IN FORCE Advance Authorisation

DGFT Minutes

Reliability

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Office of Directorate General of Foreign Trade New Delhi -0

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

Minutes of the Norms Committee – 3 Meeting No. 14/82-ALC4/2019 dated 06.03.2020 (actually held on 19.03.2020) 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. 13/82-ALC4/2019 dated 31.01.2020 (actually held on 12.02.2020 and 20.02.2020).

ONLINE CASES

1	Case No.:179/6/82-ALC4/2019	Party Name:CIPLA LIMITED.	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020<br> <br><br>Lic.No/Date:0310805901<br>04.07.2016	Status:<br>Withdrawn
	HQ File<br>:01/82/050/00405/AM20/	RLA File<br>:03/94/040/00257/AM17/
	Decision:The firm vide e-mail dated 29.01.2020 has informed that they have surrendered the subject<br>Advance Authorization.<br>In view of above,the Committee decided towithdrawthe case.

Case No.:4/11/82-ALC4/2016	Party Name:ATUL LIMITED,	Meet No/Date:14/82-	Status:
		ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:0810138282
:01/82/050/00538/AM17/	:08/24/040/00113/AM17/	13.07.2016

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 4/82-ALC4/2019 dated 19.07.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as 2 per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl.<br>No.	Import items	Qty.
CYCLOALIPHATIC<br>AMINE ADDUCT	1 kg	1	ISOPHORONE DIAMINE	0.525 kg
		2	BASIC LIQUID RESIN (YD 128)	0.135 kg

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

--| |CYCLOALIPHATIC AMINE ADDUCT|1 kg|1|ISOPHORONE DIAMINE|0.525 kg| |||2|BASIC LIQUID RESIN (YD 128)|0.135 kg|

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

Case No.:382/4/82-	Party Name:ELPPE	Meet No/Date:14/82-	Status:
ALC4/2017	CHEMICALS PRIVATE	ALC4/2019	Deferred
	LIMITED	06.03.2020
HQ File	RLA File	Lic.No/Date:0310812684	Defer
:01/82/050/00390/AM18/	:03/94/040/00036/AM18/	24.04.2017	Date:06.03.2020

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

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

Case No.:384/4/82-ALC4/2017	Party Name:ELPPE	Meet No/Date:14/82-	Status:
	CHEMICALS PRIVATE	ALC4/2019	Approved
	LIMITED	06.03.2020
HQ File	RLA File	Lic.No/Date:0310812683
:01/82/050/00392/AM18/	:03/94/040/00024/AM18/	24.04.2017

-|---|---|---| |||CHEMICALS PRIVATE||ALC4/2019||Approved| |||LIMITED||06.03.2020||| |HQ File||RLA File||Lic.No/Date:0310812683||| |:01/82/050/00392/AM18/||:03/94/040/00024/AM18/||24.04.2017|||

	Decision:The Committee considered the	Decision:The Committee considered the	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 given below or as applied by the firm, whichever is less:
4
		Export product	Qty.	Sl.	Import items	Qty.
				No.
		NICLOSAMIDE PIPERAZINE	1 kg	1.	SALICYLIC ACID	0.65 kg
		SALT		2.	TRIETHYL AMINE	0.26 kg
				3.	PIPERAZINE ANHYDROUS	0.13 kg
				4.	THIONYL CHLORIDE	0.20 kg
				5.	ISOPROPYL ALCOHOL	0.30 kg
	RA concerned maytake further necessaryaction asper above decision of NC.

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

Case No.:260/4/82-ALC4/2017	Party Name:YASHO	Meet No/Date:14/82-	Status:
	INDUSTRIES PVT.LTD.	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:0310813142
:01/82/050/00268/AM18/	:03/95/040/00097/AM18/	09.05.2017

--|---|---|---|---| |||INDUSTRIES PVT.LTD.||ALC4/2019||Approved| |||||06.03.2020||| |HQ File||RLA File||Lic.No/Date:0310813142||| |:01/82/050/00268/AM18/||:03/95/040/00097/AM18/||09.05.2017|||

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 5 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	Qty.	Sl.	Import items	Qty.
		No.
METHYL EUGENOL	1 kg	1.	CLOVE LEAF OIL	1.137 kg

Case No.:427/4/82-ALC4/2017	Party Name:YASHO	Meet No/Date:14/82-	Status:
	INDUSTRIES PVT.LTD.	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:0310813692
:01/82/050/00435/AM18/	:03/95/040/00169/AM18/	31.05.2017

		Decision:The Committee considered the cases as per agenda and in the light of earlier decision taken in	Decision:The Committee considered the cases as per agenda and in the light of earlier decision taken in	Decision:The Committee considered the cases as per agenda and in the light of earlier decision taken in
		meeting no.

agenda and in the light of earlier decision taken in|**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in| |---|---|---|---|---| |||meeting no. 2/82-ALC4/2018 dated 16.05.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as||| |6||per details given below or as applied by the firm, whichever is less:||| |||Export product Qty. Sl. Import items|Qty.|| |||No.||| |||BUTYLATED HYDROXY 1 kg 1. HYDROQUINONE|1.247 kg|| |||ANISOLE(BHA)(FLAKES/POWDER/FF) 2. TERTIARY BUTANOL|0.839 kg|| |||3. PHOSPHORIC ACID|1.00 kg|| |||4. HEXANE|1.00 kg|| |||RA concerned maytake further necessaryaction asper above decision of NC.|||

Case No.:437/4/82-ALC4/2017	Party Name:YASHO	Meet No/Date:14/82-	Status:
	INDUSTRIES PVT.LTD.	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:0310813870
:01/82/050/00445/AM18/	:03/95/040/00210/AM18/	08.06.2017

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

Export product	Qty.	Sl.	Import items	Qty.
		No.
OCTYLATED	1 kg	1.	DIPHENYLAMINE	0.405 kg
DIPHENYLAMINE(OCD		2.	DI-ISOBUTYLENE	0.62 kg
FLAKES/POWDER)		3.	ACTIVATED CLAY	0.1 kg

ct	Qty.	Sl.	Import items	Qty.
		No.
OCTYLATED	1 kg	1.	DIPHENYLAMINE	0.405 kg
DIPHENYLAMINE(OCD		2.	DI-ISOBUTYLENE	0.62 kg
FLAKES/POWDER)		3.	ACTIVATED CLAY	0.1 kg

	Case No.:136/6/82-	Party Name:ENCUBE	Meet No/Date:14/82-	Status:
	ALC4/2019	ETHICALS PVT LTD	ALC4/2019	Deferred
			06.03.2020
8	HQ File	RLA File	Lic.No/Date:0310827548	Defer
	:01/82/050/00362/AM20/	:03/94/040/01057/AM19/	08.03.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

Case No.:222/1/82-	Party Name:ANLON	Meet No/Date:14/82-	Status:
ALC4/2019	HEALTHCARE	ALC4/2019	Deferred
	PRIVATELIMITED	06.03.2020
HQ File	RLA File	Lic.No/Date:2410042706	Defer
:01/82/050/02617/AM19/	:24/24/040/00062/AM19/	25.03.2019	Date:06.03.2020

Decision: The Committee considered the case as per online agenda in the presence of technical experts and 9 it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 11/82-ALC4/2019 dated 03.01.2020 , followed by Reminder on 12.02.2020 :

(i) Complete technical details as per Appendix 4E showing chemical reaction, molecular weight, % of yield on molar basis. In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

l reaction, molecular weight, % of yield on molar basis.** In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:223/1/82-	Party Name:ANLON	Meet No/Date:14/82-	Status:
ALC4/2019	HEALTHCARE	ALC4/2019	Deferred
	PRIVATELIMITED	06.03.2020
HQ File	RLA File	Lic.No/Date:2410042707	Defer
:01/82/050/02618/AM19/	:24/24/040/00063/AM19/	25.03.2019	Date:06.03.2020

Decision: The Committee considered the case as per online agenda in the presence of technical experts 10 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 11/82-ALC4/2019 dated 03.01.2020 , followed by Reminder on 12.02.2020 :

(i) Complete technical details as per Appendix 4E showing chemical reaction, molecular weight, % of yield on molar basis.

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

Case No.:224/1/82-	Party Name:SAINOR	Meet No/Date:14/82-	Status:
ALC4/2019	LABORATORIES PVT LTD	ALC4/2019	Deferred
		06.03.2020
HQ File	RLA File	Lic.No/Date:0910067319	Defer
:01/82/050/02619/AM19/	:09/24/040/00647/AM19/	26.03.2019	Date:06.03.2020

||LABORATORIES PVT LTD||ALC4/2019||Deferred| |||||06.03.2020||| |HQ File||RLA File||Lic.No/Date:0910067319||Defer| |:01/82/050/02619/AM19/||:09/24/040/00647/AM19/||26.03.2019||Date:06.03.2020|

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 11 Meeting No. 11/82-ALC4/2019 dated 03.01.2020 , followed by Reminder on 12.02.2020 :

(i) Complete material balance in terms of percentage concentration in export and import. (ii) Authentic literature for decreased degradation in 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.:225/1/82-	Party Name:SAINOR	Meet No/Date:14/82-	Status:
ALC4/2019	LABORATORIES PVT LTD	ALC4/2019	Deferred
		06.03.2020
HQ File	RLA File	Lic.No/Date:0910067320	Defer
:01/82/050/02620/AM19/	:09/24/040/00646/AM19/	26.03.2019	Date:06.03.2020

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 12 Meeting No. 11/82-ALC4/2019 dated 03.01.2020 , followed by Reminder on 12.02.2020 :

it was noted that the firm still has not furnished the following information asked for by NC-3 in its 12 Meeting No. 11/82-ALC4/2019 dated 03.01.2020 , followed by Reminder on 12.02.2020 :

(i) Complete material balance in terms of percentage concentration in export and import. (ii) Authentic literature for decreased degradation in 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.

13	<br>Case No.:11/1/82-ALC4/2019	Party Name:VASUDHA<br>PHARMA CHEM LTD	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00011/AM20/	RLA File<br>:09/24/040/00620/AM19/	Lic.No/Date:0910067361<br>03.04.2019	Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

14	<br>Case No.:12/1/82-ALC4/2019	Party Name:SUVEN LIFE<br>SCIENCES LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00012/AM20/	RLA File<br>:09/24/040/00661/AM19/	Lic.No/Date:0910067365<br>04.04.2019	Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

Case No.:20/1/82-ALC4/2019	Party Name:THINQ	Meet No/Date:14/82-	Status:
	PHARMA-CRO LIMITED	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:0310828192
:01/82/050/00020/AM20/	:03/95/040/01366/AM19/	05.04.2019

---|---|---|---|---| |||PHARMA-CRO LIMITED||ALC4/2019||Approved| |||||06.03.2020||| |HQ File||RLA File||Lic.No/Date:0310828192||| |:01/82/050/00020/AM20/||:03/95/040/01366/AM19/||05.04.2019|||

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

Export Product	Qty.	Sl.<br>No.	Import items	Qty.
Dimethyl Isosorbide	1 kg	1	Isosorbide	0.93 kg

Case No.:25/1/82-ALC4/2019	Party Name:SAINOR	Meet No/Date:14/82-	Status:
	LABORATORIES PVT LTD	ALC4/2019	Deferred
		06.03.2020
HQ File	RLA File	Lic.No/Date:0910067371	Defer
:01/82/050/00025/AM20/	:09/24/040/00659/AM19/	05.04.2019	Date:06.03.2020

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 16 Meeting No. 11/82-ALC4/2019 dated 03.01.2020 , followed by Reminder on 12.02.2020 :

(i) Complete material balance in terms of percentage concentration in export and import. (ii) Authentic literature for decreased degradation in 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.

terature for decreased degradation in 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.

17	<br>Case No.:41/1/82-ALC4/2019	Party Name:ORTIN<br>LABORATORIES LTD	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00041/AM20/	RLA File<br>:09/24/040/00650/AM19/	Lic.No/Date:0910067389<br>15.04.2019	Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

18	<br>Case No.:42/1/82-ALC4/2019	Party Name:JODAS EXPOIM<br>PVT.LTD	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00042/AM20/	RLA File<br>:05/23/040/00015/AM20/	Lic.No/Date:0510410233<br>15.04.2019	Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

	Case No.:43/1/82-ALC4/2019	Party Name:HEMA DYE	Meet No/Date:14/82-	Status:
		CHEM PVT. LTD.	ALC4/2019	Deferred
			06.03.2020
19	HQ File	RLA File	Lic.No/Date:0310828400	Defer
	:01/82/050/00043/AM20/	:03/94/040/01141/AM19/	16.04.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

3.2020||| |19||HQ File||RLA File||Lic.No/Date:0310828400||Defer| |||:01/82/050/00043/AM20/||:03/94/040/01141/AM19/||16.04.2019||Date:06.03.2020| |||**Decision:**Deferred for comments of TE.|||||||

Case No.:47/1/82-	Party Name:SYMBIOSIS	Meet No/Date:14/82-	Status:
ALC4/2019	PHARMACEUTICALS.PRIVATE	ALC4/2019	Deferred
	LIMITED.	06.03.2020
HQ File	RLA File	Lic.No/Date:3310030527	Defer
:01/82/050/00047/AM20/	:33/24/040/00002/AM20/	16.04.2019	Date:06.03.2020

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. 11/82-ALC4/2019 dated 03.01.2020 , followed by Reminder on 12.02.2020 : 20

(i) Copy of the Drug Manufacturing License (DML) for the items of export. (ii) Weight of the one unit of Empty Soft Gelatine Capsules.

(iii) Whether the export quantity (9803.921 kg) is for Empty Soft Gelatin Capsules or filled with Medicament.

(iv) COA of import item from foreign supplier.

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

Case No.:49/1/82-ALC4/2019	Party Name:COVALENT	Meet No/Date:14/82-	Status:
	LABORATORIES PRIVATE	ALC4/2019	Approved
	LIMITED	06.03.2020
HQ File	RLA File	Lic.No/Date:0910067394
:01/82/050/00049/AM20/	:09/24/040/00020/AM20/	23.04.2019

---|---|---| |||LABORATORIES PRIVATE||ALC4/2019||Approved| |||LIMITED||06.03.2020||| |HQ File||RLA File||Lic.No/Date:0910067394||| |:01/82/050/00049/AM20/||:09/24/040/00020/AM20/||23.04.2019|||

	Decision:The Committee considered case as per agenda in the presence of the technical experts and it	Decision:The Committee considered case as per agenda in the presence of the technical experts and it	Decision:The Committee considered case as per agenda in the presence of the technical experts and it	Decision:The Committee considered case as per agenda in the presence of the technical experts and it	Decision:The Committee considered case as per agenda in the presence of the technical experts and it	Decision:The Committee considered case as per agenda in the presence of the technical experts and it
	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.
21				No.
		Cefprozil	1 kg	1	7-Amino-3-[(Z)-propen-1-yl]-3-	0.77 kg
					cephem-4 carboxylic acid (7-
					APCA)
				2	Hexamethyl Disilizane(HMDS)	0.342 kg
				3	Trimethyl Chloro silane(TMCS)	0.230 kg
				4	Ethyl Chloro Formate(ECF)	0.383 kg
				5	Methane sulfonic acid(MSA)	0.0150 kg
				6	Methylene Chloride(MDC)	3.74 kg
				7	Acetone	4.40 kg

rimethyl Chloro silane(TMCS)|0.230 kg|| ||||||4|Ethyl Chloro Formate(ECF)|0.383 kg|| ||||||5|Methane sulfonic acid(MSA)|0.0150 kg|| ||||||6|Methylene Chloride(MDC)|3.74 kg|| ||||||7|Acetone|4.40 kg|| |||RA concerned maytake further necessaryaction asper above decision of NC.|||||||

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

Case No.:50/1/82-ALC4/2019	Party Name:COVALENT	Meet No/Date:14/82-	Status:
	LABORATORIES PRIVATE	ALC4/2019	Approved
	LIMITED	06.03.2020
HQ File	RLA File	Lic.No/Date:0910067395
:01/82/050/00050/AM20/	:09/24/040/00019/AM20/	23.04.2019

Decision:The Committee considered	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	case as per agenda in the presence of the technical experts and it	case as per agenda in the presence of the technical experts and it
was decided to ratify the ad-hoc			input output norms under para 4.7 of HBP as per details			below or as applied
by firm whichever is lower:
	Export Product	Qty.		Sl.	Import items		Qty.
				No.

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.||||| |22|||Ceftibuten|1 kg||1|METHYL-3-METHOXYACRYLATE(E-MMA)||1.62 kg|| |||||||2|Prenol||3.114 kg|| |||||||3|Methane Sulfonic acid(MSA)||0.403 kg|| |||||||4|7-Amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-||1.644 kg|| ||||||||ene-2-carboxylic acid diphenylmethyl|ester||| ||||||||(NAM)|||| |||||||5|Acetonitrile||5.00 kg|| |||||||6|Methylene Chloride(MDC)||9.10 kg|| |||||||7|Methanol||10.00 kg|| |||||||8|Acetone||1.00 kg|| |||RA concerned maytake further|||necessary||action asper above decision of NC.||||

Case No.:60/1/82-	Party Name:MANKIND	Meet No/Date:14/82-	Status:
ALC4/2019	PHARMA LTD	ALC4/2019	Deferred
		06.03.2020
HQ File	RLA File	Lic.No/Date:0510410328	Defer
:01/82/050/00060/AM20/	:05/24/040/00024/AM20/	23.04.2019	Date:06.03.2020

Decision: The Committee considered the case as per online agenda in the presence of technical experts 23 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 11/82-ALC4/2019 dated 03.01.2020 , followed by Reminder on 13.02.2020 :

and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 11/82-ALC4/2019 dated 03.01.2020 , followed by Reminder on 13.02.2020 :

(i) Copy of Drug Manufacturing License (DML) for all the export products 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.:62/1/82-ALC4/2019	Party Name:KEVA	Meet No/Date:14/82-	Status:
	FRAGRANCES PRIVATE	ALC4/2019	Deferred
	LIMITED	06.03.2020
HQ File	RLA File	Lic.No/Date:0310828561	Defer
:01/82/050/00062/AM20/	:03/94/040/00052/AM20/	24.04.2019	Date:06.03.2020

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 24 Meeting No. 11/82-ALC4/2019 dated 03.01.2020 , followed by Reminder on 12.02.2020 :

(i) Percentage yield with molecular weight (ii) Stoichiometric mass balance between import and export.

