IN FORCE Advance Authorisation

DGFT Minutes

Reliability

In force — no superseding record on file.

Document text

Office of Directorate General of Foreign Trade New Delhi -0

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

Minutes of the Norms Committee – 3 Meeting No. 2/82-ALC4/2020 dated 10.07.2020 (actually held on 10.07.2020 and 24.07.2020) 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 Ajay Kumar, Assistant Director (ii) Consultant, Technical Expert Pharmaceuticals (iii) Consultant, Technical Expert Chemicals

The committee went through the minutes of earlier meeting No. 1/82-ALC4/2020 dated 17.04.2020 (actually held on 06.05.2020)

ONLINE CASES

1	Case No.:820/15/82-<br>ALC4/2018	Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00508/AM19/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0910067061<br>16.01.2019	Status:<br>Deferred
	HQ File<br>:01/82/050/02277/AM19/
	Decision:Deferred for comments of TE.

2	Case No.:1026/15/82-<br>ALC4/2018	Party Name:ANLON<br>HEALTHCARE<br>PRIVATELIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	HQ File<br>:01/82/050/02483/AM19/	RLA File<br>:24/24/040/00049/AM19/	Lic.No/Date:2410042628<br>16.01.2019
	Decision:Deferred for comments of TE.

3	Case No.:829/15/82-<br>ALC4/2018	Party Name:AUROBINDO<br>PHARMA LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	HQ File<br>:01/82/050/02286/AM19/	RLA File<br>:09/24/040/00499/AM19/	Lic.No/Date:0910067071<br>18.01.2019
	Decision:Deferred for comments of TE.

Case No.:830/15/82-	Party Name:R CHEM	Meet No/Date:2/82-	Status:
ALC4/2018	(SOMANAHALLI) PVT.LTD,	ALC4/2020	Deferred
		10.07.2020
HQ File	RLA File	Lic.No/Date:0910067074
:01/82/050/02287/AM19/	:09/24/040/00516/AM19/	18.01.2019

--| |ALC4/2018||(SOMANAHALLI) PVT.LTD,||ALC4/2020||Deferred| |||||10.07.2020||| |HQ File||RLA File||Lic.No/Date:0910067074||| |:01/82/050/02287/AM19/||:09/24/040/00516/AM19/||18.01.2019|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts 4 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020 , followed by Reminder on 20.03.2020 :

(i) Complete chemical name of the Export Product. (ii) Complete technical details as per Appendix 4E.

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

5	Case No.:837/15/82-<br>ALC4/2018	Party Name:DANOPHARM<br>CHEMICALS PRIVATE LTD.	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	HQ File<br>:01/82/050/02294/AM19/	RLA File<br>:03/94/040/00886/AM19/	Lic.No/Date:0310826539<br>22.01.2019
	Decision:Deferred for comments of TE.

6	Case No.:842/15/82-<br>ALC4/2018	Party Name:S.M. HERBALS<br>PVT.LTD.	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	HQ File<br>:01/82/050/02299/AM19/	RLA File<br>:05/24/040/00602/AM19/	Lic.No/Date:0510409465<br>24.01.2019
	Decision:Deferred for comments of TE.

.2020|Status: Deferred| ||HQ File :01/82/050/02299/AM19/|RLA File :05/24/040/00602/AM19/|Lic.No/Date:0510409465 24.01.2019|| ||**Decision:**Deferred for comments of TE.||||

Case No.:845/15/82-	Party Name:J.B. CHEMICALS	Meet No/Date:2/82-	Status:
ALC4/2018	& PHARMACEUTICALS	ALC4/2020	Approved
	LIMITED	10.07.2020
HQ File	RLA File	Lic.No/Date:0310826640
:01/82/050/02302/AM19/	:03/94/040/00925/AM19/	25.01.2019

	Case No.:845/15/82-<br>ALC4/2018	Case No.:845/15/82-<br>ALC4/2018	Case No.:845/15/82-<br>ALC4/2018	Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED	Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED	Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved
	HQ File<br>:01/82/050/02302/AM19/			RLA File<br>:03/94/040/00925/AM19/			Lic.No/Date:0310826640<br>25.01.2019
7	Decision:The Committee considered case as per agenda in the presence of the technical experts and it was<br>decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.

2019|||| |7|**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: Sl. No. Export Product Qty. Sl. No. Import items Qty. 1 Bupivacaine with Adrenaline Injection 10 x 20ml Ampoules. Each ml contains Bupivacaine Hydrochloride 5.3175 mg. Net content - 8.811 Kgs. 1 Number Ampoule 1 Bupivacaine Hydrochloride 111.67 mg 2 Bupivacaine Hydrochloride and Dextrose Injection 10x4ml. Each ml contains Bupivacaine Hydrochloride 5.3175 mg. Net content - 8.811 Kgs. 1 Number Ampoule 1 Bupivacaine Hydrochloride 23.40 mg RA concerned maytake further necessaryaction asper above decision of NC.|||||||||| |||Sl. No.|Export Product||Qty.|Sl. No.||Import items|Qty.|| |||1|Bupivacaine with Adrenaline Injection 10 x 20ml Ampoules. Each ml contains Bupivacaine Hydrochloride 5.3175 mg. Net content - 8.811 Kgs.||1 Number Ampoule|1||Bupivacaine Hydrochloride|111.67 mg|| |||2|Bupivacaine Hydrochloride and Dextrose Injection 10x4ml. Each ml contains Bupivacaine Hydrochloride 5.3175 mg. Net content - 8.811 Kgs.||1 Number Ampoule|1||Bupivacaine Hydrochloride|23.40 mg|| ||||||||||||

r>10x4ml. Each ml contains Bupivacaine Hydrochloride 5.3175 mg. Net content - 8.811 Kgs.||1 Number Ampoule|1||Bupivacaine Hydrochloride|23.40 mg|| ||||||||||||

Case No.:848/15/82-	Party Name:VIVIMED LIFE	Meet No/Date:2/82-	Status:
ALC4/2018	SCIENCES PRIVATE	ALC4/2020	Approved
	LIMITED	10.07.2020
HQ File	RLA File	Lic.No/Date:0910067112
:01/82/050/02305/AM19/	:09/24/040/00505/AM19/	28.01.2019

	C<br>A	ase No.:848/15/82-<br>LC4/2018	ase No.:848/15/82-<br>LC4/2018	P<br>S<br>L	arty Name:VIVIMED LIFE<br>CIENCES PRIVATE<br>IMITED	arty Name:VIVIMED LIFE<br>CIENCES PRIVATE<br>IMITED	arty Name:VIVIMED LIFE<br>CIENCES PRIVATE<br>IMITED	arty Name:VIVIMED LIFE<br>CIENCES PRIVATE<br>IMITED	M<br>A<br>1	eet No/Date:2/82-<br>LC4/2020<br>0.07.2020	eet No/Date:2/82-<br>LC4/2020<br>0.07.2020	S<br>A	tatus:<br>pproved	tatus:<br>pproved	tatus:<br>pproved
	H<br>:0	Q File<br>1/82/050/02305/AM19/		R<br>:0	LA File<br>9/24/040/00505/AM19/				L<br>2	ic.No/Date:0910067112<br>8.01.2019
	Decision:The Committee considered case as per agenda in the presence of the technical experts and it was<br>decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.

019|||||| ||**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: Sl. No Export Product Qty. Sl. No. Import items Qty. 1 Amlodipine Besylate USP - 2.5 Mg 90000000 Numbers 1 Amlodipine Besylate 312.3 kg 2 Anhydrous dibasic calcium 1080.0 kg||||||||||||||| ||||Export Product|||Qty.|Sl. No.|Import items|||Qty.||||| ||||Amlodipine Besylate USP - 2.5 Mg|||90000000 Numbers|1|Amlodipine Besylate|||312.3 kg||||| ||||||||2|Anhydrous dibasic calcium |||1080.0 kg||||| |||||||||Pho|spahte(A-TAB)||||||| ||||||||3|Mic|rocrystalline Cellulose||7202.7 kg||||| ||||||||4 |Sod |ium Starch Glycolate ||180.0 kg ||||| ||||||||5|Col Dio|loidal Silicon xide(Aerosil 200)||45.00 kg||||| ||||||||6|S|i Aid H||13500 k||||| |||||||||te 501|rc c (ystrene 6 FG)||.

|ium Starch Glycolate ||180.0 kg ||||| ||||||||5|Col Dio|loidal Silicon xide(Aerosil 200)||45.00 kg||||| ||||||||6|S|i Aid H||13500 k||||| |||||||||te 501|rc c (ystrene 6 FG)||. g||||| |8||2|||||7|Magnesium Stearate|||45.00 kg||||| ||||Amlodipine Besylate USP –|||180000000|1|Amlodipine Besylate|||1167.540 kg||||| ||||5 Mg|||Numbers|||||||||| ||||||||2|Anhyd Phosp ||rous dibasic calcium ahte(A-TAB) |403 |||9.200 kg || ||||||||3|Micro||crystalline Cellulose|269|||38.560 kg|| ||||||||4|Sodiu||m Starch Glycolate|673.|||200 kg|| ||||||||5|Colloi||dal Silicon|168|||300 k|| ||||||||| Dioxide(Aerosil 200)|||.|||g|| ||||||||6|Stearic Acid (Hystrene|||504.|||900 kg|| || 5016 FG) 7 Magnesium Stearate 3 Amlodipine Besylate USP – 10 Mg 135000000 Numbers 1 Amlodipine Besylate 2 Anhydrous dibasic calcium Phospahte(A-TAB) 3 Microcrystalline Cellulose 4 Sodium Starch Glycolate 5 Colloidal Silicon Dioxide(Aerosil 200) 6 Stearic Acid (Hystrene 5016 FG) 7 Magnesium Stearate RA concerned maytake further necessaryaction asper above decision of NC.||||||| 5016 FG)|||||||| ||||||||7|Magnesium Stearate|||168.300 kg||||| ||||Amlodipine Besylate USP – 10 Mg|||135000000 Numbers|1|Amlodipine Besylate|||1167.540 kg||||| ||||||||2|Anhydrous dibasic calcium Phospahte(A-TAB)|||4039.200 kg||||| ||||||||3|Microcrystalline Cellulose|||26938.560 kg||||| ||||||||4|Sodium Starch Glycolate|||673.200 kg||||| ||||||||5|Colloidal Silicon Dioxide(Aerosil 200)|||168.300 kg|||||

)|||4039.200 kg||||| ||||||||3|Microcrystalline Cellulose|||26938.560 kg||||| ||||||||4|Sodium Starch Glycolate|||673.200 kg||||| ||||||||5|Colloidal Silicon Dioxide(Aerosil 200)|||168.300 kg||||| ||||||||6|Stearic Acid (Hystrene 5016 FG)|||504.900 kg||||| ||||||||7|Magnesium Stearate|||168.300 kg|||||

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

Case No.:851/15/82-	Party Name:SI GROUP -	Meet No/Date:2/82-	Status:
ALC4/2018	INDIA PRIVATE LIMITED	ALC4/2020	Deferred
		10.07.2020
HQ File	RLA File	Lic.No/Date:0310826724
:01/82/050/02308/AM19/	:03/95/040/01108/AM19/	30.01.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 9 Meeting No. 9/82-ALC4/2019 dated 18.10.2019 , followed by Reminder on 20.03.2020 :

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

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

age yield on molar basis at each step of the reaction.**

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.:853/15/82-			Party Name:ALPHAMED		Meet No/Date:2/82-			Status:
	ALC4/2018			FORMULATIONS P LTD.		ALC4/2020			Deferred
						10.07.2020
10	HQ File			RLA File		Lic.No/Date:0910067120
	:01/82/050/02310/AM19/			:09/24/040/00511/AM19/		31.01.2019
	Decision:Deferred for comments of TE.

	Case No.:855/15/82-		Party Name:SMS		Meet No/Date:2/82-		Status:
	ALC4/2018		LIFESCIENCES INDIA		ALC4/2020		Deferred
			LIMITED		10.07.2020
11	HQ File<br>:01/82/050/02312/AM19/		RLA File<br>:09/24/040/00542/AM19/		Lic.No/Date:0910067122<br>31.01.2019
	Decision:The Committee considered the case as per agenda in the presence of technical						experts and it
	was noted that the firm vide its	e-mail dated 04.05.2020 has furnished its reply. Deferred for						comments of
	TE.

	Case No.:861/15/82-	Party Name:INNOVARE	Meet No/Date:2/82-	Status:
	ALC4/2018	LABS PRIVATE LIMITED	ALC4/2020	Deferred
			10.07.2020
12	HQ File	RLA File	Lic.No/Date:0910067125
	:01/82/050/02318/AM19/	:09/24/040/00535/AM19/	01.02.2019
	Decision:Deferred for comments of TE.

erred**| |||||||10.07.2020||| |12||HQ File||RLA File||Lic.No/Date:0910067125||| |||:01/82/050/02318/AM19/||:09/24/040/00535/AM19/||01.02.2019||| |||**Decision:**Deferred for comments of TE.|||||||

	Case No.:863/15/82-		Party Name:JAYANT AGRO	Meet No/Date:2/82-			Status:
	ALC4/2018		ORGANICS LTD.,	ALC4/2020			Deferred
				10.07.2020
13	HQ File<br>:01/82/050/02320/AM19/		RLA File<br>:03/94/040/00948/AM19/	Lic.No/Date:0310826798<br>04.02.2019
	Decision:The Committee	considered the case as per agenda in the presence of technical			experts and it
	was noted that the firm vide its e-mail dated 08.11.2019 has furnished its reply. Deferred for					comments of
	TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide its e-mail dated 08.11.2019 has furnished its reply. Deferred for comments of TE.

14	<br>Case No.:864/15/82-<br>ALC4/2018	Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED<br>RLA File<br>:03/94/040/00944/AM19/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0310826799<br>04.02.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02321/AM19/
	Decision:Deferred for comments of TE.

br>10.07.2020 Lic.No/Date:0310826799 04.02.2019|Status: Deferred| |---|---|---|---|---| || HQ File :01/82/050/02321/AM19/|||| ||**Decision:**Deferred for comments of TE.||||

Case No.:873/15/82-	Party Name:CADILA	Meet No/Date:2/82-	Status:
ALC4/2018	HEALTHCARE LTD	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0810144496
:01/82/050/02330/AM19/	:08/24/040/00379/AM19/	05.02.2019

	Case No.:873/15/82-<br>ALC4/2018	Party Name:CADILA<br>HEALTHCARE LTD<br>RLA File<br>:08/24/040/00379/AM19/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved
	HQ File<br>:01/82/050/02330/AM19/		Lic.No/Date:0810144496<br>05.02.2019
15	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>BROMOCRIPTINE<br>MESYLATE CAPSULES USP<br>5<br>MG<br>(ACTIVE<br>INGREDIENT<br>:<br>BROMOCRIPTINE<br>MESYLATE<br>USP<br>EQUIVALENT TO 8.633 KGS<br>OF BROMOCRIPTINE)<br>1 Number<br>1<br>BROMOCRIPTINE<br>MESYLATE USP<br>5.855 mg / capsule<br>RA concerned maytake further necessaryaction asper above decision of NC.

EQUIVALENT TO 8.633 KGS OF BROMOCRIPTINE) 1 Number 1 BROMOCRIPTINE MESYLATE USP 5.855 mg / capsule RA concerned maytake further necessaryaction asper above decision of NC.||||

==> picture [454 x 438] intentionally omitted <==

----- Start of picture text ----- Case No.:874/15/82- Party Meet No/Date:2/82- Status: ALC4/2018 Name:CADILAHEALTHCAR ALC4/2020 Approved E LTD 10.07.2020 HQ File RLA File Lic.No/Date:0810144497 :01/82/050/02331/AM19/ :08/24/040/00372/AM19/ 05.02.2019 Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: Sl. No. Export Product Qty. 1 DESMOPRESSIN ACETATE INJECTION USP 4MCG/ML (1ML VIAL) 456450.000 (ACTIVE INGREDIENT : DESMOPRESSIN ACETATE USP - NET WT. Vials 1.826 GMS.) & (PACKING MATERIAL IN FINISHED FORM - NET NOS. 456450) 2 DESMOPRESSIN ACETATE INJECTION USP 4MCG/ML (10ML VIAL) 96060.000 (ACTIVE INGREDIENT : DESMOPRESSIN ACETATE USP - NET WT. Vials 3.842 GMS.) & (PACKING MATERIAL IN FINISHED FORM - NET 16 NOS. 96060) Sl.

TATE INJECTION USP 4MCG/ML (10ML VIAL) 96060.000 (ACTIVE INGREDIENT : DESMOPRESSIN ACETATE USP - NET WT. Vials 3.842 GMS.) & (PACKING MATERIAL IN FINISHED FORM - NET 16 NOS. 96060) Sl. Import Items Qty. No. 1 DESMOPRESSIN ACETATE USP 6.235 Gram 2 2ML CLEAR USP TYPE I TUBULAR GLASS VIALS Relevant as (AS PER GENERAL NOTE FOR CHEMICAL AND ALLIED per packing PRODUCTS POINT NO. 5, WASTAGE ALLOWED @ 5%) policy 3 13MM RFS FLUROTEC RUBBER STOPPERS Relevant as (AS PER GENERAL NOTE FOR CHEMICAL AND ALLIED per packing PRODUCTS POINT NO. 5, WASTAGE ALLOWED @ 1%) policy 4 10ML CLEAR USP TYPE I TUBULAR GLASS VIALS Relevant as (AS PER GENERAL NOTE FOR CHEMICAL AND ALLIED per packing PRODUCTS POINT NO. 5, WASTAGE ALLOWED @ 5%) policy 5 20MM RFS FLUROTEC RUBBER STOPPERS Relevant as (AS PER GENERAL NOTE FOR CHEMICAL AND ALLIED per packing PRODUCTS POINT NO. 5, WASTAGE ALLOWED @ 1%) policy RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

17	<br>Case No.:1027/15/82-<br>ALC4/2018	Party Name:ANLON<br>HEALTHCARE<br>PRIVATELIMITED<br>RLA File<br>:24/24/040/00053/AM19/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02484/AM19/		Lic.No/Date:2410042653<br>05.02.2019
	Decision:Deferred for comments of TE.

br>10.07.2020|Status: Deferred| |---|---|---|---|---| || HQ File :01/82/050/02484/AM19/||Lic.No/Date:2410042653 05.02.2019|| ||**Decision:**Deferred for comments of TE.||||

Case No.:880/15/82-	Party Name:DEEPAK	Meet No/Date:2/82-	Status:
ALC4/2018	NOVOCHEM	ALC4/2020	Deferred
	TECHNOLOGIES LTD	10.07.2020
HQ File	RLA File	Lic.No/Date:3110067309
:01/82/050/02337/AM19/	:31/83/040/00162/AM19/	06.02.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 18 Meeting No. 13/82-ALC4/2019 dated 31.01.2020 , followed by Reminder on 19.03.2020 :

(i) A copy of 4.07 application of subject advance authorization alongwith all technical details as per Appendix 4E. (ii) Exact Chemical name of the Export Product.

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

ix 4E. (ii) Exact Chemical name of the Export Product.**

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

19	Case No.:881/15/82-<br>ALC4/2018	Party Name:SHILPA<br>MEDICARE LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0710114519<br>07.02.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02338/AM19/	RLA File<br>:07/24/040/00263/AM19/
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not available.<br>Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly<br>from the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

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

20	Case No.:883/15/82-<br>ALC4/2018	Party Name:MAHESHRAJ<br>CHEMICALS PVT.LTD	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02340/AM19/	RLA File<br>:08/24/040/00374/AM19/	Lic.No/Date:0810144562<br>08.02.2019
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not available.<br>Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly<br>from the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

21	<br>Case No.:885/15/82-<br>ALC4/2018	Party Name:ORTIN<br>LABORATORIES LTD	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0910067148<br>08.02.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02342/AM19/	RLA File<br>:09/24/040/00538/AM19/
	Decision:Deferred for comments of TE.

