IN FORCE Advance Authorisation

DGFT Minutes

Reliability

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Office of Directorate General of Foreign Trade New Delhi -0

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Para 4.07 Decision

Minutes of the Norms Committee – 3 Meeting No. 5/82-ALC4/2020 dated 09.10.2020 (actually held on 26.10.2020 and 09.11.2020) 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 Rajbir Sharma, Jt. DGFT in Room No.4 and 11, Udyog Bhawan, New Delhi.

Following members were present in the Meeting:

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

ONLINE CASES

Case No.:820/15/82-	Party Name:AURORE LIFE	Meet No/Date:5/82-	Status:
ALC4/2018	SCIENCES PRIVATE	ALC4/2020	Approved
	LIMITED	09.10.2020
HQ File	RLA File	Lic.No/Date:0910067061
:01/82/050/02277/AM19/	:09/24/040/00508/AM19/	16.01.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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: 1

Export product	Qty.	Sl.<br>No.	Import items	Qty.
2,6-Dihydroxy Acetophenone	1 kg	1	Resorcinol	1.77 kg
		2	Methyl Aceto Acetate	1.86 kg
		3	Chloroform	2.65 kg
		4	Toulene	1.32 kg

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

Case No.:1026/15/82-	Party Name:ANLON	Meet No/Date:5/82-	Status:
ALC4/2018	HEALTHCARE	ALC4/2020	Approved
	PRIVATELIMITED	09.10.2020
HQ File	RLA File	Lic.No/Date:2410042628
:01/82/050/02483/AM19/	:24/24/040/00049/AM19/	16.01.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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 2 Vol. I as per details below or as applied by firm whichever is lower:

er 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 2 Vol. I as per details below or as applied by firm whichever is lower:

Export product	Qty.	Sl.<br>No.	Import items	Qty.
2-(4- ((2-oxocyclopentyl)methyl)phenyl)<br>propanoic acid-Case No.68767-14-6	1 kg	1	2-phenyl propionic acid-<br>Case No.492-37-5	1.276 kg

Case No.:829/15/82-	Party Name:AUROBINDO	Meet No/Date:5/82-	Status:
ALC4/2018	PHARMA LIMITED	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0910067071
:01/82/050/02286/AM19/	:09/24/040/00499/AM19/	18.01.2019

	Case No.:829/15/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/02286/AM19/	Party Name:AUROBINDO<br>PHARMA LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
		RLA File<br>:09/24/040/00499/AM19/	Lic.No/Date:0910067071<br>18.01.2019
3	Decision:The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol.

Case No.:830/15/82-	Party Name:R CHEM	Meet No/Date:5/82-	Status:
ALC4/2018	(SOMANAHALLI) PVT.LTD,	ALC4/2020	Deferred
		09.10.2020
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| |||||09.10.2020||| |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 and Final Reminder on 23.10.2020:

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

ply awaited from the firm.

Case No.:837/15/82-	Party Name:DANOPHARM	Meet No/Date:5/82-	Status:
ALC4/2018	CHEMICALS PRIVATE LTD.	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310826539
:01/82/050/02294/AM19/	:03/94/040/00886/AM19/	22.01.2019

Export product	Qty.	Sl.<br>No.	Import items	Qty.
Cyclopropyl<br>Carboxamido<br>Benzophenone	1 kg	1	2-Amino-5-Chloro Benzophenone	0.813 kg
		2	Dimethyl Sulfoxide (DMSO)	0.50 kg
		3	Cyclopropane Carbonyl Chloride	0.274 kg
		4	Iso Propyl Alcohol	0.75 kg
		5	Ethylene Di Chloride (EDC)	0.25 kg

ino-5-Chloro Benzophenone|0.813 kg| |||2|Dimethyl Sulfoxide (DMSO)|0.50 kg| |||3|Cyclopropane Carbonyl Chloride|0.274 kg| |||4|Iso Propyl Alcohol|0.75 kg| |||5|Ethylene Di Chloride (EDC)|0.25 kg|

Case No.:842/15/82-	Party Name:S.M. HERBALS	Meet No/Date:5/82-	Status:
ALC4/2018	PVT.LTD.	ALC4/2020	Deferred
		09.10.2020
HQ File	RLA File	Lic.No/Date:0510409465
:01/82/050/02299/AM19/	:05/24/040/00602/AM19/	24.01.2019

Decision: The Committee considered the case as per agenda in the presence of technical experts and it 6 was decided to call for following information from the firm:

(i) Content of 10-DAB III in the imported Twig and Leaf supported by COA from foreign supplier. (ii) Content of 10-DAB-III in the export item supported by COA. (iii) Stepwise process details with wastage in each step of active ingredient. (iv) Whether norms applied at Appendix 4E justify the import requirements.

Case No.:851/15/82-	Party Name:SI GROUP -	Meet No/Date:5/82-	Status:
ALC4/2018	INDIA PRIVATE LIMITED	ALC4/2020	Deferred
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310826724
:01/82/050/02308/AM19/	:03/95/040/01108/AM19/	30.01.2019

---| |ALC4/2018||INDIA PRIVATE LIMITED||ALC4/2020||Deferred| |||||09.10.2020||| |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 7 Meeting No. 13/82-ALC4/2019 dated 31.01.2020, followed by Reminder on 20.03.2020 and Final Reminder on 23.10.2020:

(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.

ply awaited from the firm.

8	Case No.:853/15/82-<br>ALC4/2018	Party Name:ALPHAMED<br>FORMULATIONS P LTD.	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0910067120<br>31.01.2019	Status:<br>Deferred
	HQ File<br>:01/82/050/02310/AM19/	RLA File<br>:09/24/040/00511/AM19/
	Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information from the firm:<br>(i)<br>Copy of Master Batch Formula for each export item.

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

for each export item.**||||

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

9	Case No.:855/15/82-<br>ALC4/2018	Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0910067122<br>31.01.2019	Status:<br>Deferred
	HQ File<br>:01/82/050/02312/AM19/	RLA File<br>:09/24/040/00542/AM19/
	Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information from the firm:<br>(i)<br>Technical literature in support of requirement of Enzyme and its recovery<br>for reactivation.<br>(ii)<br>Requirement and Recovery of solvents at each stage.

Case No.:861/15/82-	Party Name:INNOVARE	Meet No/Date:5/82-	Status:
ALC4/2018	LABS PRIVATE LIMITED	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0910067125
:01/82/050/02318/AM19/	:09/24/040/00535/AM19/	01.02.2019

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.<br>No.	Import items	Qty.
OSELTAMIVIR PHOPHATE<br>(N-1) or (Ethyl(3R,4R,5S)-4-N-<br>AcetaMido-5-Azido-3-(1-<br>Ethylpropoxy)-1-Cyclohexene-1-<br>Carboxylate)	1 kg	1	(1S,5R,6S)-Ethyl 5-(Pentan-3-yl-oxy)-<br>7-oxabicyclo[4.1.0]hept-3-ene-3-<br>carboxylate	1.30 kg

11	Case No.:863/15/82-<br>ALC4/2018	Party Name:JAYANT AGRO<br>ORGANICS LTD.,	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>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<br>was noted that the firm vide 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 e-mail dated 08.11.2019 has furnished its reply. Deferred for comments of TE.

Case No.:864/15/82-	Party Name:J.B. CHEMICALS	Meet No/Date:5/82-	Status:
ALC4/2018	& PHARMACEUTICALS	ALC4/2020	Approved
	LIMITED	09.10.2020
HQ File	RLA File	Lic.No/Date:0310826799
:01/82/050/02321/AM19/	:03/94/040/00944/AM19/	04.02.2019

| |ALC4/2018||& PHARMACEUTICALS||ALC4/2020||Approved| |||LIMITED||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0310826799||| |:01/82/050/02321/AM19/||:03/94/040/00944/AM19/||04.02.2019|||

	Case No.:864/15/82-<br>ALC4/2018	Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED<br> <br> <br> <br>RLA File<br>:03/94/040/00944/AM19/<br> <br>	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
	HQ File<br>:01/82/050/02321/AM19/		Lic.No/Date:0310826799<br>04.02.2019
12	<br>Decision:The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or 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>GLIPIZIDE<br>EXTENDED-<br>RELEASE<br>TABLETS<br>10<br>MG.Each<br>tablet<br>contains<br>(i)<br>Glipizide<br>USP-<br>10<br>mg<br>(ii)<br>Eastman<br>(TM<br>Cellulose<br>Acetate(CA 398-10NF/EP)- 29.70<br>mg (iii) Sentry Polyox WSR N80<br>FP NF- 178.10 mg (iv) Sentry<br>Polyox WSR 303 NF- 100 mg.<br>Net content (i) 281.25 Kgs (ii)<br>835.313 Kgs (iii) 5009.063 Kgs<br>(iv) 2812.50 Kgs.<br>1 Number<br>Tablet<br>1<br>GLIPIZIDE USP<br>10.20 mg<br>2<br>EASTMAN<br>(TM)<br>CELLULOSE<br>ACETATE (CA 398-<br>10NF/EP)<br>29.70 mg<br>3<br>SENTRY<br>POLYOX<br>WSR N80 FP NF<br>178.10 mg<br>4<br>SENTRY<br>POLYOX<br>WSR 303 NF<br>100.00 mg<br>2<br>GLIPIZIDE<br>EXTENDED-<br>RELEASE TABLETS 5 MG.<b

TE (CA 398- 10NF/EP) 29.70 mg 3 SENTRY POLYOX WSR N80 FP NF 178.10 mg 4 SENTRY POLYOX WSR 303 NF 100.00 mg 2 GLIPIZIDE EXTENDED- RELEASE TABLETS 5 MG. Each tablet contains (i) Glipizide USP- 5 mg (ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii) Sentry Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR 303 NF- 50 mg. Net content (i) 104.167 Kgs (ii) 425.001 Kgs (iii) 1855.214 Kgs (iv) 1041.670 Kgs. 1 Number Tablet 5 GLIPIZIDE USP 5.10 mg 6 EASTMAN (TM) CELLULOSE ACETATE (CA 398- 10NF/EP) 20.40 mg 7 SENTRY POLYOX WSR N80 FP NF 89.05 mg 8 SENTRY POLYOX WSR 303 NF 50.00 mg 3 GLIPIZIDE EXTENDED- RELEASE TABLETS 2.5 MG. Each tablet contains (i) Glipizide USP- 2.5 mg (ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii) Sentry Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR 303 NF- 50 mg. Net content (i) 31.25 Kgs (ii) 255.00 Kgs (iii) 1113.125 Kgs (iv) 625.00 Kgs. 1 Number Tablet 9 GLIPIZIDE USP 2.55 mg 10 EASTMAN (TM) CELLULOSE ACETATE (CA 398- 10NF/EP) 20.40 mg 11 SENTRY POLYOX WSR N80 FP NF 89.05 mg 12 SENTRY POLYOX WSR 303 NF 50.00 mg 4 NIFEDIPINE EXTENDED- RELEASE TABLETS 60 MG. Each tablet contains (i) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 42.32 mg (ii) Sentry Polyox WSR N80 FP NF- 236.80 mg.

IFEDIPINE EXTENDED- RELEASE TABLETS 60 MG. Each tablet contains (i) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 42.32 mg (ii) Sentry Polyox WSR N80 FP NF- 236.80 mg. Net content (i) 63.705 Kgs (ii) 356.457 Kgs. 1 Number Tablet 13 EASTMAN (TM) CELLULOSE ACETATE (CA 398- 10NF/EP) 42.32 mg 14 SENTRY POLYOX WSR N80 FP NF 236.80 mg||||

5 NIFEDIPINE EXTENDED1 Number 15 EASTMAN (TM) 33.12 mg RELEASE TABLETS 30 MG. Tablet CELLULOSE Each tablet contains (i) Eastman ACETATE (CA 398(TM Cellulose 10NF/EP) Acetate (CA 398-10NF/EP)16 SENTRY POLYOX 118.40 mg 33.12 mg (ii) Sentry Polyox WSR WSR N80 FP NF N80 FP NF- 118.40 mg. Net content (i) 66.669 Kgs (ii) 238.332 Kgs.

Case No.:1027/15/82-	Party Name:ANLON	Meet No/Date:5/82-	Status:
ALC4/2018	HEALTHCARE	ALC4/2020	Approved
	PRIVATELIMITED	09.10.2020
HQ File	RLA File	Lic.No/Date:2410042653
:01/82/050/02484/AM19/	:24/24/040/00053/AM19/	05.02.2019

| |ALC4/2018||HEALTHCARE||ALC4/2020||Approved| |||PRIVATELIMITED||09.10.2020||| |HQ File||RLA File||Lic.No/Date:2410042653||| |:01/82/050/02484/AM19/||:24/24/040/00053/AM19/||05.02.2019|||

Decision: The Committee considered case as per agenda and deliberated on the matter 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 13 Vol. I as per details below or as applied by firm whichever is lower:

Export product	Qty.	Sl.<br>No.	Import items	Qty.
2-(4-((2-oxocyclopentyl)<br>methyl)<br>phenyl) propanoic acid. case No.<br>68767-14-6	1 kg	1	2-Phenyl propionic acid - case<br>no.492-37-5	1.276 kg

Case No.:880/15/82-	Party Name:DEEPAK	Meet No/Date:5/82-	Status:
ALC4/2018	NOVOCHEM	ALC4/2020	Rejected
	TECHNOLOGIES LTD	09.10.2020
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 Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2019 14 dated 31.01.2020, followed by Reminder on 19.03.2020 and Final Reminder on 04.09.2020:

(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.

l Reminder on 04.09.2020:

(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.

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

15	Case No.:881/15/82-<br>ALC4/2018	Party Name:SHILPA<br>MEDICARE LIMITED<br>RLA File<br>:07/24/040/00263/AM19/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0710114519<br>07.02.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02338/AM19/
	Decision:Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated<br>15.05.2019.

Decision: Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.

5.05.2019. Application is still awaited. Hence, it was decided to issue Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.

16	Case No.:883/15/82-<br>ALC4/2018	Party Name:MAHESHRAJ<br>CHEMICALS PVT.LTD<br>RLA File<br>:08/24/040/00374/AM19/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0810144562<br>08.02.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02340/AM19/
	Decision:Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated<br>15.05.2019.

Case No.:885/15/82-	Party Name:ORTIN	Meet No/Date:5/82-	Status:
ALC4/2018	LABORATORIES LTD	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0910067148
:01/82/050/02342/AM19/	:09/24/040/00538/AM19/	08.02.2019

|---|---| |ALC4/2018||LABORATORIES LTD||ALC4/2020||Approved| |||||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0910067148||| |:01/82/050/02342/AM19/||:09/24/040/00538/AM19/||08.02.2019|||

	Case No.:885/15/82-<br>ALC4/2018<br> <br> <br>HQ File<br>:01/82/050/02342/AM19/<br> <br>	Party Name:ORTIN<br>LABORATORIES LTD<br> <br> <br> <br>RLA File<br>:09/24/040/00538/AM19/<br> <br>	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
			Lic.No/Date:0910067148<br>08.02.2019
17	<br>Decision:The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.<br>I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>[2S,3S,5S]-5-t-<br>butyloxycarbonylamino-2-Amino-3-<br>hydroxy-1,6-diphenylhexane<br>succinate(BDH Succinic Acid RIT)<br>1 kg<br>1<br>1,2-dimethoxy ethane(1,2-DME)<br>4.74 kg<br>2<br>SODIUM BORO HYDRIDE<br>0.45 kg<br>3<br>METHANE SULPHONIC<br>ACID<br>1.50 kg<br>4<br>L-Phenylalanine<br>Not shown<br>in process<br>chemistry<br>RA concerned maytake further necessaryaction asper above decision of NC.

tter 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:

18	Case No.:891/15/82-<br>ALC4/2018	Party Name:GELTEC<br>PRIVATE LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02348/AM19/	RLA File<br>:03/94/040/00970/AM19/	Lic.No/Date:0310826970<br>11.02.2019
	Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 23.10.2020 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 23.10.2020 has furnished its reply. Deferred for comments of TE.

19	Case No.:894/15/82-<br>ALC4/2018	Party Name:DEEPAK<br>PHENOLICS LIMITED	Meet No/Date:5/82-<br>ALC4/200014020<br>09.10.2020	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
	Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 17.09.2020 has furnished its reply. Deferred for comments of TE.

ttee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 17.09.2020 has furnished its reply. Deferred for comments of TE.||||

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 17.09.2020 has furnished its reply. Deferred for comments of TE.

Case No.:896/15/82-	Party Name:AUROBINDO	Meet No/Date:5/82-	Status:
ALC4/2018	PHARMA LIMITED	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0910067168
:01/82/050/02353/AM19/	:09/24/040/00555/AM19/	13.02.2019

	Case No.:896/15/82-<br>ALC4/2018<br> <br> <br>HQ File<br>:01/82/050/02353/AM19/<br> <br>	Party Name:AUROBINDO<br>PHARMA LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
		RLA File<br>:09/24/040/00555/AM19/	Lic.No/Date:0910067168<br>13.02.2019

ROBINDO PHARMA LIMITED|Meet No/Date:5/82- ALC4/2020 09.10.2020|Status: Approved| |---|---|---|---|---| |||RLA File :09/24/040/00555/AM19/|Lic.No/Date:0910067168 13.02.2019|| |20| **Decision:**The Committee considered case as per agenda and deliberated on the matter 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. DARUNAVIR PROPYLENE GLYCOLATE 1 kg 1 (2S,3S)-1,2-Epoxy-3-(Boc-amino)-4- phenylbutane (or) BOC-Epoxide 0.587 kg 2 Activated Carbon (Carbon Enoanticromos) 0.100 kg 3 [3R,3aS,6aR]-3- Hydroxyhexahydrofuro[2,3-b]furanyl succicinamidyl carbonate 0.480 kg 4 Isobutylamine 0.330 kg 5 Methanol (Methyl Alcohol) 1.92 kg 6 Methylene Chloride 2.51 kg 7 Toluene 0.77 kg 8 Triethylamine 0.600 kg RA concerned maytake further necessaryaction asper above decision of NC.||||

tter 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:

21	<br>Case No.:903/15/82-<br>ALC4/2018	Party Name:MATRIX FINE<br>SCIENCES PVT.LTD.,	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02360/AM19/	RLA File<br>:03/95/040/01113/AM19/	Lic.No/Date:0310827030<br>14.02.2019
	Decision:Deferred for comments of TE.