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

Stoichiometric mass balance between import and export.**

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

25	<br>Case No.:66/1/82-ALC4/2019	Party Name:SUVEN LIFE<br>SCIENCES LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00066/AM20/	RLA File<br>:09/24/040/00013/AM20/	Lic.No/Date:0910067405<br>24.04.2019	Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

26	<br>Case No.:67/1/82-ALC4/2019	Party Name:AUROBINDO<br>PHARMA LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00067/AM20/	RLA File<br>:09/24/040/00025/AM20/	Lic.No/Date:0910067414<br>24.04.2019	Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

27	<br>Case No.:75/1/82-ALC4/2019	Party Name:LABORATE<br>PHARMACEUTICAL INDIA<br>LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00075/AM20/	RLA File<br>:33/24/040/00003/AM20/	Lic.No/Date:3310030529<br>24.04.2019	Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

Case No.:68/1/82-ALC4/2019	Party Name:SRF LIMITED	Meet No/Date:14/82-	Status:
		ALC4/2019	Deferred
		06.03.2020
HQ File	RLA File	Lic.No/Date:0510410372	Defer
:01/82/050/00068/AM20/	:05/24/040/00438/AM19/	25.04.2019	Date:06.03.2020

-|---|---|---|---| |||||ALC4/2019||Deferred| |||||06.03.2020||| |HQ File||RLA File||Lic.No/Date:0510410372||Defer| |:01/82/050/00068/AM20/||:05/24/040/00438/AM19/||25.04.2019||Date:06.03.2020|

Decision: The Committee considered the case as per online agenda in the presence of technical experts 28 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 11/82-ALC4/2019 dated 03.01.2020 , followed by Reminder on 13.02.2020 :

(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.:84/1/82-ALC4/2019	Party Name:SHIVA	Meet No/Date:14/82-	Status:
	PHARMACHEM LTD	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:3410045091
:01/82/050/00084/AM20/	:34/24/040/00032/AM20/	29.04.2019

er 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: 29

Export Product	Qty.	Sl.	Import items				Qty.
		No.
DECYL+DODECYL	1 kg	1	DECYL ALCOHOL				0.796 kg
CHLORIDE (Mixture of		2	LAURYL	ALCOHOL	/	DODECYL	0.1974 kg
80% Decyl Chloride &			ALCOHOL
20% Dodecyl Chloride)

30<br> <br> <br> <br> <br> <br>	Case No.:86/1/82-ALC4/2019	Party Name:ASCENT<br>FINECHEM PVT. LTD.,	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020<br>Lic.No/Date:0810145144<br>01.05.2019	Status:<br>Deferred
	HQ File<br>:01/82/050/00086/AM20/	RLA File<br>:08/24/040/00005/AM20/		Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

Case No.:88/1/82-ALC4/2019	Party Name:SMS	Meet No/Date:14/82-	Status:
	LIFESCIENCES INDIA	ALC4/2019	Approved
	LIMITED	06.03.2020
HQ File	RLA File	Lic.No/Date:0910067429
:01/82/050/00088/AM20/	:09/24/040/00037/AM20/	01.05.2019

|---|---|---| |||LIFESCIENCES INDIA||ALC4/2019||Approved| |||LIMITED||06.03.2020||| |HQ File||RLA File||Lic.No/Date:0910067429||| |:01/82/050/00088/AM20/||:09/24/040/00037/AM20/||01.05.2019|||

	Case No.:88/1/82-ALC4/2019	Case No.:88/1/82-ALC4/2019	Party Name:SMS	Party Name:SMS	Party Name:SMS	Party Name:SMS	Party Name:SMS	Meet No/Date:14/82-	Meet No/Date:14/82-	Status:	Status:
<br> <br>			<br>L<br>L	<br>IFESCIENCES INDIA<br>IMITED				<br>A<br>0<br>L	<br>LC4/2019<br>6.03.2020	<br>A	<br>pproved
	HQ File<br>:01/82/050/00088/AM20/		R	LA File					ic.No/Date:0910067429
			:	09/24/040/00037/AM20/				<br>0	<br>1.05.2019
<br> <br> <br>	Decision:The Committee considered case<br>was decided to ratify the ad-hoc input output no<br>by firm whichever is lower:			sidered case		as per agenda in		th	e presence of the technical		experts and it
						<br>rms under para 4.7 of HBP as per details below or as applied
31		Export Product			Qty.	Sl.<br>No.	Import items			Qty.
		(3R,<br>3aS,<br>6aR)<br>-<br>HE<br>HYDRO FURO - [2, 3-<br>FURAN - 3 - YL - 4 - NIT<br>PHENYL<br>CARBON	XA<br>b] -<br>RO<br>TE		1 kg	1	BIS IV<br>[2,3-B	(HEXA HYDRO FURO<br> ]FURAN-3-OL)		1.61 kg
						2	METH	YLENE DI CHLORIDE		5.32 kg
		<br> <br>(DRU-IV) - Intermediate<br>Darunavir	<br>of

	RA concerned maytake further necessaryaction asper above decision of NC.

DI CHLORIDE|||5.32 kg||| ||| (DRU-IV) - Intermediate Darunavir| of||||||||||| ||||||||||||||| ||RA concerned maytake further necessaryaction asper above decision of NC.|||||||||||||

Case No.:102/1/82-	Party Name:SV	Meet No/Date:14/82-	Status:
ALC4/2019	PLASTOCHEM PVT.LTD.	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:3110067406
:01/82/050/00102/AM20/	:31/83/040/00006/AM20/	02.05.2019

	Decision:The Committee considered	Decision:The Committee considered		case as per agenda in the presence of the technical experts and it	case as per agenda in the presence of the technical experts and it
32	was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:
	Export Product<br>Qty.	Sl.		Import items	Qty.
		No.
	TRI BUTYL TIN<br>1 kg	1		TIN INGOTS	0.122 kg
	OXIDE(TBTO)	2		TETRA BUTYL TIN(TBT)	0.969 kg
	RA concerned maytake further necessary		action asper above decision of NC.

| ||||No.||||| |||TRI BUTYL TIN 1 kg|1||TIN INGOTS|0.122 kg|| |||OXIDE(TBTO)|2||TETRA BUTYL TIN(TBT)|0.969 kg|| |||RA concerned maytake further necessary||action asper above decision of NC.||||

	Case No.:101/1/82-	Party Name:JODAS EXPOIM	Party Name:JODAS EXPOIM	Meet No/Date:14/82-<br>	Meet No/Date:14/82-<br>	Status:	Status:
33<br> <br> <br> <br>	ALC4/2019	P	VT.LTD	A<br>06	LC4/2019<br>.03.2020<br><br>c.No/Date:0510410475<br>	De	ferred
	HQ File<br>:01/82/050/00101/AM20/	R	LA File	Li		De	fer
		:0	5/23/040/00048/AM20/	03	.05.2019<br>	Da	te:06.03.2020
	Decision:Deferred for commen		ts of TE.

Case No.:135/1/82-	Party Name:SV	Meet No/Date:14/82-	Status:
ALC4/2019	PLASTOCHEM PVT.LTD.	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:3110067409
:01/82/050/00135/AM20/	:31/83/040/00087/AM19/	07.05.2019

-|---| |ALC4/2019||PLASTOCHEM PVT.LTD.||ALC4/2019||Approved| |||||06.03.2020||| |HQ File||RLA File||Lic.No/Date:3110067409||| |:01/82/050/00135/AM20/||:31/83/040/00087/AM19/||07.05.2019|||

	Case No.:135/1/82-<br>ALC4/2019	Party Name:SV<br>PLASTOCHEM PVT.LTD.<br>RLA File<br>:31/83/040/00087/AM19/	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Approved
	HQ File<br>:01/82/050/00135/AM20/		Lic.No/Date:3110067409<br>07.05.2019
34	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>TRI BUTYL TIN OXIDE<br>(TBTO)<br>1 kg<br>1<br>TIN INGOT<br>0.122 kg<br>2<br>TETRA BUTYL TIN(TBT)<br>0.969kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Case No.:136/1/82-	Party Name:SV	Meet No/Date:14/82-	Status:
ALC4/2019	PLASTOCHEM PVT.LTD.	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:3110067410
:01/82/050/00136/AM20/	:31/83/040/00113/AM18/	07.05.2019

Decision: The Committee considered case as per agenda in the presence of the technical experts and it 35 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:

er agenda in the presence of the technical experts and it 35 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.
TRI<br>BUTYL<br>TIN<br>OXIDE<br>(TBTO)	1 kg	1	TETRA BUTYL TIN(TBT)	0.969kg
		2	TIN INGOTS	0.122 kg

36	Case No.:106/1/82-<br>ALC4/2019	Party Name:PRACHEM<br>LABORATORIES	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00106/AM20/	RLA File<br>:08/24/040/00003/AM20/	Lic.No/Date:0810145205<br>08.05.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

37	Case No.:107/1/82-<br>ALC4/2019	Party Name:SHANKUS<br>PHARMACEUTICALS	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00107/AM20/	RLA File<br>:08/24/040/00040/AM20/	Lic.No/Date:0810145203<br>08.05.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

Case No.:111/1/82-	Party Name:SAINOR	Meet No/Date:14/82-	Status: Deferred
ALC4/2019	LABORATORIES PVT LTD	ALC4/2019
		06.03.2020
HQ File	RLA File	Lic.No/Date:0910067455	Defer
:01/82/050/00111/AM20/	:09/24/040/00057/AM20/	08.05.2019	Date:06.03.2020

ALC4/2019*||LABORATORIES PVT LTD||ALC4/2019||| |||||06.03.2020||| |HQ File||RLA File||Lic.No/Date:0910067455||Defer| |:01/82/050/00111/AM20/||:09/24/040/00057/AM20/||08.05.2019||Date:06.03.2020|

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 38 Meeting No. 11/82-ALC4/2019 dated 03.01.2020 , followed by Reminder on 12.02.2020 :

(i) Complete material balance in terms of percentage concentration in export and import. (ii) Authentic literature for decreased degradation in 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.:113/1/82-	Party Name:AURORE LIFE	Meet No/Date:14/82-	Status:
	ALC4/2019	SCIENCES PRIVATE	ALC4/2019	Deferred
		LIMITED	06.03.2020
39	HQ File	RLA File	Lic.No/Date:0910067466	Defer
	:01/82/050/00113/AM20/	:09/24/040/00011/AM20/	09.05.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

3.2020||| |39||HQ File||RLA File||Lic.No/Date:0910067466||Defer| |||:01/82/050/00113/AM20/||:09/24/040/00011/AM20/||09.05.2019||Date:06.03.2020| |||**Decision:**Deferred for comments of TE.|||||||

	Case No.:109/1/82-	Party Name:SAURAV	Meet No/Date:14/82-	Status:
	ALC4/2019	CHEMICALS LIMITED	ALC4/2019	Deferred
			06.03.2020
40	HQ File	RLA File	Lic.No/Date:2210016146	Defer
	:01/82/050/00109/AM20/	:22/24/040/00011/AM20/	10.05.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

Case No.:137/1/82-	Party Name:ANLON	Meet No/Date:14/82-	Status:
ALC4/2019	HEALTHCARE	ALC4/2019	Deferred
	PRIVATELIMITED	06.03.2020
HQ File	RLA File	Lic.No/Date:2410042746	Defer
:01/82/050/00137/AM20/	:24/24/040/00004/AM20/	10.05.2019	Date:06.03.2020

Decision: The Committee considered the case as per online agenda in the presence of technical experts 41 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 11/82-ALC4/2019 dated 03.01.2020 , followed by Reminder on 12.02.2020 :

(i) Complete technical details as per Appendix 4E showing chemical reaction, molecular weight, % of yield on molar basis.

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

ion, molecular weight, % of yield on molar basis.**

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

Case No.:138/1/82-	Party Name:ANLON	Meet No/Date:14/82-	Status:
ALC4/2019	HEALTHCARE	ALC4/2019	Deferred
	PRIVATELIMITED	06.03.2020
HQ File	RLA File	Lic.No/Date:2410042747	Defer
:01/82/050/00138/AM20/	:24/24/040/00005/AM20/	10.05.2019	Date:06.03.2020

Decision: The Committee considered the case as per online agenda in the presence of technical experts 42 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 11/82-ALC4/2019 dated 03.01.2020 , followed by Reminder on 12.02.2020 :

(i) Complete technical details as per Appendix 4E showing chemical reaction, molecular weight, % of yield on molar basis.

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

	Case No.:250/1/82-	Party Name:GLAND	Meet No/Date:14/82-	Status:
	ALC4/2019	PHARMA LIMITED	ALC4/2019	Deferred
			06.03.2020
43	HQ File	RLA File	Lic.No/Date:0910067505	Defer
	:01/82/050/00156/AM20/	:09/24/040/00042/AM20/	13.05.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

3.2020||| |43||HQ File||RLA File||Lic.No/Date:0910067505||Defer| |||:01/82/050/00156/AM20/||:09/24/040/00042/AM20/||13.05.2019||Date:06.03.2020| |||**Decision:**Deferred for comments of TE.|||||||

	Case No.:250/1/82-	Party Name:GLAND	Party Name:GLAND	Meet No/Date:14/82-	Meet No/Date:14/82-	Status:	Status:
43	<br>ALC4/2019	<br>PHARMA LIMITED		<br>ALC4/2019<br>06.03.2020		<br>Deferred
	HQ File<br>:01/82/050/00156/AM20/	RLA File<br>:09/24/040/00042/AM20/		Lic.No/Date:0910067505		Defer
				<br>13.05.2019		<br>Date:06.03.2020
	Decision:Deferred for comm	ents of TE.

44	Case No.:251/1/82-<br>ALC4/2019	Party Name:GLAND<br>PHARMA LIMITED		Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020		Status:<br>Deferred
	HQ File<br>:01/82/050/00157/AM20/	RLA File<br>:09/24/040/00043/AM20/		Lic.No/Date:0910067519<br>14.05.2019		Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.



45	Case No.:252/1/82-<br>ALC4/2019	Pa<br>PH	rty Name:GLAND<br>ARMA LIMITED	Me<br>AL<br>06.	et No/Date:14/82-<br>C4/2019<br>03.2020	Stat<br>Defe	us:<br>rred
	HQ File<br>:01/82/050/00158/AM20/
		R<br>:0	A File<br>9/24/040/00069/AM20/	Lic<br>15.	.No/Date:0910067532<br>05.2019	Defe<br>Date	r<br>:06.03.2020
	Decision:Deferred for comments of TE.

20/||||||| |||R :0|A File 9/24/040/00069/AM20/|Lic 15.|.No/Date:0910067532 05.2019|Defe Date|r :06.03.2020| ||**Decision:**Deferred for comments of TE.||||||| ||||||||| |||||||||

	Case No.:276/1/82-<br>	Party Name:PIRAMAL<br>	Party Name:PIRAMAL<br>	Meet No/Date:14/82-<br>	Meet No/Date:14/82-<br>	Status:<br>	Status:<br>
46	ALC4/2019	E	NTERPRISES LIMITED	AL<br>06.	C4/2019<br>03.2020	Def<br> <br>Def<br>	erred
	HQ File<br>:01/82/050/00182/AM20/	R<br>	LA File<br>	Lic<br>	.No/Date:0310829108<br>		er<br>
		:0	3/95/040/00143/AM20/	17.	05.2019	Dat	e:06.03.2020
	Decision:The Committee considered the case as per agenda and<br>dated 25.02.2020 has furnished its reply. Deferred for comments of		idered the case as per agenda<br>	and<br>	it was noted that the firm v<br>		ide its e-mail
					TE.

Case No.:275/1/82-	Party Name:SUNSHIELD	Meet No/Date:14/82-	Status:
ALC4/2019	CHEMICALS LTD.	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:0310829140
:01/82/050/00181/AM20/	:03/95/040/00149/AM20/	20.05.2019

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

Export Product			Qty.	Sl.	Import items	Qty.
				No.
SUNOX<br>1022	D	BIS	1 kg	1	Nonene(Propylene Trimer)	0.651 kg
(NONYLPHENYL	AMINE)			2	DI Phenylamine	0.455 kg

48	Case No.:280/1/82-<br>ALC4/2019	Pa<br>LI<br>LI	rty Name:SMS<br>FESCIENCES INDIA<br>MITED	Me<br>AL<br>06.	et No/Date:14/82-<br>C4/2019<br>03.2020	Stat<br>Defe	us:<br>rred
	HQ File<br>:01/82/050/00186/AM20/	RL<br>:0	A File<br>9/24/040/00084/AM20/	Lic<br>22.	.No/Date:0910067561<br>05.2019	Defe<br>Date	r<br>:06.03.2020
	Decision:Deferred for comments of TE.

Case No.:299/1/82-	Party Name:RUBICON	Meet No/Date:14/82-	Status:
ALC4/2019	RESEARCH PVT. LTD.,	ALC4/2019	Deferred
		06.03.2020
HQ File	RLA File	Lic.No/Date:0310829246	Defer
:01/82/050/00205/AM20/	:03/95/040/00103/AM20/	24.05.2019	Date:06.03.2020

Decision: The Committee considered the case as per online agenda in the presence of technical experts 49 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 11/82-ALC4/2019 dated 03.01.2020 , followed by Reminder on 12.02.2020 :

(i) Master Batch Formula (MBF) and (ii) Drug Manufacturing License (DML).

asked for by NC-3 in its Meeting No. 11/82-ALC4/2019 dated 03.01.2020 , followed by Reminder on 12.02.2020 :

(i) Master Batch Formula (MBF) and (ii) Drug Manufacturing License (DML).

