br>18.05.2017 Status:<br>Deferred
HQ File<br>:01/82/050/01746/AM19/ RLA File<br>:08/24/040/00043/AM18/ Defer Date:
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide its e-mail dated 25.02.2020 has furnished its reply. Deferred for comments of<br>TE.

10

the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide its e-mail dated 25.02.2020 has furnished its reply. Deferred for comments of<br>TE.||||

10

Case No.:290/15/82- Party Name:WINTAC Meet No/Date:1/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0710111636 Defer Date:
:01/82/050/01747/AM19/ :07/24/040/00052/AM18/ 23.05.2017

Decision: The Committee considered the case as per online agenda in the presence of technical experts 28 and it was noted that the firm still has not furnished the 4.07 application of subject Advancer Authorization as asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 21.02.2020 as per Policy Circular No. 23/2015-20 dated 15.05.2019.

Hence, it was decided to issue Final Reminder to firm with the request to furnish a copy of 4.07 application of the subject advance authorization immediately to this Directorate as per Policy Circular No. 23/2015-20, dated 15.05.2019, failing which its case will be rejected.

Case No.:291/15/82- Party Name:WINTAC Meet No/Date:1/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0710111650 Defer Date:
:01/82/050/01748/AM19/ :07/24/040/00056/AM18/ 24.05.2017

-|---| |ALC4/2018||LIMITED,||ALC4/2020||Deferred| |||||17.04.2020||| |HQ File||RLA File||Lic.No/Date:0710111650||Defer Date:| |:01/82/050/01748/AM19/||:07/24/040/00056/AM18/||24.05.2017|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts 29 and it was noted that the firm still has not furnished the 4.07 application of subject Advancer Authorization as asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 21.02.2020 as per Policy Circular No. 23/2015-20 dated 15.05.2019.

Hence, it was decided to issue Final Reminder to firm with the request to furnish a copy of 4.07 application of the subject advance authorization immediately to this Directorate as per Policy Circular No. 23/2015-20, dated 15.05.2019, failing which its case will be rejected.

Case No.:525/4/82-ALC4/2017 Party Name:CIPLA LIMITED. Meet No/Date:1/82- Status:
ALC4/2020 Approved
17.04.2020
HQ File RLA File Lic.No/Date:0310813980
:01/82/050/00533/AM18/ :03/94/040/00211/AM18/ 14.06.2017

atus:**| |---|---|---|---|---|---|---| |||||ALC4/2020||Approved| |||||17.04.2020||| |HQ File||RLA File||Lic.No/Date:0310813980||| |:01/82/050/00533/AM18/||:03/94/040/00211/AM18/||14.06.2017|||

**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in **Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in **Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in **Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in **Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in **Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in **Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in
meeting no. 3/82-ALC4/2018
dated 05.06.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as
applied by the firm, whichever is less:
30 Export product Qty. Sl.<br>No. Import items Qty.

t was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as||||||| |||applied by the firm, whichever is less:||||||| |30|||Export product|Qty.|Sl.<br>No.|Import items|Qty. allowed<br>mg/tablet|| ||||Tenofovir Disoproxil Fumarate|1 Number|1|Efavirenz|612.0|| ||||300mg+ Lamivudine 300mg +||2|Lamivudine|306.0|| ||||Efavirenz 600mg Tablets||3|9-[2-(Phosphonyl Methoxy)|235.3|| ||||Each Tablet contain Efavirenz|||Propyl] Adenine (PMPA)||| ||||600mg + Tenofovir Disoproxil||4|Chloromethyl Isopropyl|413.92|| ||||Fumarate 300mg + Lamivudine<br>300mg Tablets||5<br>6|Carbonate<br>N-Methyl 2-Pyrrolidone<br>Methylene Dichloride|455.27<br>2050.20|| |||RA concerned maytake further necessaryaction asper above decision of NC.|||||||

11

Case No.:109/12/82- Party Name:VIVIMED LABS Meet No/Date:1/82- Status:
ALC4/2017 LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0910065247 Defer Date:
:01/82/050/01064/AM18/ :09/24/040/00181/AM18/ 06.07.2017

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following informationas asked for by NC-3 in its 31 Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 13.02.2020 :

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

2-ALC4/2019 dated 17.01.2020** , followed by Reminder on 13.02.2020 :

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

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

32 Case No.:309/15/82-<br>ALC4/2018 Party Name:DISCOVERY<br>INTERMEDIATES PVT LTD. Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01766/AM19/ RLA File<br>:09/24/040/00157/AM18/ Lic.No/Date:0910065252<br>07.07.2017 Defer Date:
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it was<br>noted that the firm vide its e-mail dated 20.02.2020 has furnished its reply. Deferred for comments of TE.
33 Case No.:311/15/82-<br>ALC4/2018 Party Name:ASSOCIATED<br>DYESTUFF PVT. LTD Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01768/AM19/ RLA File<br>:08/24/040/00123/AM18/ Lic.No/Date:0810140725<br>26.07.2017 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019

ot<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

34 Case No.:297/12/82-<br>ALC4/2018 Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED, Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<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 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>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

12

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

12

Case No.:116/12/82- Party Name:VIVIMED LABS Meet No/Date:1/82- Status:
ALC4/2017 LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0910065373 Defer Date:
:01/82/050/01071/AM18/ :09/24/040/00234/AM18/ 23.08.2017

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 35 Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 13.02.2020 :

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

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

Case No.:134/12/82- Party Name:VIVIMED LABS Meet No/Date:1/82- Status:
ALC4/2017 LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0910065372 Defer Date:
:01/82/050/01089/AM18/ :09/24/040/00233/AM18/ 23.08.2017

--|---| |ALC4/2017||LIMITED||ALC4/2020||Deferred| |||||17.04.2020||| |HQ File||RLA File||Lic.No/Date:0910065372||Defer Date:| |:01/82/050/01089/AM18/||:09/24/040/00233/AM18/||23.08.2017|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 36 Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 13.02.2020 :

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

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

Case No.:131/12/82- Party Name:VIVIMED LABS Meet No/Date:1/82- Status:
ALC4/2017 LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0910065396 Defer Date:
:01/82/050/01086/AM18/ :09/24/040/00238/AM18/ 28.08.2017

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting 37 No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 13.02.2020 :

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

2-ALC4/2019 dated 17.01.2020** , followed by Reminder on 13.02.2020 :

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

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

13

Case No.:132/12/82- Party Name:VIVIMED LABS Meet No/Date:1/82- Status:
ALC4/2017 LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0910065398 Defer Date:
:01/82/050/01087/AM18/ :09/24/040/00235/AM18/ 28.08.2017

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting 38 No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 13.02.2020 :

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

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

Case No.:141/12/82- Party Name:VIVIMED LABS Meet No/Date:1/82- Status:
ALC4/2017 LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0910065397 Defer Date:
:01/82/050/01096/AM18/ :09/24/040/00236/AM18/ 28.08.2017

--|---| |ALC4/2017||LIMITED||ALC4/2020||Deferred| |||||17.04.2020||| |HQ File||RLA File||Lic.No/Date:0910065397||Defer Date:| |:01/82/050/01096/AM18/||:09/24/040/00236/AM18/||28.08.2017|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 39 Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 13.02.2020 :

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

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

40 Case No.:321/15/82-<br>ALC4/2018 Party Name:AASHA<br>BIOCHEM Meet No/Date:1/82-<br>ALC4/2020<br>17042020 Status:<br>Deferred
..
HQ File<br>:01/82/050/01778/AM19/ RLA File<br>10/24/040/00018/AM18/ Lic.No/Date:1010059805<br>31082017 Defer Date:
: ..
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it was<br>noted that the firm vide its e-mail dated 25022020 has furnished its relDeferred for comments of TE
..py. .

the case as per agenda in the presence of technical experts and it was<br>noted that the firm vide its e-mail dated 25022020 has furnished its relDeferred for comments of TE|||| ||..py. .||||

41 Case No.:198/4/82-<br>ALC4/2018 Party Name:SAPTAGIR<br>CAMPHOR LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
HQ File<br>:01/82/050/00198/AM19/ RLA File<br>:09/24/040/00293/AM18/ Lic.No/Date:0910065468<br>15.09.2017 Defer Date:
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide its e-mail dated 24.02.2020 has furnished its reply. Deferred for comments of<br>TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide its e-mail dated 24.02.2020 has furnished its reply. Deferred for comments of TE.

14

Case No.:327/15/82-<br>Party Name:JODAS EXPOIM<br>Meet No/Date:1/82- Status:
ALC4/2018<br>PVT.LTD.,<br>ALC4/2020 Deferred
17.04.2020
42 HQ File<br>:01/82/050/01784/AM19/<br>RLA File<br>:05/23/040/00268/AM18/<br>Lic.No/Date:0510404290<br>13.10.2017 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

|||available. Hence, it was decided to call for a copy of 4.07 application of the subject advance|authorization|| |||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.

Case No.:328/15/82-<br>Party Name:JODAS EXPOIM<br>Meet No/Date:1/82- Status:
ALC4/2018<br>PVT.LTD.,<br>ALC4/2020 Deferred
17.04.2020
43 HQ File<br>:01/82/050/01785/AM19/<br>RLA File<br>:05/23/040/00266/AM18/<br>Lic.No/Date:0510404285<br>13.10.2017 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
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.

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.:329/15/82-<br>Party Name:JODAS EXPOIM<br>Meet No/Date:1/82- Status:
ALC4/2018<br>PVT.LTD.,<br>ALC4/2020 Deferred
17.04.2020
44 HQ File<br>:01/82/050/01786/AM19/<br>RLA File<br>:05/23/040/00267/AM18/<br>Lic.No/Date:0510404287<br>13.10.2017 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
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.

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.:550/15/82- Party Name:TADIMETY Meet No/Date:1/82- Status:
ALC4/2018 AROMATICS PVT. LTD ALC4/2020 Deferred
17.04.2020
45 HQ File<br>:01/82/050/02007/AM19/ RLA File<br>:07/24/040/00202/AM18/ Lic.No/Date:0710112366<br>08.11.2017 Defer Date:
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it
was noted that the firm vide its e-mail dated 21.03.2020 has furnished its reply. Deferred for comments
of TE.

15

Case No.:236/4/82- Party Name:VIVIMED LABS Meet No/Date:1/82- Status:
ALC4/2018 LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0910065688 Defer Date:
:01/82/050/00236/AM19/ :09/24/040/00403/AM18/ 24.11.2017

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 46 Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 13.02.2020 :

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

2-ALC4/2019 dated 17.01.2020** , followed by Reminder on 13.02.2020 :

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

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

Case No.:243/4/82- Party Name:VIVIMED LABS Meet No/Date:1/82- Status:
ALC4/2018 LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0910065687 Defer Date:
:01/82/050/00243/AM19/ :09/24/040/00404/AM18/ 24.11.2017

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 47 Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 13.02.2020 :

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

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

ntary evidence. (ii) Complete set of 4.07 application.**

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

Case No.:1021/15/82-<br>Party Name:ANLON<br>Meet No/Date:1/82- Status:
ALC4/2018<br>HEALTHCARE<br>ALC4/2020 Deferred
PRIVATELIMITED<br>17.04.2020
48 HQ File<br>:01/82/050/02478/AM19/<br>RLA File<br>:24/24/040/00039/AM18/<br>Lic.No/Date:2410042334<br>12.01.2018 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
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.

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.

49 Case No.:12/4/82-ALC4/2018 Party Name:MELOG<br>SPECIALITY CHEMICALS<br>PVT. LTD. Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
HQ File<br>:01/82/050/00012/AM19/ RLA File<br>:03/95/040/00810/AM18/ Lic.No/Date:0310818490<br>15.01.2018 Defer Date:
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide its e-mail dated 07.11.2019 has furnished its reply. Deferred for comments of<br>TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide its e-mail dated 07.11.2019 has furnished its reply. Deferred for comments of TE.

16

Case No.:165/10/82- Party Name:AURORE LIFE Meet No/Date:1/82- Status:
ALC4/2018 SCIENCES PRIVATE ALC4/2020 Deferred
LIMITED 17.04.2020
HQ File RLA File Lic.No/Date:0910065915 Defer Date:
:01/82/050/00452/AM19/ :09/24/040/00438/AM18/ 20.01.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 50 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 13.02.2020 :

and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 13.02.2020 :

(i) Percentage of yield on molar basis for each step.

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

Case No.:187/10/82- Party Name:NISARG Meet No/Date:1/82- Status:
ALC4/2018 BIOSCIENCES PVT LTD ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0910065945 Defer Date:
:01/82/050/00474/AM19/ :09/24/040/00497/AM18/ 31.01.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting 51 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.

52 <br>Case No.:132/10/82-<br>ALC4/2018 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 Defer Date:
**Decision:**Deferred for comments of TE.

17

Case No.:131/10/82- Case No.:131/10/82- Party Name:SUVEN LIFE Party Name:SUVEN LIFE Party Name:SUVEN LIFE Party Name:SUVEN LIFE Party Name:SUVEN LIFE Meet No/Date:1/82- Meet No/Date:1/82- Status:
53 <br>ALC4/2018 <br>SCIENCES LIMITED ALC4/2020<br>17.04.2020 <br>Approved
HQ File<br>:01/82/050/00418/AM19/ RLA File Lic.No/Date:091006 5961
:09/24/040/00561/AM18/ 02.02.2018
**Decision:**The Committee considered<br>meeting<br>no.<br>31.01.2020, it was decided to ratify norms<br>by the firm, whichever is less: onsidered the cases as per age nda and in the light of earl ier decision taken in
<br>13/82-ALC4/2019<br>dated<br>under Para 4.7 of HBP v1 as per details given below or as applied
Export product Qty. Sl.<br>N Import items Qty.
o.
Cis MONOQUATERNARY<br>BESYLATE SALT ACID 1 kg 1 HOM OVERATRYLAMINE 2.10 kg
2 HOM OVERATRIC ACID 2.27 kg
3 RuCI[ (S,S)-Tsdpen(p-cymene)] 0.010 kg
4 ACET <br>ONITRILE <br>3.10 kg
5 TETR AHYDROFURAN 3.57 kg

kg|1|HOM||OVERATRYLAMINE||2.10 kg| ||||||2|HOM||OVERATRIC ACID||2.27 kg| ||||||3|RuCI[||(S,S)-Tsdpen(p-cymene)]||0.010 kg| ||||||4|ACET||<br>ONITRILE||<br>3.10 kg| ||||||5|TETR||AHYDROFURAN||3.57 kg| ||RA concerned maytake further necessaryaction asper above decision of NC.|||||||||| ||||||||||||

Case No.:135/10/82- Party Name:NISARG Meet No/Date:1/82- Status:
ALC4/2018 BIOSCIENCES PVT LTD ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0910065963 Defer Date:
:01/82/050/00422/AM19/ :09/24/040/00498/AM18/ 02.02.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 54 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.

