IN FORCE Advance Authorisation

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Para 4.7 Decision

Minutes of the Norms Committee – 3 Meeting No. 13/82-ALC4/2019 dated 31.01.2020 (actually held on 12.02.2020 and 20.02.2020) 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. 12/82-ALC4/2019 dated 17.01.2020 (actually held on 21.01.2020)

ONLINE CASES

Case No.:164/13/82-ALC4/2019	Party Name:PCL OIL &	Meet No/Date:13/82-	Status:
	SOLVENTS LTD.,	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01007/AM20/	RLA File	Lic.No/Date:0510393743
	:05/24/040/00591/AM15/	26.03.2015

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting 1 no. 6/82-ALC4/2019 dated 16.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
PVC Plasticizer (DOP )	1 kg	1	PHTHALIC ANHYDRIDE	0.400 kg
		2	2 ETHYLHEXANOL (OCTANOL)	0.700 kg

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

2	Case No.:230/15/82-ALC4/2018	Party Name:WINTAC LIMITED,<br>RLA File<br>:07/24/040/00083/AM17/	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:0710109922<br>08.06.2016	Status:<br>Deferred<br>Defer Date:
	HQ File :01/82/050/01687/AM19/
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not available.<br>Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the<br>firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

ilable. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.||||

Case No.:160/13/82-ALC4/2019	Party Name:ALKALOIDS	Meet No/Date:13/82-	Status:
	CORPORATION	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01003/AM20/	RLA File	Lic.No/Date:0210206771
	:02/24/040/00051/AM17/	20.06.2016

	Case No.:160/13/82-ALC4/2019	Party Name:ALKALOIDS<br>CORPORATION	Party Name:ALKALOIDS<br>CORPORATION	Party Name:ALKALOIDS<br>CORPORATION	Party Name:ALKALOIDS<br>CORPORATION	Status:<br>Approved
	HQ File :01/82/050/01003/AM20/	RLA File<br>:02/24/040/00051/AM17/
3	Decision:The Committee considered case<br>decided to ratify the ad-hoc input output norms<br>whichever is lower:		as per<br>under
	Export product		Qty.	Sl.<br>No.	Import items	Qty.
	Noscapine BP/Noscapine Hydrochloride BP		1 kg	1	Noscapine Crude Content 95%	1.05 kg
	RA concerned maytake further necessaryaction		asper above decision of NC.

Case No.:1/13/85-ALC3/2016	Party Name:SRIAM LABS	Meet No/Date:13/82-	Status:
	PRIVATE LIMITED	ALC4/2019	Approved
		31.01.2020
HQ File	RLA File	Lic.No/Date:0910064049
:01/85/050/00109/AM17/	:09/24/040/00260/AM17/	17.08.2016

--|---|---|---|---|---| |||PRIVATE LIMITED||ALC4/2019||Approved| |||||31.01.2020||| |HQ File||RLA File||Lic.No/Date:0910064049||| |:01/85/050/00109/AM17/||:09/24/040/00260/AM17/||17.08.2016|||

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 10/82-ALC4/2019 dated 29.11.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details 4 given below or as applied by the firm, whichever is less:

iven below or as applied by the firm, whichever is	less:
Export product	Qty.	Sl.	Import items	Qty.
		No.
N1-(2,4-Difluorobenzyl)-4-ethoxy-3-	1 kg	1	2,4 - Difluorobenzylamine	0.642 kg
oxobutanamide (ATFD/II)

Case No.:139/13/82-ALC4/2019	Party Name:ALMELO PRIVATE	Meet No/Date:13/82-	Status:
	LIMITED	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/00982/AM20/	RLA File	Lic.No/Date:0910064313
	:09/24/040/00404/AM17/	26.10.2016

|---|---|---|---|---|---|---| |||LIMITED||ALC4/2019||Approved| |||||31.01.2020||| |HQ File :01/82/050/00982/AM20/||RLA File||Lic.No/Date:0910064313||| |||:09/24/040/00404/AM17/||26.10.2016|||

	Case No.:139/13/82-ALC4/2019	Party Name:ALMELO PRIVATE<br>LIMITED	Party Name:ALMELO PRIVATE<br>LIMITED	Party Name:ALMELO PRIVATE<br>LIMITED	Party Name:ALMELO PRIVATE<br>LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020
	HQ File :01/82/050/00982/AM20/	RLA File<br>:09/24/040/00404/AM17/				Lic.No/Date:0910064313<br>26.10.2016
5	Decision:The Committee considered case as per agenda in the presence of the technical experts and it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm<br>whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Oxo- Erythronolide A-11,12-<br>Carbamate<br>1 kg<br>1<br>Clarithromycin<br>2.344 kg<br>2<br>1,1-Carbonyldiimidazole<br>1.917 kg<br>3<br>1,8-Diazabicyclo[5.4.0] undec-<br>7-ene<br>1.509 kg<br>4<br>4-Dimethyl Amino Pyridine<br>0.786 kg<br>5<br>Triphenyl Phosphine<br>1.148 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.
	Export product		Qty.	Sl.<br>No.	Import items		Qty.
	Oxo- Erythronolide A-11,12-<br>Carbamate		1 kg	1	Clarithromycin		2.344 kg
				2	1,1-Carbonyldiimidazole		1.917 kg
				3	1,8-Diazabicyclo[5.4.0] undec-<br>7-ene		1.509 kg

mport items||Qty.|| ||Oxo- Erythronolide A-11,12- Carbamate||1 kg|1|Clarithromycin||2.344 kg|| |||||2|1,1-Carbonyldiimidazole||1.917 kg|| |||||3|1,8-Diazabicyclo[5.4.0] undec- 7-ene||1.509 kg|| |||||4|4-Dimethyl Amino Pyridine||0.786 kg|| |||||5|Triphenyl Phosphine||1.148 kg|| ||RA concerned maytake further necessary||action as|per above decision of NC.|||||

6	Case No.:234/4/82-ALC4/2018<br>Party Name:VIVIMED LIFE<br>SCIENCES PRIVATE LIMITED<br>Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Status:<br>Withdrawn<br>HQ File :01/82/050/00234/AM19/ RLA File<br>:09/24/040/00396/AM18/<br>Lic.No/Date:0910065686<br>24.11.2017<br>Decision:The Committee considered the case as per agenda in the presence of technical experts and it was<br>observed that the Committee has already rejected this case vide its Meeting No. 12/AM20 dated 17.01.2020.<br>In view of above,the Committee decided towithdrawthe case.	Party Name:VIVIMED LIFE<br>SCIENCES PRIVATE LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Withdrawn
		RLA File<br>:09/24/040/00396/AM18/	Lic.No/Date:0910065686<br>24.11.2017

NCES PRIVATE LIMITED|Meet No/Date:13/82- ALC4/2019 31.01.2020|Status: Withdrawn| |---|---|---|---|---| |||RLA File :09/24/040/00396/AM18/|Lic.No/Date:0910065686 24.11.2017||

7	Case No.:417/15/82-ALC4/2018Party Name:JODAS EXPOIM<br>PVT.LTD<br>HQ File :01/82/050/01874/AM19/ RLA File<br>:05/23/040/00167/AM19/<br>Decision:The Committee considered the case as per agenda and it<br>Cause Notice vide letter dated 10.10.2019.	Party Name:JODAS EXPOIM<br>PVT.LTD	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
		RLA File<br>:05/23/040/00167/AM19/	Lic.No/Date:0510407069<br>04.07.2018	Defer Date:
			was observed that the firm wa	s issued Show

8	Case No.:418/15/82-ALC4/2018	Party Name:JODAS EXPOIM<br>PVT.LTD	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:0510407077<br>04.07.2018	Status:<br>Deferred<br>Defer Date:
	HQ File<br>:01/82/050/01875/AM19/	RLA File<br>:05/23/040/00163/AM19/
	Decision:The Committee considered the case as per agenda and<br>Cause Notice vide letter dated 10.10.2019.		it was observed that the firm was issued Show

File :05/23/040/00163/AM19/||| ||**Decision:**The Committee considered the case as per agenda and Cause Notice vide letter dated 10.10.2019.||it was observed that the firm was issued Show||

9	Case No.:419/15/82-ALC4/2018	Party Name:JODAS EXPOIM<br>PVT.LTD	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status: Deferred
	HQ File<br>:01/82/050/01876/AM19/	RLA File<br>:05/23/040/00164/AM19/	Lic.No/Date:0510407078<br>04.07.2018	Defer Date:
	Decision:The Committee considered the case as per agenda and it was observed that the firm was issued Show<br>Cause Notice vide letter dated 10.10.2019.

10	<br>Case No.:58/15/82-ALC4/2018<br>Party Name:AUROBINDO<br>PHARMA LIMITED<br>HQ File :01/82/050/01515/AM19/ RLA File<br>:09/24/040/00168/AM19/<br>Decision:Deferred for comments of TE.	Party Name:AUROBINDO<br>PHARMA LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
		RLA File<br>:09/24/040/00168/AM19/	Lic.No/Date:0910066418<br>04.07.2018	Defer Date:

TED|Meet No/Date:13/82- ALC4/2019 31.01.2020|Status: Deferred| |---|---|---|---|---| |||RLA File :09/24/040/00168/AM19/|Lic.No/Date:0910066418 04.07.2018|Defer Date:| ||||||

11	<br>Case No.:389/15/82-ALC4/2018	Party Name:ATUL LIMITED,	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	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.

12	Case No.:617/15/82-ALC4/2018	Party Name:JODAS EXPOIM<br>PVT.LTD	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	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<br>Cause Notice vide letter dated 10.10.2019.		it was observed that the firm was issued Show

Case No.:247/12/82-ALC4/2018	Party Name:MOREPEN	Meet No/Date:13/82-	Status:
	LABORATORIES LTD.,	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/00874/AM19/	RLA File	Lic.No/Date:0510407132
	:05/24/040/00203/AM19/	09.07.2018

--|---|---|---|---| |||LABORATORIES LTD.,||ALC4/2019||Approved| |||||31.01.2020||| |HQ File :01/82/050/00874/AM19/||RLA File||Lic.No/Date:0510407132||| |||:05/24/040/00203/AM19/||09.07.2018|||

	Case No.:247/12/82-ALC4/2018	Party Name:MOREPEN<br>LABORATORIES LTD.,	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Approved
	HQ File :01/82/050/00874/AM19/	RLA File<br>:05/24/040/00203/AM19/	Lic.No/Date:0510407132<br>09.07.2018
13	Decision:The Committee considered case as per agenda in the presence of the technical experts and it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm<br>whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Empagliflozin<br>1 kg<br>1<br>(3S)-3-(4-[(2-chloro-5-iodophenyl)<br>methyl] phenoxy)tetrahydrofuran<br>(EG01) /<br>(3S)-3-(4-(2-chloro-5-<br>iodobenzyl)phenoxy)tetrahydrofuran<br>(EG01)/(S)-3-(4-(2-Chloro-5-<br>iodobenzyl)phenoxy)<br>tetrahydrofuran<br>2.04 kg<br>2<br>2,3,4,6-tetra-O-trimethyl silyl-beta-<br>D-glucolactone ( EGS01) / 2,3,4,5-<br>Tetrakis-O-Trimethylsilyl-D-<br>Gluconolactone<br>2.53 kg<br>3<br>Acetonitrile<br>2.16 kg<br>4<br>Methylene chloride<br>3.25 kg<br>5<br>Toluene<br>1.525kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

olactone 2.53 kg 3 Acetonitrile 2.16 kg 4 Methylene chloride 3.25 kg 5 Toluene 1.525kg RA concerned maytake further necessaryaction asper above decision of NC.||||

14	Case No.:96/12/82-ALC4/2018	Party Name:STERLING<br>AUXILIARIES PVT LTD	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status: Deferred
	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 dated<br>31.10.2019 has furnished its reply. Deferred for comments of TE.

Case No.:43/15/82-ALC4/2018	Party Name:AKTINOS	Meet No/Date:13/82-	Status:
	PHARMA PVT LTD,	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01500/AM19/	RLA File	Lic.No/Date:0910066433
	:09/24/040/00174/AM19/	11.07.2018

-|---|---|---|---|---| |||PHARMA PVT LTD,||ALC4/2019||Approved| |||||31.01.2020||| |HQ File :01/82/050/01500/AM19/||RLA File||Lic.No/Date:0910066433||| |||:09/24/040/00174/AM19/||11.07.2018|||

	Case No.:43/15/82-ALC4/2018	Party Name:AKTINOS<br>PHARMA PVT LTD,	Party Name:AKTINOS<br>PHARMA PVT LTD,	Party Name:AKTINOS<br>PHARMA PVT LTD,	Party Name:AKTINOS<br>PHARMA PVT LTD,	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020
	HQ File :01/82/050/01500/AM19/	RLA File<br>:09/24/040/00174/AM19/				Lic.No/Date:0910066433<br>11.07.2018
15	Decision:The Committee considered ca<br>decided to ratify the ad-hoc input output nor<br>whichever is lower:		se as per<br>ms under
	Export product		Qty.	Sl.<br>No.	Import items		Qty.
	2-CHLORO-5-FLUOROPYRIMIDIN-4-<br>AMINE (FLUCYTOSINE STATE-1)		1 kg	1	5-FLUORO URACIL		1.38 kg
	RA concerned maytake further necessaryaction asper above decision of NC.

Case No.:45/15/82-ALC4/2018	Party Name:AUROBINDO	Meet No/Date:13/82-	Status:
	PHARMA LIMITED	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01502/AM19/	RLA File	Lic.No/Date:0910066444
	:09/24/040/00185/AM19/	11.07.2018

--|---|---|---|---|---| |||PHARMA LIMITED||ALC4/2019||Approved| |||||31.01.2020||| |HQ File :01/82/050/01502/AM19/||RLA File||Lic.No/Date:0910066444||| |||:09/24/040/00185/AM19/||11.07.2018|||

	Case No.:45/15/82-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:13/82-<br>ALC4/2019<br>31.01.2020	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Approved
	HQ File :01/82/050/01502/AM19/	RLA File<br>:09/24/040/00185/AM19/				Lic.No/Date:0910066444<br>11.07.2018
16	Decision:The Committee considered case as per agenda in the presence of the technical experts and it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm<br>whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>PIPERACILLIN SODIUM AND<br>TAZOBACTAM SODIUM 8:1 FOR<br>INJECTION<br>1 kg<br>1<br>4-Ethyl-2, 3 Dioxo Piperazine<br>(EDP)<br>0.3323 kg<br>2<br>6-Amino Penicillanic Acid (6-APA)<br>0.436 kg<br>3<br>Benzhydril<br>Tazobactam<br>(or) (2S, 3S, 5R)-3-Methyl-7-Oxo-<br>3- (1H-1, 2,3-Triazole-1-ylmethyl) -<br>4-Thia-1-Azabicyclo<br>[3.2.0]<br>Heptane-2-Carboxylic<br>Acid<br>Diphenylmethyl Ester, 4,4-Dioxide<br>0.1783 kg<br>4<br>Activated Carbon (Carbon<br>Enoanticromos)<br>0.050 kg<br>5<br>10% Palladium On Charcoal /<br>Carbon (Catalyst-type 5T39 Paste)<br>0.0009 kg<br>6<br>Isopropyl Alcohol (IPA)<br>0.105 kg<br>7<br>Meth

br>Activated Carbon (Carbon Enoanticromos) 0.050 kg 5 10% Palladium On Charcoal / Carbon (Catalyst-type 5T39 Paste) 0.0009 kg 6 Isopropyl Alcohol (IPA) 0.105 kg 7 Methanol (Methyl Alcohol) 0.335 kg 8 Methylene Chloride (MDC) 2.27 kg 9 Penicillin G Amidase (Particle size 250 - 500 micron, Creamish to Brown regularly shaped beads) or (Immobilized Acylase Enzyme) Xinase 0.0015 kg 10 D-Phenyl Glycine Methyl Ester Hydrochloride 0.4384 kg 11 Triethylamine 0.466 kg 12 Trimethyl Chlorosilane 0.3069 kg 13 Triphosgene 0.2761 kg 14 Aluminium Canisters / Bottles with Chloro Butyl Plug / Inner & Outer Lid and Gasket / Alu Caps [20 Ltrs (10Kg Cap)] Relevant as per packing policy RA concerned maytake further necessaryaction asper above decision of NC.|||||||| ||Export product||Qty.|Sl. No.|Import items||Qty.|| ||PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM 8:1 FOR INJECTION||1 kg|1|4-Ethyl-2, 3 Dioxo Piperazine (EDP)||0.3323 kg|| |||||2|6-Amino Penicillanic Acid (6-APA)||0.436 kg|| |||||3|Benzhydril Tazobactam (or) (2S, 3S, 5R)-3-Methyl-7-Oxo- 3- (1H-1, 2,3-Triazole-1-ylmethyl) - 4-Thia-1-Azabicyclo [3.2.0] Heptane-2-Carboxylic Acid Diphenylmethyl Ester, 4,4-Dioxide||0.1783 kg|| |||||4|Activated Carbon (Carbon Enoanticromos)||0.050 kg|| |||||5|10% Palladium On Charcoal / Carbon (Catalyst-type 5T39 Paste)||0.0009 kg|| |||||6|Isopropyl Alcohol (IPA)||0.105 kg|| |||||7|Methanol (Methyl Alcohol)||0.335 kg||

Enoanticromos)||0.050 kg|| |||||5|10% Palladium On Charcoal / Carbon (Catalyst-type 5T39 Paste)||0.0009 kg|| |||||6|Isopropyl Alcohol (IPA)||0.105 kg|| |||||7|Methanol (Methyl Alcohol)||0.335 kg|| |||||8|Methylene Chloride (MDC)||2.27 kg|| |||||9|Penicillin G Amidase (Particle size 250 - 500 micron, Creamish to Brown regularly shaped beads) or (Immobilized Acylase Enzyme) Xinase||0.0015 kg|| |||||10|D-Phenyl Glycine Methyl Ester Hydrochloride||0.4384 kg|| |||||11|Triethylamine||0.466 kg|| |||||12|Trimethyl Chlorosilane||0.3069 kg|| |||||13|Triphosgene||0.2761 kg|| |||||14|Aluminium Canisters / Bottles with Chloro Butyl Plug / Inner & Outer Lid and Gasket / Alu Caps [20 Ltrs (10Kg Cap)]||Relevant as per packing policy|| ||RA concerned maytake further necessary||action as|per above decision of NC.|||||

17	Case No.:46/15/82-ALC4/2018	Party Name:AUROBINDO<br>PHARMA LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:0910066442<br>11.07.2018	Status:<br>Deferred
	HQ File :01/82/050/01503/AM19/	RLA File<br>:09/24/040/00181/AM19/		Defer Date:
	Decision:Deferred for comments of TE.

18	Case No.:93/13/82-ALC4/2018	Party Name:PORUS<br>LABORATORIES PVT LTD	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:0910066447<br>12.07.2018	Status:<br>Rejected
	HQ File :01/82/050/01071/AM19/	RLA File<br>:09/24/040/00172/AM19/

RIES PVT LTD|Meet No/Date:13/82- ALC4/2019 31.01.2020 Lic.No/Date:0910066447 12.07.2018|Status: Rejected| ||HQ File :01/82/050/01071/AM19/|RLA File :09/24/040/00172/AM19/||| ||Decision:The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No.13/82-ALC4/2018 dated 14.01.2019, 4/82-ALC4/2019dated19.07.2019 and 8/82-ALC4/2019dated20.09.2019,followed by Final Reminder on 05.09.2019: (i) Complete technical details as per Appendix 4E along with Chemical reaction, molecular weight and percentage of yield on molar basis. Hence, the Committee decided torejectthe case. RA concerned maytake further necessaryaction asper above decision of NC.||||

Case No.:91/13/82-ALC4/2018	Party Name:SUVEN LIFE	Meet No/Date:13/82-	Status:
	SCIENCES LIMITED	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01069/AM19/	RLA File	Lic.No/Date:0910066455
	:09/24/040/00177/AM19/	13.07.2018

|---|---|---|---|---| |||SCIENCES LIMITED||ALC4/2019||Approved| |||||31.01.2020||| |HQ File :01/82/050/01069/AM19/||RLA File||Lic.No/Date:0910066455||| |||:09/24/040/00177/AM19/||13.07.2018|||

	Case No.:91/13/82-ALC4/2018	Party Name:SUVEN LIFE<br>SCIENCES LIMITED	Party Name:SUVEN LIFE<br>SCIENCES LIMITED	Party Name:SUVEN LIFE<br>SCIENCES LIMITED	Party Name:SUVEN LIFE<br>SCIENCES LIMITED	Status:<br>Approved
	HQ File :01/82/050/01069/AM19/	RLA File<br>:09/24/040/00177/AM19/
19	Decision:The Committee considered case<br>decided to ratify the ad-hoc input output norms<br>whichever is lower:			as per<br>under
	Export product		Qty.	Sl.<br>No.	Import items	Qty.
	1-[2-[5-METHYL-3-<br>(TRIFLUOROMETHYL)-1H-<br>PYRAZOL-1-YL]<br>ACETYL]PIPERIDINE-4-<br>CARBOTHIOAMIDE		1 kg	1	4-CYANO PYRIDINE	0.524 kg
				2	TERTIARY BUTANOL	0.488 kg
				3	N,N-DIMETHYL FORMAMIDE (DMF)	2.89 kg
				4	ETHYL TRIFLUORO ACETATE	0.708 kg
				5	ACETONE	0.315 kg
				6	HYDRAZINE HYDRATE (80%)	0.398 kg
				7	METHYL TERTIARY BUTYL ETHER	2.88 kg
	RA concerned maytake further necessaryaction			asper above decision of NC.

Case No.:98/13/82-ALC4/2018	Party Name:SUVEN LIFE	Meet No/Date:13/82-	Status:
	SCIENCES LIMITED	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01076/AM19/	RLA File	Lic.No/Date:0910066454
	:09/24/040/00176/AM19/	13.07.2018

|---|---|---|---|---| |||SCIENCES LIMITED||ALC4/2019||Approved| |||||31.01.2020||| |HQ File :01/82/050/01076/AM19/||RLA File||Lic.No/Date:0910066454||| |||:09/24/040/00176/AM19/||13.07.2018|||

	Case No.:98/13/82-ALC4/2018<br>	Case No.:98/13/82-ALC4/2018<br>	Case No.:98/13/82-ALC4/2018<br>	Case No.:98/13/82-ALC4/2018<br>	Party Name:SUVEN LIFE	Party Name:SUVEN LIFE	Party Name:SUVEN LIFE	Party Name:SUVEN LIFE	Party Name:SUVEN LIFE	Party Name:SUVEN LIFE	Meet No/Date:13/82-	Meet No/Date:13/82-	Status:<br>Approved	Status:<br>Approved
			<br> <br> <br>File :01/82/050/01076/AM19/		<br>SCIENCES LIMITED						<br>ALC4/2019<br>31.01.2020	4	<br>Approved
	HQ				RLA File<br>:09/24/040/00176/AM19/						Lic.No/Date:091006645
			<br>								<br>13.07.2018
20	Dec<br>deci<br>whi<br> <br>4<br>F<br>RA		ision:The Committee cons		idered c		se as per agenda in th			presence of the technical		experts and it		was<br>irm<br> <br> <br>
			<br>ded to ratify the ad-hoc input output nor<br>chever is lower:				<br>ms under para 4.7 of HBP as per details below or as applied by f
			Export product				Qty.	Sl.	Import items				Qty.
								No.
		4<br>F	-(4<br>OR	-BROMO-3-			1 kg	1	4-FLUOROBENZONITRILE				0.55 kg
				MYLPHENOXY)BENZONITRIL		E		2	3-HYDROXYBENZALDEHYD			E	0.63 kg
								3	DIMETHYL SULFOXIDE				1.59 kg

|||||||| |||4 F|-(4 OR|-BROMO-3-|||1 kg||1||4-FLUOROBENZONITRILE||||0.55 kg|| |||||MYLPHENOXY)BENZONITRIL||E|||2||3-HYDROXYBENZALDEHYD|||E|0.63 kg|| ||||||||||3||DIMETHYL SULFOXIDE||||1.59 kg|| ||||concerned maytake further necessaryaction asper above|||||||||||||| ||||||||||||decision of NC.|||||| ||||||||||||||||||

Case No.:100/13/82-ALC4/2018	Party Name:RA CHEM	Meet No/Date:13/82-	Status:
	PHARMA LIMITED	ALC4/2019	Deferred
		31.01.2020
HQ File :01/82/050/01078/AM19/	RLA File	Lic.No/Date:0910066457	Defer Date:
	: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 21 noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 8/82ALC4/2019 dated 20.09.2019 , followed by Reminder on 31.10.2019 :

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

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.:189/13/82-ALC4/2018	Party Name:YASH RASAYAN &	Meet No/Date:13/82-	Status:
	CHEMICALS	ALC4/2019	Deferred
		31.01.2020
HQ File :01/82/050/01167/AM19/	RLA File	Lic.No/Date:3410044333	Defer Date:
	:34/24/040/00114/AM19/	16.07.2018

|---|---|---|---| |||CHEMICALS||ALC4/2019||Deferred| |||||31.01.2020||| |HQ File :01/82/050/01167/AM19/||RLA File||Lic.No/Date:3410044333||Defer Date:| |||: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 22 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 30.10.2019 : (i) Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction and % of yield at every stage.