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.:301/1/82-	Party Name:GLENMARK	Meet No/Date:14/82-	Status:
	ALC4/2019	LIFE SCIENCES LIMITED	ALC4/2019	Deferred
			06.03.2020
50	HQ File	RLA File	Lic.No/Date:0310829265	Defer
	:01/82/050/00207/AM20/	:03/94/040/00134/AM20/	27.05.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

51	Case No.:305/1/82-<br>ALC4/2019	Party Name:RUMIT<br>CHEMISYNTH PRIVATE<br>LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00211/AM20/	RLA File<br>:03/95/040/00196/AM20/	Lic.No/Date:0310829292<br>28.05.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

52	Case No.:319/1/82-<br>ALC4/2019	Party Name:RAVESHIA<br>ORGANICS LLP	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00225/AM20/	RLA File<br>:03/95/040/00204/AM20/	Lic.No/Date:0310829355<br>30.05.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

53	Case No.:1/6/82-ALC4/2019	Party Name:MALLADI<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00227/AM20/	RLA File<br>:04/24/040/00048/AM20/	Lic.No/Date:0410165665<br>31.05.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

Case No.:4/6/82-ALC4/2019	Party Name:DIVIS	Meet No/Date:14/82-	Status:
	LABORATORIES LTD	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:0910067620
:01/82/050/00230/AM20/	:09/24/040/00101/AM20/	31.05.2019

-|---|---|---|---|---| |||LABORATORIES LTD||ALC4/2019||Approved| |||||06.03.2020||| |HQ File||RLA File||Lic.No/Date:0910067620||| |:01/82/050/00230/AM20/||:09/24/040/00101/AM20/||31.05.2019|||

|||Case No.:4/6/82-ALC4/2019Party Name:DIVIS LABORATORIES LTD Meet No/Date:14/82- ALC4/2019 06.03.2020 Status: Approved HQ File :01/82/050/00230/AM20/ RLA File :09/24/040/00101/AM20/ Lic.No/Date:0910067620 31.05.2019|Case No.:4/6/82-ALC4/2019Party Name:DIVIS LABORATORIES LTD Meet No/Date:14/82- ALC4/2019 06.03.2020 Status: Approved HQ File :01/82/050/00230/AM20/ RLA File :09/24/040/00101/AM20/ Lic.No/Date:0910067620 31.05.2019|Case No.:4/6/82-ALC4/2019Party Name:DIVIS LABORATORIES LTD Meet No/Date:14/82- ALC4/2019 06.03.2020 Status: Approved HQ File :01/82/050/00230/AM20/ RLA File :09/24/040/00101/AM20/ Lic.No/Date:0910067620 31.05.2019|Case No.:4/6/82-ALC4/2019Party Name:DIVIS LABORATORIES LTD Meet No/Date:14/82- ALC4/2019 06.03.2020 Status: Approved HQ File :01/82/050/00230/AM20/ RLA File :09/24/040/00101/AM20/ Lic.No/Date:0910067620 31.05.2019|Case No.:4/6/82-ALC4/2019Party Name:DIVIS LABORATORIES LTD Meet No/Date:14/82- ALC4/2019 06.03.2020 Status: Approved HQ File :01/82/050/00230/AM20/ RLA File :09/24/040/00101/AM20/ Lic.No/Date:0910067620 31.05.2019|Case No.:4/6/82-ALC4/2019Party Name:DIVIS LABORATORIES LTD Meet No/Date:14/82

HQ File :01/82/050/00230/AM20/ RLA File :09/24/040/00101/AM20/ Lic.No/Date:0910067620 31.05.2019|Case No.:4/6/82-ALC4/2019Party Name:DIVIS LABORATORIES LTD Meet No/Date:14/82- ALC4/2019 06.03.2020 Status: Approved HQ File :01/82/050/00230/AM20/ RLA File :09/24/040/00101/AM20/ Lic.No/Date:0910067620 31.05.2019|Case No.:4/6/82-ALC4/2019Party Name:DIVIS LABORATORIES LTD Meet No/Date:14/82- ALC4/2019 06.03.2020 Status: Approved HQ File :01/82/050/00230/AM20/ RLA File :09/24/040/00101/AM20/ Lic.No/Date:0910067620 31.05.2019| |---|---|---|---|---|---|---|---|---| |||**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it||||||| |||was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied||||||| |||by firm whichever is lower:||||||| ||||Export Product|Qty.|Sl.|Import items|Qty.|| ||||||No.|||| ||||VALACYCLOVIR HCL|1 kg|1|BENZYL CHLORO|1.19 kg|| |54|||(Valacyclovir HCL Anhydrous)||2|FORMATE L-VALINE|0.77 kg|| ||||||3|PETROLEUM ETHER 90-100|1.07 kg|| |||||||(HEPTANES)||| ||||||4|DI METHYL FORMAMIDE|2.00 kg|| ||||||5|ACETONE|7.50 kg|| ||||||6|FORMIC ACID-94%|0.52 kg|| ||||||7|PALLADIUM METAL|0.00020 kg|| ||||||8|ACYCLOVIR|0.820 kg|| ||||||9|CYCLO HEXYL AMINE|2.04 kg|| ||||||10|UREA|0.570 kg|| ||||||11|ETHYLENE DI CHLORIDE|0.880 kg|| |||RA concerned maytake further necessaryaction asper above decision of NC.|||||||

|0.820 kg|| ||||||9|CYCLO HEXYL AMINE|2.04 kg|| ||||||10|UREA|0.570 kg|| ||||||11|ETHYLENE DI CHLORIDE|0.880 kg|| |||RA concerned maytake further necessaryaction asper above decision of NC.|||||||

Case No.:14/6/82-ALC4/2019	Party Name:GLENMARK	Meet No/Date:14/82-	Status:
	LIFE SCIENCES LIMITED	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:0310829437
:01/82/050/00240/AM20/	:03/94/040/00176/AM20/	06.06.2019

Export Product	Qty.	Sl.	Import items	Qty.
		No.
APREPITANT	1 kg	1	(2S, 3R)-2-[(1R)-1-[3, 5-	1.90 kg
			bis(trifluoromethyl)phenyl]ethoxy]-3-(4-
		2	METHANOL	9.48 Litre
		3	DIMETHYL FORMAMIDE	3.80 Litre

|---|---|---|---| |||No.||| |APREPITANT|1 kg|1|(2S, 3R)-2-[(1R)-1-[3, 5-|1.90 kg| ||||bis(trifluoromethyl)phenyl]ethoxy]-3-(4-|| |||2|METHANOL|9.48 Litre| |||3|DIMETHYL FORMAMIDE|3.80 Litre|

56	Case No.:18/6/82-<br>ALC4/2019	Party Name:SMILAX<br>LABORATORIES LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00244/AM20/	RLA File<br>:09/24/040/00103/AM20/	Lic.No/Date:0910067628<br>06.06.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

57	<br>Case No.:25/6/82-<br>ALC4/2019	Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020<br> <br>Lic.No/Date:0910067641<br>07.06.2019<br> <br>	Status: Deferred
	<br>HQ File<br>:01/82/050/00251/AM20/	RLA File<br>:09/24/040/00098/AM20/		Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

|Status: Deferred| |---|---|---|---|---| || HQ File :01/82/050/00251/AM20/|RLA File :09/24/040/00098/AM20/||Defer Date:06.03.2020| ||**Decision:**Deferred for comments of TE.||||

58	Case No.:30/6/82-<br>ALC4/2019	Party Name:TIDE<br>INDUSTRIES	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00256/AM20/	RLA File<br>:34/24/040/00083/AM20/	Lic.No/Date:3410045200<br>10.06.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

Case No.:31/6/82-ALC4/2019	Party Name:GITANJALI	Meet No/Date:14/82-	Status:
	CHEMICALS PVT LTD	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:0310829535
:01/82/050/00257/AM20/	:03/94/040/01070/AM19/	11.06.2019

|---|---|---|---|---| |||CHEMICALS PVT LTD||ALC4/2019||Approved| |||||06.03.2020||| |HQ File||RLA File||Lic.No/Date:0310829535||| |:01/82/050/00257/AM20/||:03/94/040/01070/AM19/||11.06.2019|||

Decision: The Committee considered case as per agenda in the presence of the technical experts and it 59 was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

Export Product	Qty.	Sl.<br>No.	Import items	Qty.
4-CHLOROANISOLE	1 kg	1	PARA CHLORO PHENOL	0.990 kg

60	Case No.:36/6/82-<br>ALC4/2019	Party Name:NOVEL<br>NUTRIENTS PVT LTD	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00262/AM20/	RLA File<br>:07/24/040/00056/AM20/	Lic.No/Date:0710115041<br>11.06.2019	Defer<br>Date:06.03.2020
	Decision:The Committee considered the case as per agenda and it was noted that the firm vide its e-<br>mail dated 28.02.2020 has furnished its reply. Deferred for comments of TE.

61	<br>Case No.:33/6/82-ALC4/2019	Party Name:ASHISH LIFE<br>SCIENCE PVT.LTD.<br>RLA File<br>:03/94/040/00197/AM20/	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred<br> <br>Defer<br>Date:06.03.2020
	<br>HQ File<br>:01/82/050/00259/AM20/		Lic.No/Date:0310829569<br>12.06.2019
	Decision:Deferred for comment of TE.

Deferred Defer Date:06.03.2020| |---|---|---|---|---| || HQ File :01/82/050/00259/AM20/||Lic.No/Date:0310829569 12.06.2019|| ||**Decision:**Deferred for comment of TE.||||

62	<br>Case No.:34/6/82-<br>ALC4/2019	Party Name:DIPS<br>BIOSCIENCE PVT.LTD.	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00260/AM20/	RLA File<br>:03/94/040/00199/AM20/	Lic.No/Date:0310829573<br>12.06.2019	Defer<br>Date:06.03.2020
	Decision:Deferred for comment of TE.

63	<br>Case No.:40/6/82-<br>ALC4/2019	Party Name:NECTAR<br>LIFESCIENCES LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00266/AM20/	RLA File<br>:22/24/040/00101/AM19/	Lic.No/Date:2210016183<br>12.06.2019	Defer<br>Date:06.03.2020
	Decision:Deferred for comment of TE.

64	<br>Case No.:41/6/82-<br>ALC4/2019	Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00267/AM20/	RLA File<br>:09/24/040/00107/AM20/	Lic.No/Date:0910067652<br>12.06.2019	Defer<br>Date:06.03.2020
	Decision:Deferred for comment of TE.

-|---| || HQ File :01/82/050/00267/AM20/|RLA File :09/24/040/00107/AM20/|Lic.No/Date:0910067652 12.06.2019|Defer Date:06.03.2020| ||**Decision:**Deferred for comment of TE.||||

Case No.:44/6/82-ALC4/2019	Party Name:DIVIS	Meet No/Date:14/82-	Status:
	LABORATORIES LTD	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:0910067663
:01/82/050/00270/AM20/	:09/24/040/00118/AM20/	13.06.2019

	Case No.:44/6/82-ALC4/2019	Party Name:DIVIS<br>LABORATORIES LTD<br>RLA File<br>:09/24/040/00118/AM20/	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Approved
	HQ File<br>:01/82/050/00270/AM20/		Lic.No/Date:0910067663<br>13.06.2019
65	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>LEVETIRACETAM<br>1 kg<br>1<br>SODIUM METHOXIDE<br>POWDWE<br>0.72 kg<br>2<br>TOLUENE<br>2.12 kg<br>3<br>METHYLENE CHLORIDE<br>2.55 kg<br>4<br>D(+)ALPHA PHENYL<br>ETHYL AMINE<br>0.35 kg<br>5<br>TRI ETHYL AMINE<br>1.17 kg<br>6<br>ISO PROPYL ALCOHOL<br>0.90 kg<br>7<br>ACETONE<br>0.56 kg<br>8<br>ETHYL CHLORO FORMATE<br>1.04 kg<br>9<br>2-PYRROLIDONE<br>1.36 kg<br>10<br>N-BUTYRIC ACID<br>1.82 kg<br>11<br>LIQUID BROMINE<br>3.63 kg<br>12<br>ETHYL ACETATE<br>2.03 kg<br>RA concerned maytake further necessarya

O FORMATE 1.04 kg 9 2-PYRROLIDONE 1.36 kg 10 N-BUTYRIC ACID 1.82 kg 11 LIQUID BROMINE 3.63 kg 12 ETHYL ACETATE 2.03 kg RA concerned maytake further necessaryaction asper above decision of NC.||||

66	Case No.:45/6/82-<br>ALC4/2019	Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00271/AM20/	RLA File<br>:09/24/040/00114/AM20/	Lic.No/Date:0910067664<br>13.06.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

67	<br>Case No.:49/6/82-<br>ALC4/2019	Party Name:DHANUKA<br>LABORATORIES LTD	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00275/AM20/	RLA File<br>:05/23/040/00104/AM20/	Lic.No/Date:0510410949<br>14.06.2019	Defer<br>Date:06.03.2020
	Decision:Deferred for comment of TE.

68	<br>Case No.:50/6/82-<br>ALC4/2019	Party Name:VISION DRUGS<br>PRIVATE LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020<br> <br>Lic.No/Date:0910067669<br>14.06.2019<br> <br>	Status: Deferred
	<br>HQ File<br>:01/82/050/00276/AM20/	RLA File<br>:09/24/040/00121/AM20/		Defer<br>Date:06.03.2020
	Decision:Deferred for comment of TE.

Case No.:52/6/82-ALC4/2019	Party Name:DECCAN	Meet No/Date:14/82-	Status:
	NUTRACEUTICALS PVT	ALC4/2019	Deferred
	LTD	06.03.2020
HQ File	RLA File	Lic.No/Date:0210209261	Defer
:01/82/050/00278/AM20/	:02/24/040/00042/AM20/	17.06.2019	Date:06.03.2020

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 69 meeting no. 7/82-ALC4/2018 dated 24.08.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

er decision taken in 69 meeting no. 7/82-ALC4/2018 dated 24.08.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export product<br>Digoxin	Qty.	Sl.<br>No.	Import items	Qty.<br>266.24 kg
	1 kg	1	Digitalis Lanata Leaves (Dried)

Case No.:53/6/82-	Party Name:KAIRAV	Meet No/Date:14/82-	Status:
ALC4/2019	CHEMOFARBE	ALC4/2019	Deferred
	INDUSTRIES LTD.	06.03.2020
HQ File	RLA File	Lic.No/Date:0310829703	Defer
:01/82/050/00279/AM20/	:03/94/040/00201/AM20/	17.06.2019	Date:06.03.2020

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not 70 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. Further, the Committee considered the case as per online generated agenda in the presence of technical experts and it was decided to call for following information from the firm: (i) Certificate of Analysis ( CoA) of import item from foreign supplier. (ii) Certificate of Analysis ( CoA) of export product.

Case No.:54/6/82-ALC4/2019	Party Name:COVALENT	Meet No/Date:14/82-	Status:
	LABORATORIES PRIVATE	ALC4/2019	Approved
	LIMITED	06.03.2020
HQ File	RLA File	Lic.No/Date:0910067671
:01/82/050/00280/AM20/	:09/24/040/00130/AM20/	18.06.2019

--|---|---| |||LABORATORIES PRIVATE||ALC4/2019||Approved| |||LIMITED||06.03.2020||| |HQ File||RLA File||Lic.No/Date:0910067671||| |:01/82/050/00280/AM20/||:09/24/040/00130/AM20/||18.06.2019|||

	Case No.:54/6/82-ALC4/2019	Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00130/AM20/	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020<br>Lic.No/Date:0910067671<br>18.06.2019	Status:<br>Approved<br>
	HQ File<br>:01/82/050/00280/AM20/
71	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Cefuroxime Axetil Amorphous<br>1 kg<br>1<br>Descarbamoyl<br>Cefuroxime<br>Acid<br>(DCC)<br>1.10 kg<br>2<br>Cholorosulphonyl Isocynate<br>0.53 kg<br>3<br>Dimethyl Acetamide<br>2.14 kg<br>4<br>Acetone<br>6.50 kg<br>5<br>Methanol<br>2.27 kg<br>6<br>Activated Carbon<br>0.100 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

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

Case No.:56/6/82-ALC4/2019	Party Name:SOLARA ACTIVE	Meet No/Date:14/82-	Status:
	PHARMA SCIENCES	ALC4/2019	Approved
	LIMITED	06.03.2020
HQ File	RLA File	Lic.No/Date:0410165732
:01/82/050/00282/AM20/	:04/24/040/00050/AM20/	18.06.2019

|||Case No.:56/6/82-ALC4/2019Party Name:SOLARA ACTIVE PHARMA SCIENCES LIMITED Meet No/Date:14/82- ALC4/2019 06.03.2020 Status: Approved HQ File :01/82/050/00282/AM20/ RLA File :04/24/040/00050/AM20/ Lic.No/Date:0410165732 18.06.2019|Case No.:56/6/82-ALC4/2019Party Name:SOLARA ACTIVE PHARMA SCIENCES LIMITED Meet No/Date:14/82- ALC4/2019 06.03.2020 Status: Approved HQ File :01/82/050/00282/AM20/ RLA File :04/24/040/00050/AM20/ Lic.No/Date:0410165732 18.06.2019|Case No.:56/6/82-ALC4/2019Party Name:SOLARA ACTIVE PHARMA SCIENCES LIMITED Meet No/Date:14/82- ALC4/2019 06.03.2020 Status: Approved HQ File :01/82/050/00282/AM20/ RLA File :04/24/040/00050/AM20/ Lic.No/Date:0410165732 18.06.2019|Case No.:56/6/82-ALC4/2019Party Name:SOLARA ACTIVE PHARMA SCIENCES LIMITED Meet No/Date:14/82- ALC4/2019 06.03.2020 Status: Approved HQ File :01/82/050/00282/AM20/ RLA File :04/24/040/00050/AM20/ Lic.

ACTIVE PHARMA SCIENCES LIMITED Meet No/Date:14/82- ALC4/2019 06.03.2020 Status: Approved HQ File :01/82/050/00282/AM20/ RLA File :04/24/040/00050/AM20/ Lic.No/Date:0410165732 18.06.2019|Case No.:56/6/82-ALC4/2019Party Name:SOLARA ACTIVE PHARMA SCIENCES LIMITED Meet No/Date:14/82- ALC4/2019 06.03.2020 Status: Approved HQ File :01/82/050/00282/AM20/ RLA File :04/24/040/00050/AM20/ Lic.No/Date:0410165732 18.06.2019|Case No.:56/6/82-ALC4/2019Party Name:SOLARA ACTIVE PHARMA SCIENCES LIMITED Meet No/Date:14/82- ALC4/2019 06.03.2020 Status: Approved HQ File :01/82/050/00282/AM20/ RLA File :04/24/040/00050/AM20/ Lic.No/Date:0410165732 18.06.2019|Case No.:56/6/82-ALC4/2019Party Name:SOLARA ACTIVE PHARMA SCIENCES LIMITED Meet No/Date:14/82- ALC4/2019 06.03.2020 Status: Approved HQ File :01/82/050/00282/AM20/ RLA File :04/24/040/00050/AM20/ Lic.No/Date:0410165732 18.06.2019| |---|---|---|---|---|---|---|---|---| |||**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in||||||| |||meeting no.

te:0410165732 18.06.2019| |---|---|---|---|---|---|---|---|---| |||**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in||||||| |||meeting 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:||||||| |72|||Export product|Qty.|Sl. No.|Import items|Qty.|| ||||IBUPROFEN USP|1 kg|1|ISO BUTYL BENZENE (IBB)|0.887 kg|| ||||||2|ACETYL CHLORIDE|0.588 kg|| ||||||3|SODIUM METAL|0.219 kg|| ||||||4|MANOCHLORO ACETIC ACID|0.919 kg|| ||||||5|ISO-PROPYL ALCOHOL|0.250 kg|| ||||||6|ISO-PROPYL ALCOHOL|0.250 kg|| ||||||7|SODIUM DICHROMATE|0.630 kg|| |||RA concerned maytake further necessaryaction asper above decision of NC.|||||||

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting 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:

rlier decision taken in meeting 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:

	Case No.:60/6/82-ALC4/2019Party Name:TIDE	Meet No/Date:14/82-	Status:
	INDUSTRIES	ALC4/2019	Deferred
		06.03.2020
73	HQ File<br>:01/82/050/00286/AM20/<br>RLA File<br>:34/24/040/00101/AM20/	Lic.No/Date:3410045217<br>18.06.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of 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.:61/6/82-<br>Party Name:ASTRAL	Meet No/Date:14/82-	Status:
	ALC4/2019<br>STERITECH PVT. LTD.	ALC4/2019	Deferred
		06.03.2020
74	HQ File<br>:01/82/050/00287/AM20/<br>RLA File<br>:34/24/040/00102/AM20/	Lic.No/Date:3410045218<br>19.06.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

75	Case No.:67/6/82-<br>ALC4/2019	Party Name:ASTRAL<br>STERITECH PVT. LTD.	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00293/AM20/	RLA File<br>:34/24/040/00100/AM20/	Lic.No/Date:3410045222<br>20.06.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

76	<br>Case No.:75/6/82-ALC4/2019	Party Name:NAARI PHARMA<br>PRIVATE LIMITED<br>RLA File<br>:05/24/040/00172/AM20/	<br>Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred<br> <br>Defer<br>Date:06.03.2020
	<br>HQ File<br>:01/82/050/00301/AM20/		Lic.No/Date:0510411026<br>24.06.2019
	Decision:Deferred for comments of TE.