22	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:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0510409675<br>15.02.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02362/AM19/
	Decision:The Committee considered the case as per agenda and<br>Show Cause Notice vide letter dated 10.10.2019.		it was observed that the firm was issued

23	Case No.:906/15/82-<br>ALC4/2018	Party Name:JODAS EXPOIM<br>PVT.LTD<br>RLA File<br>:05/23/040/00507/AM19/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02363/AM19/		Lic.No/Date:0510409676<br>15.02.2019
	Decision:The Committee considered the case as per agenda and it was observed that the firm was issued<br>Show Cause Notice vide letter dated 10.10.2019.

o/Date:0510409676 15.02.2019|| ||**Decision:**The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.||||

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

Case No.:907/15/82-	Party Name:AURORE LIFE	Meet No/Date:5/82-	Status:
ALC4/2018	SCIENCES PRIVATE	ALC4/2020	Deferred
	LIMITED	09.10.2020
HQ File	RLA File	Lic.No/Date:0910067181
:01/82/050/02364/AM19/	:09/24/040/00515/AM19/	15.02.2019

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

(i) Complete chemical description of import item No. 1. (ii) COA of import item No. 1 from foreign supplier. (iii) Whether import item No. 2 is Pt Metal or 5% Pt on carbon.

Case No.:916/15/82-	Party Name:OPTIMUS	Meet No/Date:5/82-	Status:
ALC4/2018	DRUGS PRIVATE LIMITED	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0910067192
:01/82/050/02373/AM19/	:09/24/040/00569/AM19/	20.02.2019

---| |ALC4/2018||DRUGS PRIVATE LIMITED||ALC4/2020||Approved| |||||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0910067192||| |:01/82/050/02373/AM19/||:09/24/040/00569/AM19/||20.02.2019|||

	Case No.:916/15/82-<br>ALC4/2018<br> <br> <br>HQ File<br>:01/82/050/02373/AM19/<br> <br>	Party Name:OPTIMUS<br>DRUGS PRIVATE LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
		RLA File<br>:09/24/040/00569/AM19/	Lic.No/Date:0910067192<br>20.02.2019
25	<br>Decision:The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.<br>I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Ledipasvir Copovidone IH<br>1 kg<br>1<br>Methyl [(2S)-1-{(1R,3S,4S)-3-[5-(9,9-<br>difluoro-7-{2-[(6S)-5-{(2S)-2-<br>[(methoxy<br>carbonyl)amino]-3-methyl<br>butanoyl}-5-Azaspiro [2.4]hept-6-yl]-<br>1H-imidazol-4-yl}-9H-fluoren-2-yl)-<br>1H-benzimidazol-2-yl]-2-<br>azabicyclo[2.2.1]hept-2-yl}-3-methyl-<br>1-oxo-2-butanyl] carbamate acetone<br>solvate<br>0.55 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

idazol-2-yl]-2- azabicyclo[2.2.1]hept-2-yl}-3-methyl- 1-oxo-2-butanyl] carbamate acetone solvate 0.55 kg RA concerned maytake further necessaryaction asper above decision of NC.||||

Case No.:919/15/82-	Party Name:ORTIN	Meet No/Date:5/82-	Status:
ALC4/2018	LABORATORIES LTD	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0910067198
:01/82/050/02376/AM19/	:09/24/040/00573/AM19/	21.02.2019

	Case No.:919/15/82-<br>ALC4/2018	Party Name:ORTIN<br>LABORATORIES LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
	HQ File<br>:01/82/050/02376/AM19/	RLA File<br>:09/24/040/00573/AM19/	Lic.No/Date:0910067198<br>21.02.2019

/Date:5/82- ALC4/2020 09.10.2020|Status: Approved| |---|---|---|---|---| ||HQ File :01/82/050/02376/AM19/|RLA File :09/24/040/00573/AM19/|Lic.No/Date:0910067198 21.02.2019|| |26| **Decision:**The Committee considered case as per agenda and deliberated on the matter 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. (3R,3aS,6aR)-Hexahydrofuro[2,3- b]furan-3-ol(BIS-IV) 1 kg 1 2,3-dihydrofuran 1.05 kg 2 Sodium borohydride 0.72 kg RA concerned maytake further necessaryaction asper above decision of NC.||||

Case No.:922/15/82-	Party Name:GLOBE	Meet No/Date:5/82-	Status:
ALC4/2018	TROTTERS PVT LTD	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310827201
:01/82/050/02379/AM19/	:03/94/040/01015/AM19/	21.02.2019

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

Export product	Qty.	Sl.<br>No.	Import items	Qty.
AMPICILLIN SODIUM +<br>SULBACTUM SODIUM STERILE<br>(2:1)	1 kg	1	SULBACTUM ACID	0.328 kg
		2	SODIUM<br>2<br>ETHYL<br>HEXANOATE	0.256 kg
		3	ETHYL ACETATE	1.12 kg

28	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:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02381/AM19/		Lic.No/Date:0310827206<br>21.02.2019
	<br>Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information from the firm:<br>(i)<br>Exact chemical name of import and export.<br>(ii)<br>COA andpurity of import item.

experts and it was decided to call for following information from the firm: (i) Exact chemical name of import and export. (ii) COA andpurity of import item.||||

29	Case No.:929/15/82-<br>ALC4/2018	Party Name:THINQ PHARMA-<br>CRO LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	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:Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated<br>15.05.2019.

Case No.:934/15/82-	Party Name:ASTRAL	Meet No/Date:5/82-	Status:
ALC4/2018	STERITECH PVT. LTD.	ALC4/2020	Deferred
		09.10.2020
HQ File	RLA File	Lic.No/Date:3410044929
:01/82/050/02391/AM19/	:34/24/040/00356/AM19/	22.02.2019

-|---| |ALC4/2018||STERITECH PVT. LTD.||ALC4/2020||Deferred| |||||09.10.2020||| |HQ File||RLA File||Lic.No/Date:3410044929||| |:01/82/050/02391/AM19/||:34/24/040/00356/AM19/||22.02.2019|||

30 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was observed that the reply given by firm was not proper as the DML given by the firm was for three different doses and not specific to the Advance Authorization. Hence, it was decided to call for following information from the firm:

(i) Specific details of export items alongwith their export obligation.

31	Case No.:935/15/82-<br>ALC4/2018	Party Name:ASTRAL<br>STERITECH PVT. LTD.	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>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<br>decided to call for following information from the firm:<br>(i)<br>Specific export items asper DML and their export obligation separately.

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

ligation separately. **||||

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

32	<br>Case No.:936/15/82-<br>ALC4/2018	Party Name:VISION DRUGS<br>PVT LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02393/AM19/	RLA File<br>:09/24/040/00575/AM19/	Lic.No/Date:0910067217<br>25.02.2019
	Decision:Deferred for comments of TE.

33	Case No.:1033/15/82-<br>ALC4/2018	Party Name:SRIAM LABS<br>PRIVATE LIMITED<br>RLA File<br>:09/24/040/00591/AM19/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02490/AM19/		Lic.No/Date:0910067219<br>26.02.2019
	Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information from the firm:<br>(i)<br>Complete technical details asper Appendix 4E.

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

Case No.:1038/15/82-	Party Name:GLAND	Meet No/Date:5/82-	Status:
ALC4/2018	PHARMA LIMITED	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0910067224
:01/82/050/02495/AM19/	:09/24/040/00530/AM19/	27.02.2019

--|---|---| |ALC4/2018||PHARMA LIMITED||ALC4/2020||Approved| |||||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0910067224||| |:01/82/050/02495/AM19/||:09/24/040/00530/AM19/||27.02.2019|||

	Case No.:1038/15/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/02495/AM19/	Party Name:GLAND<br>PHARMA LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
		RLA File<br>:09/24/040/00530/AM19/	Lic.No/Date:0910067224<br>27.02.2019
34	<br>Decision:The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.<br>I as per details below or as applied by firm whichever is lower:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>1<br>Enoxaparin Sodium Injection 20mg Pre-filled Syringes<br>1 Number<br>2<br>Enoxaparin Sodium Injection 30mg Pre-filled Syringes<br>1 Number<br>3<br>Enoxaparin Sodium Injection 40mg Pre-filled Syringes<br>1 Number<br>4<br>Enoxaparin Sodium Injection 60mg Pre-filled Syringes<br>1 Number<br>5<br>Enoxaparin Sodium Injection 80mg Pre-filled Syringes<br>1 Number<br>6<br>Enoxaparin Sodium Injection 100mg Pre-filled Syringes<br>1 Number<br>7<br>Enoxaparin Sodium Injection 120mg Pre-filled Syringes<br>1 Number<br>8<br>EnoxaparinSodium Injection 150mgPre-filled Syringes<br>1Number<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>Enoxaparin Sodium<br>1.10 kg / kg content in the<br>export product<br>2<br>Barrel Syringes<br>Net + 5% wastage<br>3<br>Needle Shield<br>Net + 5% w

1Number Sl. No. Import items Qty. 1 Enoxaparin Sodium 1.10 kg / kg content in the export product 2 Barrel Syringes Net + 5% wastage 3 Needle Shield Net + 5% wastage 4 Plunger Stoppers Net + 5% wastage 5 Plunger Rods Net + 2% wastage 6 Preventis Needle shielding System Net + 2% wastage RA concerned maytake further necessaryaction asper above decision of NC.||||

35	<br>Case No.:1039/15/82-<br>ALC4/2018	Party Name:GLAND PHARMA<br>LIMITED<br>RLA File<br>:09/24/040/00491/AM19/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02496/AM19/		Lic.No/Date:0910067225<br>27.02.2019
	Decision:Deferred for comments of TE.

Case No.:1057/15/82-	Party Name:CIPLA LIMITED.	Meet No/Date:5/82-	Status:
ALC4/2018		ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310827414
:01/82/050/02514/AM19/	:03/94/040/01019/AM19/	01.03.2019

|---|---|---|---|---|---| |ALC4/2018||||ALC4/2020||Approved| |||||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0310827414||| |:01/82/050/02514/AM19/||:03/94/040/01019/AM19/||01.03.2019|||

	Case No.:1057/15/82-<br>ALC4/2018	Party Name:CIPLA LIMITED.	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
	HQ File<br>:01/82/050/02514/AM19/	RLA File<br>:03/94/040/01019/AM19/	Lic.No/Date:0310827414<br>01.03.2019
36	<br>Decision:The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.<br>I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Efavirenz 600mg, Lamivudine<br>300mg, Tenofovir Disoproxil<br>Fumarate<br>300mg<br>Tablets<br>Each Tablet contains: Efavirenz<br>600mg, Tenofovir Disoproxil<br>Fumarate 300mg, Lamivudine<br>300mg Tablets<br>1 Number<br>Tablet<br>1<br>Efavirenz<br>612.00 mg<br>2<br>Lamivudine<br>306.00 mg<br>3<br>Tenofovir<br>Disoproxil<br>Fumarate<br>306.00 mg<br>4<br>Croscarmellose Sodium (AC-<br>DI-SOL) NF<br>123.00 mg<br>5<br>Microcrystalline Cellulose NF<br>(Avicel PH 101)<br>297.60 mg<br>6<br>Magnesium<br>Stearate<br>NF<br>(Vegetable Grade)<br>17.00 mg<br>7<br>Hydroxy Propyl Cellulose NF<br>(Klucel LF)<br>38.40 mg<br>8<br>Lactose for DC (Tablettose<br>80/Super Tab) BP/PH Eur<br>199.60 mg<br>9<br>Silica Gel bags 3 GM Stripax<br>R/F<br>Not an<br>ingredient<br>RA con

Propyl Cellulose NF (Klucel LF) 38.40 mg 8 Lactose for DC (Tablettose 80/Super Tab) BP/PH Eur 199.60 mg 9 Silica Gel bags 3 GM Stripax R/F Not an ingredient RA concerned maytake further necessaryaction asper above decision of NC.||||

Case No.:143/1/82-ALC4/2019	Party Name:TINA ORGANICS	Meet No/Date:5/82-	Status:
	PRIVATE LIMITED	ALC4/2020	Deferred
		09.10.2020
HQ File	RLA File	Lic.No/Date:0510409855
:01/82/050/02538/AM19/	:05/24/040/00695/AM19/	06.03.2019

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

(i) Manufacturing process and chemistry starting from Yellow Phosphorus which is indicated as imported item.

Case No.:159/1/82-	Party Name:EMMENNAR	Meet No/Date:5/82-	Status:
ALC4/2019	PHARMA PRIVATE	ALC4/2020	Approved
	LIMITED	09.10.2020
HQ File	RLA File	Lic.No/Date:0910067264
:01/82/050/02554/AM19/	:09/24/040/00600/AM19/	12.03.2019

---| |ALC4/2019||PHARMA PRIVATE||ALC4/2020||Approved| |||LIMITED||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0910067264||| |:01/82/050/02554/AM19/||:09/24/040/00600/AM19/||12.03.2019|||

	Case No.:159/1/82-<br>ALC4/2019	Party Name:EMMENNAR<br>PHARMA PRIVATE<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
	HQ File<br>:01/82/050/02554/AM19/	RLA File<br>:09/24/040/00600/AM19/	Lic.No/Date:0910067264<br>12.03.2019
38	<br>Decision:The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.<br>I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>S(+)-2-AMINOBUTYRAMIDE<br>HYDROCHLORIDE<br>1 kg<br>1<br>PROPIONALDEHYDE<br>1.27 kg<br>2<br>SODIUM CYANIDE<br>1.08 kg<br>3<br>L(+) TARTARIC ACID<br>1.12 kg<br>4<br>METHYLENE DI CHLORIDE<br>1.12 kg<br>5<br>ACETONE<br>1.86 kg<br>6<br>METHANOL<br>1.39 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

tter 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:

39	<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:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02562/AM19/		Lic.No/Date:0910067275<br>13.03.2019
	Decision:Deferred for comments of TE.

Case No.:169/1/82-	Party Name:RUSAN	Meet No/Date:5/82-	Status:
ALC4/2019	PHARMA LTD.	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310827685
:01/82/050/02564/AM19/	:03/95/040/01315/AM19/	13.03.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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 40 Vol. I as per details below or as applied by firm whichever is lower:

Export product	Qty.	Sl.<br>No.	Import items	Qty.
APOMORPHINE HYDROCHLORIDE<br>EP/USP/BP	1 kg	1	MORPHINE SULPHATE	4.00 kg

Case No.:170/1/82- Party Name:J.B. CHEMICALS Meet No/Date:5/82- Status: ALC4/2019 & PHARMACEUTICALS ALC4/2020 Approved LIMITED 09.10.2020 HQ File RLA File Lic.No/Date:0310827686 :01/82/050/02565/AM19/ :03/94/040/01071/AM19/ 13.03.2019

Meet No/Date:5/82- Status: ALC4/2019 & PHARMACEUTICALS ALC4/2020 Approved LIMITED 09.10.2020 HQ File RLA File Lic.No/Date:0310827686 :01/82/050/02565/AM19/ :03/94/040/01071/AM19/ 13.03.2019

	Case No.:170/1/82-<br>ALC4/2019	Case No.:170/1/82-<br>ALC4/2019	Case No.:170/1/82-<br>ALC4/2019	Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED	Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED	<br>Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	<br>Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	<br>Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved	Status:<br>Approved
	HQ File<br>:01/82/050/02565/AM19/			RLA File<br>:03/94/040/01071/AM19/		Lic.No/Date:0310827686<br>13.03.2019
41	<br>Decision:The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or 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>Bupivacaine with Adrenaline Injection<br>10<br>x<br>20ml<br>Ampoules.<br>Each<br>ml<br>contains<br>Bupivacaine<br>Hydrochloride 5.3175 mg. Net content -<br>8.811 Kgs.<br>1 Number<br>Ampoule<br>1<br>Bupivacaine<br>Hydrochloride<br>111.67 mg<br>2<br>Bupivacaine Hydrochloride and Dextrose<br>Injection<br>10x4ml.<br>Each<br>ml<br>contains<br>Bupivacaine<br>Hydrochloride 5.3175 mg.

r>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 2 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||2|Bupivacaine Hydrochloride||23.40 mg| |||||||||NC.|||

Case No.:204/1/82-ALC4/2019	Party Name:DEEPAK	Meet No/Date:5/82-	Status:
	PHENOLICS LIMITED	ALC4/2020	Deferred
		09.10.2020
HQ File	RLA File	Lic.No/Date:3410044969
:01/82/050/02599/AM19/	:34/24/040/00353/AM19/	14.03.2019

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

(i) On the basis of chemistry and molecular weight, calculation sheet to arrive at the quantity of raw material asked.

erts and it was decided to call for following information from the firm:

(i) On the basis of chemistry and molecular weight, calculation sheet to arrive at the quantity of raw material asked.

(ii) Whether value of co-product is offsetted in calculation. (iii) Guaranteed norms of consumption from collaborator, if any.

Case No.:179/1/82-ALC4/2019	Party Name:SHANKUS	Meet No/Date:5/82-	Status:
	PHARMACEUTICALS	ALC4/2020	Deferred
		09.10.2020
HQ File	RLA File	Lic.No/Date:0810144782
:01/82/050/02574/AM19/	:08/24/040/00430/AM19/	18.03.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts 43 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, followed by Reminder on 03.09.2020:

(i) Complete chemistry, molecular weight 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.

e chemistry, molecular weight 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.

44	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:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0910067285<br>18.03.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02576/AM19/
	Decision:Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated<br>15.05.2019.

Case No.:133/6/82-ALC4/2019 Party Name:ORIENTAL Meet No/Date:5/82- Status: AROMATICS LTD ALC4/2020 Deferred 09.10.2020 HQ File RLA File Lic.No/Date:0310827769 :01/82/050/00359/AM20/ :03/95/040/01320/AM19/ 18.03.2019 45 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

/040/01320/AM19/ 18.03.2019 45 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

(i) Stiochiometric balance of the reaction. (ii) No. of moles used for each raw material in reaction.