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

Case No.:300/13/82-ALC4/2018	Party Name:ATHENA DRUG	Meet No/Date:13/82-	Status:
	DELIVERY SOLUTIONS	ALC4/2019	Approved
	PRIVATE LIMITED	31.01.2020
HQ File	RLA File	Lic.No/Date:0310822337
:01/82/050/01278/AM19/	:03/94/040/00312/AM19/	17.07.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting 23 no. 1/82-ALC4/2919 dated 03.06.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. FENOFIBRATE 160 mg PELLETS 1 kg 1 FENOFIBRATE EP 9.0 0.320 kg

a 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. FENOFIBRATE 160 mg PELLETS 1 kg 1 FENOFIBRATE EP 9.0 0.320 kg

24	Case No.:432/15/82-ALC4/2018	Party Name:JODAS EXPOIM<br>PVT.LTD<br>RLA File<br>:05/23/040/00183/AM19/	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
	HQ File :01/82/050/01889/AM19/		Lic.No/Date:0510407217<br>17.07.2018	Defer Date:
	Decision:The Committee considered the case as per agenda and it<br>Cause Notice vide letter dated 10.10.2019.		was observed that the firm wa	s issued Show

Case No.:87/13/82-ALC4/2018	Party Name:VIVIMED LIFE	Meet No/Date:13/82-	Status:
	SCIENCES PRIVATE LIMITED	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01065/AM19/	RLA File	Lic.No/Date:0910066481
	:09/24/040/00148/AM19/	19.07.2018

|---|---|---| |||SCIENCES PRIVATE LIMITED||ALC4/2019||Approved| |||||31.01.2020||| |HQ File :01/82/050/01065/AM19/||RLA File||Lic.No/Date:0910066481||| |||:09/24/040/00148/AM19/||19.07.2018|||

	Case No.:87/13/82-ALC4/2018	Party Name:VIVIMED LIFE<br>SCIENCES PRIVATE LIMITED<br>RLA File<br>:09/24/040/00148/AM19/	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Approved
	HQ File :01/82/050/01065/AM19/		Lic.No/Date:0910066481<br>19.07.2018
25	Decision:The Committee considered the cases as per agenda in the presence of technical experts and it was<br>decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is<br>less:<br>Sl.<br>No.<br>Import Items<br>For export of Gabapentin Capsules<br>100 mg capsule<br>(704000 Thousand)<br>300 mg capsule<br>(106650 Thousand)<br>400 mg capsule<br>(32020 Thousand)<br>1<br>Gabapentine USP<br>7180.8 kg<br>17626.62 kg<br>8097.858 kg<br>2<br>Pregelatinized starch(Starch<br>1500) NF<br>1038.4 kg<br>2599.926 kg<br>1194.346 kg<br>3<br>Talc USP/BP<br>1425.6 kg<br>3569.391 kg<br>1639.424 kg<br>4<br>Empty hard gelatin capsules<br>of relevant size<br>Relevant, as per packing policy with accountability.<br>Note: Details of other import items not given by firm.<br>RA maytake appropriate action asper the decision of Norms Committee.

evant, as per packing policy with accountability. Note: Details of other import items not given by firm. RA maytake appropriate action asper the decision of Norms Committee.||||

Case No.:444/15/82-ALC4/2018	Party Name:OPTIMUS DRUGS	Meet No/Date:13/82-	Status:
	PRIVATE LIMITED	ALC4/2019	Deferred
		31.01.2020
HQ File :01/82/050/01901/AM19/	RLA File	Lic.No/Date:0910066488	Defer Date:
	:09/24/040/00193/AM19/	19.07.2018

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

(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.

Case No.:255/12/82-ALC4/2018 Party Name:ESKAG PHARMA Meet No/Date:13/82- Status: PRIVATE LIMITED, ALC4/2019 Approved 31.01.2020 HQ File :01/82/050/00882/AM19/ RLA File Lic.No/Date:0210208597 :02/24/040/00064/AM19/ 20.07.2018

ame:ESKAG PHARMA Meet No/Date:13/82- Status: PRIVATE LIMITED, ALC4/2019 Approved 31.01.2020 HQ File :01/82/050/00882/AM19/ RLA File Lic.No/Date:0210208597 :02/24/040/00064/AM19/ 20.07.2018

	Case No.:255/12/82-ALC4/2018	Party Name:ESKAG PHARMA<br>PRIVATE LIMITED,	Party Name:ESKAG PHARMA<br>PRIVATE LIMITED,	Party Name:ESKAG PHARMA<br>PRIVATE LIMITED,	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020
	HQ File :01/82/050/00882/AM19/	RLA File<br>:02/24/040/00064/AM19/			Lic.No/Date:0210208597<br>20.07.2018
27	Decision:The Committee considered case as per agenda in the presence of the technical experts and it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm<br>whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>SUCRALFATO SUSPENSION ORAL - 200 ML<br>(3,00,000 bottles of 200 ml each)<br>3,00,000<br>Number<br>bottles<br>1<br>SUCRALFATE<br>12,600 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.
	Export product		Qty.	Sl.<br>No.		Import items	Qty.
	SUCRALFATO SUSPENSION ORAL - 200 ML<br>(3,00,000 bottles of 200 ml each)		3,00,000<br>Number<br>bottles	1		SUCRALFATE	12,600 kg
	RA concerned maytake further necessaryaction asper above decision of					NC.

SPENSION ORAL - 200 ML (3,00,000 bottles of 200 ml each)||3,00,000 Number bottles|1||SUCRALFATE|12,600 kg| ||RA concerned maytake further necessaryaction asper above decision of|||||NC.||

Case No.:34/13/82-ALC4/2018	Party Name:NITIKA	Meet No/Date:13/82-	Status:
	PHARMACEUTICAL	ALC4/2019	Approved
	SPECIALITIES PVT. LTD.	31.01.2020
HQ File :01/82/050/01012/AM19/	RLA File	Lic.No/Date:5010002462
	:50/24/040/00013/AM19/	24.07.2018

	Case No.:34/13/82-ALC4/2018	Party Name:NITIKA<br>PHARMACEUTICAL<br>SPECIALITIES PVT. LTD.	Party Name:NITIKA<br>PHARMACEUTICAL<br>SPECIALITIES PVT. LTD.	Party Name:NITIKA<br>PHARMACEUTICAL<br>SPECIALITIES PVT. LTD.	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020
	HQ File :01/82/050/01012/AM19/	RLA File<br>:50/24/040/00013/AM19/			Lic.No/Date:5010002462<br>24.07.2018
28	Decision:<br>The Committee considered c<br>decided to ratify the ad-hoc input output norm<br>whichever is lower:
	Export product		Qty.	Sl.<br>No.	Import items	Qty.
	MAGNESIUM<br>STEARATE<br>FATTY ACID OF SALT MAGNESIUM		400.000 MT	1	STEARIC ACID	516.4 MT
	MANGANESE<br>STEARATE<br>MANGANESE DISTEARATE		80.000 MT
	FERRIC<br>STEARATE<br>IRON TRISTEARATE		40.000 MT
	RA concerned maytake further necessaryaction asper above decision of NC.

STEARATE MANGANESE DISTEARATE||80.000 MT||||| ||FERRIC STEARATE IRON TRISTEARATE||40.000 MT||||| ||RA concerned maytake further necessaryaction asper above decision of NC.|||||||

Case No.:78/13/82-ALC4/2018	Party Name:SMS	Meet No/Date:13/82-	Status:
	LIFESCIENCES INDIA	ALC4/2019	Approved
	LIMITED	31.01.2020
HQ File :01/82/050/01056/AM19/	RLA File	Lic.No/Date:0910066505
	:09/24/040/00205/AM19/	24.07.2018

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

Export product	Qty.	Sl.	Import items	Qty.
		No.
(3R, 3aS, 6aR) - HEXA HYDRO FURO -	1 kg	1	BIS IV (HEXA HYDRO FURO	1.61 kg
[2, 3-b] - FURAN - 3 - YL - 4 - NITRO			[2,3-B] FURAN-3-OL)
PHENYL CARBONATE (DARUNAVIR-<br>IV)		2	METHYLENE DI CHLORIDE	5.32 kg

Case No.:446/15/82-ALC4/2018	Party Name:GRANULES INDIA	Meet No/Date:13/82-	Status:
	LIMITED	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01903/AM19/	RLA File	Lic.No/Date:0910066498
	:09/24/040/00194/AM19/	24.07.2018

|---|---|---|---|---|---|---| |||LIMITED||ALC4/2019||Approved| |||||31.01.2020||| |HQ File :01/82/050/01903/AM19/||RLA File||Lic.No/Date:0910066498||| |||:09/24/040/00194/AM19/||24.07.2018|||

|||Case No.:446/15/82-ALC4/2018Party Name:GRANULES INDIA LIMITED Meet No/Date:13/82- ALC4/2019 31.01.2020 Status: Approved HQ File :01/82/050/01903/AM19/ RLA File :09/24/040/00194/AM19/ Lic.No/Date:0910066498 24.07.2018|Case No.:446/15/82-ALC4/2018Party Name:GRANULES INDIA LIMITED Meet No/Date:13/82- ALC4/2019 31.01.2020 Status: Approved HQ File :01/82/050/01903/AM19/ RLA File :09/24/040/00194/AM19/ Lic.No/Date:0910066498 24.07.2018|Case No.:446/15/82-ALC4/2018Party Name:GRANULES INDIA LIMITED Meet No/Date:13/82- ALC4/2019 31.01.2020 Status: Approved HQ File :01/82/050/01903/AM19/ RLA File :09/24/040/00194/AM19/ Lic.No/Date:0910066498 24.07.2018|Case No.:446/15/82-ALC4/2018Party Name:GRANULES INDIA LIMITED Meet No/Date:13/82- ALC4/2019 31.01.2020 Status: Approved HQ File :01/82/050/01903/AM19/ RLA File :09/24/040/00194/AM19/ Lic.No/Date:0910066498 24.07.2018|Case No.:446/15/82-ALC4/2018Party Name:GRANULES INDIA LIMITED Meet No/Date:13/82- ALC4/2019 31.01.2020 Status: Approved HQ File :01/82/050/01903/AM19/ RLA File :09/24/040/00194/AM19/ Lic.No/Date:0910066498 24.07.2018|Case No.:446/15/82-ALC4/2018Party Name:GRANULES INDIA LIMITED Meet No/Date:13/82- ALC4/20

:01/82/050/01903/AM19/ RLA File :09/24/040/00194/AM19/ Lic.No/Date:0910066498 24.07.2018|Case No.:446/15/82-ALC4/2018Party Name:GRANULES INDIA LIMITED Meet No/Date:13/82- ALC4/2019 31.01.2020 Status: Approved HQ File :01/82/050/01903/AM19/ RLA File :09/24/040/00194/AM19/ Lic.No/Date:0910066498 24.07.2018|Case No.:446/15/82-ALC4/2018Party Name:GRANULES INDIA LIMITED Meet No/Date:13/82- ALC4/2019 31.01.2020 Status: Approved HQ File :01/82/050/01903/AM19/ RLA File :09/24/040/00194/AM19/ Lic.No/Date:0910066498 24.07.2018| |---|---|---|---|---|---|---|---|---| |||**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was||||||| |||decided to ratify the ad-hoc input output||norms under para 4.7 of HBP as per details below or as applied by firm||||| |||whichever is lower:||||||| |30|||Export product|Qty.|Sl.|Import items|Qty.|| ||||||No.|||| ||||Compresso CIP 65|1 kg|1|Ciprofloxacin Hcl|0.757 kg|| ||||||2|Maize Starch|0.159 kg|| ||||||3|Sodium Starch Glycollate|0.040 kg|| ||||||4|Povidone K-30|0.005 kg|| ||||||5|Pregelatinised Starch|0.025 kg|| ||||||6|Magnesium Stearate|0.009 kg|| ||||||7|Silica Colloidal Anhydrous|0.005 kg|| |||RA concerned maytake further necessary||action asper above decision of NC.|||||

gelatinised Starch|0.025 kg|| ||||||6|Magnesium Stearate|0.009 kg|| ||||||7|Silica Colloidal Anhydrous|0.005 kg|| |||RA concerned maytake further necessary||action asper above decision of NC.|||||

	Case No.:448/15/82-ALC4/2018Party Name:AUROBINDO	Meet No/Date:13/82-	Status:
	PHARMA LIMITED	ALC4/2019	Deferred
		31.01.2020
31	HQ File :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 available.
	Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the
	firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

Case No.:323/13/82-ALC4/2018	Party Name:ALEMBIC	Meet No/Date:13/82-	Status:
	PHARMACEUTICALS LTD	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01301/AM19/	RLA File	Lic.No/Date:3410044364
	:34/24/040/00140/AM19/	25.07.2018

-|---|---|---|---| |||PHARMACEUTICALS LTD||ALC4/2019||Approved| |||||31.01.2020||| |HQ File :01/82/050/01301/AM19/||RLA File||Lic.No/Date:3410044364||| |||:34/24/040/00140/AM19/||25.07.2018|||

	Case No.:323/13/82-ALC4/2018	Party Name:ALEMBIC<br>PHARMACEUTICALS LTD	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Approved
	HQ File :01/82/050/01301/AM19/	RLA File<br>:34/24/040/00140/AM19/	Lic.No/Date:3410044364<br>25.07.2018
32	Decision:The Committee considered the cases as per agenda in the presence of technical experts and it was<br>decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is<br>less:<br>Export Product<br>Norms recommended for export of 1 No. Tablet of IRBESARTAN (Qty. in mg)<br>Sl.<br>No.<br>Import Items<br>Norms for 1 No. tablet (Qty. in mg)<br>75 mg<br>150 mg<br>300 mg<br>150<br>/12.5<br>mg<br>300 /<br>12.5 mg<br>300 /<br>25 mg<br>1<br>Irbesartan ph Eur<br>76.5<br>153.000<br>306.00<br>153.00<br>306.00<br>306.00<br>2<br>Lactose Monohydrate<br>(Granulac-200)<br>62.375<br>124.75<br>249.50<br>105.90<br>211.80<br>211.80<br>3<br>Croscarmellose Sodium (Ac<br>Di Sol)<br>7.00<br>14.00<br>28.00<br>12.00<br>24.00<br>24.00<br>4<br>Hydrochlorothiazide<br>--<br>--<br>--<br>12.75<br>12.75<br>25.50<br>5<br>Magnesium Stearate<br>1.125<br>2.25<br>4.50<br>2.25<br>4.50<br>4.50<br>RA maytake appropriate action asper the decision of Norms Committee.

br>-- -- -- 12.75 12.75 25.50 5 Magnesium Stearate 1.125 2.25 4.50 2.25 4.50 4.50 RA maytake appropriate action asper the decision of Norms Committee.||||

Case No.:239/13/82-ALC4/2018	Party Name:KEVA	Meet No/Date:13/82-	Status:
	FRAGRANCES PRIVATE	ALC4/2019	Deferred
	LIMITED	31.01.2020
HQ File :01/82/050/01217/AM19/	RLA File	Lic.No/Date:0310822723	Defer Date:
	: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. 33 8/82-ALC4/2019 dated 20.09.2019 , followed by Reminder on 31.10.2019 :

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

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

Case No.:454/15/82-ALC4/2018	Party Name:AUROBINDO	Meet No/Date:13/82-	Status:
	PHARMA LIMITED	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01911/AM19/	RLA File	Lic.No/Date:0910066526
	:09/24/040/00209/AM19/	31.07.2018

--|---|---|---|---|---| |||PHARMA LIMITED||ALC4/2019||Approved| |||||31.01.2020||| |HQ File :01/82/050/01911/AM19/||RLA File||Lic.No/Date:0910066526||| |||:09/24/040/00209/AM19/||31.07.2018|||

	Case No.:454/15/82-ALC4/2018	Case No.:454/15/82-ALC4/2018	Party Name:AUROBINDO<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00209/AM19/	Party Name:AUROBINDO<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00209/AM19/	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:0910066526<br>31.07.2018
	HQ File :01/82/050/01911/AM19/
34	Decision:The Committee considered case as per agenda in the presence of the technical<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or<br>whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>EMTRICITABINE<br>1 kg<br>1<br>Emtricitabine Coupled Ester<br>2<br>Triethylamine<br>3<br>Sodium Borohydride<br>4<br>Activated Carbon (Carbon Enoanticromos)<br>5<br>Methanol (Methyl Alcohol)<br>6<br>Toluene<br>RA concerned maytake further necessaryaction asper above decision of NC.			as per agenda in the presence of the technical<br>s under para 4.7 of HBP as per details below or	experts and it was<br>as applied by firm<br>Qty.<br>2.50 kg<br>0.663 kg<br>0.50 kg<br>0.100 kg<br>3.23 kg<br>1.08 kg
		Qty.	Sl.<br>No.	Import items	Qty.

ara 4.7 of HBP as per details below or||experts and it was as applied by firm Qty. 2.50 kg 0.663 kg 0.50 kg 0.100 kg 3.23 kg 1.08 kg|| |||Qty.||Sl. No.|Import items||Qty.|| |||1 kg||1|Emtricitabine Coupled Ester||2.50 kg|| |||||2|Triethylamine||0.663 kg|| |||||3|Sodium Borohydride||0.50 kg|| |||||4|Activated Carbon (Carbon Enoanticromos)||0.100 kg|| |||||5|Methanol (Methyl Alcohol)||3.23 kg|| |||||6|Toluene||1.08 kg||

Case No.:642/15/82-ALC4/2018	Party Name:DANOPHARM	Meet No/Date:13/82-	Status:
	CHEMICALS PRIVATE LTD.	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/02099/AM19/	RLA File	Lic.No/Date:0310822727
	:03/94/040/00300/AM19/	31.07.2018

	Case No.:642/15/82-ALC4/2018	Party Name:DANOPHARM<br>CHEMICALS PRIVATE LTD.<br>RLA File<br>:03/94/040/00300/AM19/	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Approved
	HQ File :01/82/050/02099/AM19/		Lic.No/Date:0310822727<br>31.07.2018
35	Decision:The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting<br>no.

||HQ File :01/82/050/02099/AM19/||Lic.No/Date:0310822727 31.07.2018|| |35|**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 7/82-ALC4/2015 dated 24.07.2015, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 4-Sulphonamido Phenyl Hydrazine HCL (4-SPH HCL) 1 kg 1 Sulfanilamide 1.01 kg 2 Sodium Nitrite 0.40 kg 3 Sodium Bisulphite 1.10 kg 4 Isopropyl Alcohol 0.75 kg 5 Activated Carbon 0.100 kg RA concerned maytake further necessaryaction asper above decision of NC.||||

Case No.:135/13/82-ALC4/2019	Party Name:ACEBRIGHT	Meet No/Date:13/82-	Status:
	(INDIA) PHARMA PVT LTD,	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/00978/AM20/	RLA File	Lic.No/Date:0710113675
	:07/24/040/00086/AM19/	02.08.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 12/82-ALC4/2018 dated 12.12.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details 36 given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl.<br>No.	Import items	Qty.
TENOFOVIR<br>DISOPROXIL<br>FUMARATE (TDF)	1 kg	1	(R)-9-(2-PHOSPHONOMETHOXYPROPYL)<br>ADENINE (PMPA)	0.689 kg

is less:

Export product	Qty.	Sl.<br>No.	Import items	Qty.
TENOFOVIR<br>DISOPROXIL<br>FUMARATE (TDF)	1 kg	1	(R)-9-(2-PHOSPHONOMETHOXYPROPYL)<br>ADENINE (PMPA)	0.689 kg

Case No.:77/13/82-ALC4/2018	Party Name:ORTIN	Meet No/Date:13/82-	Status:
	LABORATORIES LTD	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01055/AM19/	RLA File	Lic.No/Date:0910066546
	:09/24/040/00211/AM19/	03.08.2018

	Case No.:77/13/82-ALC4/2018	Party Name:ORTIN<br>LABORATORIES LTD<br>RLA File<br>:09/24/040/00211/AM19/	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:0910066546<br>03.08.2018	Status:<br>Approved
	HQ File :01/82/050/01055/AM19/
37	Decision:The Committee considered case as per agenda in the presence of the technical experts and it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm<br>whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>[2S,3S,5S]-5-t-<br>butyloxycarbonylamino-2-Amino-3-<br>hydroxy-1,6-diphenylhexane<br>succinate(BDH Succinic Acid RIT)<br>1 kg<br>1<br>1,2-dimethoxy ethane(1,2-<br>DME)<br>4.74 kg<br>2<br>SODIUM BORO HYDRIDE<br>0.45 kg<br>3<br>METHANE SULPHONIC<br>ACID<br>1.50 kg<br>4<br>TRIETHANOLAMINE<br>1.167 kg<br>5<br>Di-Tert-Butyl-Di-Carbonate<br>0.60 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

THANE SULPHONIC ACID 1.50 kg 4 TRIETHANOLAMINE 1.167 kg 5 Di-Tert-Butyl-Di-Carbonate 0.60 kg RA concerned maytake further necessaryaction asper above decision of NC.||||

38	Case No.:460/15/82-ALC4/2018	Party Name:WINTAC LIMITED,<br>RLA File<br>:07/24/040/00087/AM19/	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:0710113686<br>06.08.2018	Status:<br>Deferred
	HQ File :01/82/050/01917/AM19/			Defer Date:
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not available.<br>Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the<br>firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

Case No.:11/13/82-ALC4/2018	Party Name:SRI VYJAYANTHI	Meet No/Date:13/82-	Status:
	LABS PVT LTD	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/00989/AM19/	RLA File	Lic.No/Date:2610012846
	:26/24/040/00007/AM19/	07.08.2018

Export product<br>MELDRUMS ACID	Qty.	Sl.<br>No.	Import items	Qty.
	1 kg	1	MALONIC ACID	1.132 kg
		2	ACETONE	0.70kg

below or as applied by firm 39 whichever is lower:

Export product<br>MELDRUMS ACID	Qty.	Sl.<br>No.	Import items	Qty.
	1 kg	1	MALONIC ACID	1.132 kg
		2	ACETONE	0.70kg

40	Case No.:172/13/82-ALC4/2018	Party Name:TIDE INDUSTRIES	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
	HQ File<br>:01/82/050/01150/AM19/	RLA File<br>:34/24/040/00094/AM19/	Lic.No/Date:3410044399<br>08.08.2018	Defer Date:
	Decision:The Committee considered the case as per agenda and it was noted that the firm vide its e-mail dated<br>01.11.2019 has furnished its reply. Deferred for comments of TE.

41	Case No.:134/13/82-ALC4/2018	Party Name:YASHO<br>INDUSTRIES LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
	HQ File<br>:01/82/050/01112/AM19/	RLA File<br>:03/95/040/00445/AM19/	Lic.No/Date:0310822942<br>09.08.2018	Defer Date:
	Decision:The Committee considered the case as per agenda and it was noted that the firm vide its e-mail dated<br>24.10.2019 has furnished its reply. Deferred for comments of TE.

Case No.:133/13/82-ALC4/2018	Party Name:RUBICON	Meet No/Date:13/82-	Status:
	RESEARCH PVT. LTD.,	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01111/AM19/	RLA File	Lic.No/Date:0310822983
	:03/95/040/00417/AM19/	10.08.2018

-|---|---|---|---| |||RESEARCH PVT. LTD.,||ALC4/2019||Approved| |||||31.01.2020||| |HQ File :01/82/050/01111/AM19/||RLA File||Lic.No/Date:0310822983||| |||:03/95/040/00417/AM19/||10.08.2018|||

	Case No.:133/13/82-ALC4/2018	Party Name:RUBICON<br>RESEARCH PVT. LTD.,	Party Name:RUBICON<br>RESEARCH PVT. LTD.,	Party Name:RUBICON<br>RESEARCH PVT. LTD.,	Party Name:RUBICON<br>RESEARCH PVT. LTD.,	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Approved
	HQ File :01/82/050/01111/AM19/	RLA File<br>:03/95/040/00417/AM19/				Lic.No/Date:0310822983<br>10.08.2018
42	Decision:The Committee considered<br>decided to ratify the ad-hoc input output n<br>whichever is lower:
	Export product		Qty.	Sl.<br>No.	Import items		Qty.
	CLOBENZAPRINE TABS 5 mg Nos of<br>tablet 75,000,000.000 (Net Content of<br>SUPER TAB 7,125 Kgs.)		75000000<br>Number	1	Anhydrous Lactose USP /<br>NF<br>(Supertab 21 AN )		31,425 kg
	CYCLOBENZAPRINE TABS 10 mg<br>Nos of tablet 270,000,000.000 (Net<br>Content of SUPER TAB 24,300 Kgs.)		270000000<br>Number
	RA concerned maytake further necessaryaction asper above decision of NC.