8 08.02.2019|Status: Deferred| |---|---|---|---|---| || HQ File :01/82/050/02342/AM19/|RLA File :09/24/040/00538/AM19/||| ||**Decision:**Deferred for comments of TE.||||

Case No.:887/15/82- Party Name:ENAL DRUGS Meet No/Date:2/82- Status: ALC4/2018 PVT LTD., ALC4/2020 Approved 10.07.2020 HQ File RLA File Lic.No/Date:0910067153 :01/82/050/02344/AM19/ :09/24/040/00543/AM19/ 08.02.2019 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 48/82-ALC4/2010 22 , dated 01.03.2011, it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

Export Product	Qty.	Sl.No.	Import items	Qty.
2-CHLORO<br>METHYL-3-METHYL-4-	1 kg	1.	2,3, Lutidine	0.79 kg
(2,2,2-TRIFLUOROETHOXY)<br>PYRIDINE HCL		2.	2,2,2-Trifluoro Ethanol	0.915 kg

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

ETHYL-4-|1 kg|1.|2,3, Lutidine|0.79 kg| |(2,2,2-TRIFLUOROETHOXY) PYRIDINE HCL||2.|2,2,2-Trifluoro Ethanol|0.915 kg|

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

23	Case No.:891/15/82-<br>ALC4/2018	Party Name:GELTEC<br>PRIVATE LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br> <br><br>Lic.No/Date:0310826970<br>11.02.2019	Status:<br>Deferred
	HQ File<br>:01/82/050/02348/AM19/	RLA File<br>:03/94/040/00970/AM19/
	<br>Decision:The Committee considered the case as per agenda and it was decided to call<br>information from the firm:<br>(i)<br>Copy of revised Advance Authorization.<br>(ii) Net weight of empty capsules to be exported.<br>(iii) Composition of softgelatine capsule.			for following

24	Case No.:894/15/82-<br>ALC4/2018	Party Name:DEEPAK<br>PHENOLICS LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02351/AM19/	RLA File<br>:34/24/040/00328/AM19/	Lic.No/Date:3410044883<br>12.02.2019
	<br>Decision:The Committee considered the case as per agenda and it was decided to call for following<br>information from the firm:<br>(i)<br>Quantity and commercial value of Co-Product Phenol obtained.<br>(ii)<br>Percentage yield on molar basis.

s decided to call for following information from the firm: (i) Quantity and commercial value of Co-Product Phenol obtained. (ii) Percentage yield on molar basis.||||

25	<br>Case No.:896/15/82-<br>ALC4/2018	Party Name:AUROBINDO<br>PHARMA LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02353/AM19/	RLA File<br>:09/24/040/00555/AM19/	Lic.No/Date:0910067168<br>13.02.2019
	Decision:Deferred for comments of TE.

26	<br>Case No.:903/15/82-<br>ALC4/2018	Party Name:MATRIX FINE<br>SCIENCES PVT.LTD.,<br> <br> <br> <br>RLA File<br>:03/95/040/01113/AM19/<br> <br>	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br> <br><br>Lic.No/Date:0310827030<br>14.02.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02360/AM19/
	Decision:Deferred for comments of TE.

27	Case No.:905/15/82-<br>ALC4/2018	Party Name:JODAS EXPOIM<br>PVT.LTD<br>RLA File<br>:05/23/040/00508/AM19/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0510409675<br>15.02.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02362/AM19/
	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.||||

28	Case No.:906/15/82-<br>ALC4/2018	Party Name:JODAS EXPOIM<br>PVT.LTD	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02363/AM19/	RLA File<br>:05/23/040/00507/AM19/	Lic.No/Date:0510409676<br>15.02.2019
	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.

29	<br>Case No.:907/15/82-<br>ALC4/2018	Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00515/AM19/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0910067181<br>15.02.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02364/AM19/
	Decision:Deferred for comments of TE.

30	<br>Case No.:916/15/82-<br>ALC4/2018	Party Name:OPTIMUS<br>DRUGS PRIVATE LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02373/AM19/	RLA File<br>:09/24/040/00569/AM19/	Lic.No/Date:0910067192<br>20.02.2019
	Decision:Deferred for comments of TE.

31	<br>Case No.:919/15/82-<br>ALC4/2018	Party Name:ORTIN<br>LABORATORIES LTD	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02376/AM19/	RLA File<br>:09/24/040/00573/AM19/	Lic.No/Date:0910067198<br>21.02.2019
	Decision:Deferred for comments of TE.

rred**| |---|---|---|---|---| || HQ File :01/82/050/02376/AM19/|RLA File :09/24/040/00573/AM19/|Lic.No/Date:0910067198 21.02.2019|| ||**Decision:**Deferred for comments of TE.||||

32	<br>Case No.:922/15/82-<br>ALC4/2018	Party Name:GLOBE<br>TROTTERS PVT LTD	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02379/AM19/	RLA File<br>:03/94/040/01015/AM19/	Lic.No/Date:0310827201<br>21.02.2019
	Decision:Deferred for comments of TE.

33	Case No.:924/15/82-<br>ALC4/2018	Party Name:INDO AMINES<br>LIMITED<br>RLA File<br>:03/94/040/00984/AM19/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0310827206<br>21.02.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02381/AM19/
	Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide its e-mail dated 27.11.2019 has furnished its reply. Deferred for comments of<br>TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide its e-mail dated 27.11.2019 has furnished its reply. Deferred for comments of TE.

ommittee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide its e-mail dated 27.11.2019 has furnished its reply. Deferred for comments of TE.

34	Case No.:929/15/82-<br>ALC4/2018	Party Name:THINQ PHARMA-<br>CRO LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02386/AM19/	RLA File<br>:03/95/040/01186/AM19/	Lic.No/Date:0310827227<br>22.02.2019
	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.:931/15/82-	Party Name:MEHK	Meet No/Date:2/82-	Status:
ALC4/2018	CHEMICALS PVT. LTD.	ALC4/2020	Rejected
		10.07.2020
HQ File	RLA File	Lic.No/Date:0310827242
:01/82/050/02388/AM19/	:03/95/040/01227/AM19/	22.02.2019

-|---| |ALC4/2018||CHEMICALS PVT. LTD.||ALC4/2020||Rejected| |||||10.07.2020||| |HQ File||RLA File||Lic.No/Date:0310827242||| |:01/82/050/02388/AM19/||:03/95/040/01227/AM19/||22.02.2019|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 35 Meeting No. 7/82-ALC4/2019 dated 06.09.2019, followed by Reminder on 30.10.2019 and Final Reminder on 18.03.2020 :

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

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

Case No.:932/15/82-	Party Name:MEHK	Meet No/Date:2/82-	Status:
ALC4/2018	CHEMICALS PVT. LTD.	ALC4/2020	Rejected
		10.07.2020
HQ File	RLA File	Lic.No/Date:0310827243
:01/82/050/02389/AM19/	:03/95/040/01209/AM19/	22.02.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 36 Meeting No. 7/82-ALC4/2019 dated 06.09.2019, followed by Reminder on 30.10.2019 and Final Reminder on 18.03.2020 :

as not furnished the following information asked for by NC-3 in its 36 Meeting No. 7/82-ALC4/2019 dated 06.09.2019, followed by Reminder on 30.10.2019 and Final Reminder on 18.03.2020 :

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

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

	Case No.:934/15/82-		Party Name:ASTRAL	Meet No/Date:2/82-		Status:
	ALC4/2018		STERITECH PVT. LTD.	ALC4/2020		Deferred
				10.07.2020
37	HQ File<br>:01/82/050/02391/AM19/		RLA File<br>:34/24/040/00356/AM19/	Lic.No/Date:3410044929<br>22.02.2019
	Decision:The Committee considered the case as per agenda in the presence of technical				experts and it
	was noted that the firm vide its	e-mail dated 02.08.2019 has furnished its reply. Deferred for				comments of
	TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide its e-mail dated 02.08.2019 has furnished its reply. Deferred for comments of TE.

ommittee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide its e-mail dated 02.08.2019 has furnished its reply. Deferred for comments of TE.

	Case No.:935/15/82-		Party Name:ASTRAL	Meet No/Date:2/82-		Status:
	ALC4/2018		STERITECH PVT. LTD.	ALC4/2020		Deferred
				10.07.2020
38	HQ File<br>:01/82/050/02392/AM19/		RLA File<br>:34/24/040/00355/AM19/	Lic.No/Date:3410044930<br>22.02.2019
	Decision:The Committee considered the case as per agenda in the presence of technical				experts and it
	was noted that the firm vide its	e-mail dated 02.08.2019 has furnished its reply. Deferred for				comments of
	TE.

	Case No.:936/15/82-	Party Name:VISION DRUGS	Meet No/Date:2/82-	Status:
	ALC4/2018	PVT LTD	ALC4/2020	Deferred
			10.07.2020
39	HQ File	RLA File	Lic.No/Date:0910067217
	:01/82/050/02393/AM19/	:09/24/040/00575/AM19/	25.02.2019
	Decision:Deferred for comments of TE.

erred**| |||||||10.07.2020||| |39||HQ File||RLA File||Lic.No/Date:0910067217||| |||:01/82/050/02393/AM19/||:09/24/040/00575/AM19/||25.02.2019||| |||**Decision:**Deferred for comments of TE.|||||||

	Case No.:1033/15/82-	Party Name:SRIAM LABS	Meet No/Date:2/82-	Status:
	ALC4/2018	PRIVATE LIMITED	ALC4/2020	Deferred
			10.07.2020
40	HQ File	RLA File	Lic.No/Date:0910067219
	:01/82/050/02490/AM19/	:09/24/040/00591/AM19/	26.02.2019
	Decision:Deferred for comments of TE.

Case No.:1038/15/82- ALC4/2018 Party Name:GLAND PHARMA LIMITED Meet No/Date:2/82- ALC4/2020 10.07.2020 Status: Deferred HQ File :01/82/050/02495/AM19/ RLA File :09/24/040/00530/AM19/ Lic.No/Date:0910067224 27.02.2019 **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.

42	<br>Case No.:1039/15/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/02496/AM19/	Party Name:GLAND PHARMA<br>LIMITED<br>RLA File<br>:09/24/040/00491/AM19/	<br>Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0910067225<br>27.02.2019	Status:<br>Deferred
	Decision:Deferred for comments of TE.

Case No.:1041/15/82-	Party Name:WEXFORD	Meet No/Date:2/82-	Status:
ALC4/2018	LABORATORIES P LTD	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0710114597
:01/82/050/02498/AM19/	:07/24/040/00276/AM19/	27.02.2019

	Case No.:1041/15/82-<br>ALC4/2018	Party Name:WEXFORD<br>LABORATORIES P LTD	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved
	HQ File<br>:01/82/050/02498/AM19/	RLA File<br>:07/24/040/00276/AM19/	Lic.No/Date:0710114597<br>27.02.2019
43	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.

9|| |43| **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: Sl. No. Export Product Qty. Sl. No. Import items Qty. 1 CEFADROXIL 250MG/5ML SUSPENSION 100ML BOTTLE(182.28KG) 36456.000 Number 1 CEFADROXIL MONOHYDRATE COMPACTED-USP 191.34 kg 2 CEFADROXIL 500MG CAPSULES (91.3KG) 182600.000 Number 2 CEFADROXIL MONOHYDRATE PLAIN-USP 93.126 kg RA concerned maytake further necessaryaction asper above decision of NC.||||

Case No.:1045/15/82-	Party Name:SAVA	Meet No/Date:2/82-	Status:
ALC4/2018	HEALTHCARE LTD.	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:3110067341
:01/82/050/02502/AM19/	:31/83/040/00183/AM19/	01.03.2019

-|---|---| |ALC4/2018||HEALTHCARE LTD.||ALC4/2020||Approved| |||||10.07.2020||| |HQ File||RLA File||Lic.No/Date:3110067341||| |:01/82/050/02502/AM19/||:31/83/040/00183/AM19/||01.03.2019|||

	Case No.:1045/15/82-<br>ALC4/2018	Party Name:SAVA<br>HEALTHCARE LTD.	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved
	HQ File<br>:01/82/050/02502/AM19/	RLA File<br>:31/83/040/00183/AM19/	Lic.No/Date:3110067341<br>01.03.2019
44	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Sl.<br>No<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>VETERINARY PRODUCT -<br>SELAFORTE<br>-<br>SELAMECTIN<br>SPOT<br>ON<br>SOLUTION 6% w/v FOR<br>CATS<br>5.1<br>TO<br>7.5<br>KG<br>STRENGTH 0.75 ML EACH<br>PIPPET<br>CONTENT<br>SELAMECTIN EP 45 MG<br>NET<br>CONTENT<br>IN<br>RP<br>TOTAL 18000 PIPPET<br>18000.000<br>Number<br>1<br>SELAMECTIN EP<br>850.5 Gram<br>2<br>VETERINARY PRODUCT -<br>SELAFORTE<br>-<br>SELAMECTIN<br>SPOT<br>ON<br>SOLUTION 6% w/v FOR<br>PUPPIES<br>AND<br>KITTENS<br>2.5.<br>KGS<br>STRENGTH 0.25 ML EACH<br>PIPPET<br>CONTENT<br>SELAMECTIN EP 15 MG<br>NET<br>CONTENT<br>IN<br>RP<br>TOTAL 6000 PIPPET<br>6000.000<br>Number<br>1<br>SELAMECTIN EP<br>94.5 Gram<br>3<br>VETERINARY PRODUCT -<br>SELAFORTE<br>-<br>SELAMECTIN<br>SPOT<br>ON<br>SOLUTION 12% w/v FOR<br>DOGS<br>2.6.<br>TO<br>5<br>KGS<br>STRENG

6000.000 Number 1 SELAMECTIN EP 94.5 Gram 3 VETERINARY PRODUCT - SELAFORTE - SELAMECTIN SPOT ON SOLUTION 12% w/v FOR DOGS 2.6. TO 5 KGS STRENGTH 0.25 ML EACH PIPPET CONTENT SELAMECTIN EP 30 MG NET CONTENT IN RP TOTAL 6000 PIPPET 6000.000 Number 1 SELAMECTIN EP 189.0 Gram 4 VETERINARY PRODUCT - SELAFORTE - SELAMECTIN SPOT ON SOLUTION 12% w/v FOR DOGS 5.1 TO 10 KG STRENGTH 0.50 ML EACH PIPPET CONTENT SELAMECTIN EP 60 MG NET CONTENT IN RP TOTAL 6000 PIPPET 6000.000 Number 1 SELAMECTIN EP 378.0 Gram RA concerned maytake further necessaryaction asper above decision of NC.||||

45	<br>Case No.:1057/15/82-<br>ALC4/2018	Party Name:CIPLA LIMITED.<br>RLA File<br>:03/94/040/01019/AM19/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0310827414<br>01.03.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02514/AM19/
	Decision:Deferred for comments of TE.

br>10.07.2020 Lic.No/Date:0310827414 01.03.2019|Status: Deferred| |---|---|---|---|---| || HQ File :01/82/050/02514/AM19/|||| ||**Decision:**Deferred for comments of TE.||||

Case No.:143/1/82-ALC4/2019 Party Name:TINA ORGANICS Meet No/Date:2/82- Status: PRIVATE LIMITED ALC4/2020 Deferred 10.07.2020 46 HQ File RLA File Lic.No/Date:0510409855 :01/82/050/02538/AM19/ :05/24/040/00695/AM19/ 06.03.2019

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide its letter dated 11.03.2020 has furnished its reply. Deferred for comments of TE.

Case No.:149/1/82- Party Name:SRIAM LABS Meet No/Date:2/82- Status: ALC4/2019 PRIVATE LIMITED ALC4/2020 Approved 10.07.2020 HQ File RLA File Lic.No/Date:0910067252 :01/82/050/02544/AM19/ :09/24/040/00604/AM19/ 11.03.2019

	Case No.:149/1/82-<br>ALC4/2019<br>Party Name:SRIAM LABS<br>PRIVATE LIMITED<br>Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Status:<br>Approved<br>HQ File<br>:01/82/050/02544/AM19/<br>RLA File<br>:09/24/040/00604/AM19/<br>Lic.No/Date:0910067252<br>11.03.2019
47	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.

--| |47| **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: Export Product Qty. Sl. No. Import items Qty. ABACAVIR SULFATE (ABC- III) 1 kg 1 2-Azabicylo [2.2.1] hept-5- en-3-one(Vincelactam) 2.50 kg 2 Sodium borohydride(SBH) 0.48 kg 3 N-(2-amino-4,6-dichloro-5- pyrimidinyl) Formamide (FADCP) 1.042 kg 4 L(+)Tartaric acid 1.251 kg 5 D(-)Tartaric acid 1.30 kg 6 Cyclopropylamine 0.19kg RA concerned maytake further necessaryaction asper above decision of NC.|

Case No.:150/1/82-ALC4/2019	Party Name:ALKALI METALS	Meet No/Date:2/82-	Status:
	LTD.,	ALC4/2020	Rejected
		10.07.2020
HQ File	RLA File	Lic.No/Date:0910067258
:01/82/050/02545/AM19/	:09/24/040/00561/AM19/	11.03.2019

**| |---|---|---|---|---|---|---| |||LTD.,||ALC4/2020||Rejected| |||||10.07.2020||| |HQ File||RLA File||Lic.No/Date:0910067258||| |:01/82/050/02545/AM19/||:09/24/040/00561/AM19/||11.03.2019|||

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 48 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 9/82-ALC4/2019 dated 18.10.2019, followed by Reminder on 09.12.2019 and Final Reminder on 20.03.2020 :

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

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

49	<br>Case No.:159/1/82-ALC4/2019	Party Name:EMMENNAR<br>PHARMA PRIVATE<br>LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02554/AM19/	RLA File<br>:09/24/040/00600/AM19/	Lic.No/Date:0910067264<br>12.03.2019
	Decision:Deferred for comments of TE.