Case No.:185/1/82-	Party Name:MANGALAM	Meet No/Date:5/82-	Status:
ALC4/2019	ORGANICS LIMITED	ALC4/2020	Approved
	(FORMERLY DUJODWALA	09.10.2020
HQ File	RLA File	Lic.No/Date:0310827775
:01/82/050/02580/AM19/	:03/95/040/00899/AM19/	19.03.2019

Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and after taking cue from SION A-1268, 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 46 lower:

Export product	Qty.	Sl.<br>No.	Import items	Qty.
CAMPHOR	1 kg	1	GUM TURPENTINE OIL	1.561 kg
		2	ACETIC ACID	0.387 kg
		3	CAUSTIC SODA LYE	0.62 kg

Case No.:187/1/82-ALC4/2019	Party Name:OPTRIX	Meet No/Date:5/82-	Status:
	LABORATORIES PRIVATE	ALC4/2020	Deferred
	LIMITED	09.10.2020
HQ File	RLA File	Lic.No/Date:0910067297
:01/82/050/02582/AM19/	:09/24/040/00619/AM19/	19.03.2019

--|---|---| |||LABORATORIES PRIVATE||ALC4/2020||Deferred| |||LIMITED||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0910067297||| |:01/82/050/02582/AM19/||:09/24/040/00619/AM19/||19.03.2019|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts 47 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, followed by Reminder on 03.09.2020:

(i) It was observed that the applied inputs do not match with manufacturing process, chemistry, material balance and flow chart. Please clarify it.

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

48	<br>Case No.:200/1/82-ALC4/2019	Party Name:AETHER<br>INDUSTRIES LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/02595/AM19/	RLA File<br>:52/24/040/00085/AM19/	Lic.No/Date:5210043000<br>19.03.2019
	Decision:Deferred for comments of TE.

49	Case No.:211/1/82-ALC4/2019	Party Name:PORUS<br>LABORATORIES PVT LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	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:Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited.

3 20.03.2019|| ||**Decision:**Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.||||

50	Case No.:214/1/82-ALC4/2019	Party Name:DEEPAK<br>PHENOLICS LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	HQ File<br>:01/82/050/02609/AM19/	RLA File<br>:34/24/040/00327/AM19/	Lic.No/Date:3410044990<br>20.03.2019
	<br>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<br>Meeting No. 2/82-ALC4/2019 dated 10.07.2020, followed by Reminder on 23.10.2020:<br>(i)<br>Quantity and commercial value of Co-Product Phenol obtained.<br>(ii)<br>Percentage yield on molar basis.<br>Replyawaited from the firm.

Case No.:13/1/82-ALC4/2019	Party Name:DEEPAK	Meet No/Date:5/82-	Status:
	NOVOCHEM	ALC4/2020	Rejected
	TECHNOLOGIES LTD	09.10.2020
HQ File	RLA File	Lic.No/Date:3110067362
:01/82/050/00013/AM20/	:31/83/040/00296/AM19/	02.04.2019

-|---|---|---| |||NOVOCHEM||ALC4/2020||Rejected| |||TECHNOLOGIES LTD||09.10.2020||| |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 51 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.

52	Case No.:14/1/82-ALC4/2019	Party Name:CLEAN SCIENCE<br>AND TECHNOLOGY<br>PVT.LTD.	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00014/AM20/	RLA File<br>:31/83/040/00299/AM19/	Lic.No/Date:3110067371<br>04.04.2019
	Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 04.09.2020 has furnished its reply. Deferred for comments of TE.

ttee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 04.09.2020 has furnished its reply. Deferred for comments of TE.||||

53	Case No.:39/1/82-ALC4/2019	Party Name:TIDE<br>INDUSTRIES	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	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 in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 17.09.2020 has furnished its reply. Deferred for comments of TE.

54	Case No.:97/1/82-ALC4/2019	Party Name:CLEAN SCIENCE<br>AND TECHNOLOGY<br>PVT.LTD.	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00097/AM20/	RLA File<br>:31/83/040/00013/AM20/	Lic.No/Date:3110067404<br>01.05.2019
	Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 04.09.2020 has furnished its reply. Deferred for comments of TE.

ttee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 04.09.2020 has furnished its reply. Deferred for comments of TE.||||

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 04.09.2020 has furnished its reply. Deferred for comments of TE.

55	Case No.:194/6/82-ALC4/2019	Party Name:ETERNIS FINE<br>CHEMICALS LIMITED,<br>RLA File<br>:03/94/040/00023/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0310828815<br>07.05.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00420/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 e-mail dated 18.09.2020 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 18.09.2020 has furnished its reply. Deferred for comments of TE.

Case No.:140/1/82-ALC4/2019	Party Name:MALWA	Meet No/Date:5/82-	Status:
	OXYGEN & INDUSTRIAL	ALC4/2020	Deferred
	GASES PVT.LTD.,	09.10.2020
HQ File	RLA File	Lic.No/Date:5610005605
:01/82/050/00140/AM20/	:56/24/040/00035/AM19/	09.05.2019

---| |||OXYGEN & INDUSTRIAL||ALC4/2020||Deferred| |||GASES PVT.LTD.,||09.10.2020||| |HQ File||RLA File||Lic.No/Date:5610005605||| |:01/82/050/00140/AM20/||:56/24/040/00035/AM19/||09.05.2019|||

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

(i) Justification for low yield of 33%. (ii) Recovery of solvent i.e. MCB. (iii) Production / Consumption data for last two years duly certified by GST.

Case No.:141/1/82-	Party Name:MALWA	Meet No/Date:5/82-	Status:
ALC4/2019	OXYGEN & INDUSTRIAL	ALC4/2020	Approved
	GASES PVT.LTD.,	09.10.2020
HQ File	RLA File	Lic.No/Date:5610005606
:01/82/050/00141/AM20/	:56/24/040/00034/AM19/	09.05.2019

	Case No.:141/1/82-<br>ALC4/2019	Party Name:MALWA<br>OXYGEN & INDUSTRIAL<br>GASES PVT.LTD.,	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
	HQ File<br>:01/82/050/00141/AM20/	RLA File<br>:56/24/040/00034/AM19/	Lic.No/Date:5610005606<br>09.05.2019

/Date:5/82- ALC4/2020 09.10.2020|Status: Approved| |---|---|---|---|---| ||HQ File :01/82/050/00141/AM20/|RLA File :56/24/040/00034/AM19/|Lic.No/Date:5610005606 09.05.2019|| |57| **Decision:**The Committee considered case as per agenda and deliberated on the matter 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. 4,4-DIHYDROXY BENZOPHENONE 1 kg 1 PARA CHLORO BENZOTRICHLORIDE 1.73 kg 2 PHENOL 0.71 kg 3 ALUMINIUM CHLORIDE 1.00 kg 4 SODIUM HYDROXIDE 0.23 kg 5 DICHLOROETHEN 2.50 kg 6 CUPROUS CHLORIDE 0.10 kg 7 METHYLE ALCOHOL 2.50 kg RA concerned maytake further necessaryaction asper above decision of NC.||||

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:

58	Case No.:285/1/82-ALC4/2019	Party Name:SALVI<br>CHEMICAL INDUSTRIES<br>LIMITED<br>RLA File<br>:03/95/040/00157/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0310829190<br>22.05.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00191/AM20/
	Decision:Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated<br>15.05.2019.

5.05.2019. Application is still awaited. Hence, it was decided to issue Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.

59	Case No.:163/13/82-<br>ALC4/2019	Party Name:RESONANCE<br>SPECIALTIES LTD<br>RLA File<br>:03/95/040/00166/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0310829318<br>29.05.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01006/AM20/
	Decision:Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited.			as per policy

Decision: Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Application is still awaited.

Case No.:320/1/82-ALC4/2019	Party Name:DEEPAK	Meet No/Date:5/82-	Status:
	PHENOLICS LIMITED	ALC4/2020	Deferred
		09.10.2020
HQ File	RLA File	Lic.No/Date:3410045179
:01/82/050/00226/AM20/	:34/24/040/00036/AM20/	30.05.2019

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

(i) On the basis of chemistry and molecular weight, calculation sheet to arrive at the quantity of raw material asked. (ii) Whether value of co-product is offsetted in calculation. (iii) Guaranteed norms of consumption from collaborator, if any.

, calculation sheet to arrive at the quantity of raw material asked. (ii) Whether value of co-product is offsetted in calculation. (iii) Guaranteed norms of consumption from collaborator, if any.**

61	Case No.:144/6/82-ALC4/2019	Party Name:LACTOSE<br>(INDIA) LTD.,	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	HQ File<br>:01/82/050/00370/AM20/	RLA File<br>:03/95/040/00296/AM20/	Lic.No/Date:0310830184<br>09.07.2019
	<br>Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information from the firm:<br>(i)<br>Separate quantity of export for Lactose Solution, Lactose Concentration &<br>Lactose Food Grade.<br>(ii)<br>COA of Lactose Food Grade.

Case No.:154/6/82-ALC4/2019	Party Name:INDO AMINES	Meet No/Date:5/82-	Status:
	LIMITED	ALC4/2020	Deferred
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310830244
:01/82/050/00380/AM20/	:03/94/040/00122/AM20/	12.07.2019

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 62 Meeting No. 2/82-ALC4/2020 dated 10.07.2020, followed by Reminder on 03.09.2020:

(i) Complete specifications of import item No. 2 - Ni-Catalyst with catalogue of Export Product.

C-3 in its 62 Meeting No. 2/82-ALC4/2020 dated 10.07.2020, followed by Reminder on 03.09.2020:

(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.

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.:203/6/82-ALC4/2019	Party Name:SONGWON	Meet No/Date:5/82-	Status:
	SPECIALTY CHEMICALS	ALC4/2020	Deferred
	INDIA PVT. LTD.	09.10.2020
HQ File	RLA File	Lic.No/Date:3410045298
:01/82/050/00429/AM20/	:34/24/040/00069/AM20/	18.07.2019

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

(i) % yield of each step of reaction alongwith stoichiometric balance. (ii) As per reaction, import item No. 5 is not used. Please clarify it. (iii) % recovery of DMF. (iv) Justification for import of item No. 2 and 3 together.

Case No.:15/7/82-ALC4/2019	Party Name:GLOBAL	Meet No/Date:5/82-	Status:
	CALCIUM PRIVATE	ALC4/2020	Approved
	LIMITED	09.10.2020
HQ File	RLA File	Lic.No/Date:0710115208
:01/82/050/00510/AM20/	:07/24/040/00093/AM20/	23.07.2019

--|---|---| |||CALCIUM PRIVATE||ALC4/2020||Approved| |||LIMITED||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0710115208||| |:01/82/050/00510/AM20/||:07/24/040/00093/AM20/||23.07.2019|||

Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in meeting No. 8/82-ALC4/2014 dated 25.09.2014 against advance authorization No. 0710103209 dated 26.03.2014, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Sl. No.	Export product	Qty.	Sl.<br>No.	Import items	Qty.
1	MAGNESIUM OROTATE	1 kg	1	OROTIC ACID	1.104 kg
2	CALCIUM OROTATE	1 kg	1	OROTIC ACID	1.059 kg
3	POTASSIUM OROTATE	1 kg	1	OROTIC ACID	1.020 kg
4	ZINC OROTATE	1 kg	1	OROTIC ACID	0.980 kg
5	FERROUS OROTATE	1 kg	1	OROTIC ACID	0.976 kg

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

Case No.:248/6/82-ALC4/2019	Party Name:HUBERGROUP	Meet No/Date:5/82-	Status:
	INDIA PRIVATE LIMITED.	ALC4/2020	Deferred
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310830713
:01/82/050/00474/AM20/	:03/94/040/00346/AM20/	31.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts 65 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, followed by Reminder on 03.09.2020:

experts 65 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, followed by Reminder on 03.09.2020:

(i) Material balance in terms of 53% solid resin content between import and export taking into account 5% wastage claimed.

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.:4/7/82-ALC4/2019	Party Name:KEVA	Meet No/Date:5/82-	Status:
	FRAGRANCES PRIVATE	ALC4/2020	Deferred
	LIMITED	09.10.2020
HQ File	RLA File	Lic.No/Date:0310830887
:01/82/050/00499/AM20/	:03/94/040/00373/AM20/	07.08.2019

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

(i) Exact chemical name of import and export. (ii) COA of import from foreign supplier. (iii) Exact manufacturing process with material balance.

67	<br>Case No.:28/7/82-ALC4/2019	Party Name:UPL LTD.<br>RLA File<br>:03/95/040/01337/AM19/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0310830995<br>14.08.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00523/AM20/
	Decision:Deferred for comments of TE.

.10.2020 Lic.No/Date:0310830995 14.08.2019|Status: Deferred| |---|---|---|---|---| || HQ File :01/82/050/00523/AM20/|||| ||**Decision:**Deferred for comments of TE.||||

Case No.:29/7/82-ALC4/2019	Party Name:ETERNIS FINE	Meet No/Date:5/82-	Status:
	CHEMICALS LIMITED,	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310831004
:01/82/050/00524/AM20/	:03/94/040/00381/AM20/	14.08.2019

	Case No.:29/7/82-ALC4/2019 <br> <br>HQ File<br>:01/82/050/00524/AM20/<br> <br>	Party Name:ETERNIS FINE<br>CHEMICALS LIMITED,	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
		RLA File<br>:03/94/040/00381/AM20/	Lic.No/Date:0310831004<br>14.08.2019
68	<br>Decision:The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>METHYL - 3 - OXO - 2 -<br>PENTYL<br>-<br>1<br>-<br>CYCLOPENTANE ACETATE<br>1 kg<br>1<br>PENTYL<br>ENDO<br>(85%)<br>(2<br>Pentyl-2-Cyclopentene-1-one)<br>0.764 kg<br>2<br>DIMETHYL MALONATE<br>0.663 kg<br>3<br>SODIUM METHOXIDE<br>0.100 kg<br>4<br>MS BARREL (Lacquered)<br>Relevant<br>as<br>per packing<br>policy<br>RA concerned maytake further necessaryaction asper above decision of NC.

663 kg 3 SODIUM METHOXIDE 0.100 kg 4 MS BARREL (Lacquered) Relevant as per packing policy RA concerned maytake further necessaryaction asper above decision of NC.||||

69	<br>Case No.:33/7/82-ALC4/2019	Party Name:AETHER<br>INDUSTRIES LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:5210043146<br>14.08.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00528/AM20/	RLA File<br>:52/21/040/00085/AM20/
	Decision:Deferred for comments of TE.

70	<br>Case No.:34/7/82-ALC4/2019	Party Name:AETHER<br>INDUSTRIES LIMITED<br>RLA File<br>:52/21/040/00086/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:5210043147<br>14.08.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00529/AM20/
	Decision:Deferred for comments of TE.

71	<br>Case No.:35/7/82-ALC4/2019	Party Name:AETHER<br>INDUSTRIES LIMITED<br>RLA File<br>:52/21/040/00061/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:5210043148<br>14.08.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00530/AM20/
	Decision:Deferred for comments of TE.

82- ALC4/2020 09.10.2020 Lic.No/Date:5210043148 14.08.2019|Status: Deferred| || HQ File :01/82/050/00530/AM20/|||| ||**Decision:**Deferred for comments of TE.||||

72	Case No.:38/7/82-ALC4/2019	Party Name:FRESENIUS KABI<br>INDIA PRIVATE LTD<br>RLA File<br>:03/94/040/00397/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00533/AM20/		Lic.No/Date:0310831038<br>16.08.2019
	Decision:Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated<br>15.05.2019.

Case No.:39/7/82-ALC4/2019	Party Name:TADIMETY	Meet No/Date:5/82-	Status:
	AROMATICS PRIVATE	ALC4/2020	Approved
	LIMITED	09.10.2020
HQ File	RLA File	Lic.No/Date:0710115296
:01/82/050/00534/AM20/	:07/24/040/00104/AM20/	19.08.2019

-|---|---|---| |||AROMATICS PRIVATE||ALC4/2020||Approved| |||LIMITED||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0710115296||| |:01/82/050/00534/AM20/||:07/24/040/00104/AM20/||19.08.2019|||

Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of 73 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.<br>No.	Import items	Qty.
ISO NONYL ACETATE	1 kg	1	ISO NONANOL	0.774 kg

Case No.:40/7/82-ALC4/2019	Party Name:ORTIN	Meet No/Date:5/82-	Status:
	LABORATORIES LTD	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0910067901
:01/82/050/00535/AM20/	:09/24/040/00259/AM20/	19.08.2019

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:

Export product	Qty.	Sl.<br>No.	Import items	Qty.
[2S,3S,5S]-5-t-<br>butyloxycarbonylamino-2-<br>Amino-3-hydroxy-1,6-<br>diphenylhexane<br>succinate(BDH<br>Succinic Acid RIT)	1 kg	1	1,2-dimethoxy ethane(1,2-DME)	4.74 kg
		2	SODIUM BORO HYDRIDE	0.45 kg
		3	METHANE SULPHONIC<br>ACID	1.50 kg
		4	L-Phenylalanine	Not required<br>in<br>the<br>process
		5	N,N-DIMETHYL ACETAMIDE	2.40 kg
		6	Di-Tert-Butyl- Di-Carbonate	0.60kg

75	Case No.:44/7/82-ALC4/2019	Party Name:SWATI<br>MENTHOL & ALLIED<br>CHEMICALS LTD.,	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00539/AM20/	RLA File<br>:29/24/040/00011/AM20/	Lic.No/Date:2910025423<br>19.08.2019
	Decision:Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated<br>15.05.2019.

Application is still awaited. Hence, it was decided to issue Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.||||

76	Case No.:45/7/82-ALC4/2019	Party Name:SUPERMINT<br>EXPORTS PRIVATE<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00540/AM20/	RLA File<br>:29/24/040/00010/AM20/	Lic.No/Date:2910025424<br>19.08.2019
	Decision:Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated<br>15.05.2019.

77	<br>Case No.:48/7/82-ALC4/2019	Party Name:SRINI<br>PHARMACEUTICALS<br>PRIVATE LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00543/AM20/	RLA File<br>:09/24/040/00269/AM20/	Lic.No/Date:0910067906<br>20.08.2019
	Decision:Deferred for comments of TE.

Deferred*| |---|---|---|---|---| || HQ File :01/82/050/00543/AM20/|RLA File :09/24/040/00269/AM20/|Lic.No/Date:0910067906 20.08.2019|| ||**Decision:**Deferred for comments of TE.||||

78	<br>Case No.:54/7/82-ALC4/2019	Party Name:LYRUS LIFE<br>SCIENCES PVT LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00549/AM20/	RLA File<br>:07/24/040/00091/AM20/	Lic.No/Date:0710115309<br>20.08.2019
	Decision:Deferred for comments of TE.

79	Case No.:56/7/82-ALC4/2019	Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED<br>RLA File<br>:07/24/040/00107/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br> <br><br>Lic.No/Date:0710115314<br>21.08.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00551/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 e-mail dated 10.09.2020 has furnished its reply. Deferred for comments of TE.

considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 10.09.2020 has furnished its reply. Deferred for comments of TE.||||

80	Case No.:59/7/82-ALC4/2019	Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0710115318<br>22.08.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00554/AM20/	RLA File<br>:07/24/040/00117/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 e-mail dated 30.06.2020 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 30.06.2020 has furnished its reply. Deferred for comments of TE.