77	Case No.:76/6/82-<br>ALC4/2019	Party Name:ORTIN<br>LABORATORIES LTD	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00302/AM20/	RLA File<br>:09/24/040/00132/AM20/	Lic.No/Date:0910067687<br>24.06.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

78	Case No.:77/6/82-<br>ALC4/2019	Party Name:ORTIN<br>LABORATORIES LTD	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00303/AM20/	RLA File<br>:09/24/040/00133/AM20/	Lic.No/Date:0910067688<br>24.06.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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.:83/6/82-ALC4/2019Party Name:THINQ PHARMA<br>Meet No/Date:14/82-	Case No.:83/6/82-ALC4/2019Party Name:THINQ PHARMA<br>Meet No/Date:14/82-		Status:
	CRO LIMITED	ALC4/2019		Approved
		06.03.2020
	HQ File<br>RLA File	Lic.No/Date:0310829925
	:01/82/050/00309/AM20/<br>:03/95/040/00279/AM20/<br>26.06.2019
	Decision:<br>The Committee considered case as per	agenda in the presence of the technical experts and
79	it was decided to ratify the ad-hoc input output norms	under para 4.7 of HBP as per	details below or as
	applied by firm whichever is lower:
	Export Product<br>Qty.<br>Sl.	Import items	Qty.
	No.
	Dimethyl Isosorbide<br>1 kg<br>1	Isosorbide	0.93 kg
	RA concerned maytake further necessaryaction asper above decision of NC.

Case No.:88/6/82-ALC4/2019	Party Name:DIVIS	Meet No/Date:14/82-	Status:
	LABORATORIES LTD	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:0910067706
:01/82/050/00314/AM20/	:09/24/040/00151/AM20/	27.06.2019

-|---|---|---|---|---| |||LABORATORIES LTD||ALC4/2019||Approved| |||||06.03.2020||| |HQ File||RLA File||Lic.No/Date:0910067706||| |:01/82/050/00314/AM20/||:09/24/040/00151/AM20/||27.06.2019|||

	:01/82/050/00314/AM20/<br>:09/24/040/00151/AM20/<br>27.06.2019	:01/82/050/00314/AM20/<br>:09/24/040/00151/AM20/<br>27.06.2019	:01/82/050/00314/AM20/<br>:09/24/040/00151/AM20/<br>27.06.2019	:01/82/050/00314/AM20/<br>:09/24/040/00151/AM20/<br>27.06.2019	:01/82/050/00314/AM20/<br>:09/24/040/00151/AM20/<br>27.06.2019
	Decision:The Committee considered case as per agenda in the presence					of the technical experts and it
	was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as					per details below or as applied
	by firm whichever is lower:
		Export Product	Qty.	Sl.	Import items		Qty.
				No.
		VALACYCLOVIR HCL	1 kg	1	BENZYL	CHLORO	1.19 kg
80		(Valacyclovir HCL Anhydrous)		2	FORMATE<br>L-VALINE		0.77 kg
				3	PETROLEUM ETHER 90-100		1.07 kg
					(HEPTANES)
				4	DI METHYL FORMAMIDE		2.00 kg
				5	ACETONE		7.50 kg
				6	FORMIC ACID-94%		0.52 kg
				7	PALLADIUM METAL		0.00020 kg
				8	ACYCLOVIR		0.820 kg
				9	CYCLO HEXYL AMINE		2.04 kg
				10	UREA		0.570 kg
				11	ETHYLENE DI CHLORIDE		0.880 kg
	RA concerned maytake further necessaryaction asper above decision of NC.

20 kg|| ||||||9|CYCLO HEXYL AMINE||2.04 kg|| ||||||10|UREA||0.570 kg|| ||||||11|ETHYLENE DI CHLORIDE||0.880 kg|| |||RA concerned maytake further necessaryaction asper above decision of NC.||||||||

	Case No.:89/6/82-ALC4/2019	Party Name:AURORE LIFE	Meet No/Date:14/82-	Status:
		SCIENCES PRIVATE	ALC4/2019	Deferred
		LIMITED	06.03.2020
81	HQ File	RLA File	Lic.No/Date:0910067709	Defer
	:01/82/050/00315/AM20/	:09/24/040/00157/AM20/	27.06.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

	Case No.:93/6/82-	Party Name:CONCORD	Meet No/Date:14/82-	Status:
82<br> <br> <br> <br> <br> <br>	<br>ALC4/2019<br>HQ File<br>:01/82/050/00319/AM20/	<br>BIOTECH LTD	<br>ALC4/2019<br>06.03.2020	<br>Deferred
		RLA File<br>:08/24/040/00101/AM20/	Lic.No/Date:0810145581	Defer
			<br>27.06.2019	<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 applicatio<br>available. Hence, it was decided to call for a copy of 4.07 app	e noted that the 407 applicatio	n of subject Advance Au	thorization is not
			<br>lication of the subject adv	<br>ance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

applicatio|n of subject Advance Au|thorization is not| |||| lication of the subject adv| ance authorization| ||directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.||||

	Case No.:103/6/82-		Party	Meet No/Date:14/82-		Status: Deferred
	ALC4/2019		Name:SMILAX LABORATORI	ALC4/2019
			ES LIMITED	06.03.2020
	HQ File		RLA File	Lic.No/Date:0910067		Defer
83	:01/82/050/00329/AM20/		:09/24/040/00146/AM20/	735		Date:06.03.2020
				02.07.2019
	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
	directlyfrom the firm asper	PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

	Case No.:107/6/82-	Party Name:VIVIMED LIFE	Meet No/Date:14/82-	Status:
	ALC4/2019	SCIENCES PRIVATE	ALC4/2019	Deferred
		LIMITED	06.03.2020
84	HQ File	RLA File	Lic.No/Date:0910067741	Defer
	:01/82/050/00333/AM20/	:09/24/040/00156/AM20/	03.07.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

	Case No.:108/6/82-	Party Name:FRESENIUS		Meet No/Date:14/82-	Status:
	ALC4/2019	KABI ONCOLOGY LIMITED		ALC4/2019	Deferred
				06.03.2020
	HQ File	RLA File		Lic.No/Date:0510411135	Defer
85	:01/82/050/00334/AM20/<br>:05/23/040/00129/AM20/<br>03.07.2019<br>Decision:The firm vide e-mail dated 31.01.2020 has informed that they had obtained the				Date:06.03.2020<br>subject Advance
	Authorization under self ratification scheme.
	The Committee considered the request of firm and it was		decided to verify the same		from CLA, New
	Delhi.

r>subject Advance| |||Authorization under self ratification scheme.||||||| |||The Committee considered the request of firm and it was|||decided to verify the same|||from CLA, New| |||Delhi.|||||||

	Case No.:112/6/82-	Party Name:MAHARSHI	Meet No/Date:14/82-	Status:
	ALC4/2019	PHARMA CHEM PRIVATE	ALC4/2019	Deferred
		LIMITED	06.03.2020
86	HQ File	RLA File	Lic.No/Date:0810145626	Defer
	:01/82/050/00338/AM20/	:08/24/040/00112/AM20/	03.07.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

	Case No.:114/6/82-	Party Name:TITAN<br>Meet No/Date:14/82-		Status:
	ALC4/2019	LABORATORIES PVT. LTD.<br>ALC4/2019		Deferred
		06.03.2020
	HQ File	RLA File<br>Lic.No/Date:0310830043		Defer
87	:01/82/050/00340/AM20/<br>:03/95/040/00318/AM20/<br>03.07.2019<br>Decision:The Committee considered the case as per online agenda in the presence of		Date:06.03.2020<br>technical experts
	and it was decided to call	for following information from the firm:
	(i)	Master Batch Formula (MBF) and
	(ii)	Drug Manufacturing License(DML).

technical experts|| |||and it was decided to call|for following information from the firm:||| |||(i)|Master Batch Formula (MBF) and||| |||(ii)|**Drug Manufacturing License(DML). **|||

	Case No.:117/6/82-<br>Party Name:SYNTHO	Meet No/Date:14/82-	Status:
	ALC4/2019<br>CHIRALS PRIVATE	ALC4/2019	Deferred
	LIMITED	06.03.2020
88	HQ File<br>:01/82/050/00343/AM20/<br>RLA File<br>:09/24/040/00172/AM20/	Lic.No/Date:0910067749<br>03.07.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

	Case No.:116/6/82-<br>Party Name:LUPIN LIMITED Meet No/Date:14/82-	Status:
	ALC4/2019<br>ALC4/2019	Deferred
	06.03.2020
	HQ File<br>RLA File<br>Lic.No/Date:0310830087	Defer
89	:01/82/050/00342/AM20/<br>:03/95/040/00301/AM20/<br>04.07.2019<br>Date:06.03.2020<br>Decision:The firm vide e-mail dated 30.01.2020 has informed that they had applied under para 4.18 of
	HBP Vol. I and hence they should be exempted from approval of NC.
	The Committee considered the request of firm and it was decided to verify the same from
	RLA,Mumbai.

	Case No.:122/6/82-<br>Party Name:PROLIFE	Meet No/Date:14/82-	Status:
	ALC4/2019<br>INDUSTRIES LIMITED	ALC4/2019	Deferred
		06.03.2020
90	HQ File<br>:01/82/050/00348/AM20/<br>RLA File<br>:03/95/040/00329/AM20/	Lic.No/Date:0310830123<br>05.07.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:127/6/82-	Party Name:APNAR	Meet No/Date:14/82-	Status:
ALC4/2019	PHARMA PRIVATE	ALC4/2019	Deferred
	LIMITED	06.03.2020
HQ File	RLA File	Lic.No/Date:3410045258	Defer
:01/82/050/00353/AM20/	:34/24/040/00098/AM20/	05.07.2019	Date:06.03.2020

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

(i) Export quantity to be given in number of Tablets / Capsules. (ii) Detailed working of inputs applied. (iii) Master Batch Formula for each export product.

lowing information from the firm:

(i) Export quantity to be given in number of Tablets / Capsules. (ii) Detailed working of inputs applied. (iii) Master Batch Formula for each export product.

92	Case No.:130/6/82-<br>ALC4/2019	Party Name:ACME<br>GENERICS LLP	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00356/AM20/	RLA File<br>:22/24/040/00026/AM20/	Lic.No/Date:2210016194<br>08.07.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

93	<br>Case No.:145/6/82-<br>ALC4/2019	Party Name:MAHARSHI<br>PHARMA CHEM PRIVATE<br>LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred<br> <br>Defer<br>Date:06.03.2020
	<br>HQ File<br>:01/82/050/00371/AM20/	RLA File<br>:08/24/040/00114/AM20/	Lic.No/Date:0810145666<br>09.07.2019
	Decision:Deferred for comments of TE.

:06.03.2020| |---|---|---|---|---| || HQ File :01/82/050/00371/AM20/|RLA File :08/24/040/00114/AM20/|Lic.No/Date:0810145666 09.07.2019|| ||**Decision:**Deferred for comments of TE.||||

94	<br>Case No.:146/6/82-<br>ALC4/2019	Party Name:MAHARSHI<br>PHARMA CHEM PRIVATE<br>LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00372/AM20/	RLA File<br>:08/24/040/00115/AM20/	Lic.No/Date:0810145667<br>09.07.2019	Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

95	<br>Case No.:150/6/82-<br>ALC4/2019	Party Name:MAHARSHI<br>PHARMA CHEM PRIVATE<br>LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00376/AM20/	RLA File<br>:08/24/040/00116/AM20/	Lic.No/Date:0810145668<br>09.07.2019	Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

96	<br>Case No.:151/6/82-<br>ALC4/2019	Party Name:MAHARSHI<br>PHARMA CHEM PRIVATE<br>LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00377/AM20/	RLA File<br>:08/24/040/00117/AM20/	Lic.No/Date:0810145669<br>09.07.2019	Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

-|---|---| || HQ File :01/82/050/00377/AM20/|RLA File :08/24/040/00117/AM20/|Lic.No/Date:0810145669 09.07.2019|Defer Date:06.03.2020| ||**Decision:**Deferred for comments of TE.||||

Case No.:147/6/82-ALC4/2019	Party Name:CIPLA LIMITED.	Meet No/Date:14/82-	Status:
		ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:0310830195
:01/82/050/00373/AM20/	:03/94/040/00281/AM20/	10.07.2019

	Case No.:147/6/82-ALC4/2019	Party Name:CIPLA LIMITED.	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Approved
	HQ File<br>:01/82/050/00373/AM20/	RLA File<br>:03/94/040/00281/AM20/	Lic.No/Date:0310830195<br>10.07.2019
97	<br>Decision:The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 10/AM20 dated 29.11.2019, 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:Amoxicillin and Clavulanate Potassium for Oral Suspension USP 250mg / 62.5mg in<br>75 ml, 100 ml and 150 ml<br>S.No.<br>Import Item<br>For export of 1000 No.pack<br>75 ml<br>100 ml<br>150 ml<br>1.<br>Amoxycillin Trihydrate<br>4.200 kg<br>5.649 kg<br>8.274 kg<br>2.<br>CLAVULANATE<br>POTASSIUM<br>WITH<br>SILICON DIOXIDE 1:1<br>2.3444 kg<br>3.126 kg<br>4.6888 kg<br>3.<br>SILICONE DIOXIDE(SYLOID 244FP)<br>1.50 kg<br>2.00 kg<br>3.00 kg<br>4.<br>115CC HDPE BOTTLES 75 ML(250/62.5)<br>Relevant as per packing policy<br>5.<br>185 CC HD

44 kg 3.126 kg 4.6888 kg 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 RA concerned maytake further necessaryaction asper above decision of NC.||||

98	Case No.:148/6/82-<br>ALC4/2019	Party Name:THINQ<br>PHARMA CRO LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00374/AM20/	RLA File<br>:03/95/040/00338/AM20/	Lic.No/Date:0310830207<br>10.07.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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.

99<br> <br> <br> <br> <br> <br> <br>	Case No.:155/6/82-<br>ALC4/2019<br> <br> <br>HQ File<br>:01/82/050/00381/AM20/<br> <br>:	Party Name:ORIENTAL<br>AROMATICS LTD	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
		RLA File<br>03/95/040/00335/AM20/	Lic.No/Date:0310830246<br>12.07.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

100	<br>Case No.:157/6/82-<br>ALC4/2019<br>Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>HQ File<br>:01/82/050/00383/AM20/<br>RLA File<br>:09/24/040/00187/AM20/<br>Decision:Deferred for comments of TE.	Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00187/AM20/	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred<br> <br>Defer<br>Date:06.03.2020
			Lic.No/Date:0910067778<br>12.07.2019

101	<br>Case No.:162/6/82-<br>ALC4/2019<br>Party Name:ANG<br>LIFESCIENCES INDIA LTD<br>Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020<br>Status:<br>Deferred<br>HQ File<br>:01/82/050/00388/AM20/<br>RLA File<br>:30/24/040/00064/AM20/<br>Lic.No/Date:3010104756<br>12.07.2019<br>Defer<br>Date:06.03.2020<br>Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.	Party Name:ANG<br>LIFESCIENCES INDIA LTD<br>RLA File<br>:30/24/040/00064/AM20/	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
			Lic.No/Date:3010104756<br>12.07.2019	<br>Defer<br>Date:06.03.2020

e :30/24/040/00064/AM20/|Meet No/Date:14/82- ALC4/2019 06.03.2020|Status: Deferred| |---|---|---|---|---| ||||Lic.No/Date:3010104756 12.07.2019| Defer Date:06.03.2020|

102	<br>Case No.:160/6/82-<br>ALC4/2019<br>Party Name:ORIENTAL<br>AROMATICS LTD<br>Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020<br>Status:<br>Deferred<br>HQ File<br>:01/82/050/00386/AM20/<br>RLA File<br>:03/95/040/00363/AM20/<br>Lic.No/Date:0310830298<br>15.07.2019<br>Defer<br>Date:06.03.2020<br>Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.	Party Name:ORIENTAL<br>AROMATICS LTD<br>RLA File<br>:03/95/040/00363/AM20/	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
			Lic.No/Date:0310830298<br>15.07.2019	<br>Defer<br>Date:06.03.2020

e :03/95/040/00363/AM20/|Meet No/Date:14/82- ALC4/2019 06.03.2020|Status: Deferred| |---|---|---|---|---| ||||Lic.No/Date:0310830298 15.07.2019| Defer Date:06.03.2020|

Case No.:128/10/82-	Party Name:SRIAM LABS	Meet No/Date:14/82-	Status:
ALC4/2019	PRIVATE LIMITED	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:091006778
:01/82/050/00702/AM20/	:09/24/040/00200/AM20/	9
		16.07.2019

Decision: The Committee considered case as per agenda in the presence of the technical experts and it 103 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.
Hydroxychloroquine(2-[[4-[(7-Chloro-4-	1 kg	1	4,7-dichloroquinoline	0.934 kg
quinolyl)amino]pentyl]ethylamino]ethanol)		2	Hydroxynovaldiamine	0.866 kg

ms|Qty.| |---|---|---|---|---| |||No.||| |Hydroxychloroquine(2-[[4-[(7-Chloro-4-|1 kg|1|4,7-dichloroquinoline|0.934 kg| |quinolyl)amino]pentyl]ethylamino]ethanol)||2|Hydroxynovaldiamine|0.866 kg|

	Case No.:169/6/82-<br>Party Name:PRACHEM	Meet No/Date:14/82-	Status:
	ALC4/2019<br>LABORATORIES	ALC4/2019	Deferred
		06.03.2020
104	HQ File<br>:01/82/050/00395/AM20/<br>RLA File<br>:08/24/040/00123/AM20/	Lic.No/Date:0810145731<br>17.07.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

	Case No.:170/6/82-	Party Name:RUBICON	Meet No/Date:14/82-	Status:
	ALC4/2019	RESEARCH PVT. LTD.,	ALC4/2019	Deferred
			06.03.2020
105	HQ File	RLA File	Lic.No/Date:0310830404	Defer
	:01/82/050/00396/AM20/	:03/95/040/00251/AM20/	18.07.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

.2020||| |105||HQ File||RLA File||Lic.No/Date:0310830404||Defer| |||:01/82/050/00396/AM20/||:03/95/040/00251/AM20/||18.07.2019||Date:06.03.2020| |||**Decision:**Deferred for comments of TE.|||||||

	Case No.:199/6/82-	Party Name:CIRON DRUGS	Meet No/Date:14/82-	Status:
	ALC4/2019	& PHARMACEUTICALS P.	ALC4/2019	Deferred
		LTD.,	06.03.2020
106	HQ File	RLA File	Lic.No/Date:0310830435	Defer
	:01/82/050/00425/AM20/	:03/94/040/00312/AM20/	19.07.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

Case No.:208/6/82-ALC4/2019	Party Name:VISION DRUGS	Meet No/Date:14/82-	Status:
	PVT LTD	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:0910067812
:01/82/050/00434/AM20/	:09/24/040/00210/AM20/	23.07.2019

	Case No.:208/6/82-ALC4/2019	Case No.:208/6/82-ALC4/2019	Party Name:VISION DRUGS<br>PVT LTD<br>RLA File<br>:09/24/040/00210/AM20/	Party Name:VISION DRUGS<br>PVT LTD<br>RLA File<br>:09/24/040/00210/AM20/	Party Name:VISION DRUGS<br>PVT LTD<br>RLA File<br>:09/24/040/00210/AM20/	Party Name:VISION DRUGS<br>PVT LTD<br>RLA File<br>:09/24/040/00210/AM20/	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Approved
	HQ File<br>:01/82/050/00434/AM20/						Lic.No/Date:0910067812<br>23.07.2019
107	<br>Decision:The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no.