Case No.:160/1/82-	Party Name:ASHISH LIFE	Meet No/Date:2/82-	Status:
ALC4/2019	SCIENCE PVT.LTD.	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0310827639
:01/82/050/02555/AM19/	:03/94/040/00693/AM19/	12.03.2019

|---|---| |ALC4/2019||SCIENCE PVT.LTD.||ALC4/2020||Approved| |||||10.07.2020||| |HQ File||RLA File||Lic.No/Date:0310827639||| |:01/82/050/02555/AM19/||:03/94/040/00693/AM19/||12.03.2019|||

	Case No.:160/1/82-<br>ALC4/2019	Case No.:160/1/82-<br>ALC4/2019	Case No.:160/1/82-<br>ALC4/2019	Party Name:ASHISH LIFE<br>SCIENCE PVT.LTD.	Party Name:ASHISH LIFE<br>SCIENCE PVT.LTD.	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved	Status:<br>Approved
	HQ File<br>:01/82/050/02555/AM19/			RLA File<br>:03/94/040/00693/AM19/		Lic.No/Date:0310827639<br>12.03.2019
50	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>TYLOSIN TARTRATE POWDER<br>100%-100GM<br>SACHET<br>(EACH<br>GRAM<br>CONTAINS<br>TYLOSIN<br>TARTRATE<br>100%)<br>(nett content of exempt material is 20<br>kgs)<br>200.000<br>Number<br>1<br>TYLOSIN<br>TARTRATE<br>235.088 kg<br>2<br>TYLOSIN TARTRATE POWDER<br>100% -500GM SACHET (EACH<br>GRAM<br>CONTAINS<br>TYLOSIN<br>TARTRATE<br>100%)<br>(nett content of exempt material is 20<br>kgs)<br>40.000<br>Number<br>3<br>TYLOSIN TARTRATE POWDER<br>100% -1KG JAR (EACH GRAM<br>CONTAINS TYLOSIN T

GRAM CONTAINS TYLOSIN TARTRATE 100%) (nett content of exempt material is 20 kgs) 40.000 Number 3 TYLOSIN TARTRATE POWDER 100% -1KG JAR (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) (nett content of exempt material is 20 kgs) 20.000 Number 4 TYLOSIN TARTRATE POWDER 99% -100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 99%) (nett content of exempt material is 9.90kgs) 100.000 Number 5 TYLOSIN TARTRATE POWDER 99% -500GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 99%) (nett content of exempt material is 12.375kgs) 25.000 Number 6 TYLOSIN TARTRATE POWDER 99% -1KG JAR (EACH GRAM CONTAINS TYLOSIN TARTRATE 99%) (nett content of exempt material is 19.80kgs) 20.000 Number 7 TYLOSIN TARTRATE POWDER 20% -100GM (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%) (nett content of exempt material is 14.50 kgs) 725.000 Number|||||||||| |||Sl. No.|Export Product||Qty.||Sl. No.|Import items||Qty.| |||1|TYLOSIN TARTRATE POWDER 100%-100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) (nett content of exempt material is 20 kgs)||200.000 Number||1|TYLOSIN TARTRATE||235.088 kg| |||2|TYLOSIN TARTRATE POWDER 100% -500GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) (nett content of exempt material is 20 kgs)||40.000 Number||||||

ATE||235.088 kg| |||2|TYLOSIN TARTRATE POWDER 100% -500GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) (nett content of exempt material is 20 kgs)||40.000 Number|||||| |||3|TYLOSIN TARTRATE POWDER 100% -1KG JAR (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) (nett content of exempt material is 20 kgs)||20.000 Number|||||| |||4|TYLOSIN TARTRATE POWDER 99% -100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 99%) (nett content of exempt material is 9.90kgs)||100.000 Number|||||| |||5|TYLOSIN TARTRATE POWDER 99% -500GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 99%) (nett content of exempt material is 12.375kgs)||25.000 Number|||||| |||6|TYLOSIN TARTRATE POWDER 99% -1KG JAR (EACH GRAM CONTAINS TYLOSIN TARTRATE 99%) (nett content of exempt material is 19.80kgs)||20.000 Number|||||| |||7|TYLOSIN TARTRATE POWDER 20% -100GM (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%) (nett content of exempt material is 14.50 kgs)||725.000 Number||||||

IN TARTRATE POWDER 20% -100GM (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%) (nett content of exempt material is 14.50 kgs)||725.000 Number||||||

||8 TYLOSIN TARTRATE POWDER 20% -500GM (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%) (nett content of exempt material is 5.00 kgs) 50.000 Number 9 TYLOSIN TARTRATE POWDER 20% -1KG JAR (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%) (nett content of exempt material is 5.00 kgs) 25.000 Number 10 TYLOSIN BOLUS 200MG (EACH BOLUS CONTAINS TYLOSIN 200MG) (nett content of exempt material is 20 kgs) 100000.000 Number 11 TYLOSIN INJECTION 5%-30 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) (nett content of exempt material is 15 kgs) 10000.000 Number 12 TYLOSIN INJECTION 5%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) (nett content of exempt material is 25 kgs) 10000.000 Number 13 TYLOSIN INJECTION 5%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) (nett content of exempt material is 25kgs) 5000.000 Number RA concerned maytake further necessaryaction asper above decision of NC.|8|TYLOSIN TARTRATE POWDER 20% -500GM (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%) (nett content of exempt material is 5.00 kgs)|50.000 Number||||

f NC.|8|TYLOSIN TARTRATE POWDER 20% -500GM (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%) (nett content of exempt material is 5.00 kgs)|50.000 Number|||| |---|---|---|---|---|---|---|---| |||9|TYLOSIN TARTRATE POWDER 20% -1KG JAR (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%) (nett content of exempt material is 5.00 kgs)|25.000 Number|||| |||10|TYLOSIN BOLUS 200MG (EACH BOLUS CONTAINS TYLOSIN 200MG) (nett content of exempt material is 20 kgs)|100000.000 Number|||| |||11|TYLOSIN INJECTION 5%-30 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) (nett content of exempt material is 15 kgs)|10000.000 Number|||| |||12|TYLOSIN INJECTION 5%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) (nett content of exempt material is 25 kgs)|10000.000 Number|||| |||13|TYLOSIN INJECTION 5%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) (nett content of exempt material is 25kgs)|5000.000 Number||||

Case No.:161/1/82-	Party Name:OPTRIX	Meet No/Date:2/82-	Status:
ALC4/2019	LABORATORIES PRIVATE	ALC4/2020	Approved
	LIMITED	10.07.2020
HQ File	RLA File	Lic.No/Date:0910067270
:01/82/050/02556/AM19/	:09/24/040/00621/AM19/	13.03.2019

ALC4/2019||LABORATORIES PRIVATE||ALC4/2020||Approved| |||LIMITED||10.07.2020||| |HQ File||RLA File||Lic.No/Date:0910067270||| |:01/82/050/02556/AM19/||:09/24/040/00621/AM19/||13.03.2019|||

	Case No.:161/1/82-<br>ALC4/2019	Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved
	HQ File<br>:01/82/050/02556/AM19/	RLA File<br>:09/24/040/00621/AM19/	Lic.No/Date:0910067270<br>13.03.2019
51	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>VELPATASVIR-COPOVIDONE (1:1)<br>1 kg<br>1<br>Methyl [(2S)-1-[(2S,5S)-2-[9-[2-<br>[(2S,4S)-1-[(2R)-2-<br>[(methoxycarbonyl)amino]-2-<br>phenylacetyl]-<br>4-(methoxymethyl)pyrrolidin-2-<br>yl]-1H-imidazol-5-yl]-1,11-<br>dihydroisochromeno[4,3:6,7]<br>naphtha[1,2-d]imidazol-2-yl]-5-<br>methylpyrrolidin-1-yl]-3-methyl-<br>1-oxobutan-2-yl)carbamate<br>0.555 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

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

Case No.:166/1/82-	Party Name:ENAL DRUGS	Meet No/Date:2/82-	Status:
ALC4/2019	PVT LTD.,	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0910067274
:01/82/050/02561/AM19/	:09/24/040/00614/AM19/	13.03.2019

Export Product	Qty.	Sl.<br>No.	Import items	Qty.
RABEPRAZOLE<br>SODIUM<br>BP/EP/USP/JP/CP<br>.	1 kg	1	3-METHOXY -1-PROPANOL	0.90 kg

53	<br>Case No.:167/1/82-ALC4/2019	Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00612/AM19/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0910067275<br>13.03.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02562/AM19/
	Decision:Deferred for comments of TE.

br>10.07.2020 Lic.No/Date:0910067275 13.03.2019|Status: Deferred| |---|---|---|---|---| || HQ File :01/82/050/02562/AM19/|||| ||**Decision:**Deferred for comments of TE.||||

54	<br>Case No.:169/1/82-ALC4/2019	Party Name:RUSAN PHARMA<br>LTD.<br>RLA File<br>:03/95/040/01315/AM19/	<br>Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0310827685<br>13.03.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02564/AM19/
	Decision:Deferred for comments of TE.

55	<br>Case No.:170/1/82-ALC4/2019	Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED<br>RLA File<br>:03/94/040/01071/AM19/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0310827686<br>13.03.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02565/AM19/
	Decision:Deferred for comments of TE.

Case No.:175/1/82-	Party Name:MALLADI	Meet No/Date:2/82-	Status:
ALC4/2019	DRUGS &	ALC4/2020	Approved
	PHARMACEUTICALS	10.07.2020
	LIMITED
HQ File	RLA File	Lic.No/Date:0410165324
:01/82/050/02570/AM19/	:04/24/040/00244/AM19/	14.03.2019

**||DRUGS &||ALC4/2020||Approved| |||PHARMACEUTICALS||10.07.2020||| |||LIMITED||||| |HQ File||RLA File||Lic.No/Date:0410165324||| |:01/82/050/02570/AM19/||:04/24/040/00244/AM19/||14.03.2019|||

	Case No.:175/1/82-<br>ALC4/2019<br> <br> <br> <br> <br>HQ File<br>:01/82/050/02570/AM19/<br> <br>	Party Name:MALLADI<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED<br> <br> <br> <br>RLA File<br>:04/24/040/00244/AM19/<br> <br>	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved
			Lic.No/Date:0410165324<br>14.03.2019
56	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>(4S,5R)-(-)-4-Methyl-5-Phenyl-<br>2-Oxazolidinone (Chiral<br>Oxazolidinone)<br>1 kg<br>1<br>Propiophenone<br>5.98 kg<br>2<br>Diethyl Carbonate<br>0.95 kg<br>3<br>Heptane<br>6.82 kg<br>4<br>Toluene<br>8.90 kg<br>5<br>Iso Propyl Alcohol<br>11.22 kg<br>6<br>Methyl Isobutyl Ketone<br>3.11 kg<br>7<br>Acetone<br>3.56 kg<br>8<br>Causticsoda Flakes<br>3.11 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

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

Case No.:198/1/82-	Party Name:LABORATE	Meet No/Date:2/82-	Status:
ALC4/2019	PHARMACEUTICAL INDIA	ALC4/2020	Approved
	LIMITED	10.07.2020
HQ File	RLA File	Lic.No/Date:3310030519
:01/82/050/02593/AM19/	:33/24/040/00020/AM19/	14.03.2019

	Case No.:198/1/82-<br>ALC4/2019<br> <br> <br> <br>HQ File<br>:01/82/050/02593/AM19/<br> <br>:	Party Name:LABORATE<br>PHARMACEUTICAL INDIA<br>LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved
		RLA File<br>33/24/040/00020/AM19/	Lic.No/Date:3310030519<br>14.03.2019
57	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Clindamycin Phosphate Cream<br>/Gel 30gm (Clindamycin<br>Phosphate 0.41gm is equivalent<br>to 30 gm Clindamycin)<br>128.049 Kg consuming in<br>426830 Tubes/Cream 30gm<br>each<br>1 Number<br>Tube of 30<br>gms<br>1<br>Clindamycin Phosphate<br>IP/BP/USP A raw material in<br>powder form<br>364.14 mg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Number Tube of 30 gms 1 Clindamycin Phosphate IP/BP/USP A raw material in powder form 364.14 mg RA concerned maytake further necessaryaction asper above decision of NC.||||

58	Case No.:204/1/82-ALC4/2019	Party Name:DEEPAK<br>PHENOLICS LIMITED<br>RLA File<br>:34/24/040/00353/AM19/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02599/AM19/		Lic.No/Date:3410044969<br>14.03.2019
	<br>Decision:The Committee considered the case as per agenda and it was decided to call for following<br>information from the firm:<br>(i)<br>Quantity and commercial value of Co-Product Phenol obtained.<br>(ii)<br>Percentage yield on molar basis.

59	Case No.:179/1/82-ALC4/2019	Party Name:SHANKUS<br>PHARMACEUTICALS<br>RLA File<br>:08/24/040/00430/AM19/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0810144782<br>18.03.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02574/AM19/
	Decision:The Committee considered the case as per agenda and it was decided to call for following<br>information from the firm:<br>(i)<br>Complete chemistry, molecular weight asper Appendix 4E.

n:**The Committee considered the case as per agenda and it was decided to call for following information from the firm: (i) Complete chemistry, molecular weight asper Appendix 4E.||||

60	Case No.:181/1/82-ALC4/2019	Party Name:DINAKARA LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00571/AM19/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02576/AM19/		Lic.No/Date:0910067285<br>18.03.2019
	Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not available.<br>Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly<br>from 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.

61	Case No.:133/6/82-ALC4/2019	Party Name:ORIENTAL<br>AROMATICS LTD<br>RLA File<br>:03/95/040/01320/AM19/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0310827769<br>18.03.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00359/AM20/
	Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide its letter dated 26.12.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide its letter dated 26.12.2019 has furnished its reply. Deferred for comments of TE.

Case No.:184/1/82-	Party Name:KLJ	Meet No/Date:2/82-	Status:
ALC4/2019	PLASTICIZERS LIMITED.	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0510409975
:01/82/050/02579/AM19/	:05/23/040/00562/AM19/	19.03.2019

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

Export Product	Qty.	Sl.<br>No.	Import items	Qty.
DI-BUTYL<br>TEREPHTHALATE(DBTP)	1 kg	1	TEREPHTHALIC ACID	0.350 kg
		2	N-BUTANOL	0.588 kg

Case No.:185/1/82-ALC4/2019	Party Name:MANGALAM	Meet No/Date:2/82-	Status:
	ORGANICS LIMITED	ALC4/2020	Deferred
	(FORMERLY DUJODWALA	10.07.2020
HQ File	RLA File	Lic.No/Date:0310827775
:01/82/050/02580/AM19/	:03/95/040/00899/AM19/	19.03.2019

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

(i) Manufacturing process furnished is for Pine Oil and not for Camphor. (ii) Manufacturing details as per Appendix 4E with all technical details, quantity of By Products and their commercial value.

facturing process furnished is for Pine Oil and not for Camphor. (ii) Manufacturing details as per Appendix 4E with all technical details, quantity of By Products and their commercial value.**

	Case No.:187/1/82-ALC4/2019	Party Name:OPTRIX	Meet No/Date:2/82-	Status:
64		<br>LABORATORIES PRIVATE<br>LIMITED	<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0910067297<br>19.03.2019	<br>Deferred
	HQ File<br>:01/82/050/02582/AM19/	RLA File<br>:09/24/040/00619/AM19/
	Decision:The Committee considered the case as per agenda and it was observed that theapplied inputs<br>do not match with manufacturing process, chemistry, material balance and flow chart.<br>In view of above, the Committee decided to call for clarification from the firm.	sidered the case as per agenda an	d it was observed that the	applied inputs

Case No.:188/1/82-	Party Name:VASUDHA	Meet No/Date:2/82-	Status:
ALC4/2019	PHARMA CHEM LTD	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0910067299
:01/82/050/02583/AM19/	:09/24/040/00629/AM19/	19.03.2019

-|---|---| |ALC4/2019||PHARMA CHEM LTD||ALC4/2020||Approved| |||||10.07.2020||| |HQ File||RLA File||Lic.No/Date:0910067299||| |:01/82/050/02583/AM19/||:09/24/040/00629/AM19/||19.03.2019|||

		ALC4/2019<br>PHARMA CHEM LTD<br>ALC4/2020<br>10.07.2020<br>Approved<br>HQ File<br>:01/82/050/02583/AM19/<br>RLA File<br>:09/24/040/00629/AM19/<br>Lic.No/Date:0910067299<br>19.03.2019	ALC4/2019<br>PHARMA CHEM LTD<br>ALC4/2020<br>10.07.2020<br>Approved<br>HQ File<br>:01/82/050/02583/AM19/<br>RLA File<br>:09/24/040/00629/AM19/<br>Lic.No/Date:0910067299<br>19.03.2019	ALC4/2019<br>PHARMA CHEM LTD<br>ALC4/2020<br>10.07.2020<br>Approved<br>HQ File<br>:01/82/050/02583/AM19/<br>RLA File<br>:09/24/040/00629/AM19/<br>Lic.No/Date:0910067299<br>19.03.2019	ALC4/2019<br>PHARMA CHEM LTD<br>ALC4/2020<br>10.07.2020<br>Approved<br>HQ File<br>:01/82/050/02583/AM19/<br>RLA File<br>:09/24/040/00629/AM19/<br>Lic.No/Date:0910067299<br>19.03.2019	ALC4/2019<br>PHARMA CHEM LTD<br>ALC4/2020<br>10.07.2020<br>Approved<br>HQ File<br>:01/82/050/02583/AM19/<br>RLA File<br>:09/24/040/00629/AM19/<br>Lic.No/Date:0910067299<br>19.03.2019	ALC4/2019<br>PHARMA CHEM LTD<br>ALC4/2020<br>10.07.2020<br>Approved<br>HQ File<br>:01/82/050/02583/AM19/<br>RLA File<br>:09/24/040/00629/AM19/<br>Lic.No/Date:0910067299<br>19.03.2019	ALC4/2019<br>PHARMA CHEM LTD<br>ALC4/2020<br>10.07.2020<br>Approved<br>HQ File<br>:01/82/050/02583/AM19/<br>RLA File<br>:09/24/040/00629/AM19/<br>Lic.No/Date:0910067299<br>19.03.2019

TD ALC4/2020 10.07.2020 Approved HQ File :01/82/050/02583/AM19/ RLA File :09/24/040/00629/AM19/ Lic.No/Date:0910067299 19.03.2019| |---|---|---|---|---|---|---|---|---| |||**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it||||||| |||was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as||||||| |||applied by firm whichever is lower:||||||| ||||Export Product|Qty.|Sl.|Import items|Qty.|| ||||||No.|||| |65|||LOSARTAN POTASSIUM (OR) LOSARTAN|1 kg|1|2-Cyano-4-Bromomethyl Biphenyl(BR-OTBN)|0.75 kg|| ||||POTASSIUM USP||2|Toluene|1.46 kg|| ||||||3|Methanol|2.09kg|| ||||||4|Sodium Boro Hydride|0.048 kg|| ||||||5|Sodium Azide|0.38 kg|| ||||||6|Activated Carbon"SC40V"|0.100 kg|| ||||||7|Iso Propyl Alcohol|0.91 kg|| ||||||8|Valeronitrile|0.45 kg|| ||||||9|Glycine Technical Grade|0.37 kg|| ||||||10|Dimethyl Formamide|0.54 kg|| |||RA concerned maytake further necessaryaction asper above decision of NC.|||||||

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

	Case No.:200/1/82-ALC4/2019	Party Name:AETHER	Meet No/Date:2/82-	Status:
		INDUSTRIES LIMITED	ALC4/2020	Deferred
			10.07.2020
66	HQ File	RLA File	Lic.No/Date:5210043000
	:01/82/050/02595/AM19/	:52/24/040/00085/AM19/	19.03.2019
	Decision:Deferred for comments of TE.