Case No.:140/10/82- Party Name:ORTIN Meet No/Date:1/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2020 Deferred
17.04.2020
55 HQ File RLA File Lic.No/Date:0910065968 Defer Date:
:01/82/050/00427/AM19/ :09/24/040/00527/AM18/ 06.02.2018
**Decision:**Deferred for comments of TE.

18

17.04.2020||| |55||HQ File||RLA File||Lic.No/Date:0910065968||Defer Date:| |||:01/82/050/00427/AM19/||:09/24/040/00527/AM18/||06.02.2018||| |||**Decision:**Deferred for comments of TE.|||||||

18

Case No.:142/4/82-ALC4/2018 Party Name:HERBOCHEM Meet No/Date:1/82- Status:
INDUSTRIES ALC4/2020 Deferred
17.04.2020
56 HQ File<br>:01/82/050/00142/AM19/ RLA File<br>:06/24/040/00047/AM18/ Lic.No/Date:0610038810<br>07.02.2018 Defer Date:
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it
was noted that the firm vide its e-mail dated 25.02.2020 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 its e-mail dated 25.02.2020 has furnished its reply. Deferred for comments of TE.

Case No.:166/10/82- Party Name:ORTIN Meet No/Date:1/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2020 Deferred
17.04.2020
57 HQ File RLA File Lic.No/Date:0910065973 Defer Date:
:01/82/050/00453/AM19/ :09/24/040/00528/AM18/ 07.02.2018
**Decision:**Deferred for comments of TE.

|||||17.04.2020||| |57||HQ File||RLA File||Lic.No/Date:0910065973||Defer Date:| |||:01/82/050/00453/AM19/||:09/24/040/00528/AM18/||07.02.2018||| |||**Decision:**Deferred for comments of TE.|||||||

Case No.:819/15/82-<br>Party Name:DHANUKA Meet No/Date:1/82- Status:
ALC4/2018<br>LABORATORIES LTD ALC4/2020 Deferred
17.04.2020
58 HQ File<br>:01/82/050/02276/AM19/<br>RLA File<br>:05/23/040/00440/AM18/ Lic.No/Date:0510405609<br>09.02.2018 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
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.

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.:1009/15/82- Party Name:TADIMETY Meet No/Date:1/82- Status:
ALC4/2018 AROMATICS PVT. LTD ALC4/2020 Deferred
17.04.2020
59 HQ File<br>:01/82/050/02466/AM19/ RLA File<br>:07/24/040/00305/AM18/ Lic.No/Date:0710112820<br>13.02.2018 Defer Date:
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it
was noted that the firm vide its 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 its e-mail dated 16.11.2019 has furnished its reply. Deferred for comments of TE.

60 Case No.:82/10/82-ALC4/2018 Party Name:FRESENIUS KABI<br>INDIA PRIVATE LTD Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
HQ File<br>:01/82/050/00369/AM19/ RLA File<br>:03/94/040/00911/AM18/ Lic.No/Date:0310819230<br>19.02.2018 Defer Date:
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide its e-mail dated 14.10.2019 has furnished its reply to the query raised during PH<br>on 20.09.2019. Deferred for comments of TE.

ce of technical experts and it<br>was noted that the firm vide its e-mail dated 14.10.2019 has furnished its reply to the query raised during PH<br>on 20.09.2019. 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 its e-mail dated 14.10.2019 has furnished its reply to the query raised during PH on 20.09.2019. Deferred for comments of TE.

19

61 Case No.:93/10/82-ALC4/2018 Party Name:YASHO<br>INDUSTRIES PVT.LTD. Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 Defer Date:
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it was<br>noted that the firm vide its letter 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 its letter dated 24.10.2019 has furnished its reply. Deferred for comments of TE.

62 <br>Case No.:47/13/82-ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01025/AM19/ RLA File<br>:09/24/040/00587/AM18/ Lic.No/Date:0910066003<br>20.02.2018 Defer Date:
**Decision:**Deferred for comments of TE.

| |---|---|---|---|---| ||<br>HQ File<br>:01/82/050/01025/AM19/|RLA File<br>:09/24/040/00587/AM18/|Lic.No/Date:0910066003<br>20.02.2018|Defer Date:| ||**Decision:**Deferred for comments of TE.||||

63 Case No.:186/13/82-<br>ALC4/2018 Party Name:SONGWON<br>SPECIALTY CHEMICALS<br>INDIA PVT. LTD. Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01164/AM19/ RLA File<br>:34/24/040/00341/AM18/ Lic.No/Date:3410043908<br>22.02.2018 Defer Date:
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide its e-mail dated 01.11.2019 has furnished its reply. Deferred for comments of<br>TE.

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

Case No.:286/4/82-ALC4/2018 Party Name:SURVIVAL Meet No/Date:1/82- Status: TECHNOLOGIES PVT.LTD. ALC4/2020 Deferred 17.04.2020 HQ File RLA File Lic.No/Date:0310819412 Defer Date: 64 :01/82/050/00286/AM19/ :03/95/040/00993/AM18/ 26.02.2018 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide its e-mail dated 20.06.2019 has furnished its reply . Deferred for comments of TE.

mmittee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide its e-mail dated 20.06.2019 has furnished its reply . Deferred for comments of TE.

65 <br>Case No.:125/13/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01103/AM19/ RLA File<br>:09/24/040/00611/AM18/ Lic.No/Date:0910066054<br>12.03.2018 Defer Date:
**Decision:**Deferred for comments of TE.

20

66 Case No.:33/13/82-ALC4/2018 Party Name:VISWAAT<br>CHEMICALS LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01011/AM19/ RLA File<br>:03/95/040/01027/AM18/ Lic.No/Date:0310819857<br>16.03.2018 Defer Date:
**Decision:**The firm vide email dated. 14.02.2020 has stated that due to oversight, the application was<br>filled for ratification of norms instead of repeat norms. Accordingly they have requested to consider the<br>norms for the licence number 0310819857 dated 16.03.2018 as Repeat Norms basis.

Decision: The firm vide email dated. 14.02.2020 has stated that due to oversight, the application was filled for ratification of norms instead of repeat norms. Accordingly they have requested to consider the norms for the licence number 0310819857 dated 16.03.2018 as Repeat Norms basis.

ication was filled for ratification of norms instead of repeat norms. Accordingly they have requested to consider the norms for the licence number 0310819857 dated 16.03.2018 as Repeat Norms basis.

67 Case No.:127/13/82-<br>ALC4/2018 Party Name:SPANSULES<br>FORMULATIONS Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01105/AM19/ RLA File<br>:09/24/040/00619/AM18/ Lic.No/Date:0910066066<br>20.03.2018 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail<br>dated 03.09.2019 has furnished its reply. Deferred for comments of TE.
68 Case No.:258/12/82-<br>ALC4/2018 Party Name:SYNTHO<br>CHIRALS PRIVATE LIMITED <br>Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00885/AM19/ RLA File<br>:09/24/040/00669/AM18/ Lic.No/Date:0910066087<br>26.03.2018 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail<br>dated 25.02.2020 has furnished its reply. Deferred for comments of TE.
69 <br>Case No.:126/13/82-<br>ALC4/2018 Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01104/AM19/ RLA File<br>:09/24/040/00639/AM18/ Lic.No/Date:0910066086<br>26.03.2018 Defer Date:
**Decision:**Deferred for comments of TE.

21

-|---|---|---|---| ||<br>HQ File<br>:01/82/050/01104/AM19/|RLA File<br>:09/24/040/00639/AM18/|Lic.No/Date:0910066086<br>26.03.2018|Defer Date:| ||**Decision:**Deferred for comments of TE.||||

21

Case No.:5/10/82-ALC4/2018 Party Name:DCM SHRIRAM Meet No/Date:1/82- Status:
INDUSTRIES LTD, ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0510406067 Defer Date:
:01/82/050/00292/AM19/ :05/23/040/00515/AM18/ 09.04.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 70 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

71 Case No.:1014/15/82-<br>ALC4/2018 Party Name:TADIMETY<br>AROMATICS PVT. LTD Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail<br>dated 16.11.2019 has furnished its reply. Deferred for comments of TE.

r Date:| ||**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail<br>dated 16.11.2019 has furnished its reply. Deferred for comments of TE.||||

72 <br>Case No.:261/12/82-<br>ALC4/2018 <br>Case No.:261/12/82-<br>ALC4/2018 Party Name:AKTINOS<br>HEALTHCARE PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00888/AM19/ RLA File<br>:09/24/040/00668/AM18/ Lic.No/Date:0910066131<br>11.04.2018 Defer Date:
**Decision:**Deferred for comments of TE.
73 <br>Case No.:156/13/82-<br>ALC4/2018 Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01134/AM19/ RLA File<br>:09/24/040/00654/AM18/ Lic.No/Date:0910066137<br>12.04.2018 Defer Date:
**Decision:**Deferred for comments of TE.

22

Deferred**|| ||<br>HQ File<br>:01/82/050/01134/AM19/|RLA File<br>:09/24/040/00654/AM18/||Lic.No/Date:0910066137<br>12.04.2018||Defer Date:|| ||**Decision:**Deferred for comments of TE.|||||||

22

Case No.:26/15/82-ALC4/2018Party Name:GLAND<br>Meet No/Date:1/82- Status:
CHEMICALS PVT LTD<br>ALC4/2020 Deferred
17.04.2020
74 HQ File<br>:01/82/050/01483/AM19/<br>RLA File<br>:09/24/040/00008/AM19/<br>Lic.No/Date:0910066148<br>17.04.2018 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
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.

Case No.:122/13/82- Party Name:SUVEN LIFE Meet No/Date:1/82- Status:
ALC4/2018 SCIENCES LIMITED ALC4/2020 Deferred
17.04.2020
75 HQ File RLA File Lic.No/Date:0910066156 Defer Date:
:01/82/050/01100/AM19/ :09/24/040/00024/AM19/ 18.04.2018
**Decision:**Deferred for comments of TE.

|||||17.04.2020||| |75||HQ File||RLA File||Lic.No/Date:0910066156||Defer Date:| |||:01/82/050/01100/AM19/||:09/24/040/00024/AM19/||18.04.2018||| |||**Decision:**Deferred for comments of TE.|||||||

Case No.:6/15/82- Party Name:AUROBINDO Meet No/Date:1/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2020 Deferred
17.04.2020
76 HQ File RLA File Lic.No/Date:0910066157 Defer Date:
:01/82/050/01463/AM19/ :09/24/040/00015/AM19/ 18.04.2018
**Decision:**Deferred for comments of TE.
Case No.:153/12/82- Party Name:ETERNIS FINE Meet No/Date:1/82- Status:
ALC4/2018 CHEMICALS LIMITED, ALC4/2020 Deferred
17.04.2020
77 HQ File RLA File Lic.No/Date:0310820647 Defer Date:
:01/82/050/00780/AM19/ :03/94/040/00055/AM19/ 25.04.2018
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail
dated 17.06.2019 has furnished its reply. Deferred for comments of TE.
Case No.:121/13/82- Party Name:VIVIMED LABS Meet No/Date:1/82- Status:
ALC4/2018 LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0910066198 Defer Date:
:01/82/050/01099/AM19/ :09/24/040/00044/AM19/ 04.05.2018

--|---| |ALC4/2018||LIMITED||ALC4/2020||Deferred| |||||17.04.2020||| |HQ File||RLA File||Lic.No/Date:0910066198||Defer Date:| |:01/82/050/01099/AM19/||:09/24/040/00044/AM19/||04.05.2018|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts 78 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 13.02.2020 :

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

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

23

79 <br>Case No.:225/10/82-<br>ALC4/2018 Party Name:DR J<br>PHARMACHEM PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00512/AM19/ RLA File<br>:31/83/040/00014/AM19/ Lic.No/Date:3110067038<br>07.05.2018 Defer Date:
**Decision:**Deferred for comments of TE.
80 <br>Case No.:107/13/82-<br>ALC4/2018 Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01085/AM19/ RLA File<br>:09/24/040/00006/AM19/ Lic.No/Date:0910066210<br>09.05.2018 Defer Date:
**Decision:**Deferred for comments of TE.

| |---|---|---|---|---| ||<br>HQ File<br>:01/82/050/01085/AM19/|RLA File<br>:09/24/040/00006/AM19/|Lic.No/Date:0910066210<br>09.05.2018|Defer Date:| ||**Decision:**Deferred for comments of TE.||||

81 <br>Case No.:250/10/82-<br>ALC4/2018 Party Name:AETHER<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00537/AM19/ RLA File<br>:52/24/040/00016/AM19/ Lic.No/Date:5210042638<br>10.05.2018 Defer Date:
**Decision:**Deferred for comments of TE.
82 Case No.:196/12/82-<br>ALC4/2018 Party Name:SHREE BANKEY<br>BEHARI LAL FLAVORS Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Approved
HQ File<br>:01/82/050/00823/AM19/ RLA File<br>:05/24/040/00067/AM19/ Lic.No/Date:0510406412<br>10.05.2018
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting<br>no.<br>13/82-ALC4/2019<br>dated<br>31.01.2020, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied<br>by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>L-MENTHOL /MENTHOL<br>(LAVEO) / MENTHOL(L) / LIQUID<br>MENTHOL<br>1 kg<br>1<br>META - CRESOL ABOVE<br>98.5% PURE<br>0.922 kg<br>2<br>ISO PROPYL ALCOHOL<br>0.543 kg<br>3<br>ARROWZYME/LIPASE<br>AMANO IME<br>0.01 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

24

98.5% PURE<br>0.922 kg<br>2<br>ISO PROPYL ALCOHOL<br>0.543 kg<br>3<br>ARROWZYME/LIPASE<br>AMANO IME<br>0.01 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.||||

24

Case No.:366/15/82- Party Name:WINTAC Meet No/Date:1/82- Status:
ALC4/2018 LIMITED, ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0710113260 Defer Date:
:01/82/050/01823/AM19/ :07/24/040/00008/AM19/ 10.05.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 83 and it was noted that the firm still has not furnished the 4.07 application of subject Advancer Authorization as asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 21.02.2020 as per Policy Circular No. 23/2015-20 dated 15.05.2019.