:01/82/050/00434/AM20/||||||Lic.No/Date:0910067812 23.07.2019|| |107| **Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 11/82-ALC4/2019 dated 03.01.2020, 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-Methyl-6-(2,4,4- trimethylpentyl)-2-Hpyron- 2-one 1 kg 1 3,3-dimethylacrylic acid 0.687 kg 2 Isononanoyl Chloride (3,5,5- trimethylhexonyl chloride) 1.05 kg 3 Acetic Acid 0.40 kg 4 Methylene Chloride 0.60 kg 5 Toulene 0.30kg|||||||| |||Export product||Qty.|Sl. No.|Import items||Qty.| |||4-Methyl-6-(2,4,4- trimethylpentyl)-2-Hpyron- 2-one||1 kg|1|3,3-dimethylacrylic acid||0.687 kg| ||||||2|Isononanoyl Chloride (3,5,5- trimethylhexonyl chloride)||1.05 kg| ||||||3|Acetic Acid||0.40 kg| ||||||4|Methylene Chloride||0.60 kg| ||||||5|Toulene||0.30kg| |||||||||| ||RA concerned maytake further necessaryaction asper above decision of NC.||||||||

Case No.:210/6/82-	Party Name:HETERO LABS	Meet No/Date:14/82-	Status:
ALC4/2019	LIMITED	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:0910067817
:01/82/050/00436/AM20/	:09/24/040/00212/AM20/	23.07.2019

-|---|---|---|---| |ALC4/2019||LIMITED||ALC4/2019||Approved| |||||06.03.2020||| |HQ File||RLA File||Lic.No/Date:0910067817||| |:01/82/050/00436/AM20/||:09/24/040/00212/AM20/||23.07.2019|||

	Decision:The Committee considered case as per agenda in the presence of the technical experts and it	Decision:The Committee considered case as per agenda in the presence of the technical experts and it	Decision:The Committee considered case as per agenda in the presence of the technical experts and it	Decision:The Committee considered case as per agenda in the presence of the technical experts and it	Decision:The Committee considered case as per agenda in the presence of the technical experts and it	Decision:The Committee considered case as per agenda in the presence of the technical experts and it	Decision:The Committee considered case as per agenda in the presence of the technical experts and it	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:
108		Export Product		Qty.	Sl.	Import items	Qty.
					No.

ad-hoc input output|||norms under para 4.7 of HBP as per details below or||||as| |||applied by firm whichever||is lower:|||||||| |108|||Export Product|||Qty.|Sl.||Import items|Qty.|| ||||||||No.||||| ||||[4-AMINO-N-(2R,|3S)|(3-|1 kg|1||(2S,3S)-3-(tert-butoxycarbonyl|0.91 kg|| ||||AMINO-2-HYDROXY-4-||||||amino)-1,2-epoxy-4-phenylbutane||| ||||PHENYL-BUTYL)-N-||||2||Isobutylamine|0.98 kg|| ||||ISOBUTYLBENZENE||||3||4 Nitrobenzene sulfonyl chloride|0.91 kg|| ||||SULFONAMIDE]||||4||Methanol|2.37 kg|| ||||||||5||Isopropyl alcohol|6.20 kg|| |||RA concerned maytake further necessaryaction asper above decision of NC.||||||||||

Case No.:212/6/82-	Party Name:HETERO LABS	Meet No/Date:14/82-	Status:
ALC4/2019	LIMITED	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:0910067819
:01/82/050/00438/AM20/	:09/24/040/00211/AM20/	24.07.2019

-|---|---|---|---| |ALC4/2019||LIMITED||ALC4/2019||Approved| |||||06.03.2020||| |HQ File||RLA File||Lic.No/Date:0910067819||| |:01/82/050/00438/AM20/||:09/24/040/00211/AM20/||24.07.2019|||

	Case No.:212/6/82-<br>ALC4/2019	Party Name:HETERO LABS<br>LIMITED<br>RLA File<br>:09/24/040/00211/AM20/	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020<br>Lic.No/Date:0910067819<br>24.07.2019	Status:<br>Approved<br>
	HQ File<br>:01/82/050/00438/AM20/
109	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>3-[3-(4 FLUORO PHENYL)-1-<br>(METHYL ETHYL)-1H-INDOL-<br>2YL]-(E)-2<br>PROPENOL(FENOL)<br>1 kg<br>1<br>3-(4-FLUOROPHENYL)-1-(1-<br>METHYLETHYL)-1H-<br>INDOLE<br>1.03 kg<br>2<br>N-METHYL-N-PHENYL-3-<br>AMINOACROLEIN<br>0.82 kg<br>3<br>PHOSPHORUS<br>OXYCHLORIDE<br>1.00 kg<br>4<br>ACETONITRILE<br>1.00 kg<br>5<br>ETHANOL<br>3.00 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

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

110	<br>Case No.:214/6/82-<br>ALC4/2019	Party Name:CIPLA<br>LIMITED.	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00440/AM20/	RLA File<br>:03/94/040/00324/AM20/	Lic.No/Date:0310830527<br>24.07.2019	Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

111	Case No.:215/6/82-<br>ALC4/2019	Party Name:DEEPAK<br>NOVOCHEM<br>TECHNOLOGIES LTD	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00441/AM20/	RLA File<br>:31/83/040/00047/AM20/	Lic.No/Date:3110067483<br>24.07.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

112	Case No.:216/6/82-<br>ALC4/2019	Party Name:ORIENTAL<br>AROMATICS LTD<br> <br> <br>	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020<br> <br><br>Lic.No/Date:0310830547<br>24.07.2019<br> <br>	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00442/AM20/	RLA File<br>:03/95/040/00413/AM20/<br> <br>		Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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.

113	<br>Case No.:220/6/82-<br>ALC4/2019	Party Name:BHARAT<br>SERUMS & VACCINES<br>LTD<br>RLA File<br>:03/94/040/00313/AM20/	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred<br> <br>Defer<br>Date:06.03.2020
	<br>HQ File<br>:01/82/050/00446/AM20/		Lic.No/Date:0310830591<br>25.07.2019
	Decision:Deferred for comments of TE.

114	Case No.:221/6/82-<br>ALC4/2019	Party Name:ALPHAMED<br>FORMULATIONS<br>PRIVATE LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00447/AM20/	RLA File<br>:09/24/040/00222/AM20/	Lic.No/Date:0910067834<br>25.07.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

115	Case No.:231/6/82-<br>ALC4/2019	Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00457/AM20/	RLA File<br>:09/24/040/00215/AM20/	Lic.No/Date:0910067841<br>26.07.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

116	<br>Case No.:234/6/82-<br>ALC4/2019<br>Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>HQ File<br>:01/82/050/00460/AM20/<br>RLA File<br>:09/24/040/00226/AM20/<br>Decision:Deferred for comments of TE.	Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00226/AM20/	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
			Lic.No/Date:0910067843<br>26.07.2019	<br>Defer<br>Date:06.03.2020


117	<br>Case No.:235/6/82-<br>ALC4/2019	Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00225/AM20/	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred<br> <br>Defer<br>Date:06.03.2020
	<br>HQ File<br>:01/82/050/00461/AM20/		Lic.No/Date:0910067844<br>26.07.2019
	Decision:Deferred for comments of TE.

118	<br>Case No.:236/6/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00462/AM20/	Party Name:ACME<br>GENERICS LLP<br> <br> <br>	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020<br> <br><br>Lic.No/Date:2210016214<br>26.07.2019<br> <br>	Status:<br>Deferred
		RLA File<br>:22/24/040/00031/AM20/<br> <br>		Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available.

eferred**| |||RLA File :22/24/040/00031/AM20/ ||Defer Date:06.03.2020| ||**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.||||

	Case No.:237/6/82-<br>Party Name:ACME	Meet No/Date:14/82-	Status:
	ALC4/2019<br>GENERICS LLP	ALC4/2019	Deferred
		06.03.2020
119	HQ File<br>:01/82/050/00463/AM20/<br>RLA File<br>:22/24/040/00030/AM20/	Lic.No/Date:2210016215<br>26.07.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

	Case No.:238/6/82-	Party Name:WOCKHARDT	Meet No/Date:14/82-	Status:
	ALC4/2019	LIMITED	ALC4/2019	Deferred
			06.03.2020
120	HQ File	RLA File	Lic.No/Date:0310830632	Defer
	:01/82/050/00464/AM20/	:03/95/040/00426/AM20/	29.07.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

	Case No.:243/6/82-	Party Name:MAHAVIR	Meet No/Date:14/82-	Status:
	ALC4/2019	SYNTHESIS PRIVATE	ALC4/2019	Deferred
		LIMITED	06.03.2020
121	HQ File	RLA File	Lic.No/Date:5210043127	Defer
	:01/82/050/00469/AM20/	:52/24/040/00023/AM20/	29.07.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

.2020||| |121||HQ File||RLA File||Lic.No/Date:5210043127||Defer| |||:01/82/050/00469/AM20/||:52/24/040/00023/AM20/||29.07.2019||Date:06.03.2020| |||**Decision:**Deferred for comments of TE.|||||||

	Case No.:249/6/82-	Case No.:249/6/82-	Party Name:AUROBINDO	Party Name:AUROBINDO			Meet No/Date:14/82-	Status:
	ALC4/2019		PHARMA LIMITED				ALC4/2019	Deferred
							06.03.2020
122	HQ File		RLA File				Lic.No/Date:0910067851	Defer
	:01/82/050/00475/AM20/		<br>:09/24/040/00232/AM20/				30.07.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

	Case No.:254/6/82-		Party Name:POLYGEL				Meet No/Date:14/82-	Status:
	ALC4/2019		INDUSTRIES PVT.LTD				ALC4/2019	Approved
							06.03.2020
	HQ File		RLA File				Lic.No/Date:0310830745
	:01/82/050/00480/AM20/		<br>:03/95/040/00373/AM20/				01.08.2019
	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
123	applied by firm whichever is lower:
		Export Product	Qty.<br>Sl.	Import items				Qty.
			No.
		ISO PROPYL BUTYL	TITANATE<br>1 kg<br>1	TETRA ISO PROPYL TITANATE<br>0.8405 kg
		(PURETI TPT 15B)	2	TETRA<br>NORMAL<br>BUTYL<br>0.1795 kg
				TITANATE

||No.||||||||| |||||ISO PROPYL BUTYL|TITANATE 1 kg 1|TETRA ISO PROPYL TITANATE 0.8405 kg|||||||| |||||(PURETI TPT 15B)|2|TETRA NORMAL BUTYL 0.1795 kg|||||||| |||||||TITANATE|||||||| ||||RA concerned maytake further necessaryaction asper above|||||decision of NC.|||||| |||||||||||||||

124	Case No.:256/6/82-<br>ALC4/2019	Party Name:WEXFORD<br>LABORATORIES P LTD	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020<br> <br><br>Lic.No/Date:0710115236<br>01.08.2019<br> <br>	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00482/AM20/	RLA File<br>:07/24/040/00100/AM20/		Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

125	<br>Case No.:257/6/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00483/AM20/	Party Name:EMMENNAR<br>PHARMA PRIVATE<br>LIMITED<br> <br> <br>	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020<br>S<br><br>Lic.No/Date:0910067855<br>01.08.2019<br> <br>	tatus:<br>Deferred
		RLA File<br>:09/24/040/00229/AM20/<br> <br>		Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

126	Case No.:264/6/82-<br>ALC4/2019	Party Name:DEEPAK<br>NOVOCHEM<br>TECHNOLOGIES LTD	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00490/AM20/	RLA File<br>:31/83/040/00051/AM20/	Lic.No/Date:3110067490<br>02.08.2019	<br>Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

Case No.:265/6/82-	Party Name:GOVIND	Meet No/Date:14/82-	Status:
ALC4/2019	LABORATORIES PVT.	ALC4/2019	Approved
	LTD.,	06.03.2020
HQ File	RLA File	Lic.No/Date:0810145905
:01/82/050/00491/AM20/	:08/24/040/00145/AM20/	02.08.2019

--| |ALC4/2019||LABORATORIES PVT.||ALC4/2019||Approved| |||LTD.,||06.03.2020||| |HQ File||RLA File||Lic.No/Date:0810145905||| |:01/82/050/00491/AM20/||:08/24/040/00145/AM20/||02.08.2019|||

Export Product	Qty.	Sl.<br>No.	Import items	Qty.
NANDROLONE DECANOATE	1 kg	1	19<br>HYDROXY<br>4<br>ANDROSTENE 3,17 DIONE	<br>0.982 kg

Case No.:259/6/82-	Party Name:VISION DRUGS	Meet No/Date:14/82-	Status:
ALC4/2019	PRIVATE LIMITED	ALC4/2019	Deferred
		06.03.2020
HQ File	RLA File	Lic.No/Date:0910067863	Defer
:01/82/050/00485/AM20/	:09/24/040/00240/AM20/	05.08.2019	Date:06.03.2020

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 11/82-ALC4/2019 dated 03.01.2020, 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:

128

Export product	Qty.	Sl.<br>No.	Import items	Qty.
4-Methyl-6-(2,4,4-<br>trimethylpentyl)-2-Hpyron-<br>2-one	1 kg	1	3,3-dimethylacrylic acid	0.687 kg
		2	Isononanoyl Chloride (3,5,5-<br>trimethylhexonyl chloride)	1.05 kg
		3	Acetic Acid	0.40 kg
		4	Methylene Chloride	0.60 kg
		5	Toulene	0.30 kg

1 kg|1|3,3-dimethylacrylic acid|0.687 kg| |||2|Isononanoyl Chloride (3,5,5- trimethylhexonyl chloride)|1.05 kg| |||3|Acetic Acid|0.40 kg| |||4|Methylene Chloride|0.60 kg| |||5|Toulene|0.30 kg|

Case No.:261/6/82-ALC4/2019	Party Name:SUVEN LIFE	Meet No/Date:14/82-	Status:
	SCIENCES LIMITED	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:0910067865
:01/82/050/00487/AM20/	:09/24/040/00242/AM20/	05.08.2019

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 10/82-ALC4/2013 dated 22.08.2013, it was decided to ratify norms under Para 4.7 of HBP v1 129 as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl.<br>No.	Import items	Qty.
3,5-DIACETOXY<br>ACETOPHENONE	1 kg	1	3,5-DIHYDROXY ACETOPHENONE	0.89 kg

	Case No:262/6/82-<br>	art Name:SUVEN LIFE	Meet No/Date:14/82-	Meet No/Date:14/82-	Status:	Status:
130	<br>.<br>ALC4/2019<br> <br> <br>HQ File<br>	y<br>SCIENCES LIMITED	<br>AL<br>06.	<br>C4/2019<br>03.2020	<br>Defe	<br>rred
		RLA File<br>09/24/040/00244/AM20/	Li	No/Date:0910067866	Def	r
	<br>:01/82/050/00488/AM20/<br> <br>:		<br>05.	.<br>08.2019	<br>Date	<br>:06.03.2020
	DiiDfd f	t f TE
	ecson:eerre or com	ens o .

/|Li|No/Date:0910067866|Def|r| || :01/82/050/00488/AM20/ :|| 05.|. 08.2019| Date| :06.03.2020| ||DiiDfd f|t f TE||||| ||**ecson:**eerre or com|ens o .||||| ||||||||


131	<br>Case No.:268/6/82-<br>ALC4/2019	Party Name:CHEMIESYNTH<br>(VAPI)LTD.,<br>RLA File<br>:03/94/040/00363/AM20/	Party Name:CHEMIESYNTH<br>VAPI)LTD.,	<br>M<br>A<br>06	eet No/Date:14/82-<br>LC4/2019<br>.03.2020	Sta<br>Def<br> <br>Def<br>Dat	tus:<br>erred
	<br>HQ File<br>:01/82/050/00494/AM20/			Li<br>05	c.No/Date:0310830809<br>.08.2019		er<br>e:06.03.2020
	Decision:Deferred for comments of TE.

	Case No.:1/10/82-	Party Name:MALLADI	Meet No/Date:14/82-	Status:
	ALC4/2019	DRUGS &	ALC4/2019	Deferred
		PHARMACEUTICALS	06.03.2020
		LIMITED
132	HQ File	RLA File	Lic.No/Date:0410166026	Defer
	:01/82/050/00575/AM20/	:04/24/040/00089/AM20/	29.08.2019	Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:4/10/82-ALC4/2019	Party Name:AURORE LIFE	Meet No/Date:14/82-	Status:
	SCIENCES PRIVATE	ALC4/2019	Approved
	LIMITED	06.03.2020
HQ File	RLA File	Lic.No/Date:0910067959
:01/82/050/00578/AM20/	:09/24/040/00300/AM20/	30.08.2019

133

Export product	Qty.	Sl.	Import items	Qty.
		No.
Piroctone Olamine	1 kg	1	4-methyl-6-(2,4,4-trimethylpentyl)-2-	1.164 kg
			Hpyron-2-one
		2	Hydroxylamine HCl	0.73 kg
		3	Potassium Carbonate	0.90 kg
		4	2-Amino ethanol	0.26 kg

| ||Piroctone Olamine|1 kg|1|4-methyl-6-(2,4,4-trimethylpentyl)-2-|1.164 kg| |||||Hpyron-2-one|| ||||2|Hydroxylamine HCl|0.73 kg| ||||3|Potassium Carbonate|0.90 kg| ||||4|2-Amino ethanol|0.26 kg|

	Case No.:15/10/82-<br>Party Name:SRINI	Meet No/Date:14/82-	Status:
	ALC4/2019<br>PHARMACEUTICALS	ALC4/2019	Deferred
	PRIVATE LIMITED	06.03.2020
134	HQ File<br>:01/82/050/00589/AM20/<br>RLA File<br>:09/24/040/00304/AM20/	Lic.No/Date:0910067970<br>05.09.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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.:16/10/82-<br>ALC4/2019	P<br>&<br>L	arty Name:VIVIN DRUGS<br>PHARMACEUTICALS<br>IMITED	Me<br>AL<br>06.	et No/Date:14/82-<br>C4/2019<br>03.2020	Stat<br>Defe	us:<br>rred
<br>HQ File<br>:01/82/050/00590/AM20/	R<br>:	LA File<br>09/24/040/00289/AM20/	Lic<br>05.	.No/Date:0910067973<br>09.2019	Defe<br>Date	r<br>:06.03.2020
Decision:The Committee noted that the 4.07 application of subject Advance Authori<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance						zation is not<br>authorization
directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

	Case No.:18/10/82-	Party Name:CADILA	Meet No/Date:14/82-	Status:
	ALC4/2019	PHARMACEUTICALS LTD.	ALC4/2019	Deferred
			06.03.2020
136	HQ File	RLA File	Lic.No/Date:0810146100	Defer
	:01/82/050/00592/AM20/	:08/24/040/00175/AM20/	05.09.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

.2020||| |136||HQ File||RLA File||Lic.No/Date:0810146100||Defer| |||:01/82/050/00592/AM20/||:08/24/040/00175/AM20/||05.09.2019||Date:06.03.2020| |||**Decision:**Deferred for comments of TE.|||||||

	Case No.:19/10/82-	Party Name:MEHK	Meet No/Date:14/82-	Status:
	ALC4/2019	CHEMICALS PVT. LTD.	ALC4/2019	Deferred
			06.03.2020
137	HQ File	RLA File	Lic.No/Date:0310831392	Defer
	:01/82/050/00593/AM20/	:03/95/040/00555/AM20/	06.09.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

	Case No.:22/10/82-	Party Name:RELIANCE	Meet No/Date:14/82-	Status:
	ALC4/2019	INDUSTRIES LIMITED	ALC4/2019	Deferred
			06.03.2020
138	HQ File	RLA File	Lic.No/Date:0310831402	Defer
	:01/82/050/00596/AM20/	:03/95/040/00516/AM20/	06.09.2019	Date:29.11.2019
	Decision:The Committee decided to refer the case to Special		Committee for further consideration.