Case No.:205/1/82-	Party Name:ALEOR	Meet No/Date:2/82-	Status:
ALC4/2019	DERMACEUTICALS	ALC4/2020	Approved
	LIMITED	10.07.2020
HQ File	RLA File	Lic.No/Date:3410044985
:01/82/050/02600/AM19/	:34/24/040/00396/AM19/	19.03.2019

	Case No.:205/1/82-<br>ALC4/2019	Case No.:205/1/82-<br>ALC4/2019	Case No.:205/1/82-<br>ALC4/2019	Party Name:ALEOR<br>DERMACEUTICALS<br>LIMITED	Party Name:ALEOR<br>DERMACEUTICALS<br>LIMITED	Party Name:ALEOR<br>DERMACEUTICALS<br>LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved	Status:<br>Approved
	HQ File<br>:01/82/050/02600/AM19/			RLA File<br>:34/24/040/00396/AM19/			Lic.No/Date:3410044985<br>19.03.2019

proved**|Status: Approved| |---|---|---|---|---|---|---|---|---|---|---| ||HQ File :01/82/050/02600/AM19/|||RLA File :34/24/040/00396/AM19/|||Lic.No/Date:3410044985 19.03.2019|||| |67| **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: Sl. No. Export Product Qty. Sl. No. Import items Qty. 1 CLOBETASOL PROPIONATE TOPICAL SOLUTION USP 0.05% 25 ML (net Content of active ingredients - 70.022 gm Plus 62.073 gm for Process Loss / Quality Control Analysis/ HandlingLoss/ Bulk Hold Batch) 1 Pack 1 Clobetasol Propionate USP (Micronized) 12.75 mg per pack 2 CLOBETASOL PROPIONATE TOPICAL SOLUTION USP 0.05% 50 ML (net Content of active ingredients - 822.974 gm Plus 587.487 gm for Process Loss / Quality Control Analysis / HandlingLoss /Bulk HoldBatch)" 1 Pack 1 Clobetasol Propionate USP (Micronized) 25.50 mg per pack RA concerned maytake further necessaryaction asper above decision of NC.|||||||||| |||Sl. No.|Export Product||Qty.|Sl. No.||Import items||Qty.|

br>USP (Micronized) 25.50 mg per pack RA concerned maytake further necessaryaction asper above decision of NC.|||||||||| |||Sl. No.|Export Product||Qty.|Sl. No.||Import items||Qty.| |||1|CLOBETASOL PROPIONATE TOPICAL SOLUTION USP 0.05% 25 ML (net Content of active ingredients - 70.022 gm Plus 62.073 gm for Process Loss / Quality Control Analysis/ HandlingLoss/ Bulk Hold Batch)||1 Pack|1||Clobetasol Propionate USP (Micronized)||12.75 mg per pack| |||2|CLOBETASOL PROPIONATE TOPICAL SOLUTION USP 0.05% 50 ML (net Content of active ingredients - 822.974 gm Plus 587.487 gm for Process Loss / Quality Control Analysis / HandlingLoss /Bulk HoldBatch)"||1 Pack|1||Clobetasol Propionate USP (Micronized)||25.50 mg per pack| |||||||decision of NC.|||||

Case No.:206/1/82-	Party Name:ALEOR	Meet No/Date:2/82-	Status:
ALC4/2019	DERMACEUTICALS	ALC4/2020	Approved
	LIMITED	10.07.2020
HQ File	RLA File	Lic.No/Date:3410044986
:01/82/050/02601/AM19/	:34/24/040/00397/AM19/	19.03.2019

---| |ALC4/2019||DERMACEUTICALS||ALC4/2020||Approved| |||LIMITED||10.07.2020||| |HQ File||RLA File||Lic.No/Date:3410044986||| |:01/82/050/02601/AM19/||:34/24/040/00397/AM19/||19.03.2019|||

	Case No.:206/1/82-<br>ALC4/2019	Case No.:206/1/82-<br>ALC4/2019	Case No.:206/1/82-<br>ALC4/2019	Party Name:ALEOR<br>DERMACEUTICALS<br>LIMITED	Party Name:ALEOR<br>DERMACEUTICALS<br>LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved	Status:<br>Approved
	HQ File<br>:01/82/050/02601/AM19/			RLA File<br>:34/24/040/00397/AM19/		Lic.No/Date:3410044986<br>19.03.2019
68	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.

||| |68| **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: Sl. No. Export Product Qty. Sl. No. Import items Qty. 1 DESONIDE OINTMENT 0.05% - 15 GM (net Content of active ingredients - 338.250 gm Plus 176.534 gm for Process Loss / Quality Control Analysis / Handling Loss / Bulk Hold Batch) 1 Number Tube 1 Desonide USP (Micronized) 7.65 mg 2 DESONIDE OINTMENT 0.05% - 60 GM (net Content of active ingredients - 461.250 gm Plus 224.064 gm for Process Loss / Quality Control Analysis / Handling Loss / Bulk Hold Batch) 1 Number Tube 1 Desonide USP (Micronized) 30.60 mg RA concerned maytake further necessaryaction asper above decision of NC.||||||||||| |||Sl. No.|Export Product||Qty.|||Sl. No.|Import items||Qty.| |||1|DESONIDE OINTMENT 0.05% - 15 GM (net Content of active ingredients - 338.250 gm Plus 176.534 gm for Process Loss / Quality Control Analysis / Handling Loss / Bulk Hold Batch)||1 Number Tube|||1|Desonide USP (Micronized)|| 7.65 mg| |||2|DESONIDE OINTMENT 0.05% - 60 GM (net Content of active ingredients - 461.250 gm Plus 224.064 gm for Process Loss / Quality Control Analysis / Handling Loss / Bulk Hold Batch)||1 Number Tube|||1|Desonide USP (Micronized)|| 30.60 mg| ||||||||||||| |||||||||||||

r>gm Plus 224.064 gm for Process Loss / Quality Control Analysis / Handling Loss / Bulk Hold Batch)||1 Number Tube|||1|Desonide USP (Micronized)|| 30.60 mg| ||||||||||||| ||||||||||||| |69|Case No.:210/1/82-ALC4/2019|||Party Name:V.D.H. ORGANICS PVT. LTD RLA File :05/24/040/00721/AM19/|||Meet No/Date:2/82- ALC4/2020 10.07.2020||||Status: Rejected| ||HQ File :01/82/050/02605/AM19/||||||Lic.No/Date:0510410010 20.03.2019||||| || Decision:The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No.9/82-ALC4/2019 dated 18.10.2019,followed by Reminder on09.12.2019and Final Reminder on20.03.2020: (i) Complete 4E with all technical details i.e chemistry, molecular weight, stoichiometric reaction and % of yield on molar basis at every stage Hence, the Committee decided torejectthe case. RA concerned maytake further necessaryaction asper above decision of NC.|||||||||||

ion and % of yield on molar basis at every stage** Hence, the Committee decided torejectthe case. RA concerned maytake further necessaryaction asper above decision of NC.|||||||||||

70	Case No.:211/1/82-ALC4/2019	Party Name:PORUS<br>LABORATORIES PVT LTD	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02606/AM19/	RLA File<br>:09/24/040/00633/AM19/	Lic.No/Date:0910067303<br>20.03.2019
	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.:214/1/82-	Party Name:DEEPAK	Meet No/Date:2/82-	Status:
ALC4/2019	PHENOLICS LIMITED	ALC4/2020	Deferred
		10.07.2020
HQ File	RLA File	Lic.No/Date:3410044990
:01/82/050/02609/AM19/	:34/24/040/00327/AM19/	20.03.2019

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

:01/82/050/02609/AM19/||:34/24/040/00327/AM19/||20.03.2019|||

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

(i) Quantity and commercial value of Co-Product Phenol obtained. (ii) Percentage yield on molar basis.

Case No.:215/1/82-ALC4/2019	Party Name:BEST VALUE	Meet No/Date:2/82-	Status:
	CHEM PVT. LTD.	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:3410044991
:01/82/050/02610/AM19/	:34/24/040/00389/AM19/	22.03.2019

Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 1/82-ALC4/2018 72 , dated 01.05.2018, it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

Export Product		Qty.	Sl.No.	Import items	Qty.
Undecavertol	(Kakdinol)	1 kg	1.	Propionaldehyde	0.842 kg
(4-Methyl-3-decen-5-ol)			2.	1-Pentanol/N Amyl Alcohol	0.639 kg

Case No.:216/1/82-ALC4/2019	Party Name:BEST VALUE	Meet No/Date:2/82-	Status:
	CHEM PVT. LTD.	ALC4/2020	Withdrawn
		10.07.2020
HQ File	RLA File	Lic.No/Date:3410044992
:01/82/050/02611/AM19/	:34/24/040/00390/AM19/	22.03.2019

--|---|---|---|---|---| |||CHEM PVT. LTD.||ALC4/2020||Withdrawn| |||||10.07.2020||| |HQ File||RLA File||Lic.No/Date:3410044992||| |:01/82/050/02611/AM19/||:34/24/040/00390/AM19/||22.03.2019|||

Decision: The firm vide e-mail dated 02.07.2019 has informed that they had applied for issuance of 73 Advance Authorization under para 4.07 A (self declaration and self ratification) in view of its becoming AEO status holder, but while issuing the subject Advance Authorization, RA inadvertantly indicated Advance Licence issued under para 4.7 of HBP 2015-20, for which they have requested RLA,Vadodara to amend the condition sheet of advance authorization to read as Advance Licence issued under para 4.07 A of HBP Vol. I.

The Committee considered the case as per agenda in the presence of technical experts and in light of above e-mail of firm, it wasdecided to withdraw the case.

Case No.:13/1/82-ALC4/2019	Party Name:DEEPAK	Meet No/Date:2/82-	Status:
	NOVOCHEM	ALC4/2020	Deferred
	TECHNOLOGIES LTD	10.07.2020
HQ File	RLA File	Lic.No/Date:3110067362
:01/82/050/00013/AM20/	:31/83/040/00296/AM19/	02.04.2019

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 9/82-ALC4/2019 74 dated 18.10.2019, followed by Reminder on 09.12.2019 and Final Reminder on 19.03.2020 :

the information on following deficiencies raised by NC-3 in its Meeting No. 9/82-ALC4/2019 74 dated 18.10.2019, followed by Reminder on 09.12.2019 and Final Reminder on 19.03.2020 :

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

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

	Case No.:14/1/82-ALC4/2019Party Name:CLEAN SCIENCE<br>Meet No/Date:2/82-	Status:
	AND TECHNOLOGY<br>ALC4/2020	Deferred
	PVT.LTD.<br>10.07.2020
	HQ File<br>RLA File<br>Lic.No/Date:3110067371
	:01/82/050/00014/AM20/<br>:31/83/040/00299/AM19/<br>04.04.2019
75	Decision:The Committee considered the case as per online agenda in the presence of technical experts<br>and it was noted that the firm still has not furnished the following information asked for by NC-3 in its
	Meeting No.13/82-ALC4/2019 dated 31.01.2020, followed by Reminder on18.03.2020:
	(i)<br>Quantity and value of By-Product- Acetic Anhydride.
	In view of above, the Committee decided to issueFinal Reminder to firm to furnish its reply,	failing which
	the case will be rejected.

alue of By-Product- Acetic Anhydride.||| |||In view of above, the Committee decided to issueFinal Reminder** to firm to furnish its reply,||failing which| |||the case will be rejected.|||

76	Case No.:39/1/82-ALC4/2019	Party Name:TIDE<br>INDUSTRIES	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00039/AM20/	RLA File<br>:34/24/040/00009/AM20/	Lic.No/Date:3410045044<br>11.04.2019
	Decision:The Committee considered the case as per agenda and it was noted that the firm<br>dated 30.06.2020 has furnished its reply. Deferred for comments of TE.			vide its e-mail

Case No.:97/1/82-ALC4/2019	Party Name:CLEAN SCIENCE	Meet No/Date:2/82-	Status:
	AND TECHNOLOGY	ALC4/2020	Deferred
	PVT.LTD.	10.07.2020
HQ File	RLA File	Lic.No/Date:3110067404
:01/82/050/00097/AM20/	:31/83/040/00013/AM20/	01.05.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts 77 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020 , followed by Reminder on 18.03.2020 :

(i) Quantity and value of By-Product- Acetic Anhydride.

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

i) Quantity and value of By-Product- Acetic Anhydride.**

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.:194/6/82-ALC4/2019 Party Name:ETERNIS FINE Meet No/Date:2/82- Status: CHEMICALS LIMITED, ALC4/2020 Deferred 10.07.2020 HQ File RLA File Lic.No/Date:0310828815 :01/82/050/00420/AM20/ :03/94/040/00023/AM20/ 07.05.2019 78 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:

(i) Quantity and Commercial value of distillation residue obtained in manufacturing process.

79	Case No.:140/1/82-ALC4/2019	Party Name:MALWA<br>OXYGEN & INDUSTRIAL<br>GASES PVT.LTD.,	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00140/AM20/	RLA File<br>:56/24/040/00035/AM19/	Lic.No/Date:5610005605<br>09.05.2019
	Decision:The Committee considered the case as per agenda and it was noted that the firm<br>dated 24.07.2020 has furnished its reply. Deferred for comments of TE.			vide its e-mail

19|| ||**Decision:**The Committee considered the case as per agenda and it was noted that the firm dated 24.07.2020 has furnished its reply. Deferred for comments of TE.|||vide its e-mail|

80	Case No.:141/1/82-ALC4/2019	Party Name:MALWA<br>OXYGEN & INDUSTRIAL<br>GASES PVT.LTD.,	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00141/AM20/	RLA File<br>:56/24/040/00034/AM19/	Lic.No/Date:5610005606<br>09.05.2019
	Decision:The Committee considered the case as per agenda and it was noted that the firm<br>dated 24.07.2020 has furnished its reply. Deferred for comments of TE.			vide its e-mail

Case No.:283/1/82-ALC4/2019	Party Name:SALVI	Meet No/Date:2/82-	Status:
	CHEMICAL INDUSTRIES	ALC4/2020	Rejected
	LIMITED	10.07.2020
HQ File	RLA File	Lic.No/Date:0310829176
:01/82/050/00189/AM20/	:03/95/040/00158/AM20/	22.05.2019

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 81 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 9/82-ALC4/2019 dated 18.10.2019, followed by Reminder on 09.12.2019 and Final Reminder on 18.03.2020 :

(i) Chemical reaction with molecular weight. (ii) Percentage yield on molar basis.

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

ion with molecular weight. (ii) Percentage yield on molar basis.**

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

Case No.:284/1/82-ALC4/2019 Party Name:SALVI Meet No/Date:2/82- Status: CHEMICAL INDUSTRIES ALC4/2020 Rejected LIMITED 10.07.2020 HQ File RLA File Lic.No/Date:0310829177 :01/82/050/00190/AM20/ :03/95/040/00156/AM20/ 22.05.2019

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 82 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 9/82-ALC4/2019 dated 18.10.2019, followed by Reminder on 09.12.2019 and Final Reminder on 18.03.2020 :

(i) Chemical reaction with molecular weight. (ii) Percentage yield on molar basis.

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

Case No.:285/1/82-ALC4/2019 Party Name:SALVI Meet No/Date:2/82- Status: CHEMICAL INDUSTRIES ALC4/2020 Deferred LIMITED 10.07.2020 HQ File RLA File Lic.No/Date:0310829190 83 :01/82/050/00191/AM20/ :03/95/040/00157/AM20/ 22.05.2019

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.:286/1/82-ALC4/2019 Party Name:SALVI Meet No/Date:2/82- Status: CHEMICAL INDUSTRIES ALC4/2020 Rejected LIMITED 10.07.2020 HQ File RLA File Lic.No/Date:0310829199 :01/82/050/00192/AM20/ :03/95/040/00160/AM20/ 22.05.2019

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 84 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 9/82-ALC4/2019 dated 18.10.2019, followed by Reminder on 09.12.2019 and Final Reminder on 18.03.2020 :

(i) Chemical reaction with molecular weight. (ii) Percentage yield on molar basis.

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

Case No.:287/1/82-ALC4/2019 Party Name:SALVI Meet No/Date:2/82- Status: CHEMICAL INDUSTRIES ALC4/2020 Rejected LIMITED 10.07.2020 HQ File RLA File Lic.No/Date:0310829200 :01/82/050/00193/AM20/ :03/95/040/00161/AM20/ 22.05.2019

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 85 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 9/82-ALC4/2019 dated 18.10.2019, followed by Reminder on 09.12.2019 and Final Reminder on 18.03.2020 :

nished the information on following deficiencies raised by NC-3 in its Meeting No. 9/82-ALC4/2019 dated 18.10.2019, followed by Reminder on 09.12.2019 and Final Reminder on 18.03.2020 :

(i) Chemical reaction with molecular weight. (ii) Percentage yield on molar basis.

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

Case No.:288/1/82-ALC4/2019	Party Name:SALVI	Meet No/Date:2/82-	Status:
	CHEMICAL INDUSTRIES	ALC4/2020	Rejected
	LIMITED	10.07.2020
HQ File	RLA File	Lic.No/Date:0310829205
:01/82/050/00194/AM20/	:03/95/040/00159/AM20/	22.05.2019

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 86 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 9/82-ALC4/2019 dated 18.10.2019, followed by Reminder on 09.12.2019 and Final Reminder on 18.03.2020 :

(i) Chemical reaction with molecular weight. (ii) Percentage yield on molar basis.

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

Case No.:163/13/82- Party Meet No/Date:2/82- Status: ALC4/2019 Name:RESONANCESPECIALTIES ALC4/2020 Deferred LTD 10.07.2020 HQ File RLA File :03/95/040/00166/AM20/ Lic.No/Date:0310829318 87 :01/82/050/01006/AM20/ 29.05.2019

Date:2/82- Status: ALC4/2019 Name:RESONANCESPECIALTIES ALC4/2020 Deferred LTD 10.07.2020 HQ File RLA File :03/95/040/00166/AM20/ Lic.No/Date:0310829318 87 :01/82/050/01006/AM20/ 29.05.2019

Case No.:320/1/82-ALC4/2019 Party Name:DEEPAK Meet No/Date:2/82- Status: PHENOLICS LIMITED ALC4/2020 Deferred 10.07.2020 HQ File RLA File Lic.No/Date:3410045179 :01/82/050/00226/AM20/ :34/24/040/00036/AM20/ 30.05.2019 88 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:

(i) Quantity and commercial value of Co-Product Phenol obtained. (ii) Percentage yield on molar basis.

Case No.:144/6/82-ALC4/2019 Party Name:LACTOSE Meet No/Date:2/82- Status: (INDIA) LTD., ALC4/2020 Deferred 10.07.2020 89 HQ File RLA File Lic.No/Date:0310830184 :01/82/050/00370/AM20/ :03/95/040/00296/AM20/ 09.07.2019 Decision: The Committee considered the case as per agenda and it was noted that the firm vide its e-mail dated 07.07.2020 has furnished its reply. Deferred for comments of TE.

/ 09.07.2019 Decision: The Committee considered the case as per agenda and it was noted that the firm vide its e-mail dated 07.07.2020 has furnished its reply. Deferred for comments of TE.

Case No.:154/6/82-ALC4/2019	Party Name:INDO AMINES	Meet No/Date:2/82-	Status:
	LIMITED	ALC4/2020	Deferred
		10.07.2020
HQ File	RLA File	Lic.No/Date:0310830244
:01/82/050/00380/AM20/	:03/94/040/00122/AM20/	12.07.2019

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

(i) Complete specifications of import item No. 2 - Ni-Catalyst with catalogue of Export Product. (ii) Last two years Production & corresponding consumption of different raw materials duly certified by GST.

91	Case	No.:203/6/82-ALC4/2019	Party Name:SONGWON<br>SPECIALTY CHEMICALS<br>INDIA PVT LTD	Party Name:SONGWON<br>SPECIALTY CHEMICALS<br>INDIA PVT LTD	Party Name:SONGWON<br>SPECIALTY CHEMICALS<br>INDIA PVT LTD	Party Name:SONGWON<br>SPECIALTY CHEMICALS<br>INDIA PVT LTD	Meet No/Date:2/82-<br>ALC4/2020<br>10072020
1				.	.		..
	<br>HQ<br>	File<br>	RLA F	ile			Lic.No/Date:3410045298
	:01/8	2/050/00429/AM20/	:34/24	/040/000	69/AM	20/	18.07.2019
	Deci	sion:Deferred for comments of T		E.

| ||| HQ |File |RLA F|ile|||Lic.No/Date:3410045298|| |||:01/8|2/050/00429/AM20/|:34/24|/040/000|69/AM|20/|18.07.2019|| |||Deci|**sion:**Deferred for comments of T||E.||||| |||||||||||

	Case No.:15/7/82-ALC4/2019	Case No.:15/7/82-ALC4/2019	Party Name:GLOBAL		Meet No/Date:2/82-	Status:
			CALCIUM PRIVATE		ALC4/2020	Deferred
			LIMITED		10.07.2020
	HQ File		RLA File		Lic.No/Date:0710115208
92	:01/82/050/00510/AM20/		:07/24/040/00093/AM20/		23.07.2019
	Decision:	The Committee considered the case as per agenda		and it was decided to call for following
	information	from the firm:
		(i)<br>Complete technical details asper Appendix 4E.