Hence, it was decided to issue Final Reminder to firm with the request to furnish a copy of 4.07 application of the subject advance authorization immediately to this Directorate as per Policy Circular No. 23/2015-20, dated 15.05.2019, failing which its case will be rejected.

Case No.:120/13/82- Party Name:ORTIN Meet No/Date:1/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2020 Deferred
17.04.2020
84 HQ File RLA File Lic.No/Date:0910066236 Defer Date:
:01/82/050/01098/AM19/ :09/24/040/00614/AM18/ 15.05.2018
**Decision:**Deferred for comments of TE.

|||||17.04.2020||| |84||HQ File||RLA File||Lic.No/Date:0910066236||Defer Date:| |||:01/82/050/01098/AM19/||:09/24/040/00614/AM18/||15.05.2018||| |||**Decision:**Deferred for comments of TE.|||||||

Case No.:18/13/82- Party Name:SMS Meet No/Date:1/82- Status:
ALC4/2018 LIFESCIENCES INDIA ALC4/2020 Deferred
LIMITED 17.04.2020
85 HQ File RLA File Lic.No/Date:0910066242 Defer Date:
:01/82/050/00996/AM19/ :09/24/040/00067/AM19/ 18.05.2018
**Decision:**Deferred for comments of TE.
Case No.:168/12/82- Party Name:MANGALAM Meet No/Date:1/82- Status:
ALC4/2018 ORGANICS LIMITED ALC4/2020 Deferred
FORMERLY DUJODWALA 17.04.2020
PRODU
HQ File RLA File Lic.No/Date:0310821107 Defer Date:
:01/82/050/00795/AM19/ :03/95/040/01140/AM18/ 21.05.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 86 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 at every stage

25

y 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

25

Case No.:373/15/82- Party Name:TADIMETY Meet No/Date:1/82- Status:
ALC4/2018 AROMATICS PVT. LTD ALC4/2020 Deferred
17.04.2020
87 HQ File RLA File Lic.No/Date:0710113330 Defer Date:
:01/82/050/01830/AM19/ :07/24/040/00046/AM19/ 25.05.2018
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail
dated 16.11.2019 has furnished its reply. Deferred for comments of TE.
Case No.:39/13/82-ALC4/2018 Party Name:ORTIN Meet No/Date:1/82- Status:
LABORATORIES LTD ALC4/2020 Deferred
17.04.2020
88 HQ File RLA File Lic.No/Date:0910066291 Defer Date:
:01/82/050/01017/AM19/ :09/24/040/00082/AM19/ 01.06.2018
**Decision:**Deferred for comments of TE.
Case No.:376/15/82- Party Name:GRANULES Meet No/Date:1/82- Status: Deferred
ALC4/2018 INDIA LIMITED ALC4/2020
17.04.2020
HQ File RLA File Lic.No/Date:0910066295 Defer Date:
:01/82/050/01833/AM19/ :09/24/040/00099/AM19/ 04.06.2018

|---|---|---| |ALC4/2018||INDIA LIMITED||ALC4/2020||| |||||17.04.2020||| |HQ File||RLA File||Lic.No/Date:0910066295||Defer Date:| |:01/82/050/01833/AM19/||:09/24/040/00099/AM19/||04.06.2018|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts 89 and it was noted that the firm still has not furnished the 4.07 application of subject Advancer Authorization as asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 21.02.2020 as per Policy Circular No. 23/2015-20 dated 15.05.2019.

Hence, it was decided to issue Final Reminder to firm with the request to furnish a copy of 4.07 application of the subject advance authorization immediately to this Directorate as per Policy Circular No. 23/2015-20, dated 15.05.2019, failing which its case will be rejected.

Case No.:378/15/82-<br>Party Name:JODAS EXPOIM<br>Meet No/Date:1/82- Status:
ALC4/2018<br>PVT.LTD<br>ALC4/2020 Deferred
17.04.2020
90 HQ File<br>:01/82/050/01835/AM19/<br>RLA File<br>:05/23/040/00080/AM19/<br>Lic.No/Date:0510406733<br>05.06.2018 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

|||available. Hence, it was decided to call for a copy of 4.07 application of the subject advance|authorization|| |||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.

Case No.:379/15/82- Party Name:JODAS EXPOIM Meet No/Date:1/82- Status:
ALC4/2018 PVT.LTD ALC4/2020 Deferred
17.04.2020
91 HQ File RLA File Lic.No/Date:0510406734 Defer Date:
:01/82/050/01836/AM19/ :05/23/040/00070/AM19/ 05.06.2018
**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.

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.

26

de 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.

26

Case No.:380/15/82-<br>Party Name:JODAS EXPOIM<br>Meet No/Date:1/82- Status:
ALC4/2018<br>PVT.LTD<br>ALC4/2020 Deferred
17.04.2020
92 HQ File<br>:01/82/050/01837/AM19/<br>RLA File<br>:05/23/040/00022/AM19/<br>Lic.No/Date:0510406736<br>05.06.2018 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
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.

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.:279/10/82- Party Name:J.B. CHEMICALS Meet No/Date:1/82- Status:
ALC4/2018 & PHARMACEUTICALS ALC4/2020 Deferred
LIMITED 17.04.2020
93 HQ File<br>:01/82/050/00566/AM19/ RLA File<br>:03/94/040/00207/AM19/ Lic.No/Date:0310821556<br>08.06.2018 Defer Date:
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it
was noted that the firm vide its e-mail dated 14.02.2020 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 its e-mail dated 14.02.2020 has furnished its reply. Deferred for comments of TE.

Case No.:81/12/82-ALC4/2018 Party Name:KOPRAN Meet No/Date:1/82- Status:
RESEARCH LABORATORIES ALC4/2020 Deferred
LTD. 17.04.2020
94 HQ File RLA File Lic.No/Date:0310821554 Defer Date:
:01/82/050/00708/AM19/ :03/94/040/00194/AM19/ 08.06.2018
**Decision:**Deferred for comments of TE.

TD.||17.04.2020||| |94||HQ File||RLA File||Lic.No/Date:0310821554||Defer Date:| |||:01/82/050/00708/AM19/||:03/94/040/00194/AM19/||08.06.2018||| |||**Decision:**Deferred for comments of TE.|||||||

Case No.:60/15/82- Party Name:ALPHAMED Meet No/Date:1/82- Status:
ALC4/2018 FORMULATIONS P LTD. ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0910066310 Defer Date:
:01/82/050/01517/AM19/ :09/24/040/00075/AM19/ 08.06.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 95 and it was noted that the firm still has not furnished the 4.07 application of subject Advancer Authorization as asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 21.02.2020 as per Policy Circular No. 23/2015-20 dated 15.05.2019.

Hence, it was decided to issue Final Reminder to firm with the request to furnish a copy of 4.07 application of the subject advance authorization immediately to this Directorate as per Policy Circular No. 23/2015-20, dated 15.05.2019, failing which its case will be rejected.

ish a copy of 4.07 application of the subject advance authorization immediately to this Directorate as per Policy Circular No. 23/2015-20, dated 15.05.2019, failing which its case will be rejected.

96 <br>Case No.:383/15/82-<br>ALC4/2018<br>HQ File<br> Party Name:JODAS EXPOIM<br>PVT.LTD Meet No/Date:1/82-<br>ALC4/2020<br> Status:<br>Deferred
17.04.2020
RLA File<br> Lic.No/Date:0510406800<br> Defer Date:
:01/82/050/01840/AM19/ :05/23/040/00121/AM19/ 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.

27

97 Case No.:385/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 Defer Date:
**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.

Case No.:59/13/82-ALC4/2018 Party Name:VIVIMED LABS Meet No/Date:1/82- Status:
LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0910066318 Defer Date:
:01/82/050/01037/AM19/ :09/24/040/00106/AM19/ 11.06.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following informationas asked for by NC-3 in its 98 Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 13.02.2020 :

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

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

Case No.:35/13/82- Party Name:VIVIMED LABS Meet No/Date:1/82- Status: ALC4/2018 LIMITED ALC4/2020 Deferred 17.04.2020 HQ File RLA File Lic.No/Date:0910066375 Defer Date: :01/82/050/01013/AM19/ :09/24/040/00136/AM19/ 22.06.2018

LABS Meet No/Date:1/82- Status: ALC4/2018 LIMITED ALC4/2020 Deferred 17.04.2020 HQ File RLA File Lic.No/Date:0910066375 Defer Date: :01/82/050/01013/AM19/ :09/24/040/00136/AM19/ 22.06.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following informationas asked for by NC-3 in its 99 Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 13.02.2020 :

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

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

28

Case No.:71/13/82- Party Name:VIVIMED LABS Meet No/Date:1/82- Status:
ALC4/2018 LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0910066374 Defer Date:
:01/82/050/01049/AM19/ :09/24/040/00134/AM19/ 22.06.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following informationas asked for by NC-3 in its 100 Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 13.02.2020 :

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

2-ALC4/2019 dated 17.01.2020** , followed by Reminder on 13.02.2020 :

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

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

Case No.:76/13/82- Party Name:VIVIMED LABS Meet No/Date:1/82- Status:
ALC4/2018 LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0910066376 Defer Date:
:01/82/050/01054/AM19/ :09/24/040/00135/AM19/ 22.06.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following informationas asked for by NC-3 in its 101 Meeting No. 12/82-ALC4/2019 dated 17.01.2020 , followed by Reminder on 13.02.2020 :

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

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

ntary evidence. (ii) Complete set of 4.07 application.**

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

102 Case No.:274/10/82-<br>ALC4/2018 Party Name:MELOG<br>SPECIALITY CHEMICALS<br>PVT. LTD. Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00561/AM19/ RLA File<br>:03/95/040/00235/AM19/ Lic.No/Date:0310821895<br>25.06.2018 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail<br>dated 07.11.2019 has furnished its reply. Deferred for comments of TE.
103 <br>Case No.:185/13/82-<br>ALC4/2018 Party Name:SPC LIFE<br>SCIENCES PVT. LTD. Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01163/AM19/ RLA File<br>:34/24/040/00109/AM19/ Lic.No/Date:3410044282<br>26.06.2018 Defer Date:
**Decision:**Deferred for comments of TE.

29

104 <br>Case No.:117/13/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01095/AM19/ RLA File<br>:09/24/040/00150/AM19/ Lic.No/Date:0910066395<br>27.06.2018 <br>Defer Date:
**Decision:**Deferred for comments of TE.

--|---|---|---|---| ||<br>HQ File<br>:01/82/050/01095/AM19/|RLA File<br>:09/24/040/00150/AM19/|Lic.No/Date:0910066395<br>27.06.2018|<br>Defer Date:| ||**Decision:**Deferred for comments of TE.||||

105 <br>Case No.:12/15/82-ALC4/2018 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01469/AM19/ RLA File<br>:09/24/040/00113/AM19/ Lic.No/Date:0910066403<br>28.06.2018 Defer Date:
**Decision:**Deferred for comments of TE.
106 <br>Case No.:221/12/82-<br>ALC4/2018 Party Name:IOL CHEMICALS<br>AND PHARMACEUTICALS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00848/AM19/ RLA File<br>:30/24/040/00017/AM19/ Lic.No/Date:3010104375<br>29.06.2018 Defer Date:
**Decision:**Deferred for comments of TE.
107 Case No.:417/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01874/AM19/ RLA File<br>:05/23/040/00167/AM19/ Lic.No/Date:0510407069<br>04.07.2018 Defer Date:
**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.

108 Case No.:418/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD <br>Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01875/AM19/ RLA File<br>:05/23/040/00163/AM19/ Lic.No/Date:0510407077<br>04.07.2018 <br>Defer Date:
**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.

30

109 Case No.:419/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD <br>Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 <br>Defer Date:
**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.

78<br>04.07.2018|<br>Defer Date:| ||**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.||||

Case No.:58/15/82-ALC4/2018 Party Name:AUROBINDO Meet No/Date:1/82- Status: PHARMA LIMITED ALC4/2020 Approved 17.04.2020 HQ File RLA File Lic.No/Date:0910066418 :01/82/050/01515/AM19/ :09/24/040/00168/AM19/ 04.07.2018 Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 1/82-ALC4/2019 dated 03.06.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Case No.:58/15/82-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:1/82-<br>ALC4/2020<br>17.04.2020 Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Approved
HQ File<br>:01/82/050/01515/AM19/ RLA File<br>:09/24/040/00168/AM19/ Lic.No/Date:0910066418<br>04.07.2018

2020<br>17.04.2020|Status:<br>Approved| |---|---|---|---|---|---|---|---|---| ||HQ File<br>:01/82/050/01515/AM19/|RLA File<br>:09/24/040/00168/AM19/||||Lic.No/Date:0910066418<br>04.07.2018||| |110|<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting<br>no.<br>1/82-ALC4/2019<br>dated 03.06.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as<br>applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>CEFEPIME FOR INJECTION<br>1 kg<br>1<br>Cefepime Hydrochloride<br>0.655 kg<br>2<br>L - Arginine<br>1.816 kg<br>3<br>Acetone<br>0.37 kg<br>4<br>Isopropyl Alcohol<br>0.392 kg<br>5<br>Methanol<br>Relevant as per<br>packing policy<br>RA concerned maytake further necessaryaction asper above decision of NC.|||||||| ||<br>Export product||Qty.|Sl.<br>No.|Import items||Qty.|| ||CEFEPIME FOR INJECTION||1 kg|1|Cefepime Hydrochloride||0.655 kg|| |||||2|L - Arginine||1.816 kg|| |||||3|Acetone||0.37 kg|| |||||4|Isopropyl Alcohol||0.392 kg|| |||||5|Methanol||Relevant as per<br>packing policy|| ||RA concerned maytake further necessaryaction asper above decision of NC.||||||||

111 <br>Case No.:389/15/82-<br>ALC4/2018 Party Name:ATUL LIMITED, Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 Defer Date:
**Decision:**Deferred for comments of TE.

| |---|---|---|---|---| ||<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|Defer Date:| ||**Decision:**Deferred for comments of TE.||||

112 Case No.:617/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 Defer Date:
**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

113 Case No.:96/12/82-ALC4/2018 Party Name:STERLING<br>AUXILIARIES PVT LTD Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00723/AM19/ RLA File<br>:03/95/040/00332/AM19/ Lic.No/Date:0310822247<br>11.07.2018 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail<br>dated 31.10.2019 has furnished its reply. Deferred for comments of TE.