Case No.:462/15/82-ALC4/2018	Party Name:SMILAX	Meet No/Date:13/82-	Status:
	LABORATORIES LIMITED	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01919/AM19/	RLA File	Lic.No/Date:0910066557
	:09/24/040/00223/AM19/	10.08.2018

|---|---|---|---| |||LABORATORIES LIMITED||ALC4/2019||Approved| |||||31.01.2020||| |HQ File :01/82/050/01919/AM19/||RLA File||Lic.No/Date:0910066557||| |||:09/24/040/00223/AM19/||10.08.2018|||

	Case No.:462/15/82-ALC4/2018	Party Name:SMILAX<br>LABORATORIES LIMITED	Party Name:SMILAX<br>LABORATORIES LIMITED	Party Name:SMILAX<br>LABORATORIES LIMITED	Party Name:SMILAX<br>LABORATORIES LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020
	HQ File :01/82/050/01919/AM19/	RLA File<br>:09/24/040/00223/AM19/				Lic.No/Date:0910066557<br>10.08.2018
43	Decision:The Committee considered case as per agenda in the presence of the technical experts and it was decided<br>to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever<br>is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>(1-((2-(2H-Tetrazole-5-yl) biphenyl -4-<br>yl)<br>methyl)-2-Butyl-4-Chloro-1H-<br>Imidazol-5-yl) Methanol<br>1 kg<br>1<br>2-Cyano-4-Methyl<br>Biphenyl<br>(OTBN)<br>0.645 kg<br>2<br>2-Butyl-4-chloro-5-formyl-<br>imidazole<br>(BCFI)<br>0.474 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.
	Export product		Qty.	Sl.<br>No.	Import items		Qty.
	(1-((2-(2H-Tetrazole-5-yl) biphenyl -4-<br>yl)<br>methyl)-2-Butyl-4-Chloro-1H-<br>Imidazol-5-yl) Methanol		1 kg	1	2-Cyano-4-Methyl<br>Biphenyl<br>(OTBN)		0.645 kg

|Sl. No.|Import items||Qty.|| ||(1-((2-(2H-Tetrazole-5-yl) biphenyl -4- yl) methyl)-2-Butyl-4-Chloro-1H- Imidazol-5-yl) Methanol||1 kg|1|2-Cyano-4-Methyl Biphenyl (OTBN)||0.645 kg|| |||||2|2-Butyl-4-chloro-5-formyl- imidazole (BCFI)||0.474 kg|| ||RA concerned maytake further necessaryaction asper above decision of NC.||||||||

Case No.:464/15/82-ALC4/2018	Party Name:MYLAN	Meet No/Date:13/82-	Status:
	LABORATORIES LIMITED	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01921/AM19/	RLA File	Lic.No/Date:0910066565
	:09/24/040/00175/AM19/	13.08.2018

	Case No.:464/15/82-ALC4/2018	Party Name:MYLAN<br>LABORATORIES LIMITED	Party Name:MYLAN<br>LABORATORIES LIMITED	Party Name:MYLAN<br>LABORATORIES LIMITED	Party Name:MYLAN<br>LABORATORIES LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Approved
	HQ File :01/82/050/01921/AM19/	RLA File<br>:09/24/040/00175/AM19/				Lic.No/Date:0910066565<br>13.08.2018

C4/2019 31.01.2020|Status: Approved| |---|---|---|---|---|---|---|---|---| ||HQ File :01/82/050/01921/AM19/|RLA File :09/24/040/00175/AM19/||||Lic.No/Date:0910066565 13.08.2018||| |44|**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Qty. Sl. No. Import items Qty. FEBUXOSTAT 1 kg 1 Ethyl-2-(3-Formyl-4- Hydroxyphenyl)-4-methylthiaole- 5-carboxylate (EFH) 1.28 kg 2 Dimethyl Formamide (DMF) 1.00 kg 3 Hydroxyl amine Hydrochloride 0.425 kg 4 Potassium Carbonate 0.50 kg 5 Iso Propyl alcohol (IPA) 0.25 kg 6 Acetone 1.50 kg RA concerned maytake further necessaryaction asper above decision of NC.|||||||| ||Export product||Qty.|Sl. No.|Import items||Qty.|| ||FEBUXOSTAT||1 kg|1|Ethyl-2-(3-Formyl-4- Hydroxyphenyl)-4-methylthiaole- 5-carboxylate (EFH)||1.28 kg|| |||||2|Dimethyl Formamide (DMF)||1.00 kg|| |||||3|Hydroxyl amine Hydrochloride||0.425 kg|| |||||4|Potassium Carbonate||0.50 kg|| |||||5|Iso Propyl alcohol (IPA)||0.25 kg|| |||||6|Acetone||1.50 kg|| ||RA concerned maytake further necessaryaction a|||sper above decision of NC.|||||

5 kg|| |||||4|Potassium Carbonate||0.50 kg|| |||||5|Iso Propyl alcohol (IPA)||0.25 kg|| |||||6|Acetone||1.50 kg|| ||RA concerned maytake further necessaryaction a|||sper above decision of NC.|||||

Case No.:537/15/82-ALC4/2018	Party Name:MEDWISE	Meet No/Date:13/82-	Status:
	OVERSEAS PRIVATE LIMITED	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01994/AM19/	RLA File	Lic.No/Date:0810143251
	:08/24/040/00141/AM19/	13.08.2018

Export product	Qty.	Sl.<br>No.	Import items	Qty.
Pegod Tablet (Eplerenone Tablet)	1 Number	1	Eplerenone	25.50 mg / 25 mg tablet
Pegod Tablet (Eplerenone Tablet)	1 Number	1	Eplerenone	51.00 mg / 50 mg tablet
Note: RA will ensure the export quantity in number of tablets to work-out the entitlement.

Case No.:89/13/82-ALC4/2018	Party Name:SUVEN LIFE	Meet No/Date:13/82-	Status:
	SCIENCES LIMITED	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01067/AM19/	RLA File	Lic.No/Date:0910066569
	:09/24/040/00227/AM19/	16.08.2018

|---|---|---|---|---| |||SCIENCES LIMITED||ALC4/2019||Approved| |||||31.01.2020||| |HQ File :01/82/050/01067/AM19/||RLA File||Lic.No/Date:0910066569||| |||:09/24/040/00227/AM19/||16.08.2018|||

	Case No.:89/13/82-ALC4/2018	Party Name:SUVEN LIFE<br>SCIENCES LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Approved
	HQ File :01/82/050/01067/AM19/	RLA File<br>:09/24/040/00227/AM19/	Lic.No/Date:0910066569<br>16.08.2018
46	Decision:The Committee considered case as per agenda in the presence of the technical experts and it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm<br>whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Cis Monoquaternary Acid Besylate<br>Salt<br>1 kg<br>1<br>HOMOVERATRYLAMINE<br>2.10 kg<br>2<br>HOMOVERATRIC ACID<br>2.27 kg<br>3<br>RuCI[(S,S)-Tsdpen (p-<br>Cymene)]<br>0.010 kg<br>4<br>ACETONITRILE<br>3.10 kg<br>5<br>TETRAHYDROFURAN<br>3.57 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

RuCI[(S,S)-Tsdpen (p- Cymene)] 0.010 kg 4 ACETONITRILE 3.10 kg 5 TETRAHYDROFURAN 3.57 kg RA concerned maytake further necessaryaction asper above decision of NC.||||

47	Case No.:326/13/82-ALC4/2018	Party Name:BALAJI AMINES<br>LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:3110067147<br>20.08.2018	Status:<br>Deferred
	HQ File<br>:01/82/050/01304/AM19/	RLA File<br>:31/83/040/00082/AM19/		Defer Date:
	Decision:The Committee considered the case as per agenda and it was noted that the firm vide its e-mail dated<br>26.11.2019 has furnished its reply. Deferred for comments of TE.

48	Case No.:470/15/82-ALC4/2018	Party Name:JODAS EXPOIM<br>PVT.LTD	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
	HQ File :01/82/050/01927/AM19/	RLA File<br>:05/23/040/00232/AM19/	Lic.No/Date:0510407550<br>20.08.2018	Defer Date:
	Decision:The Committee considered the case as per agenda and it<br>Cause Notice vide letter dated 10.10.2019.		was observed that the firm wa	s issued Show

0407550 20.08.2018|Defer Date:| ||**Decision:**The Committee considered the case as per agenda and it Cause Notice vide letter dated 10.10.2019.||was observed that the firm wa|s issued Show|

49	Case No.:471/15/82-ALC4/2018	Party Name:JODAS EXPOIM<br>PVT.LTD	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred<br>Defer<br>Date:06.09.2019
	HQ File<br>:01/82/050/01928/AM19/	RLA File<br>:05/23/040/00231/AM19/	Lic.No/Date:0510407551<br>20.08.2018
	Decision:The Committee considered the case as per agenda and it was observed that the firm<br>Cause Notice vide letter dated 10.10.2019.			was issued Show

Cas	e No.:472/15/82-ALC4/2018	P	arty Name:WINTAC LIMITED,	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
HQ	File :01/82/050/01929/AM19/	R<br>:0	LA File<br>7/24/040/00131/AM19/	Lic.No/Date:0710113733<br>20.08.2018	Defer Dat	e:
Dec<br>Hen<br>firm	ision:The Committee noted that the 4.07 application of subject Advance Authorization is not availa<br>ce, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from<br>asper PolicyCircular No. 23/2015-20,dated 15.05.2019.					ble.<br>the

r>ce, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from asper PolicyCircular No. 23/2015-20,dated 15.05.2019.||||||ble. the| ||||||||||

Case No.:474/15/82-ALC4/2018	Party Name:MEDREICH	Meet No/Date:13/82-	Status:
	LIMITED	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01931/AM19/	RLA File	Lic.No/Date:0710113746
	:07/24/040/00129/AM19/	23.08.2018

Export product	Qty.	Sl.	Import items	Qty.
		No.
REBAMIPIDE 100MG TABLETS	1 Number	1	REBAMIPIDE JP	102.00 mg / tablet
[91000000 NO.]	tablet	2	ETHANOL	151.00 mg / tablet
[EXP QTY: 9100 + 16205.580 =			[ETHYL ALCOHOL 200
25305.580 KG]			PROOF]

Case No.:142/13/82-ALC4/2018	Party Name:PALADIN PAINTS	Meet No/Date:13/82-	Status:
	AND CHEMICALS PVT. LTD.,	ALC4/2019	Deferred
		31.01.2020
HQ File :01/82/050/01120/AM19/	RLA File	Lic.No/Date:0310823254	Defer Date:
	:03/95/040/00456/AM19/	24.08.2018

-| |||AND CHEMICALS PVT. LTD.,||ALC4/2019||Deferred| |||||31.01.2020||| |HQ File :01/82/050/01120/AM19/||RLA File||Lic.No/Date:0310823254||Defer Date:| |||: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 52 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 :

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

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

Case No.:209/13/82-ALC4/2018	Party Name:DEEPAK	Meet No/Date:13/82-	Status:
	NOVOCHEM	ALC4/2019	Deferred
	TECHNOLOGIES LTD	31.01.2020
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. 53 9/82-ALC4/2019 dated 18.10.2019 , followed by Reminder on 09.12.2019 :

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

No. 53 9/82-ALC4/2019 dated 18.10.2019 , followed by Reminder on 09.12.2019 :

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

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

54	Case No.:475/15/82-ALC4/2018	Party Name:WINTAC LIMITED,<br>RLA File<br>:07/24/040/00098/AM19/	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
	<br>HQ File :01/82/050/01932/AM19/		Lic.No/Date:0710113754<br>24.08.2018	Defer Date:
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not available.<br>Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the<br>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.:86/13/82-ALC4/2018	Party Name:RAKSHIT	Meet No/Date:13/82-	Status:
	PHARMACEUTICALS LTD	ALC4/2019	Approved
		31.01.2020
HQ File	RLA File	Lic.No/Date:0910066593
:01/82/050/01064/AM19/	:09/24/040/00239/AM19/	27.08.2018

--|---|---|---|---| |||PHARMACEUTICALS LTD||ALC4/2019||Approved| |||||31.01.2020||| |HQ File||RLA File||Lic.No/Date:0910066593||| |:01/82/050/01064/AM19/||:09/24/040/00239/AM19/||27.08.2018|||

Decision: The Committee considered the case as per agenda in the presence of technical experts and 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 55 less:

ss:
Export product	Qty.	Sl. No.	Import items	Qty.
Pantoprazole Sodium / Pantoprazole<br>Sodium Sesquihydrate	1 kg	1	Maltol	0.728 kg
		2	Methylene Dichloride	1.34 kg
		3	Acetone	0.95 kg

Case No.:164/13/82-ALC4/2018	Party Name:SARNA	Meet No/Date:13/82-	Status:
	CHEMICALS PVT LTD	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01142/AM19/	RLA File	Lic.No/Date:5210042742
	:52/24/040/00044/AM19/	27.08.2018

---|---|---|---|---| |||CHEMICALS PVT LTD||ALC4/2019||Approved| |||||31.01.2020||| |HQ File :01/82/050/01142/AM19/||RLA File||Lic.No/Date:5210042742||| |||:52/24/040/00044/AM19/||27.08.2018|||

		Case No.:164/13/82-ALC4/2018Party Name:SARNA<br>CHEMICALS PVT LTD<br>Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Status:<br>Approved<br>HQ File :01/82/050/01142/AM19/ RLA File<br>:52/24/040/00044/AM19/<br>Lic.No/Date:5210042742<br>27.08.2018	Case No.:164/13/82-ALC4/2018Party Name:SARNA<br>CHEMICALS PVT LTD<br>Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Status:<br>Approved<br>HQ File :01/82/050/01142/AM19/ RLA File<br>:52/24/040/00044/AM19/<br>Lic.No/Date:5210042742<br>27.08.2018	Case No.:164/13/82-ALC4/2018Party Name:SARNA<br>CHEMICALS PVT LTD<br>Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Status:<br>Approved<br>HQ File :01/82/050/01142/AM19/ RLA File<br>:52/24/040/00044/AM19/<br>Lic.No/Date:5210042742<br>27.08.2018	Case No.:164/13/82-ALC4/2018Party Name:SARNA<br>CHEMICALS PVT LTD<br>Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Status:<br>Approved<br>HQ File :01/82/050/01142/AM19/ RLA File<br>:52/24/040/00044/AM19/<br>Lic.No/Date:5210042742<br>27.08.2018
		Decision:The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting
56		no. 2/AM20 dated 21.06.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below<br>or as applied by the firm, whichever is less:
		Export product<br>Qty.<br>Sl.

||no. 2/AM20 dated 21.06.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:|||| |||Export product Qty. Sl. No.|Import items|Qty.|| |||2-(2-Amino Ethoxy)-2-chloro 1 kg 1|2-Amino Ethoxy Ethanol|0.800 kg|| |||Diethyl Sulfone / Etheramine / 2|2-Mercapto Ethanol|0.700 kg|| |||Organic Dye Intermediate SR-72 3|Caustic Soda (100%)|0.520 kg|| |||RA concerned maytake further necessaryaction asper above decision of NC.||||

	Case No.:368/13/82-ALC4/2018Party Name:DANOPHARM		Meet No/Date:13/82-	Status:
	CHEMICALS PRIVATE LTD.		ALC4/2019	Deferred
			31.01.2020
57	HQ File<br>RLA File		Lic.No/Date:0310823354	Defer Date:
	:01/82/050/01346/AM19/<br>:03/94/040/00340/AM19/		28.08.2018
	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.

	Case No.:369/13/82-ALC4/2018Party Name:DANOPHARM		Meet No/Date:13/82-	Status:
	CHEMICALS PRIVATE LTD.		ALC4/2019	Deferred
			31.01.2020
58	HQ File<br>RLA File		Lic.No/Date:0310823358	Defer Date:
	:01/82/050/01347/AM19/<br>:03/94/040/00413/AM19/		28.08.2018
	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.

|||**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.||||||

Case No.:147/13/82-ALC4/2018	Party Name:NAPROD LIFE	Meet No/Date:13/82-	Status:
	SCIENCES PVT. LTD.	ALC4/2019	Approved
		31.01.2020
HQ File	RLA File	Lic.No/Date:0310823401
:01/82/050/01125/AM19/	:03/95/040/00537/AM19/	29.08.2018

		Case No.:147/13/82-ALC4/2018Party Name:NAPROD LIFE<br>SCIENCES PVT. LTD.<br>HQ File<br>:01/82/050/01125/AM19/<br>RLA File<br>:03/95/040/00537/AM19/	Case No.:147/13/82-ALC4/2018Party Name:NAPROD LIFE<br>SCIENCES PVT. LTD.<br>HQ File<br>:01/82/050/01125/AM19/<br>RLA File<br>:03/95/040/00537/AM19/	Case No.:147/13/82-ALC4/2018Party Name:NAPROD LIFE<br>SCIENCES PVT. LTD.<br>HQ File<br>:01/82/050/01125/AM19/<br>RLA File<br>:03/95/040/00537/AM19/	<br>Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Status:<br>Approved<br>Lic.No/Date:0310823401<br>29.08.2018	<br>Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Status:<br>Approved<br>Lic.No/Date:0310823401<br>29.08.2018	<br>Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Status:<br>Approved<br>Lic.No/Date:0310823401<br>29.08.2018	<br>Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Status:<br>Approved<br>Lic.No/Date:0310823401<br>29.08.2018

.No/Date:0310823401 29.08.2018| Meet No/Date:13/82- ALC4/2019 31.01.2020 Status: Approved Lic.No/Date:0310823401 29.08.2018|| |---|---|---|---|---|---|---|---|---|---| |||**Decision:**The Committee considered the case as per agenda in|||the presence of technical experts and it was decided||||| |59||to ratify norms under Para 4.7 of HBP v1 as per details given below or||||as applied by the firm, whichever is less:|||| ||||Export product|Qty.|Sl.|Import items|Qty.||| ||||||No.||||| ||||L-Asparaginase for Injection 10000IU|9643 Vials|1|L-Asparaginase|0.900 kg||| ||||(net contain of L-Asparaginase 0.8380||||||| ||||Kgs )||||||| |||RA concerned maytake further necessaryaction asper above decision||||of NC.|||| |||||||||||

Case No.:35/15/82-ALC4/2018	Case No.:35/15/82-ALC4/2018	Party Name:AUROBINDO<br>	Party Name:AUROBINDO<br>	Meet No/Date:13/82-	Status:<br>Deferred<br>Defer Date:
		<br>P	<br>HARMA LIMITED<br> <br> <br>3<br>LA File<br>9/24/040/00249/AM19/<br> <br>2	<br>ALC4/2019<br>1.01.2020	<br>Deferred<br>Defer Date:
HQ<br>:01/	File	R		Lic.No/Date:0910066604
	<br>82/050/01492/AM19/	<br>:0		<br>9.08.2018
Deci	sion:Deferred for comments		of TE.

| Deferred Defer Date:|| ||HQ :01/|File|R||Lic.No/Date:0910066604||| ||| 82/050/01492/AM19/| :0|| 9.08.2018||| ||Deci|**sion:**Deferred for comments||of TE.|||| |||||||||

61	Case No.:492/15/82-ALC4/2018	Case No.:492/15/82-ALC4/2018	Party Name:ORTIN	Meet No/Date:13/82-	Status:<br>Deferred	Status:<br>Deferred
		<br> <br>File :01/82/050/01949/AM19/	<br>LABORATORIES LTD	<br>ALC4/2019<br>31.01.2020	<br>Deferred
	HQ		RLA File<br>:09/24/040/00245/AM19/	Lic.No/Date:0910066600	Defer Date	:
		<br>		<br>29.08.2018
	Dec	ision:Deferred for comments	of TE.


62	Case No.:84/13/82-ALC4/2018		Party Name:SRINI	Meet No/Date:13/82-	Status:<br>Deferred<br>Defer Date:
		<br>File :01/82/050/01062/AM19/	<br>PHARMACEUTICALS<br>PRIVATE LIMITED	<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:0910066620<br>03.09.2018	<br>Deferred<br>Defer Dat
	HQ		RLA File<br>:09/24/040/00251/AM19/			e:

	Dec	ision:Deferred for comments	of TE.

63	Cas	e No.:88/13/82-ALC4/2018<br>File :01/82/050/01066/AM19/	Party Name:SATYADEVA<br>	Meet No/Date:13/82-<br>	Status:<br>Deferred<br>Defer Dat

.||||||||| |||||||||||||||| |63|Cas|e No.:88/13/82-ALC4/2018 File :01/82/050/01066/AM19/||||Party Name:SATYADEVA ||Meet No/Date:13/82- ||||Status: Deferred Defer Dat||| |||||||PHARMACEUTIC |ALS PVT|A |C4/2019 |||Deferr||| |||||050/01066/AM19/||LTD||31 Li 03|.01.2020|||Defer D||| ||HQ|Fil|e :01/82/|||RLA File :09/24/040/00247/A|M19/||c.No/Date:0910066 .09.2018|623|||at|e:| ||Dec|isi|**on:**De|ferred for comments of TE.||||||||||| |||||||||||||||| |||||||||||||||| |64|Cas|e No.:502/15/82-ALC4/2018|||Party Name:SUVEN LIFE |||Meet No/Date:13/82- |||Status: |||| ||||||SCIENCES LIMITED 3 RLA File :09/24/040/00260/AM19/ L 0|||LC4/2019 1.01.2020||||||| ||HQ File :01/82/050/01959/AM19/|||||||ic.No/Date:0910066621 3.09.2018||||||| ||**Decision:**Deferred for comments of TE.||||||||||||||

Case No.:230/13/82-ALC4/2018	Party Name:KAIRAV	Meet No/Date:13/82-	Status:
	CHEMOFARBE INDUSTRIES	ALC4/2019	Approved
	LTD.	31.01.2020
HQ File :01/82/050/01208/AM19/	RLA File	Lic.No/Date:0310823513
	:03/94/040/00403/AM19/	04.09.2018

---|---|---| |||CHEMOFARBE INDUSTRIES||ALC4/2019||Approved| |||LTD.||31.01.2020||| |HQ File :01/82/050/01208/AM19/||RLA File||Lic.No/Date:0310823513||| |||:03/94/040/00403/AM19/||04.09.2018|||

	Case No.:230/13/82-ALC4/2018	Party Name:KAIRAV<br>CHEMOFARBE INDUSTRIES<br>LTD.	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Approved
	HQ File :01/82/050/01208/AM19/	RLA File<br>:03/94/040/00403/AM19/	Lic.No/Date:0310823513<br>04.09.2018
65	Decision:The Committee considered case as per agenda in the presence of the technical experts and it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm<br>whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>N-Methyl Pyrrolidone<br>240.00 kg<br>1<br>N-Methyl<br>Pyrrolidone<br>(Low<br>Purity)<br>240.00 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

66	Case No.:435/13/82-ALC4/2018	Party Name:DCM SHRIRAM<br>INDUSTRIES LTD,	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
	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.

ed**| |---|---|---|---|---| ||HQ File :01/82/050/01413/AM19/|RLA File :05/23/040/00242/AM19/|Lic.No/Date:0510407689 05.09.2018|Defer Date:| ||**Decision:**Deferred for comments of TE.||||

Case No.:44/15/82-ALC4/2018	Party Name:DISCOVERY	Meet No/Date:13/82-	Status:
	LABORATORIES PRIVATE	ALC4/2019	Deferred
	LIMITED	31.01.2020
HQ File :01/82/050/01501/AM19/	RLA File	Lic.No/Date:0910066631	Defer Date:
	: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 67 noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 3/82-ALC4/2019 dated 05.07.2019 , followed by Reminder on 02.08.2019 :

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

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.:227/13/82-ALC4/2018	Party Name:GLENMARK	Meet No/Date:13/82-	Status:
	PHARMACEUTICALS LTD.,	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01205/AM19/	RLA File	Lic.No/Date:0310823648
	:03/94/040/00518/AM19/	07.09.2018

---|---|---|---| |||PHARMACEUTICALS LTD.,||ALC4/2019||Approved| |||||31.01.2020||| |HQ File :01/82/050/01205/AM19/||RLA File||Lic.No/Date:0310823648||| |||:03/94/040/00518/AM19/||07.09.2018|||

	Case No.:227/13/82-ALC4/2018	Party Name:GLENMARK<br>PHARMACEUTICALS LTD.,	Party Name:GLENMARK<br>PHARMACEUTICALS LTD.,	Party Name:GLENMARK<br>PHARMACEUTICALS LTD.,	Party Name:GLENMARK<br>PHARMACEUTICALS LTD.,	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020
	HQ File :01/82/050/01205/AM19/	RLA File<br>:03/94/040/00518/AM19/				Lic.No/Date:0310823648<br>07.09.2018
68	Decision:The Committee considered case as per agenda in the presence of the technical<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or<br>whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>OFLOMIL<br>LAK<br>(Oflomil<br>Lacquer/Amorolfine<br>Hydrochloride<br>Nail Lacquer) (Pack size 2.5ml)<br>(Each 1 ml contains Amorolfine<br>hydrochloride 55.7 mg equivalent to<br>Amorolfine 50.00 mg) (Net wt of<br>Amorolfine<br>Hydrochloride<br>is<br>100.260Kgs)<br>720000<br>Packs<br>1<br>Amorolfine Hydrochloride<br>RA concerned maytake further necessaryaction asper above decision of NC.			agenda in the presence of the technical<br>para 4.7 of HBP as per details below or			experts and it was<br>as applied by firm<br>Qty.<br>102.267 kg
			Qty.	Sl.<br>No.	Import items		Qty.

of NC.|||agenda in the presence of the technical para 4.7 of HBP as per details below or|||experts and it was as applied by firm Qty. 102.267 kg|| ||||Qty.|Sl. No.|Import items||Qty.|| ||||720000 Packs|1|Amorolfine Hydrochloride||102.267 kg||

69	Case No.:429/13/82-ALC4/2018	Party Name:CADILA<br>HEALTHCARE LTD	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
	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.