Case No.:229/6/82-ALC4/2019	Party Name:NISARG	Meet No/Date:2/82-	Status:
	BIOSCIENCES PVT LTD	ALC4/2020	Rejected
		10.07.2020
HQ File	RLA File	Lic.No/Date:0910067836
:01/82/050/00455/AM20/	:09/24/040/00221/AM20/	25.07.2019

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 9/82-ALC4/2019 93 dated 18.10.2019, followed by Reminder on 09.12.2019 and Final Reminder on 18.03.2020 :

(i) Percentage yield on molar basis. (ii) Calculation Sheet showing the necessary calculations to arrive at the export quantity.

inder on 09.12.2019 and Final Reminder on 18.03.2020 :

(i) Percentage yield on molar basis. (ii) Calculation Sheet showing the necessary calculations to arrive at the export quantity.

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

94	Case No.:248/6/82-ALC4/2019	Party Name:HUBERGROUP<br>INDIA PRIVATE LIMITED.	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0310830713<br>31.07.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00474/AM20/	RLA File<br>:03/94/040/00346/AM20/
	<br>Decision:The Committee considered the case as per agenda and it was decided to call for following<br>information from the firm:<br>(i)<br>Material balance in terms of 53% solid resin content between import and<br>export taking into account 5% wastage claimed.

Case No.:258/6/82-ALC4/2019	Party Name:NISARG	Meet No/Date:2/82-	Status:
	BIOSCIENCES PVT LTD	ALC4/2020	Rejected
		10.07.2020
HQ File	RLA File	Lic.No/Date:0910067858
:01/82/050/00484/AM20/	:09/24/040/00236/AM20/	01.08.2019

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 9/82-ALC4/2019 95 dated 18.10.2019, followed by Reminder on 09.12.2019 and Final Reminder on 18.03.2020 :

the information on following deficiencies raised by NC-3 in its Meeting No. 9/82-ALC4/2019 95 dated 18.10.2019, followed by Reminder on 09.12.2019 and Final Reminder on 18.03.2020 :

(i) Percentage yield on molar basis. (ii) Calculation Sheet showing the necessary calculations to arrive at the export quantity.

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

96	<br>Case No.:4/7/82-ALC4/2019	Party Name:KEVA<br>FRAGRANCES PRIVATE<br>LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0310830887<br>07.08.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00499/AM20/	RLA File<br>:03/94/040/00373/AM20/
	Decision:Deferred for comments of TE.

Case No.:25/7/82-ALC4/2019	Party Name:UNILINK	Meet No/Date:2/82-	Status:
	PHARMA PVT LTD	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0410165953
:01/82/050/00520/AM20/	:04/24/040/00074/AM20/	13.08.2019

---|---|---|---|---|---| |||PHARMA PVT LTD||ALC4/2020||Approved| |||||10.07.2020||| |HQ File||RLA File||Lic.No/Date:0410165953||| |:01/82/050/00520/AM20/||:04/24/040/00074/AM20/||13.08.2019|||

	Case No.:25/7/82-ALC4/2019 <br> <br>HQ File<br>:01/82/050/00520/AM20/<br> <br>	Case No.:25/7/82-ALC4/2019 <br> <br>HQ File<br>:01/82/050/00520/AM20/<br> <br>	Party Name:UNILINK<br>PHARMA PVT LTD<br> <br> <br> <br>RLA File<br>:04/24/040/00074/AM20/<br> <br>	Party Name:UNILINK<br>PHARMA PVT LTD<br> <br> <br> <br>RLA File<br>:04/24/040/00074/AM20/<br> <br>	Party Name:UNILINK<br>PHARMA PVT LTD<br> <br> <br> <br>RLA File<br>:04/24/040/00074/AM20/<br> <br>	Party Name:UNILINK<br>PHARMA PVT LTD<br> <br> <br> <br>RLA File<br>:04/24/040/00074/AM20/<br> <br>	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved
							Lic.No/Date:0410165953<br>13.08.2019
97	Decision:The Committee considered case as<br>was decided to ratify the ad-hoc input output norm<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>PENICILLIN - V TABLETS<br>PHENOXY<br>METHYL<br>PENICILLIN<br>POTASSIUM<br>BP<br>EQUIVALENT<br>TO<br>PHENOXY<br>METHYL<br>PENICILLIN 250 MG<br>(400000IU)<br>1 Number<br>Tablet<br>RA concerned maytake further necessaryaction as				per agenda in the presence of the technical experts and it<br>s under para 4.07 of HBP Vol.

PENICILLIN 250 MG (400000IU) 1 Number Tablet RA concerned maytake further necessaryaction as||||per agenda in the presence of the technical experts and it s under para 4.07 of HBP Vol. I as per details below or as Sl. No. Import items Qty. 1 PHENOXY MEHTYL PENICILLIN POTASSIUM BP PHENOXY MEHTYL PENICILLIN POTASSIUM BP 278.00 mg per above decision of NC.|||| |||Export Product||Qty.|Sl. No.|Import items||Qty.| |||PENICILLIN - V TABLETS PHENOXY METHYL PENICILLIN POTASSIUM BP EQUIVALENT TO PHENOXY METHYL PENICILLIN 250 MG (400000IU)||1 Number Tablet|1|PHENOXY MEHTYL PENICILLIN POTASSIUM BP PHENOXY MEHTYL PENICILLIN POTASSIUM BP||278.00 mg| ||||||per above decision of NC.||||

98	Case No.:28/7/82-ALC4/2019	Party Name:UPL LTD.	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0310830995<br>14.08.2019	Status:<br>Deferred
	HQ File<br>:01/82/050/00523/AM20/	RLA File<br>:03/95/040/01337/AM19/
	Decision:Deferred for comments of TE.

310830995 14.08.2019|Status: Deferred| |---|---|---|---|---| ||HQ File :01/82/050/00523/AM20/|RLA File :03/95/040/01337/AM19/||| ||**Decision:**Deferred for comments of TE.||||

99	Case No.:29/7/82-ALC4/2019	Party Name:ETERNIS FINE<br>CHEMICALS LIMITED,	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0310831004<br>14.08.2019	Status:<br>Deferred
	HQ File<br>:01/82/050/00524/AM20/	RLA File<br>:03/94/040/00381/AM20/
	Decision:Deferred for comments of TE.

100	<br>Case No.:33/7/82-ALC4/2019Party Name:AETHER<br>INDUSTRIES LIMITED<br>HQ File<br>:01/82/050/00528/AM20/<br>RLA File<br>:52/21/040/00085/AM20/<br>Decision:Deferred for comments of TE.	Party Name:AETHER<br>INDUSTRIES LIMITED<br>RLA File<br>:52/21/040/00085/AM20/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:5210043146<br>14.08.2019	Status:<br>Deferred

ED RLA File :52/21/040/00085/AM20/|Meet No/Date:2/82- ALC4/2020 10.07.2020 Lic.No/Date:5210043146 14.08.2019|Status: Deferred| |---|---|---|---|---| |||||| ||||||

	Case No.:34/7/82-ALC4/2019Party Name:AETHER	Meet No/Date:2/82-	Status:
	INDUSTRIES LIMITED	ALC4/2020	Deferred
		10.07.2020
101	HQ File<br>RLA File	Lic.No/Date:5210043147
	:01/82/050/00529/AM20/<br>:52/21/040/00086/AM20/	14.08.2019
	Decision:Deferred for comments of TE.

	Case No.:35/7/82-ALC4/2019Party Name:AETHER	Meet No/Date:2/82-	Status:
	INDUSTRIES LIMITED	ALC4/2020	Deferred
		10.07.2020
102	HQ File<br>RLA File	Lic.No/Date:5210043148
	:01/82/050/00530/AM20/<br>:52/21/040/00061/AM20/	14.08.2019
	Decision:Deferred for comments of TE.

	Case No.:38/7/82-ALC4/2019Party Name:FRESENIUS	Meet No/Date:2/82-	Status:
	KABI INDIA PRIVATE LTD	ALC4/2020	Deferred
		10.07.2020
103	HQ File<br>:01/82/050/00533/AM20/<br>RLA File<br>:03/94/040/00397/AM20/	Lic.No/Date:0310831038<br>16.08.2019
	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.

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.:39/7/82-ALC4/2019Party Name:TADIMETY<br>Meet No/Date:2/82-	Status:
	AROMATICS PRIVATE<br>ALC4/2020	Deferred
	LIMITED<br>10.07.2020
104	HQ File<br>:01/82/050/00534/AM20/<br>RLA File<br>:07/24/040/00104/AM20/<br>Lic.No/Date:0710115296<br>19.08.2019
	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.:40/7/82-ALC4/2019Party Name:ORTIN<br>Meet No/Date:2/82-	Status:
	LABORATORIES LTD<br>ALC4/2020	Deferred
	10.07.2020
105	HQ File<br>:01/82/050/00535/AM20/<br>RLA File<br>:09/24/040/00259/AM20/<br>Lic.No/Date:0910067901<br>19.08.2019
	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.

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.

106	Case No.:44/7/82-ALC4/2019	Party Name:SWATI<br>MENTHOL & ALLIED<br>CHEMICALS LTD.,<br>RLA File<br>:29/24/040/00011/AM20/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00539/AM20/		Lic.No/Date:2910025423<br>19.08.2019
	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.

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.

107	Case No.:45/7/82-ALC4/2019	Party Name:SUPERMINT<br>EXPORTS PRIVATE<br>LIMITED<br>RLA File<br>:29/24/040/00010/AM20/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00540/AM20/		Lic.No/Date:2910025424<br>19.08.2019
	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.

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.

108	Case No.:48/7/82-ALC4/2019	Party Name:SRINI<br>PHARMACEUTICALS<br>PRIVATE LIMITED<br>RLA File<br>:09/24/040/00269/AM20/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00543/AM20/		Lic.No/Date:0910067906<br>20.08.2019
	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.:50/7/82-ALC4/2019	Party Name:DIVIS	Meet No/Date:2/82-	Status:
	LABORATORIES LTD	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0910067908
:01/82/050/00545/AM20/	:09/24/040/00264/AM20/	20.08.2019

-|---|---|---|---|---| |||LABORATORIES LTD||ALC4/2020||Approved| |||||10.07.2020||| |HQ File||RLA File||Lic.No/Date:0910067908||| |:01/82/050/00545/AM20/||:09/24/040/00264/AM20/||20.08.2019|||

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

109

Export Product	Qty.	Sl. No.	Import items	Qty.
NAPROXEN	1 kg	1	DL-NAPROXEN	1.25 kg
		2	N-OCTYL-D-GLUCAMINE	0.09kg
		3	METHANOL	2.03 kg
		4	ACETIC ACID	0.54 kg
		5	TOLUENE	1.13 kg

Case No.:51/7/82-ALC4/2019	Party Name:SUN	Meet No/Date:2/82-	Status:
	PHARMACEUTICAL	ALC4/2020	Approved
	INDUSTRIES LTD.	10.07.2020
HQ File	RLA File	Lic.No/Date:0510411567
:01/82/050/00546/AM20/	:05/24/040/00291/AM20/	20.08.2019

|---|---| |||PHARMACEUTICAL||ALC4/2020||Approved| |||INDUSTRIES LTD.||10.07.2020||| |HQ File||RLA File||Lic.No/Date:0510411567||| |:01/82/050/00546/AM20/||:05/24/040/00291/AM20/||20.08.2019|||

	Case No.:51/7/82-ALC4/2019	Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD.	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved
	HQ File<br>:01/82/050/00546/AM20/	RLA File<br>:05/24/040/00291/AM20/	Lic.No/Date:0510411567<br>20.08.2019
110	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or<br>as applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Ciprofloxacin<br>and<br>Dexamethasone<br>Sterile<br>Otic<br>Suspension<br>7.5ml<br>(Each ml contains Ciprofloxacin<br>3mg. & Dexamethasone 1mg<br>(Equivalent<br>to<br>15750gm<br>Ciprofloxacin<br>and<br>5250gm<br>Dexamethasone Bulk Drug)<br>700000.000<br>Number<br>1<br>Ciprofloxacin<br>(Ciprofloxacin Hcl)<br>18356.62 gms<br>2<br>Dexamethasone USP<br>5512.50 gms<br>RA concerned maytake further necessaryaction asper above decision of NC.

.000 Number 1 Ciprofloxacin (Ciprofloxacin Hcl) 18356.62 gms 2 Dexamethasone USP 5512.50 gms RA concerned maytake further necessaryaction asper above decision of NC.||||

111	Case No.:54/7/82-ALC4/2019	Party Name:LYRUS LIFE<br>SCIENCES PVT LTD<br>RLA File<br>:07/24/040/00091/AM20/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00549/AM20/		Lic.No/Date:0710115309<br>20.08.2019
	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.:56/7/82-ALC4/2019	Party Name:GLOBAL	Meet No/Date:2/82-	Status:
	CALCIUM PRIVATE	ALC4/2020	Deferred
	LIMITED	10.07.2020
HQ File	RLA File	Lic.No/Date:0710115314
:01/82/050/00551/AM20/	:07/24/040/00107/AM20/	21.08.2019

---|---|---|---| |||CALCIUM PRIVATE||ALC4/2020||Deferred| |||LIMITED||10.07.2020||| |HQ File||RLA File||Lic.No/Date:0710115314||| |:01/82/050/00551/AM20/||:07/24/040/00107/AM20/||21.08.2019|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm was asked to furnish following information asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020 , followed by Reminder on 19.03.2020 :

112

(i) Chemical reaction, molecular weight, stiochometric balance. (ii) Production / Consumption data duly certified by GST. (iii) Justification for low yield.

The firm vide its e-mail dated 24.07.2020 has furnished its reply. Technical Expert after examining the reply of firm stated that the reply is not proper as whatever available in the application is again forwarded.

In view of above, the Committee decided to issue Final Reminder to firm with the request to furnish its reply strictly as per above points mentioned in earlier DL, failing which the case will be rejected.

113	Case No.:59/7/82-ALC4/2019	Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00554/AM20/	RLA File<br>:07/24/040/00117/AM20/	Lic.No/Date:0710115318<br>22.08.2019
	Decision:The Committee considered the case as per agenda and it was noted that the firm<br>dated 30.06.2020 has furnished its reply. Deferred for comments of TE.			vide its e-mail

Case No.:68/7/82-ALC4/2019	Party Name:NEOGEN	Meet No/Date:2/82-	Status:
	CHEMICALS LIMITED	ALC4/2020	Deferred
		10.07.2020
HQ File	RLA File	Lic.No/Date:0310831251
:01/82/050/00563/AM20/	:03/95/040/00310/AM20/	27.08.2019

|---|---|---|---|---| |||CHEMICALS LIMITED||ALC4/2020||Deferred| |||||10.07.2020||| |HQ File||RLA File||Lic.No/Date:0310831251||| |:01/82/050/00563/AM20/||:03/95/040/00310/AM20/||27.08.2019|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts 114 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020 , followed by Reminder on 20.03.2020 :

(i) Justification of lower yield. (ii) Quantity and commercial value of By-product –HBr in the process.

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

115	Case No.:71/7/82-ALC4/2019	Party Name:SYNTHO<br>CHIRALS PVT. LTD	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00566/AM20/	RLA File<br>:09/24/040/00275/AM20/	Lic.No/Date:0910067938<br>27.08.2019
	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.

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.||||

Case No.:72/7/82-ALC4/2019	Party Name:AUROBINDO	Meet No/Date:2/82-	Status:
	PHARMA LIMITED	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0910067940
:01/82/050/00567/AM20/	:09/24/040/00274/AM20/	27.08.2019

	Case No.:72/7/82-ALC4/2019	Case No.:72/7/82-ALC4/2019	Party Name:AUROBINDO<br>PHARMA LIMITED	Party Name:AUROBINDO<br>PHARMA LIMITED	Party Name:AUROBINDO<br>PHARMA LIMITED	Party Name:AUROBINDO<br>PHARMA LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved	Status:<br>Approved
	HQ File<br>:01/82/050/00567/AM20/		RLA File<br>:09/24/040/00274/AM20/				Lic.No/Date:0910067940<br>27.08.2019
116	Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.

019||| |116|**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: Export Product Qty. Sl. No. Import items Qty. CEFUROXIME AXETIL AMORPHOUS 1 kg 1 3-Hydroxycefuroxime (or) Descarbamoyl Cefuroxime Acid 0.963 kg 2 Acetone 3.691 kg 3 Carbon Enoanticromos (Activated Carbon) 0.097 kg 4 Chlorosulfonyl Isocyanate(CSI) 0.53 kg 5 Cyclohexane(Benzene Free) 1.10 kg 6 Methanol(Methyl Alcohol) 1.70 kg 7 N,N- Dimethyl Acetamide 1.62 kg RA concerned maytake further necessaryaction asper above decision of NC.||||||||| |||Export Product||Qty.|Sl. No.|Import items|||Qty.| |||CEFUROXIME AXETIL AMORPHOUS||1 kg|1|3-Hydroxycefuroxime (or) Descarbamoyl Cefuroxime Acid|||0.963 kg| ||||||2|Acetone|||3.691 kg| ||||||3|Carbon Enoanticromos (Activated Carbon)|||0.097 kg| ||||||4|Chlorosulfonyl Isocyanate(CSI)|||0.53 kg| ||||||5|Cyclohexane(Benzene Free)|||1.10 kg| ||||||6|Methanol(Methyl Alcohol)|||1.70 kg| ||||||7|N,N- Dimethyl Acetamide|||1.62 kg| |||||||per above decision of NC.||||

Isocyanate(CSI)|||0.53 kg| ||||||5|Cyclohexane(Benzene Free)|||1.10 kg| ||||||6|Methanol(Methyl Alcohol)|||1.70 kg| ||||||7|N,N- Dimethyl Acetamide|||1.62 kg| |||||||per above decision of NC.||||

Case No.:74/7/82-	Party Name:UNICHEM	Meet No/Date:2/82-	Status:
ALC4/2019	LABORATORIES LIMITED	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0310831283
:01/82/050/00569/AM20/	:03/95/040/00541/AM20/	28.08.2019

	Case No.:74/7/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00569/AM20/	Party Name:UNICHEM<br>LABORATORIES LIMITED<br> <br> <br> <br>RLA File<br>:03/95/040/00541/AM20/<br> <br>	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br> <br> <br>Lic.No/Date:0310831283<br>28.08.2019	Status:<br>Approved

117	Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or<br>as applied by firm whichever is lower:<br>Sl. No.

sence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: Sl. No. Export Product Qty. Sl. No. Import items Qty. 1 DOXAZOSIN 1 MG TABLETS 1 Number 1 DOXAZOSIN MESYLATE 1.236 mg / 1 mgtablet 2 DOXAZOSIN 2 MG TABLETS 1 Number 1 DOXAZOSIN MESYLATE 2.472 mg / 2 mgtablet 3 DOXAZOSIN 4 MG TABLETS 1 Number 1 DOXAZOSIN MESYLATE 4.945 mg / 4 mgtablet 4 DOXAZOSIN 8 MG TABLETS 1 Number 1 DOXAZOSIN MESYLATE 9.890 mg/ 8 mgtablet RA concerned maytake further necessaryaction asper above decision of NC.||||

Case No.:77/7/82-ALC4/2019	Party Name:HETERO LABS	Meet No/Date:2/82-	Status:
	LIMITED	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0910067953
:01/82/050/00572/AM20/	:09/24/040/00291/AM20/	28.08.2019

| |---|---|---|---|---|---|---| |||LIMITED||ALC4/2020||Approved| |||||10.07.2020||| |HQ File||RLA File||Lic.No/Date:0910067953||| |:01/82/050/00572/AM20/||:09/24/040/00291/AM20/||28.08.2019|||

	Case No.:77/7/82-ALC4/2019	Case No.:77/7/82-ALC4/2019	Case No.:77/7/82-ALC4/2019	Party Name:HETERO LABS<br>LIMITED<br>RLA File<br>:09/24/040/00291/AM20/	Party Name:HETERO LABS<br>LIMITED<br>RLA File<br>:09/24/040/00291/AM20/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved
	HQ File<br>:01/82/050/00572/AM20/					Lic.No/Date:0910067953<br>28.08.2019
118	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or<br>as applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>ROSUVASTATIN<br>CALCIUM<br>1 kg<br>1<br>(E)tertbutyl2-(6-(2-(4-(4fluorophenyl)<br>6isopropyl2(Nmethylsulfonamido)<br>pyrimidin5yl)vinyl)2,2dimethyl1,3dioxan4-<br>yl)acetate<br>(E)-tert-butyl<br>2-(6-(2-(4-(4-<br>fluorophenyl)-<br>6-isopropyl-2-(N-methylmethylsulfonamido)<br>pyrimidin-5-yl)vinyl)-2,2-dimethyl-1,3-dioxan-4-<br>yl)acetate<br>1.30 kg<br>2<br>CALCIUM ACETATE<br>0.30 kg<br>3<br>C.S.