Defer| |||:01/82/050/00596/AM20/||:03/95/040/00516/AM20/||06.09.2019||Date:29.11.2019| |||**Decision:**The Committee decided to refer the case to Special||||Committee for further consideration.|||

	Case No.:27/10/82-	Party Name:M/S	Meet No/Date:14/82-	Status:
	ALC4/2019	HIMALAYAN PRODUCTS	ALC4/2019	Deferred
		& INDUSTRIES CORPN.,	06.03.2020
		P.LTD
139	HQ File	RLA File	Lic.No/Date:6110001614	Defer
	:01/82/050/00601/AM20/	:61/24/040/00007/AM20/	06.09.2019	Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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.

140	Case No.:28/10/82-<br>ALC4/2019	Party Name:SRF LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred<br> <br>Defer<br>Date:06.03.2020
	<br>HQ File<br>:01/82/050/00602/AM20/	RLA File<br>:05/24/040/00296/AM20/	Lic.No/Date:0510411778<br>06.09.2019
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

Case No.:30/10/82-	Party Name:MANGALAM	Meet No/Date:14/82-	Status:
ALC4/2019	DRUGS AND ORGANICS	ALC4/2019	Deferred
	LIMITED	06.03.2020
HQ File	RLA File	Lic.No/Date:0310831434	Defer
:01/82/050/00604/AM20/	:03/95/040/00483/AM20/	09.09.2019	Date:06.03.2020

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 141 Meeting No. 10/82-ALC4/2019 dated 29.11.2019 , followed by Reminder on 20.01.2020 :

it was noted that the firm still has not furnished the following information asked for by NC-3 in its 141 Meeting No. 10/82-ALC4/2019 dated 29.11.2019 , followed by Reminder on 20.01.2020 :

“It was observed that the quantity of import item No. 1 – Ethoxy Methylene Malonic Acid Ester (EMME) – 82000 kg applied by the firm is not correct. Accordingly, the Committee decided to call the correct quantity of import item No. 1 from the firm .”

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

142	<br>Case No.:31/10/82-<br>ALC4/2019	Party Name:SUVEN LIFE<br>SCIENCES LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred<br> <br>Defer<br>Date:06.03.2020
	<br>HQ File<br>:01/82/050/00605/AM20/	RLA File<br>:09/24/040/00307/AM20/	Lic.No/Date:0910067982<br>09.09.2019
	Decision:Deferred for comments of TE.

143	Case No.:32/10/82-<br>ALC4/2019	Party Name:DEEPAK<br>NITRITE LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00606/AM20/	RLA File<br>:34/24/040/00111/AM20/	Lic.No/Date:3410045437<br>09.09.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

	Case No.:33/10/82-	Party Name:NISARG	Meet No/Date:14/82-	Status:
	ALC4/2019	BIOSCIENCES PVT LTD	ALC4/2019	Deferred
			06.03.2020
144	HQ File	RLA File	Lic.No/Date:0910067984	Defer
	:01/82/050/00607/AM20/	:09/24/040/00309/AM20/	11.09.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

	Case No.:34/10/82-	Party Name:OPTRIX	Meet No/Date:14/82-	Status:
	ALC4/2019	LABORATORIES PRIVATE	ALC4/2019	Deferred
		LIMITED	06.03.2020
145	HQ File	RLA File	Lic.No/Date:0910067989	Defer
	:01/82/050/00608/AM20/	:09/24/040/00310/AM20/	11.09.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

.2020||| |145||HQ File||RLA File||Lic.No/Date:0910067989||Defer| |||:01/82/050/00608/AM20/||:09/24/040/00310/AM20/||11.09.2019||Date:06.03.2020| |||**Decision:**Deferred for comments of TE.|||||||

	Case No.:36/10/82-<br>Party Name:HETERO LABS	Meet No/Date:14/82-	Status:
	ALC4/2019<br>LIMITED	ALC4/2019	Deferred
		06.03.2020
146	HQ File<br>:01/82/050/00610/AM20/<br>RLA File<br>:09/24/040/00295/AM20/	Lic.No/Date:0910067990<br>11.09.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

	Case No.:37/10/82-	Party Name:MANKIND	Meet No/Date:14/82-	Status:
	ALC4/2019	PHARMA LTD	ALC4/2019	Deferred
			06.03.2020
	HQ File	RLA File	Lic.No/Date:0510411802	Defer
147	:01/82/050/00611/AM20/	:05/24/040/00336/AM20/	11.09.2019	Date:06.03.2020
	Decision:The Committee considered the case as per agenda and it was decided to call for following
	information from the firm:
	(i) Drug Manufacturing Licence(DML) showing approved composition.

Case No.:38/10/82- Party Name:J.B. Meet No/Date:14/82- Status: ALC4/2019 CHEMICALS & ALC4/2019 Deferred PHARMACEUTICALS 06.03.2020 LIMITED 148 HQ File RLA File Lic.No/Date:0310831483 Defer :01/82/050/00612/AM20/ :03/94/040/00455/AM20/ 11.09.2019 Date:06.03.2020 Decision: Deferred for comments of TE.


149	Case No.:42/10/82-<br>ALC4/2019	P<br>I	arty Name:BENZO CHEM<br>NDUSTRIES PRIVATE	Me<br>AL	et No/Date:14/82-<br>C4/2019	Stat<br>Defe	us:<br>rred
		L	IMITED	06.	03.2020
	<br>HQ File	R	LA File	Lic	.No/Date:0310831519	<br>Defe	r
	:01/82/050/00616/AM20/	:03/94/040/00444/AM20/		13.	09.2019	Date	:06.03.2020
	Decision:Deferred for comments of TE.

|---|---| |ALC4/2019||LABORATORIES LTD||ALC4/2019||Approved| |||||06.03.2020||| |HQ File||RLA File||Lic.No/Date:0910068002||| |:01/82/050/00649/AM20/||:09/24/040/00315/AM20/||17.09.2019|||

	Case No.:75/10/82-<br>ALC4/2019	Party Name:DIVIS<br>LABORATORIES LTD<br>RLA File<br>:09/24/040/00315/AM20/	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020<br>Lic.No/Date:0910068002<br>17.09.2019	Status:<br>Approved<br>
	HQ File<br>:01/82/050/00649/AM20/
160	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>IOPAMIDOL<br>1 kg<br>1<br>ATIPA DI CHLORIDE<br>1.40 kg<br>2<br>DIMETHYL FORMAMIDE<br>0.78 kg<br>3<br>ISOPROPYL ALCOHOL<br>8.13 kg<br>4<br>METHANOL<br>3.21 kg<br>5<br>N,N-DIMETHYL<br>ACETAMIDE<br>1.46 kg<br>6<br>NITRO METHANE<br>0.48 kg<br>7<br>TOLUENE<br>1.00 kg<br>8<br>TRI ETHYL AMINE<br>0.48 kg<br>9<br>L-LACTIC ACID<br>0.73 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

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

Case No.:64/10/82-	Party Name:GLENMARK	Meet No/Date:14/82-	Status:
ALC4/2019	PHARMACEUTICALS LTD	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:0310831612
:01/82/050/00638/AM20/	:03/94/040/00473/AM20/	18.09.2019

	Decision:The Committee considered case as	Decision:The Committee considered case as	Decision:The Committee considered case as	per agenda in the presence of the technical experts and it	per agenda in the presence of the technical experts and it	per agenda in the presence of the technical experts and it	per agenda in the presence of the technical experts and it	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.
161	Estradiol<br>Vaginal<br>Tablet	1 Number		1		Estradiol Hemihydrate USP	10.2 mcg /
	10MCG (Pack size 8 Tabs.)						10 mcg tablet
	(Net<br>Wt.<br>of<br>Estradiol
	Hemihydrate USP is 32.960
	gm.)
	Estradiol<br>Vaginal<br>Tablet	1 Number		1		Estradiol Hemihydrate USP	10.2 mcg /
	10MCG (Pack size 18 Tabs.)						10 mcg tablet

l|||||||| |||Hemihydrate USP is 32.960|||||||| |||gm.)|||||||| |||Estradiol Vaginal Tablet|1 Number||1||Estradiol Hemihydrate USP|10.2 mcg /|| |||10MCG (Pack size 18 Tabs.)||||||10 mcg tablet|| |||(Net Wt. of Estradiol|||||||| |||Hemihydrate USP is 64.890|||||||| |||gm.)|||||||| |||RA concerned maytake further necessaryaction asper||||above decision of NC.||||

Case No.:72/10/82-	Party Name:ASTRAL	Meet No/Date:14/82-	Status:
ALC4/2019	STERITECH PVT. LTD.	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:3410045460
:01/82/050/00646/AM20/	:34/24/040/00183/AM20/	19.09.2019

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

e technical experts|**Decision:**The Committee considered case as per agenda in the presence of the technical experts|**Decision:**The Committee considered case as per agenda in the presence of the technical experts|and it|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.|||||| |162|||CEFEPIME FOR INJECTION USP 1 gm vial|1 Number|1|STERILE CEFEPIME(A Sterile Mixture of|1.8975 gm|||| |||||||CefepimeHydrochloride & L||||| |||||||Arginine)||||| |||||||(Cefepime Content NLT||||| |||||||47.00% and NMT 60.00%)||||| |||||||LArginineContent NLT||||| |||||||32.00% NMT 42.00%||||| ||||||2|RUBBER STOPPER ( AS|Relevant||as|| |||||||PER GENERAL NOTES)|per|packing||| |||||||RUBBER STOPPER ( AS|policy|||| |||||||PER GENERAL NOTES)||||| |||RA concerned maytake further necessaryaction|||asper|above decision of NC.|||||

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:

163	Case No.:73/10/82-<br>ALC4/2019	Party Name:CLEAN<br>SCIENCE AND<br>TECHNOLOGY PVT.LTD.<br>RLA File<br>:31/82/040/00056/AM20/	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred<br> <br>Defer<br>Date:06.03.2020
	<br>HQ File<br>:01/82/050/00647/AM20/		Lic.No/Date:3110067535<br>19.09.2019
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

164	<br>Case No.:77/10/82-<br>ALC4/2019	Party Name:TRANSPEK<br>INDUSTRY LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00651/AM20/	RLA File<br>:34/24/040/00184/AM20/	Lic.No/Date:3410045472<br>20.09.2019	<br>Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

-|---| || HQ File :01/82/050/00651/AM20/|RLA File :34/24/040/00184/AM20/|Lic.No/Date:3410045472 20.09.2019| Defer Date:06.03.2020| ||**Decision:**Deferred for comments of TE.||||

165	<br>Case No.:129/10/82-<br>ALC4/2019	Party Name:TRANSPEK<br>INDUSTRY LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00703/AM20/	RLA File<br>:34/24/040/00187/AM20/	Lic.No/Date:3410045471<br>20.09.2019	<br>Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

166	<br>Case No.:130/10/82-<br>ALC4/2019	Party Name:TRANSPEK<br>INDUSTRY LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00704/AM20/	RLA File<br>:34/24/040/00188/AM20/	Lic.No/Date:3410045473<br>20.09.2019	<br>Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

167	<br>Case No.:131/10/82-<br>ALC4/2019	Party Name:TRANSPEK<br>INDUSTRY LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00705/AM20/	RLA File<br>:34/24/040/00189/AM20/	Lic.No/Date:3410045470<br>20.09.2019	<br>Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

| || HQ File :01/82/050/00705/AM20/|RLA File :34/24/040/00189/AM20/|Lic.No/Date:3410045470 20.09.2019| Defer Date:06.03.2020| ||**Decision:**Deferred for comments of TE.||||

168	<br>Case No.:78/10/82-<br>ALC4/2019	Party Name:STERLING<br>AUXILIARIES PVT LTD	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00652/AM20/	RLA File<br>:03/95/040/00621/AM20/	Lic.No/Date:0310831732<br>23.09.2019	Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

169	<br>Case No.:176/10/82-<br>ALC4/2019	Party Name:SUVEN LIFE<br>SCIENCES LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00750/AM20/	RLA File<br>:09/24/040/00322/AM20/	Lic.No/Date:0910068026<br>23.09.2019	Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

170	<br>Case No.:79/10/82-<br>ALC4/2019	Party Name:AUROBINDO<br>PHARMA LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00653/AM20/	RLA File<br>:09/24/040/00327/AM20/	Lic.No/Date:0910068031<br>24.09.2019	Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

-|---|---| || HQ File :01/82/050/00653/AM20/|RLA File :09/24/040/00327/AM20/|Lic.No/Date:0910068031 24.09.2019|Defer Date:06.03.2020| ||**Decision:**Deferred for comments of TE.||||

171	<br>Case No.:82/10/82-<br>ALC4/2019	Party Name:DANOPHARM<br>CHEMICALS PRIVATE<br>LTD.	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred<br> <br>Defer<br>Date:06.03.2020
	<br>HQ File<br>:01/82/050/00656/AM20/	RLA File<br>:03/94/040/00422/AM20/	Lic.No/Date:0310831769<br>24.09.2019
	Decision:Deferred for comments of TE.

172	Case No.:87/10/82-<br>ALC4/2019	Party Name:OPES HEALTH<br>CARE PRIVATE LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred<br> <br>Defer<br>Date:06.03.2020
	<br>HQ File<br>:01/82/050/00661/AM20/	RLA File<br>:08/24/040/00202/AM20/	Lic.No/Date:0810146231<br>25.09.2019
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

173	<br>Case No.:94/10/82-<br>ALC4/2019	Party Name:GOVIND<br>LABORATORIES PVT LTD	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred<br> <br>Defer<br>Date:06.03.2020
	<br>HQ File<br>:01/82/050/00668/AM20/	RLA File<br>:08/24/040/00207/AM20/	Lic.No/Date:0810146235<br>26.09.2019
	Decision:Deferred for comments of TE.

:06.03.2020| |---|---|---|---|---| || HQ File :01/82/050/00668/AM20/|RLA File :08/24/040/00207/AM20/|Lic.No/Date:0810146235 26.09.2019|| ||**Decision:**Deferred for comments of TE.||||

					tatus:<br>eferred
174	Case No.:98/10/82-<br>ALC4/2019	Party Name:O C<br>SPECIALITIES PVT.LTD.	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	S<br>D	tatus:<br>eferred

	<br>HQ File	RLA File	Lic.No/Date:0310831873	<br>D	efer
	:01/82/050/00672/AM20/	:03/95/040/00625/AM20/	27.09.2019	D	ate:06.03.2020
	Decision:Deferred for comments of TE.

						:<br>red
175	Case No.:100/10/82-<br>ALC4/2019	Party Name:AVIK<br>PHARMACEUTICAL LTD.,	Me<br>AL	et No/Date:14/82-<br>C4/2019	Status<br>Defer	:<br>red
			06.	03.2020
	<br>HQ File	RLA File	Lic	.No/Date:0310831890	<br>Defer
	:01/82/050/00674/AM20/	:03/94/040/00496/AM20/	27.	09.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

	176	<br>Case No.:102/10/82-<br>ALC4/2019	Party Name:AVIK<br>PHARMACEUTICAL LTD.,	Me<br>AL<br>06.	et No/Date:14/82-<br>C4/2019<br>03.2020	Status<br>Defer	:<br>red
		<br>HQ File<br>:01/82/050/00676/AM20/	RLA File<br>:03/94/040/00497/AM20/	Lic<br>27.	.No/Date:0310831894<br>09.2019	<br>Defer<br>Date:0	6.03.2020
		Decision:Deferred for comments of TE.

r>HQ File :01/82/050/00676/AM20/|RLA File :03/94/040/00497/AM20/|Lic 27.|.No/Date:0310831894 09.2019| Defer Date:0|6.03.2020|| |||**Decision:**Deferred for comments of TE.|||||||

	177	<br>Case No.:103/10/82-<br>ALC4/2019	Party Name:AVIK<br>PHARMACEUTICAL LTD.,	Me<br>AL<br>06.	et No/Date:14/82-<br>C4/2019<br>03.2020	Status<br>Defer	:<br>red
		<br>HQ File<br>:01/82/050/00677/AM20/	RLA File<br>:03/94/040/00494/AM20/	Lic<br>27.	.No/Date:0310831896<br>09.2019	<br>Defer<br>Date:0	6.03.2020
		Decision:Deferred for comments of TE.