Case No.:68/7/82-ALC4/2019	Party Name:NEOGEN	Meet No/Date:5/82-	Status:
	CHEMICALS LIMITED	ALC4/2020	Approved
		09.10.2020
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 case as per agenda and deliberated on the matter 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. 81 I as per details below or as applied by firm whichever is lower:

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

Export product	Qty.	Sl.<br>No.	Import items	Qty.
1-BROMO-4-FLUOROBENZENE	1 kg	1	FLUOROBENZENE	0.80 kg
		2	LIQUID BROMINE	1.32 kg

82	Case No.:71/7/82-ALC4/2019	Party Name:SYNTHO<br>CHIRALS PVT. LTD<br>RLA File<br>:09/24/040/00275/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0910067938<br>27.08.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00566/AM20/
	Decision:Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated<br>15.05.2019.

Application is still awaited. Hence, it was decided to issue Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.||||

83	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:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:3410045631<br>20.11.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00844/AM20/
	Decision:Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated<br>15.05.2019.

84	Case No.:3/13/82-ALC4/2019	Party Name:SRF LIMITED<br>RLA File<br>:05/24/040/00445/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0510412564<br>21.11.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00846/AM20/
	<br>Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information from the firm:<br>(i)<br>Complete technical details as per Appendix 4E having chemistry, molecular<br>weight, yield of reaction, stoichiometric balance of chemical reaction.

mation from the firm: (i) Complete technical details as per Appendix 4E having chemistry, molecular weight, yield of reaction, stoichiometric balance of chemical reaction.||||

85	Case No.:4/13/82-ALC4/2019	Party Name:SRF LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00847/AM20/	RLA File<br>:05/24/040/00471/AM20/	Lic.No/Date:0510412565<br>21.11.2019
	<br>Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information from the firm:<br>(i)<br>Complete technical details as per Appendix 4E having chemistry, molecular<br>weight, %yield, stoichiometric balance of chemical reaction.

Case No.:7/13/82-ALC4/2019	Party Name:AVIK	Meet No/Date:5/82-	Status:
	PHARMACEUTICAL LTD	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310832928
:01/82/050/00850/AM20/	:03/94/040/00657/AM20/	21.11.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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. 86 I as per details below or as applied by firm whichever is lower:

Export product	Qty.	Sl.<br>No.	Import items	Qty.
METHYLPREDNISOLONE<br>USP/BP/EP	1 kg	1	6A-METHYL-11B,17A-<br>DIHYDROXY-1,4-<br>DIENE-<br>PREGNA-3,20-DIONE	1.30 kg

Export product	Qty.	Sl.<br>No.	Import items	Qty.
METHYLPREDNISOLONE<br>USP/BP/EP	1 kg	1	6A-METHYL-11B,17A-<br>DIHYDROXY-1,4-<br>DIENE-<br>PREGNA-3,20-DIONE	1.30 kg

Case No.:8/13/82-ALC4/2019	Party Name:SWISS	Meet No/Date:5/82-	Status:
	PARENTERALS LTD	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0810146613
:01/82/050/00851/AM20/	:08/24/040/00195/AM20/	21.11.2019

Export product	Qty.	Sl.<br>No.	Import items	Qty.
APROTININ FOR INJECTION<br>10000 KIU/VIAL (EACH VIAL<br>CONTAINS : APROTININ BP<br>10000 KIU)	1 No.<br>Vial	1	APROTININ<br>USP/BP/IP/CEP/EP<br>(RELEVANT BULK DRUG)	1.54 mg

88	Case No.:11/13/82-ALC4/2019	Party Name:MANGALAM<br>ORGANICS LIMITED<br>FORMERLY DUJODWALA<br>PRODU	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00854/AM20/	RLA File<br>:03/95/040/00790/AM20/	Lic.No/Date:0310832931<br>21.11.2019
	Decision:The Committee considered the case as per agenda in the presence of technical<br>was decided to call for following information from the firm:<br>(i)<br>Complete technical details asper Appendix 4E.			experts and it

he case as per agenda in the presence of technical was decided to call for following information from the firm: (i) Complete technical details asper Appendix 4E.|||experts and it|

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

89	Case No.:12/13/82-ALC4/2019	Party Name:LINK PHARMA<br>CHEM LIMITED<br>RLA File<br>:34/24/040/00256/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:3410045634<br>21.11.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00855/AM20/
	<br>Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information from the firm:<br>(i)<br>Recovery of dromium sulphate per kg export item and its sale-value.<br>(ii)<br>Recovery of sodium sulphateper kg export item and its sale-value.

Case No.:17/13/82-ALC4/2019	Party Name:GOVIND	Meet No/Date:5/82-	Status:
	LABORATORIES PVT LTD	ALC4/2020	Deferred
		09.10.2020
HQ File	RLA File	Lic.No/Date:0810146634
:01/82/050/00860/AM20/	:08/24/040/00272/AM20/	22.11.2019

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

272/AM20/||22.11.2019|||

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

(i) Complete and balanced chemical reactions, molecular weight and % yield on molar basis. (ii) % recovery of solvents at each step.

Case No.:18/13/82-	Party Name:HETERO LABS	Meet No/Date:5/82-	Status:
ALC4/2019	LIMITED	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0910068219
:01/82/050/00861/AM20/	:09/24/040/00431/AM20/	25.11.2019

	Case No.:18/13/82-<br>ALC4/2019	Party Name:HETERO LABS<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
	HQ File<br>:01/82/050/00861/AM20/	RLA File<br>:09/24/040/00431/AM20/	Lic.No/Date:0910068219<br>25.11.2019
91	<br>Decision:The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.<br>I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>(2S,3S,5S)-2-(2,6-DIMETHYL<br>PHENOXYACETYL)AMINO-<br>3-HYDROXY-5-AMINO-1,6-<br>DIPHENYLHEXANE<br>1 kg<br>1<br>(2S,3S,5S)-2-amino-3-hydroxy-<br>5-tert butyl carbonyl amino-1,6-<br>diphenyl-hexane<br>1.345 kg<br>2<br>METHANOL<br>0.40 kg<br>3<br>Methylene Chloride<br>0.769 kg<br>4<br>ETHYL BROMO ACETATE<br>0.84 kg<br>5<br>2

-amino-3-hydroxy- 5-tert butyl carbonyl amino-1,6- diphenyl-hexane 1.345 kg 2 METHANOL 0.40 kg 3 Methylene Chloride 0.769 kg 4 ETHYL BROMO ACETATE 0.84 kg 5 2,6 XYLENOL 0.59 kg 6 N N DI ISO PROPYL ETHER 0.27 kg RA concerned maytake further necessaryaction asper above decision of NC.||||

92	Case No.:23/13/82-ALC4/2019	Party Name:SRF LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00866/AM20/	RLA File<br>:05/24/040/00501/AM20/	Lic.No/Date:0510412619<br>25.11.2019
	Decision:Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited.			as per policy

Decision: Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Application is still awaited.

per policy|

Decision: Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Application is still awaited.

93	<br>Case No.:26/13/82-ALC4/2019	Party Name:GLAND PHARMA<br>LIMITED<br>RLA File<br>:09/70/040/00130/AM20/	<br>Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0910068227<br>27.11.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00869/AM20/
	Decision:Deferred for comments of TE.

94	Case No.:31/13/82-ALC4/2019	Party Name:DEEPAK<br>PHENOLICS LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00874/AM20/	RLA File<br>:34/24/040/00223/AM20/	Lic.No/Date:3410045650<br>27.11.2019
	Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 17.09.2020 has furnished its reply. Deferred for comments of TE.

he Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 17.09.2020 has furnished its reply. Deferred for comments of TE.

95	Case No.:32/13/82-ALC4/2019	Party Name:DEEPAK<br>PHENOLICS LIMITED<br>RLA File<br>:34/24/040/00205/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br> <br><br>Lic.No/Date:3410045651<br>27.11.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00875/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 e-mail dated 17.09.2020 has furnished its reply. Deferred for comments of TE.

Case No.:33/13/82-ALC4/2019	Party Name:DEEPAK	Meet No/Date:5/82-	Status:
	NITRITE LIMITED	ALC4/2020	Deferred
		09.10.2020
HQ File	RLA File	Lic.No/Date:3410045652
:01/82/050/00876/AM20/	:34/24/040/00240/AM20/	27.11.2019

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

(i) Justification for low yield. (ii) Value of By-Product, if any. (iii) Production / Consumption Data for last one year duly certified by GST.

o call for following information from the firm:

(i) Justification for low yield. (ii) Value of By-Product, if any. (iii) Production / Consumption Data for last one year duly certified by GST.

97	Case No.:34/13/82-ALC4/2019	Party Name:DEEPAK<br>NITRITE LIMITED<br>RLA File<br>:34/24/040/00239/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br> <br><br>Lic.No/Date:3410045653<br>27.11.2019	Status:<br>Deferred
	HQ File<br>:01/82/050/00877/AM20/
	<br>Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information from the firm:<br>(i)<br>Justification for low yield.<br>(ii)<br>Value of By-Product, if any.<br>(iii)<br>Production / Consumption Data for last oneyear duly certified by GST.

Case No.:35/13/82-	Party Name:BLISS GVS	Meet No/Date:5/82-	Status:
ALC4/2019	PHARMA LIMITED	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310833065
:01/82/050/00878/AM20/	:03/94/040/00681/AM20/	28.11.2019

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: 98

Export product				Qty.	Sl.	Import items	Qty.
					No.
Glycerin<br>Suppositories	USP	2	gm	817000.000	1	Glycerin USP	1500.000 kg
(Net Contain Glycerin USP-1470.60 Kgs)				Number
Glycerol<br>Suppositories	BP	4	gm	525214.000	2	Glycerol BP	1500.000 kg
(Net Contain Glycerol BP-1470.60		Kgs)		Number

Case No.:36/13/82-	Party Name:OPTIMUS	Meet No/Date:5/82-	Status:
ALC4/2019	DRUGS PRIVATE LIMITED	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0910068236
:01/82/050/00879/AM20/	:09/24/040/00435/AM20/	28.11.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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. 99 I as per details below or as applied by firm whichever is lower:

Qty.	Sl.<br>No.	Import items	Qty.
1 kg	1	2-Chloro-3-methyl thiophene	1.10 kg
	2	SM-01(1-(2,4-dichlorophenyl)-2-<br>(1H-imidazol-1-yl)ethanol	1.10 kg

whichever is lower:

Qty.	Sl.<br>No.	Import items	Qty.
1 kg	1	2-Chloro-3-methyl thiophene	1.10 kg
	2	SM-01(1-(2,4-dichlorophenyl)-2-<br>(1H-imidazol-1-yl)ethanol	1.10 kg

100	<br>Case No.:40/13/82-ALC4/2019	Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00883/AM20/	RLA File<br>:03/94/040/00677/AM20/	Lic.No/Date:0310833120<br>02.12.2019
	Decision:Deferred for comments of TE.

101	Case No.:42/13/82-ALC4/2019	Party Name:VIVIMED LIFE<br>SCIENCES PRIVATE<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00885/AM20/	RLA File<br>:09/24/040/00374/AM20/	Lic.No/Date:0910068241<br>02.12.2019
	Decision:Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited.			as per policy

Case No.:43/13/82-	Party Name:VIVIMED LIFE	Meet No/Date:5/82-	Status:
ALC4/2019	SCIENCES PRIVATE	ALC4/2020	Deferred
	LIMITED	09.10.2020
HQ File	RLA File	Lic.No/Date:0910068242
:01/82/050/00886/AM20/	:09/24/040/00425/AM20/	02.12.2019

-| |ALC4/2019||SCIENCES PRIVATE||ALC4/2020||Deferred| |||LIMITED||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0910068242||| |:01/82/050/00886/AM20/||:09/24/040/00425/AM20/||02.12.2019|||

Decision: The Committee considered the case as per online agenda in the presence of technical experts 102 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, followed by Reminder on 03.09.2020:

(i) Master Batch formula for 600 mg tablet.

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

103	<br>Case No.:44/13/82-ALC4/2019	Party Name:BALAJI AMINES<br>LIMITED<br>RLA File<br>:31/83/040/00117/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00887/AM20/		Lic.No/Date:3110067616<br>02.12.2019
	Decision:Deferred for comments of TE.

Case No.:132/13/82-	Party Name:TRANSPEK	Meet No/Date:5/82-	Status:
ALC4/2019	INDUSTRY LIMITED	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:3410045672
:01/82/050/00975/AM20/	:34/24/040/00269/AM20/	02.12.2019

|---|---| |ALC4/2019||INDUSTRY LIMITED||ALC4/2020||Approved| |||||09.10.2020||| |HQ File||RLA File||Lic.No/Date:3410045672||| |:01/82/050/00975/AM20/||:34/24/040/00269/AM20/||02.12.2019|||

Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and on the basis of MSDS submitted by the firm it was decided to ratify the ad-hoc 104 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.<br>No.	Import items	Qty.
n-VALERYL CHLORIDE	1 kg	1	n-VALERIC ACID LIQUID	0.973 kg

105	<br>Case No.:46/13/82-<br>ALC4/2019<br> <br> <br> <br>HQ File<br>:01/82/050/00889/AM20/<br> <br>	Party Name:RUBICON<br>RESEARCH PRIVATE<br>LIMITED<br> <br> <br>	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
		RLA File<br>:03/95/040/00793/AM20/<br> <br>	Lic.No/Date:0310833193<br>04.12.2019
	Decision:Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20<br>dated 15.05.2019.

Application is still awaited. Hence, it was decided to issue Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.||||

106	Case No.:49/13/82-ALC4/2019	Party Name:VN CREATIVE<br>CHEMICALS PRIVATE<br>LIMITED<br>RLA File<br>:03/95/040/00849/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00892/AM20/		Lic.No/Date:0310833213<br>04.12.2019
	Decision:Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20<br>dated 15.05.2019.

5.05.2019. Application is still awaited. Hence, it was decided to issue Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.

107	<br>Case No.:54/13/82-ALC4/2019	Party Name:US AMINO<br>PRIVATE LIMITED<br>RLA File<br>:03/95/040/00816/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00897/AM20/		Lic.No/Date:0310833244<br>05.12.2019
	Decision:Deferred for comments of TE.

108	<br>Case No.:59/13/82-ALC4/2019	Party Name:M/S<br>HIMALAYAN PRODUCTS &<br>INDUSTRIES CORPN.,<br>P.LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0510412862<br>12.12.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00902/AM20/	RLA File<br>:05/24/040/00483/AM20/
	Decision:Deferred for comments of TE.

Case No.:60/13/82-	Party Name:VEERAL	Meet No/Date:5/82-	Status:
ALC4/2019	ADDITIVES PRIVATE	ALC4/2020	Approved
	LIMITED	09.10.2020
HQ File	RLA File	Lic.No/Date:0310833378
:01/82/050/00903/AM20/	:03/95/040/00847/AM20/	12.12.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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 109 Vol. I as per details below or as applied by firm whichever is lower:

in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP 109 Vol. I as per details below or as applied by firm whichever is lower:

Export product	Qty.	Sl.<br>No.	Import items	Qty.
VEENOX 1300 (METILOX)<br>Methyl 3-(3,5-di-tert-butyl-4-<br>hydroxyphenyl)propionate	1 kg	1	2 ,6 Di tertiary Butyl Phenol	0.783 kg
		2	Methyl Acrylate	0.346 kg

110	<br>Case No.:66/13/82-ALC4/2019	Party Name:AETHER<br>INDUSTRIES LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00909/AM20/	RLA File<br>:52/24/040/00044/AM20/	Lic.No/Date:5210043258<br>12.12.2019
	Decision:Deferred for comments of TE.

111	<br>Case No.:67/13/82-ALC4/2019	Party Name:ARIHANTANAM<br>LIFECARE PVT. LTD.	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00910/AM20/	RLA File<br>:52/24/040/00046/AM20/	Lic.No/Date:5210043259<br>12.12.2019
	Decision:Deferred for comments of TE.

112	Case No.:64/13/82-ALC4/2019	Party Name:ANTHEA<br>AROMATICS PRIVATE<br>LIMITED<br>RLA File<br>:03/94/040/00576/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br> <br><br>Lic.No/Date:0310833390<br>13.12.2019	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00907/AM20/
	Decision:Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019.

d**| || HQ File :01/82/050/00907/AM20/|||| ||**Decision:**Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.||||

113	<br>Case No.:65/13/82-ALC4/2019	Party Name:ASHISH LIFE<br>SCIENCE PRIVATE LIMITED	<br>Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	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:Deferred for comments of TE.

114	<br>Case No.:70/13/82-ALC4/2019	Party Name:PANACEA<br>BIOTEC LTD.,	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	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:Deferred for comments of TE.

|Status: Deferred| || HQ File :01/82/050/00913/AM20/|RLA File :05/24/040/00566/AM20/|Lic.No/Date:0510412934 17.12.2019|| ||**Decision:**Deferred for comments of TE.||||

115	Case No.:76/13/82-<br>ALC4/2019	Party Name:KLJ<br>PLASTICIZERS LIMITED.	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred<br>
	<br>HQ File<br>:01/82/050/00919/AM20/	RLA File<br>:05/23/040/00363/AM20/	Lic.No/Date:0510412972<br>19.12.2019
	Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide letter dated 24.10.2020 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide letter dated 24.10.2020 has furnished its reply. Deferred for comments of TE.