6-(2-(4-(4- fluorophenyl)- 6-isopropyl-2-(N-methylmethylsulfonamido) pyrimidin-5-yl)vinyl)-2,2-dimethyl-1,3-dioxan-4- yl)acetate 1.30 kg 2 CALCIUM ACETATE 0.30 kg 3 C.S. FLAKES 0.16 kg 4 HYDROCHLORIC ACID 0.24 kg 5 TOLUENE 2.68 kg 6 METHANOL 0.64 kg RA concerned maytake further necessaryaction asper above decision of NC.||||||| |||Export Product|Qty.|Sl. No.|Import items||Qty.| |||ROSUVASTATIN CALCIUM|1 kg|1|(E)tertbutyl2-(6-(2-(4-(4fluorophenyl) 6isopropyl2(Nmethylsulfonamido) pyrimidin5yl)vinyl)2,2dimethyl1,3dioxan4- yl)acetate (E)-tert-butyl 2-(6-(2-(4-(4- fluorophenyl)- 6-isopropyl-2-(N-methylmethylsulfonamido) pyrimidin-5-yl)vinyl)-2,2-dimethyl-1,3-dioxan-4- yl)acetate||1.30 kg| |||||2|CALCIUM ACETATE||0.30 kg| |||||3|C.S. FLAKES||0.16 kg| |||||4|HYDROCHLORIC ACID||0.24 kg| |||||5|TOLUENE||2.68 kg| |||||6|METHANOL||0.64 kg| |||||necessaryaction asper above decision of NC.|||| ||||||||| |119|Case No.:79/7/82-ALC4/2019|||Party Name:SENTISS PHARMA PVT.LTD. RLA File :05/24/040/00292/AM20/||Meet No/Date:2/82- ALC4/2020 10.07.2020 Lic.No/Date:0510411666 28.08.2019|Status: Approved| ||HQ File :01/82/050/00574/AM20/||||||| || **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.

||||| || **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: Export Product Qty. Sl. No. Import items Qty. Tobriss (Tobramycin 0.3%) Eye Drops 5ml Pack 1 Number Pack 1 Tobramycin Sulphate 19.057 mg RA concerned maytake further necessaryaction asper above decision of NC.|||||||

	Case No.:131/13/82-<br>ALC4/2019	Case No.:131/13/82-<br>ALC4/2019	Party Name:NECTAR<br>LIFESCIENCES LIMITED,	Party Name:NECTAR<br>LIFESCIENCES LIMITED,	Party Name:NECTAR<br>LIFESCIENCES LIMITED,	Party Name:NECTAR<br>LIFESCIENCES LIMITED,	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved
	HQ File<br>:01/82/050/00974/AM20/		RLA File<br>:22/24/040/00001/AM16/				Lic.No/Date:2210016280<br>31.10.2019
120	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.

|| |120| **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: Export Product Qty. Sl. No. Import items Qty. Cefpodoxime Proxetil 1 kg 1 7-ACA 0.8378 kg 2 Methane Sulfonicacid 1.626 kg 3 Methanol 1.635 kg 4 Ammonium Hydroxide 2.13 kg 5 S-2 Benzothiazolyl-2-Amino-2- (methoxyimino)-4-tiazolyl acetate (MAEM) 0.8378 kg 6 Triethylamine(TEA) 0.260 kg 7 1-CEIPC 0.55 kg 8 Sodium Iodide 0.28 kg 9 Toluene 0.263 kg 10 N,N-Dimethyl Acetamide 0.665 kg 11 TMG 0.223 kg 12 Ethyl acetate 1.842 kg 13 Sodium thio-sulphate 0.080 kg 14 Activated carbon 0.100 kg 15 Acetone 1.863 kg 16 Ethylenediamine Tetra Acetic Acid Disodium Salt Dihydrate(EDTA) 0.005 kg 17 Cyclohexane 3.572 kg RA concerned maytake further necessaryaction asper above decision of NC.||||as per norms|agenda in the presence of the technical experts and it under para 4.07 of HBP Vol.

hexane 3.572 kg RA concerned maytake further necessaryaction asper above decision of NC.||||as per norms|agenda in the presence of the technical experts and it under para 4.07 of HBP Vol. I as per details below or||| |||Export Product||Qty.|Sl. No.|Import items||Qty.| |||Cefpodoxime Proxetil||1 kg|1|7-ACA||0.8378 kg| ||||||2|Methane Sulfonicacid||1.626 kg| ||||||3|Methanol||1.635 kg| ||||||4|Ammonium Hydroxide||2.13 kg| ||||||5|S-2 Benzothiazolyl-2-Amino-2- (methoxyimino)-4-tiazolyl acetate (MAEM)||0.8378 kg| ||||||6|Triethylamine(TEA)||0.260 kg| ||||||7|1-CEIPC||0.55 kg| ||||||8|Sodium Iodide||0.28 kg| ||||||9|Toluene||0.263 kg| ||||||10|N,N-Dimethyl Acetamide||0.665 kg| ||||||11|TMG||0.223 kg| ||||||12|Ethyl acetate||1.842 kg| ||||||13|Sodium thio-sulphate||0.080 kg| ||||||14|Activated carbon||0.100 kg| ||||||15|Acetone||1.863 kg| ||||||16|Ethylenediamine Tetra Acetic Acid Disodium Salt Dihydrate(EDTA)||0.005 kg| ||||||17|Cyclohexane||3.572 kg| ||||||||||

| ||||||14|Activated carbon||0.100 kg| ||||||15|Acetone||1.863 kg| ||||||16|Ethylenediamine Tetra Acetic Acid Disodium Salt Dihydrate(EDTA)||0.005 kg| ||||||17|Cyclohexane||3.572 kg| ||||||||||

	Case No.:131/13/82-<br>ALC4/2019	Case No.:131/13/82-<br>ALC4/2019	Party Name:NECTAR<br>LIFESCIENCES LIMITED,	Party Name:NECTAR<br>LIFESCIENCES LIMITED,	Party Name:NECTAR<br>LIFESCIENCES LIMITED,	Party Name:NECTAR<br>LIFESCIENCES LIMITED,	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved
	HQ File<br>:01/82/050/00974/AM20/		RLA File<br>:22/24/040/00001/AM16/				Lic.No/Date:2210016280<br>31.10.2019
120	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or<br>as applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Cefpodoxime Proxetil<br>1 kg<br>1<br>7-ACA<br>0.8378 kg<br>2<br>Methane Sulfonicacid<br>1.626 kg<br>3<br>Methanol<br>1.635 kg<br>4<br>Ammonium Hydroxide<br>2.13 kg<br>5<br>S-2<br>Benzothiazolyl-2-Amino-2-<br>(methoxyimino)-4-tiazolyl<br>acetate<br>(MAEM)<br>0.8378 kg<br>6<br>Triethylamine(TEA)<br>0.260 kg<br>7<br>1-CEIPC<br>0.55 kg<br>8<br>Sodium Iodide<br>0.28 kg<br>9<br>Toluene<br>0.263 kg<br>10<br>N,N-Dimethyl Acetamide<br>0.665 kg<br>11<br>TMG<br>0.223 kg<br>12<br>Ethyl acetate<br>1.842 kg<br>13<br>Sodium thio-sulphate<br>0.080 kg<br>14<br>Activated carbon<br>0.100 kg<br>15<

0.263 kg 10 N,N-Dimethyl Acetamide 0.665 kg 11 TMG 0.223 kg 12 Ethyl acetate 1.842 kg 13 Sodium thio-sulphate 0.080 kg 14 Activated carbon 0.100 kg 15 Acetone 1.863 kg 16 Ethylenediamine Tetra Acetic Acid Disodium Salt Dihydrate(EDTA) 0.005 kg 17 Cyclohexane 3.572 kg RA concerned maytake further necessaryaction asper above decision of NC.||||as per norms|agenda in the presence of the technical experts and it under para 4.07 of HBP Vol. I as per details below or||| |||Export Product||Qty.|Sl. No.|Import items||Qty.| |||Cefpodoxime Proxetil||1 kg|1|7-ACA||0.8378 kg| ||||||2|Methane Sulfonicacid||1.626 kg| ||||||3|Methanol||1.635 kg| ||||||4|Ammonium Hydroxide||2.13 kg| ||||||5|S-2 Benzothiazolyl-2-Amino-2- (methoxyimino)-4-tiazolyl acetate (MAEM)||0.8378 kg| ||||||6|Triethylamine(TEA)||0.260 kg| ||||||7|1-CEIPC||0.55 kg| ||||||8|Sodium Iodide||0.28 kg| ||||||9|Toluene||0.263 kg| ||||||10|N,N-Dimethyl Acetamide||0.665 kg| ||||||11|TMG||0.223 kg| ||||||12|Ethyl acetate||1.842 kg| ||||||13|Sodium thio-sulphate||0.080 kg| ||||||14|Activated carbon||0.100 kg| ||||||15|Acetone||1.863 kg| ||||||16|Ethylenediamine Tetra Acetic Acid Disodium Salt Dihydrate(EDTA)||0.005 kg| ||||||17|Cyclohexane||3.572 kg| ||||||||||

| ||||||14|Activated carbon||0.100 kg| ||||||15|Acetone||1.863 kg| ||||||16|Ethylenediamine Tetra Acetic Acid Disodium Salt Dihydrate(EDTA)||0.005 kg| ||||||17|Cyclohexane||3.572 kg| ||||||||||

121	Case No.:1/13/82-ALC4/2019	Party Name:LINK PHARMA<br>CHEM LIMITED<br>RLA File<br>:34/24/040/00248/AM20/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00844/AM20/		Lic.No/Date:3410045631<br>20.11.2019
	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.

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.:62/13/82-	Party Name:CADILA	Meet No/Date:2/82-	Status:
ALC4/2019	HEALTHCARE LTD	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0810146758
:01/82/050/00905/AM20/	:08/24/040/00276/AM20/	13.12.2019

	Case No.:62/13/82-<br>ALC4/2019	Case No.:62/13/82-<br>ALC4/2019	Case No.:62/13/82-<br>ALC4/2019	Party Name:CADILA<br>HEALTHCARE LTD	Party Name:CADILA<br>HEALTHCARE LTD	Party Name:CADILA<br>HEALTHCARE LTD	Party Name:CADILA<br>HEALTHCARE LTD	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved
	HQ File<br>:01/82/050/00905/AM20/			RLA File<br>:08/24/040/00276/AM20/				Lic.No/Date:0810146758<br>13.12.2019
154	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.

|| |154| **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: Sl. No. Export Product Qty. Sl. No. Import items Qty. 1 URSODIOL TABLETS USP 250 MG (ACTIVE INGREDIENT : URSODIOL USP (URSODEOXYCHOLIC ACID USP) - NET WT. 1719.700 KGS.) 1 Number 1 URSODIOL USP (URSODEOXYCHOLIC ACID USP) 255 mg 2 MAGNESIUM STEARATE PH.E/NF/JP Not shown in the Master Batch Formula 3 MICROCRYSTALLINE CELLULOSE NF/PH.E (AVICEL PH200) 31.00 mg 4 SODIUM STARCH GLYCOLATE NF/JP 28.00 mg 5 POVIDONE USP (PLASDONE K-29/32) 18.00 mg 6 MICROCRYSTALLINE CELLULOSE NF 101 (COMPRECEL M101D+) 64.00 mg 2 URSODIOL TABLETS USP 500 MG (ACTIVE INGREDIENT : URSODIOL USP (URSODEOXYCHOLIC ACID USP) - NET WT. 3439.300 KGS.) 1 Number 1 URSODIOL USP (URSODEOXYCHOLIC ACID USP) 510 mg 2 MAGNESIUM STEARATE PH.E/NF/JP Not shown in the Master Batch Formula 3 MICROCRYSTALLINE CELLULOSE NF/PH.E (AVICEL PH200) 62.00 mg 4 SODIUM STARCH GLYCOLATE NF/JP 56.00 mg 5 POVIDONE USP (PLASDONE K-29/32) 36.00 mg 6 MICROCRYSTALLINE CELLULOSE NF 101 (COMPRECEL M101D+) 128.00 mg RA concerned maytake further necessaryaction aspe

mg 5 POVIDONE USP (PLASDONE K-29/32) 36.00 mg 6 MICROCRYSTALLINE CELLULOSE NF 101 (COMPRECEL M101D+) 128.00 mg RA concerned maytake further necessaryaction asper above decision of NC.||||||||| |||Sl. No.|Export Product||Qty.|Sl. No.|Import items||Qty.| |||1|URSODIOL TABLETS USP 250 MG (ACTIVE INGREDIENT : URSODIOL USP (URSODEOXYCHOLIC ACID USP) - NET WT. 1719.700 KGS.)||1 Number|1|URSODIOL USP (URSODEOXYCHOLIC ACID USP)||255 mg| |||||||2|MAGNESIUM STEARATE PH.E/NF/JP||Not shown in the Master Batch Formula| |||||||3|MICROCRYSTALLINE CELLULOSE NF/PH.E (AVICEL PH200)||31.00 mg| |||||||4|SODIUM STARCH GLYCOLATE NF/JP||28.00 mg| |||||||5|POVIDONE USP (PLASDONE K-29/32)||18.00 mg| |||||||6|MICROCRYSTALLINE CELLULOSE NF 101 (COMPRECEL M101D+)||64.00 mg| |||2|URSODIOL TABLETS USP 500 MG (ACTIVE INGREDIENT : URSODIOL USP (URSODEOXYCHOLIC ACID USP) - NET WT. 3439.300 KGS.)||1 Number|1|URSODIOL USP (URSODEOXYCHOLIC ACID USP)||510 mg| |||||||2|MAGNESIUM STEARATE PH.E/NF/JP||Not shown in the Master Batch Formula| |||||||3|MICROCRYSTALLINE CELLULOSE NF/PH.E (AVICEL PH200)||62.00 mg| |||||||4|SODIUM STARCH GLYCOLATE NF/JP||56.00 mg| |||||||5|POVIDONE USP (PLASDONE K-29/32)||36.00 mg| |||||||6|MICROCRYSTALLINE CELLULOSE NF 101 (COMPRECEL M101D+)||128.00 mg| |||||||per above decision of NC.||||

|56.00 mg| |||||||5|POVIDONE USP (PLASDONE K-29/32)||36.00 mg| |||||||6|MICROCRYSTALLINE CELLULOSE NF 101 (COMPRECEL M101D+)||128.00 mg| |||||||per above decision of NC.||||

155	Case No.:64/13/82-<br>ALC4/2019	Party Name:ANTHEA<br>AROMATICS PRIVATE<br>LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status: Deferred
	<br>HQ File<br>:01/82/050/00907/AM20/	RLA File<br>:03/94/040/00576/AM20/	Lic.No/Date:0310833390<br>13.12.2019
	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.

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.

156	Case No.:65/13/82-ALC4/2019	Party Name:ASHISH LIFE<br>SCIENCE PRIVATE<br>LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00908/AM20/	RLA File<br>:03/94/040/00662/AM20/	Lic.No/Date:0310833391<br>13.12.2019
	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.

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.

157	Case No.:70/13/82-ALC4/2019	Party Name:PANACEA<br>BIOTEC LTD.,	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00913/AM20/	RLA File<br>:05/24/040/00566/AM20/	Lic.No/Date:0510412934<br>17.12.2019
	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.

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.

158	Case No.:76/13/82-ALC4/2019	Party Name:KLJ<br>PLASTICIZERS LIMITED.<br>RLA File<br>:05/23/040/00363/AM20/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00919/AM20/		Lic.No/Date:0510412972<br>19.12.2019
	<br>Decision:The Committee considered the case as per agenda and it was decided to call for following<br>information from the firm:<br>(i)<br>Molecular weight of export and import items.<br>(ii)<br>Stoichiometric balance in terms of molar basis between import and export.

Case No.:78/13/82-	Party Name:GLENMARK	Meet No/Date:2/82-	Status:
ALC4/2019	LIFE SCIENCES LIMITED	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0310833584
:01/82/050/00921/AM20/	:03/94/040/00787/AM20/	20.12.2019

159

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

159

Export Product<br>Qty.<br>Tadalafil<br>1 kg	Sl.<br>No.<br>1<br>2	Import items<br>(6R,12aR)-Methyl-1,2,3,4-tetrahydro-2-<br>chloroacetyl-1-[3,4<br>Methylene<br>dioxyphenyl)-9H-pyrido-[3,4-b]indole-3-<br>carboxylate<br>Methanol	Qty.<br>1.64 kg<br>7.14 kg

160

Case No.:79/13/82- ALC4/2019 Party Name:INDOCOREMEDIES LIMITED Meet No/Date:2/82- ALC4/2020 10.07.2020 Status: Deferred HQ File :01/82/050/00922/AM20/ RLA File :03/94/040/00780/AM20/ Lic.No/Date:0310833599 23.12.2019 **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.

161	<br>Case No.:80/13/82-ALC4/2019<br>HQ File<br>:01/82/050/00923/AM20/	Party Name:FINE ORGANIC<br>INDUSTRIES LTD<br>RLA File<br>:03/94/040/00783/AM20/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
			Lic.No/Date:0310833601<br>23.12.2019
	Decision:The Committee considered the case as per agenda and it was noted that the firm vide its e-mail<br>dated 18.03.2020 has furnished its reply. Deferred for comments of TE.

Case No.:81/13/82-	Party Name:GLAND	Meet No/Date:2/82-	Status:
ALC4/2019	PHARMA LIMITED	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0910068297
:01/82/050/00924/AM20/	:09/24/040/00472/AM20/	23.12.2019

--|---|---| |ALC4/2019||PHARMA LIMITED||ALC4/2020||Approved| |||||10.07.2020||| |HQ File||RLA File||Lic.No/Date:0910068297||| |:01/82/050/00924/AM20/||:09/24/040/00472/AM20/||23.12.2019|||

	Case No.:81/13/82-<br>ALC4/2019	Party Name:GLAND<br>PHARMA LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved
	HQ File<br>:01/82/050/00924/AM20/	RLA File<br>:09/24/040/00472/AM20/	Lic.No/Date:0910068297<br>23.12.2019
162	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or<br>as applied by firm whichever is lower:<br>S. No. Export Product<br>Qty.<br>1<br>Esmolol Hydrochloride in Sodium Chloride Injection 2000<br>mg per 100ml(20mg per ml)single dose bags<br>4265.000 Number<br>2<br>Esmolol Hydrochloride in Sodium Chloride Injection 2500<br>mg per 250ml(10mg per ml)single dose bags<br>7500.000 Number<br>S. No. Import Items<br>Qty.<br>1<br>Esmolol<br>Hydrochloride<br>Condition: Pre Import condition is imposed in Additional<br>Condition asper Appendix 4J<br>28.644 kg<br>2<br>Flexible bags<br>Net to Net with accountability<br>3<br>Twist offport stoppers<br>Net to Net with accountability<br>RA concerned maytake further necessaryaction asper above decision of NC.