Date:| ||**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail<br>dated 31.10.2019 has furnished its reply. Deferred for comments of TE.||||

114 <br>Case No.:46/15/82-ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01503/AM19/ RLA File<br>:09/24/040/00181/AM19/ Lic.No/Date:0910066442<br>11.07.2018 Defer Date:
**Decision:**Deferred for comments of TE.
Case No.:100/13/82- Party Name:RA CHEM Meet No/Date:1/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0910066457 Defer Date:
:01/82/050/01078/AM19/ :09/24/040/00188/AM19/ 13.07.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 115 Meeting No. 8/82-ALC4/2019 dated 06.09.2019, followed by Reminder on 31.10.2019 and Final Reminder on 13.02.2020.

(i) Drug Manufacturing License (DML) of the export product showing approved composition.

Case No.:189/13/82- Party Name:YASH RASAYAN Meet No/Date:1/82- Status:
ALC4/2018 & CHEMICALS ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:3410044333 Defer Date:
:01/82/050/01167/AM19/ :34/24/040/00114/AM19/ 16.07.2018

--| |ALC4/2018||& CHEMICALS||ALC4/2020||Deferred| |||||17.04.2020||| |HQ File||RLA File||Lic.No/Date:3410044333||Defer Date:| |:01/82/050/01167/AM19/||:34/24/040/00114/AM19/||16.07.2018|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 116 Meeting No. 8/82-ALC4/2019 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.

32

117 Case No.:432/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD <br>Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01889/AM19/ RLA File<br>:05/23/040/00183/AM19/ Lic.No/Date:0510407217<br>17.07.2018 <br>Defer Date:
**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.

Case No.:444/15/82- Party Name:OPTIMUS Meet No/Date:1/82- Status:
ALC4/2018 DRUGS PRIVATE LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0910066488 Defer Date:
:01/82/050/01901/AM19/ :09/24/040/00193/AM19/ 19.07.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020 , followed by Reminder on 18.03.2020 : 118

(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.

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

ED ENZYME POWDER. (iii) End-use of the export product.**

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

119 Case No.:448/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01905/AM19/ RLA File<br>:09/24/040/00200/AM19/ Lic.No/Date:0910066511<br>24.07.2018 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>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.

33

Case No.:239/13/82- Party Name:KEVA Meet No/Date:1/82- Status:
ALC4/2018 FRAGRANCES PRIVATE ALC4/2020 Deferred
LIMITED 17.04.2020
HQ File RLA File Lic.No/Date:0310822723 Defer Date:
:01/82/050/01217/AM19/ :03/94/040/00390/AM19/ 31.07.2018

18**||FRAGRANCES PRIVATE||ALC4/2020||Deferred| |||LIMITED||17.04.2020||| |HQ File||RLA File||Lic.No/Date:0310822723||Defer Date:| |:01/82/050/01217/AM19/||:03/94/040/00390/AM19/||31.07.2018|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information 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 120 on 18.03.2020.

(i) Exact name of the export product. (ii) Crude to finished product. (iii) Past production consumption data.

Case No.:460/15/82-<br>Party Name:WINTAC<br>Meet No/Date:1/82- Status:
ALC4/2018<br>LIMITED,<br>ALC4/2020 Deferred
17.04.2020
121 HQ File<br>:01/82/050/01917/AM19/<br>RLA File<br>:07/24/040/00087/AM19/<br>Lic.No/Date:0710113686<br>06.08.2018 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
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.

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.:172/13/82- Party Name:TIDE Meet No/Date:1/82- Status:
ALC4/2018 INDUSTRIES ALC4/2020 Deferred
17.04.2020
122 HQ File RLA File Lic.No/Date:3410044399 Defer Date:
:01/82/050/01150/AM19/ :34/24/040/00094/AM19/ 08.08.2018
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its 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:1/82- Status:
ALC4/2018 INDUSTRIES LIMITED ALC4/2020 Deferred
17.04.2020
123 HQ File RLA File Lic.No/Date:0310822942 Defer Date:
:01/82/050/01112/AM19/ :03/95/040/00445/AM19/ 09.08.2018
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail
dated 24.10.2019 has furnished its reply. Deferred for comments of TE.

34

cision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail||||||| |||dated 24.10.2019 has furnished its reply. Deferred for comments of TE.|||||||

34

124 Case No.:326/13/82-<br>ALC4/2018 Party Name:BALAJI AMINES<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail<br>dated 26.11.2019 has furnished its reply. Deferred for comments of TE.
125 Case No.:470/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01927/AM19/ RLA File<br>:05/23/040/00232/AM19/ Lic.No/Date:0510407550<br>20.08.2018 Defer Date:
Decision:<br>The Committee considered the case as per agenda and it was observed that the firm was<br>issued 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.

126 Case No.:471/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01928/AM19/ RLA File<br>:05/23/040/00231/AM19/ Lic.No/Date:0510407551<br>20.08.2018 Defer Date:
**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.

127 Case No.:472/15/82-<br>ALC4/2018 Party Name:WINTAC<br>LIMITED, Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01929/AM19/ RLA File<br>:07/24/040/00131/AM19/ Lic.No/Date:0710113733<br>20.08.2018 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

t<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.

35

Case No.:142/13/82- Party Name:PALADIN Meet No/Date:1/82- Status:
ALC4/2018 PAINTS AND CHEMICALS ALC4/2020 Deferred
PVT. LTD., 17.04.2020
HQ File RLA File Lic.No/Date:0310823254 Defer Date:
:01/82/050/01120/AM19/ :03/95/040/00456/AM19/ 24.08.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 128 Meeting No. 9/82-ALC4/2019 dated 18.10.2019, followed by Reminder on 09.12.2019 and Final Reminder on 18.03.2020.

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

Case No.:209/13/82- Party Name:DEEPAK Meet No/Date:1/82- Status:
ALC4/2018 NOVOCHEM ALC4/2020 Deferred
TECHNOLOGIES LTD 17.04.2020
HQ File RLA File Lic.No/Date:3110067162 Defer Date:
:01/82/050/01187/AM19/ :31/83/040/00081/AM19/ 24.08.2018

018**||NOVOCHEM||ALC4/2020||Deferred| |||TECHNOLOGIES LTD||17.04.2020||| |HQ File||RLA File||Lic.No/Date:3110067162||Defer Date:| |:01/82/050/01187/AM19/||:31/83/040/00081/AM19/||24.08.2018|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information 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 129 on 18.03.2020.

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

130 Case No.:475/15/82-<br>ALC4/2018 Party Name:WINTAC<br>LIMITED, Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01932/AM19/ RLA File<br>:07/24/040/00098/AM19/ Lic.No/Date:0710113754<br>24.08.2018 <br>Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>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.

36

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.

36

131 Case No.:368/13/82-<br>ALC4/2018 Party Name:DANOPHARM<br>CHEMICALS PRIVATE LTD. Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm<br>dated 28.11.2019 has furnished its reply. Deferred for comments of TE. vide its letter
132 Case No.:369/13/82-<br>ALC4/2018 Party Name:DANOPHARM<br>CHEMICALS PRIVATE<br>LTD. Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 <br>Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the<br>dated 28.11.2019 has furnished its reply. Deferred for comments of TE. firm vide its letter

Decision: The Committee considered the case as per agenda and it was noted that the firm vide its letter dated 28.11.2019 has furnished its reply. Deferred for comments of TE.

de its letter|

Decision: The Committee considered the case as per agenda and it was noted that the firm vide its letter dated 28.11.2019 has furnished its reply. Deferred for comments of TE.

133 <br>Case No.:35/15/82-ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01492/AM19/ RLA File<br>:09/24/040/00249/AM19/ Lic.No/Date:0910066604<br>29.08.2018 Defer Date:
**Decision:**Deferred for comments of TE.
134 <br>Case No.:492/15/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01949/AM19/ RLA File<br>:09/24/040/00245/AM19/ Lic.No/Date:0910066600<br>29.08.2018 <br>Defer Date:
**Decision:**Deferred for comments of TE.
135 <br>Case No.:84/13/82-ALC4/2018 Party Name:SRINI<br>PHARMACEUTICALS<br>PRIVATE LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01062/AM19/ RLA File<br>:09/24/040/00251/AM19/ Lic.No/Date:0910066620<br>03.09.2018 Defer Date:
**Decision:**Deferred for comments of TE.

37

-|---|---|---|---| ||<br>HQ File<br>:01/82/050/01062/AM19/|RLA File<br>:09/24/040/00251/AM19/|Lic.No/Date:0910066620<br>03.09.2018|Defer Date:| ||**Decision:**Deferred for comments of TE.||||

37

Case No.:88/13/82-<br>ALC4/2018 Party Name:SATYADEVA<br>PHARMACEUTICALS PVT<br>LTD Party Name:SATYADEVA<br>PHARMACEUTICALS PVT<br>LTD Party Name:SATYADEVA<br>PHARMACEUTICALS PVT<br>LTD Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/01066/AM19/ RLA File<br>:09/24/040/00247/AM19/ Lic.No/Date:091006662<br>03.09.2018 3
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting<br>no.<br>7/82-ALC4/2019<br>dated<br>06.09.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as
applied by the firm, whichever is less:<br>d<br>
l
Export Prouct<br>(2S,3S,5S)-2-Amino-3-<br>Hydroxy-5-(1-Tetra hydro<br>pyramid-2-only)-3-Methyl<br>butanoyl) Qty S.<br>No. Import Items Qty
1 kg 1 DAH-II 1.13 kg
6.74 kg
2 1,2 DIMETH XYETHANE
3 SODIUM BO ROHYDRIDE 0.406 kg
<br>
<br>Amino-1,6-diphenyl<br> 4 METHANE<br>(OR)METHA SULFONIC<br>ACID<br>NESULPHONIC ACID 1.57 kg
Hexane-s-pyro glutamate<br>(THP) 5 <br>ISOPROPYL ALCOHOL 1.27 kg
6 Triethanolamine(99%) 1.167 kg
136 7 <br>N.N-DIMETH<br>DIMETHYL <br>YL ACETAMIDE (OR)<br>ACETAMIDE 1.60 kg

|| ||Hexane-s-pyro glutamate<br>(THP)||5|<br>ISOPROPYL ALCOHOL|||1.27 kg||| ||||6|Triethanolamine(99%)|||1.167 kg||| |136|||7|<br>N.N-DIMETH<br>DIMETHYL|<br>YL ACETAMIDE (OR)<br>ACETAMIDE||1.60 kg||| ||||8|L-VALINE|||0.630 kg||| ||||9|MCF|||1.00 kg||| ||||10|MDC|||3.25 kg||| ||||11|ACERLONITRILE|||0.30 kg||| ||||12|METHANOL|||3.30 kg||| ||||13|METHYL<br>TETR-BUTYL<br>ETHER|||2.45 kg||| |||||<br> <br> <br>(OR)TERTIARY BUTYL METHYL<br>ETHER|||||| ||||14|N,N-CARBO|NYL DIMIDAZOLE||0.443 kg||| ||||15|AMMONIUM|FORMATE||0.500 kg||| ||||16|DIMETHYL|FORMAMIDE||3.95 kg||| ||||17|L-PYROGLU|TAMIC ACID||0.295 kg||| ||||18|AMMONIUM|CHLORIDE||2.00 kg||| ||||19|PALLADIUM<br>SPONGE<br>(99.95%<br>MIN)|||0.001 kg||| ||||||||||| ||RA concerned maytake further necessaryaction asper above decision of NC.|||||||||

137 <br>Case No.:502/15/82-<br>ALC4/2018<br>Party Name:SUVEN LIFE<br>SCIENCES LIMITED<br>HQ File<br>:01/82/050/01959/AM19/<br>RLA File<br>:09/24/040/00260/AM19/<br>**Decision:**Deferred for comments of TE. Party Name:SUVEN LIFE<br>SCIENCES LIMITED<br>RLA File<br>:09/24/040/00260/AM19/ Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
Lic.No/Date:0910066621<br>03.09.2018 Defer Date:

38

LA File<br>:09/24/040/00260/AM19/|Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020|Status:<br>Deferred| |---|---|---|---|---| ||||Lic.No/Date:0910066621<br>03.09.2018|Defer Date:| ||||||

38

138 <br>Case No.:435/13/82-<br>ALC4/2018 Party Name:DCM SHRIRAM<br>INDUSTRIES LTD, Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01413/AM19/ RLA File<br>:05/23/040/00242/AM19/ Lic.No/Date:0510407689<br>05.09.2018 Defer Date:
**Decision:**Deferred for comments of TE.
Case No.:44/15/82-ALC4/2018 Party Name:DISCOVERY Meet No/Date:1/82- Status:
LABORATORIES PRIVATE ALC4/2020 Deferred
LIMITED 17.04.2020
HQ File RLA File Lic.No/Date:0910066631 Defer Date:
:01/82/050/01501/AM19/ :09/24/040/00283/AM19/ 06.09.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 139 Meeting No. 3/82-ALC4/2019 dated 05.07.2019, followed by Reminder on 02.08.2019 and Final Reminder on 18.03.2020.