Case No.:79/13/82-	Party Name:INDOCO	Meet No/Date:5/82-	Status:
ALC4/2019	REMEDIES LIMITED	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310833599
:01/82/050/00922/AM20/	:03/94/040/00780/AM20/	23.12.2019

|---|---| |ALC4/2019||REMEDIES LIMITED||ALC4/2020||Approved| |||||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0310833599||| |:01/82/050/00922/AM20/||:03/94/040/00780/AM20/||23.12.2019|||

	Case No.:79/13/82-<br>ALC4/2019	Party Name:INDOCO<br>REMEDIES LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
	HQ File<br>:01/82/050/00922/AM20/	RLA File<br>:03/94/040/00780/AM20/	Lic.No/Date:0310833599<br>23.12.2019
116	<br>Decision:The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>AZELASTINE<br>HYDROCHLORIDE<br>OPHTHALMIC<br>SOLUTION,<br>0.05% - 0.5mg/ml - 6ml Bottle<br>(Each ml Contains:Azelastine Hcl<br>Equivalent to Azelastine 0.5mg) =<br>3 mg per btl of 6 ml.) (i.e. 3 mg ./6<br>m.l.) (Nt wt in Exp products is378<br>Gm.& Packing Material - (1)Eye<br>Drops Bottle (2)Eye Drops Caps &<br>(3)Eye<br>Drops<br>Insert-each<br>of<br>126000-Nos.)<br>126000.000<br>Number<br>1<br>AZELASTINE HCL<br>385.56 Gram<br>2<br>Eye Drop Bottle<br>Relevant<br>as<br>per<br>packing<br>policy<br>3<br>Eye Drop Caps<br>Relevant<br>as<br>per<br>packing<br>policy<br>4<br>Eye Drop Insert<br>Relevant<br>as<br>per<br>packing<br>policy<br>RA concerned maytake further necessaryaction asper above decision of NC.

Relevant as per packing policy 4 Eye Drop Insert Relevant as per packing policy RA concerned maytake further necessaryaction asper above decision of NC.||||

Case No.:80/13/82-	Party Name:FINE ORGANIC	Meet No/Date:5/82-	Status:
ALC4/2019	INDUSTRIES LTD	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310833601
:01/82/050/00923/AM20/	:03/94/040/00783/AM20/	23.12.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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 117 Vol. I as per details below or as applied by firm whichever is lower:

Export product	Qty.	Sl.<br>No.	Import items	Qty.
GLYCERYL DI BEHENATE	1 kg	1	BEHENIC ACID	0.939 kg
		2	GLYCERINE	0.140 kg

Case No.:84/13/82-	Party Name:GLENMARK	Meet No/Date:5/82-	Status:
ALC4/2019	PHARMACEUTICALS LTD	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310833636
:01/82/050/00927/AM20/	:03/94/040/00724/AM20/	24.12.2019

-|---| |ALC4/2019||PHARMACEUTICALS LTD||ALC4/2020||Approved| |||||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0310833636||| |:01/82/050/00927/AM20/||:03/94/040/00724/AM20/||24.12.2019|||

	Case No.:84/13/82-<br>ALC4/2019	Party Name:GLENMARK<br>PHARMACEUTICALS LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br> <br> <br>Lic.No/Date:0310833636<br>24.12.2019	Status:<br>Approved
	HQ File<br>:01/82/050/00927/AM20/	RLA File<br>:03/94/040/00724/AM20/
118	Decision:The Committee considered case as per agenda and deliberated on the matter in the presence<br>of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or 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>Drospirenone and Ethinyl Estradiol<br>Tablets (YASMIN) 3 mg / 0.03 mg<br>(Pack<br>3<br>x<br>28s)<br>(Net wt of Drospirenone USP<br>(Micronized) is 49.140 Kgs)<br>260000.000<br>Number<br>1<br>Drospirenone<br>USP (Micronized)<br>108.50 kg<br>2<br>Drospirenone and Ethinyl Estradiol<br>Tablets (YAZ) ( Pack 3 x 28s) 3 mg<br>/<br>0.02<br>mg<br>(Net wt of Drospirenone USP<br>(Micronized) is 57.240 Kgs)<br>265000.000<br>Number<br>RA concerned maytake further necessaryaction asper above decision of NC.

x 28s) 3 mg / 0.02 mg (Net wt of Drospirenone USP (Micronized) is 57.240 Kgs) 265000.000 Number RA concerned maytake further necessaryaction asper above decision of NC.||||

Case No.:88/13/82-	Party Name:CLARIANT	Meet No/Date:5/82-	Status:
ALC4/2019	CHEMICALS INDIA LTD	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310833685
:01/82/050/00931/AM20/	:03/94/040/00797/AM20/	24.12.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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 119 Vol. I as per details below or as applied by firm whichever is lower:

Qty.	Sl.<br>No.	Import items	Qty.
1 kg	1	BRANCH ALKYL BENZENE	0.978 kg

Case No.:92/13/82-	Party Name:TADIMETY	Meet No/Date:5/82-	Status:
ALC4/2019	AROMATICS PVT. LTD	ALC4/2020	Deferred
		09.10.2020
HQ File	RLA File	Lic.No/Date:0710115939
:01/82/050/00935/AM20/	:07/24/040/00229/AM20/	27.12.2019

--| ||ALC4/2019||AROMATICS PVT. LTD||ALC4/2020||Deferred| ||||||09.10.2020||| ||HQ File||RLA File||Lic.No/Date:0710115939||| ||:01/82/050/00935/AM20/||:07/24/040/00229/AM20/||27.12.2019|||

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

(i) Complete technical details as per Appendix 4E having complete chemistry, molecular weight, percentage yield and Stoichiometric balance.

Case No.:93/13/82-	Party Name:TADIMETY	Meet No/Date:5/82-	Status:
ALC4/2019	AROMATICS PVT. LTD	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0710115940
:01/82/050/00936/AM20/	:07/24/040/00230/AM20/	27.12.2019

	Case No.:93/13/82-<br>ALC4/2019	Party Name:TADIMETY<br>AROMATICS PVT. LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
	HQ File<br>:01/82/050/00936/AM20/	RLA File<br>:07/24/040/00230/AM20/	Lic.No/Date:0710115940<br>27.12.2019
121	<br>Decision:The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol.

122	<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:5/82-<br>ALC4/2020<br>09.10.2020	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.

123	Case No.:96/13/82-<br>ALC4/2019	Party Name:STYRAX<br>PHARMA PRIVATE<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00939/AM20/	RLA File<br>:26/24/040/00014/AM20/	Lic.No/Date:2610012889<br>27.12.2019
	Decision:Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited.

Decision: Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Application is still awaited.

waited.||||

Decision: Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Application is still awaited.

Case No.:97/13/82-	Party Name:MAITHRI	Meet No/Date:5/82-	Status:
ALC4/2019	DRUGS PVT LTD	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0910068306
:01/82/050/00940/AM20/	:09/24/040/00465/AM20/	27.12.2019

	Case No.:97/13/82-<br>ALC4/2019	Party Name:MAITHRI<br>DRUGS PVT LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
	HQ File<br>:01/82/050/00940/AM20/	RLA File<br>:09/24/040/00465/AM20/	Lic.No/Date:0910068306<br>27.12.2019
124	<br>Decision:The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>TIGECYCLINE<br>1 kg<br>1<br>MINOCYCLINE HYDROCHLORIDE<br>2.666 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

t Qty. Sl. No. Import items Qty. TIGECYCLINE 1 kg 1 MINOCYCLINE HYDROCHLORIDE 2.666 kg RA concerned maytake further necessaryaction asper above decision of NC.||||

125	Case No.:99/13/82-ALC4/2019	Party Name:DIPS<br>BIOSCIENCE PVT.LTD.<br>RLA File<br>:03/94/040/00788/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00942/AM20/		Lic.No/Date:0310833754<br>27.12.2019
	Decision:Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20<br>dated 15.05.2019.

Case No.:102/13/82-	Party Name:CLARIANT	Meet No/Date:5/82-	Status:
ALC4/2019	CHEMICALS [INDIA] LTD.	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310833771
:01/82/050/00945/AM20/	:03/94/040/00817/AM20/	30.12.2019

--| |ALC4/2019||CHEMICALS [INDIA] LTD.||ALC4/2020||Approved| |||||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0310833771||| |:01/82/050/00945/AM20/||:03/94/040/00817/AM20/||30.12.2019|||

Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of 126 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.<br>No.	Import items	Qty.
Dodecyl Aniline (DODAN-IN)	1 kg	1	BRANCH ALKYL BENZENE	0.978 kg

127	<br>Case No.:104/13/82-<br>ALC4/2019	Party Name:MENTHA &<br>ALLIED PRODUCTS<br>PRIVATE LIMITED<br>RLA File<br>:05/24/040/00601/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00947/AM20/		Lic.No/Date:0510413159<br>01.01.2020
	Decision:Deferred for comments of TE.

128	Case No.:105/13/82-<br>ALC4/2019	Party Name:REFLUX<br>ENTERPRISES	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00948/AM20/	RLA File<br>:03/95/040/00931/AM20/	Lic.No/Date:0310833815<br>01.01.2020
	Decision:Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited.			as per policy

1.01.2020|| ||**Decision:**Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application circular no 23/2015-20 dated 15.05.2019. Application is still awaited.|||as per policy|

Decision: Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Application is still awaited.

129	<br>Case No.:107/13/82-<br>ALC4/2019	Party Name:SRIAM LABS<br>PRIVATE LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00950/AM20/	RLA File<br>:09/24/040/00477/AM20/	Lic.No/Date:0910068319<br>01.01.2020
	Decision:Deferred for comments of TE.

130	<br>Case No.:108/13/82-<br>ALC4/2019	Party Name:PANACEA<br>BIOTEC LTD.,<br>RLA File<br>:05/24/040/00619/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br> <br><br>Lic.No/Date:0510413189<br>02.01.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00951/AM20/
	Decision:Deferred for comments of TE.

2020 Lic.No/Date:0510413189 02.01.2020|Status: Deferred| |---|---|---|---|---| || HQ File :01/82/050/00951/AM20/|||| ||**Decision:**Deferred for comments of TE.||||

131	<br>Case No.:112/13/82-<br>ALC4/2019	Party Name:TOJO VIKAS<br>INTERNATIONAL PRIVATE<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>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:Deferred for comments of TE.

132	Case No.:119/13/82-<br>ALC4/2019	Party Name:STYRAX LIFE<br>SCIENCES PRIVATE<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	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:Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited.			as per policy

133	<br>Case No.:133/13/82-<br>ALC4/2019	Party Name:INTAS<br>PHARMACEUTICALS LTD.	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>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.

rred**| |---|---|---|---|---| || 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.||||

134	<br>Case No.:118/13/82-<br>ALC4/2019	Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00496/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00961/AM20/		Lic.No/Date:0910068340<br>06.01.2020
	Decision:Deferred for comments of TE.

Case No.:120/13/82-	Party Name:BRAWN	Meet No/Date:5/82-	Status:
ALC4/2019	LABORATORIES LTD	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0510413216
:01/82/050/00963/AM20/	:05/23/040/00390/AM20/	06.01.2020

	Case No.:120/13/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00963/AM20/	Case No.:120/13/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00963/AM20/	Case No.:120/13/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00963/AM20/	Party Name:BRAWN<br>LABORATORIES LTD	Party Name:BRAWN<br>LABORATORIES LTD	Party Name:BRAWN<br>LABORATORIES LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
				RLA File<br>:05/23/040/00390/AM20/			Lic.No/Date:0510413216<br>06.01.2020

|Meet No/Date:5/82- ALC4/2020 09.10.2020|Status: Approved| |---|---|---|---|---|---|---|---|---|---| |||||RLA File :05/23/040/00390/AM20/|||Lic.No/Date:0510413216 06.01.2020||| |135| **Decision:**The Committee considered case as per agenda and deliberated on the matter 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 AZITHROMYCIN TABLETS 250MG (WHITE ,ROUND, BICONVEX, FILM COATED TABLETS) 1 Number 1 AZITHROMYCIN DIHYDRATE USP (WHITE OR ALMOST WHITE POWDER) 267.256 mg / 250 mg Tablet 2 AZITHROMYCIN TABLETS 500 MG (WHITE ELONGATED , BICONVEX, SCORED ON ONE SIDE , FILM COATED TABLETS) 1 Number 2 AZITHROMYCIN DIHYDRATE USP (WHITE OR ALMOST WHITE POWDER) 534.512 mg / 500 mg Tablet 3 AZITHROMYCIN CAPSULE 250 MG (HARD GELATIN CAPSULES CONTAINING WHITE GRANLAR POWDER) 1 Number 3 AZITHROMYCIN DIHYDRATE USP (WHITE OR ALMOST WHITE POWDER) 267.256 mg / 250 mg Capsule 4 AZITHROMYCIN CAPSULE 500 MG (HARD GELATIN CAPSULES CONTAINING WHITE GRANULAR POWDER) 1 Number 4 AZITHROMYCIN DIHYDRATE USP (WHITE OR ALMOST WHITE POWDER) 534.512 mg / 500 mg Capsule 5 AZITHROMYCI

S CONTAINING WHITE GRANULAR POWDER) 1 Number 4 AZITHROMYCIN DIHYDRATE USP (WHITE OR ALMOST WHITE POWDER) 534.512 mg / 500 mg Capsule 5 AZITHROMYCIN ORAL SUSPENSION 200MG/5ML- 30ML (PINKISH WHITE GRANULAR POWDER FORMING PINK COLOURED SUSPENSION ON RECONSITITUTION) 1 Number 5 AZITHROMYCIN DIHYDRATE USP (WHITE OR ALMOST WHITE POWDER) 1320.48 mg / 30 ml Bottle RA concerned maytake further necessaryaction asper above decision of NC.||||||||| |||Sl. No.|Export product||Qty.|Sl. No.||Import items|Qty.| |||1|AZITHROMYCIN TABLETS 250MG (WHITE ,ROUND, BICONVEX, FILM COATED TABLETS)||1 Number|1||AZITHROMYCIN DIHYDRATE USP (WHITE OR ALMOST WHITE POWDER)|267.256 mg / 250 mg Tablet| |||2|AZITHROMYCIN TABLETS 500 MG (WHITE ELONGATED , BICONVEX, SCORED ON ONE SIDE , FILM COATED TABLETS)||1 Number|2||AZITHROMYCIN DIHYDRATE USP (WHITE OR ALMOST WHITE POWDER)|534.512 mg / 500 mg Tablet| |||3|AZITHROMYCIN CAPSULE 250 MG (HARD GELATIN CAPSULES CONTAINING WHITE GRANLAR POWDER)||1 Number|3||AZITHROMYCIN DIHYDRATE USP (WHITE OR ALMOST WHITE POWDER)|267.256 mg / 250 mg Capsule| |||4|AZITHROMYCIN CAPSULE 500 MG (HARD GELATIN CAPSULES CONTAINING WHITE GRANULAR POWDER)||1 Number|4||AZITHROMYCIN DIHYDRATE USP (WHITE OR ALMOST WHITE POWDER)|534.512 mg / 500 mg Capsule|

MG (HARD GELATIN CAPSULES CONTAINING WHITE GRANULAR POWDER)||1 Number|4||AZITHROMYCIN DIHYDRATE USP (WHITE OR ALMOST WHITE POWDER)|534.512 mg / 500 mg Capsule| |||5|AZITHROMYCIN ORAL SUSPENSION 200MG/5ML- 30ML (PINKISH WHITE GRANULAR POWDER FORMING PINK COLOURED SUSPENSION ON RECONSITITUTION)||1 Number|5||AZITHROMYCIN DIHYDRATE USP (WHITE OR ALMOST WHITE POWDER)|1320.48 mg / 30 ml Bottle| |||||||||||

136	Case No.:121/13/82-<br>ALC4/2019	Party Name:REYAANSH<br>HEALTHCARE	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	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:Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited.

Decision: Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Application is still awaited.

ill awaited.||||

Decision: Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Application is still awaited.

137	Case No.:140/13/82-<br>ALC4/2019	Party Name:DEEPAK<br>PHENOLICS LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/00983/AM20/	RLA File<br>:34/24/040/00267/AM20/	Lic.No/Date:3410045769<br>07.01.2020
	Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 17.09.2020 has furnished its reply. Deferred for comments of TE.

138	Case No.:141/13/82-<br>ALC4/2019	Party Name:DEEPAK<br>PHENOLICS LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	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
	Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm vide e-mail dated 17.09.2020 has furnished its reply. Deferred for comments of TE.

he Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 17.09.2020 has furnished its reply. Deferred for comments of TE.

139	<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/	<br>Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred<br>
	<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-	Party Name:EMMENNAR	Meet No/Date:5/82-	Status:
ALC4/2019	PHARMA PRIVATE	ALC4/2020	Approved
	LIMITED	09.10.2020
HQ File	RLA File	Lic.No/Date:0910068366
:01/82/050/00998/AM20/	:09/24/040/00485/AM20/	13.01.2020

	Case No.:155/13/82-<br>ALC4/2019	Party Name:EMMENNAR<br>PHARMA PRIVATE<br>LIMITED<br> <br> <br>	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>S<br> <br>Lic.No/Date:0910068366<br>13.01.2020	tatus:<br>Approved
	HQ File<br>:01/82/050/00998/AM20/	RLA File<br>:09/24/040/00485/AM20/<br> <br>
140	<br>Decision:The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol.

Case No.:161/13/82-	Party Name:VIVIN DRUGS &	Meet No/Date:5/82-	Status:
ALC4/2019	PHARMACEUTICALS	ALC4/2020	Approved
	LIMITED	09.10.2020
HQ File	RLA File	Lic.No/Date:0910068369
:01/82/050/01004/AM20/	:09/24/040/00484/AM20/	14.01.2020

--| |ALC4/2019||PHARMACEUTICALS||ALC4/2020||Approved| |||LIMITED||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0910068369||| |:01/82/050/01004/AM20/||:09/24/040/00484/AM20/||14.01.2020|||

	Case No.:161/13/82-<br>ALC4/2019	Party Name:VIVIN DRUGS &<br>PHARMACEUTICALS<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
	HQ File<br>:01/82/050/01004/AM20/	RLA File<br>:09/24/040/00484/AM20/	Lic.No/Date:0910068369<br>14.01.2020
141	<br>Decision:The Committee considered the case as per agenda and in the light of earlier decision taken in<br>meeting No. 7/82-ALC4/2019 dated 06.09.2019 against advance authorization No. 0910066857 dated<br>15.11.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>4-AMINO-2-OXO<br>PYRIMIDINYL<br>OXATHIOLANE-2-<br>CARBOXYLIC<br>ACID<br>ISO<br>PROPYL<br>METHYL<br>CYCLO HEXYL ESTER (CEI-<br>II)<br>1 kg<br>1<br>GLYOXYLIC ACID 50%<br>0.743 kg<br>2<br>2,5 DI HYDROXY 1,4<br>DITHIANE<br>0.325 kg<br>3<br>CYTOSINE<br>0.428 kg<br>4<br>HEXAMETHYLDISILAZANE<br>0.509 kg<br>5<br>TRIETHYLAMINE<br>0.034 kg<br>6<br>METHYLENE CHLORIDE<br>2.63 kg<br>7<br>L-MENTHOL<br>0.751 kg<br>8<br>TRIPHOSGENE<br>0.40 kg<br>9<br>DI METHYL FORMAMIDE<br>0.316 kg<br>RA maytake appropriate action asper the decision of Norms Committee.