Case No.:94/13/82-ALC4/2018	Party Name:VIVIMED LABS	Meet No/Date:13/82-	Status:
	LIMITED	ALC4/2019	Rejected
		31.01.2020
HQ File :01/82/050/01072/AM19/	RLA File	Lic.No/Date:0910066645
	:09/24/040/00273/AM19/	10.09.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished
70 the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019, 4/82-ALC4/2019 dated 19.07.2019 and 8/82-ALC4/2019 dated 20.09.2019, followed by Final Reminder on 05.09.2019 :

(i) Percentage of yield at every stage with stiochiometric balance.

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

entage of yield at every stage with stiochiometric balance.**

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

71	Case No.:40/15/82-ALC4/2018	Party Name:INCHEM<br>LABORATORIES PRIVATE<br>LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:0910066657<br>11.09.2018	Status:<br>Deferred<br>Defer Date:
	HQ File :01/82/050/01497/AM19/	RLA File<br>:09/24/040/00230/AM19/
	Decision:Deferred for comments of TE.

72	Case No.:41/15/82-ALC4/2018	Party Name:INCHEM<br>LABORATORIES PRIVATE<br>LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
	HQ File<br>:01/82/050/01498/AM19/	RLA File<br>:09/24/040/00261/AM19/	Lic.No/Date:0910066658<br>11.09.2018	Defer Date:
	Decision:Deferred for comments of TE.

Case No.:108/13/82-ALC4/2018	Party Name:SHREE BANKEY	Meet No/Date:13/82-	Status:
	BEHARI LAL FLAVORS	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01086/AM19/	RLA File	Lic.No/Date:0510407757
	:05/24/040/00324/AM19/	12.09.2018

--|---|---|---|---| |||BEHARI LAL FLAVORS||ALC4/2019||Approved| |||||31.01.2020||| |HQ File :01/82/050/01086/AM19/||RLA File||Lic.No/Date:0510407757||| |||:05/24/040/00324/AM19/||12.09.2018|||

	Case No.:108/13/82-ALC4/2018	Party Name:SHREE BANKEY<br>BEHARI LAL FLAVORS	Party Name:SHREE BANKEY<br>BEHARI LAL FLAVORS	Party Name:SHREE BANKEY<br>BEHARI LAL FLAVORS	Party Name:SHREE BANKEY<br>BEHARI LAL FLAVORS	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:0510407757<br>12.09.2018
	HQ File :01/82/050/01086/AM19/	RLA File<br>:05/24/040/00324/AM19/
73	Decision:The Committee considered case<br>decided to ratify the ad-hoc input output norms<br>whichever is lower:<br>Export product<br>Qty.<br>L-MENTHOL<br>/MENTHOL(LAVEO)<br>/MENTHOL(L)/LIQUID<br>MENTHOL<br>1 kg<br>RA concerned maytake further necessaryaction			as per<br>under
			Qty.	Sl.<br>No.	Import items	Qty.
			1 kg	1	META - CRESOL ABOVE 98.5%<br>PURE	0.922 kg
				2	ISO PROPYL ALCOHOL	0.543 kg
				3	ARROWZYME/LIPASE AMANO<br>IME	0.01 kg
				asper above decision of NC.

t items||Qty.|| ||||1 kg|1|META - CRESOL ABOVE 98.5% PURE||0.922 kg|| |||||2|ISO PROPYL ALCOHOL||0.543 kg|| |||||3|ARROWZYME/LIPASE AMANO IME||0.01 kg|| |||||asper above decision of NC.|||||

74	Case No.:17/7/82-ALC4/2019	Party Name:GLOBAL CALCIUM<br>PRIVATE LIMITED	<br>Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:0710113843<br>12.09.2018	Status:<br>Deferred<br>Defer Date:
	HQ File :01/82/050/00512/AM20/	RLA File<br>:07/24/040/00144/AM19/
	Decision:Deferred for comments of TE.

Case No.:180/13/82-ALC4/2018	Party Name:SARNA	Meet No/Date:13/82-	Status:
	CHEMICALS PVT LTD	ALC4/2019	Approved
		31.01.2020
HQ File	RLA File	Lic.No/Date:5210042764
:01/82/050/01158/AM19/	:52/24/040/00050/AM19/	14.09.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 2/AM20 dated 21.06.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below 75 or as applied by the firm, whichever is less:

r as applied by the firm, whichever is less:
Export product	Qty.	Sl. No.	Import items	Qty.
PARA<br>ANISIDINE<br>/<br>4-METHOXY<br>BENZENEAMINE<br>/ORGANIC<br>DYE<br>INTERMEDIATE<br>SR-92<br>/<br>4-ANISIDINE<br>99.9%	1 kg	1	PARA ANISIDINE	1.00 kg

roduct|Qty.|Sl. No.|Import items|Qty.| |PARA ANISIDINE / 4-METHOXY BENZENEAMINE /ORGANIC DYE INTERMEDIATE SR-92 / 4-ANISIDINE 99.9%|1 kg|1|PARA ANISIDINE|1.00 kg|

76	<br>Case No.:400/13/82-ALC4/2018	Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	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	Defer Date:
	Decision:Deferred for comments of TE.

77	<br>Case No.:519/15/82-ALC4/2018	Party Name:SUVEN LIFE<br>SCIENCES LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	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	Defer Date:
	Decision:Deferred for comments of TE.

78	Case No.:525/15/82-ALC4/2018	Party Name:SHILPA<br>MEDICARE LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	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 available. Hence,<br>it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as<br>per PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

79	Case No.:176/13/82-ALC4/2018	Party Name:VOVANTIS<br>LABORATORIES PRIVATE<br>LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:3410044518<br>26.09.2018	Status:<br>Deferred
	HQ File :01/82/050/01154/AM19/	RLA File<br>:34/24/040/00145/AM19/		Defer Date:
	Decision:The Committee considered the case as per agenda and it<br>from the firm:<br>(i)<br>Copy of Drug Manufacturing License(DML).		was decided to call for following information<br>

Case No.:213/13/82-ALC4/2018	Party Name:DEEPAK	Meet No/Date:13/82-	Status:
	NOVOCHEM TECHNOLOGIES	ALC4/2019	Deferred
	LTD	31.01.2020
HQ File :01/82/050/01191/AM19/	RLA File	Lic.No/Date:3110067177	Defer Date:
	: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 80 noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 9/82ALC4/2019 dated 18.10.2019 , followed by Reminder on 09.12.2019 :

(i) Exact chemical name of the Export Product.

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

(i) Exact chemical name of the Export Product.

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

Case No.:365/13/82-ALC4/2018 Party Name:ELPPE Meet No/Date:13/82- Status: CHEMICALS PRIVATE ALC4/2019 Approved LIMITED 31.01.2020 HQ File :01/82/050/01343/AM19/ RLA File Lic.No/Date:0310823993 :03/94/040/00551/AM19/ 26.09.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 39/82-ALC4/2010 dated 28.12.2010, it was decided to ratify norms under Para 4.7 of HBP v1 as per details 81 given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
NICLOSAMIDE<br>PIPERAZINE SALT	1 kg	1	SALICYLIC ACID	0.65 kg
		2	TRIETHYL AMINE	0.26 kg
		3	PIPERAZINE ANHYDROUS	0.13 kg

	Case No.:534/15/82-ALC4/2018Party Name:YASH RASAYAN &	Meet No/Date:13/82-	Status:
	CHEMICALS	ALC4/2019	Deferred
		31.01.2020
82	HQ File :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 available.
	Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the
	firm asper PolicyCircular No.

ce 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 asper PolicyCircular No. 23/2015-20,dated 15.05.2019.|||||| |||||||||| ||||Case No.:536/15/82-ALC4/2018Party Name:YASH RASAYAN &||Meet No/Date:13/82-||Status:|| ||||CHEMICALS||ALC4/2019||Deferred|| ||||||31.01.2020|||| ||83||HQ File :01/82/050/01993/AM19/ RLA File||Lic.No/Date:3410044524||Defer Date:|| ||||:34/24/040/00185/AM19/||26.09.2018|||| ||||**Decision:**Deferred for comments of TE.|||||| ||||||||||

	Case No.:112/13/82-ALC4/2018	Party Name:VARAHI PHARMA	Meet No/Date:13/82-	Status:
		PRIVATE LIMITED	ALC4/2019	Deferred
			31.01.2020
84	HQ File	RLA File	Lic.No/Date:6610000013	Defer Date:
	:01/82/050/01090/AM19/	:66/24/040/00004/AM19/	03.10.2018
	Decision:Deferred for comments of TE.

	Case No.:612/15/82-ALC4/2018	Party Name:MANGALAM	Meet No/Date:13/82-	Status:
		ORGANICS LIMITED	ALC4/2019	Deferred
		(FORMERLY DUJODWALA	31.01.2020
85	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.

**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:13/82-	Status:
		LTD	ALC4/2019	Deferred
			31.01.2020
86	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.:56/13/82-ALC4/2018	Party Name:S M S	Meet No/Date:13/82-	Status:
	PHARMACEUTICALS LTD	ALC4/2019	Approved
		31.01.2020
HQ File	RLA File	Lic.No/Date:0910066717
:01/82/050/01034/AM19/	:09/24/040/00321/AM19/	04.10.2018

	Case No.:56/13/82-ALC4/2018	Case No.:56/13/82-ALC4/2018	Party Name:S M S<br>PHARMACEUTICALS LTD<br>RLA File<br>:09/24/040/00321/AM19/	Party Name:S M S<br>PHARMACEUTICALS LTD<br>RLA File<br>:09/24/040/00321/AM19/	Status:<br>Approved
	HQ File<br>:01/82/050/01034/AM19/
87	Decision:The Committee considered case<br>decided to ratify the ad-hoc input output norm<br>whichever is lower:
	Export product	Qty.	Sl.<br>No.	Import items	Qty.

34/AM19/|||||||| |87|**Decision:**The Committee considered case decided to ratify the ad-hoc input output norm whichever is lower:|||||||| ||Export product|Qty.||Sl. No.|Import items|||Qty.| ||LAMIVUDINE|1 kg||1|2, 5-DIHYDROXY-1, 4-DITHANE|||0.739 kg| |||||2|AQUEOUS GLYOXYLIC ACID (50%)|||1.738 kg| |||||3|CYCLO HEXANE|||3.42 kg| |||||4|CYTOSINE|||0.94 kg| |||||5|HEXA METHYL DISILAZANE (HMDS)|||1.45 kg| |||||6|ISO PROPYL ALCOHOL (IPA)|||3.17 kg| |||||7|L-MENTHOL|||1.45 kg| |||||8|METHYLENE DICHLORIDE (MDC)|||2.50 kg| |||||9|N, N-DIMETHYL FORMAMIDE (DMF)|||0.71 kg| |||||10|SODIUM BORO HYDRIDE (SBH)|||0.48 kg| |||||11|TRI ETHYL AMINE (TEA)|||1.00 kg| |||||12|TRIPHOSGENE|||0.876 kg| ||RA concerned maytake further necessaryaction asper above decision of NC.||||||||

Case No.:442/13/82-	Party Name:MOREPEN	Meet No/Date:13/82-	Status:
ALC4/2018	LABORATORIES LTD.,	ALC4/2019	Approved
		31.01.2020
HQ File	RLA File	Lic.No/Date:0510407973
:01/82/050/01420/AM19/	:05/24/040/00367/AM19/	04.10.2018

--|---| |ALC4/2018||LABORATORIES LTD.,||ALC4/2019||Approved| |||||31.01.2020||| |HQ File||RLA File||Lic.No/Date:0510407973||| |:01/82/050/01420/AM19/||:05/24/040/00367/AM19/||04.10.2018|||

	Case No.:442/13/82-<br>ALC4/2018	Case No.:442/13/82-<br>ALC4/2018	Party Name:MOREPEN<br>LABORATORIES LTD.,	Party Name:MOREPEN<br>LABORATORIES LTD.,	Party Name:MOREPEN<br>LABORATORIES LTD.,	Status:<br>Approved
	HQ File<br>:01/82/050/01420/AM19/		RLA File<br>:05/24/040/00367/AM19/
88	Decision:The Committee considered case<br>decided to ratify the ad-hoc input output norms<br>whichever is lower:				as per agenda in the presence of the technical<br>under para 4.7 of HBP as per details below or
	Export product	Qty.		Sl.<br>No.	Import items	Qty.
	Empagliflozin	1 kg		1	(3S)-3-(4-[(2-chloro-5-iodophenyl)<br>methyl]<br>phenoxy)tetrahydrofuran<br>(EG01)<br>/<br>(3S)-3-(4-(2-chloro-5-<br>iodobenzyl)phenoxy)tetrahydrofuran (EG01)/(S)-<br>3-(4-(2-Chloro-5-iodobenzyl)phenoxy)<br>tetrahydrofuran	2.04 kg
				2	2,3,4,6-tetra-O-trimethyl silyl-beta-D-<br>glucolactone ( EGS01) / 2,3,4,5-Tetrakis-O-<br>Trimethylsilyl-D-Gluconolactone	2.53 kg
				3	Acetonitrile	2.16 kg
				4	Methylene chloride	3.25 kg
				5	Toluene	1.525 kg
	RA concerned maytake further necessary			action	asper above decision of NC.

one|||2.53 kg| |||||3|Acetonitrile|||2.16 kg| |||||4|Methylene chloride|||3.25 kg| |||||5|Toluene|||1.525 kg| ||RA concerned maytake further necessary|||action|asper above decision of NC.||||

89	<br>Case No.:562/15/82-<br>ALC4/2018	Party<br>Name:ORTINLABORATORIES<br>LTD<br>RLA File<br>:09/24/040/00302/AM19/	<br>Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02019/AM19/		Lic.No/Date:0910066712<br>04.10.2018	Defer Date:
	Decision:Deferred for comments of TE.

Case No.:563/15/82-ALC4/2018	Party Name:S M S	Meet No/Date:13/82-	Status:
	PHARMACEUTICALS LTD	ALC4/2019	Approved
		31.01.2020
HQ File	RLA File	Lic.No/Date:0910066714
:01/82/050/02020/AM19/	:09/24/040/00318/AM19/	04.10.2018

	Case No.:563/15/82-ALC4/2018	Party Name:S M S<br>PHARMACEUTICALS LTD<br>RLA File<br>:09/24/040/00318/AM19/	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:0910066714<br>04.10.2018	Status:<br>Approved
	HQ File<br>:01/82/050/02020/AM19/
90	<br>Decision:The Committee considered the cases as per agenda and in the light of earlier decisio<br>no.

atus:** Approved| |---|---|---|---|---| ||HQ File :01/82/050/02020/AM19/|||| |90| **Decision:**The Committee considered the cases as per agenda and in the light of earlier decisio no. 10/82-ALC4/2919 dated 29.11.2019, it was decided to ratify norms under Para 4.7 of HBP given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items TENOFOVIR DISOPROXIL FUMARATE 1 kg 1 (R)-9-[2-(PHOSPHONO METHOXY) PROPYL] ADENINE MONO HYDRATE (PMPA) 2 TRI METHYL CHLORO SILANE 3 CHLORO METHYL-2-ISOPROPYL CARBONATE 4 N-METHYL-2-PYRROLIDONE 5 TRI ETHYL AMINE 6 CYCLO HEXANE 7 METHYLENE DICHLORIDE 8 ISO PROPYL ALCOHOL 9 FUMARIC ACID 10 METHANOL RA concerned maytake further necessaryaction asper above decision of NC.|||n taken in meeting v1 as per details Qty. 0.769 kg 0.070 kg 1.3527 kg 1.4478 kg 0.4477 kg 1.444 kg 2.146 kg 2.113 kg 0.340 kg 0.548kg|

91	<br>Case No.:565/15/82-<br>ALC4/2018	Party Name:S M S<br>PHARMACEUTICALS LTD<br> <br> <br> <br>RLA File<br>:09/24/040/00319/AM19/<br> <br>	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br> <br>Lic.No/Date:0910066716<br>04.10.2018<br>	Status: Deferred
	<br>HQ File<br>:01/82/050/02022/AM19/			Defer Date:
	Decision:Deferred for comments of TE.

br> Lic.No/Date:0910066716 04.10.2018 |Status: Deferred| |---|---|---|---|---| || HQ File :01/82/050/02022/AM19/|||Defer Date:| ||**Decision:**Deferred for comments of TE.||||

92	Case No.:567/15/82-ALC4/2018	Party Name:VERVE HUMAN<br>CARE LABORATORIES	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02024/AM19/	RLA File<br>:61/24/040/00009/AM19/	Lic.No/Date:6110001546<br>04.10.2018	Defer Date:
	Decision:The Committee considered the case as per agenda and it was noted that the firm vide its e-mail dated<br>09.08.2019 has furnished its reply. Deferred for comments of TE.

93	<br>Case No.:454/13/82-<br>ALC4/2018	Party Name:IND-SWIFT<br>LABORATORIES LTD.,	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status: Deferred
	<br>HQ File<br>:01/82/050/01432/AM19/	RLA File<br>:22/24/040/00058/AM19/	Lic.No/Date:2210015989<br>05.10.2018	Defer Date:
	Decision:Deferred for comments of TE.

94	<br>Case No.:569/15/82-ALC4/2018Party Name:JODAS EXPOIM<br>PVT.LTD<br>HQ File :01/82/050/02026/AM19/ RLA File<br>:05/23/040/00297/AM19/<br>Decision:The Committee considered the case as per agenda and it<br>Cause Notice vide letter dated 10.10.2019.	Party Name:JODAS EXPOIM<br>PVT.LTD	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
		RLA File<br>:05/23/040/00297/AM19/	Lic.No/Date:0510408024<br>08.10.2018	Defer Date:
			was observed that the firm wa	s issued Show

.01.2020|Status: Deferred| |---|---|---|---|---| |||RLA File :05/23/040/00297/AM19/|Lic.No/Date:0510408024 08.10.2018|Defer Date:| ||||was observed that the firm wa|s issued Show|

95	<br>Case No.:570/15/82-ALC4/2018Party Name:JODAS EXPOIM<br>PVT.LTD<br>HQ File :01/82/050/02027/AM19/ RLA File<br>:05/23/040/00295/AM19/<br>Decision:The Committee considered the case as per agenda and it<br>Cause Notice vide letter dated 10.10.2019.	Party Name:JODAS EXPOIM<br>PVT.LTD	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
		RLA File<br>:05/23/040/00295/AM19/	Lic.No/Date:0510408025<br>08.10.2018	Defer Date:
			was observed that the firm wa	s issued Show

96	<br>Case No.:572/15/82-ALC4/2018	Party Name:A.R. LIFE<br>SCIENCES PVT LTD<br>RLA File<br>:09/24/040/00309/AM19/	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:0910066726<br>08.10.2018	Status:<br>Deferred<br>Defer Date:
	<br>HQ File<br>:01/82/050/02029/AM19/
	Decision:Deferred for comments of TE.

r>Lic.No/Date:0910066726 08.10.2018|Status: Deferred Defer Date:| |---|---|---|---|---| || HQ File :01/82/050/02029/AM19/|||| ||**Decision:**Deferred for comments of TE.||||

97	<br>Case No.:224/13/82-<br>ALC4/2018	Party<br>Name:ASTRALSTERITECH<br>PVT. LTD.	Party<br>Name:ASTRALSTERITECH<br>PVT. LTD.	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:Defferedand<br>Re-indexed	Status:Defferedand<br>Re-indexed
	<br>HQ File<br>:01/82/050/01202/AM19/	RLA File<br>:34/24/040/00225/AM19/		Lic.No/Date:3410044573<br>10.10.2018		Defer Date:
	Decision:Deferred for comments of TE.

98	<br>Case No.:582/15/82-<br>ALC4/2018		Party Name:MACSON<br>PRODUCTS		Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020		Status: Deferred
	<br>HQ File<br>:01/82/050/02039/AM19/		RLA File<br>:52/24/040/00039/AM19/		Lic.No/Date:5210042796<br>11.10.2018		Defer Date:
	Decision:Deferred for comments of TE.

Deferred**| || HQ File :01/82/050/02039/AM19/||RLA File :52/24/040/00039/AM19/||Lic.No/Date:5210042796 11.10.2018||Defer Date:| ||**Decision:**Deferred for comments of TE.|||||||

99	Case No.:590/15/82-ALC4/2018	Party Name:VERVE HUMAN<br>CARE LABORATORIES<br>RLA File<br>:61/24/040/00011/AM19/	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
	HQ File :01/82/050/02047/AM19/		Lic.No/Date:6110001553<br>11.10.2018	Defer Date:
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not available.<br>Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the<br>firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

100	<br>Case No.:801/15/82-ALC4/2018	Party Name:DEEPAK<br>PHENOLICS LIMITED<br>RLA File<br>:34/24/040/00230/AM19/	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:3410044580<br>11.10.2018	Status:<br>Deferred
	<br>HQ File :01/82/050/02258/AM19/			Defer Date:
	Decision:Deferred for comments of TE.

101	<br>Case No.:169/13/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/01147/AM19/	Party Name:SPC LIFE<br>SCIENCES PVT. LTD.	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
		RLA File<br>:34/24/040/00211/AM19/	Lic.No/Date:3410044586<br>12.10.2018	Defer Date:
	Decision:Deferred for comments of TE.

1.01.2020|Status: Deferred| |---|---|---|---|---| |||RLA File :34/24/040/00211/AM19/|Lic.No/Date:3410044586 12.10.2018|Defer Date:| ||**Decision:**Deferred for comments of TE.||||

102	<br>Case No.:592/15/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/02049/AM19/	Party Name:SRIAM LABS<br>PRIVATE LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
		RLA File<br>:09/24/040/00338/AM19/	Lic.No/Date:0910066753<br>16.10.2018	Defer Date:
	Decision:Deferred for comments of TE.

Case No.:157/15/82-ALC4/2018	Party Name:VAKS PHARMA	Meet No/Date:13/82-	Status:
	PVT.LTD.,	ALC4/2019	Rejected
		31.01.2020
HQ File :01/82/050/01614/AM19/	RLA File	Lic.No/Date:0310824491
	:03/95/040/00732/AM19/	17.10.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 3/82-ALC4/2018 dated 05.07.2019, 7/82-ALC4/2019 dated 06.09.2019 followed by Reminder on 02.08.2019 and Final Reminder on 103 30.10.2019 :

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

case of Filled Capsules, complete details of each type of capsules such as weight of empty capsules, weight of finished goods, their approved composition, wastage claimed etc. is to be furnished.**

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

Case No.:322/13/82-ALC4/2018	Party Name:ANLON	Meet No/Date:13/82-	Status:
	HEALTHCARE	ALC4/2019	Deferred
	PRIVATELIMITED	31.01.2020
HQ File :01/82/050/01300/AM19/	RLA File	Lic.No/Date:2410042548	Defer Date:
	:24/24/040/00033/AM19/	24.10.2018

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

(i) Complete chemical reaction, molecular weight and % yield on molar basis for each step of manufacturing process.

	Case No.:169/15/82-ALC4/2018	Party Name:WOCKHARDT	Meet No/Date:13/82-	Status:
		LIMITED	ALC4/2019	Deferred
			31.01.2020
105	HQ File :01/82/050/01626/AM19/	RLA File	Lic.No/Date:0310824651	Defer Date:
		:03/95/040/00755/AM19/	24.10.2018
	Decision:Deferred for comments of TE.

|||31.01.2020||| |105||HQ File :01/82/050/01626/AM19/||RLA File||Lic.No/Date:0310824651||Defer Date:| |||||:03/95/040/00755/AM19/||24.10.2018||| |||**Decision:**Deferred for comments of TE.|||||||

	Case No.:424/13/82-ALC4/2018Party Name:DEEPAK NITRITE	Meet No/Date:13/82-	Status:
	LIMITED	ALC4/2019	Deferred
		31.01.2020
	HQ File :01/82/050/01402/AM19/ RLA File	Lic.No/Date:3410044635	Defer Date:
106	:34/24/040/00144/AM19/	25.10.2018
	Decision:The Committee considered the case as per agenda and it was observed that the firm vide its e-mail
	dated17.12.2019has 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.