Flexible bags Net to Net with accountability 3 Twist offport stoppers Net to Net with accountability RA concerned maytake further necessaryaction asper above decision of NC.||||

163	Case No.:84/13/82-ALC4/2019	Party Name:GLENMARK<br>PHARMACEUTICALS LTD<br>RLA File<br>:03/94/040/00724/AM20/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0310833636<br>24.12.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00927/AM20/
	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.:86/13/82-	Party Name:GLENMARK	Meet No/Date:2/82-	Status:
ALC4/2019	PHARMACEUTICALS LTD	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0310833644
:01/82/050/00929/AM20/	:03/94/040/00790/AM20/	24.12.2019

|||ALC4/2019 PHARMACEUTICALS LTD ALC4/2020 10.07.2020 Approved HQ File :01/82/050/00929/AM20/ RLA File :03/94/040/00790/AM20/ Lic.No/Date:0310833644 24.12.2019|ALC4/2019 PHARMACEUTICALS LTD ALC4/2020 10.07.2020 Approved HQ File :01/82/050/00929/AM20/ RLA File :03/94/040/00790/AM20/ Lic.No/Date:0310833644 24.12.2019|ALC4/2019 PHARMACEUTICALS LTD ALC4/2020 10.07.2020 Approved HQ File :01/82/050/00929/AM20/ RLA File :03/94/040/00790/AM20/ Lic.No/Date:0310833644 24.12.2019|ALC4/2019 PHARMACEUTICALS LTD ALC4/2020 10.07.2020 Approved HQ File :01/82/050/00929/AM20/ RLA File :03/94/040/00790/AM20/ Lic.No/Date:0310833644 24.12.2019|ALC4/2019 PHARMACEUTICALS LTD ALC4/2020 10.07.2020 Approved HQ File :01/82/050/00929/AM20/ RLA File :03/94/040/00790/AM20/ Lic.No/Date:0310833644 24.12.2019|ALC4/2019 PHARMACEUTICALS LTD ALC4/2020 10.07.2020 Approved HQ File :01/82/050/00929/AM20/

/ RLA File :03/94/040/00790/AM20/ Lic.No/Date:0310833644 24.12.2019|ALC4/2019 PHARMACEUTICALS LTD ALC4/2020 10.07.2020 Approved HQ File :01/82/050/00929/AM20/ RLA File :03/94/040/00790/AM20/ Lic.No/Date:0310833644 24.12.2019|ALC4/2019 PHARMACEUTICALS LTD ALC4/2020 10.07.2020 Approved HQ File :01/82/050/00929/AM20/ RLA File :03/94/040/00790/AM20/ Lic.No/Date:0310833644 24.12.2019|ALC4/2019 PHARMACEUTICALS LTD ALC4/2020 10.07.2020 Approved HQ File :01/82/050/00929/AM20/ RLA File :03/94/040/00790/AM20/ Lic.No/Date:0310833644 24.12.2019| |---|---|---|---|---|---|---|---|---|---| |||**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it|||||||| |||was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or|||||||| |||as|applied by firm whichever is lower:||||||| ||||Sl.|Export Product|Qty.|Sl.|Import items|Qty.|| ||||No.|||No.|||| |164|||1|THEOPHYLLINE ER TABS|25000.000|1|THEOPHYLLINE|2550.00 kg|| |||||400MG (Pack Size 100 Tabs.) ( Net|Number||ANHYDROUS||| |||||Wt. of THEOPHYLLINE|||USP||| |||||ANHYDROUS USP is 1000.000|||||| |||||Kgs)|||||| ||||2|THEOPHYLLINE ER TABS|25000.000||||| |||||600MG (Pack Size 100 Tabs.) ( Net|Number||||| |||||Wt. of THEOPHYLLINE|||||| |||||ANHYDROUS USP is 1500.000|||||| |||||Kgs)|||||| |||RA concerned maytake further necessaryaction asper above decision of NC.||||||||

100 Tabs.) ( Net|Number||||| |||||Wt. of THEOPHYLLINE|||||| |||||ANHYDROUS USP is 1500.000|||||| |||||Kgs)|||||| |||RA concerned maytake further necessaryaction asper above decision of NC.||||||||

	Case No.:88/13/82-ALC4/2019	Party Name:CLARIANT	Meet No/Date:2/82-	Status:
		CHEMICALS INDIA LTD	ALC4/2020	Deferred
			10.07.2020
165	HQ File	RLA File	Lic.No/Date:0310833685
	:01/82/050/00931/AM20/	:03/94/040/00797/AM20/	24.12.2019
	Decision:Deferred for comments of TE.

Case No.:91/13/82-	Party Name:RADIANT	Meet No/Date:2/82-	Status:
ALC4/2019	CORPORATION	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0310833719
:01/82/050/00934/AM20/	:03/95/040/00938/AM20/	26.12.2019

Export Product	Qty.	Sl.<br>No.	Import items	Qty.<br>1.10 kg<br>0.95 kg
METHYL PROPYL KETOXIME<br>(MPKO)	1 kg	1	METHYL<br>PROPYL<br>KETONE<br>(MPK) (95%)
		2	HYDROXYLAMINE SULPHATE<br>(HS)

l. No.|Import items|Qty. 1.10 kg 0.95 kg| |---|---|---|---|---| |METHYL PROPYL KETOXIME (MPKO)|1 kg|1|METHYL PROPYL KETONE (MPK) (95%)|| |||2|HYDROXYLAMINE SULPHATE (HS)||

167	Case No.:92/13/82-ALC4/2019	Party Name:TADIMETY<br>AROMATICS PVT. LTD	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00935/AM20/	RLA File<br>:07/24/040/00229/AM20/	Lic.No/Date:0710115939<br>27.12.2019
	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.

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.

168	Case No.:93/13/82-ALC4/2019	Party Name:TADIMETY<br>AROMATICS PVT. LTD	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00936/AM20/	RLA File<br>:07/24/040/00230/AM20/	Lic.No/Date:0710115940<br>27.12.2019
	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.:94/13/82- Party Name:SUN Meet No/Date:2/82- Status: ALC4/2019 PHARMACEUTICAL ALC4/2020 Approved INDUSTRIES LTD. 10.07.2020 HQ File RLA File Lic.No/Date:0510413115 :01/82/050/00937/AM20/ :05/24/040/00607/AM20/ 27.12.2019

No/Date:2/82- Status: ALC4/2019 PHARMACEUTICAL ALC4/2020 Approved INDUSTRIES LTD. 10.07.2020 HQ File RLA File Lic.No/Date:0510413115 :01/82/050/00937/AM20/ :05/24/040/00607/AM20/ 27.12.2019

	Case No.:94/13/82-<br>ALC4/2019	Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD.	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved
	HQ File<br>:01/82/050/00937/AM20/	RLA File<br>:05/24/040/00607/AM20/	Lic.No/Date:0510413115<br>27.12.2019
169	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or<br>as applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Brinzolamide Ophthalmic<br>Suspension, 1%w/v 5ml ( Sterile<br>Eye Drops) (BRINOLAR)<br>(Each ml contains Brinzolamide<br>equivalent to Brinzolamide<br>Micronized Sterile 10 mg<br>(Equivalent to 650.000 Gm of<br>Bulk Drug),<br>13000.000<br>Number<br>1<br>Brinzolamide<br>Micronized<br>Sterile<br>663 Gram<br>RA concerned maytake further necessaryaction asper above decision of NC.

170	<br>Case No.:95/13/82-ALC4/2019	Party Name:PHALANX LABS<br>PRIVATE LIMITED<br>RLA File<br>:26/24/040/00013/AM20/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00938/AM20/		Lic.No/Date:2610012888<br>27.12.2019
	Decision:Deferred for comments of TE.

020 10.07.2020|Status: Deferred| |---|---|---|---|---| || HQ File :01/82/050/00938/AM20/||Lic.No/Date:2610012888 27.12.2019|| ||**Decision:**Deferred for comments of TE.||||

171	Case No.:96/13/82-<br>ALC4/2019	Party Name:STYRAX<br>PHARMA PRIVATE<br>LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br> <br><br>Lic.No/Date:2610012889<br>27.12.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00939/AM20/	RLA File<br>:26/24/040/00014/AM20/
	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.

172	Case No.:97/13/82-ALC4/2019	Party Name:MAITHRI<br>DRUGS PVT LTD<br>RLA File<br>:09/24/040/00465/AM20/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00940/AM20/		Lic.No/Date:0910068306<br>27.12.2019
	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.

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.

173	<br>Case No.:99/13/82-<br>ALC4/2019<br> <br> <br>HQ File<br>:01/82/050/00942/AM20/<br> <br>	Party Name:DIPS<br>BIOSCIENCE PVT.LTD.	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
		RLA File<br>:03/94/040/00788/AM20/	Lic.No/Date:0310833754<br>27.12.2019
	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.


174	Case No.:102/13/82-<br>ALC4/2019	Pa<br>C	rty Name:CLARIANT<br>HEMICALS [INDIA]	Meet<br>ALC	No/Date:2/82-<br>4/2020	Status	: Deferred
	<br>HQ File	L	TD.	10.07	.2020
		R	LA File	Lic.N	o/Date:0310833771
	:01/82/050/00945/AM20/	:03/94/040/00817/AM20/		30.12	.2019
	Decision:Deferred for comments of TE.

red**| || HQ File|L|TD.|10.07|.2020||| |||R|LA File|Lic.N|o/Date:0310833771||| ||:01/82/050/00945/AM20/|:03/94/040/00817/AM20/||30.12|.2019||| ||**Decision:**Deferred for comments of TE.|||||||

	Case No.:104/13/82-<br>Party Name:MENTHA&<br>Meet No/Date:2/82-	Status:
	ALC4/2019<br>ALLIED PRODUCTS<br>ALC4/2020	Deferred
	PRIVATE LIMITED<br>10.07.2020
175	HQ File<br>:01/82/050/00947/AM20/<br>RLA File<br>:05/24/040/00601/AM20/<br>Lic.No/Date:0510413159<br>01.01.2020
	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.:105/13/82-<br>Party Name:REFLUX<br>Meet No/Date:2/82-	Status:
	ALC4/2019<br>ENTERPRISES<br>ALC4/2020	Deferred
	10.07.2020
176	HQ File<br>:01/82/050/00948/AM20/<br>RLA File<br>:03/95/040/00931/AM20/<br>Lic.No/Date:0310833815<br>01.01.2020
	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.:107/13/82-<br>Party Name:SRIAM LABS<br>Meet No/Date:2/82-	Status:
	ALC4/2019<br>PRIVATE LIMITED<br>ALC4/2020	Deferred
	10.07.2020
177	HQ File<br>:01/82/050/00950/AM20/<br>RLA File<br>:09/24/040/00477/AM20/<br>Lic.No/Date:0910068319<br>01.01.2020
	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.:108/13/82-<br>Party Name:PANACEA<br>Meet No/Date:2/82-	Status:
	ALC4/2019<br>BIOTEC LTD.,<br>ALC4/2020	Deferred
	10.07.2020
178	HQ File<br>:01/82/050/00951/AM20/<br>RLA File<br>:05/24/040/00619/AM20/<br>Lic.No/Date:0510413189<br>02.01.2020	:31.01.2020
	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.:110/13/82-	Party Name:GLENMARK	Meet No/Date:2/82-	Status:
ALC4/2019	PHARMACEUTICALS LTD	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0310833861
:01/82/050/00953/AM20/	:03/94/040/00807/AM20/	02.01.2020

-|---| |ALC4/2019||PHARMACEUTICALS LTD||ALC4/2020||Approved| |||||10.07.2020||| |HQ File||RLA File||Lic.No/Date:0310833861||| |:01/82/050/00953/AM20/||:03/94/040/00807/AM20/||02.01.2020|||

	Case No.:110/13/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00953/AM20/	Party Name:GLENMARK<br>PHARMACEUTICALS LTD	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved
		RLA File<br>:03/94/040/00807/AM20/	Lic.No/Date:0310833861<br>02.01.2020
179	Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or<br>as applied by firm whichever is lower:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>Hydrocortison Butyrate Cream -<br>Lipophilic<br>0.1%<br>45gm<br>( Net. wt. of Hydrocortisone<br>Butyarte Micronized USP is<br>3.150 Kgs.)<br>1 Number Pack<br>1<br>Hydrocortisone<br>Butyarte<br>Micronized USP<br>45.90 mg<br>2<br>Hydrocortison Butyrate Cream -<br>Lipophilic<br>0.1%<br>60gm<br>( Net. wt. of Hydrocortisone<br>Butyarte Micronized USP is<br>4.200 Kgs.)<br>1 Number Pack<br>1<br>Hydrocortisone<br>Butyarte<br>Micronized USP<br>61.20 mg<br>RA concerned maytake further necessaryaction asper above decision of NC.

e Micronized USP is 4.200 Kgs.) 1 Number Pack 1 Hydrocortisone Butyarte Micronized USP 61.20 mg RA concerned maytake further necessaryaction asper above decision of NC.||||

180	Case No.:112/13/82-<br>ALC4/2019	Party Name:TOJO VIKAS<br>INTERNATIONAL<br>PRIVATE LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status: Deferred
	HQ File<br>:01/82/050/00955/AM20/	RLA File<br>:05/24/040/00616/AM20/	Lic.No/Date:0510413195<br>03.01.2020
	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.

181	Case No.:119/13/82-<br>ALC4/2019	Party Name:STYRAX LIFE<br>SCIENCES PRIVATE<br>LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00962/AM20/	RLA File<br>:26/24/040/00010/AM20/	Lic.No/Date:2610012891<br>03.01.2020
	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.

182	<br>Case No.:133/13/82-<br>ALC4/2019	Party Name:INTAS<br>PHARMACEUTICALS<br>LTD.	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status: Deferred
	<br>HQ File<br>:01/82/050/00976/AM20/	RLA File<br>:08/24/040/00321/AM20/	Lic.No/Date:0810146922<br>03.01.2020
	Decision:Deferred for comments of TE.

Deferred**| |---|---|---|---|---| || HQ File :01/82/050/00976/AM20/|RLA File :08/24/040/00321/AM20/|Lic.No/Date:0810146922 03.01.2020|| ||**Decision:**Deferred for comments of TE.||||

183	Case No.:118/13/82-<br>ALC4/2019	Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00961/AM20/	RLA File<br>:09/24/040/00496/AM20/	Lic.No/Date:0910068340<br>06.01.2020
	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.

184	<br>Case No.:120/13/82-<br>ALC4/2019	Party Name:BRAWN<br>LABORATORIES LTD<br>RLA File<br>:05/23/040/00390/AM20/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00963/AM20/		Lic.No/Date:0510413216<br>06.01.2020
	Decision:Deferred for comments of TE.

020 10.07.2020|Status: Deferred| |---|---|---|---|---| || HQ File :01/82/050/00963/AM20/||Lic.No/Date:0510413216 06.01.2020|| ||**Decision:**Deferred for comments of TE.||||

185	Case No.:121/13/82-<br>ALC4/2019	Party Name:REYAANSH<br>HEALTHCARE	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00964/AM20/	RLA File<br>:03/95/040/00826/AM20/	Lic.No/Date:0310833938<br>06.01.2020
	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.:140/13/82-	Party Name:DEEPAK	Meet No/Date:2/82-	Status:
ALC4/2019	PHENOLICS LIMITED	ALC4/2020	Deferred
		10.07.2020
HQ File	RLA File	Lic.No/Date:3410045769
:01/82/050/00983/AM20/	:34/24/040/00267/AM20/	07.01.2020

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

(i) Quantity and commercial value of Co-Product Acetone produced. (ii) Percentage yield on molar basis.

case as per agenda and it was decided to call for following information from the firm:

(i) Quantity and commercial value of Co-Product Acetone produced. (ii) Percentage yield on molar basis.

187	Case No.:141/13/82-<br>ALC4/2019	Party Name:DEEPAK<br>PHENOLICS LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00984/AM20/	RLA File<br>:34/24/040/00263/AM20/	Lic.No/Date:3410045770<br>07.01.2020
	<br>Decision:The Committee considered the case as per agenda and it was decided to call for following<br>information from the firm:<br>(i)<br>Quantity and commercial value of Co-Product Phenol obtained.<br>(ii)<br>Percentage yield on molar basis.

Case No.:142/13/82-	Party Name:INDO AMINES	Meet No/Date:2/82-	Status:
ALC4/2019	LIMITED	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0310833988
:01/82/050/00985/AM20/	:03/94/040/00834/AM20/	08.01.2020

-|---|---|---|---| |ALC4/2019||LIMITED||ALC4/2020||Approved| |||||10.07.2020||| |HQ File||RLA File||Lic.No/Date:0310833988||| |:01/82/050/00985/AM20/||:03/94/040/00834/AM20/||08.01.2020|||

	Case No.:142/13/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00985/AM20/	Party Name:INDO AMINES<br>LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved
		RLA File<br>:03/94/040/00834/AM20/	Lic.No/Date:0310833988<br>08.01.2020
188	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or<br>as applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>LAURYL AMINE<br>1 kg<br>1<br>LAURIC ACID<br>1.48 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Case No.:145/13/82-	Party Name:YASHO	Meet No/Date:2/82-	Status:
ALC4/2019	INDUSTRIES LIMITED	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0310834010
:01/82/050/00988/AM20/	:03/95/040/00991/AM20/	08.01.2020

in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or 189 as applied by firm whichever is lower:

Export Product	Qty.	Sl.<br>No.	Import items	Qty.
ZINC DIBUTYL<br>DITHIOCARBAMATE<br>(ZDBC)	1 kg	1	ZINC OXIDE	0.18 kg
		2	DI-BUTYLAMINE	0.573 kg
		3	CARBON DISULPHIDE	0.338 kg

Case No.:149/13/82-	Party Name:SIGMA	Meet No/Date:2/82-	Status:
ALC4/2019	LABORATORIES PRIVATE	ALC4/2020	Approved
	LIMITED	10.07.2020
HQ File	RLA File	Lic.No/Date:0310834031
:01/82/050/00992/AM20/	:03/95/040/00950/AM20/	09.01.2020

190

Export Product	Qty.	Sl.<br>No.	Import items	Qty.
PROBENECID TABLETS-<br>500MG<br>BRAND NAME : PRO-CID /<br>PROBENECID-AFT	1 Number Tablet	1	PROBENECID USP	510.00 mg
Note: Firmwilldeclare export quantity in number of Tablets in line with DML.

ABLETS- 500MG BRAND NAME : PRO-CID / PROBENECID-AFT|1 Number Tablet|1|PROBENECID USP|510.00 mg| |Note: Firmwilldeclare export quantity in number of Tablets in line with DML.|||||

191	<br>Case No.:150/13/82-<br>ALC4/2019	Party Name:TINA ORGANICS<br>PRIVATE LIMITED<br>RLA File<br>:05/24/040/00633/AM20/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00993/AM20/		Lic.No/Date:0510413266<br>09.01.2020
	Decision:Deferred for comments of TE.