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

The requisite reply is still awaited from the firm. In view of above, the Committee decided to defer the case.

cal details as per Appendix 4E alongwith chemistry, Molecular weight and % of yield.

The requisite reply is still awaited from the firm. In view of above, the Committee decided to defer the case.

140 <br>Case No.:429/13/82-<br>ALC4/2018 Party Name:CADILA<br>HEALTHCARE LTD Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01407/AM19/ RLA File<br>:08/24/040/00131/AM19/ Lic.No/Date:0810143413<br>07.09.2018 Defer Date:
**Decision:**Deferred for comments of TE.
141 <br>Case No.:40/15/82-<br>ALC4/2018 Party Name:INCHEM<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01497/AM19/ RLA File<br>:09/24/040/00230/AM19/ Lic.No/Date:0910066657<br>11.09.2018 <br>Defer Date:
**Decision:**Deferred for comments of TE.
142 <br>Case No.:41/15/82-<br>ALC4/2018 Party Name:INCHEM<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01498/AM19/ RLA File<br>:09/24/040/00261/AM19/ Lic.No/Date:0910066658<br>11.09.2018 <br>Defer Date:
**Decision:**Deferred for comments of TE.

39

-|---|---|---| ||<br>HQ File<br>:01/82/050/01498/AM19/|RLA File<br>:09/24/040/00261/AM19/|Lic.No/Date:0910066658<br>11.09.2018|<br>Defer Date:| ||**Decision:**Deferred for comments of TE.||||

39

143 <br>Case No.:17/7/82-<br>ALC4/2019 Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00512/AM20/ RLA File<br>:07/24/040/00144/AM19/ Lic.No/Date:0710113843<br>12.09.2018 <br>Defer Date:
**Decision:**Deferred for comments of TE.
144 <br>Case No.:400/13/82-<br>ALC4/2018 Party Name:J.B.<br>CHEMICALS &<br>PHARMACEUTICALS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01378/AM19/ RLA File<br>:03/94/040/00504/AM19/ Lic.No/Date:0310823779<br>17.09.2018 <br>Defer Date:
**Decision:**Deferred for comments of TE.
145 <br>Case No.:519/15/82-<br>ALC4/2018 Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01976/AM19/ RLA File<br>:09/24/040/00288/AM19/ Lic.No/Date:0910066679<br>18.09.2018 <br>Defer Date:
**Decision:**Deferred for comments of TE.

--|---|---|---|---| ||<br>HQ File<br>:01/82/050/01976/AM19/|RLA File<br>:09/24/040/00288/AM19/|Lic.No/Date:0910066679<br>18.09.2018|<br>Defer Date:| ||**Decision:**Deferred for comments of TE.||||

146 Case No.:525/15/82-<br>ALC4/2018 Party Name:SHILPA<br>MEDICARE LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01982/AM19/ RLA File<br>:07/24/040/00164/AM19/ Lic.No/Date:0710113890<br>25.09.2018 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>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.

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.

147 Case No.:176/13/82-<br>ALC4/2018 Party Name:VOVANTIS<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020<br>Lic.No/Date:3410044518<br>26.09.2018 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01154/AM19/ RLA File<br>:34/24/040/00145/AM19/ Defer Date:
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide its e-mail dated 03.04.2020 has furnished its reply. Deferred for comments of<br>TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide its e-mail dated 03.04.2020 has furnished its reply. Deferred for comments of TE.

40

Case No.:213/13/82- Party Name:DEEPAK Meet No/Date:1/82- Status:
ALC4/2018 NOVOCHEM ALC4/2020 Deferred
TECHNOLOGIES LTD 17.04.2020
HQ File RLA File Lic.No/Date:3110067177 Defer Date:
:01/82/050/01191/AM19/ :31/83/040/00094/AM19/ 26.09.2018

018**||NOVOCHEM||ALC4/2020||Deferred| |||TECHNOLOGIES LTD||17.04.2020||| |HQ File||RLA File||Lic.No/Date:3110067177||Defer Date:| |:01/82/050/01191/AM19/||:31/83/040/00094/AM19/||26.09.2018|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 148 Meeting No. 9/82-ALC4/2019 dated 18.10.2019, followed by Reminder on 09.12.2019 and Final Reminder on 18.03.2020.

(i) Exact chemical name of the export product.

149 Case No.:534/15/82-<br>ALC4/2018 Party Name:YASH RASAYAN<br>& CHEMICALS Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01991/AM19/ RLA File<br>:34/24/040/00184/AM19/ Lic.No/Date:3410044523<br>26.09.2018 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>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.

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.

150 <br>Case No.:536/15/82-<br>ALC4/2018 Party Name:YASH RASAYAN<br>& CHEMICALS Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 Defer Date:
**Decision:**Deferred for comments of TE.
151 <br>Case No.:112/13/82-<br>ALC4/2018 Party Name:VARAHI<br>PHARMA PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 <br>Defer Date:
**Decision:**Deferred for comments of TE.

41

Case No.:612/15/82- Party Name:MANGALAM Meet No/Date:1/82- Status:
ALC4/2018 ORGANICS LIMITED ALC4/2020 Deferred
(FORMERLY DUJODWALA 17.04.2020
152 HQ File RLA File Lic.No/Date:0310824148 Defer Date:
:01/82/050/02069/AM19/ :03/95/040/00560/AM19/ 03.10.2018
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail
dated 04.11.2019 has furnished its reply. Deferred for comments of TE.

|**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail||||||| |||dated 04.11.2019 has furnished its reply. Deferred for comments of TE.|||||||

Case No.:52/13/82-ALC4/2018 Party Name:S V LABS PVT Meet No/Date:1/82- Status:
LTD ALC4/2020 Deferred
17.04.2020
153 HQ File RLA File Lic.No/Date:0910066711 Defer Date:
:01/82/050/01030/AM19/ :09/24/040/00301/AM19/ 04.10.2018
**Decision:**Deferred for comments of TE.
Case No.:562/15/82- Party Name:ORTIN Meet No/Date:1/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2020 Deferred
17.04.2020
154 HQ File RLA File Lic.No/Date:0910066712 Defer Date:
:01/82/050/02019/AM19/ :09/24/040/00302/AM19/ 04.10.2018
**Decision:**Deferred for comments of TE.
Case No.:565/15/82- Party Name:S M S Meet No/Date:1/82- Status:
ALC4/2018 PHARMACEUTICALS LTD ALC4/2020 Deferred
17.04.2020
155 HQ File RLA File Lic.No/Date:0910066716 Defer Date:
:01/82/050/02022/AM19/ :09/24/040/00319/AM19/ 04.10.2018
**Decision:**Deferred for comments of TE.

||||17.04.2020||| |155||HQ File||RLA File||Lic.No/Date:0910066716||Defer Date:| |||:01/82/050/02022/AM19/||:09/24/040/00319/AM19/||04.10.2018||| |||**Decision:**Deferred for comments of TE.|||||||

Case No.:567/15/82- Party Name:VERVE HUMAN Meet No/Date:1/82- Status:
ALC4/2018 CARE LABORATORIES ALC4/2020 Deferred
17.04.2020
156 HQ File RLA File Lic.No/Date:6110001546 Defer Date:
:01/82/050/02024/AM19/ :61/24/040/00009/AM19/ 04.10.2018
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail
dated 09.08.2019 has furnished its reply. Deferred for comments of TE.
Case No.:454/13/82- Party Name:IND-SWIFT Meet No/Date:1/82- Status:
ALC4/2018 LABORATORIES LTD., ALC4/2020 Deferred
17.04.2020
157 HQ File RLA File Lic.No/Date:2210015989 Defer Date:
:01/82/050/01432/AM19/ :22/24/040/00058/AM19/ 05.10.2018
**Decision:**Deferred for comments of TE.

42

7.04.2020||| |157||HQ File||RLA File||Lic.No/Date:2210015989||Defer Date:| |||:01/82/050/01432/AM19/||:22/24/040/00058/AM19/||05.10.2018||| |||**Decision:**Deferred for comments of TE.|||||||

42

Case No.:569/15/82- Party Name:JODAS EXPOIM Meet No/Date:1/82- Status:
ALC4/2018 PVT.LTD ALC4/2020 Deferred
17.04.2020
158 HQ File RLA File Lic.No/Date:0510408024 Defer Date:
:01/82/050/02026/AM19/ :05/23/040/00297/AM19/ 08.10.2018
**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.

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.:570/15/82- Party Name:JODAS EXPOIM Meet No/Date:1/82- Status:
ALC4/2018 PVT.LTD ALC4/2020 Deferred
17.04.2020
159 HQ File RLA File Lic.No/Date:0510408025 Defer Date:
:01/82/050/02027/AM19/ :05/23/040/00295/AM19/ 08.10.2018
**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.

295/AM19/||08.10.2018||| |||**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.:572/15/82- Party Name:A.R. LIFE Meet No/Date:1/82- Status:
ALC4/2018 SCIENCES PVT LTD ALC4/2020 Deferred
17.04.2020
160 HQ File RLA File Lic.No/Date:0910066726 Defer Date:
:01/82/050/02029/AM19/ :09/24/040/00309/AM19/ 08.10.2018
**Decision:**Deferred for comments of TE.
Case No.:224/13/82- Party Name:ASTRAL Meet No/Date:1/82- Status:
ALC4/2018 STERITECH PVT. LTD. ALC4/2020 Deferred
17.04.2020
161 HQ File RLA File Lic.No/Date:3410044573 Defer Date:
:01/82/050/01202/AM19/ :34/24/040/00225/AM19/ 10.10.2018
**Decision:**Deferred for comments of TE.

||||17.04.2020||| |161||HQ File||RLA File||Lic.No/Date:3410044573||Defer Date:| |||:01/82/050/01202/AM19/||:34/24/040/00225/AM19/||10.10.2018||| |||**Decision:**Deferred for comments of TE.|||||||

Case No.:582/15/82-<br> Party Name:MACSON Party Name:MACSON Meet No/Date:1/82- Meet No/Date:1/82- Status:<br>
162 <br>ALC4/2018<br>HQ File<br>:01/82/050/02039/AM19/<br>**Decision:**The firm vide e PRODUCTS<br>RLA File<br> ALC4/2020<br>17.04.2020 Deferred
Lic.No/Date:5210042<br> 796 Defer Date:
:52/24/040/00039/AM19/ 11.10.2018
-mail dated 05.02.2020 has in formed that they have not taken any benefit
against the subject advance authorization as they have not imported anything (as per the custom certified<br>non-utilization certificate).

43

163 Case No.:590/15/82-<br>ALC4/2018 Party Name:VERVE HUMA<br>CARE LABORATORIES N Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02047/AM19/ RLA File<br>:61/24/040/00011/AM19/ Lic.No/Date:6110001<br>11.10.2018 553 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

r>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.

164 <br>Case No.:801/15/82-<br>ALC4/2018 Party Name:DEEPAK<br>PHENOLICS LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02258/AM19/ RLA File<br>:34/24/040/00230/AM19/ Lic.No/Date:3410044<br>11.10.2018 580 Defer Date:
**Decision:**Deferred for comments of TE.
Case No.:169/13/82- Party Name:SPC LIFE Meet No/Date:1/82- Status:
ALC4/2018 SCIENCES PVT. LTD. ALC4/2020 Deferred
17.04.2020
165 HQ File RLA File Lic.No/Date:3410044586 Defer Date:
:01/82/050/01147/AM19/ :34/24/040/00211/AM19/ 12.10.2018
**Decision:**Deferred for comments of TE.

||||17.04.2020||| |165||HQ File||RLA File||Lic.No/Date:3410044586||Defer Date:| |||:01/82/050/01147/AM19/||:34/24/040/00211/AM19/||12.10.2018||| |||**Decision:**Deferred for comments of TE.|||||||

Case No.:592/15/82- Party Name:SRIAM LABS Meet No/Date:1/82- Status:
ALC4/2018 PRIVATE LIMITED ALC4/2020 Deferred
17.04.2020
166 HQ File RLA File Lic.No/Date:0910066753 Defer Date:
:01/82/050/02049/AM19/ :09/24/040/00338/AM19/ 16.10.2018
**Decision:**Deferred for comments of TE.
Case No.:322/13/82- Party Name:ANLON Meet No/Date:1/82- Status:
ALC4/2018 HEALTHCARE ALC4/2020 Deferred
PRIVATELIMITED 17.04.2020
HQ File RLA File Lic.No/Date:2410042548 Defer Date:
:01/82/050/01300/AM19/<br>:24/24/040/00033/AM19/ 24.10.2018
**Decision:**The Committee considered the case as per online agenda in the presence of technical experts
167 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its
Meeting No.13/82-ALC4/2019 dated 31.01.2020, followed by Reminder on18.03.2020:
(i) Complete chemical reaction, molecular weight and % yield on molar basis for
each step of manufacturing process.
In view of above, the Committee decided to issueFinal Reminder to firm to furnish its reply, failing
which the case will be rejected.

44

of manufacturing** process.||||| |||In view of above, the Committee decided to issueFinal Reminder to firm to furnish its reply, failing|||||| |||which the case will be|rejected.|||||

44

168 <br>Case No.:169/15/82-<br>ALC4/2018 Party Name:WOCKHARDT<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01626/AM19/ RLA File<br>:03/95/040/00755/AM19/ Lic.No/Date:0310824651<br>24.10.2018 Defer Date:
**Decision:**Deferred for comments of TE.
Case No.:424/13/82- Party Name:DEEPAK Meet No/Date:1/82- Status:
ALC4/2018 NITRITE LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:3410044635 Defer Date:
:01/82/050/01402/AM19/ :34/24/040/00144/AM19/ 25.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 169 Meeting No. 13/82-ALC4/2019 dated 31.01.2020 , followed by Reminder on 23.03.2020 :

(i) The Committee considered the case as per agenda and it was observed that the firm vide its e-mail dated 17.12.2019 has furnished a copy of Appendix 4E. However, the same is not readable. Hence, the Committee decided to call for a clear copy of Appendix 4E having complete technical details from the firm through Speed Post.

a copy of Appendix 4E. However, the same is not readable. Hence, the Committee decided to call for a clear copy of Appendix 4E having complete technical details from the firm through Speed Post.**

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

Case No.:426/13/82- Party Name:DEEPAK Meet No/Date:1/82- Status:
ALC4/2018 NITRITE LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:3410044636 Defer Date:
:01/82/050/01404/AM19/ :34/24/040/00208/AM19/ 25.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 170 Meeting No. 13/82-ALC4/2019 dated 31.01.2020 , followed by Reminder on 23.03.2020 :

(i) The Committee considered the case as per agenda and it was observed that the firm vide its e-mail dated 17.12.2019 has furnished a copy of Appendix 4E. However, the same is not readable. Hence, the Committee decided to call for a clear copy of Appendix 4E having complete technical details from the firm through Speed Post.