	Case No.:426/13/82-ALC4/2018Party Name:DEEPAK NITRITE	Meet No/Date:13/82-	Status:
	LIMITED	ALC4/2019	Deferred
		31.01.2020
	HQ File :01/82/050/01404/AM19/ RLA File	Lic.No/Date:3410044636	Defer Date:
107	:34/24/040/00208/AM19/	25.10.2018
	Decision:The Committee considered the case as per agenda and it	was observed that the firm vide its e-mail
	dated17.12.2019has 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.

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.|||||

Case No.:453/13/82-ALC4/2018	Party Name:HESTER	Meet No/Date:13/82-	Status:
	BIOSCIENCES LIMITED	ALC4/2019	Deferred
		31.01.2020
HQ File :01/82/050/01431/AM19/	RLA File	Lic.No/Date:0810143739	Defer Date:
	: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 as asked for by NC-3 in its Meeting No. 108 8 /82-ALC4/2019 dated 20.09.2019 , followed by Reminder on 26.08.2019 :

(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.

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.:597/15/82-ALC4/2018	Party Name:AUROBINDO	Meet No/Date:13/82-	Status:
		PHARMA LIMITED	ALC4/2019	Deferred
			31.01.2020
109	HQ File :01/82/050/02054/AM19/	RLA File	Lic.No/Date:0910066762	Defer Date:
		:09/24/040/00345/AM19/	25.10.2018
	Decision:Deferred for comments of TE.

.01.2020||| |109||HQ File :01/82/050/02054/AM19/||RLA File||Lic.No/Date:0910066762||Defer Date:| |||||:09/24/040/00345/AM19/||25.10.2018||| |||**Decision:**Deferred for comments of TE.|||||||

Case No.:599/15/82-ALC4/2018	Party Name:LITMUS	Meet No/Date:13/82-	Status:
	ORGANICS P. LTD.	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/02056/AM19/	RLA File	Lic.No/Date:0310824684
	:03/95/040/00747/AM19/	25.10.2018

110

Export product	Qty.	Sl.<br>No.	Import items	Qty.
METHYL ISOBUTYRYL<br>ACETATE	1 kg	1	METHYL ACETO ACETATE<br>(MAA)	1.12 kg
		2	ISO BUTYRIC ACID	0.848 kg
		3	POTASSIUM HYDROXIDE	1.00 kg

Case No.:201/6/82-ALC4/2019	Party Name:DEEPAK NITRITE	Meet No/Date:13/82-	Status:
	LIMITED	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/00427/AM20/	RLA File	Lic.No/Date:3410044637
	:34/24/040/00257/AM18/	25.10.2018

|---|---|---|---|---|---|---| |||LIMITED||ALC4/2019||Approved| |||||31.01.2020||| |HQ File :01/82/050/00427/AM20/||RLA File||Lic.No/Date:3410044637||| |||:34/24/040/00257/AM18/||25.10.2018|||

	Case No.:201/6/82-ALC4/2019	Case No.:201/6/82-ALC4/2019	Party Name:DEEPAK NITRITE<br>LIMITED	Party Name:DEEPAK NITRITE<br>LIMITED	Party Name:DEEPAK NITRITE<br>LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020
	HQ File :01/82/050/00427/AM20/		RLA File<br>:34/24/040/00257/AM18/			Lic.No/Date:3410044637<br>25.10.2018
111	Decision:The Committee considered case<br>decided to ratify the ad-hoc input output norms<br>whichever is lower:
	Export product	Qty.		Sl.<br>No.	Import items		Qty.
	3-TRIFLUOROMETHYL<br>ACETO PHENONE	1 kg		1	3 Amino Benzo Trifluoride 99.5%<br>Min		1.297 kg
				2	Sodium Nitrite		Not<br>allowed,<br>since<br>shown as indigenous.
				3	Toluene		0.50 kg
				4	Caustic Soda Lye 47%		0.50 kg
				5	Acetaldoxime 50% Min Solution<br>in Water		0.951 kg
				6	Copper Sulphate		Not<br>allowed,<br>since<br>shown as indigenous.
				7	Acetic Acid		Not<br>allowed,<br>since<br>shown as indigenous.
				8	Sulphamic Acid		Not<br>allowed,<br>since<br>shown as indigenous.
				9	Soda Ash		Not<br>allowed,<br>since<br>shown as indigenous.
	RA concerned maytake further	necessaryaction asper above decision of NC.

lowed, since shown as indigenous.|| |||||9|Soda Ash||Not allowed, since shown as indigenous.|| ||RA concerned maytake further|necessaryaction asper above decision of NC.|||||||

112	<br>Case No.:602/15/82-<br>ALC4/2018	Party Name:GLAND PHARMA<br>LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:0910066775<br>26.10.2018	Status:<br>Deferred<br>Defer Date:
	<br>HQ File<br>:01/82/050/02059/AM19/	RLA File<br>:09/24/040/00229/AM19/
	Decision:Deferred for comments of TE.

Case No.:603/15/82- Party Name:THERAPIVA Meet No/Date:13/82- Status: Deferred ALC4/2018 PRIVATE LIMITED ALC4/2019 31.01.2020 HQ File RLA File Lic.No/Date:0910066778 Defer Date: :01/82/050/02060/AM19/ :09/24/040/00359/AM19/ 26.10.2018 113 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:

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

Case No.:604/15/82-ALC4/2018	Party Name:ORTIN	Meet No/Date:13/82-	Status:
	LABORATORIES LTD	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/02061/AM19/	RLA File	Lic.No/Date:0910066780
	:09/24/040/00347/AM19/	26.10.2018

|---|---|---|---|---| |||LABORATORIES LTD||ALC4/2019||Approved| |||||31.01.2020||| |HQ File :01/82/050/02061/AM19/||RLA File||Lic.No/Date:0910066780||| |||:09/24/040/00347/AM19/||26.10.2018|||

	Case No.:604/15/82-ALC4/2018	Party Name:ORTIN<br>LABORATORIES LTD	Party Name:ORTIN<br>LABORATORIES LTD	Party Name:ORTIN<br>LABORATORIES LTD	Party Name:ORTIN<br>LABORATORIES LTD	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020
	HQ File :01/82/050/02061/AM19/	RLA File<br>:09/24/040/00347/AM19/				Lic.No/Date:0910066780<br>26.10.2018
114	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm<br>whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>[2S,3S,5S]-5-t-<br>butyloxycarbonylamino-2-Amino-3-<br>hydroxy-1,6-diphenylhexane<br>succinate(BDH Succinic Acid RIT)<br>1 kg<br>1<br>1,2-dimethoxy ethane(1,2-<br>DME)<br>4.74 kg<br>2<br>SODIUM BORO HYDRIDE<br>0.45 kg<br>3<br>METHANE SULPHONIC<br>ACID<br>1.50 kg<br>4<br>TRIETHANOLAMINE<br>1.167 kg<br>5<br>Di-Tert-Butyl- Di-Carbonate<br>0.60kg<br>RA concerned maytake further necessaryaction asper above decision of NC.
	<br>Export product		Qty.	Sl.<br>No.	Import items		Qty.

r>1.167 kg 5 Di-Tert-Butyl- Di-Carbonate 0.60kg RA concerned maytake further necessaryaction asper above decision of NC.|||||||| || Export product||Qty.|Sl. No.|Import items||Qty.|| ||[2S,3S,5S]-5-t- butyloxycarbonylamino-2-Amino-3- hydroxy-1,6-diphenylhexane succinate(BDH Succinic Acid RIT)||1 kg|1|1,2-dimethoxy ethane(1,2- DME)||4.74 kg|| |||||2|SODIUM BORO HYDRIDE||0.45 kg|| |||||3|METHANE SULPHONIC ACID||1.50 kg|| |||||4|TRIETHANOLAMINE||1.167 kg|| |||||5|Di-Tert-Butyl- Di-Carbonate||0.60kg|| ||RA concerned maytake further necessaryaction asper above decision of NC.||||||||

115	<br>Case No.:605/15/82-ALC4/2018	Party Name:SUVEN LIFE<br>SCIENCES LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
	<br>HQ File :01/82/050/02062/AM19/	RLA File<br>:09/24/040/00354/AM19/	Lic.No/Date:0910066781<br>26.10.2018	Defer Date:
	Decision:Deferred for comments of TE.

|---|---|---|---|---| || HQ File :01/82/050/02062/AM19/|RLA File :09/24/040/00354/AM19/|Lic.No/Date:0910066781 26.10.2018|Defer Date:| ||**Decision:**Deferred for comments of TE.||||

	Case No.:608/15/82-ALC4/2018	Party Name:MACSON	Meet No/Date:13/82-		Status:
		PRODUCTS	ALC4/2019		Deferred
			31.01.2020
116	HQ File :01/82/050/02065/AM19/	RLA File	Lic.No/Date:5210042821		Defer Date:
		:52/24/040/00058/AM19/	26.10.2018
	Decision:Deferred for comments of TE.

	Case No.:232/13/82-ALC4/2018	Party Name:DEEPAK	Meet No/Date:13/82-		Status:
		NOVOCHEM TECHNOLOGIES	ALC4/2019		Deferred
		LTD	31.01.2020
	HQ File :01/82/050/01210/AM19/	RLA File	Lic.No/Date:3110067218		Defer Date:
		: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.
117	4/82-ALC4/2019 dated 19.07.2019, 8/82-ALC4/2019 dated 20.09.2019, followed by Reminder on01.11.2019:
	(i)<br>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 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.|||||||| ||||In view of above, the Committee decided to issueFinal Reminder** to||||firm to furnish its reply, failing which the|||| ||||case will be rejected.|||||||| ||||||||||||

	Case No.:183/13/82-ALC4/2018	Party Name:PHAROSE		Meet No/Date:13/82-		Status:
		REMEDIES LTD.		ALC4/2019		Deferred
				31.01.2020
118	HQ File :01/82/050/01161/AM19/	RLA File		Lic.No/Date:3010104485		Defer Date:
		:30/24/040/00032/AM19/		31.10.2018
	Decision:Deferred for comments of TE.

	Case No.:363/13/82-ALC4/2018	Party Name:CIPLA LIMITED.	Meet No/Date:13/82-		Status:
			ALC4/2019		Approved
			31.01.2020
	HQ File :01/82/050/01341/AM19/	RLA File	Lic.No/Date:0310824906
		:03/94/040/00699/AM19/	05.11.2018
	Decision:The Committee considered case as per agenda in the presence of the technical experts and it was

te:0310824906|||||||| ||||||:03/94/040/00699/AM19/||||05.11.2018|||||||| ||||**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was|||||||||||||| ||||decided to ratify the ad-hoc input||output norms under para|||4.7 of HBP as per details below or as applied by firm||||||||| ||||whichever is lower:|||||||||||||| ||119|||Export product|Qty.|Sl.||Import items|||Qty.|||||| |||||||No.||||||||||| |||||Azelastine Hydrochloride and|1 kg|1||Azelastine|Hydrochloride||16.44 mg|||||| |||||Fluticasone Propionate Nasal Spray /||2||Fluticasone||Propionate|6.00 mg|||||| |||||Dymista Nasal Spray (Pack 120MD)||3||140 mcl pumps|||Net to Net|||||| |||||Each Spray delivers: Azelastine||4||25ml USP type 1 amber glass vial|||Net +1%|||||| |||||Hydrochloride BP 137mcg||5||Nasal actuator|||Net to Net|||||| |||||FluticasonePropionate 50mcg||||||||||||| ||||RA concerned maytake further necessaryaction asper above decision of NC.|||||||||||||| ||||||||||||||||||

Case No.:362/13/82-ALC4/2018	Party Name:AARTI DRUGS	Meet No/Date:13/82-	Status:
	LIMITED	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/01340/AM19/	RLA File	Lic.No/Date:0310824929
	:03/94/040/00683/AM19/	06.11.2018

|---|---|---|---|---|---|---| |||LIMITED||ALC4/2019||Approved| |||||31.01.2020||| |HQ File :01/82/050/01340/AM19/||RLA File||Lic.No/Date:0310824929||| |||:03/94/040/00683/AM19/||06.11.2018|||

	Decision:The Committee considered	Decision:The Committee considered	Decision:The Committee considered	Decision:The Committee considered	case as per agenda in the presence of the technical experts and it was	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:
120
		Export product	Qty.	Sl.	Import items	Qty.
				No.
		Enrofloxacin	1 kg	1	Ethyl 3- Cyclopropylamino-2-(2,4-Dichloro-5-	1.12 kg
					Fluorobenzoyl)Acrylate
				2	N-Ethyl Piperazine	0.49 kg
				3	Methanol	0.334 kg
				4	Caustic Soda Flakes	0.360 kg
	RA concerned maytake further necessary				action asper above decision of NC.

te||| ||||||2||N-Ethyl Piperazine|0.49 kg|| ||||||3||Methanol|0.334 kg|| ||||||4||Caustic Soda Flakes|0.360 kg|| |||RA concerned maytake further necessary|||||action asper above decision of NC.|||

	Case No.:614/15/82-ALC4/2018	Case No.:614/15/82-ALC4/2018	Case No.:614/15/82-ALC4/2018	Party Name:SUVEN LIFE		Meet No/Date:13/82-				Status:
				SCIENCES LIMITED		ALC4/2019				Deferred
						31.01.2020
121	HQ File :01/82/050/02071/AM19/			RLA File		Lic.No/Date:0910066814				Defer Date:
				:09/24/040/00360/AM19/		08.11.2018
	Decision:Deferred for comments of TE.

	Case No.:351/13/82-ALC4/2018			Party Name:AARTI DRUGS	Meet No/Date:13/82-				Status:
				LIMITED	ALC4/2019				Approved
					31.01.2020
	HQ File :01/82/050/01329/AM19/			RLA File	Lic.No/Date:0310824972
				:03/94/040/00682/AM19/	12.11.2018
	Decision:The Committee considered case as per agenda in the presence of the technical experts and it was
	decided to ratify the ad-hoc input			output norms under para 4.7 of HBP as per details below or as applied by firm
	whichever is lower:
122
		Export product	Qty.	Sl.<br>Import items			Qty.
				No.
		Enrofloxacin	1 kg	1<br>Ethyl 3- Cyclopropylamino-2-(2,4-Dichloro-5-			1.12	kg
				Fluorobenzoyl)Acrylate

roduct|Qty.||Sl. Import items||||Qty.|||||| ||||||||No.|||||||||| |||||Enrofloxacin|1 kg||1 Ethyl 3- Cyclopropylamino-2-(2,4-Dichloro-5-||||1.12|kg||||| ||||||||Fluorobenzoyl)Acrylate|||||||||| ||||||||2 N-Ethyl Piperazine||||0.49|kg||||| ||||||||3 Methanol||||0.334||kg|||| ||||||||4 Caustic Soda Flakes||||0.360||kg|||| ||||RA concerned maytake further necessaryaction asper above decision||||||of NC.|||||||| ||||||||||||||||||

	Case No.:111/15/82-ALC4/2018	Party Name:PUNJAB	Meet No/Date:13/82-	Status:
		CHEMICALS AND CROP	ALC4/2019	Deferred
		PROTECTION LTD	31.01.2020
123	HQ File	RLA File	Lic.No/Date:0310824946	Defer Date:
	:01/82/050/01568/AM19/	:03/95/040/00709/AM19/	12.11.2018
	Decision:Deferred for comments of TE.

	Case No.:616/15/82-	Party Name:VIVIMED LIFE	Meet No/Date:13/82-	Status:
	ALC4/2018	SCIENCES PRIVATE	ALC4/2019	Deferred
		LIMITED	31.01.2020
124	HQ File	RLA File	Lic.No/Date:0910066821	Defer Date:
	:01/82/050/02073/AM19/	:09/24/040/00387/AM19/	12.11.2018
	Decision:The Committee considered the case as per agenda and		it was noted that the firm vide its e-mail dated
	09.12.2019 has furnished its reply. Deferred for comments of TE.

The Committee considered the case as per agenda and||||it was noted that the firm vide its e-mail dated|||| |||09.12.2019 has furnished its reply. Deferred for comments of TE.|||||||| |||||||||||

123	Case No.:111/15/82-ALC4/2018 <br>	Case No.:111/15/82-ALC4/2018 <br>	Party Name:PUNJAB<br>CHEMICALS AND CROP<br> <br>	Meet No/Date:13/82-<br>ALC4/2019	Status:<br>Deferred	Status:<br>Deferred
	<br>HQ<br>:01<br>De	<br> <br>File<br>/82/050/01568/AM19/<br> <br>:	<br>PROTECTION LTD<br> <br>	<br>31.01.2020
			RLA File<br>03/95/040/00709/AM19/<br> <br>	Lic.No/Date:0310824946<br>12.11.2018	Defer Date:
		cision:Deferred for comment	s of TE.


124	Ca<br>AL	se No.:616/15/82-<br>C4/2018<br> <br> <br>	Party Name:VIVIMED LIFE<br>SCIENCES PRIVATE<br>IMITED<br> <br> <br>	Meet No/Date:13/82-<br>ALC4/2019<br>1012020	Status:<br>Deferred
	<br> <br>HQ File<br> <br> <br>		<br> <br>RLA File<br> <br> <br>	..
				Lic.No/Date:0910066821<br>	Defer Date:
	:01<br>De<br>09.	/82/050/02073/AM19/<br>:	09/24/040/00387/AM19/<br>	12.11.2018
		cision:The Committee cons<br>12.2019 has furnished its reply.	idered the case as per agenda and<br>Deferred for comments of TE.	it was noted that the firm vi	de its e-mail da	ted

| |||**cision:**The Committee cons 12.2019 has furnished its reply.|idered the case as per agenda and Deferred for comments of TE.|it was noted that the firm vi|de its e-mail da||ted| ||||||||| |125| Ca HQ|se No.:87/15/82-ALC4/2018 File |Party Name:DEEPAK NITRITE LIMITED RLA File |Meet No/Date:13/82- ALC4/2019 31.01.2020|Status: Deferred||| |||||Lic.No/Date:3410044685|Defer Date:||| ||||34/24/040/00267/AM19/ |13.11.2018|||| ||02.|12.2019 has furnished its reply.|Deferred for comments of TE.||||| ||||||||| |126| Case No.:634/15/82-ALC4/2018Party Name:AUROBINDO PHARMA LIMITED HQ File :01/82/050/02091/AM19/ RLA File :09/24/040/00376/AM19/ **Decision:**Deferred for comments of TE.|se No.:634/15/82-ALC4/2018|Party Name:AUROBINDO PHARMA LIMITED|Meet No/Date:13/82- ALC4/2019||Status: Deferred|| |||||31.01.2020 Lic.No/Date:0910066832 13.11.2018|||| |||File :01/82/050/02091/AM19/|RLA File :09/24/040/00376/AM19/|||Defer Date|:| ||||||||| ||||||||| |127| Ca HQ De fro|se No.:623/15/82-ALC4/2018|Party Name:VINS BIOPRODUCTS LTD`|Meet No/Date:13/82- ALC4/2019 31.01.2020||Status: Deferred|| |||File :01/82/050/02080/AM19/|RLA File :09/24/040/00363/AM19/|Lic.No/Date:0910066851 14.11.2018||Defer Date|:|

TD`|Meet No/Date:13/82- ALC4/2019 31.01.2020||Status: Deferred|| |||File :01/82/050/02080/AM19/|RLA File :09/24/040/00363/AM19/|Lic.No/Date:0910066851 14.11.2018||Defer Date|:| |||cision:The Committee considered the case as per agenda and it was decided to call for following informat m the firm: (i) Number of vials to be exported each for 1000 IU and 1500 IU separately to work out t||||||

128	<br>Case No.:627/15/82-ALC4/2018	<br>Case No.:627/15/82-ALC4/2018	Party Name:AUROBINDO<br>PHARMA LIMITED		Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
	<br>HQ File :01/82/050/02084/AM19/		RLA File<br>:09/24/040/00382/AM19/		Lic.No/Date:0910066853<br>15.11.2018		Defer Date:
	Decision:Deferred for comments of TE.

129	<br>Case No.:630/15/82-ALC4/2018		Party Name:VIVIN DRUGS &<br>PHARMACEUTICALS<br>LIMITED		Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020		Status:<br>Deferred
	<br>HQ File :01/82/050/02087/AM19/		RLA File<br>:09/24/040/00391/AM19/		Lic.No/Date:0910066856<br>15.11.2018		Defer Date:
	Decision:Deferred for comments of TE.

130	Case No.:2/15/82-ALC4/2018	Party Name:DEEPAK NITRITE<br>LIMITED		Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020		Status: Deferred
	<br>HQ File<br>:01/82/050/01459/AM19/	RLA File<br>:34/24/040/00254/AM19/		Lic.No/Date:3410044710<br>20.11.2018		Defer Date:

Meet No/Date:13/82- ALC4/2019 31.01.2020||Status: Deferred|| || HQ File :01/82/050/01459/AM19/|RLA File :34/24/040/00254/AM19/||Lic.No/Date:3410044710 20.11.2018||Defer Date:|| ||Decision:The Committee considered the case as per agenda and it was observed that the reply furnished by the firm vide e-mail dated17.12.2019is not readable. Hence, the Committee decided to again call for a clear copy of replyfrom firm through Speed Post.|||||||

131	Case No.:85/15/82-ALC4/2018	Party Name:DEEPAK NITRITE<br>LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status: Deferred
	<br>HQ File<br>:01/82/050/01542/AM19/	RLA File<br>:34/24/040/00255/AM19/	Lic.No/Date:3410044711<br>20.11.2018	Defer Date:
	Decision:The Committee considered the case as per agenda and it was observed that the reply furnished by the<br>firm vide e-mail dated17.12.2019is not readable. . Hence, the Committee decided to again call for a clear copy<br>of replyfrom firm through Speed Post.

that the reply furnished by the firm vide e-mail dated17.12.2019is not readable. . Hence, the Committee decided to again call for a clear copy of replyfrom firm through Speed Post.||||

132	Case No.:86/15/82-ALC4/2018	Party Name:DEEPAK NITRITE<br>LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status: Deferred
	<br>HQ File<br>:01/82/050/01543/AM19/	RLA File<br>:34/24/040/00256/AM19/	Lic.No/Date:3410044712<br>20.11.2018	Defer Date:
	Decision:The Committee considered the case as per agenda and it was observed that the reply furnished by the<br>firm vide e-mail dated17.12.2019is not readable. Hence, the Committee decided to again call for reply of firm<br>through Speed Post.

	Case No.:638/15/82-ALC4/2018	Party Name:AUROBINDO	Meet No/Date:13/82-	Status:
		PHARMA LIMITED	ALC4/2019	Deferred
			31.01.2020
133	HQ File :01/82/050/02095/AM19/	RLA File	Lic.No/Date:0910066874	Defer Date:
		:09/24/040/00386/AM19/	20.11.2018
	Decision:Deferred for comments of TE.

	Case No.:639/15/82-ALC4/2018	Party Name:CADILA	Meet No/Date:13/82-	Status:
		HEALTHCARE LTD	ALC4/2019	Deferred
			31.01.2020
134	HQ File :01/82/050/02096/AM19/	RLA File	Lic.No/Date:0810143923	Defer Date:
		:08/24/040/00187/AM19/	20.11.2018
	Decision:Deferred for comments of TE.

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

Case No.:640/15/82-ALC4/2018	Party Name:AETHER	Meet No/Date:13/82-	Status:
	INDUSTRIES LIMITED	ALC4/2019	Approved
		31.01.2020
HQ File	RLA File	Lic.No/Date:5210042834
:01/82/050/02097/AM19/	:52/24/040/00064/AM19/	20.11.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 9/82-ALC4/2919 dated 18.10.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details 135 given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl.	Import items	Qty.
		No.
THIOPHENE-2-	1 kg	1	THIOPHENE	1.325 kg
ETHANOL		2	TETRAHYDROFURAN	1.116 kg

Case No.:641/15/82-	Party Name:HONEST BIO-	Meet No/Date:13/82-	Status:
ALC4/2018	VET PVT. LTD	ALC4/2019	Approved
		31.01.2020
HQ File	RLA File	Lic.No/Date:0810143924
:01/82/050/02098/AM19/	:08/24/040/00268/AM19/	20.11.2018

r 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 136 whichever is lower:

Export product	Qty.	Sl.<br>No.	Import items	Qty.
3-Chloro peroxy benzoic acid	1 kg	1	Meta chloro toluene(3-chloro toluene)	0.862 kg
		2	Tertiary Butanol	0.875 kg

Case No.:463/13/82-	Party Name:INDIA GLYCOLS	Meet No/Date:13/82-	Status: Deferred
ALC4/2018	LTD.,	ALC4/2019
		31.01.2020
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 : 137

(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.

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

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

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

	Case No.:649/15/82-ALC4/2018	Party Name:GLOBE TROTTERS	Meet No/Date:13/82-	Status:
		PVT LTD	ALC4/2019	Deferred
			31.01.2020
138	HQ File :01/82/050/02106/AM19/	RLA File	Lic.No/Date:0310825212	Defer Date:
		:03/94/040/00713/AM19/	26.11.2018
	Decision:Deferred for comments of TE.