	Case No.:155/13/82-<br>Party Name:EMMENNAR<br>Meet No/Date:2/82-	Status:
	ALC4/2019<br>PHARMA PRIVATE<br>ALC4/2020	Deferred
	LIMITED<br>10.07.2020
192	HQ File<br>:01/82/050/00998/AM20/<br>RLA File<br>:09/24/040/00485/AM20/<br>Lic.No/Date:0910068366<br>13.01.2020
	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.:156/13/82-	Party Name:GLENMARK	Meet No/Date:2/82-	Status:
ALC4/2019	PHARMACEUTICALS LTD	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0310834099
:01/82/050/00999/AM20/	:03/94/040/00843/AM20/	13.01.2020

			Case No.:155/13/82-<br>ALC4/2019	Case No.:155/13/82-<br>ALC4/2019	Case No.:155/13/82-<br>ALC4/2019	Case No.:155/13/82-<br>ALC4/2019	Party Name:EMMENNAR<br>PHARMA PRIVATE<br>LIMITED	Party Name:EMMENNAR<br>PHARMA PRIVATE<br>LIMITED	Party Name:EMMENNAR<br>PHARMA PRIVATE<br>LIMITED	Party Name:EMMENNAR<br>PHARMA PRIVATE<br>LIMITED	Party Name:EMMENNAR<br>PHARMA PRIVATE<br>LIMITED	Party Name:EMMENNAR<br>PHARMA PRIVATE<br>LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred	Status:<br>Deferred	Status:<br>Deferred
	192		<br>HQ File<br>:01/82/050/00998/AM20/				RLA File<br>:09/24/040/00485/AM20/						Lic.No/Date:0910068366<br>13.01.2020
			Decision:The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available.

A File :09/24/040/00485/AM20/||||||Lic.No/Date:0910068366 13.01.2020|||||||| ||||**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.:156/13/82- ALC4/2019||||Party Name:GLENMARK PHARMACEUTICALS LTD ||||||Meet No/Date:2/82- ALC4/2020 0072020|||Status: Approved||||| |||||||| RLA File ||||||..|||||||| ||||HQ File ||||||||||Lic.No/Date:0310834099 |||||||| ||||:01/82/050/00999/AM20/||||:03/94/040/00843/AM20/ ||||||3.01.2020|||||||| ||||**Decision:**The Committee c was decided to ratify the ad-ho ||||onsidered case as per agenda in th c input output norms under para 4 ||||||e presence of the technical exp .07 of HBP Vol.

ecision:**The Committee c was decided to ratify the ad-ho ||||onsidered case as per agenda in th c input output norms under para 4 ||||||e presence of the technical exp .07 of HBP Vol. I as per detail|||||erts and it s below or||| ||||as|applied by firm whichever is|||lower:|||||||||||||| |||||Sl||Exort Product|||Qt||||Imort items||Qt|||||| |||||. No.||p|||y.||||p||y.|||||| |||||1||Calcipotrene Ointment USP|||2000.000 Number||||CALCIPOTRIENE||152.0|||0||| |||||||0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 60gm) |||||||(CALCIPOTRIOL)||Gram|||||| |||||||(Net Wt. of C (Calcipotriol)is 6.00|alcipotriene Gms.)|||||||||||||| |||||2||Calcipotrene Oint 0005% Clit|ment USP Oitt||2000.000 Number|||||||||||| |||||||. (acren USP (Pack Size 5gm) (|nmen 0.005%) Net Wt. of|||||||||||||| ||193||||| Calcipotriene (Calcipotriol) is 0.50Gms.)||||||||||||||| |||||3||Calcipotrene Ointment 0.005% (Calcitrene Oint USP 0.00||USP ment 5%)|2000.000 Number|||||||||||| |||||||(Pack Size 120gm) (Net W Calcipotriene (Calcipotriol 12.00Gms.)||t. of||||||||||||| |||||||||) is||||||||||||| |||||4||Calcipotrene Ointment ||USP|2000.000 Numb|||er||||||||| |||||||0.005% (Calcitrene Oint USP 0.0||ment 05%||||||||||||| |||||||) (Pack Size 15gm) (Net W||t.

||||) is||||||||||||| |||||4||Calcipotrene Ointment ||USP|2000.000 Numb|||er||||||||| |||||||0.005% (Calcitrene Oint USP 0.0||ment 05%||||||||||||| |||||||) (Pack Size 15gm) (Net W||t. of||||||||||||| |||||||Calcipotriene (Calcipotriol 1.50Gms.)||) is||||||||||||| |||||5||Calcipotrene Ointment USP|||2000.000 Number|||||||||||| |||||||0.005% (Calcitrene Ointment USP 0.005%) ||||||||||||||| |||||||(Pack Size 45gm) (Net Wt. of Calcipotriene (Calcipotriol) is 4.50Gms.)||||||||||||||| |||||6||Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 30gm) (Net Wt. of Calcipotriene (Calcipotriol) is 3.00Gms.)|||2000.000 Number||||||||||||

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

||7 Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 90gm) (Net Wt. of Calcipotriene (Calcipotriol) is 9.00Gms.) 2000.000 Number 8 Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 100gm) (Net Wt. of Calcipotriene (Calcipotriol)is 10.00Gms.) 2000.000 Number 9 Calcipotriene Cream 0.005% (Calcitrene Cream USP 0.005%) (Pack Size 5gm) (Net Wt. of Calcipotriene (Calcipotriol) is 1.25Gms.) 5000.000 Number 10 Calcipotriene Cream 0.005% (Calcitrene Cream USP 0.005%) (Pack Size 30gm) (Net Wt. of Calcipotriene (Calcipotriol) is 7.50Gms.) 5000.000 Number 11 Calcipotriene Cream 0.005% (Calcitrene Cream USP 0.005%) (Pack Size 45gm) (Net Wt. of Calcipotriene (Calcipotriol) is 11.25Gms.) 5000.000 Number 12 Calcipotriene Cream 0.005% (Calcitrene Cream USP 0.005%) (Pack Size 60gm) (Net Wt. of Calcipotriene (Calcipotriol) is 15.00Gms.) 5000.000 Number 13 Calcipotriene Cream 0.005% (Calcitrene Cream USP 0.005%) (Pack Size 100gm) (Net Wt. of Calcipotriene (Calcipotriol) is 25.00Gms.) 5000.000 Number 14 Calcipotriene Cream 0.005% (Calcitrene Cream USP 0.005%) (Pack Size 120gm) (Net Wt.

Size 100gm) (Net Wt. of Calcipotriene (Calcipotriol) is 25.00Gms.) 5000.000 Number 14 Calcipotriene Cream 0.005% (Calcitrene Cream USP 0.005%) (Pack Size 120gm) (Net Wt. of Calcipotriene (Calcipotriol) is 30.00Gms.) 5000.000 Number 15 Calcipotriene Ointment 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 50gm) (Net Wt. of Calcipotriene (Calcipotriol) is 12.50Gms.) 5000.000 Number RA concerned maytake further necessaryaction asper above decision of NC.| |---|---|

Case No.:157/13/82-	Party Name:GLENMARK	Meet No/Date:2/82-	Status:
ALC4/2019	PHARMACEUTICALS LTD	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0310834101
:01/82/050/01000/AM20/	:03/94/040/00844/AM20/	13.01.2020

	Case No.:157/13/82-<br>ALC4/2019	Case No.:157/13/82-<br>ALC4/2019	Case No.:157/13/82-<br>ALC4/2019	Party Name:GLENMARK<br>PHARMACEUTICALS LTD	Party Name:GLENMARK<br>PHARMACEUTICALS LTD	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved<br>
	HQ File<br>:01/82/050/01000/AM20/			RLA File<br>:03/94/040/00844/AM20/		Lic.No/Date:0310834101<br>13.01.2020
194	<br>Decision:The Committee considered case as per agenda in<br>was decided to ratify the ad-hoc input output norms under para<br>as applied by firm whichever is lower:<br>Sl.

r>13.01.2020||| |194| **Decision:**The Committee considered case as per agenda in was decided to ratify the ad-hoc input output norms under para as applied by firm whichever is lower: Sl. No. Export Product Qty. 1 Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 60gm) (Net Wt. of Calcipotriene (Calcipotriol) is 6.00 Gms.) 2000.000 Number 2 Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 5gm) (Net Wt. of Calcipotriene (Calcipotriol) is 0.50Gms.) 2000.000 Number 3 Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 120gm) (Net Wt. of Calcipotriene (Calcipotriol) is 12.00Gms.) 2000.000 Number 4 Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 15gm) (Net Wt. of Calcipotriene (Calcipotriol) is 1.50Gms.) 2000.000 Number 5 Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 45gm) (Net Wt. of Calcipotriene (Calcipotriol) is 4.50Gms.) 2000.000 Number 6 Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 30gm) (Net Wt. of Calcipotriene (Calcipotriol) is 3.00Gms.) 2000.000 Number 7 Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 90gm) (Net Wt.

30gm) (Net Wt. of Calcipotriene (Calcipotriol) is 3.00Gms.) 2000.000 Number 7 Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 90gm) (Net Wt. of Calcipotriene (Calcipotriol) is 9.00Gms.) 2000.000 Number 8 Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 100gm) (Net Wt. of Calcipotriene (Calcipotriol) is 10.00Gms.) 2000.000 Number 9 Calcipotriene Cream 0.005% (Calcitrene Cream USP 0.005%) (Pack Size 5gm) (Net Wt. of Calcipotriene (Calcipotriol) is 1.25Gms.) 5000.000 Number 10 Calcipotriene Cream 0.005% 5000.000|||||the presence of the technical experts and it 4.07 of HBP Vol. I as per details below or Import items Qty. CALCIPOTRIENE (CALCIPOTRIOL) 152.00 Gram||| |||Sl. No.|Export Product||Qty.||Import items|Qty.| |||1|Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 60gm) (Net Wt. of Calcipotriene (Calcipotriol) is 6.00 Gms.)||2000.000 Number||CALCIPOTRIENE (CALCIPOTRIOL)|152.00 Gram| |||2|Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 5gm) (Net Wt. of Calcipotriene (Calcipotriol) is 0.50Gms.)||2000.000 Number|||| |||3|Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 120gm) (Net Wt.

5gm) (Net Wt. of Calcipotriene (Calcipotriol) is 0.50Gms.)||2000.000 Number|||| |||3|Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 120gm) (Net Wt. of Calcipotriene (Calcipotriol) is 12.00Gms.)||2000.000 Number|||| |||4|Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 15gm) (Net Wt. of Calcipotriene (Calcipotriol) is 1.50Gms.)||2000.000 Number|||| |||5|Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 45gm) (Net Wt. of Calcipotriene (Calcipotriol) is 4.50Gms.)||2000.000 Number|||| |||6|Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 30gm) (Net Wt. of Calcipotriene (Calcipotriol) is 3.00Gms.)||2000.000 Number|||| |||7|Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 90gm) (Net Wt. of Calcipotriene (Calcipotriol) is 9.00Gms.)||2000.000 Number|||| |||8|Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 100gm) (Net Wt. of Calcipotriene (Calcipotriol) is 10.00Gms.)||2000.000 Number|||| |||9|Calcipotriene Cream 0.005% (Calcitrene Cream USP 0.005%) (Pack Size 5gm) (Net Wt. of Calcipotriene (Calcipotriol) is 1.25Gms.)||5000.000 Number|||| |||10|Calcipotriene Cream 0.005%||5000.000||||

% (Calcitrene Cream USP 0.005%) (Pack Size 5gm) (Net Wt. of Calcipotriene (Calcipotriol) is 1.25Gms.)||5000.000 Number|||| |||10|Calcipotriene Cream 0.005%||5000.000||||

(Calcitrene Cream USP 0.005%) (Pack Size 30gm) (Net Wt. of Calcipotriene (Calcipotriol) is 7.50Gms.) Number 11 Calcipotriene Cream 0.005% (Calcitrene Cream USP 0.005%) (Pack Size 45gm) (Net Wt. of Calcipotriene (Calcipotriol) is 11.25Gms.) 5000.000 Number 12 Calcipotriene Cream 0.005% (Calcitrene Cream USP 0.005%) (Pack Size 60gm) (Net Wt. of Calcipotriene (Calcipotriol) is 15.00Gms.) 5000.000 Number 13 Calcipotriene Cream 0.005% (Calcitrene Cream USP 0.005%) (Pack Size 100gm) (Net Wt. of Calcipotriene (Calcipotriol) is 25.00Gms.) 5000.000 Number 14 Calcipotriene Cream 0.005% (Calcitrene Cream USP 0.005%) (Pack Size 120gm) (Net Wt. of Calcipotriene (Calcipotriol) is 30.00Gms.) 5000.000 Number 15 Calcipotrene Ointment USP 0.005% (Calcitrene Ointment USP 0.005%) (Pack Size 50gm) (Net Wt. of Calcipotriene (Calcipotriol) is 12.50 Gms.) 5000.000 Number RA concerned maytake further necessaryaction asper above decision of NC.

05%) (Pack Size 50gm) (Net Wt. of Calcipotriene (Calcipotriol) is 12.50 Gms.) 5000.000 Number RA concerned maytake further necessaryaction asper above decision of NC.| |---|---|

195	Case No.:161/13/82-<br>ALC4/2019	Party Name:VIVIN DRUGS &<br>PHARMACEUTICALS<br>LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01004/AM20/	RLA File<br>:09/24/040/00484/AM20/	Lic.No/Date:0910068369<br>14.01.2020
	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.:166/13/82-	Party Name:SHIRDI	Meet No/Date:2/82-	Status:
ALC4/2019	CHEMICALS PRIVATE	ALC4/2020	Approved
	LIMITED	10.07.2020
HQ File	RLA File	Lic.No/Date:0310834190
:01/82/050/01009/AM20/	:03/95/040/01005/AM20/	15.01.2020

| |ALC4/2019||CHEMICALS PRIVATE||ALC4/2020||Approved| |||LIMITED||10.07.2020||| |HQ File||RLA File||Lic.No/Date:0310834190||| |:01/82/050/01009/AM20/||:03/95/040/01005/AM20/||15.01.2020|||

	Case No.:166/13/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/01009/AM20/	Party Name:SHIRDI<br>CHEMICALS PRIVATE<br>LIMITED	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Approved
		RLA File<br>:03/95/040/01005/AM20/	Lic.No/Date:0310834190<br>15.01.2020
196	<br>Decision:The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or<br>as applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>DMBPC OR 4,4-Cyclohexylidene<br>bis<br>2-methylphenol<br>OR<br>Dimethylbisphenolcyclohexane<br>DMBPC<br>1 kg<br>1<br>Ortho<br>Cresol<br>Cas No.95-48-7<br>0.974 kg<br>2<br>3-Mercaptopropionic<br>Acid<br>Minimum99%<br>0.025 kg<br>3<br>Dodecyl Benzene Sulphonic Acid<br>Minimum94%<br>0.065 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Mercaptopropionic Acid Minimum99% 0.025 kg 3 Dodecyl Benzene Sulphonic Acid Minimum94% 0.065 kg RA concerned maytake further necessaryaction asper above decision of NC.||||

197	Case No.:167/13/82-<br>ALC4/2019	Party Name:ARCH<br>PHARMALABS LTD	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020<br>Lic.No/Date:0310834233<br>16.01.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01010/AM20/	RLA File<br>:03/94/040/00862/AM20/
	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.

198	<br>Case No.:168/13/82-<br>ALC4/2019	Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED<br>RLA File<br>:03/94/040/00846/AM20/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01011/AM20/		Lic.No/Date:0310834236<br>16.01.2020
	Decision:Deferred for comments of TE.

020 10.07.2020|Status: Deferred| |---|---|---|---|---| || HQ File :01/82/050/01011/AM20/||Lic.No/Date:0310834236 16.01.2020|| ||**Decision:**Deferred for comments of TE.||||

199	<br>Case No.:169/13/82-<br>ALC4/2019	Party Name:INNOVARE<br>LABS PRIVATE LIMITED<br>RLA File<br>:09/24/040/00514/AM20/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01012/AM20/		Lic.No/Date:0910068370<br>16.01.2020
	Decision:Deferred for comments of TE.

Case No.:170/13/82-	Party Name:DIVIS	Meet No/Date:2/82-	Status:
ALC4/2019	LABORATORIES LTD	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0910068375
:01/82/050/01013/AM20/	:09/24/040/00516/AM20/	16.01.2020

Export Product	Qty.	Sl. No.	Import items	Qty.
NAPROXEN	1 kg	1	DL-NAPROXEN	1.25 kg
		2	N-OCTYL-D-GLUCAMINE	0.09kg
		3	METHANOL	2.03 kg
		4	ACETIC ACID	0.54 kg
		5	TOLUENE	1.13 kg

Qty.|Sl. No.|Import items|Qty.| |---|---|---|---|---| |NAPROXEN|1 kg|1|DL-NAPROXEN|1.25 kg| |||2|N-OCTYL-D-GLUCAMINE|0.09kg| |||3|METHANOL|2.03 kg| |||4|ACETIC ACID|0.54 kg| |||5|TOLUENE|1.13 kg|

201	Case No.:173/13/82-<br>ALC4/2019	Party Name:VHB<br>MEDISCIENCES LTD.<br>RLA File<br>:03/95/040/01016/AM20/	Meet No/Date:2/82-<br>ALC4/2020<br>10.07.2020	Status:<br>Deferred<br>
	<br>HQ File<br>:01/82/050/01016/AM20/		Lic.No/Date:0310834259<br>16.01.2020
	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.:171/13/82-	Party Name:GLENMARK	Meet No/Date:2/82-	Status:
ALC4/2019	PHARMACEUTICALS LTD	ALC4/2020	Approved
		10.07.2020
HQ File	RLA File	Lic.No/Date:0310834275
:01/82/050/01014/AM20/	:03/94/040/00850/AM20/	17.01.2020

-|---| |ALC4/2019||PHARMACEUTICALS LTD||ALC4/2020||Approved| |||||10.07.2020||| |HQ File||RLA File||Lic.No/Date:0310834275||| |:01/82/050/01014/AM20/||:03/94/040/00850/AM20/||17.01.2020|||

Case No.:171/13/82-<br>ALC4/2019	Case No.:171/13/82-<br>ALC4/2019	Party Name:GLENMARK<br>PHARMACEUTICALS LTD	Party Name:GLENMARK<br>PHARMACEUTICALS LTD	Meet No/Date:2/82-<br>ALC4/2020	Meet No/Date:2/82-<br>ALC4/2020	Status:<br>Approved
		<br>RLA File<br>:03/94/040/00850/AM20/		<br>10.07.2020<br>Lic.No/Date:0310834275<br>17.01.2020
HQ File<br>:01/82/050/01014/AM20/
Decision:The Committee c<br>was decided to ratify the ad-ho		onsidered case as<br>c input output nor	per agenda in t<br>ms under para	he presence of the technical exp<br>407 of HBP Vol I as per detail		erts and it<br>s below or
<br>as	<br>applied by firm whichever is lower:		.		.<br>Import items<br>Qty.<br>Alclometasone<br>Dipropionate USP<br>5.036 kg
	Sl.

Vol I as per detail||||erts and it s below or||| ||| as| applied by firm whichever is lower:||||||.|||. Import items Qty. Alclometasone Dipropionate USP 5.036 kg|||||| ||||Sl. No.|Export Product|||||Qty.|||Import items||Qty.|||| ||||1|Alclometasone Dipropionate USP|||||90000.000 Packs|||Alclometasone||5.036 kg|||| ||||| Cream 0.05% 15gm ( 15gm)||| Pack Siz| e||||Dipropionate USP|||||| ||||| (Net Wt. of Alc Dipropionate USP is 0.6|||lometason 75 Kgs.)|e|||||||||| ||||||||||||||||||| ||||2|Alclometasone Dipropionate USP Cream 0.05% 45gm ( Pack Size |||||47000.000 Packs||||||||| |||||45gm) (Net Wt. of Alclometasone Diroionate USP is 1058 Ks)|||||||||||||| ||202|||pp|.g.||||||||||||| ||||3|Alclometasone Cream 0.05% 60gm)|Dipropionate USP 60gm ( Pack Size||||48000.000 Pa||cks||||||| ||||| (Net Wt. o Dipropionate U|f Alclometasone SP is 1.440 Kgs.)||||||||||||| ||||4|Alclometasone Dipropionate

Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.

Analysis

No analysis generated for this document yet (analysis runs over brief docs + on-demand). Run build_analysis.py --ids 7943 --apply.