CHLORIDE 2.63 kg 7 L-MENTHOL 0.751 kg 8 TRIPHOSGENE 0.40 kg 9 DI METHYL FORMAMIDE 0.316 kg RA maytake appropriate action asper the decision of Norms Committee.||||

Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in meeting No. 7/82-ALC4/2019 dated 06.09.2019 against advance authorization No. 0910066857 dated 15.11.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Case No.:167/13/82-	Party Name:ARCH	Meet No/Date:5/82-	Status:
ALC4/2019	PHARMALABS LTD	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310834233
:01/82/050/01010/AM20/	:03/94/040/00862/AM20/	16.01.2020

142

Export product	Qty.	Sl.<br>No.	Import items	Qty.
Benzyl 1R 2S -3- Chloro-2-<br>Hydroxy-1<br>(Phenylthiomethyl)<br>propyl carbament (CBZ-CA)	1 kg	1	N-Carbobenzoxy-S-phenyl-L-<br>cysteine	1.85 kg
		2	Aluminum tri secondary-butoxide<br>(ATSB)	1.37 kg

ittee considered case as per agenda and deliberated on the matter 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. (4-R-CIS)-1,1-DIMETHYL-6- CYANOMETHYL-2,2- DIMETHYL-1,3- DIOXANE-4-ACETATE (ATS- 8) 1 kg 1 ETHYL-4-CHLORO ACETO ACETATE 1.06 kg 2 LITHIUM METAL 0.10 kg 3 TERT BUTYL ACETATE 2.11 kg 4 LYOPHILISED ENZYME POWDER CDX-403 0.0102 kg 5 IEP OX 58 SPRAY DRIED ENZYME POWDER 0.016 kg 6 IEP OX 56 SPRAY DRIED ENZYME POWDER 0.117 kg 7 (B-NAD) B-NICOTINAMIDE- ADENINE DINUCLEOTIDE ( COENZYME-1) 0.00132 kg 8 2,2-DIMETHOXY PROPANE 0.95 kg 9 ETHYL ACETATE 3.60 kg 10 IEP DE 08 SPRAY DRIED ENZYME POWDER Not required in the process RA concerned maytake further necessaryaction asper above decision of NC.||||||||| |||Export product||Qty.|Sl. No.|Import items||Qty.|| |||(4-R-CIS)-1,1-DIMETHYL-6- CYANOMETHYL-2,2- DIMETHYL-1,3- DIOXANE-4-ACETATE (ATS- 8)||1 kg|1|ETHYL-4-CHLORO ACETO ACETATE||1.06 kg|| ||||||2|LITHIUM METAL||0.10 kg|| ||||||3|TERT BUTYL ACETATE||2.11 kg|| ||||||4|LYOPHILISED ENZYME POWDER CDX-403||0.0102 kg|| ||||||5|IEP OX 58 SPRAY DRIED ENZYME POWDER||0.016 kg|| ||||||6|IEP OX 56 SPRAY DRIED ENZYME POWDER||0.117 kg||

UTYL ACETATE||2.11 kg|| ||||||4|LYOPHILISED ENZYME POWDER CDX-403||0.0102 kg|| ||||||5|IEP OX 58 SPRAY DRIED ENZYME POWDER||0.016 kg|| ||||||6|IEP OX 56 SPRAY DRIED ENZYME POWDER||0.117 kg|| ||||||7|(B-NAD) B-NICOTINAMIDE- ADENINE DINUCLEOTIDE ( COENZYME-1)||0.00132 kg|| ||||||8|2,2-DIMETHOXY PROPANE||0.95 kg|| ||||||9|ETHYL ACETATE||3.60 kg|| ||||||10|IEP DE 08 SPRAY DRIED ENZYME POWDER||Not required in the process|| ||||||||||| ||||||||||| |160| Case No.:191/13/82- ALC4/2019||Party Name:AUROBINDO PHARMA LIMITED||||Meet No/Date:5/82- ALC4/2020 09.10.2020||Status: Deferred| || HQ File :01/82/050/01034/AM20/||RLA File :09/24/040/00527/AM20/||||Lic.No/Date:0910068384 20.01.2020||| ||**Decision:**Deferred for comments of TE.|||||||||

161	<br>Case No.:1/2/82-ALC4/2020	Party Name:ARCH<br>PHARMALABS LTD<br>RLA File<br>:03/94/040/00888/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01035/AM20/		Lic.No/Date:0310834332<br>20.01.2020
	Decision:Deferred for comments of TE.

Case No.:2/2/82-ALC4/2020	Party Name:ARCH	Meet No/Date:5/82-	Status:
	PHARMALABS LTD	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310834333
:01/82/050/01036/AM20/	:03/94/040/00890/AM20/	20.01.2020

---|---|---|---|---|---| |||PHARMALABS LTD||ALC4/2020||Approved| |||||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0310834333||| |:01/82/050/01036/AM20/||:03/94/040/00890/AM20/||20.01.2020|||

	Case No.:2/2/82-ALC4/2020 <br>HQ File<br>:01/82/050/01036/AM20/	Party Name:ARCH<br>PHARMALABS LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved<br>
		RLA File<br>:03/94/040/00890/AM20/	Lic.No/Date:0310834333<br>20.01.2020
162	<br>Decision:The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>(4-R-CIS)-1,1-DIMETHYL-6-<br>CYANOMETHYL-2,2-<br>DIMETHYL-1,3-<br>DIOXANE-4-ACETATE (ATS-<br>8)<br>1 kg<br>1<br>ETHYL-4-CHLORO<br>ACETO<br>ACETATE<br>1.06 kg<br>2<br>LITHIUM METAL<br>0.10 kg<br>3<br>TERT BUTYL ACETATE<br>2.11 kg<br>4<br>LYOPHILISED<br>ENZYME<br>POWDER CDX-403<br>0.0102 kg<br>5<br>IEP OX 58 SPRAY DRIED<br>ENZYME POWDER<br>0.0160 kg<br>6<br>IEP OX 56 SPRAY DRIED<br>ENZYME POWDER<br>0.117 kg<br>7<br>(B-NAD) B-NICOTINAMIDE-<br>ADENINE DINUCLEOTIDE (<br>COENZYME-1)<br>0.00132 kg<br>8<br>2,2-DIMETHOXY PROPANE<br>0.95 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

NAD) B-NICOTINAMIDE- ADENINE DINUCLEOTIDE ( COENZYME-1) 0.00132 kg 8 2,2-DIMETHOXY PROPANE 0.95 kg RA concerned maytake further necessaryaction asper above decision of NC.||||

163	<br>Case No.:3/2/82-ALC4/2020	Party Name:ETERNIS FINE<br>CHEMICALS LIMITED,<br>RLA File<br>:03/94/040/00715/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01037/AM20/		Lic.No/Date:0310834342<br>20.01.2020
	Decision:Deferred for comments of TE.

164	Case No.:5/2/82-ALC4/2020	Party Name:ARCH<br>PHARMALABS LTD<br>RLA File<br>:03/94/040/00889/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01039/AM20/		Lic.No/Date:0310834354<br>21.01.2020
	Decision:Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited.			as per policy

2020|| ||**Decision:**Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application circular no 23/2015-20 dated 15.05.2019. Application is still awaited.|||as per policy|

165	Case No.:6/2/82-ALC4/2020	Party Name:VETBIOCHEM<br>INDIA PRIVATE LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:3110067663<br>21.01.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01040/AM20/	RLA File<br>:31/83/040/00138/AM20/
	Decision:Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited.

Decision: Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Application is still awaited.

166	Case No.:7/2/82-ALC4/2020	Party Name:PANACEA<br>BIOTEC LTD.,	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01041/AM20/	RLA File<br>:05/24/040/00683/AM20/	Lic.No/Date:0510413419<br>22.01.2020
	Decision:The Committee considered the case as per agenda in the presence of technical experts and<br>after deliberation, it was decided to forward a copy of 4.07 application to Department of Biotechnology<br>(DBT)for obtainingits comments.

er agenda in the presence of technical experts and after deliberation, it was decided to forward a copy of 4.07 application to Department of Biotechnology (DBT)for obtainingits comments.||||

Decision: The Committee considered the case as per agenda in the presence of technical experts and after deliberation, it was decided to forward a copy of 4.07 application to Department of Biotechnology (DBT) for obtaining its comments.

167	Case No.:8/2/82-ALC4/2020	Party Name:AQUILA<br>ORGANICS PVT.LTD.	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0310834406<br>22.01.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01042/AM20/	RLA File<br>:03/94/040/00879/AM20/
	Decision:Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited.

Decision: Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Application is still awaited.

168	<br>Case No.:9/2/82-ALC4/2020	Party Name:LACTOSE<br>(INDIA) LTD.,	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01043/AM20/	RLA File<br>:03/95/040/01033/AM20/	Lic.No/Date:0310834414<br>23.01.2020
	Decision:Deferred for comments of TE.

Deferred*| |---|---|---|---|---| || HQ File :01/82/050/01043/AM20/|RLA File :03/95/040/01033/AM20/|Lic.No/Date:0310834414 23.01.2020|| ||**Decision:**Deferred for comments of TE.||||

Case No.:10/2/82-ALC4/2020	Party Name:GLENMARK	Meet No/Date:5/82-	Status:
	LIFE SCIENCES LIMITED	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310834427
:01/82/050/01044/AM20/	:03/94/040/00902/AM20/	23.01.2020

Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in meeting No. 2/82-ALC4/2020 dated 10.07.2020 against advance authorization No. 0310833584 dated 20.12.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as 169 applied by the firm, whichever is less:

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

170	<br>Case No.:11/2/82-ALC4/2020	Party Name:AURA LIFECARE<br>PRIVATE LIMITED	<br>Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01045/AM20/	RLA File<br>:34/24/040/00323/AM20/	Lic.No/Date:3410045804<br>23.01.2020
	Decision:Deferred for comments of TE.

Deferred*| |---|---|---|---|---| || HQ File :01/82/050/01045/AM20/|RLA File :34/24/040/00323/AM20/|Lic.No/Date:3410045804 23.01.2020|| ||**Decision:**Deferred for comments of TE.||||

171	<br>Case No.:12/2/82-ALC4/2020	Party Name:GLENMARK<br>PHARMACEUTICALS LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01046/AM20/	RLA File<br>:03/94/040/00906/AM20/	Lic.No/Date:0310834474<br>24.01.2020
	Decision:Deferred for comments of TE.

172	<br>Case No.:15/2/82-ALC4/2020	Party Name:SWAASA<br>PHARMA LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01049/AM20/	RLA File<br>:26/24/040/00016/AM20/	Lic.No/Date:2610012902<br>24.01.2020
	Decision:Deferred for comments of TE.

Case No.:16/2/82-ALC4/2020	Party Name:AMI LIFE	Meet No/Date:5/82-	Status:
	SCIENCES PRIVATE	ALC4/2020	Approved
	LIMITED	09.10.2020
HQ File	RLA File	Lic.No/Date:3410045821
:01/82/050/01050/AM20/	:34/24/040/00300/AM20/	28.01.2020

--|---|---|---| |||SCIENCES PRIVATE||ALC4/2020||Approved| |||LIMITED||09.10.2020||| |HQ File||RLA File||Lic.No/Date:3410045821||| |:01/82/050/01050/AM20/||:34/24/040/00300/AM20/||28.01.2020|||

Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in meeting No. 10/AM20 dated 29.11.2019 against advance authorization No. 3410044289 dated 29.06.2018, 173 it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. Import items Qty. No. Benfotiamine 1 kg 1 Thiamine Hydrochloride 0.922 kg

Case No.:17/2/82-ALC4/2020	Party Name:AMI LIFE	Meet No/Date:5/82-	Status:
	SCIENCES PRIVATE	ALC4/2020	Approved
	LIMITED	09.10.2020
HQ File	RLA File	Lic.No/Date:3410045822
:01/82/050/01051/AM20/	:34/24/040/00301/AM20/	28.01.2020

Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in meeting No. 10/AM20 dated 29.11.2019 against advance authorization No. 3410044289 dated 29.06.2018, 174 it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. Import items Qty. No. Benfotiamine 1 kg 1 Thiamine Hydrochloride 0.922 kg

Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. Import items Qty. No. Benfotiamine 1 kg 1 Thiamine Hydrochloride 0.922 kg

Case No.:18/2/82-ALC4/2020	Party Name:AMI LIFE	Meet No/Date:5/82-	Status:
	SCIENCES PRIVATE	ALC4/2020	Approved
	LIMITED	09.10.2020
HQ File	RLA File	Lic.No/Date:3410045823
:01/82/050/01052/AM20/	:34/24/040/00302/AM20/	28.01.2020

Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in meeting No. 10/AM20 dated 29.11.2019 against advance authorization No. 3410044289 dated 29.06.2018, 175 it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product<br>Benfotiamine	Qty.	Sl.<br>No.	Import items	Qty.
	1 kg	1	Thiamine Hydrochloride	0.922 kg

Case No.:19/2/82-ALC4/2020	Party Name:AUROBINDO	Meet No/Date:5/82-	Status:
	PHARMA LIMITED	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0910068419
:01/82/050/01053/AM20/	:09/24/040/00532/AM20/	28.01.2020

---|---|---|---|---|---| |||PHARMA LIMITED||ALC4/2020||Approved| |||||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0910068419||| |:01/82/050/01053/AM20/||:09/24/040/00532/AM20/||28.01.2020|||

	Case No.:19/2/82-ALC4/2020	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:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0910068419<br>28.01.2020	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0910068419<br>28.01.2020	Status:<br>Approved
	HQ File<br>:01/82/050/01053/AM20/	RLA File<br>:09/24/040/00532/AM20/
176	Decision:The Committee considered the case as per agenda and in the light of earlier decision taken in<br>meeting No. 12/82-ALC4/2019 dated 17.01.2020 against advance authorization No. 0910065719 dated<br>30.11.2017, it was decided to ratify norms under Para 4.07 of HBP Vol.

earlier decision taken in meeting No. 12/82-ALC4/2019 dated 17.01.2020 against advance authorization No. 0910065719 dated 30.11.2017, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:|||||||| ||Export product||Qty.|Sl. No.|Import items||Qty.|| || DORIPENEM STERILE / DORIPENEM MONOHYDRATE STERILE||1 kg|1|1- Beta-Methyl Vinyl Phosphate (MAP)||2.50 kg|| |||||2|10% Palladium on Charcoal (Type: RD9210)||0.100 kg|| |||||3|Doripenem side chain||2.463 kg|| |||||4|Activated Carbon (Carbon Enoanticromos)||0.100 kg|| |||||5|Dimethylformamide(DMF)||3.30 kg|| |||||6|Isopropyl alcohol(IPA)||4.70 kg|| |||||7|Methanol||2.00 kg|| |||||8|Methylene chloride(MDC)||4.00 kg|| |||||9|Tetrahydrofuran(THF)||4.00 kg|| |||||10|Aluminium Canisters / Bottles with Chloro Butyl Plug / Inner & Outer Lid and Gasket / Alu Caps [14Ltrs (5Kg Cap)]||Relevant as per packing policy with accountability|| ||RA concerned maytake further necessaryaction asper above decision of NC.||||||||

177	<br>Case No.:20/2/82-ALC4/2020	Party Name:GLENMARK<br>PHARMACEUTICALS LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0310834502<br>28.01.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01054/AM20/	RLA File<br>:03/94/040/00908/AM20/
	Decision:Deferred for comments of TE.

34502 28.01.2020|Status: Deferred| |---|---|---|---|---| || HQ File :01/82/050/01054/AM20/|RLA File :03/94/040/00908/AM20/||| ||**Decision:**Deferred for comments of TE.||||

178	Case No.:21/2/82-ALC4/2020	Party Name:SYNTHO<br>CHIRALS PVT. LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0910068421<br>28.01.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01055/AM20/	RLA File<br>:09/24/040/00540/AM20/
	Decision:Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20<br>dated 15.05.2019.

Case No.:22/2/82-ALC4/2020	Party Name:STERILE INDIA	Meet No/Date:5/82-	Status:
	PRIVATE LIMITED	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0510413470
:01/82/050/01056/AM20/	:05/24/040/00693/AM20/	29.01.2020

Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in meeting No. 10/82-ALC4/2019 dated 29.11.2019 against advance authorization No. 0510411779 dated 179 06.09.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

nst advance authorization No. 0510411779 dated 179 06.09.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl.<br>No.	Import items	Qty.
Ceftriaxone Sodium Sterile	1 kg	1	Ceftriaxone Sodium (Non Sterile)	1.04 kg

180	Case No.:23/2/82-ALC4/2020	Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD.<br> <br> <br> <br>RLA File<br>:05/24/040/00689/AM20/<br> <br>	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
	HQ File<br>:01/82/050/01057/AM20/		Lic.No/Date:0510413471<br>29.01.2020
	<br>Decision:The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Tobramycin 300mg / 5 ml Nebuliser<br>Solution (Each ml contains Tobramycin<br>Ph.<br>Eur.<br>60<br>mg)<br>(Equivalent to100.800Kg of Bulk Drug)<br>336000.000<br>Number<br>1<br>Tobramycin<br>102.82 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

r>Eur. 60 mg) (Equivalent to100.800Kg of Bulk Drug) 336000.000 Number 1 Tobramycin 102.82 kg RA concerned maytake further necessaryaction asper above decision of NC.||||

181	Case No.:24/2/82-ALC4/2020	Party Name:GENERIC<br>HEALTHCARE PRIVATE<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:3110067669<br>29.01.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01058/AM20/	RLA File<br>:31/83/040/00135/AM20/
	Decision:Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited.

182	<br>Case No.:26/2/82-ALC4/2020	Party Name:GLAND<br>PHARMA LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01060/AM20/	RLA File<br>:09/24/040/00545/AM20/	Lic.No/Date:0910068434<br>31.01.2020
	Decision:Deferred for comments of TE.

183	<br>Case No.:27/2/82-ALC4/2020	Party Name:KLJ<br>PLASTICIZERS LIMITED.	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01061/AM20/	RLA File<br>:05/23/040/00417/AM20/	Lic.No/Date:0510413496<br>31.01.2020
	Decision:Deferred for comments of TE.