Case No.:658/15/82-ALC4/2018	Party Name:ATHENA DRUG	Meet No/Date:13/82-	Status:
	DELIVERY SOLUTIONS	ALC4/2019	Approved
	PRIVATE LIMITED	31.01.2020
HQ File	RLA File	Lic.No/Date:0310825255
:01/82/050/02115/AM19/	:03/94/040/00744/AM19/	28.11.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting 139 no. 1/82-ALC4/2919 dated 03.06.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

	Export product	Qty.	Sl.	Import items	Qty.
			No.
	FENOFIBRATE 160 mg PELLETS	1 kg	1	FENOFIBRATE EP 9.0	0.320 kg
RA concerned maytake further necessaryaction asper above decision of NC.

rt items|Qty.| |---|---|---|---|---|---| ||||No.||| ||FENOFIBRATE 160 mg PELLETS|1 kg|1|FENOFIBRATE EP 9.0|0.320 kg| |RA concerned maytake further necessaryaction asper above decision of NC.||||||

	Case No.:659/15/82-ALC4/2018	Party Name:AUROBINDO	Meet No/Date:13/82-	Status:
		PHARMA LIMITED	ALC4/2019	Deferred
			31.01.2020
140	HQ File :01/82/050/02116/AM19/	RLA File	Lic.No/Date:0910066905	Defer Date:
		:09/24/040/00410/AM19/	28.11.2018
	Decision:Deferred for comments of TE.

Case No.:664/15/82-	Case No.:664/15/82-	Party	Party	Meet No/Date:13/82-	Status: Deferred
<br> <br>AL<br>HQ<br>:01<br>De	<br>C4/2018	<br>Name:<br>MITE	SMILAX LABORATORIES LI<br>D	<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:0910066915
	File	RLA F	ile :09/24/040/00358/AM19/		Defer Date:
	<br>/82/050/02121/AM19/			<br>28.11.2018
	cision:Deferred for comment		s of TE.

No/Date:13/82- ALC4/2019 31.01.2020|Status: Approved| |---|---|---|---|---| ||HQ File :01/82/050/01583/AM19/|RLA File :03/95/040/00969/AM19/|Lic.No/Date:0310825887 24.12.2018|| |182| **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Qty. Sl. No. Import items Qty. TITANIUM PHOSPHATE COMPLEX (PURETI TIC30) 300000.000 kg 1 TETRA ISO PROPYL TITANATE 176280.00 kg 2 RETARDER (Dentatured Absolute Alcohol Base) 54330.00 kg 3 BUTYL PHOSPHATE 84385.00 kg The Committee allowed the above norms on one time basis and no repeat norms is allowed. RA concerned maytake further necessaryaction asper above decision of NC.||||

	Case No.:925/15/82-ALC4/2018	Party Name:OPTRIX	Meet No/Date:13/82-	Status:
		LABORATORIES PRIVATE	ALC4/2019	Deferred
		LIMITED	31.01.2020
183	HQ File :01/82/050/02382/AM19/	RLA File	Lic.No/Date:0910066998	Defer Date:
		:09/24/040/00470/AM19/	24.12.2018
	Decision:Deferred for comments of TE.

D||31.01.2020||| |183||HQ File :01/82/050/02382/AM19/||RLA File||Lic.No/Date:0910066998||Defer Date:| |||||:09/24/040/00470/AM19/||24.12.2018||| |||**Decision:**Deferred for comments of TE.|||||||

Case No.:767/15/82-	Party Name:CIPLA LIMITED.	Meet No/Date:13/82-	Status:
ALC4/2018		ALC4/2019	Approved
		31.01.2020
HQ File	RLA File	Lic.No/Date:0310825972
:01/82/050/02224/AM19/	:03/94/040/00826/AM19/	27.12.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 10/AM20 dated 29.11.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export Product: Amoxicillin and Clavulanate Potassium for Oral Suspension USP 250mg / 62.5mg in 75 ml, 100 ml and 150 ml

184

S.No.	Import Item		For export of 1000 No. pack	For export of 1000 No. pack	For export of 1000 No. pack
			75 ml	100 ml	150 ml
1.	Amoxycillin Trihydrate		4.200 kg	5.649 kg	8.274 kg
2.	CLAVULANATE<br>POTASSIUM<br>WITH	SILICON	2.3444 kg	3.126 kg	4.6888 kg
	DIOXIDE 1:1
3.	SILICONE DIOXIDE(SYLOID 244FP)		1.50 kg	2.00 kg	3.00 kg
4.	115CC HDPE BOTTLES 75 ML (250/62.5)		Relevant as per packing policy
5.	185 CC HDPE BOTTLES 100 ML (250/62.5)
6.	225 CC HDPE BOTTLES 150 ML (250/62.5)
7	28-400 WHITE CLIC LOC CAP WITH	PRINTED
	FSM-1
8	Cap 28/400 WHT CRC W/FS M-I WITH INDUCTION
	SEALING

ML (250/62.5)||||| ||6.|225 CC HDPE BOTTLES 150 ML (250/62.5)||||| ||7|28-400 WHITE CLIC LOC CAP WITH|PRINTED|||| |||FSM-1||||| ||8|Cap 28/400 WHT CRC W/FS M-I WITH INDUCTION||||| |||SEALING|||||

	Case No.:772/15/82-ALC4/2018	Party Name:AUROBINDO	Meet No/Date:13/82-	Status:
		PHARMA LIMITED	ALC4/2019	Deferred
			31.01.2020
185	HQ File :01/82/050/02229/AM19/	RLA File	Lic.No/Date:0910067006	Defer Date:
		:09/24/040/00445/AM19/	31.12.2018
	Decision:Deferred for comments of TE.

186	<br>Case No.:775/15/82-ALC4/2018Party Name:SUVEN LIFE<br>SCIENCES LIMITED<br>HQ File :01/82/050/02232/AM19/ RLA File<br>:09/24/040/00482/AM19/<br>Decision:Deferred for comments of TE.	Party Name:SUVEN LIFE<br>SCIENCES LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:0910067014<br>31.12.2018	Status:<br>Deferred
		RLA File<br>:09/24/040/00482/AM19/		Defer Date:

Case No.:8/7/82-ALC4/2019	Party Name:GLOBAL	Meet No/Date:13/82-	Status:
	CALCIUM PRIVATE LIMITED	ALC4/2019	Approved
		31.01.2020
HQ File	RLA File	Lic.No/Date:0710114345
:01/82/050/00503/AM20/	:07/24/040/00223/AM19/	31.12.2018

--|---|---|---| |||CALCIUM PRIVATE LIMITED||ALC4/2019||Approved| |||||31.01.2020||| |HQ File||RLA File||Lic.No/Date:0710114345||| |:01/82/050/00503/AM20/||:07/24/040/00223/AM19/||31.12.2018|||

	Case No.:8/7/82-ALC4/2019	Party Name:GLOBAL<br>CALCIUM PRIVATE LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Approved
	HQ File<br>:01/82/050/00503/AM20/	RLA File<br>:07/24/040/00223/AM19/	Lic.No/Date:0710114345<br>31.12.2018
187	<br>Decision:The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting<br>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<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>MAGNESIUM ASPARTATE (BP /<br>DIHYDRATE Eur.Ph)<br>1 kg<br>1<br>L-ASPARTIC ACID<br>1.05 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Case No.:9/7/82-ALC4/2019	Party Name:GLOBAL	Meet No/Date:13/82-	Status:
	CALCIUM PRIVATE LIMITED	ALC4/2019	Approved
		31.01.2020
HQ File	RLA File	Lic.No/Date:0710114346
:01/82/050/00504/AM20/	:07/24/040/00222/AM19/	31.12.2018

188

|---|---| |||CALCIUM PRIVATE LIMITED||ALC4/2019||Approved| |||||31.01.2020||| |HQ File||RLA File||Lic.No/Date:0710114346||| |:01/82/050/00504/AM20/||:07/24/040/00222/AM19/||31.12.2018|||

188

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:

Export product	Qty.	Sl. No.	Import items	Qty.
CALCIUM<br>LEVULINATE<br>/<br>CALCIUM<br>LEVULINATE<br>DIHYDRATE<br>BP<br>/<br>CALCIUM<br>LEVULINATE EP / CALCIUM<br>LEVULINATE USP	1 kg	1	LEVULINIC ACID	1.02 kg

Case No.:784/15/82-ALC4/2018	Party Name:SMS	Meet No/Date:13/82-	Status:
	LIFESCIENCES INDIA	ALC4/2019	Approved
	LIMITED	31.01.2020
HQ File :01/82/050/02241/AM19/	RLA File	Lic.No/Date:0910067021
	:09/24/040/00490/AM19/	01.01.2019

Export product<br>(3R, 3aS, 6aR) - HEXA HYDRO<br>FURO - [2, 3-b] - FURAN - 3 - YL - 4<br>- NITRO PHENYL CARBONATE<br>(DARUNAVIR-IV)	Qty.	Sl.<br>No.	Import items	Qty.
	1 kg	1	BIS IV (HEXA HYDRO FURO<br>[2,3-B] FURAN-3-OL)	1.61 kg
		2	METHYLENE DI CHLORIDE	5.32 kg

ENYL CARBONATE<br>(DARUNAVIR-IV)	Qty.	Sl.<br>No.	Import items	Qty.
	1 kg	1	BIS IV (HEXA HYDRO FURO<br>[2,3-B] FURAN-3-OL)	1.61 kg
		2	METHYLENE DI CHLORIDE	5.32 kg

Case No.:788/15/82-	Case No.:788/15/82-	Party Name:MANKIND	Party Name:MANKIND	Meet No/Date:13/82-	Status: Deferred
<br> <br>AL<br>HQ<br>:01<br>De	<br>C4/2018	<br>P	<br>HARMA LTD	<br>ALC4/2019<br>31.01.2020
	File	R	LA File	Lic.No/Date:0510409149	Defer Date:
	<br>/82/050/02245/AM19/	<br>:	<br>05/24/040/00552/AM19/	<br>02.01.2019
	cision:Deferred for commen		ts of TE.

Case No.:792/15/82-ALC4/2018	Party Name:BIOLOGICAL E	Meet No/Date:13/82-	Status:
	LTD	ALC4/2019	Withdrawn
		31.01.2020
HQ File :01/82/050/02249/AM19/	RLA File	Lic.No/Date:0910067026
	:09/24/040/00479/AM19/	03.01.2019

191 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 11/82-ALC4/2019 dated 03.01.2020.

, the Committee decided to withdraw the case.

rved that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 11/82-ALC4/2019 dated 03.01.2020.

, the Committee decided to withdraw the case.

Case No.:798/15/82-ALC4/2018	Party Name:NEULAND	Meet No/Date:13/82-	Status:
	LABORATORIES LTD	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/02255/AM19/	RLA File	Lic.No/Date:0910067032
	:09/24/040/00488/AM19/	04.01.2019

Export product	Qty.	Sl.	Import items	Qty.
		No.
3-alpha-hydroxy-7-oxo-5-beta-	1 kg	1	CHOLIC ACID	1.705 kg
cholan-24-oic Acid
(ChenodeoxycholicAcidKetone)


193	<br>Ca<br>HQ	se No.:1072/15/82-ALC4/2018	Party Name:MALLADI DRUG<br>	S	Meet No/Date:13/82-<br>		Status:<br>
			& PHARMACEUTICALS<br>LIMITED		ALC4/2019<br>31.01.2020<br>		Deferred<br>
								e:
		File :01/82/050/02529/AM19/	RLA File<br>:04/24/040/00218/AM19/		Lic.No/Date:0410165<br>04.01.2019	065	Defer Dat
	Decision:Deferred for comments of TE.

d** || |||||||||e:| |||File :01/82/050/02529/AM19/|RLA File :04/24/040/00218/AM19/||Lic.No/Date:0410165 04.01.2019|065|Defer Dat|| ||**Decision:**Deferred for comments of TE.||||||||

Case No.:109/15/82-	Party Name:U SQUARE	Meet No/Date:13/82-	Status: Deferred
ALC4/2018	LIFESCIENCE PRIVATE	ALC4/2019
	LIMITED	31.01.2020
HQ File	RLA File	Lic.No/Date:0810144243	Defer Date:
:01/82/050/01566/AM19/	:08/24/040/00329/AM19/	07.01.2019

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

(i) COA of import item from foreign supplier for the import made against present Advance Authorization alonwith copy of USP.

Case No.:805/15/82-ALC4/2018	Party Name:DEEPAK	Meet No/Date:13/82-	Status:
	NOVOCHEM TECHNOLOGIES	ALC4/2019	Deferred
	LTD	31.01.2020
HQ File :01/82/050/02262/AM19/	RLA File	Lic.No/Date:3110067278	Defer Date:
	: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 195 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 :

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

ing No. 9/82-ALC4/2019 dated 18.10.2019 , followed by Reminder on 09.12.2019 :

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

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

Case No.:144/1/82-ALC4/2019	Party Name:VIRCHOW	Meet No/Date:13/82-	Status:
	BIOTECH PVT LTD.,	ALC4/2019	Approved
		31.01.2020
HQ File	RLA File	Lic.No/Date:0910067053
:01/82/050/02539/AM19/	:09/24/040/00484/AM19/	09.01.2019

Decision:The Committee considered the cases	Decision:The Committee considered the cases	Decision:The Committee considered the cases	Decision:The Committee considered the cases
no.9/82-ALC4/2017 dated 27.12.2017, it was decided to ratify norms under Para 4.7 of HBP v1 as per details
given below or as applied by the firm, whichever is less:
	Export product	Qty.	Sl.

/2017 dated 27.12.2017**, it was decided to ratify norms under Para 4.7 of HBP v1 as per details||||||| |||given below or as applied by the firm, whichever is less:||||||| ||||Export product|Qty.|Sl. No.|Import items|Qty.|| ||||TODAY|1 Number|1|NONOXYNOL-9|0.9983 gm|| ||||CONTRACEPTIVE||2|SORBIC ACID|0.0061 gm|| ||||SPONGE||3|PREPOL HDW-2002|2.4030 gm|| |196|||||4|SODIUM METABISULFITE|0.0015 gm|| |||||||GRANULAR||| ||||||5|SODIUM HYDROXIDE NF|0.0015 gm|| ||||||6|BENZOIC ACID USP|0.0031 gtm|| ||||||7|CITRIC ACID USP|0.0141 gm|| ||||||8|TAPE REMOVAL|0.2457 yards|| ||||||9|ANCHORING SCRIM|0.0864 yards|| ||||||10|MOULD CUPS BOTTOM|0.0039 Nos.|| ||||||11|MOULD CUPS-TOP|0.0039 Nos.|| ||||||12|POUCH-TOP WEB|0.0233 yards|| ||||||13|POUCH-BOTTOM WEB|0.0233 yards|| ||||||14|TDI INDICATORS|0.0769 per thousand units|| |||RA concerned maytake further necessaryaction asper above decision of NC.|||||||

197	Case No.:123/15/82-ALC4/2018	Party Name:REYAANSH<br>HEALTHCARE<br>RLA File<br>:03/95/040/01019/AM19/	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
	<br>HQ File :01/82/050/01580/AM19/		Lic.No/Date:0310826282<br>10.01.2019	Defer Date:
	<br>Decision:The Committee considered the case as per agenda in the presence of technical experts and it was<br>decided to call for following information:<br>(i)<br>Number of pipettes in each carton.<br>(ii) Drug Manufacturing license(DML) of the exportproduct.

experts and it was decided to call for following information: (i) Number of pipettes in each carton. (ii) Drug Manufacturing license(DML) of the exportproduct.||||

Case No.:811/15/82-ALC4/2018 Party Name:ATUL LIMITED, Meet No/Date:13/82- Status: ALC4/2019 Deferred 31.01.2020 198 HQ File :01/82/050/02268/AM19/ RLA File Lic.No/Date:0810144290 Defer Date: :08/24/040/00328/AM19/ 10.01.2019 Decision: The Committee considered the case as per agenda and it was noted that the firm vide its e-mail dated 11.11.2019 has furnished its reply. Deferred for comments of TE.

199	Case No.:812/15/82-ALC4/2018	Party Name:BALAJI AMINES<br>LIMITED<br>RLA File<br>:31/83/040/00158/AM19/	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
	<br>HQ File :01/82/050/02269/AM19/		Lic.No/Date:3110067279<br>10.01.2019	Defer Date:
	Decision:The Committee considered the case as per agenda and it<br>13.12.2019 has furnished its reply. Deferred for comments of TE.		was noted that the firm vide its e-mail dated

Case No.:815/15/82-ALC4/2018	Party Name:ELPPE	Meet No/Date:13/82-	Status:
	CHEMICALS PRIVATE	ALC4/2019	Approved
	LIMITED	31.01.2020
HQ File	RLA File	Lic.No/Date:0310826358
:01/82/050/02272/AM19/	:03/94/040/00889/AM19/	14.01.2019

-|---|---|---| |||CHEMICALS PRIVATE||ALC4/2019||Approved| |||LIMITED||31.01.2020||| |HQ File||RLA File||Lic.No/Date:0310826358||| |:01/82/050/02272/AM19/||:03/94/040/00889/AM19/||14.01.2019|||

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 39/82-ALC4/2010 dated 28.12.2010, it was decided to ratify norms under Para 4.7 of HBP v1 as per details 200 given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
NICLOSAMIDE<br>PIPERAZINE SALT	1 kg	1	SALICYLIC ACID	0.65 kg
		2	TRIETHYL AMINE	0.26 kg
		3	PIPERAZINE ANHYDROUS	0.13 kg

	Case No.:820/15/82-ALC4/2018	Party Name:AURORE LIFE	Meet No/Date:13/82-	Status:
		SCIENCES PRIVATE LIMITED	ALC4/2019	Deferred
			31.01.2020
201	HQ File :01/82/050/02277/AM19/	RLA File	Lic.No/Date:0910067061	Defer Date:
		:09/24/040/00508/AM19/	16.01.2019
	Decision:Deferred for comments of TE.

	Case No.:1026/15/82-ALC4/2018	Party Name:ANLON	Meet No/Date:13/82-	Status:
		HEALTHCARE	ALC4/2019	Deferred
		PRIVATELIMITED	31.01.2020
202	HQ File :01/82/050/02483/AM19/	RLA File	Lic.No/Date:2410042628	Defer Date:
		:24/24/040/00049/AM19/	16.01.2019
	Decision:Deferred for comments of TE.

	Case No.:829/15/82-ALC4/2018	Party Name:AUROBINDO	Meet No/Date:13/82-	Status:

24/24/040/00049/AM19/||16.01.2019|||| ||||**Decision:**Deferred for comments of TE.|||||||| |||||||||||| ||||Case No.:829/15/82-ALC4/2018||Party Name:AUROBINDO||Meet No/Date:13/82-||Status:|| ||||||PHARMA LIMITED||ALC4/2019||Deferred|| ||||||||31.01.2020|||| ||203||HQ File :01/82/050/02286/AM19/||RLA File||Lic.No/Date:0910067071||Defer Date:|| ||||||:09/24/040/00499/AM19/||18.01.2019|||| ||||**Decision:**Deferred for comments of TE.|||||||| ||||||||||||

	Case No.:830/15/82-<br>Party Name:R CHEM	Case No.:830/15/82-<br>Party Name:R CHEM	Meet No/Date:13/82-	Status: Deferred	Status: Deferred
	ALC4/2018	<br>(SOMANAHALLI) PVT.LTD,	ALC4/2019
			31.01.2020
	HQ File	RLA File	Lic.No/Date:0910067074	Defer	Date:
204	:01/82/050/02287/AM19/<br>:09/24/040/00516/AM19/<br>18.01.2019<br>Decision:The Committee considered the case as per agenda and it was decided to call for following information
	from the firm:
		(i)<br>Complete chemical name of the Export Product.
		(ii) Complete technical details asper Appendix 4E.

	Case No.:837/15/82-ALC4/2018Party Name:DANOPHARM		Meet No/Date:13/82-		Status:
		CHEMICALS PRIVATE LTD.<br>ALC4/2019			Deferred
			31.01.2020
205	HQ File :01/82/050/02294/AM19/ RLA File		Lic.No/Date:0310826539		Defer Date:
		:03/94/040/00886/AM19/	22.01.2019

E LTD. ALC4/2019||||||Deferred|| |||||||31.01.2020|||||| ||205||HQ File :01/82/050/02294/AM19/ RLA File|||Lic.No/Date:0310826539||||Defer Date:|| |||||:03/94/040/00886/AM19/||22.01.2019|||||| ||||Decision:|Deferred for comments of TE.|||||||| |||||||||||||

206	<br>Case No.:842/15/82-ALC4/2018	Party Name:S.M. HERBALS<br>PVT.LTD.	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred<br>Defer Date:
	<br>HQ File :01/82/050/02299/AM19/	RLA File<br>:05/24/040/00602/AM19/	Lic.No/Date:0510409465<br>24.01.2019
	Decision:Deferred for comments of TE.

207	Case No.:845/15/82-ALC4/2018	Party Name:J.B. CHEMICALS &<br>PHARMACEUTICALS<br>LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred<br>Defer Date:
	HQ File :01/82/050/02302/AM19/	RLA File<br>:03/94/040/00925/AM19/	Lic.No/Date:0310826640<br>25.01.2019
	<br>The Committee considered the case as per online agenda in the presence of technical experts and it was noted that<br>the firm still has not furnished the following information asked for by NC-3 in its Meeting No.7/82-ALC4/2019<br>dated 06.09.2019, followed by Reminder on31.10.2019:<br>(i)<br>Drug Manufacturing License (DML).<br>In view of above, the Committee decided to issueFinal Reminder to firm to furnish its reply, failing which the<br>case will be rejected.

(i) Drug Manufacturing License (DML). In view of above, the Committee decided to issueFinal Reminder to firm to furnish its reply, failing which the case will be rejected.||||

Case No.:848/15/82-ALC4/2018	Party Name:VIVIMED LIFE	Meet No/Date:13/82-	Status:
	SCIENCES PRIVATE LIMITED	ALC4/2019	Deferred
		31.01.2020
HQ File :01/82/050/02305/AM19/	RLA File	Lic.No/Date:0910067112	Defer Date:
	:09/24/040/00505/AM19/	28.01.2019

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

(i) Copy of Master Batch Formula duly authenticated by Quality Control Incharge for each export item showing the net weight of each input in the export items. (ii) Drug Manufacturing license (DML) of the export product.

Case No.:851/15/82-ALC4/2018	Party Name:SI GROUP - INDIA	Meet No/Date:13/82-	Status:
	PRIVATE LIMITED	ALC4/2019	Deferred
		31.01.2020
HQ File :01/82/050/02308/AM19/	RLA File	Lic.No/Date:0310826724	Defer Date:
	:03/95/040/01108/AM19/	30.01.2019

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

(i) Complete chemical reaction from raw material acetone to 3,3,5TRIMETHYLCYCLOHEXANONE showing molecular weights of each component with percentage yield on molar basis at each step of the reaction.

lete chemical reaction from raw material acetone to 3,3,5TRIMETHYLCYCLOHEXANONE showing molecular weights of each component with percentage yield on molar basis at each step of the reaction.**

	Case No.:853/15/82-ALC4/2018	Party Name:ALPHAMED		Meet No/Date:13/82-		Status:
		FORMULATIONS P LTD.		ALC4/2019		Deferred
				31.01.2020
210	HQ File :01/82/050/02310/AM19/	RLA File		Lic.No/Date:0910067120		Defer Date:
		:09/24/040/00511/AM19/		31.01.2019
	Decision:Deferred for comments of TE.

	Case No.:855/15/82-ALC4/2018	Party Name:SMS		Meet No/Date:13/82-		Status:
		LIFESCIENCES INDIA		ALC4/2019		Deferred
		LIMITED		31.01.2020
	HQ File :01/82/050/02312/AM19/	RLA File		Lic.No/Date:0910067122		Defer Date:
		:09/24/040/00542/AM19/		31.01.2019
	Decision:The Committee noted that the 4.07 application of		subject Advance Authorization is		not available.
211	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.
	Further, the Committee considered the case		as per agenda and it was decided to call for
	following information from the firm:
	(i)<br> Complete chemical name of the Export Product.
	(ii)<br>Complete technical details asper Appendix 4E.

information from the firm:|||||||| ||||(i) Complete chemical name of the Export Product.|||||||| ||||(ii) Complete technical details asper Appendix 4E.|||||||| ||||||||||||

	Case No.:861/15/82-ALC4/2018	Party Name:INNOVARE LABS	Meet No/Date:13/82-		Status:
		PRIVATE LIMITED	ALC4/2019		Deferred
			31.01.2020
212	HQ File :01/82/050/02318/AM19/	RLA File<br>:09/24/040/00535/AM19/	Lic.No/Date:0910067125<br>01.02.2019		Defer Date:
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is			not available.
	Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the
	firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

	Case No.:863/15/82-ALC4/2018Party Name:JAYANT AGRO		Meet No/Date:13/82-	Status:
	ORGANICS LTD.,		ALC4/2019	Deferred
			31.01.2020
213	HQ File :01/82/050/02320/AM19/ RLA File		Lic.No/Date:0310826798	Defer Date:
	:03/94/040/00948/AM19/		04.02.2019
	Decision:The Committee considered the case as per agenda and it	was noted that the firm vide its e-mail dated
	08.11.2019 has furnished its reply. Deferred for comments of TE.