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

45

chnical details from the firm through Speed Post.**

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

45

Case No.:453/13/82- Party Name:HESTER Meet No/Date:1/82- Status:
ALC4/2018 BIOSCIENCES LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0810143739 Defer Date:
:01/82/050/01431/AM19/ :08/24/040/00231/AM19/ 25.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 8/82-ALC4/2019 dated 20.09.2019, followed by Reminder on 26.08.2019 and Final Reminder 171 on 19.03.2020:

(i) Breakup total no. of vials of different doses to be exported. (ii) QA approved batch manufacturing record showing issuance and reconciliation of material for manufacturing vaccine.

172 <br>Case No.:597/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02054/AM19/ RLA File<br>:09/24/040/00345/AM19/ Lic.No/Date:0910066762<br>25.10.2018 Defer Date:
**Decision:**Deferred for comments of TE.

| |---|---|---|---|---| ||<br>HQ File<br>:01/82/050/02054/AM19/|RLA File<br>:09/24/040/00345/AM19/|Lic.No/Date:0910066762<br>25.10.2018|Defer Date:| ||**Decision:**Deferred for comments of TE.||||

173 <br>Case No.:602/15/82-<br>ALC4/2018 Party Name:GLAND<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00229/AM19/ Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02059/AM19/ Lic.No/Date:0910066775<br>26.10.2018 <br>Defer Date:
**Decision:**Deferred for comments of TE.
Case No.:603/15/82- Party Meet No/Date:1/82- Status:
ALC4/2018 Name:THERAPIVAPRIVATE ALC4/2020 Deferred
LIMITED 17.04.2020
HQ File RLA File Lic.No/Date:0910066778 Defer Date:
:01/82/050/02060/AM19/ :09/24/040/00359/AM19/ 26.10.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 174 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020 , followed by Reminder on 23.03.2020 :

(i) Complete and Balanced Chemical reaction with molecular weight. (ii) Percentage yield on molar basis for each step.

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

46

i) Percentage yield on molar basis for each step.**

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

46

Case No.:605/15/82- Party Name:SUVEN LIFE Meet No/Date:1/82- Status:
ALC4/2018 SCIENCES LIMITED ALC4/2020 Deferred
17.04.2020
175 HQ File RLA File Lic.No/Date:0910066781 Defer Date:
:01/82/050/02062/AM19/ :09/24/040/00354/AM19/ 26.10.2018
**Decision:**Deferred for comments of TE.
Case No.:608/15/82- Party Name:MACSON Meet No/Date:1/82- Status:
ALC4/2018 PRODUCTS ALC4/2020 Deferred
17.04.2020
176 HQ File RLA File Lic.No/Date:5210042821 Defer Date:
:01/82/050/02065/AM19/ :52/24/040/00058/AM19/ 26.10.2018
**Decision:**Deferred for comments of TE.
Case No.:232/13/82- Party Name:DEEPAK Meet No/Date:1/82- Status:
ALC4/2018 NOVOCHEM ALC4/2020 Deferred
TECHNOLOGIES LTD 17.04.2020
HQ File RLA File Lic.No/Date:3110067218 Defer Date:
:01/82/050/01210/AM19/ :31/83/040/00114/AM19/ 29.10.2018

018**||NOVOCHEM||ALC4/2020||Deferred| |||TECHNOLOGIES LTD||17.04.2020||| |HQ File||RLA File||Lic.No/Date:3110067218||Defer Date:| |:01/82/050/01210/AM19/||:31/83/040/00114/AM19/||29.10.2018|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 4/82-ALC4/2019 dated 19.07.2019, 8/82-ALC4/2019 dated 20.09.2019, followed by 177 Reminder on 01.11.2019 and Final Reminder on 19.03.2020.

(i) It has been observed that the chemistry given by the firm is not clear, since the firm has stated that that the raw material shown as phenol while import is of OCP 50. It was decided to ask the firm to furnish exact chemical name of OCP 50 along with manufacturing process and all technical details starting from OCP 50.

The requisite reply is still awaited from the firm. In view of above, the Committee decided to defer the case.

Case No.:183/13/82- Party Name:PHAROSE Meet No/Date:1/82- Status:
ALC4/2018 REMEDIES LTD. ALC4/2020 Deferred
17.04.2020
178 HQ File RLA File Lic.No/Date:3010104485 Defer Date:
:01/82/050/01161/AM19/ :30/24/040/00032/AM19/ 31.10.2018
**Decision:**Deferred for comments of TE.

||||17.04.2020||| |178||HQ File||RLA File||Lic.No/Date:3010104485||Defer Date:| |||:01/82/050/01161/AM19/||:30/24/040/00032/AM19/||31.10.2018||| |||**Decision:**Deferred for comments of TE.|||||||

Case No.:614/15/82- Party Name:SUVEN LIFE Meet No/Date:1/82- Status:
ALC4/2018 SCIENCES LIMITED ALC4/2020 Deferred
17.04.2020
179 HQ File RLA File Lic.No/Date:0910066814 Defer Date:
:01/82/050/02071/AM19/ :09/24/040/00360/AM19/ 08.11.2018
**Decision:**Deferred for comments of TE.

47

180 <br>Case No.:111/15/82-<br>ALC4/2018 Party Name:PUNJAB<br>CHEMICALS AND CROP<br>PROTECTION LTD Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01568/AM19/ RLA File<br>:03/95/040/00709/AM19/ Lic.No/Date:0310824946<br>12.11.2018 Defer Date:
**Decision:**Deferred for comments of TE.
181 Case No.:616/15/82-<br>ALC4/2018 Party Name:VIVIMED LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02073/AM19/ RLA File<br>:09/24/040/00387/AM19/ Lic.No/Date:0910066821<br>12.11.2018 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail<br>dated 09.12.2019 has furnished its reply. Deferred for comments of TE.

r Date:| ||**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail<br>dated 09.12.2019 has furnished its reply. Deferred for comments of TE.||||

182 Case No.:87/15/82-ALC4/2018 Party Name:DEEPAK<br>NITRITE LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01544/AM19/ RLA File<br>:34/24/040/00267/AM19/ Lic.No/Date:3410044685<br>13.11.2018 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail<br>dated 02.12.2019 has furnished its reply. Deferred for comments of TE.

48

183 Case No.:634/15/82-<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:1/82-<br>ALC4/2020<br>17.04.2020 Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Approved
HQ File<br>:01/82/050/02091/AM19/ RLA File<br>:09/24/040/00376/AM19/ Lic.No/Date:0910066832<br>13.11.2018
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting<br>no.<br>13/82-ALC4/2019<br>dated<br>31.01.2020, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as<br>applied by the firm, whichever is less:
Export product Qty. Sl.<br>No. Import items Qty.

020, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as<br>applied by the firm, whichever is less:|||||||| ||Export product||Qty.|Sl.<br>No.|Import items||Qty.|| ||PIPERACILLIN SODIUM AND<br>TAZOBACTAM<br>SODIUM<br>8:1<br>FOR INJECTION||1 kg|1|4-Ethyl-2, 3 Dioxo Piperazine<br>(EDP)||0.3323 kg|| |||||2|6-Amino Penicillanic Acid (6-<br>APA)||0.436 kg|| |||||3|Activated<br>Carbon<br>(Carbon<br>Enoanticromos)||0.1783 kg|| |||||4|Isopropyl Alcohol (IPA)||0.050 kg|| |||||5|Methanol (Methyl Alcohol)||0.0009 kg|| |||||6|Methylene Chloride (MDC)||0.105 kg|| |||||7|D(-) Alpha Phenyl Glycine Base<br>(P G Base)||0.335 kg|| |||||8|Penicillin G Amidase (Particle<br>size 250 - 500 micron, Creamish<br>to Brown regularly shaped beads)<br>or<br>(Immobilized<br>Acylase<br>Enzyme) Xinase||2.27 kg|| |||||9|Tazobactam Acid||0.0015 kg|| |||||10|Toluene||0.4384 kg|| |||||11|Triethylamine||0.466 kg|| |||||12|Trimethyl chlorosilane||0.3069 kg|| |||||13|Triphosgene||0.2761 kg|| |||||14|Aluminium Canisters / Bottles<br>with Chloro Butyl Plug / Inner &<br>Outer Lid and Gasket / Alu Caps<br>[21 Ltrs (10Kg Cap)]||Relevant as<br>per packing<br>policy|| ||RA concerned maytake further necessaryaction asper||||above decision of NC.||||

Plug / Inner &<br>Outer Lid and Gasket / Alu Caps<br>[21 Ltrs (10Kg Cap)]||Relevant as<br>per packing<br>policy|| ||RA concerned maytake further necessaryaction asper||||above decision of NC.||||

184 Case No.:623/15/82-<br>ALC4/2018 Party Name:VINS<br>BIOPRODUCTS LTD` Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
HQ File<br>:01/82/050/02080/AM19/ RLA File<br>:09/24/040/00363/AM19/ Lic.No/Date:0910066851<br>14.11.2018 <br>Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail<br>dated 26.03.2020 has furnished its reply. Deferred for comments of TE.

49

185 <br>Case No.:627/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02084/AM19/ RLA File<br>:09/24/040/00382/AM19/ Lic.No/Date:0910066853<br>15.11.2018 <br>Defer Date:
**Decision:**Deferred for comments of TE.
186 <br>Case No.:630/15/82-<br>ALC4/2018 Party Name:VIVIN DRUGS<br>& PHARMACEUTICALS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02087/AM19/ RLA File<br>:09/24/040/00391/AM19/ Lic.No/Date:0910066856<br>15.11.2018 <br>Defer Date:
**Decision:**Deferred for comments of TE.

--|---|---|---|---| ||<br>HQ File<br>:01/82/050/02087/AM19/|RLA File<br>:09/24/040/00391/AM19/|Lic.No/Date:0910066856<br>15.11.2018|<br>Defer Date:| ||**Decision:**Deferred for comments of TE.||||

Case No.:2/15/82-ALC4/2018 Party Name:DEEPAK Meet No/Date:1/82- Status:
NITRITE LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:3410044710 Defer Date:
:01/82/050/01459/AM19/ :34/24/040/00254/AM19/ 20.11.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020 , followed by Reminder on 23.03.2020 : 187

(i) The Committee considered the case as per agenda and it was observed that the firm vide its e-mail dated 17.12.2019 has furnished a copy of Appendix 4E. However, the same is not readable. Hence, the Committee decided to call for a clear copy of Appendix 4E having complete technical details from the firm through Speed Post.

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

50

Case No.:85/15/82-ALC4/2018 Party Name:DEEPAK Meet No/Date:1/82- Status:
NITRITE LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:3410044711 Defer Date:
:01/82/050/01542/AM19/ :34/24/040/00255/AM19/ 20.11.2018

---|---|---| |||NITRITE LIMITED||ALC4/2020||Deferred| |||||17.04.2020||| |HQ File||RLA File||Lic.No/Date:3410044711||Defer Date:| |:01/82/050/01542/AM19/||:34/24/040/00255/AM19/||20.11.2018|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020 , followed by Reminder on 23.03.2020 : 188

(i) The Committee considered the case as per agenda and it was observed that the firm vide its e-mail dated 17.12.2019 has furnished a copy of Appendix 4E. However, the same is not readable. Hence, the Committee decided to call for a clear copy of Appendix 4E having complete technical details from the firm through Speed Post.

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

Case No.:86/15/82-ALC4/2018 Party Name:DEEPAK Meet No/Date:1/82- Status:
NITRITE LIMITED ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:3410044712 Defer Date:
:01/82/050/01543/AM19/ :34/24/040/00256/AM19/ 20.11.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020 , followed by Reminder on 23.03.2020 : 189

it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020 , followed by Reminder on 23.03.2020 : 189

(i) The Committee considered the case as per agenda and it was observed that the firm vide its e-mail dated 17.12.2019 has furnished a copy of Appendix 4E. However, the same is not readable. Hence, the Committee decided to call for a clear copy of Appendix 4E having complete technical details from the firm through Speed Post.

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

190 <br>Case No.:638/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02095/AM19/ RLA File<br>:09/24/040/00386/AM19/ Lic.No/Date:0910066874<br>20.11.2018 Defer Date:
**Decision:**Deferred for comments of TE.

51

191 <br>Case No.:639/15/82-<br>ALC4/2018<br>Party Name:CADILA<br>HEALTHCARE LTD<br>HQ File<br>:01/82/050/02096/AM19/<br>RLA File<br>:08/24/040/00187/AM19/<br>**Decision:**Deferred for comments of TE. Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020<br>Lic.No/Date:0810143923<br>20.11.2018 Status:<br>Deferred<br>Defer Date:

19/<br>**Decision:**Deferred for comments of TE.|Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020<br>Lic.No/Date:0810143923<br>20.11.2018|Status:<br>Deferred<br>Defer Date:| |---|---|---|---|

Case No.:463/13/82- Party Name:INDIA GLYCOLS Meet No/Date:1/82- Status:
ALC4/2018 LTD., ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:0510408634 Defer Date:
:01/82/050/01441/AM19/ :05/23/040/00359/AM19/ 26.11.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information 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 18.03.2020 : 192

(i**)** Catalogue of import item No. 2 – Silver Catalyst from the supplier
(ii) Percentage activity of Silver Catalyst.
(iii) Recovery / regeneration of Silver Catalyst.
(iv) Production Consumption Data duly certified by GST/ Chartered
Engineer.
(v) Percentage of yield at every stage on molar basis.