Deferred*| |---|---|---|---|---| || HQ File :01/82/050/01061/AM20/|RLA File :05/23/040/00417/AM20/|Lic.No/Date:0510413496 31.01.2020|| ||**Decision:**Deferred for comments of TE.||||

Case No.:28/2/82-ALC4/2020	Party Name:SMS	Meet No/Date:5/82-	Status:
	LIFESCIENCES INDIA	ALC4/2020	Deferred
	LIMITED	09.10.2020
HQ File	RLA File	Lic.No/Date:0910068451
:01/82/050/01062/AM20/	:09/24/040/00521/AM20/	05.02.2020

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

(i) Technical literature in support of requirement of Enzyme and its recovery for reactivation.

(ii) Requirement and recovery of Solvents at each step.

Case No.:29/2/82-ALC4/2020	Party Name:S V LABS PVT	Meet No/Date:5/82-	Status:
	LTD	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0910068453
:01/82/050/01063/AM20/	:09/24/040/00558/AM20/	05.02.2020

s:**| |---|---|---|---|---|---|---| |||LTD||ALC4/2020||Approved| |||||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0910068453||| |:01/82/050/01063/AM20/||:09/24/040/00558/AM20/||05.02.2020|||

	Case No.:29/2/82-ALC4/2020	Party Name:S V LABS PVT<br>LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
	HQ File<br>:01/82/050/01063/AM20/	RLA File<br>:09/24/040/00558/AM20/	Lic.No/Date:0910068453<br>05.02.2020
185	<br>Decision:The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>2R 5S-5 ( 4 Amino 5 fluoro 2<br>oxo 2H Pyrimidin 1 yl ) [ 1,3 ]<br>oxathiolane<br>2 carboxylic acid, 2S -<br>isopropyl 5 R methyl 1R<br>cyclohexyl ester .<br>1 kg<br>1<br>GLYOXYLIC ACID-50%<br>0.68 kg<br>2<br>2,5 DI HYDROXY 1,4 DITHIANE<br>(DIOL)<br>0.28 kg<br>3<br>5-FLUORO CYTOSINE<br>0.49 kg<br>4<br>HEXAMETHYL DISILAZANE<br>(HMDS)<br>0.53 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:

186	Case No.:30/2/82-ALC4/2020	Party Name:JODAS EXPOIM<br>PVT.LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01064/AM20/	RLA File<br>:09/24/040/00531/AM20/	Lic.No/Date:0910068454<br>05.02.2020
	Decision:The Committee considered the case as per agenda and it was observed that the firm was issued<br>Show Cause Notice vide letter dated 10.10.2019.

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

187	Case No.:31/2/82-ALC4/2020	Party Name:SANDHYA<br>ORGANIC CHEMICALS<br>PRIVATE LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01065/AM20/	RLA File<br>:03/95/040/00985/AM20/	Lic.No/Date:0310834682<br>06.02.2020
	Decision:Reminder sent to firm on 10.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20<br>dated 15.05.2019.

Application is still awaited. Hence, it was decided to issue Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.||||

Decision: Reminder sent to firm on 10.08.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.

188	<br>Case No.:32/2/82-ALC4/2020	Party Name:CLEAN SCIENCE<br>AND TECHNOLOGY<br>PVT.LTD.<br>RLA File<br>:31/83/040/00140/AM20/	<br>Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01066/AM20/		Lic.No/Date:3110067673<br>06.02.2020
	Decision:Deferred for comments of TE.

189	<br>Case No.:35/2/82-ALC4/2020	Party Name:CLEAN SCIENCE<br>AND TECHNOLOGY<br>PVT.LTD.	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01069/AM20/	RLA File<br>:31/83/040/00142/AM20/	Lic.No/Date:3110067677<br>06.02.2020
	Decision:Deferred for comments of TE.

Deferred*| |---|---|---|---|---| || HQ File :01/82/050/01069/AM20/|RLA File :31/83/040/00142/AM20/|Lic.No/Date:3110067677 06.02.2020|| ||**Decision:**Deferred for comments of TE.||||

190	<br>Case No.:36/2/82-ALC4/2020	Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01070/AM20/	RLA File<br>:09/24/040/00459/AM20/	Lic.No/Date:0910068458<br>06.02.2020
	Decision:Deferred for comments of TE.

191	<br>Case No.:37/2/82-ALC4/2020	Party Name:ALEOR<br>DERMACEUTICALS<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01071/AM20/	RLA File<br>:34/24/040/00339/AM20/	Lic.No/Date:3410045849<br>06.02.2020
	Decision:Deferred for comments of TE.

192	<br>Case No.:38/2/82-ALC4/2020	Party Name:ALEOR<br>DERMACEUTICALS<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:3410045850<br>06.02.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01072/AM20/	RLA File<br>:34/24/040/00342/AM20/
	Decision:Deferred for comments of TE.

193	<br>Case No.:40/2/82-ALC4/2020	Party Name:MAKSON<br>HEALTH CARE PRIVATE<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:1110028682<br>10.02.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01074/AM20/	RLA File<br>:11/24/040/00008/AM20/
	Decision:Deferred for comments of TE.

20 Lic.No/Date:1110028682 10.02.2020|Status: Deferred| || HQ File :01/82/050/01074/AM20/|RLA File :11/24/040/00008/AM20/||| ||**Decision:**Deferred for comments of TE.||||

194	<br>Case No.:41/2/82-ALC4/2020	Party Name:MAKSON<br>HEALTH CARE PRIVATE<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:1110028683<br>10.02.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01075/AM20/	RLA File<br>:11/24/040/00009/AM20/
	Decision:Deferred for comments of TE.

195	<br>Case No.:42/2/82-ALC4/2020	Party Name:PHALANX LABS<br>PRIVATE LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:2610012904<br>10.02.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01076/AM20/	RLA File<br>:26/24/040/00019/AM20/
	Decision:Deferred for comments of TE.

196	<br>Case No.:43/2/82-ALC4/2020	Party Name:MATRIX FINE<br>SCIENCES PVT.LTD.,	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0310834755<br>11.02.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01077/AM20/	RLA File<br>:03/95/040/01070/AM20/
	Decision:Deferred for comments of TE.

197	<br>Case No.:45/2/82-ALC4/2020	Party Name:BALAJI AMINES<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:3110067681<br>11.02.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01079/AM20/	RLA File<br>:31/83/040/00144/AM20/
	Decision:Deferred for comments of TE.

Lic.No/Date:3110067681 11.02.2020|Status: Deferred| || HQ File :01/82/050/01079/AM20/|RLA File :31/83/040/00144/AM20/||| ||**Decision:**Deferred for comments of TE.||||

198	<br>Case No.:46/2/82-ALC4/2020	Party Name:SRINI<br>PHARMACEUTICALS<br>PRIVATE LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01080/AM20/	RLA File<br>:09/24/040/00536/AM20/	Lic.No/Date:0910068471<br>12.02.2020
	Decision:Deferred for comments of TE.

199	Case No.:48/2/82-ALC4/2020	Party Name:SHREE GANESH<br>REMEDIES LTD.	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01082/AM20/	RLA File<br>:34/24/040/00333/AM20/	Lic.No/Date:3410045871<br>13.02.2020
	Decision:Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited.

Decision: Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Application is still awaited.

200	<br>Case No.:49/2/82-ALC4/2020	Party Name:KOPRAN<br>RESEARCH<br>LABORATORIES LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01083/AM20/	RLA File<br>:03/94/040/00948/AM20/	Lic.No/Date:0310834835<br>13.02.2020
	Decision:Deferred for comments of TE.

Deferred*| |---|---|---|---|---| || HQ File :01/82/050/01083/AM20/|RLA File :03/94/040/00948/AM20/|Lic.No/Date:0310834835 13.02.2020|| ||**Decision:**Deferred for comments of TE.||||

201	<br>Case No.:50/2/82-ALC4/2020	Party Name:KAIRAV<br>CHEMOFARBE<br>INDUSTRIES LTD.	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01084/AM20/	RLA File<br>:03/94/040/00961/AM20/	Lic.No/Date:0310834847<br>13.02.2020
	Decision:Deferred for comments of TE.

202	<br>Case No.:51/2/82-ALC4/2020	Party Name:KAIRAV<br>CHEMOFARBE<br>INDUSTRIES LTD.	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01085/AM20/	RLA File<br>:03/94/040/00960/AM20/	Lic.No/Date:0310834848<br>13.02.2020
	Decision:Deferred for comments of TE.

203	<br>Case No.:53/2/82-ALC4/2020	Party Name:GLENMARK<br>LIFE SCIENCES LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01087/AM20/	RLA File<br>:03/94/040/00940/AM20/	Lic.No/Date:0310834854<br>13.02.2020
	Decision:Deferred for comments of TE.

rred**| |---|---|---|---|---| || HQ File :01/82/050/01087/AM20/|RLA File :03/94/040/00940/AM20/|Lic.No/Date:0310834854 13.02.2020|| ||**Decision:**Deferred for comments of TE.||||

204	<br>Case No.:55/2/82-ALC4/2020	Party Name:GLENMARK<br>PHARMACEUTICALS LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01089/AM20/	RLA File<br>:03/94/040/00930/AM20/	Lic.No/Date:0310834856<br>13.02.2020
	Decision:Deferred for comments of TE.

205	<br>Case No.:56/2/82-ALC4/2020	Party Name:BENZO CHEM<br>INDUSTRIES PRIVATE<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01090/AM20/	RLA File<br>:03/94/040/00962/AM20/	Lic.No/Date:0310834862<br>13.02.2020
	Decision:Deferred for comments of TE.

206	<br>Case No.:57/2/82-ALC4/2020	Party Name:YASHO<br>INDUSTRIES LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01091/AM20/	RLA File<br>:03/95/040/01083/AM20/	Lic.No/Date:0310834867<br>14.02.2020
	Decision:Deferred for comments of TE.

207	<br>Case No.:58/2/82-ALC4/2020	Party Name:GLENMARK<br>PHARMACEUTICALS LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01092/AM20/	RLA File<br>:03/94/040/00971/AM20/	Lic.No/Date:0310834878<br>17.02.2020
	Decision:Deferred for comments of TE.

Deferred*| |---|---|---|---|---| || HQ File :01/82/050/01092/AM20/|RLA File :03/94/040/00971/AM20/|Lic.No/Date:0310834878 17.02.2020|| ||**Decision:**Deferred for comments of TE.||||

Case No.:59/2/82-ALC4/2020 Party Name:ALTA Meet No/Date:5/82- Status: LABORATORIES LIMITED ALC4/2020 Approved 09.10.2020 HQ File RLA File Lic.No/Date:0310834879 :01/82/050/01093/AM20/ :03/94/040/00968/AM20/ 17.02.2020 Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in meeting No. 5/82-ALC4/2019 dated 02.08.2019 against advance authorization No. 0310828483 dated 208 23.04.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl.<br>No.	Import items	Qty.
METHYL PARABEN	1 kg	1	PARA HYDROXY BENZOIC ACID	0.969 kg
		2	METHANOL	0.500 kg

Case No.:60/2/82-	Party Name:MICRO LABS	Meet No/Date:5/82-	Status:
ALC4/2020	LTD	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0710116125
:01/82/050/01094/AM20/	:07/24/040/00275/AM20/	17.02.2020

-|---|---|---|---|---| |ALC4/2020||LTD||ALC4/2020||Approved| |||||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0710116125||| |:01/82/050/01094/AM20/||:07/24/040/00275/AM20/||17.02.2020|||

	Case No.:60/2/82-<br>ALC4/2020<br>HQ File<br>:01/82/050/01094/AM20/	Party Name:MICRO LABS<br>LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
		RLA File<br>:07/24/040/00275/AM20/	Lic.No/Date:0710116125<br>17.02.2020
209	Decision:The Committee considered case as per agenda and deliberated on the matter in the presence<br>of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or 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>AMOXICILLIN<br>125<br>MG+FLUCLOXACILLIN<br>125<br>MG/5ML<br>ORAL<br>SUSPENSION<br>100<br>ML<br>BOTTLES<br>BP/EP/USP/IP(600 KG)<br>120000.000<br>Bottles<br>1<br>AMOXICILLIN<br>TRIHYDRATE<br>BP/EP/USP/IP<br>361.539 kg<br>2<br>FLUCLOXACILLIN<br>SODIUM<br>BP/EP/USP/IP<br>342.759 kg<br>2<br>AMOXICILLIN 250 MG+<br>FLUCLOXACILLIN<br>250<br>MG<br>CAPSULES<br>BP/EP/USP/IP ( 4000 KG )<br>8000000.000<br>Number<br>1<br>AMOXICILLIN<br>TRIHYDRATE<br>BP/EP/USP/IP<br>2341.440 kg<br>2<br>FLUCLOXACILLIN<br>SODIUM<br>BP/EP/USP/IP<br>2219.760 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

ICILLIN TRIHYDRATE BP/EP/USP/IP 2341.440 kg 2 FLUCLOXACILLIN SODIUM BP/EP/USP/IP 2219.760 kg RA concerned maytake further necessaryaction asper above decision of NC.||||

210	Case No.:61/2/82-ALC4/2020	Party Name:TADIMETY<br>AROMATICS PVT. LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	HQ File<br>:01/82/050/01095/AM20/	RLA File<br>:07/24/040/00276/AM20/	Lic.No/Date:0710116142<br>18.02.2020
	Decision:Deferred for comments of TE.

Case No.:65/2/82-ALC4/2020	Party Name:GLENMARK	Meet No/Date:5/82-	Status:
	PHARMACEUTICALS LTD	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310834920
:01/82/050/01099/AM20/	:03/94/040/00984/AM20/	18.02.2020

--|---|---|---|---| |||PHARMACEUTICALS LTD||ALC4/2020||Approved| |||||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0310834920||| |:01/82/050/01099/AM20/||:03/94/040/00984/AM20/||18.02.2020|||

	Case No.:65/2/82-ALC4/2020	Case No.:65/2/82-ALC4/2020	Case No.:65/2/82-ALC4/2020	Party Name:GLENMARK<br>PHARMACEUTICALS LTD	Party Name:GLENMARK<br>PHARMACEUTICALS LTD	Party Name:GLENMARK<br>PHARMACEUTICALS LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
	HQ File<br>:01/82/050/01099/AM20/			RLA File<br>:03/94/040/00984/AM20/			Lic.No/Date:0310834920<br>18.02.2020
211	<br>Decision:The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or 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>THEOPHYLLINE<br>ER<br>TABS<br>400MG (Pack Size 100 Tabs.)<br>( Net Wt. of THEOPHYLLINE<br>ANHYDROUS USP is 1200.000<br>Kgs)<br>1 Number<br>1<br>THEOPHYLLINE<br>ANHYDROUS USP<br>408 mg /<br>400 mg<br>Tablet<br>2<br>THEOPHYLLINE<br>ER<br>TABS<br>600MG (Pack Size 100 Tabs.)<br>( Net Wt.

E ANHYDROUS USP is 1200.000 Kgs) 1 Number 1 THEOPHYLLINE ANHYDROUS USP 408 mg / 400 mg Tablet 2 THEOPHYLLINE ER TABS 600MG (Pack Size 100 Tabs.) ( Net Wt. of THEOPHYLLINE ANHYDROUS USP is 2100.000 Kgs) 1 Number 1 THEOPHYLLINE ANHYDROUS USP 612 mg / 600 mg Tablet RA concerned maytake further necessaryaction asper above decision of NC.||||||||| |||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.|| |||1|THEOPHYLLINE ER TABS 400MG (Pack Size 100 Tabs.) ( Net Wt. of THEOPHYLLINE ANHYDROUS USP is 1200.000 Kgs)||1 Number|1|THEOPHYLLINE ANHYDROUS USP|408 mg / 400 mg Tablet|| |||2|THEOPHYLLINE ER TABS 600MG (Pack Size 100 Tabs.) ( Net Wt. of THEOPHYLLINE ANHYDROUS USP is 2100.000 Kgs)||1 Number|1|THEOPHYLLINE ANHYDROUS USP|612 mg / 600 mg Tablet|| |||||||||||

Case No.:66/2/82-ALC4/2020	Party Name:VERGO	Meet No/Date:5/82-	Status:
	PHARMA RESEARCH	ALC4/2020	Approved
	LABORATORIES PVT. LTD.,	09.10.2020
HQ File	RLA File	Lic.No/Date:0310834922
:01/82/050/01100/AM20/	:03/95/040/01081/AM20/	18.02.2020

|||PHARMA RESEARCH||ALC4/2020||Approved| |||LABORATORIES PVT. LTD.,||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0310834922||| |:01/82/050/01100/AM20/||:03/95/040/01081/AM20/||18.02.2020|||

	Case No.:66/2/82-ALC4/2020	Party Name:VERGO<br>PHARMA RESEARCH<br>LABORATORIES PVT. LTD.,	Party Name:VERGO<br>PHARMA RESEARCH<br>LABORATORIES PVT. LTD.,	Party Name:VERGO<br>PHARMA RESEARCH<br>LABORATORIES PVT. LTD.,	Party Name:VERGO<br>PHARMA RESEARCH<br>LABORATORIES PVT. LTD.,	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved
	HQ File<br>:01/82/050/01100/AM20/	RLA File<br>:03/95/040/01081/AM20/				Lic.No/Date:0310834922<br>18.02.2020
212	<br>Decision:The Committee considered the case as per agenda and in the light of earlier decision taken in<br>meeting No. 15/82-ALC4/2018 dated 22.03.2019 against advance authorization No. 1710006711 dated<br>12.06.2018, it was decided to ratify norms under Para 4.07 of HBP Vol.

earlier decision taken in meeting No. 15/82-ALC4/2018 dated 22.03.2019 against advance authorization No. 1710006711 dated 12.06.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. CLINDAMYCIN HCL CAPSULES -150 MG 1 Number 1. CLINDAMYCIN HYDRO CLORIDE EP 173.53 mg CLINDAMYCIN HCL CAPSULES -150 MG 1 Number 1. CLINDAMYCIN HYDRO CLORIDE EP 173.53 mg CLINDAMYCIN HCL CAPSULES -300MG 1 Number 1. CLINDAMYCIN HYDRO CLORIDE EP 347.06 mg RA concerned may take further necessary action as per above decision of NC.||||||| ||||Qty.|Sl. No.|Import items||Qty.| ||||1 Number|1.|CLINDAMYCIN HYDRO CLORIDE EP||173.53 mg| ||||1 Number|1.|CLINDAMYCIN HYDRO CLORIDE EP||173.53 mg| ||||1 Number|1.|CLINDAMYCIN HYDRO CLORIDE EP||347.06 mg| |||||||||

Status:

213 Case No.:62/2/82-ALC4/2020 Party Name:BALAJI AMINES Meet No/Date:5/82-

<br> <br>		LIMITED<br>RLA File<br>:31/83/040/00151/AM20/	ALC4/2020<br>09.10.2020	Deferred
	HQ File<br>:01/82/050/01096/AM20/		Lic.No/Date:3110067689<br>19.02.2020
	Decision:Deferred for comments of TE.