	Case No.:109/10/82-<br>Party Name:CHIRAG	Meet No/Date:14/82-	Status:
	ALC4/2019<br>ENTERPRISE	ALC4/2019	Deferred
		06.03.2020
178	HQ File<br>:01/82/050/00683/AM20/<br>RLA File<br>:24/24/040/00028/AM20/	Lic.No/Date:2410042868<br>27.09.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

	Case No.:110/10/82-<br>Party Name:GOPINATH	Meet No/Date:14/82-	Status:
	ALC4/2019<br>CHEM-TECH LTD.,	ALC4/2019	Deferred
		06.03.2020
179	HQ File<br>:01/82/050/00684/AM20/<br>RLA File<br>:08/24/040/00190/AM20/	Lic.No/Date:0810146246<br>27.09.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

180	Case No.:112/10/82-<br>ALC4/2019	Party Name:SATYADEVA<br>PHARMACEUTICALS PVT<br>LTD	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00686/AM20/	RLA File<br>:09/24/040/00318/AM20/	Lic.No/Date:0910068049<br>27.09.2019	<br>Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

181	<br>Case No.:113/10/82-<br>ALC4/2019	Party Name:STERLING<br>AUXILIARIES PVT LTD	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00687/AM20/	RLA File<br>:03/95/040/00340/AM20/	Lic.No/Date:0310831915<br>30.09.2019	<br>Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

182	<br>Case No.:114/10/82-<br>ALC4/2019	Party Name:STERLING<br>AUXILIARIES PVT LTD	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00688/AM20/	RLA File<br>:03/95/040/00135/AM20/	Lic.No/Date:0310831916<br>30.09.2019	<br>Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

-|---| || HQ File :01/82/050/00688/AM20/|RLA File :03/95/040/00135/AM20/|Lic.No/Date:0310831916 30.09.2019| Defer Date:06.03.2020| ||**Decision:**Deferred for comments of TE.||||

183	Case No.:115/10/82-<br>ALC4/2019	Party Name:DEEPAK<br>NOVOCHEM<br>TECHNOLOGIES LTD	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00689/AM20/	RLA File<br>:31/83/040/00087/AM20/	Lic.No/Date:3110067548<br>30.09.2019	<br>Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

Case No.:117/10/82-	Party Name:GLENMARK	Meet No/Date:14/82-	Status:
ALC4/2019	LIFE SCIENCES LIMITED	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:0310831946
:01/82/050/00691/AM20/	:03/94/040/00509/AM20/	01.10.2019

184

ecision taken in meeting no. 11/82-ALC4/2019 dated 03.01.2020, 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:

184

Export product	Qty.	Sl.	Import items	Qty.
		No.
VORICONAZOLE	1 kg	1	6-ETHYL-5-FLUORO-4-	3.30 kg
			HYDROXYPYRIMIDINE
		2	METHYLENE CHLORIDE	6.87 Litre
		3	TETRA HYDRO FURAN	23.30 Litre
		4	METHANOL	1.50Litre

Case No.:118/10/82-	Party Name:MOREPEN	Meet No/Date:14/82-	Status:
ALC4/2019	LABORATORIES LTD.,	ALC4/2019	Deferred
		06.03.2020
HQ File	RLA File	Lic.No/Date:0510411995	Defer
:01/82/050/00692/AM20/	:05/24/040/00361/AM20/	01.10.2019	Date:06.03.2020

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 13/82-ALC4/2019 dated 31.01.2020, 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:

185

ecision taken in meeting no. 13/82-ALC4/2019 dated 31.01.2020, 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:

185

Export product	Qty.	Sl.	Import items		Qty.
		No.
Empagliflozin	1 kg	1	(3S)-3-(4-[(2-chloro-5-iodophenyl)		2.04 kg
			methyl]<br>phenoxy)tetrahydrofuran<br>(EG01)<br>/
			(3S)-3-(4-(2-chloro-5-
			iodobenzyl)phenoxy)tetrahydrofuran
			(EG01)/(S)-3-(4-(2-Chloro-5-
			iodobenzyl)phenoxy) tetrahydrofuran
		2	2,3,4,6-tetra-O-trimethyl<br>silyl-beta-D-		2.53 kg
			glucolactone ( EGS01) /	2,3,4,5-
			Tetrakis-O-Trimethylsilyl-D-
			Gluconolactone
		3	Acetonitrile		2.16 kg
		4	Methylene chloride		3.25 kg
		5	Toluene		1.525 kg

	Case No.:120/10/82-<br>Party Name:TADIMETY	Meet No/Date:14/82-	Status:
	ALC4/2019<br>AROMATICS PRIVATE	ALC4/2019	Deferred
	LIMITED	06.03.2020
186	HQ File<br>:01/82/050/00694/AM20/<br>RLA File<br>:07/24/040/00141/AM20/	Lic.No/Date:0710115523<br>03.10.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

	Case No.:122/10/82-	Party Name:J.B.	Meet No/Date:14/82-	Status:
	ALC4/2019	CHEMICALS &	ALC4/2019	Deferred
		PHARMACEUTICALS	06.03.2020
187		LIMITED
	HQ File	RLA File	Lic.No/Date:0310832013	Defer
	:01/82/050/00696/AM20/	:03/94/040/00514/AM20/	04.10.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

	Case No.:123/10/82-	Party Name:YASHO	Meet No/Date:14/82-	Status:
	ALC4/2019	INDUSTRIES LIMITED	ALC4/2019	Deferred
			06.03.2020
188	HQ File	RLA File	Lic.No/Date:0310832030	Defer
	:01/82/050/00697/AM20/	:03/95/040/00677/AM20/	04.10.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

	Case No.:134/10/82-	Party Name:YASHO	Meet No/Date:14/82-	Status:
	ALC4/2019	INDUSTRIES LIMITED	ALC4/2019	Deferred
			06.03.2020
189	HQ File	RLA File	Lic.No/Date:0310832068	Defer
	:01/82/050/00708/AM20/	:03/95/040/00678/AM20/	07.10.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

File||RLA File||Lic.No/Date:0310832068||Defer|| ||||:01/82/050/00708/AM20/||:03/95/040/00678/AM20/||07.10.2019||Date:06.03.2020|| ||||**Decision:**Deferred for comments of TE.|||||||| ||||||||||||

	Case No.:140/10/82-	Party Name:LINK PHARMA	Meet No/Date:14/82-	Status:
	ALC4/2019	CHEM LIMITED	ALC4/2019	Deferred
			06.03.2020
190	HQ File	RLA File	Lic.No/Date:3410045519	Defer
	:01/82/050/00714/AM20/	:34/24/040/00099/AM20/	07.10.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

	Case No.:138/10/82-	Party Name:STERLING	Meet No/Date:14/82-	Status:
	ALC4/2019	AUXILIARIES PVT LTD	ALC4/2019	Deferred
			06.03.2020
191	HQ File	RLA File	Lic.No/Date:0310832108	Defer
	:01/82/050/00712/AM20/	:03/95/040/00273/AM20/	09.10.2019	Date:06.03.2020
	Decision:The Committee considered the case as per agenda		and it was noted that the firm vide its e-mail
	dated 28.01.2020 has furnished	its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide its e-mail dated 28.01.2020 has furnished its reply. Deferred for comments of TE.

s of TE.|||||

Decision: The Committee considered the case as per agenda and it was noted that the firm vide its e-mail dated 28.01.2020 has furnished its reply. Deferred for comments of TE.

	Case No.:145/10/82-<br>Party Name:STERILE INDIA<br>Meet No/Date:14/82-	Status:
	ALC4/2019<br>PRIVATE LIMITED<br>ALC4/2019	Deferred
	06.03.2020
192	HQ File<br>:01/82/050/00719/AM20/<br>RLA File<br>:05/24/040/00377/AM20/<br>Lic.No/Date:0510412070<br>10.10.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

	Case No.:147/10/82-	Party Name:GLENMARK	Meet No/Date:14/82-	Status:
	ALC4/2019	PHARMACEUTICALS LTD	ALC4/2019	Deferred
			06.03.2020
193	HQ File	RLA File	Lic.No/Date:0310832145	Defer
	:01/82/050/00721/AM20/	:03/94/040/00541/AM20/	11.10.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

Case No.:154/10/82-	Party Name:VISION DRUGS	Meet No/Date:14/82-	Status:
ALC4/2019	PVT LTD	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:0910068079
:01/82/050/00728/AM20/	:09/24/040/00355/AM20/	14.10.2019

-|---|---|---|---| |ALC4/2019||PVT LTD||ALC4/2019||Approved| |||||06.03.2020||| |HQ File||RLA File||Lic.No/Date:0910068079||| |:01/82/050/00728/AM20/||:09/24/040/00355/AM20/||14.10.2019|||

	Case No.:154/10/82-	Case No.:154/10/82-	Case No.:154/10/82-	Party Name:VISION DRUGS	Party Name:VISION DRUGS	Party Name:VISION DRUGS	Party Name:VISION DRUGS	Meet No/Date:14/82-	Status:	Status:
	ALC4/2019			<br>PVT LTD				ALC4/2019<br>06.03.2020	Approved
	HQ File<br>:01/82/050/00728/AM20/			RLA File				Lic.No/Date:0910068079<br>14.10.2019
				:09/24/040/00355/AM20/
	Decision:The Committee co		nsidered the cases as per agenda					and in the light of earlier deci	sio	n taken in
	<br>meeting no. 11/82-ALC4/2019 dated 03.01.2020, it was decided<br>							<br>to ratify norms under Para 4.<br>	<br>7 o	<br>f HBP v1
194	<br>as per details given below or as<br>Export product		applied by the firm, whichever is					less:
		Export product			Qt	Sl	Import ite	ms		Qt
					y.	.<br>No.				y.
		4-Methyl-6-(2,4,4-<br>trimethylpentyl)-2-Hpyron	-		1 kg	1	3,3-dimeth	ylacrylic acid		0.687 kg
						2	Isononano	yl Chloride (3,5,5-<br>exonyl chloride)		1.05 kg
		2-one					trimethylh
						3	Acetic Aci	d		0.40 kg
						4	Methylene	Chloride		0.60 kg
						5	Toulene			0.30 kg
	RA concerned maytake further necessaryaction asper above decision of NC.

||||||||3|Acetic Aci|d||0.40 kg|| ||||||||4|Methylene|Chloride||0.60 kg|| ||||||||5|Toulene|||0.30 kg|| |||RA concerned maytake further necessaryaction asper above decision of NC.|||||||||||

	Case No.:159/10/82-	Party Name:U K	Meet No/Date:14/82-	Status:
	ALC4/2019	AROMATICS &	ALC4/2019	Deferred
		CHEMICALS	06.03.2020
195	HQ File	RLA File	Lic.No/Date:0310832236	Defer
	:01/82/050/00733/AM20/	:03/95/040/00700/AM20/	15.10.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

	Case No.:169/10/82-	Party Name:VEERAL	Meet No/Date:14/82-	Status:
	ALC4/2019	ADDITIVES PRIVATE	ALC4/2019	Deferred
		LIMITED	06.03.2020
196	HQ File	RLA File	Lic.No/Date:0310832307	Defer
	:01/82/050/00743/AM20/	:03/95/040/00716/AM20/	18.10.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

	Case No.:170/10/82-	Party Name:VEERAL	Meet No/Date:14/82-	Status:
	ALC4/2019	ADDITIVES PRIVATE	ALC4/2019	Deferred
		LIMITED	06.03.2020
197	HQ File	RLA File	Lic.No/Date:0310832308	Defer
	:01/82/050/00744/AM20/	:03/95/040/00717/AM20/	18.10.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

File||RLA File||Lic.No/Date:0310832308||Defer|| ||||:01/82/050/00744/AM20/||:03/95/040/00717/AM20/||18.10.2019||Date:06.03.2020|| ||||**Decision:**Deferred for comments of TE.|||||||| ||||||||||||

	Case No.:171/10/82-	Party Name:GLENMARK	Meet No/Date:14/82-	Status:
	ALC4/2019	LIFE SCIENCES LIMITED	ALC4/2019	Deferred
			06.03.2020
198	HQ File	RLA File	Lic.No/Date:0310832312	Defer
	:01/82/050/00745/AM20/	:03/94/040/00566/AM20/	18.10.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

	Case No.:173/10/82-	Party Name:BENZO CHEM	Meet No/Date:14/82-	Status:
	ALC4/2019	INDUSTRIES PRIVATE	ALC4/2019	Deferred
		LIMITED	06.03.2020
199	HQ File	RLA File	Lic.No/Date:0310832317	Defer
	:01/82/050/00747/AM20/	:03/94/040/00518/AM20/	18.10.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

200

Case No.:179/10/82-	Party Name:PANACEA	Meet No/Date:14/82-	Status:
ALC4/2019	BIOTEC LTD.,	ALC4/2019	Deferred
		06.03.2020
HQ File	RLA File	Lic.No/Date:0510412195	Defer
:01/82/050/00753/AM20/	:05/24/040/00410/AM20/	21.10.2019	Date:06.03.2020

019**||BIOTEC LTD.,||ALC4/2019||Deferred| ||||||06.03.2020||| ||HQ File||RLA File||Lic.No/Date:0510412195||Defer| ||:01/82/050/00753/AM20/||:05/24/040/00410/AM20/||21.10.2019||Date:06.03.2020|

Decision: The Committee noted that the 4.07 application of 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 and after receiving the copy of application from the firm a copy of the same may be forwarded to Department of Biotechnology (DBT) perusal for obtaining its comments.

	Case No.:186/10/82-<br>Party Name:DEEPAK	Meet No/Date:14/82-	Status:
	ALC4/2019<br>NITRITE LIMITED	ALC4/2019	Deferred
		06.03.2020
201	HQ File<br>:01/82/050/00760/AM20/<br>RLA File<br>:34/24/040/00173/AM20/	Lic.No/Date:3410045560<br>22.10.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

	Case No.:188/10/82-<br>Party Name:SPC LIFE	Meet No/Date:14/82-	Status:
	ALC4/2019<br>SCIENCES PVT. LTD.	ALC4/2019	Deferred
		06.03.2020
202	HQ File<br>:01/82/050/00762/AM20/<br>RLA File<br>:34/24/040/00143/AM20/	Lic.No/Date:3410045565<br>23.10.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

	Case No.:189/10/82-<br>Party Name:MENTHA &	Meet No/Date:14/82-	Status:
	ALC4/2019<br>ALLIED PRODUCTS	ALC4/2019	Deferred
	PRIVATE LIMITED	06.03.2020
203	HQ File<br>:01/82/050/00763/AM20/<br>RLA File<br>:05/24/040/00375/AM20/	Lic.No/Date:0510412231<br>23.10.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

	Case No.:191/10/82-<br>Party Name:ASHISH LIFE	Meet No/Date:14/82-	Status:
	ALC4/2019<br>SCIENCE PVT.LTD.	ALC4/2019	Deferred
		06.03.2020
204	HQ File<br>:01/82/050/00765/AM20/<br>RLA File<br>:03/94/040/00526/AM20/	Lic.No/Date:0310832396<br>23.10.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

	Case No.:194/10/82-	Party Name:NATURAL AND	Meet No/Date:14/82-	Status:
	ALC4/2019	ESSENTIAL OILS PVT LTD	ALC4/2019	Deferred
			06.03.2020
205	HQ File	RLA File	Lic.No/Date:0710115596	Defer
	:01/82/050/00768/AM20/	:07/24/040/00158/AM20/	24.10.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

Case No.:199/10/82-	Party Name:PI INDUSTRIES	Meet No/Date:14/82-	Status:
ALC4/2019	LTD	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:1310049428
:01/82/050/00773/AM20/	:13/24/040/00168/AM20/	24.10.2019

-|---|---|---|---|---| |ALC4/2019||LTD||ALC4/2019||Approved| |||||06.03.2020||| |HQ File||RLA File||Lic.No/Date:1310049428||| |:01/82/050/00773/AM20/||:13/24/040/00168/AM20/||24.10.2019|||

		ALC4/2019<br>LTD<br>ALC4/2019<br>06.03.2020<br>Approved<br>HQ File<br>:01/82/050/00773/AM20/<br>RLA File<br>:13/24/040/00168/AM20/<br>Lic.No/Date:1310049428<br>24.10.2019	ALC4/2019<br>LTD<br>ALC4/2019<br>06.03.2020<br>Approved<br>HQ File<br>:01/82/050/00773/AM20/<br>RLA File<br>:13/24/040/00168/AM20/<br>Lic.No/Date:1310049428<br>24.10.2019	ALC4/2019<br>LTD<br>ALC4/2019<br>06.03.2020<br>Approved<br>HQ File<br>:01/82/050/00773/AM20/<br>RLA File<br>:13/24/040/00168/AM20/<br>Lic.No/Date:1310049428<br>24.10.2019	ALC4/2019<br>LTD<br>ALC4/2019<br>06.03.2020<br>Approved<br>HQ File<br>:01/82/050/00773/AM20/<br>RLA File<br>:13/24/040/00168/AM20/<br>Lic.No/Date:1310049428<br>24.10.2019	ALC4/2019<br>LTD<br>ALC4/2019<br>06.03.2020<br>Approved<br>HQ File<br>:01/82/050/00773/AM20/<br>RLA File<br>:13/24/040/00168/AM20/<br>Lic.No/Date:1310049428<br>24.10.2019	ALC4/2019<br>LTD<br>ALC4/2019<br>06.03.2020<br>Approved<br>HQ File<br>:01/82/050/00773/AM20/<br>RLA File<br>:13/24/040/00168/AM20/<br>Lic.No/Date:1310049428<br>24.10.2019	ALC4/2019<br>LTD<br>ALC4/2019<br>06.03.2020<br>Approved<br>HQ File<br>:01/82/050/00773/AM20/<br>RLA File<br>:13/24/040/00168/AM20/<br>Lic.No/Date:1310049428<br>24.10.2019

TD ALC4/2019 06.03.2020 Approved HQ File :01/82/050/00773/AM20/ RLA File :13/24/040/00168/AM20/ Lic.No/Date:1310049428 24.10.2019| |---|---|---|---|---|---|---|---|---| |||**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:||||||| |206||||||||| |||Export Product|Qty.|Sl.|Import items||Qty.|| |||||No.||||| |||2-Aminosulfonyl-N,N-|1 kg|1|Nicotinamides compound - ASDN (Crude)||1.307 kg|| |||dimethylnicotinamide|||(Assay NMT 72%)|||| |||(Assay NLT 98%)|||(N. N- Dimethyl-2-|Sulfonyl Pyridine -3||| ||||||Carboxamide)|||| |||Note: One time basis,norepeatlicence to beissued byRA.||||||| |||RA concerned maytake further necessaryaction asper above decision of NC.|||||||

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

	Case No.:198/10/82-<br>Party Name:EMMENNAR	Meet No/Date:14/82-	Status:
	ALC4/2019<br>PHARMA PRIVATE	ALC4/2019	Deferred
	LIMITED	06.03.2020
207	HQ File<br>:01/82/050/00772/AM20/<br>RLA File<br>:09/24/040/00376/AM20/	Lic.No/Date:0910068138<br>28.10.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