The requisite reply is still awaited from the firm. In view of above, the Committee decided to defer the case.

| ||Engineer.| |(v)|Percentage of yield at every stage on molar basis.|

The requisite reply is still awaited from the firm. In view of above, the Committee decided to defer the case.

193 <br>Case No.:649/15/82-<br>ALC4/2018<br>Party Name:GLOBE<br>TROTTERS PVT LTD<br>HQ File<br>:01/82/050/02106/AM19/<br>RLA File<br>:03/94/040/00713/AM19/<br>**Decision:**Deferred for comments of TE. Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020<br>Lic.No/Date:0310825212<br>26.11.2018 Status:<br>Deferred<br>Defer Date:
194 <br>Case No.:659/15/82-<br>ALC4/2018<br>Party Name:AUROBINDO<br>PHARMA LIMITED<br>HQ File<br>:01/82/050/02116/AM19/<br>RLA File<br>:09/24/040/00410/AM19/<br>**Decision:**Deferred for comments of TE. Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020<br>Lic.No/Date:0910066905<br>28.11.2018 Status:<br>Deferred<br>Defer Date:
195 <br>Case No.:664/15/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/02121/<br>AM19/<br>**Decision:**Deferred Party Name:<br>SMILAX LABORATORIES<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
RLA File :09/24/040/00358/AM19/ Lic.No/Date:0910066915<br>28.11.2018 Defer Date:
for comments of TE.

52

2-<br>ALC4/2020<br>17.04.2020|Status:<br>Deferred| |---|---|---|---|---| |||RLA File :09/24/040/00358/AM19/|Lic.No/Date:0910066915<br>28.11.2018|Defer Date:| |||for comments of TE.|||

52

196 Case No.:669/15/82-<br>ALC4/2018 Party Name:VERVE HUMAN<br>CARE LABORATORIES Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm<br>dated 09.08.2019 has furnished its reply. Deferred for comments of TE. vide its letter

Decision: The Committee considered the case as per agenda and it was noted that the firm vide its letter dated 09.08.2019 has furnished its reply. Deferred for comments of TE.

197 <br>Case No.:670/15/82-<br>ALC4/2018 Party Name:VERVE HUMAN<br>CARE LABORATORIES Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 Defer Date:
**Decision:**Deferred for comments of TE.

| |---|---|---|---|---| ||<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|Defer Date:| ||**Decision:**Deferred for comments of TE.||||

198 <br>Case No.:671/15/82-<br>ALC4/2018 Party Name:VERVE HUMAN<br>CARE LABORATORIES Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 Defer Date:
**Decision:**Deferred for comments of TE.
199 <br>Case No.:672/15/82-<br>ALC4/2018 Party Name:VERVE HUMAN<br>CARE LABORATORIES Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 Defer Date:
**Decision:**Deferred for comments of TE.
200 <br>Case No.:673/15/82-<br>ALC4/2018 Party Name:VERVE<br>HUMAN CARE<br>LABORATORIES Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02130/AM19/ RLA File<br>:61/24/040/00018/AM19/ Lic.No/Date:6110001564<br>28.11.2018 <br>Defer Date:
**Decision:**Deferred for comments of TE.

--|---|---|---|---| ||<br>HQ File<br>:01/82/050/02130/AM19/|RLA File<br>:61/24/040/00018/AM19/|Lic.No/Date:6110001564<br>28.11.2018|<br>Defer Date:| ||**Decision:**Deferred for comments of TE.||||

201 <br>Case No.:674/15/82-<br>ALC4/2018 Party Name:VERVE HUMAN<br>CARE LABORATORIES Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 Defer Date:
**Decision:**Deferred for comments of TE.

53

202 Case No.:675/15/82-<br>ALC4/2018 Party Name:VERVE HUMA<br>CARE LABORATORIES N Meet No/Date:1/82-<br>ALC4/2020 Status:<br>Deferred
17.04.2020
<br>HQ File RLA File Lic.No/Date:61100015 66 Defer Date:
:01/82/050/02132/AM19/ :61/24/040/00016/AM19/ 28.11.2018
**Decision:**Deferred for comments of TE.
Case No.:668/15/82- Party Name:CADILA Meet No/Date:1/82- Status:
ALC4/2018 HEALTHCARE LTD ALC4/2020 Deferred
17.04.2020
203 HQ File RLA File Lic.No/Date:0810143988 Defer Date:
:01/82/050/02125/AM19/ :08/24/040/00264/AM19/ 29.11.2018
**Decision:**Deferred for comments of TE.

||||17.04.2020||| |203||HQ File||RLA File||Lic.No/Date:0810143988||Defer Date:| |||:01/82/050/02125/AM19/||:08/24/040/00264/AM19/||29.11.2018||| |||**Decision:**Deferred for comments of TE.|||||||

Case No.:689/15/82- Party Name:AUROBINDO Meet No/Date:1/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2020 Deferred
17.04.2020
204 HQ File RLA File Lic.No/Date:0910066921 Defer Date:
:01/82/050/02146/AM19/ :09/24/040/00421/AM19/ 29.11.2018
**Decision:**Deferred for comments of TE.
Case No.:684/15/82-<br> Case No.:684/15/82-<br> Party Name:GLAND<br> Party Name:GLAND<br> Meet No/Date:1/82-<br> Meet No/Date:1/82-<br> Status:<br>
205 <br>ALC4/2018 PHARMA LIMITED ALC4/2020<br>17.04.2020 Deferred
<br>HQ File<br> RLA File<br> Lic.No/Date:09100669<br> 30 Defer Date:
:01/82/050/02141/AM19/ :09/24/040/00419/AM19/ 03.12.2018
**Decision:**Deferred for comm ents of TE.

<br>HQ File<br>||RLA File<br>||Lic.No/Date:09100669<br>|30|Defer Date:| ||:01/82/050/02141/AM19/||:09/24/040/00419/AM19/||03.12.2018||| ||**Decision:**Deferred for comm|ents of TE.|||||| |||||||||

Case No.:685/15/82-<br> Case No.:685/15/82-<br> Party Name:GLAND<br> Party Name:GLAND<br> Meet No/Date:1/82-<br> Meet No/Date:1/82-<br> Status:<br>
206 <br>ALC4/2018 PHARMA LIMITED ALC4/2020<br>17.04.2020 Deferred
<br>HQ File<br> RLA File<br> Lic.No/Date:09100669<br> 31 Defer Date:
:01/82/050/02142/AM19/ :09/24/040/00420/AM19/ 03.12.2018
**Decision:**Deferred for comm ents of TE.
Case No.:688/15/82- Party Name:JODAS EXPOIM Meet No/Date:1/82- Status:
207 ALC4/2018 PVT.LTD ALC4/2020<br>17.04.2020 Deferred
<br>HQ File<br>:01/82/050/02145/AM19/ RLA File<br>:05/23/040/00385/AM19/ Lic.No/Date:0510408748<br>04.12.2018 Defer Date:
**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.

54

04.12.2018||Defer Date:| ||**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.|||||||

54

208 <br>Case No.:103/15/82-<br>ALC4/2018 Party Name:STERLING<br>AUXILIARIES PVT LTD Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 Defer Date:
**Decision:**Deferred for comments of TE.
209 <br>Case No.:692/15/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02149/AM19/ RLA File<br>:09/24/040/00424/AM19/ Lic.No/Date:0910066938<br>05.12.2018 Defer Date:
**Decision:**Deferred for comments of TE.
210 <br>Case No.:696/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02153/AM19/ RLA File<br>:09/24/040/00436/AM19/ Lic.No/Date:0910066944<br>05.12.2018 Defer Date:
**Decision:**Deferred for comments of TE.

| |---|---|---|---|---| ||<br>HQ File<br>:01/82/050/02153/AM19/|RLA File<br>:09/24/040/00436/AM19/|Lic.No/Date:0910066944<br>05.12.2018|Defer Date:| ||**Decision:**Deferred for comments of TE.||||

211 Case No.:744/15/82-<br>ALC4/2018 Party Name:LUPIN LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Withdrawn
<br>HQ File<br>:01/82/050/02201/AM19/ RLA File<br>:03/95/040/00876/AM19/ Lic.No/Date:0310825438<br>05.12.2018
Decision:The firm vide e-mail dated 30.01.2020 has informed that they had applied under para 4.18 of<br>HBP Vol. I and hence they should be exempted from approval of NC.<br>In view of above,the Committee decided towithdrawthe case.
212 Case No.:773/15/82-<br>ALC4/2018 Party Name:LUPIN LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02230/AM19/ RLA File<br>:03/95/040/00902/AM19/ Lic.No/Date:0310825460<br>05.12.2018 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

55

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.||||

55

213 <br>Case No.:466/13/82-<br>ALC4/2018 Party Name:DCM SHRIRAM<br>INDUSTRIES LTD, Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 Defer Date:
**Decision:**Deferred for comments of TE.
214 <br>Case No.:698/15/82-<br>ALC4/2018 Party Name:VISION DRUGS<br>PVT LTD Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 Defer Date:
**Decision:**Deferred for comments of TE.
215 <br>Case No.:700/15/82-<br>ALC4/2018 Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02157/AM19/ RLA File<br>:03/94/040/00748/AM19/ Lic.No/Date:0310825472<br>06.12.2018 Defer Date:
**Decision:**Deferred for comments of TE.

| |---|---|---|---|---| ||<br>HQ File<br>:01/82/050/02157/AM19/|RLA File<br>:03/94/040/00748/AM19/|Lic.No/Date:0310825472<br>06.12.2018|Defer Date:| ||**Decision:**Deferred for comments of TE.||||

216 Case No.:185/15/82-<br>ALC4/2018 Party Name:YASHO<br>INDUSTRIES LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm<br>dated 24.10.2019 has furnished its reply. Deferred for comments of TE. vide its letter

Decision: The Committee considered the case as per agenda and it was noted that the firm vide its letter dated 24.10.2019 has furnished its reply. Deferred for comments of TE.

217 <br>Case No.:88/15/82-ALC4/2018 Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01545/AM19/ RLA File<br>:03/94/040/00774/AM19/ Lic.No/Date:0310825559<br>10.12.2018 Defer Date:
**Decision:**Deferred for comments of TE.

56

-|---|---|---|---| ||<br>HQ File<br>:01/82/050/01545/AM19/|RLA File<br>:03/94/040/00774/AM19/|Lic.No/Date:0310825559<br>10.12.2018|Defer Date:| ||**Decision:**Deferred for comments of TE.||||

56

218 Case No.:715/15/82-<br>ALC4/2018 Party Name:MALLADI<br>DRUGS &<br>PHARMACEUTICALS Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
LIMITED
<br>HQ File RLA File Lic.No/Date:04101649 62 Defer Date:
:01/82/050/02172/AM19/ :04/24/040/00143/AM19/ 10.12.2018
**Decision:**Deferred for comments of TE.
Case No.:139/15/82- Case No.:139/15/82- Party Name:RUBICON Party Name:RUBICON Meet No/Date:1/82- Meet No/Date:1/82- Status:
219 <br> <br>ALC4/2018 <br>RESEARCH PRIVATE<br>LIMITED <br>ALC4/2020<br>17.04.2020 <br>Deferred
<br>HQ File RLA File Lic.No/Date:03108255 87 Defer Date:
<br>:01/82/050/01596/AM19/ <br>:03/95/040/00889/AM19/ <br>11.12.2018
**Decision:**Deferred for comm ents of TE.
Case No.:711/15/82- Party Name:SUVEN LIFE Meet No/Date:1/82- Status:
220 <br> <br>ALC4/2018 <br>SCIENCES LIMITED <br>ALC4/2020<br>17.04.2020<br>Lic.No/Date:0910066959 <br>Deferred
<br>HQ File RLA File Defer Date:
<br>:01/82/050/02168/AM19/ <br>:09/24/040/00441/AM19/ <br>11.12.2018
**Decision:**Deferred for comm ents of TE.

te:0910066959|<br>Deferred| ||<br>HQ File|RLA File||Defer Date:| ||<br>:01/82/050/02168/AM19/|<br>:09/24/040/00441/AM19/|<br>11.12.2018|| ||**Decision:**Deferred for comm|ents of TE.||| ||||||

Case No.:106/15/82- Party Name:SONGWON Meet No/Date:1/82- Status:
ALC4/2018 SPECIALTY CHEMICALS ALC4/2020 Deferred
INDIA PVT. LTD. 17.04.2020
221 HQ File RLA File Lic.No/Date:3410044750 Defer Date:
:01/82/050/01563/AM19/ :34/24/040/00294/AM19/ 12.12.2018
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail
dated 02.03.2020 has furnished its reply. Deferred for comments of TE.
Case No.:721/15/82- Party Name:VERVE HUMAN Meet No/Date:1/82- Status:
ALC4/2018 CARE LABORATORIES ALC4/2020 Deferred
17.04.2020
222 HQ File RLA File Lic.No/Date:6110001570 Defer Date:
:01/82/050/02178/AM19/ :61/24/040/00020/AM19/ 13.12.2018
**Decision:**Deferred for comments of TE.
Case No.:726/15/82- Party Name:NATCO PHARMA Meet No/Date:1/82- Status:
ALC4/2018 LIMITED ALC4/2020 Deferred
17.04.2020
223 HQ File RLA File Lic.No/Date:0910066973 Defer Date:
:01/82/050/02183/AM19/ :09/24/040/00417/AM19/ 18.12.2018
**Decision:**Deferred for comments of TE.