Decision: Deferred for comments of TE.

ed**| |---|---|---|---|---| ||HQ File :01/82/050/01096/AM20/||Lic.No/Date:3110067689 19.02.2020|| ||**Decision:**Deferred for comments of TE.||||

Decision: Deferred for comments of TE.

214<br> <br> <br> <br> <br> <br> <br>	Case No.:63/2/82-ALC4/2020	Party Name:SUPERMINT<br>EXPORTS PRIVATE<br>LIMITED<br>RLA File<br>:05/24/040/00729/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	HQ File<br>:01/82/050/01097/AM20/		Lic.No/Date:0510413656<br>19.02.2020
	Decision:Reminder sent to firm on 18.09.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20<br>dated 15.05.2019.

Decision: Reminder sent to firm on 18.09.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.

Case No.:64/2/82-	Party Name:RAJASTHAN	Meet No/Date:5/82-	Status:
ALC4/2020	ANTIBIOTICS LTD	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0510413657
:01/82/050/01098/AM20/	:05/24/040/00728/AM20/	19.02.2020

-|---|---| |ALC4/2020||ANTIBIOTICS LTD||ALC4/2020||Approved| |||||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0510413657||| |:01/82/050/01098/AM20/||:05/24/040/00728/AM20/||19.02.2020|||

Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in meeting No. 5/82-ALC4/2019 dated 02.08.2019 against advance authorization No. 0310828072 dated 215 02.04.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

ess:
Qty.	Sl.<br>No.	Import items	Qty.
1 kg	1	Meropenem trihydrate Non Sterile	0.958 kg

Case No.:68/2/82-ALC4/2020	Party Name:STERILE INDIA	Meet No/Date:5/82-	Status:
	PRIVATE LIMITED	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0510413676
:01/82/050/01102/AM20/	:05/24/040/00730/AM20/	20.02.2020

Decision : The Committee considered the case as per agenda and in the light of earlier decision taken in meeting No. 4/82-ALC4/2018 dated 19.06.2018 against advance authorization No. 0510405555 dated 216 07.02.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

pplied by the firm, whichever is less:
Export product	Qty.	Sl.	Import items	Qty.
		No.
Piperacillin and Tazobactum Sodium	1 kg	1	PIPERACILLIN ACID	0.891 kg
Sterile(8:1)		2	TAZOBACTAM ACID	0.109 kg

Status:

|---|---|---| |Export product|Qty.|Sl.|Import items|Qty.| |||No.||| |Piperacillin and Tazobactum Sodium|1 kg|1|PIPERACILLIN ACID|0.891 kg| |Sterile(8:1)||2|TAZOBACTAM ACID|0.109 kg|

Status:

217 Case No.:67/2/82-ALC4/2020 Party Name:GITANJALI Meet No/Date:5/82-

	CHEMICALS PVT LTD	ALC4/2020
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310834973
:01/82/050/01101/AM20/	:03/94/040/00928/AM20/	21.02.2020

218	Case No.:69/2/82-ALC4/2020	Party Name:ORIENTAL<br>AROMATICS LTD	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01103/AM20/	RLA File<br>:03/95/040/01082/AM20/	Lic.No/Date:0310834955<br>21.02.2020
	Decision:Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20<br>dated 15.05.2019.

Application is still awaited. Hence, it was decided to issue Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.||||

219	Case No.:73/2/82-ALC4/2020	Party Name:SUDEEP<br>PHARMA PRIVATE<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01107/AM20/	RLA File<br>:34/24/040/00272/AM20/	Lic.No/Date:3410045894<br>21.02.2020
	Decision:Reminder sent to firm on 10.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20<br>dated 15.05.2019.

5.05.2019. Application is still awaited. Hence, it was decided to issue Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.

Case No.:70/2/82-ALC4/2020 Party Name:AARTI DRUGS Meet No/Date:5/82- Status: LIMITED ALC4/2020 Deferred 09.10.2020 HQ File RLA File Lic.No/Date:0310835027 220 :01/82/050/01104/AM20/ :03/94/040/00970/AM20/ 24.02.2020 Decision: Reminder sent to firm on 19.08.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.

221	Case No.:71/2/82-ALC4/2020	Party Name:AARTI DRUGS<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01105/AM20/	RLA File<br>:03/94/040/00969/AM20/	Lic.No/Date:0310835028<br>24.02.2020
	Decision:Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20<br>dated 15.05.2019.

Application is still awaited. Hence, it was decided to issue Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.||||

Decision: Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.

Meet No/Date:5/82- Status: 222 [Case No.:72/2/82-ALC4/2020 ][ Party Name:AARTI DRUGS ] LIMITED ALC4/2020 Deferred

09.10.2020 HQ File RLA File Lic.No/Date:0310835029 :01/82/050/01106/AM20/ :03/94/040/00980/AM20/ 24.02.2020

223	<br>Case No.:74/2/82-ALC4/2020	Party Name:RECKITT<br>BENCKISER (INDIA)<br>PRIVATE LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01108/AM20/	RLA File<br>:05/24/040/00731/AM20/	Lic.No/Date:0510413690<br>24.02.2020
	Decision:Deferred for comments of TE.

Deferred*| |---|---|---|---|---| || HQ File :01/82/050/01108/AM20/|RLA File :05/24/040/00731/AM20/|Lic.No/Date:0510413690 24.02.2020|| ||**Decision:**Deferred for comments of TE.||||

224	Case No.:78/2/82-ALC4/2020	Party Name:J N P PRODUCTS	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01112/AM20/	RLA File<br>:34/24/040/00370/AM20/	Lic.No/Date:3410045901<br>24.02.2020
	Decision:Reminder sent to firm on 10.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20<br>dated 15.05.2019.

Case No.:75/2/82-ALC4/2020	Party Name:FINE ORGANIC	Meet No/Date:5/82-	Status:
	INDUSTRIES LIMITED	ALC4/2020	Rejected
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310835056
:01/82/050/01109/AM20/	:03/94/040/01001/AM20/	25.02.2020

---|---|---|---|---| |||INDUSTRIES LIMITED||ALC4/2020||Rejected| |||||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0310835056||| |:01/82/050/01109/AM20/||:03/94/040/01001/AM20/||25.02.2020|||

225 Decision: The Committee considered the case as per agenda and it was observed that one of the import items namely Refined High Oleic Sun Flower Oil having ITC HS – 15121910 comes under Chapter 15 and as per para 4.11 (a) (i) of the FTP 2015-20 , all vegetable / edible oils classified under Chapter 15 of ITC (HS) are ineligible for import on self- declaration basis under para 4.07 of the FTP.

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

226 Case No.:76/2/82-

Status:

Party Name:GLENMARK Meet No/Date:5/82-

ALC4/2020	PHARMACEUTICALS LTD	ALC4/2020
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310835057
:01/82/050/01110/AM20/	:03/94/040/00992/AM20/	25.02.2020

Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in meeting No. 10/82-ALC4/2019 dated 29.11.2019 against advance authorization No. 0310831648 dated 19.09.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

against advance authorization No. 0310831648 dated 19.09.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Sl.<br>No.	Export Product	Qty.	Sl.<br>No.	Import items	Qty.
1	Drospirenone<br>and<br>Ethinyl<br>Estradiol Tablets (YASMIN) 3<br>mg / 0.03 mg (Pack 3 x 28s)<br>(Net wt of Drospirenone USP<br>(Micronized)is 49.140 Kgs)	260000.000<br>Number	1	Drospirenone USP<br>(Micronized	108.50 kg
2	Drospirenone<br>and<br>Ethinyl<br>Estradiol Tablets (YAZ) ( Pack 3<br>x<br>28s)<br>3<br>mg<br>/<br>0.02<br>mg<br>(Net wt of Drospirenone USP<br>(Micronized)is 57.240Kgs)	265000.000<br>Number

Case No.:79/2/82-ALC4/2020	Party Name:MEDREICH	Meet No/Date:5/82-	Status:
	LIMITED	ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0710116165
:01/82/050/01113/AM20/	:07/24/040/00281/AM20/	25.02.2020

227

Qty.	Sl.<br>No.	Import items	Qty.
1 Number<br>Tablet	1	REBAMIPIDE JP	102.00 mg
	2	ETHYL<br>ALCOHOL<br>200<br>PROOF<br>[ETHANOL] [QTY IN LTRS:<br>13357.45]	151.00 mg

227

Qty.	Sl.<br>No.	Import items	Qty.
1 Number<br>Tablet	1	REBAMIPIDE JP	102.00 mg
	2	ETHYL<br>ALCOHOL<br>200<br>PROOF<br>[ETHANOL] [QTY IN LTRS:<br>13357.45]	151.00 mg

228	Case No.:80/2/82-ALC4/2020	Party Name:BALAJI AMINES<br>LIMITED<br>RLA File<br>:31/83/040/00150/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	HQ File<br>:01/82/050/01114/AM20/		Lic.No/Date:3110067697<br>25.02.2020
	Decision:Deferred for comments of TE.

229	Case No.:81/2/82-ALC4/2020	Party Name:DEEPAK<br>PHENOLICS LIMITED	Meet No/Date:5/82-<br>ALC4/2020	Status:<br>Deferred

				09.10.2020
HQ File		RLA File		Lic.No/Date:3410045910
:01/82/050/01115/AM20/		:34/24/040/00359/AM20/		25.02.2020

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 07.09.2020 has furnished its reply. Deferred for comments of TE.

230	Case No.:82/2/82-ALC4/2020	Party Name:DEEPAK<br>PHENOLICS LIMITED<br>RLA File<br>:34/24/040/00334/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br> <br><br>Lic.No/Date:3410045911<br>25.02.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01116/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 e-mail dated 07.09.2020 has furnished its reply. Deferred for comments of TE.

ttee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 07.09.2020 has furnished its reply. Deferred for comments of TE.||||

Case No.:83/2/82-ALC4/2020	Party Name:NATURAL AND	Meet No/Date:5/82-	Status:
	ESSENTIAL OILS PVT LTD	ALC4/2020	Deferred
		09.10.2020
HQ File	RLA File	Lic.No/Date:0710116169
:01/82/050/01117/AM20/	:07/24/040/00288/AM20/	25.02.2020

Decision: The Committee considered the case as per online agenda in the presence of technical experts 231 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, followed by Reminder on 03.09.2020:

(i) Complete material balance on the basis of purity of import item.

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

232	<br>Case No.:84/2/82-ALC4/2020	Party Name:PIRAMAL<br>ENTERPRISES LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01118/AM20/	RLA File<br>:03/95/040/01121/AM20/	Lic.No/Date:0310835077<br>26.02.2020
	Decision:Deferred for comments of TE.

Deferred*| |---|---|---|---|---| || HQ File :01/82/050/01118/AM20/|RLA File :03/95/040/01121/AM20/|Lic.No/Date:0310835077 26.02.2020|| ||**Decision:**Deferred for comments of TE.||||

233 [Case No.:85/2/82-] ALC4/2020

Party Name:SATYADIVIS Meet No/Date:5/82- Status: PHARMACEUTICALS ALC4/2020 Approved

		PRIVATE LIMITED		09.10.2020
HQ File		RLA File		Lic.No/Date:0910068514
:01/82/050/01119/AM20/		:09/24/040/00574/AM20/		26.02.2020

Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in meeting No. 5/82-ALC4/2019 dated 02.08.2019 against advance authorization No. 0910067437 dated 02.05.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

pplied by the firm, whichever is less:
Export product	Qty.	Sl.<br>No.	Import items	Qty.
ALPHA-(2-METHYL AMINE) ETHYL<br>BENZENE METHANOL	1 kg	1	BENZALDEHYDE	1.72 kg
		2	PALLADIUM	0.002 kg
		3	PARAFORMALDEHYDE	0.40 kg
		4	ACETOPHENONE	1.63 kg

ty.|Sl. No.|Import items|Qty.| |ALPHA-(2-METHYL AMINE) ETHYL BENZENE METHANOL|1 kg|1|BENZALDEHYDE|1.72 kg| |||2|PALLADIUM|0.002 kg| |||3|PARAFORMALDEHYDE|0.40 kg| |||4|ACETOPHENONE|1.63 kg|

234	Case No.:86/2/82-ALC4/2020	Party Name:SRINI<br>PHARMACEUTICALS<br>PRIVATE LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	HQ File<br>:01/82/050/01120/AM20/	RLA File<br>:09/24/040/00593/AM20/	Lic.No/Date:0910068522<br>27.02.2020
	Decision:Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20<br>dated 15.05.2019.

235	Case No.:87/2/82-ALC4/2020	Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	HQ File<br>:01/82/050/01121/AM20/	RLA File<br>:09/24/040/00596/AM20/	Lic.No/Date:0910068530<br>02.03.2020
	Decision:Deferred for comments of TE.

br>Deferred| |---|---|---|---|---| ||HQ File :01/82/050/01121/AM20/|RLA File :09/24/040/00596/AM20/|Lic.No/Date:0910068530 02.03.2020|| ||**Decision:**Deferred for comments of TE.||||

236	Case No.:88/2/82-ALC4/2020	Party Name:VIVIMED LIFE<br>SCIENCES PRIVATE<br>LIMITED	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	HQ File<br>:01/82/050/01122/AM20/	RLA File<br>:09/24/040/00576/AM20/	Lic.No/Date:0910068533<br>02.03.2020
	Decision:Reminder sent to firm on 23.10.2020 for furnishing a copy of 4.07 application<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited.			as per policy

Status: 237 [Case No.:89/2/82-ALC4/2020 ][ Party Name:CIPLA LIMITED. Meet No/Date:5/82-] ALC4/2020 Deferred

		RLA File<br>:03/94/040/00991/AM20/	09.10.2020
	HQ File<br>:01/82/050/01123/AM20/		Lic.No/Date:0310835171<br>03.03.2020
	Decision:Deferred for comments of TE.

Case No.:90/2/82-ALC4/2020	Party Name:FDC LTD	Meet No/Date:5/82-	Status:
		ALC4/2020	Approved
		09.10.2020
HQ File	RLA File	Lic.No/Date:0310835172
:01/82/050/01124/AM20/	:03/94/040/01023/AM20/	03.03.2020

atus:**| |---|---|---|---|---|---|---| |||||ALC4/2020||Approved| |||||09.10.2020||| |HQ File||RLA File||Lic.No/Date:0310835172||| |:01/82/050/01124/AM20/||:03/94/040/01023/AM20/||03.03.2020|||

Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in meeting No. 7/82-ALC4/2019 dated 06.09.2019 against advance authorization No. 0310831107 dated 238 20.08.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

pplied by the firm, whichever is less:
Exportproduct	Qty.	Import items	Qty.
Natoptic Eye Drops 5 ml<br>(Natamycin Ophthalmic Suspension<br>5.0% w/v)	120000 vials	NATAMYCIN (MICRONISED) IP	<br>30.6 kg

Case No.:91/2/82-ALC4/2020	Party Name:TAGOOR	Meet No/Date:5/82-	Status:
	CHEMICALS PRIVATE	ALC4/2020	Approved
	LIMITED	09.10.2020
HQ File	RLA File	Lic.No/Date:0910068543
:01/82/050/01125/AM20/	:09/24/040/00546/AM20/	03.03.2020

239

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:

239

Export product	Qty.	Sl.<br>No.	Import items	Qty.
N-BOC-4-PIPERIDONE	1 kg	1	METHYL ACRYLATE	3.55 kg
		2	SODIUM METHOXIDE	1.12 kg
		3	ETHYL CHLORO FORMATE	1.30 kg
		4	DI TERT BUTYL DICARBONATE	1.33 kg
		5	METHANOL	0.20 kg
		6	TOLUENE	0.37 kg

Case No.:92/2/82-ALC4/2020	Party Name:TAGOOR	Meet No/Date:5/82-	Status:
	CHEMICALS PRIVATE	ALC4/2020	Approved
	LIMITED	09.10.2020
HQ File	RLA File	Lic.No/Date:0910068544
:01/82/050/01126/AM20/	:09/24/040/00547/AM20/	03.03.2020

	Case No.:92/2/82-ALC4/2020 <br>HQ File<br>:01/82/050/01126/AM20/	Party Name:TAGOOR<br>CHEMICALS PRIVATE<br>LIMITED<br> <br> <br> <br>RLA File<br>:09/24/040/00547/AM20/<br> <br>	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Approved<br>
			Lic.No/Date:0910068544<br>03.03.2020
240	<br>Decision:The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol.

241	Case No.:93/2/82-ALC4/2020	Party Name:BDR<br>PHARMACEUTICALS<br>INTERNATIONAL PVT. LTD.<br>RLA File<br>:03/94/040/01012/AM20/	<br>Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01127/AM20/		Lic.No/Date:0310835222<br>04.03.2020
	Decision:Reminder sent to firm on 10.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20<br>dated 15.05.2019.

Application is still awaited. Hence, it was decided to issue Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.||||

242	Case No.:94/2/82-ALC4/2020	Party Name:THINQ PHARMA<br>CRO LIMITED<br>RLA File<br>:03/95/040/01105/AM20/	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01128/AM20/		Lic.No/Date:0310835265<br>06.03.2020
	Decision:Reminder sent to firm on 07.08.2020 for furnishing a copy of 4.07 application as per policy<br>circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, it was decided to issue<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20<br>dated 15.05.2019.

5.05.2019. Application is still awaited. Hence, it was decided to issue Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.

243	Case No.:95/2/82-ALC4/2020	Party Name:MANGALAM<br>ORGANICS LIMITED<br>FORMERLY DUJODWALA<br>PRODU	Meet No/Date:5/82-<br>ALC4/2020<br>09.10.2020<br>Lic.No/Date:0310835280<br>06.03.2020	Status:<br>Deferred
	<br>HQ File<br>:01/82/050/01129/AM20/	RLA File<br>:03/95/040/01078/AM20/
	Decision:The Committee considered the case as per agenda in the presence of technical experts and<br>it was decided to call for following information from the firm:<br>(i)<br>Complete technical details as per Appendix 4E.<br>(ii)<br>COA of import item from foreign supplier indicating Alpha Pinene content.

|244|Case No.:96/2/82-ALC4/2020|Party Name:AETHER<b

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