*The Committee considered the case as per agenda and it|was noted that the firm vide its e-mail dated||||| |||08.11.2019 has furnished its reply. Deferred for comments of TE.|||||| |||||||||

	Case No.:864/15/82-ALC4/2018Party Name:J.B. CHEMICALS &	Case No.:864/15/82-ALC4/2018Party Name:J.B. CHEMICALS &	Meet No/Date:13/82-		Status:
	PHARMACEUTICALS		ALC4/2019		Deferred
	LIMITED		31.01.2020
214	HQ File :01/82/050/02321/AM19/ RLA File		Lic.No/Date:0310826799		Defer Date:
	:03/94/040/00944/AM19/		04.02.2019
	Decision:Deferred for comments of TE.

	Case No.:870/15/82-ALC4/2018Party Name:SHREE BANKEY		Meet No/Date:13/82-		Status:
	BEHARI LAL FLAVORS		ALC4/2019		Approved
			31.01.2020
	HQ File :01/82/050/02327/AM19/ RLA File		Lic.No/Date:0510409585
	:05/24/040/00623/AM19/		05.02.2019
	Decision:The Committee considered case as per agenda in the presence of the technical			experts and it		was
215	decided to ratify the ad-hoc input output norms under para 4.7<br>whichever is lower:	of HBP as per details below or		as applied by firm
	Export product<br>Qty.<br>Sl.	Import items		Qty.
	No.
	CINNAMALDEHYDE/CINNAMIC<br>58.182 MT<br>1	BENZALDEHYDE ABOVE		63.1 MT
	ALDEHYDE	98.5%	PURE
	RA concerned maytake further necessaryaction asper above decision of NC.

HYDE/CINNAMIC 58.182 MT 1|BENZALDEHYDE ABOVE|||63.1 MT||||| ||||ALDEHYDE|98.5%||PURE|||||| ||||RA concerned maytake further necessaryaction asper above decision of NC.||||||||| |||||||||||||

	Case No.:873/15/82-ALC4/2018	Party Name:CADILA	Meet No/Date:13/82-	Status:
		HEALTHCARE LTD	ALC4/2019	Deferred
			31.01.2020
216	HQ File :01/82/050/02330/AM19/	RLA File	Lic.No/Date:0810144496	Defer Date:
		:08/24/040/00379/AM19/	05.02.2019
	Decision:Deferred for comments of TE.

	Case No.:874/15/82-ALC4/2018	Party Name:CADILA	Meet No/Date:13/82-	Status:
		HEALTHCARE LTD	ALC4/2019	Deferred
			31.01.2020
217	HQ File :01/82/050/02331/AM19/	RLA File	Lic.No/Date:0810144497	Defer Date:
		:08/24/040/00372/AM19/	05.02.2019
	Decision:Deferred for comments of TE.

Case No.:876/15/82-ALC4/2018	Party Name:MOREPEN	Meet No/Date:13/82-	Status:
	LABORATORIES LTD.,	ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/02333/AM19/	RLA File	Lic.No/Date:0510409596
	:05/24/040/00634/AM19/	05.02.2019

--|---|---|---|---| |||LABORATORIES LTD.,||ALC4/2019||Approved| |||||31.01.2020||| |HQ File :01/82/050/02333/AM19/||RLA File||Lic.No/Date:0510409596||| |||:05/24/040/00634/AM19/||05.02.2019|||

	Case No.:876/15/82-ALC4/2018	Party Name:MOREPEN<br>LABORATORIES LTD.,	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Approved
	HQ File :01/82/050/02333/AM19/	RLA File<br>:05/24/040/00634/AM19/	Lic.No/Date:0510409596<br>05.02.2019
218	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm<br>whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Empagliflozin<br>1 kg<br>1<br>(3S)-3-(4-[(2-chloro-5-iodophenyl)<br>methyl]<br>phenoxy)tetrahydrofuran<br>(EG01)<br>/<br>(3S)-3-(4-(2-chloro-5-<br>iodobenzyl)phenoxy)tetrahydrofuran (EG01)/(S)-3-(4-<br>(2-Chloro-5-iodobenzyl)phenoxy) tetrahydrofuran<br>2.04 kg<br>2<br>2,3,4,6-tetra-O-trimethyl silyl-beta-D-glucolactone (<br>EGS01)<br>/<br>2,3,4,5-Tetrakis-O-Trimethylsilyl-D-<br>Gluconolactone<br>2.53 kg<br>3<br>Acetonitrile<br>2.16 kg<br>4<br>Methylene chloride<br>3.25 kg<br>5<br>Toluene<br>1.525 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

lactone 2.53 kg 3 Acetonitrile 2.16 kg 4 Methylene chloride 3.25 kg 5 Toluene 1.525 kg RA concerned maytake further necessaryaction asper above decision of NC.||||

219	<br>Case No.:1027/15/82-ALC4/2018	Party Name:ANLON<br>HEALTHCARE<br>PRIVATELIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:2410042653<br>05.02.2019	Status:<br>Deferred<br>Defer Date:
	<br>HQ File :01/82/050/02484/AM19/	RLA File<br>:24/24/040/00053/AM19/
	Decision:Deferred for comments of TE.

220	Case No.:880/15/82-ALC4/2018	Party Name:DEEPAK<br>NOVOCHEM TECHNOLOGIES<br>LTD	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred
	HQ File :01/82/050/02337/AM19/	RLA File<br>:31/83/040/00162/AM19/	Lic.No/Date:3110067309<br>06.02.2019	Defer Date:
	<br>Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not available.<br>Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the<br>firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.<br>Further, the Committee considered the case as per agenda and it was decided to call for<br>following information from the firm:<br>(i)<br>Exact chemical name of the exportproduct.

Further, the Committee considered the case as per agenda and it was decided to call for following information from the firm: (i) Exact chemical name of the exportproduct.||||

221	Case No.:881/15/82-ALC4/2018	Party Name:SHILPA<br>MEDICARE LIMITED	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred<br>Defer Date:
	<br>HQ File :01/82/050/02338/AM19/	RLA File<br>:07/24/040/00263/AM19/	Lic.No/Date:0710114519<br>07.02.2019
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not available.<br>Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the<br>firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

222	Case No.:883/15/82-ALC4/2018	Party Name:MAHESHRAJ<br>CHEMICALS PVT.LTD	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred<br>Defer Date:
	<br>HQ File :01/82/050/02340/AM19/	RLA File<br>:08/24/040/00374/AM19/	Lic.No/Date:0810144562<br>08.02.2019
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not available.<br>Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the<br>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 directly from the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.||||

223	<br>Case No.:885/15/82-ALC4/2018	Party Name:ORTIN<br>LABORATORIES LTD<br>RLA File<br>:09/24/040/00538/AM19/	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br> <br><br>Lic.No/Date:0910067148<br>08.02.2019<br>	Status:<br>Deferred
	<br>HQ File :01/82/050/02342/AM19/			Defer Date:
	Decision:Deferred for comments of TE.

224	<br>Case No.:887/15/82-ALC4/2018	Party Name:ENAL DRUGS PVT<br>LTD.,	Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020	Status:<br>Deferred<br>Defer Date:
	<br>HQ File :01/82/050/02344/AM19/	RLA File<br>:09/24/040/00543/AM19/	Lic.No/Date:0910067153<br>08.02.2019
	Decision:Deferred for comments of TE.

Case No.:888/15/82-	Party Name:ASTRAL	Meet No/Date:13/82-	Status:
ALC4/2018	STERITECH PVT. LTD.	ALC4/2019	Approved
		31.01.2020
HQ File	RLA File	Lic.No/Date:3410044867
:01/82/050/02345/AM19/	:34/24/040/00333/AM19/	08.02.2019

-|---| |ALC4/2018||STERITECH PVT. LTD.||ALC4/2019||Approved| |||||31.01.2020||| |HQ File||RLA File||Lic.No/Date:3410044867||| |:01/82/050/02345/AM19/||:34/24/040/00333/AM19/||08.02.2019|||

	Decision:The Committee considered the cases as	Decision:The Committee considered the cases as	Decision:The Committee considered the cases as	Decision:The Committee considered the cases as	per agenda and in the light of earlier decision taken in	per agenda and in the light of earlier decision taken in	per agenda and in the light of earlier decision taken in
	meeting no. 1/82-ALC4/2018 dated 01.05.2018, it was				decided to ratify norms under Para	4.7 of HBP v1 as	per
	details given below or as applied by the firm, whichever is less:
		Export Product	Qty.	Sl.	Import items	Qty.
				No.
		CEFEPIME FOR	1 Number	1.	STERILE CEFEPIME(A Sterile	1.8975 gm/vial
		INJECTION USP, 1 gram			Mixture<br>of<br>Cefepime
225		injection			Hydrochloride & L Arginine)<br>(Cefepime<br>Content<br>NLT
					47.00% and NMT 60.00%) L-
					Arginine Content NLT 32.00%
					NMT 42.00%
				2	RUBBER STOPPER C1476720	Relevant as per
					GC 6 TP 20 MM INJECTION	packing policy
					STOPPER BROMO BUTYL
					GREY<br>ULTRA<br>CLEAN
					6 WASHING WITH HIGHLY
					PURIFIED WATER RINSED
					WITH<br>WFI<br>READY<br>TO
					STERILIZE TYVEK BAGS
					(AS PER GENERAL NOTES)

|||GREY ULTRA CLEAN|||| |||||||6 WASHING WITH HIGHLY|||| |||||||PURIFIED WATER RINSED|||| |||||||WITH WFI READY TO|||| |||||||STERILIZE TYVEK BAGS|||| |||||||(AS PER GENERAL NOTES)|||| |||RA concerned maytake further necessaryaction asper above decision of NC.||||||||

Case No.:891/15/82-ALC4/2018	Party Name:GELTEC PRIVATE	Meet No/Date:13/82-	Status:
	LIMITED	ALC4/2019	Deferred
		31.01.2020
HQ File :01/82/050/02348/AM19/	RLA File	Lic.No/Date:0310826970	Defer Date:
	:03/94/040/00970/AM19/	11.02.2019

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 as asked for by NC-3 in its Meeting No. 226 7/82-ALC4/2019 dated 06.09.2019 , followed by Reminder on 31.10.2019 :

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.:894/15/82-	Party Name:DEEPAK	Meet No/Date:13/82-	Status: Deferred
ALC4/2018	PHENOLICS LIMITED	ALC4/2019
		31.01.2020
HQ File	RLA File	Lic.No/Date:3410044883	Defer Date:
:01/82/050/02351/AM19/	:34/24/040/00328/AM19/	12.02.2019

|---|---| |ALC4/2018||PHENOLICS LIMITED||ALC4/2019||| |||||31.01.2020||| |HQ File||RLA File||Lic.No/Date:3410044883||Defer Date:| |:01/82/050/02351/AM19/||:34/24/040/00328/AM19/||12.02.2019|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it 227 was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 9/82-ALC4/2019 dated 18.10.2019 , followed by Reminder on 09.12.2019 :

(i) Percentage yield on molar basis.

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

Case No.:899/15/82-ALC4/2018	Party Name:ATUL LIMITED,	Meet No/Date:13/82-	Status:
		ALC4/2019	Approved
		31.01.2020
HQ File :01/82/050/02356/AM19/	RLA File	Lic.No/Date:0810144581
	:08/24/040/00371/AM19/	12.02.2019

228

|Export product|Qty.|Sl.<br>No.|Import items|Qty.|
|---|---|---|---|---|
|Lapox ARD 54 (Diglycidyl<br>ether of polypropylene<br>glycol)|120000.000 kg|1|Poly Propylene Glycol | PPG-425 |<br>Konix PP 400 | Wanol C 2004 |<br>Exacol PPG 425|95256.00 kg|
|||2|Epichlorohydrin|41400.00 kg|

ycidyl ether of polypropylene glycol)|120000.000 kg|1|Poly Propylene Glycol | PPG-425 | Konix PP 400 | Wanol C 2004 | Exacol PPG 425|95256.00 kg| |||2|Epichlorohydrin|41400.00 kg|





|229|<br>**Case No.:896/15/82-ALC4/2018**|Party Name:AUROBINDO<br>PHARMA LIMITED|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Deferred**|
|---|---|---|---|---|
||<br>HQ File :01/82/050/02353/AM19/|RLA File<br>:09/24/040/00555/AM19/|Lic.No/Date:0910067168<br>13.02.2019|Defer Date:|
||**Decision:**Deferred for comments of TE.||||



66 

|**Case No.:902/15/82-ALC4/2018**||Party Name:INNOVARE LABS||Meet No/Date:13/82-||**Status:**|
|---|---|---|---|---|---|---|
|||PRIVATE LIMITED||ALC4/2019||**Approved**|
|||||31.01.2020|||
|HQ File :01/82/050/02359/AM19/||RLA File||Lic.No/Date:0910067173|||
|||:09/24/040/00549/AM19/||14.02.2019|||



|||**Case No.:902/15/82-ALC4/2018**Party Name:INNOVARE LABS<br>PRIVATE LIMITED<br>Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>**Status:**<br>**Approved**<br>HQ File :01/82/050/02359/AM19/  RLA File<br>:09/24/040/00549/AM19/<br>Lic.No/Date:0910067173<br>14.02.2019|**Case No.:902/15/82-ALC4/2018**Party Name:INNOVARE LABS<br>PRIVATE LIMITED<br>Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>**Status:**<br>**Approved**<br>HQ File :01/82/050/02359/AM19/  RLA File<br>:09/24/040/00549/AM19/<br>Lic.No/Date:0910067173<br>14.02.2019|**Case No.:902/15/82-ALC4/2018**Party Name:INNOVARE LABS<br>PRIVATE LIMITED<br>Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>**Status:**<br>**Approved**<br>HQ File :01/82/050/02359/AM19/  RLA File<br>

se No.:902/15/82-ALC4/2018**Party Name:INNOVARE LABS<br>PRIVATE LIMITED<br>Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>**Status:**<br>**Approved**<br>HQ File :01/82/050/02359/AM19/  RLA File<br>:09/24/040/00549/AM19/<br>Lic.No/Date:0910067173<br>14.02.2019|**Case No.:902/15/82-ALC4/2018**Party Name:INNOVARE LABS<br>PRIVATE LIMITED<br>Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>**Status:**<br>**Approved**<br>HQ File :01/82/050/02359/AM19/  RLA File<br>:09/24/040/00549/AM19/<br>Lic.No/Date:0910067173<br>14.02.2019|**Case No.:902/15/82-ALC4/2018**Party Name:INNOVARE LABS<br>PRIVATE LIMITED<br>Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>**Status:**<br>**Approved**<br>HQ File :01/82/050/02359/AM19/  RLA File<br>:09/24/040/00549/AM19/<br>Lic.No/Date:0910067173<br>14.02.2019|**Case No.:902/15/82-ALC4/2018**Party Name:INNOVARE LABS<br>PRIVATE LIMITED<br>Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>**Status:**<br>**Approved**<br>HQ File :01/82/050/02359/AM19/  RLA File<br>:09/24/040/00549/AM19/<br>Lic.No/Date:0910067173<br>14.02.2019|**Case No.:902/15/82-ALC4/2018**Party Name:INNOVARE LABS<br>PRIVATE LIMITED<br>Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>**Status:**<br>**Approved**<br>HQ File :01/82/050/02359/AM19/  RLA File<br>:09/24/040/00549/AM19/<br>Lic.No/Date:0910067173<br>14.02.2019|
|---|---|---|---|---|---|---|---|---|
|||**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting|||||||
|||no.

te:0910067173<br>14.02.2019|
|---|---|---|---|---|---|---|---|---|
|||**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting|||||||
|||no. 2/82-ALC4/2018 dated 16.05.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details|||||||
|||given below or as applied by||the firm, whichever is less:|||||
|230|||||||||
||||Export product|Qty.|Sl.|Import items|Qty.||
||||||No.||||
||||LEVETIRACETAM|1 kg|1|(S)-2-Amino Butyramide hydrochloride or|0.95 kg||
|||||||S(+)-2-Amino Butyramide hydrochloride|||
||||||2|Dichloromethane or Methylene Chloride|2.26 kg||
||||||3|Potassium hydroxide|1.15 kg||
||||||4|Ethyl acetate|0.86 kg||
||||||5|Carbon|0.0128 kg||
|||RA concerned maytake further necessaryaction asper above decision of NC.|||||||



||**Case No.:903/15/82-ALC4/2018**||Party Name:MATRIX FINE||Meet No/Date:13/82-||**Status:**||
|---|---|---|---|---|---|---|---|---|
||||SCIENCES PVT.LTD.,||ALC4/2019||**Deferred**||
||||||31.01.2020||||
|231|HQ File :01/82/050/02360/AM19/||RLA File||Lic.No/Date:0310827030||Defer Date:||
||||:03/95/040/01113/AM19/||14.02.2019||||
||**Decision:**Deferred for comments of TE.||||||||
||||||||||
||**Case No.:905/15/82-ALC4/2018**||Party Name:JODAS EXPOIM||Meet No/Date:13/82-||**Status:**||
||||PVT.LTD||ALC4/2019||**Deferred**||
||||||31.01.2020||||
|232|HQ File :01/82/050/02362/AM19/||RLA File<br>:05/23/040/00508/AM19/||Lic.No/Date:0510409675<br>15.02.2019||Defer Date:||

|**Status:**||
||||PVT.LTD||ALC4/2019||**Deferred**||
||||||31.01.2020||||
|232|HQ File :01/82/050/02362/AM19/||RLA File<br>:05/23/040/00508/AM19/||Lic.No/Date:0510409675<br>15.02.2019||Defer Date:||
||**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is|||||not available.|||
||Hence, it was decided to call for a|copy of 4.07 application of the subject advance authorization directly from the|||||||
||firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.||||||||
||||||||||



|||**Case No.:906/15/82-**<br>Party Name:JODAS EXPOIM||Meet No/Date:13/82-||**Status:  Deferred**||
|---|---|---|---|---|---|---|---|
|||**ALC4/2018**<br>PVT.LTD||ALC4/2019||||
|||||31.01.2020||||
|233||HQ File<br>:01/82/050/02363/AM19/<br>RLA File<br>:05/23/040/00507/AM19/||Lic.No/Date:0510409676<br>15.02.2019||Defer Date:||
|||**Decision:**The Committee noted that the 4.07 application of|subject Advance Authorization is not available.|||||
|||Hence, it was decided to call for a copy of 4.07 application of the||subject advance authorization directly from the||||
|||firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.||||||
|||||||||



67

it was decided to call for a copy of 4.07 application of the||subject advance authorization directly from the||||
|||firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.||||||
|||||||||



67 

|234|<br>**Case No.:907/15/82-ALC4/2018**|Party Name:AURORE LIFE<br>SCIENCES PRIVATE LIMITED|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Deferred**|
|---|---|---|---|---|
||<br>HQ File :01/82/050/02364/AM19/|RLA File<br>:09/24/040/00515/AM19/|Lic.No/Date:0910067181<br>15.02.2019|Defer Date:|
||**Decision:**Deferred for comments of TE.||||
||||||
|235|<br>**Case No.:916/15/82-ALC4/2018**|Party Name:OPTIMUS DRUGS<br>PRIVATE LIMITED|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Deferred**|
||<br>HQ File :01/82/050/02373/AM19/|RLA File<br>:09/24/040/00569/AM19/|Lic.No/Date:0910067192<br>20.02.2019|Defer Date:|
||**Decision:**Deferred for comments of TE.||||
||||||
|236|<br>**Case No.:919/15/82-ALC4/2018**|Party Name:ORTIN<br>LABORATORIES LTD|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Deferred**|
||<br>HQ File :01/82/050/02376/AM19/|RLA File<br>:09/24/040/00573/AM19/|Lic.No/Date:0910067198<br>21.02.2019|Defer Date:|
||**Decision:**Deferred for comments of TE.||||
||||||
|237|<br>**Case No.:922/15/82-ALC4/2018**|Party Name:GLOBE TROTTERS<br>PVT LTD|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Deferred**|
||<br>HQ File :01/82/050/02379/AM19/|RLA File<br>:03/94/040/01015/AM19/|Lic.No/Date:0310827201<br>21.02.2019|Defer Date:|
||**Decision:**Deferred for comments of TE.||||
||||||

us:**<br>**Deferred**|
||<br>HQ File :01/82/050/02379/AM19/|RLA File<br>:03/94/040/01015/AM19/|Lic.No/Date:0310827201<br>21.02.2019|Defer Date:|
||**Decision:**Deferred for comments of TE.||||
||||||
|238|<br>**Case No.:924/15/82-ALC4/2018**|Party Name:INDO AMINES<br>LIMITED|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Deferred**|
||<br>HQ File :01/82/050/02381/AM19/|RLA File<br>:03/94/040/00984/AM19/|Lic.No/Date:0310827206<br>21.02.2019|Defer Date:|
||**Decision:**Deferred for comments of TE.||||



68 

|**Case No.:927/15/82-ALC4/2018**||Party Name:SUVEN LIFE||Meet No/Date:13/82-||**Status:**|
|---|---|---|---|---|---|---|
|||SCIENCES LIMITED||ALC4/2019||**Approved**|
|||||31.01.2020|||
|HQ File :01/82/050/02384/AM19/||RLA File||Lic.No/Date:0910067211|||
|||:09/24/040/00580/AM19/||22.02.2019|||



|||**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was|**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was|**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was|**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was|**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was|**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was|**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was|

mmittee considered case as per agenda in the presence of the technical experts and it was|**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:|||||||
|239|||Export product|Qty.|Sl.|Import items|Qty.||
||||||No.||||
||||1-[2-[5-METHYL-3-|1 kg|1|4-CYANO PYRIDINE|0.524 kg||
||||(TRIFLUOROMETHYL)-1H-||2|TERTIARY BUTANOL|0.488 kg||
||||PYRAZOL-1-||3|N,N-DIMETHYL FORMAMIDE|2.89 kg||
||||YL]ACETYL]PIPERIDINE-4-||4|ETHYL TRIFLUORO ACETATE|0.708 kg||
||||CARBOTHIOAMIDE||5|ACETONE|0.315 kg||
||||||6|HYDRAZINE HYDRATE (80%)|0.398 kg||
||||||7|METHYL TERTIARY BUTYL ETHER|2.88 kg||
|||RA concerned maytake further necessaryaction asper above decision of NC.|||||||



|||**Case No.:929/15/82-**|Party Name:THINQ PHARMA-||Meet No/Date:13/82-||**Status:  Deferred**|
|---|---|---|---|---|---|---|---|
|||**ALC4/2018**|CRO LIMITED||ALC4/2019|||
||||||31.01.2020|||
|240||HQ File<br>:01/82/050/02386/AM19/|RLA File<br>:03/95/040/01186/AM19/||Lic.No/Date:0310827227<br>22.02.2019||Defer Date:|
|||**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not available.||||||
|||Hence, it was decided to call for a copy of 4.07 application of the||subject advance authorization directly from the||||
|||firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.||||||

||||
|||Hence, it was decided to call for a copy of 4.07 application of the||subject advance authorization directly from the||||
|||firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.||||||



|**Case No.:931/15/82-ALC4/2018**||Party Name:MEHK||Meet No/Date:13/82-||**Status:**|
|---|---|---|---|---|---|---|
|||CHEMICALS PVT. LTD.||ALC4/2019||**Deferred**|
|||||31.01.2020|||
|HQ File :01/82/050/02388/AM19/||RLA File||Lic.No/Date:0310827242||Defer Date:|
|||:03/95/040/01227/AM19/||22.02.2019|||



**Decision:** The Committee considered the case as per online agenda in the presence of technical experts and it 241 was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. **7/82-ALC4/2019  dated 06.09.2019** , followed by Reminder on **30.10.2019** : 

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

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

69 

|**Case No.:932/15/82-ALC4/2018**||Party Name:MEHK||Meet No/Date:13/82-||**Status:**|
|---|---|---|---|---|---|---|
|||CHEMICALS PVT. LTD.||ALC4/2019||**Deferred**|
|||||31.01.2020|||
|HQ File :01/82/050/02389/AM19/||RLA File||Lic.No/Date:0310827243||Defer Date:|
|||:03/95/040/01209/AM19/||22.02.2019|||

--|---|
|||CHEMICALS PVT. LTD.||ALC4/2019||**Deferred**|
|||||31.01.2020|||
|HQ File :01/82/050/02389/AM19/||RLA File||Lic.No/Date:0310827243||Defer Date:|
|||:03/95/040/01209/AM19/||22.02.2019|||



**Decision:** The Committee considered the case as per online agenda in the presence of technical experts and it 242 was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. **7/82-ALC4/2019  dated 06.09.2019** , followed by Reminder on **30.10.2019** : 