57

7.04.2020||| |223||HQ File||RLA File||Lic.No/Date:0910066973||Defer Date:| |||:01/82/050/02183/AM19/||:09/24/040/00417/AM19/||18.12.2018||| |||**Decision:**Deferred for comments of TE.|||||||

57

224 <br>Case No.:727/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02184/AM19/ RLA File<br>:09/24/040/00443/AM19/ Lic.No/Date:0910066974<br>18.12.2018 Defer Date:
**Decision:**Deferred for comments of TE.
225 <br>Case No.:735/15/82-<br>ALC4/2018 Party Name:CIPLA LIMITED. Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02192/AM19/ RLA File<br>:03/94/040/00753/AM19/ Lic.No/Date:0310825758<br>18.12.2018 Defer Date:
**Decision:**Deferred for comments of TE.
226 <br>Case No.:736/15/82-<br>ALC4/2018 Party Name:AMI ORGANICS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02193/AM19/ RLA File<br>:52/24/040/00068/AM19/ Lic.No/Date:5210042870<br>18.12.2018 Defer Date:
**Decision:**Deferred for comments of TE.

| |---|---|---|---|---| ||<br>HQ File<br>:01/82/050/02193/AM19/|RLA File<br>:52/24/040/00068/AM19/|Lic.No/Date:5210042870<br>18.12.2018|Defer Date:| ||**Decision:**Deferred for comments of TE.||||

227 <br>Case No.:99/15/82-<br>ALC4/2018 Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD. Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01556/AM19/ RLA File<br>:05/24/040/00503/AM19/ Lic.No/Date:0510408988<br>19.12.2018 <br>Defer Date:
**Decision:**Deferred for comments of TE.
228 <br>Case No.:738/15/82-<br>ALC4/2018 Party Name:VIVIMED LABS<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02195/AM19/ RLA File<br>:09/24/040/00460/AM19/ Lic.No/Date:0910066983<br>19.12.2018 Defer Date:
**Decision:**Deferred for comments of TE.
229 <br>Case No.:1025/15/82-<br>ALC4/2018 Party Name:ANLON<br>HEALTHCARE<br>PRIVATELIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02482/AM19/ RLA File<br>:24/24/040/00044/AM19/ Lic.No/Date:2410042604<br>19.12.2018 Defer Date:
**Decision:**Deferred for comments of TE.

58

-|---|---|---|---| ||<br>HQ File<br>:01/82/050/02482/AM19/|RLA File<br>:24/24/040/00044/AM19/|Lic.No/Date:2410042604<br>19.12.2018|Defer Date:| ||**Decision:**Deferred for comments of TE.||||

58

Case No.:742/15/82- Party Name:BEST VALUE Meet No/Date:1/82- Status:
ALC4/2018 CHEM PVT. LTD. ALC4/2020 Deferred
17.04.2020
HQ File RLA File Lic.No/Date:3410044774 Defer Date:
:01/82/050/02199/AM19/ :34/24/040/00295/AM19/ 20.12.2018

Decision: The firm vide e-mail dated 29.01.2020 has 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 230 Advance Licence issued under para 4.7 of HBP 2015-20, for which they have requested RLA,Vadodara to amend the condition sheet of advance authorization to read as Advance Licence issued under para 4.07 A of HBP Vol. I. The Committee considered the request of the firm and it was decided to verify the same from RLA, Vadodara.

RLA, Vadodara vide e-mail dated 23.03.2020 has been requested to verify whether the advance authorization No. 3410044774 dated 20.12.2018 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.

3410044774 dated 20.12.2018 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.

231 Case No.:743/15/82-<br>ALC4/2018 Party Name:SHUBHLAXMI<br>INDUSTRIES Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02200/AM19/ RLA File<br>:08/24/040/00267/AM19/ Lic.No/Date:0810144119<br>20.12.2018 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>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.

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.

232 Case No.:748/15/82-<br>ALC4/2018 Party Name:SPANSULES<br>FORMULATIONS Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02205/AM19/ RLA File<br>:09/24/040/00418/AM19/ Lic.No/Date:0910066987<br>20.12.2018 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail<br>dated 03.09.2019 and 28.11.2019 has furnished its reply. Deferred for comments of TE.
233 <br>Case No.:752/15/82-<br>ALC4/2018 Party Name:ATUL LIMITED, Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02209/AM19/ RLA File<br>:08/24/040/00303/AM19/ Lic.No/Date:0810144142<br>21.12.2018 Defer Date:
**Decision:**Deferred for comments of TE.

59

Case No.:925/15/82- Party Name:OPTRIX Meet No/Date:1/82- Status:
ALC4/2018 LABORATORIES PRIVATE ALC4/2020 Deferred
LIMITED 17.04.2020
234 HQ File RLA File Lic.No/Date:0910066998 Defer Date:
:01/82/050/02382/AM19/ :09/24/040/00470/AM19/ 24.12.2018
**Decision:**Deferred for comments of TE.

ED||17.04.2020||| |234||HQ File||RLA File||Lic.No/Date:0910066998||Defer Date:| |||:01/82/050/02382/AM19/||:09/24/040/00470/AM19/||24.12.2018||| |||**Decision:**Deferred for comments of TE.|||||||

Case No.:772/15/82- Party Name:AUROBINDO Meet No/Date:1/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2020 Deferred
17.04.2020
235 HQ File RLA File Lic.No/Date:0910067006 Defer Date:
:01/82/050/02229/AM19/ :09/24/040/00445/AM19/ 31.12.2018
**Decision:**Deferred for comments of TE.
Case No.:775/15/82- Party Name:SUVEN LIFE Meet No/Date:1/82- Status:
ALC4/2018 SCIENCES LIMITED ALC4/2020 Deferred
17.04.2020
236 HQ File RLA File Lic.No/Date:0910067014 Defer Date:
:01/82/050/02232/AM19/ :09/24/040/00482/AM19/ 31.12.2018
**Decision:**Deferred for comments of TE.
Case No.:788/15/82- Party Name:MANKIND Meet No/Date:1/82- Status:
ALC4/2018 PHARMA LTD ALC4/2020 Deferred
17.04.2020
237 HQ File RLA File Lic.No/Date:0510409149 Defer Date:
:01/82/050/02245/AM19/ :05/24/040/00552/AM19/ 02.01.2019
**Decision:**Deferred for comments of TE.

||||17.04.2020||| |237||HQ File||RLA File||Lic.No/Date:0510409149||Defer Date:| |||:01/82/050/02245/AM19/||:05/24/040/00552/AM19/||02.01.2019||| |||**Decision:**Deferred for comments of TE.|||||||

Case No.:1072/15/82- Party Name:MALLADI Meet No/Date:1/82- Status:
ALC4/2018 DRUGS & ALC4/2020 Deferred
PHARMACEUTICALS 17.04.2020
238 LIMITED
HQ File RLA File Lic.No/Date:0410165065 Defer Date:
:01/82/050/02529/AM19/ :04/24/040/00218/AM19/ 04.01.2019
**Decision:**Deferred for comments of TE.
Case No.:109/15/82- Party Name:U SQUARE Meet No/Date:1/82- Status:
ALC4/2018 LIFESCIENCE PRIVATE ALC4/2020 Deferred
LIMITED 17.04.2020
239 HQ File<br>:01/82/050/01566/AM19/ RLA File<br>:08/24/040/00329/AM19/ Lic.No/Date:0810144243<br>07.01.2019 Defer Date:
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it
was noted that the firm vide its e-mail dated 20.03.2020 has furnished its reply. Deferred for comments of
TE.

60

Case No.:805/15/82- Party Name:DEEPAK Meet No/Date:1/82- Status:
ALC4/2018 NOVOCHEM ALC4/2020 Deferred
TECHNOLOGIES LTD 17.04.2020
HQ File RLA File Lic.No/Date:3110067278 Defer Date:
:01/82/050/02262/AM19/ :31/83/040/00157/AM19/ 09.01.2019

018**||NOVOCHEM||ALC4/2020||Deferred| |||TECHNOLOGIES LTD||17.04.2020||| |HQ File||RLA File||Lic.No/Date:3110067278||Defer Date:| |:01/82/050/02262/AM19/||:31/83/040/00157/AM19/||09.01.2019|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information 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 240 Reminder on 18.03.2020 :

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

241 Case No.:123/15/82-<br>ALC4/2018 Party Name:REYAANSH<br>HEALTHCARE Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01580/AM19/ RLA File<br>:03/95/040/01019/AM19/ Lic.No/Date:0310826282<br>10.01.2019 <br>Defer Date:
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide its e-mail dated 25.03.2020 has furnished its reply. Deferred for comments of<br>TE.

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

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

242 Case No.:811/15/82-<br>ALC4/2018 Party Name:ATUL LIMITED, Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02268/AM19/ RLA File<br>:08/24/040/00328/AM19/ Lic.No/Date:0810144290<br>10.01.2019 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail<br>dated 11.11.2019 has furnished its reply. Deferred for comments of TE.
243 Case No.:812/15/82-<br>ALC4/2018 Party Name:BALAJI AMINES<br>LIMITED Meet No/Date:1/82-<br>ALC4/2020<br>17.04.2020 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 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail<br>dated 13.12.2019 has furnished its reply. Deferred for comments of TE.

61

MANUAL CASES

Case No. Case No. Case No. B- 01 B- 01 B- 01
Meeting No. 1/AM21
Date 17.04.2020
Firm’s Name M/s Clean Science and Technology Private Limited, Pune
HQ F. No. 01/82/162/00035/AM20/DES-III
Advance Authorization No. and Date Not issued yet
Subject Request of M/s Clean Science and Technology Private Limited,<br>Pune for fixation of norms for the export product Ascorbyl<br>Palmitate (ITC HS Code – 29362700) under Para 4.06 of HBP<br>Vol. I (2015-20)
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it was<br>decided to ratify the norms under para 4.06 of HBP Vol. I as per details below:<br>Export Product<br>Qty<br>Sl. No. Import item<br>Qty<br>Ascorbyl Palmitate<br>1 kg<br>1<br>Palmitic Acid<br>0.727 kg<br>2<br>Thionyl Chloride<br>0.470 kg<br>3<br>Ascorbic Acid<br>0.500 kg<br>4<br>N,N Dimethyl Acetamide<br>0.266 kg<br>5<br>Methylene Dichloride<br>1.50 kg<br>RA concerned may take further necessary action as per above decision of NC.
Export Product Qty Sl. No. Import item Qty
Ascorbyl Palmitate 1 kg 1 Palmitic Acid 0.727 kg
2 Thionyl Chloride 0.470 kg
3 Ascorbic Acid 0.500 kg
4 N,N Dimethyl Acetamide 0.266 kg
5 Methylene Dichloride 1.50 kg
RA concerned may take further necessary action as per above decision of NC.

62

| ||||3||Ascorbic Acid|0.500 kg| ||||4||N,N Dimethyl Acetamide|0.266 kg| ||||5||Methylene Dichloride|1.50 kg| ||RA concerned may take further|necessary action|||as per above decision of NC.||

62

Case No. Case No. Case No. B- 02 B- 02 B- 02
Meeting No. 1/AM21
Date 17.04.2020
Firm’s Name M/s Fine Organic Industries Limited, Mumbai
HQ F. No. 01/82/162/00043/AM20/DES-III
RLA F. No. 03/94/040/01001/AM20
Advance Authorization No. and Date Not issued yet
Subject Request of M/s Fine Organic Industries Limited, Mumbai for<br>fixation of norms of the export product DATEM (DIACETYL<br>TARTARIC ESTERS OF MONGLYCERIDES) (ITC HS Code<br>– 29161590) under Para 4.06 of HBP Vol. I (2015-20)
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it was<br>decided to ratify the norms under para 4.06 of HBP Vol. I as per details below:<br>Export Product<br>Qty<br>Sl. No. Import item<br>Qty<br>DATEM<br>(DIACETYL<br>TARTARIC<br>ESTERS<br>OF<br>MONGLYCERIDES)<br>1 kg<br>1<br>REFINED HIGH OLEIC SUN FLOWER OIL<br>0.705 kg<br>2<br>Glycerine<br>0.147 kg<br>3<br>TARTARIC ACID<br>0.167 kg<br> RA concerned may take further necessary action as per above decision of NC.
Export Product Qty Sl.

N FLOWER OIL<br>0.705 kg<br>2<br>Glycerine<br>0.147 kg<br>3<br>TARTARIC ACID<br>0.167 kg<br> RA concerned may take further necessary action as per above decision of NC.|||||| ||Export Product|Qty|Sl. No.||Import item|Qty| ||DATEM<br>(DIACETYL<br>TARTARIC<br>ESTERS<br>OF<br>MONGLYCERIDES)|<br> <br>1 kg|1||REFINED HIGH OLEIC SUN FLOWER OIL|0.705 kg| ||||2||Glycerine|0.147 kg| ||||3||TARTARIC ACID|0.167 kg| ||RA concerned may take further necessary action||||as per above decision of NC.||

Case No. Case No. Case No. B- 03 B- 03 B- 03
Meeting No. 1/AM21
Date 17.04.2020
Firm’s Name M/s Fine Organic Industries Limited, Mumbai
HQ F. No. 01/82/162/00042/AM20/DES-III
RLA F. No. 03/94/040/00931/AM20
Advance Authorization No. and Date Not issued yet
Subject Request of M/s Fine Organic Industries Limited, Mumbai for<br>fixation of norms of the export product Monoglyceride (ITC HS<br>Code– 29157030) under Para 4.06 of HBP Vol. I (2015-20)
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it was<br>decided to ratify the norms under para 4.06 of HBP Vol. I as per details below:<br>Export Product<br>Qty<br>Sl. No. Import item<br>Qty<br>Monoglyceride - PS<br>1 kg<br>1<br>Hydrogenated Palm Stearin(HPS)<br>0.872 kg<br>2<br>Glycerine<br>0.222 kg<br>RA concerned may take further necessary action as per above decision of NC.
Export Product Qty Sl.

<br>1 kg<br>1<br>Hydrogenated Palm Stearin(HPS)<br>0.872 kg<br>2<br>Glycerine<br>0.222 kg<br>RA concerned may take further necessary action as per above decision of NC.|||||| ||Export Product|Qty|Sl. No.||Import item|Qty| ||Monoglyceride - PS|1 kg|1||Hydrogenated Palm Stearin(HPS)|0.872 kg| ||||2||Glycerine|0.222 kg| ||RA concerned may take further|necessary action|||as per above decision of NC.||

Meeting ended with thanks to Chair.


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