Case No.:210/10/82-	Party Name:GLENMARK	Meet No/Date:14/82-	Status:
ALC4/2019	LIFE SCIENCES LIMITED	ALC4/2019	Deferred
		06.03.2020
HQ File	RLA File	Lic.No/Date:0310832575	Defer
:01/82/050/00784/AM20/	:03/94/040/00607/AM20/	04.11.2019	Date:06.03.2020

|LIFE SCIENCES LIMITED||ALC4/2019||Deferred| |||||06.03.2020||| |HQ File||RLA File||Lic.No/Date:0310832575||Defer| |:01/82/050/00784/AM20/||:03/94/040/00607/AM20/||04.11.2019||Date:06.03.2020|

|||ALC4/2019 LIFE SCIENCES LIMITED ALC4/2019 06.03.2020 Deferred HQ File :01/82/050/00784/AM20/ RLA File :03/94/040/00607/AM20/ Lic.No/Date:0310832575 04.11.2019 Defer Date:06.03.2020|ALC4/2019 LIFE SCIENCES LIMITED ALC4/2019 06.03.2020 Deferred HQ File :01/82/050/00784/AM20/ RLA File :03/94/040/00607/AM20/ Lic.No/Date:0310832575 04.11.2019 Defer Date:06.03.2020|ALC4/2019 LIFE SCIENCES LIMITED ALC4/2019 06.03.2020 Deferred HQ File :01/82/050/00784/AM20/ RLA File :03/94/040/00607/AM20/ Lic.No/Date:0310832575 04.11.2019 Defer Date:06.03.2020|ALC4/2019 LIFE SCIENCES LIMITED ALC4/2019 06.03.2020 Deferred HQ File :01/82/050/00784/AM20/ RLA File :03/94/040/00607/AM20/ Lic.No/Date:0310832575 04.11.2019 Defer Date:06.03.2020|ALC4/2019 LIFE SCIENCES LIMITED ALC4/2019 06.03.2020 Deferred HQ File :01/82/050/00784/AM20/ RLA File :03/94/040/00607/AM20/ Lic.No/Date:0310832575 04.11.2019 Defer Date:06.03.2020|ALC4/2019 LIFE SCIENCES LIMITED ALC4/2019 06.03.2020 Deferred HQ File :01/82/050/00784/AM20/ RLA File :03/94/040/00607/AM20/ Lic.No/Date:0310832575 04.11.2019 Defer Date:06.03.2020|ALC4/2019 LIFE SCIENCES LIMITED ALC4/

eferred** HQ File :01/82/050/00784/AM20/ RLA File :03/94/040/00607/AM20/ Lic.No/Date:0310832575 04.11.2019 Defer Date:06.03.2020|ALC4/2019 LIFE SCIENCES LIMITED ALC4/2019 06.03.2020 Deferred HQ File :01/82/050/00784/AM20/ RLA File :03/94/040/00607/AM20/ Lic.No/Date:0310832575 04.11.2019 Defer Date:06.03.2020|ALC4/2019 LIFE SCIENCES LIMITED ALC4/2019 06.03.2020 Deferred HQ File :01/82/050/00784/AM20/ RLA File :03/94/040/00607/AM20/ Lic.No/Date:0310832575 04.11.2019 Defer Date:06.03.2020|ALC4/2019 LIFE SCIENCES LIMITED ALC4/2019 06.03.2020 Deferred HQ File :01/82/050/00784/AM20/ RLA File :03/94/040/00607/AM20/ Lic.No/Date:0310832575 04.11.2019 Defer Date:06.03.2020|ALC4/2019 LIFE SCIENCES LIMITED ALC4/2019 06.03.2020 Deferred HQ File :01/82/050/00784/AM20/ RLA File :03/94/040/00607/AM20/ Lic.No/Date:0310832575 04.11.2019 Defer Date:06.03.2020| |---|---|---|---|---|---|---|---|---|---|---|---| |||**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it|||||||||| |||was decided to ratify||the ad-hoc input output||norms under para 4.7 of HBP as per|||details below or||as| |||applied by firm whichever is lower:|||||||||| ||||Export Product||Qty.|Sl.||Import items||Qty.|| |||||||No.|||||| |208|||PERINDOPRIL|ERBUMINE|1 kg|1||S-(-)-INDOLINE-2-||0.947 kg|| ||||DMF|||||CARBOXYLIC ACID|||| |||||||2||L-NORVALINE||1.423 kg||

||||Export Product||Qty.|Sl.||Import items||Qty.|| |||||||No.|||||| |208|||PERINDOPRIL|ERBUMINE|1 kg|1||S-(-)-INDOLINE-2-||0.947 kg|| ||||DMF|||||CARBOXYLIC ACID|||| |||||||2||L-NORVALINE||1.423 kg|| |||||||3||ACETONITRILE||6.345 kg|| |||||||4||N,N-||0.700 kg|| |||||||||CARBONYLDIIMIDAZOLE|||| |||||||5||METHYLENE CHLORIDE||6.26 kg|| |||||||||(MDC)|||| |||||||6||SODIUM PYRUVATE||1.42 kg|| |||||||7||METHANOL||10.80 kg|| |||RA concerned maytake further necessaryaction asper above decision of NC.||||||||||

	Case No.:212/10/82-<br>Party Name:PORUS<br>Meet No/Date:14/82-	Status:
	ALC4/2019<br>LABORATORIES PRIVATE<br>ALC4/2019	Deferred
	LIMITED<br>06.03.2020
209	HQ File<br>:01/82/050/00786/AM20/<br>RLA File<br>:09/24/040/00394/AM20/<br>Lic.No/Date:0910068157<br>04.11.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

	Case No.:213/10/82-<br>Party Name:PORUS<br>Meet No/Date:14/82-	Status:
	ALC4/2019<br>LABORATORIES PRIVATE<br>ALC4/2019	Deferred
	LIMITED<br>06.03.2020
210	HQ File<br>:01/82/050/00787/AM20/<br>RLA File<br>:09/24/040/00393/AM20/<br>Lic.No/Date:0910068158<br>04.11.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

211	Case No.:214/10/82-<br>ALC4/2019	Party Name:GRANDEUR<br>PHARMA PRIVATE<br>LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020<br> <br><br>Lic.No/Date:0510412350<br>05.11.2019<br> <br>	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00788/AM20/	RLA File<br>:05/23/040/00251/AM20/		Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

212	Case No.:217/10/82-<br>ALC4/2019	Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD.	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020<br> <br><br>Lic.No/Date:0510412361<br>05.11.2019<br> <br>	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00791/AM20/	RLA File<br>:05/24/040/00439/AM20/		Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

Case No.:220/10/82-	Party Name:CHEMECA	Meet No/Date:14/82-	Status:
ALC4/2019	DRUGS PRIVATE LIMITED	ALC4/2019	Approved
		06.03.2020
HQ File	RLA File	Lic.No/Date:0910068162
:01/82/050/00794/AM20/	:09/24/040/00401/AM20/	06.11.2019

---| |ALC4/2019||DRUGS PRIVATE LIMITED||ALC4/2019||Approved| |||||06.03.2020||| |HQ File||RLA File||Lic.No/Date:0910068162||| |:01/82/050/00794/AM20/||:09/24/040/00401/AM20/||06.11.2019|||

	Case No.:220/10/82-<br>ALC4/2019	Party Name:CHEMECA<br>DRUGS PRIVATE LIMITED<br>RLA File<br>:09/24/040/00401/AM20/	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020<br>Lic.No/Date:0910068162<br>06.11.2019	Status:<br>Approved<br>
	HQ File<br>:01/82/050/00794/AM20/
213	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>3-Azido-3-deoxy-5-O-triphenyl<br>methyl thymidine<br>1 kg<br>1<br>Beta Thymidine<br>0.600 kg<br>2<br>Trityl Chloride<br>0.700 kg<br>3<br>Methane Sulfonyl Chloride<br>0.310 kg<br>4<br>Dimethyl Sulfoxide<br>1.60 kg<br>5<br>Methanol<br>0.52 kg<br>6<br>Toluene<br>0.393 kg<br>7<br>Triethyl Amine<br>0.560 kg<br>8<br>Sodium Azide<br>0.300 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

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

	Case No.:223/10/82-	Party Name:MAPAEX	Meet No/Date:14/82-	Status:
	ALC4/2019	CONSUMER	ALC4/2019	Deferred
		HEALTHCARE PRIVATE	06.03.2020
		LIMITED
214	HQ File	RLA File	Lic.No/Date:5610005722	Defer
	:01/82/050/00797/AM20/	:56/24/040/00018/AM20/	07.11.2019	Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

	Case No.:235/10/82-	Party Name:SUVEN LIFE	Meet No/Date:14/82-	Status:
	ALC4/2019	SCIENCES LIMITED	ALC4/2019	Deferred
			06.03.2020
215	HQ File	RLA File	Lic.No/Date:0910068176	Defer
	:01/82/050/00809/AM20/	:09/24/040/00407/AM20/	13.11.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

.2020||| |215||HQ File||RLA File||Lic.No/Date:0910068176||Defer| |||:01/82/050/00809/AM20/||:09/24/040/00407/AM20/||13.11.2019||Date:06.03.2020| |||**Decision:**Deferred for comments of TE.|||||||

	Case No.:238/10/82-<br>Party Name:ATUL LIMITED Meet No/Date:14/82-	Status:
	ALC4/2019<br>ALC4/2019	Deferred
	06.03.2020
216	HQ File<br>:01/82/050/00812/AM20/<br>RLA File<br>:08/24/040/00258/AM20/<br>Lic.No/Date:0810146544<br>13.11.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

	Case No.:239/10/82-<br>Party Name:INDOCO	Meet No/Date:14/82-	Status:
	ALC4/2019<br>REMEDIES LIMITED	ALC4/2019	Deferred
		06.03.2020
217	HQ File<br>:01/82/050/00813/AM20/<br>RLA File<br>:03/94/040/00587/AM20/	Lic.No/Date:0310832731<br>13.11.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:241/10/82-<br>ALC4/2019	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:14/82-<br>ALC4/2019	Status:<br>Deferred	Status:<br>Deferred
	RLA				06.03.2020
H Fil		il			LiN/Dt0910068182	<br>Df	20
<br>Q e<br>:01/82/050/00815/AM20/	<br>:09/24	e<br>/040/0041	1/AM2	0/	c.oae:<br>14.11.2019	<br>eer<br>Date:06.03.20
Decision:The Committee noted<br>available. Hence, it was decided to ca<br>		that the<br>ll for a cop<br>
			4.07 a<br>y of 4<br>	pplication of subject Advance Aut<br>.07 application of the subject adva<br>		horization is<br>nce authorizati

					tatus:<br>eferred
219	Case No.:243/10/82-<br>ALC4/2019	Party Name:U K<br>AROMATICS &	Meet No/Date:14/82-<br>ALC4/2019	S<br>D	tatus:<br>eferred
		CHEMICALS	06.03.2020	<br>D
	<br>HQ File	RLA File	Lic.No/Date:0310832762		efer
	:01/82/050/00817/AM20/	:03/95/040/00795/AM20/	14.11.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

D||| ||| HQ File||RLA File|Lic.No/Date:0310832762||efer|| |||:01/82/050/00817/AM20/||:03/95/040/00795/AM20/|14.11.2019|Date:06.03.2020||| |||**Decision:**Deferred for comments of TE.|||||||

	Case No.:244/10/82-	Party Name:GLENMARK	Meet No/Date:14/82-	Status:
	ALC4/2019	PHARMACEUTICALS LTD	ALC4/2019	Deferred
			06.03.2020
220	HQ File	RLA File	Lic.No/Date:0310832767	Defer
	:01/82/050/00818/AM20/	:03/94/040/00636/AM20/	14.11.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

	Case No.:245/10/82-	Party Name:SUVEN LIFE	Meet No/Date:14/82-	Status:
	ALC4/2019	SCIENCES LIMITED	ALC4/2019	Deferred
			06.03.2020
221	HQ File	RLA File	Lic.No/Date:0910068184	Defer
	:01/82/050/00819/AM20/	:09/24/040/00414/AM20/	14.11.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

.2020||| |221||HQ File||RLA File||Lic.No/Date:0910068184||Defer| |||:01/82/050/00819/AM20/||:09/24/040/00414/AM20/||14.11.2019||Date:06.03.2020| |||**Decision:**Deferred for comments of TE.|||||||

222	Case No.:246/10/82-<br>ALC4/2019	Party Name:NISARG<br>BIOSCIENCES PRIVATE<br>LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00820/AM20/	RLA File<br>:09/24/040/00403/AM20/	Lic.No/Date:0910068187<br>14.11.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

223	<br>Case No.:249/10/82-<br>ALC4/2019	Party Name:YASHO<br>INDUSTRIES LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00823/AM20/	RLA File<br>:03/95/040/00791/AM20/	Lic.No/Date:0310832783<br>14.11.2019	Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

|---| || HQ File :01/82/050/00823/AM20/|RLA File :03/95/040/00791/AM20/|Lic.No/Date:0310832783 14.11.2019|Defer Date:06.03.2020| ||**Decision:**Deferred for comments of TE.||||

224	Case No.:250/10/82-<br>ALC4/2019	Party Name:MANGALAM<br>ORGANICS LIMITED<br>FORMERLY DUJODWALA<br>PRODU	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00824/AM20/	RLA File<br>:03/95/040/00702/AM20/	Lic.No/Date:0310832785<br>14.11.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

225	<br>Case No.:252/10/82-<br>ALC4/2019	Party Name:CLARIANT<br>INDIA LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00826/AM20/	RLA File<br>:03/94/040/00639/AM20/	Lic.No/Date:0310832792<br>14.11.2019	Defer<br>Date:06.03.2020
	Decision:Deferred for comments of TE.

-|---|---| || HQ File :01/82/050/00826/AM20/|RLA File :03/94/040/00639/AM20/|Lic.No/Date:0310832792 14.11.2019|Defer Date:06.03.2020| ||**Decision:**Deferred for comments of TE.||||

226	Case No.:247/10/82-<br>ALC4/2019	Party Name:VEKO CARE<br>PRIVATE LIMITED	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00821/AM20/	RLA File<br>:31/83/040/00104/AM20/	Lic.No/Date:3110067591<br>15.11.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

227	Case No.:253/10/82-<br>ALC4/2019	Party Name:VINS<br>BIOPRODUCTS LTD`<br>RLA File<br>:09/24/040/00410/AM20/	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred<br> <br>Defer<br>Date:06.03.2020
	<br>HQ File<br>:01/82/050/00827/AM20/		Lic.No/Date:0910068189<br>15.11.2019
	Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to forward a copy of application to Department of Biotechnology (DBT) for obtaining its<br>comments.

228	<br>Case No.:254/10/82-<br>ALC4/2019	Party Name:GLENMARK<br>LIFE SCIENCES LIMITED<br>RLA File<br>:03/94/040/00628/AM20/	Meet No/Date:14/82-<br>ALC4/2019<br>06.03.2020	Status:<br>Deferred<br> <br>Defer<br>Date:06.03.2020
	<br>HQ File<br>:01/82/050/00828/AM20/		Lic.No/Date:0310832799<br>15.11.2019
	Decision:Deferred for comments of TE.

erred** Defer Date:06.03.2020| |---|---|---|---|---| || HQ File :01/82/050/00828/AM20/||Lic.No/Date:0310832799 15.11.2019|| ||**Decision:**Deferred for comments of TE.||||

						<br>ed
229	Case No.:255/10/82-<br>ALC4/2019	Party Name:PORUS<br>LABORATORIES PRIVATE<br>LIMITED	Mee<br>AL	t No/Date:14/82-<br>C4/2019	Status:<br>Deferr	<br>ed
			06.0	3.2020
	<br>HQ File	RLA File	Lic.	No/Date:0910068191	<br>Defer
	<br>:01/82/050/00829/AM20/	:09/24/040/00421/AM20/	15.11.2019		Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

	Case No.:256/10/82-	Party Name:MEDREICH	Meet No/Date:14/82-	Meet No/Date:14/82-	Status:	Status:
230	<br>ALC4/2019	<br>LIMITED	<br>AL<br>06.0	<br>C4/2019<br>3.2020	<br>Deferr	<br>ed
	<br>HQ File	RLA File<br>:07/24/040/00171/AM20/	Lic.	No/Date:0710115694	<br>Defer
	<br> <br>:01/82/050/00830/AM20/		<br>15.1	<br>1.2019	<br> <br>Date:0	6.03.2020
	Decision:The Committee	noted that the 407 application of		subject Advance Authorizat		ion is not
	.<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:258/10/82-<br>ALC4/2019	Party Name:WEXFORD<br>LABORATORIES P LTD	Mee<br>AL<br>06.0	t No/Date:14/82-<br>C4/2019<br>3.2020	Status:<br>Deferr	<br>ed
<br>HQ File<br>:01/82/050/00832/AM20/	RLA File<br>:07/24/040/00178/AM20/	Lic.<br>18.1	No/Date:0710115700<br>1.2019	<br>Defer<br>Date:0	6.03.2020
Decision:The Committee noted that the 4.07 application of<br>available. Hence, it was decided to call for a copy of 4.07 applicat<br>			subject Advance Authorization is not<br>ion of the subject advance authorization<br>
directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

	Case No.:259/10/82-<br>Party Name:NISARG	Meet No/Date:14/82-	Status:
	ALC4/2019<br>BIOSCIENCES PRIVATE	ALC4/2019	Deferred
	LIMITED	06.03.2020
232	HQ File<br>:01/82/050/00833/AM20/<br>RLA File<br>:09/24/040/00424/AM20/	Lic.No/Date:0910068197<br>18.11.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

	Case No.:261/10/82-<br>Party Name:AVIEUM LIFE	Meet No/Date:14/82-	Status:
	ALC4/2019<br>SCIENCES PRIVATE	ALC4/2019	Deferred
	LIMITED	06.03.2020
233	HQ File<br>:01/82/050/00835/AM20/<br>RLA File<br>:31/83/040/00101/AM20/	Lic.No/Date:3110067594<br>18.11.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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.:262/10/82-<br>Party Name:REYAANSH	Meet No/Date:14/82-	Status:
	ALC4/2019<br>HEALTHCARE	ALC4/2019	Deferred
		06.03.2020
234	HQ File<br>:01/82/050/00836/AM20/<br>RLA File<br>:03/95/040/00757/AM20/	Lic.No/Date:0310832850<br>18.11.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

	Case No.:263/10/82-	Party Name:STERLING	Meet No/Date:14/82-	Status:
	ALC4/2019	AUXILIARIES PVT LTD	ALC4/2019	Deferred
			06.03.2020
235	HQ File	RLA File	Lic.No/Date:0310832853	Defer
	:01/82/050/00837/AM20/	:03/95/040/00812/AM20/	19.11.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

.2020||| |235||HQ File||RLA File||Lic.No/Date:0310832853||Defer| |||:01/82/050/00837/AM20/||:03/95/040/00812/AM20/||19.11.2019||Date:06.03.2020| |||**Decision:**Deferred for comments of TE.|||||||

	Case No.:266/10/82-	Party Name:OPTIMUS	Meet No/Date:14/82-	Status:
	ALC4/2019	DRUGS PRIVATE LIMITED	ALC4/2019	Deferred
			06.03.2020
236	HQ File	RLA File	Lic.No/Date:0910068203	Defer
	:01/82/050/00840/AM20/	:09/24/040/00412/AM20/	19.11.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

	Case No.:267/10/82-	Party Name:AVIEUM LIFE	Meet No/Date:14/82-	Status:
	ALC4/2019	SCIENCES PRIVATE	ALC4/2019	Deferred
		LIMITED	06.03.2020
237	HQ File<br>:01/82/050/00841/AM20/	RLA File<br>:31/83/040/00108/AM20/	Lic.No/Date:3110067598<br>19.11.2019	Defer<br>Date:06.03.2020
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not
	available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization
	directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

	Case No.:268/10/82-	Party Name:JODAS EXPOIM	Meet No/Date:14/82-	Status:
	ALC4/2019	PVT.LTD	ALC4/2019	Deferred
			06.03.2020
238	HQ File	RLA File	Lic.No/Date:0910068207	Defer
	:01/82/050/00842/AM20/	:09/24/040/00365/AM20/	20.11.2019	Date:06.03.2020
	Decision:Deferred for comments of TE.

MANUAL CASE

Case No. B-1

Meeting No. 14/AM20

Date 19.03.2020 Firm’s Name M/s Pusilin Biotechnology P Ltd., Kanpur HQ F. No. 01/82/050/00846/AM16/DES-III RLA F. No. 06/24/040/00014/AM16 Advance Authorization No. and Date 0610038189 dated 09.07.2015

Subject Request of M/s Pusilin Biotechnology Pvt. Ltd., Kanpur for fixation of adhoc norms against Advance Authorization No. 0610038189 dated 09.07.2015 Decision: The Committee considered the case as per agenda and on the basis of written comments furnished by Department of Biotechnology vide Office Memorandum No. BT/IL/05/429/2015-PID, dated 19.03.2020, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower: Export product Qty. Sl. No. Import items Qty.

HEPARIN / CHONDROITIN SULPHATE 1 kg 1 ALKALI PROTEASE 25 kg

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

Meeting ended with thanks to Chair.

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