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

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

|243|**Case No.:934/15/82-ALC4/2018**|Party Name:ASTRAL<br>STERITECH PVT. LTD.|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Deferred**|
|---|---|---|---|---|
||<br>HQ File :01/82/050/02391/AM19/|RLA File<br>:34/24/040/00356/AM19/|Lic.No/Date:3410044929<br>22.02.2019|Defer Date:|
||**Decision:**The Committee considered the case as per agenda and it<br>02.08.2019 has furnished its reply.  Deferred for comments of TE.||was noted that the firm vide its e-mail dated||

r Date:|
||**Decision:**The Committee considered the case as per agenda and it<br>02.08.2019 has furnished its reply.  Deferred for comments of TE.||was noted that the firm vide its e-mail dated||



|244|**Case No.:935/15/82-ALC4/2018**|Party Name:ASTRAL<br>STERITECH PVT. LTD.|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Deferred**|
|---|---|---|---|---|
||<br>HQ File :01/82/050/02392/AM19/|RLA File<br>:34/24/040/00355/AM19/|Lic.No/Date:3410044930<br>22.02.2019|Defer Date:|
||**Decision:**The Committee considered the case as per agenda and it w<br>02.08.2019 has furnished its reply.  Deferred for comments of TE.||as noted that the firm vide its|e-mail dated|



|245|<br>**Case No.:936/15/82-ALC4/2018**|Party Name:VISION DRUGS<br>PVT LTD|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Deferred**|
|---|---|---|---|---|
||<br>HQ File :01/82/050/02393/AM19/|RLA File<br>:09/24/040/00575/AM19/|Lic.No/Date:0910067217<br>25.02.2019|Defer Date:|
||**Decision:**Deferred for comments of TE.||||



70 

|**Case No.:941/15/82-**||Party Name:AMANTA||Meet No/Date:13/82-||**Status:**|
|---|---|---|---|---|---|---|
|**ALC4/2018**||HEALTHCARE LIMITED||ALC4/2019||**Approved**|
|||||31.01.2020|||
|HQ File||RLA File||Lic.No/Date:0810144674|||
|:01/82/050/02398/AM19/||:08/24/040/00405/AM19/||25.02.2019|||

--|---|
|**ALC4/2018**||HEALTHCARE LIMITED||ALC4/2019||**Approved**|
|||||31.01.2020|||
|HQ File||RLA File||Lic.No/Date:0810144674|||
|:01/82/050/02398/AM19/||:08/24/040/00405/AM19/||25.02.2019|||



||**Case No.:941/15/82-**<br>**ALC4/2018**|Party Name:AMANTA<br>HEALTHCARE LIMITED|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Approved**|
|---|---|---|---|---|
||HQ File<br>:01/82/050/02398/AM19/|RLA File<br>:08/24/040/00405/AM19/|Lic.No/Date:0810144674<br>25.02.2019||
|246|**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 8/82-ALC4/2018 dated 31.08.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per<br>details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>SODIUM HYALURONATE<br>EYE DROPS 0.2% W/V<br>XAILIN HA<br>(EACH 10ML EYE DROPS<br>CONTANING SODIUM<br>HYALURONATE 20MG +<br>WASTAGE 29.81% = 25.961<br>MG) ( NET CONTENT OF<br>SODIUM HYALURONATE<br>12.00 KGS)<br>1 Number<br>1<br>SODIUM HYALURONATE (HA-<br>EP1)<br>20 mg /<br>10 ml Pack<br>SODIUM HYALURONATE<br>EYE DROPS 0.2% W/V<br>XILIN HA<br>(EACH 10ML EYE DROPS<br>CONTANING SODIUM<br>HYALURONATE 20MG +<br>WASTAGE 29.81% = 25.961<br>MG) ( NET CONTENT OF<br>SODIUM HYALURONATE<br>12.00KGS)<br>1 Number<br>1<br>SODIUM HYALURONATE (HA-<br>EP1)<br>20 mg /<br>10 ml Pack<br>RA concerned maytake further necessaryaction asper above decision of NC.||||

T OF<br>SODIUM HYALURONATE<br>12.00KGS)<br>1 Number<br>1<br>SODIUM HYALURONATE (HA-<br>EP1)<br>20 mg /<br>10 ml Pack<br>RA concerned maytake further necessaryaction asper above decision of NC.||||



|247|**Case No.:1033/15/82-**<br>**ALC4/2018**|Party Name:SRIAM LABS<br>PRIVATE LIMITED|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:  Deferred**|
|---|---|---|---|---|
||HQ File<br>:01/82/050/02490/AM19/|RLA File<br>:09/24/040/00591/AM19/|Lic.No/Date:0910067219<br>26.02.2019|Defer Date:|
||**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not available.<br>Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the<br>firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.||||



71 

|**Case No.:1051/15/82-ALC4/2018**||Party Name:YASHO||Meet No/Date:13/82-||**Status:**|
|---|---|---|---|---|---|---|
|||INDUSTRIES LIMITED||ALC4/2019||**Approved**|
|||||31.01.2020|||
|HQ File :01/82/050/02508/AM19/||RLA File||Lic.No/Date:0310827302|||
|||:03/95/040/01264/AM19/||26.02.2019|||



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

248 

|Export product<br>ISO EUGENYL ACETATE|Qty.|Sl.<br>No.|Import items|Qty.|
|---|---|---|---|---|
||1 kg|1|CRUDE CLOVE LEAF OIL|1.094 kg|
|||2|RUTHENIUM(III) 2,4<br>PENTANEDIONATE(RUTHENIUM<br>ACETYLACETONATE)|0.001 kg|

EUGENYL ACETATE|Qty.|Sl.<br>No.|Import items|Qty.|
|---|---|---|---|---|
||1 kg|1|CRUDE CLOVE LEAF OIL|1.094 kg|
|||2|RUTHENIUM(III) 2,4<br>PENTANEDIONATE(RUTHENIUM<br>ACETYLACETONATE)|0.001 kg|




|249|**Case No.:1038/15/82-**<br>**ALC4/2018**|Party Name:GLAND PHARMA<br>LIMITED|<br>Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:  Deferred**|
|---|---|---|---|---|
||<br>HQ File<br>:01/82/050/02495/AM19/|RLA File<br>:09/24/040/00530/AM19/|Lic.No/Date:0910067224<br>27.02.2019|Defer Date:|
||**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not available.<br>Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the<br>firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.||||



|250|<br>**Case No.:1039/15/82-ALC4/2018**|Party Name:GLAND PHARMA<br>LIMITED|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Deferred**|
|---|---|---|---|---|
||<br>HQ File :01/82/050/02496/AM19/|RLA File<br>:09/24/040/00491/AM19/|Lic.No/Date:0910067225<br>27.02.2019|Defer Date:|
||**Decision:**Deferred for comments of TE.||||



|**Case No.:1041/15/82-**||Party Name:WEXFORD||Meet No/Date:13/82-||**Status:  Deferred**|
|---|---|---|---|---|---|---|
|**ALC4/2018**||LABORATORIES P LTD||ALC4/2019|||
|||||31.01.2020|||
|HQ File||RLA File||Lic.No/Date:0710114597||Defer Date:|
|:01/82/050/02498/AM19/||:07/24/040/00276/AM19/||27.02.2019|||



251 **Decision:** The Committee considered the case as per agenda and it was decided to call for following information from the firm:

01/82/050/02498/AM19/||:07/24/040/00276/AM19/||27.02.2019|||



251 **Decision:** The Committee considered the case as per agenda and it was decided to call for following information from the firm: 

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

**(ii)            Drug Manufacturing License (DML).** 

72 

|252|<br>**Case No.:1045/15/82-ALC4/2018**|Party Name:SAVA<br>HEALTHCARE LTD.|Party Name:SAVA<br>HEALTHCARE LTD.|Party Name:SAVA<br>HEALTHCARE LTD.|Party Name:SAVA<br>HEALTHCARE LTD.|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:3110067341<br>01.03.2019|**Status:**<br>**Deferred**<br>Defer Date:|
|---|---|---|---|---|---|---|---|
||<br>HQ File :01/82/050/02502/AM19/|RLA File<br>:31/83/040/00183/AM19/||||||
||**Decision:**Deferred for comments of TE.|||||||
|||||||||
|253|<br>**Case No.:1057/15/82-ALC4/2018**|Party Name:CIPLA LIMITED.||||Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:0310827414<br>01.03.2019|**Status:**<br>**Deferred**<br>Defer Date:|
||<br>HQ File :01/82/050/02514/AM19/|RLA File<br>:03/94/040/01019/AM19/||||||
||**Decision:**Deferred for comments of TE.|||||||
|||||||||
|254|**Case No.:191/1/82-ALC4/2019**|Party Name:GLOBAL<br>CALCIUM PRIVATE LIMITED||||Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:0710114617<br>04.03.2019|**Status:**<br>**Approved**|
||HQ File :01/82/050/02586/AM19/|RLA File<br>:07/24/040/00282/AM19/||||||

IMITED||||Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020<br>Lic.No/Date:0710114617<br>04.03.2019|**Status:**<br>**Approved**|
||HQ File :01/82/050/02586/AM19/|RLA File<br>:07/24/040/00282/AM19/||||||
||<br>**Decision:**The Committee considered case<br>decided to ratify the ad-hoc input output norms<br>whichever is lower:||as per agenda in the presence of the technical experts and it was<br>under para 4.7 of HBP as per details below or as applied by firm<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1 kg<br>1<br>L-PYROGLUTAMIC ACID<br>1.02 kg<br>1 kg<br>1<br>L-PYROGLUTAMIC ACID<br>0.968 kg<br>asper above decision of NC.|||||
||Export product||Qty.|Sl.<br>No.|Import items||Qty.|
||MAGNESIUM PIDOLATE(Eur.Ph)||1 kg|1|L-PYROGLUTAMIC ACID||1.02 kg|
||CALCIUM PIDOLATE||1 kg|1|L-PYROGLUTAMIC ACID||0.968 kg|
||RA concerned maytake further necessaryaction||asper above decision of NC.|||||



73 

|**Case No.:201/1/82-ALC4/2019**||Party Name:ALEOR||Meet No/Date:13/82-||**Status:**|
|---|---|---|---|---|---|---|
|||DERMACEUTICALS||ALC4/2019||**Approved**|
|||LIMITED||31.01.2020|||
|HQ File||RLA File||Lic.No/Date:3410044950|||
|:01/82/050/02596/AM19/||:34/24/040/00370/AM19/||05.03.2019|||

|---|---|---|---|
|||DERMACEUTICALS||ALC4/2019||**Approved**|
|||LIMITED||31.01.2020|||
|HQ File||RLA File||Lic.No/Date:3410044950|||
|:01/82/050/02596/AM19/||:34/24/040/00370/AM19/||05.03.2019|||



||**Case No.:201/1/82-ALC4/2019** <br>HQ File<br>:01/82/050/02596/AM19/|Party Name:ALEOR<br>DERMACEUTICALS<br>LIMITED|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Approved**|
|---|---|---|---|---|
|||RLA File<br>:34/24/040/00370/AM19/|Lic.No/Date:3410044950<br>05.03.2019||
|255|<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting<br>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<br>given below or as applied by the firm, whichever is less:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>Import items<br>Qty.<br>1<br>CLOBETASOL PROPIONATE<br>CREAM USP 0.05% 15 GM<br>(net content of active ingreidents<br>-211.216 gm.)<br>1 Number<br>CLOBETASOL<br>PROPIONATE USP<br>(MICRONIZED)<br>7.65 mg / 15  gm/pack<br>2<br>CLOBETASOL PROPIONATE<br>CREAM USP 0.05% 30 GM<br>(net content of active ingreidents<br>-423.491 gm.)<br>1 Number<br>CLOBETASOL<br>PROPIONATE USP<br>(MICRONIZED)<br>15.30  mg / 30  gm/pack<br>3<br>CLOBETASOL PROPIONATE<br>CREAM USP 0.05% 45 GM<br>(net content of active ingreidents<br>-212.152 gm.)<br>1 Number<br>CLOBETASOL<br>PROPIONATE USP<br>(MICRONIZED)<br>22.95  mg / 45  gm/pack<br>4<br>CLOBETASOL PROPIONATE<br>CREAM USP 0.05% 60 GM<br>(net content of active ingreidents<br>-653.438 gm.)<br>1 Number<br>CLOBETASOL<br>PROPIONATE USP<br>

br>(MICRONIZED)<br>22.95  mg / 45  gm/pack<br>4<br>CLOBETASOL PROPIONATE<br>CREAM USP 0.05% 60 GM<br>(net content of active ingreidents<br>-653.438 gm.)<br>1 Number<br>CLOBETASOL<br>PROPIONATE USP<br>(MICRONIZED)<br>30.60  mg / 60  gm/pack<br>RA concerned maytake further necessaryaction asper above decision of NC.||||



|**Case No.:143/1/82-ALC4/2019**||Party Name:TINA ORGANICS||Meet No/Date:13/82-||**Status:**|
|---|---|---|---|---|---|---|
|||PRIVATE LIMITED||ALC4/2019||**Deferred**|
|||||31.01.2020|||
|HQ File :01/82/050/02538/AM19/||RLA File||Lic.No/Date:0510409855||Defer Date:|
|||:05/24/040/00695/AM19/||06.03.2019|||



**Decision:** The Committee considered the case as per online agenda in the presence of technical experts and it 256 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** : 

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

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

74 

|**Case No.:194/1/82-ALC4/2019**||Party Name:SARNA||Meet No/Date:13/82-||**Status:**|
|---|---|---|---|---|---|---|
|||CHEMICALS PVT LTD||ALC4/2019||**Approved**|
|||||31.01.2020|||
|HQ File||RLA File||Lic.No/Date:5210042986|||
|:01/82/050/02589/AM19/||:52/24/040/00090/AM19/||06.03.2019|||

|---|---|---|---|---|
|||CHEMICALS PVT LTD||ALC4/2019||**Approved**|
|||||31.01.2020|||
|HQ File||RLA File||Lic.No/Date:5210042986|||
|:01/82/050/02589/AM19/||:52/24/040/00090/AM19/||06.03.2019|||



**Decision:** The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 2/AM20 dated 21.06.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details 257 given below or as applied by the firm, whichever is less: 

|Export Product|Qty.|Import items|Qty.|
|---|---|---|---|
|PARA<br>ANISIDINE<br>/<br>4-METHOXY<br>BENZENEAMINE<br>/ORGANIC<br>DYE<br>INTERMEDIATE SR-92 / 4-ANISIDINE 99.9%|1 kg|PARA ANISIDINE|1.00 kg|




75 

|**Case No.:145/1/82-ALC4/2019**||Party Name:J.B. CHEMICALS &||Meet No/Date:13/82-||**Status:**|
|---|---|---|---|---|---|---|
|||PHARMACEUTICALS||ALC4/2019||**Approved**|
|||LIMITED||31.01.2020|||
|HQ File :01/82/050/02540/AM19/||RLA File||Lic.No/Date:0310827513|||
|||:03/94/040/01066/AM19/||07.03.2019|||

--|---|---|---|
|||PHARMACEUTICALS||ALC4/2019||**Approved**|
|||LIMITED||31.01.2020|||
|HQ File :01/82/050/02540/AM19/||RLA File||Lic.No/Date:0310827513|||
|||:03/94/040/01066/AM19/||07.03.2019|||



||**Case No.:145/1/82-ALC4/2019**|Party Name:J.B. CHEMICALS &<br>PHARMACEUTICALS<br>LIMITED|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Approved**|
|---|---|---|---|---|
||HQ File :01/82/050/02540/AM19/|RLA File<br>:03/94/040/01066/AM19/|Lic.No/Date:0310827513<br>07.03.2019||
|258|<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting<br>no. 5/82-ALC4/2019 dated 02.08.2019,  it was decided to ratify norms under Para 4.7 of HBP v1 as per details<br>given below or as applied by the firm, whichever is less:<br> <br>Sl.<br>No.<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Item<br>Qty<br>1<br>Benzocaine and Cetylpyridinium<br>Chloride Anaesthetic Throat Lozenges.<br>Flavours Black Current, Honey Lemon<br>& Other Flavours. Each Lozenge<br>Contains 12mg Benzocaine. Net<br>content of Benzocaine-191.781 Kgs.<br>1 Number<br>1<br>Benzocaine<br>12.24 mg<br>2<br>Benzocaine and Cetylpyridinium<br>Chloride Anaesthetic Throat Lozenges.<br>Flavours Black Current and Lime &<br>Lemon and Other Flavours. Each<br>Lozenge contains 10mg Benzocaine.<br>Net content of Benzocaine-49.48 Kgs.<br>1 Number<br>2<br>Benzocaine<br>10.2 mg<br>3<br>Benzocaine, Cetylpyridinium Chloride<br>And Dextromethorphan Hydrobromide<br>Anaesthetic Throat Lozenges.<br>Each Lozenge Contains 1.25mg<br>Benzocaine.

1 Number<br>2<br>Benzocaine<br>10.2 mg<br>3<br>Benzocaine, Cetylpyridinium Chloride<br>And Dextromethorphan Hydrobromide<br>Anaesthetic Throat Lozenges.<br>Each Lozenge Contains 1.25mg<br>Benzocaine. Net content of Benzocaine<br>-28.558 Kgs.<br>1 Number<br>3<br>Benzocaine<br>1.275 mg<br>4<br>Life Brand Sore Throat & Nasal<br>Congestion Relief Extra Strength<br>(Flavours Cherry/Honey & Lemon<br>/Other flavours) Sugar Free Lozenges.<br>Each Lozenges Contains Bezocaine 15<br>mg & Isomalt ST-M 2700.00 Mg. Net<br>Content Benzocaine 15.504 Kgs. And<br>Isomalt ST-M-2790.72 Kgs.<br>1 Number<br>4<br>Benzocaine<br>15.30 mg<br>5<br>Isomalt ST-M<br>2700 mg<br>5<br>Personnelle Oral Anesthetic Sore<br>Throat Lozenges Extra Strength Sugar<br>Free (Flavours Cherry/Honey Lemon<br>/Other flavours) Each Lozenges<br>Contains Bezocaine 15 mg & Isomalt<br>ST-M 2571.29 Mg. Net Content<br>Benzocaine 15.504 Kgs. And Isomalt<br>ST-M-2790.72 Kgs.<br>1 Number<br>6<br>Benzocaine<br>15.30 mg<br>7<br>Isomalt ST-M<br>2700 mg<br>6<br>Option+Oral Lozenges Sore Throat &<br>Nasal Congestion Relief Extra Strength<br>(Flavours Cherry/Honey Lemon /Other<br>flavours).<br>Each Lozenges Contains Bezocaine 15<br>mg & Isomalt ST-M 2571.29 Mg. Net<br>Content Benzocaine 15.504 Kgs. And<br>Isomalt ST-M-2790.72 Kgs.<br>1 Number<br>8<br>Benzocaine<br>15.30 mg<br>9<br>Isomalt ST-M<br>2700 mg<br>RA concerned maytake further necessaryaction asper above decision of NC.||||



76

gs. And<br>Isomalt ST-M-2790.72 Kgs.<br>1 Number<br>8<br>Benzocaine<br>15.30 mg<br>9<br>Isomalt ST-M<br>2700 mg<br>RA concerned maytake further necessaryaction asper above decision of NC.||||



76 

|259|**Case No.:174/1/82-ALC4/2019**|Party Name:BIOLOGICAL E<br>LTD|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Withdrawn**|
|---|---|---|---|---|
||<br>HQ File :01/82/050/02569/AM19/|RLA File<br>:09/24/040/00588/AM19/|Lic.No/Date:0910067245<br>07.03.2019||
||**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it was<br>observed that the Committee has already approved this case vide its Meeting No. 11/AM20 dated 03.01.2020.<br>In view of above,the Committee decided to**withdraw**the case.||||



|260|<br>**Case No.:149/1/82-ALC4/2019**|Party Name:SRIAM LABS<br>PRIVATE LIMITED|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Deferred**|
|---|---|---|---|---|
||<br>HQ File :01/82/050/02544/AM19/|RLA File<br>:09/24/040/00604/AM19/|Lic.No/Date:0910067252<br>11.03.2019|Defer Date:|
||**Decision:**Deferred for comments of TE.||||



|**Case No.:150/1/82-ALC4/2019**||Party Name:ALKALI METALS||Meet No/Date:13/82-||**Status:**|
|---|---|---|---|---|---|---|
|||LTD.,||ALC4/2019||**Deferred**|
|||||31.01.2020|||
|HQ File :01/82/050/02545/AM19/||RLA File||Lic.No/Date:0910067258||Defer Date:|
|||:09/24/040/00561/AM19/||11.03.2019|||

|---|---|---|---|---|
|||LTD.,||ALC4/2019||**Deferred**|
|||||31.01.2020|||
|HQ File :01/82/050/02545/AM19/||RLA File||Lic.No/Date:0910067258||Defer Date:|
|||:09/24/040/00561/AM19/||11.03.2019|||



**Decision:** The Committee considered the case as per online agenda in the presence of technical experts and it 261 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** : 

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

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

|262|<br>**Case No.:159/1/82-ALC4/2019**|Party Name:EMMENNAR<br>PHARMA PRIVATE LIMITED|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Deferred**|
|---|---|---|---|---|
||<br>HQ File :01/82/050/02554/AM19/|RLA File<br>:09/24/040/00600/AM19/|Lic.No/Date:0910067264<br>12.03.2019|Defer Date:|
||**Decision:**Deferred for comments of TE.||||
||||||
|263|<br>**Case No.:160/1/82-ALC4/2019**|Party Name:ASHISH LIFE<br>SCIENCE PVT.LTD.|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Deferred**|
||<br>HQ File :01/82/050/02555/AM19/|RLA File<br>:03/94/040/00693/AM19/|Lic.No/Date:0310827639<br>12.03.2019|Defer Date:|
||**Decision:**Deferred for comments of TE.||||



77

s:**<br>**Deferred**|
||<br>HQ File :01/82/050/02555/AM19/|RLA File<br>:03/94/040/00693/AM19/|Lic.No/Date:0310827639<br>12.03.2019|Defer Date:|
||**Decision:**Deferred for comments of TE.||||



77 

|264|<br>**Case No.:161/1/82-ALC4/2019**|Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Deferred**|
|---|---|---|---|---|
||<br>HQ File :01/82/050/02556/AM19/|RLA File<br>:09/24/040/00621/AM19/|Lic.No/Date:0910067270<br>13.03.2019|Defer Date:|
||**Decision:**Deferred for comments of TE.||||
||||||
|265|<br>**Case No.:166/1/82-ALC4/2019**|Party Name:ENAL DRUGS PVT<br>LTD.,|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Deferred**|
||<br>HQ File :01/82/050/02561/AM19/|RLA File<br>:09/24/040/00614/AM19/|Lic.No/Date:0910067274<br>13.03.2019|Defer Date:|
||**Decision:**Deferred for comments of TE.||||
||||||
|266|<br>**Case No.:167/1/82-ALC4/2019**|Party Name:AURORE LIFE<br>SCIENCES PRIVATE LIMITED|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Deferred**|
||<br>HQ File :01/82/050/02562/AM19/|RLA File<br>:09/24/040/00612/AM19/|Lic.No/Date:0910067275<br>13.03.2019|Defer Date:|
||**Decision:**Deferred for comments of TE.||||
||||||
|267|<br>**Case No.:169/1/82-ALC4/2019**|Party Name:RUSAN PHARMA<br>LTD.|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Deferred**|
||<br>HQ File :01/82/050/02564/AM19/|RLA File<br>:03/95/040/01315/AM19/|Lic.No/Date:0310827685<br>13.03.2019|Defer Date:|
||**Decision:**Deferred for comments of TE.||||
||||||

us:**<br>**Deferred**|
||<br>HQ File :01/82/050/02564/AM19/|RLA File<br>:03/95/040/01315/AM19/|Lic.No/Date:0310827685<br>13.03.2019|Defer Date:|
||**Decision:**Deferred for comments of TE.||||
||||||
|268|<br>**Case No.:170/1/82-ALC4/2019**|Party Name:J.B. CHEMICALS &<br>PHARMACEUTICALS<br>LIMITED|Meet No/Date:13/82-<br>ALC4/2019<br>31.01.2020|**Status:**<br>**Deferred**|
||<br>HQ File :01/82/050/02565/AM19/|RLA File<br>:03/94/040/01071/AM19/|Lic.No/Date:0310827686<br>13.03.2019|Defer Date:|
||**Decision:**Deferred for comments of TE.||||



78 

|**Case No.:197/1/82-ALC4/2019**||Party Name:STERILE INDIA||Meet No/Date:13/82-||**Status:**|
|---|---|---|---|---|---|---|
|||PRIVATE LIMITED||ALC4/2019||**Approved**|
|||||31.01.2020|||
|HQ File :01/82/050/02592/AM19/||RLA File||Lic.No/Date:3310030518|||
|||:33/24/040/00019/AM19/||13.03.2019|||



**Decision:** The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 4/82-ALC4/2018 dated 19.06.2018,  it was decided to ratify norms under Para 4.7 of HBP v1 as per 269 details given below or as applied by the firm, wh

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