IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2022-09-16

DGFT Committee Minutes

Document text

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Government of India Ministry of Commerce and Industry Department of Commerce

DIRECTORATE GENERAL OF FOREIGN TRADE (DES - III SECTION)

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Sep/202223/7 DATED: 16/09/2022

Please Note

I. For information of exporters, Norms Committee - III handles all cases pertaining to fixation/ratification of norms for Export Products falling under ITC (HS) Chapter 29, 30 .Communications in respect of cases/pertaining to NC- III may be sent to email address: nc3.dgft@nic.in
II. The Norms Committee has taken decision only with respect to technical aspect/wastage norms. While redeeming the applications, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure including those in Policy Circulars issued from time to time or any other provisions under FTP/HBP for EODC.
III. Wherever the Committee has fixed Norms, the concerned RA may ensure that AA is issued on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less.

Meeting No. NC/3/MEET/Sep/202223/7 dated 16/09/2022 of Norms Committee - III for the year 2022-23 was held on 16/09/2022 under the Chairmanship of Rajiv Soni ,Joint DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

S.No.	Name and Designation of Representatives	Department
1	AJAY KUMAR,Deputy Director	Directorate General of Foreign Trade, Delhi
3	SHAISH KUMAR,Technical Authority	Technical Consultant,DGFT
4	DINESHNARAIN MATHUR,Technical<br>Authority	Technical Consultant,DGFT

Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Sep/202223/7
Case Status	Case Approved

This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:50.

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Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM REVIW00166247AM22
RA File Number	082404000415 AM14
Licence No and Date	0810127686/03/01/2014
Norms Committee Decision:<br>Shri Anil Jain, CEO, Shri Ketan Doshi, General Manager (R&C) and Shri D.K. Singh, A.R. ; attended the Personal<br>Hearing and explained their case. The Committee after deliberation decided to revise adhoc norms as under:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>p-HYDROXY BENZALDEHYDE (LIGHT<br>YELLOW<br>CRYSTALLINE<br>POWDER),<br>PARA HYDROXY BENZALDEHYDE, 4-<br>HYDROXY BENZALDEHYDE<br>1.69 kg<br>2<br>ACETONE (COLORLESS LIQUID)<br>1.50 kg<br>RASPBERRY KETONE/ 4-(4-<br>HYDROXYPHYENYL)<br>BUTANE - 2 - ONE WHITE<br>CRYSTALLINE POWDER<br>(Assay NLT 99%)<br>1 kg<br>3<br>G2PAC ASSEMBLY 700 LITER / 250 KGS<br>(35 inch x 35 inch x 35 inch polyprpelene<br>woven fabric bags)<br>Relevant as per<br>packing policy<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	2 / NC/3/MEET/Sep/202223/7
Case Status	Case Approved
Party Name	GLAND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM REVIW00000284AM23
RA File Number	092404000563 AM15
Licence No and<br>Date	0910061513/08/01/2015
Norms Committee Decision:<br>Shri N. Prabhakar Rao, GM Commercial and Shri A. Jayateerth, DGM – Production attended the Personal Hearing<br>and explained their case. The Committee after deliberation decided to revise adhoc norms as under:

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Sl.<br>No.	Export Product	Qty.	Sl. No.	Import items	Qty.
1	Enoxaparin Sodium Injection<br>40mg Pre filled Syringes<br>Injectable	<br> <br>1 Number	1	Heparin Sodium Powder	79.466 mg
			2	Barrel Syringes Glass	Net + 5% wastage
			3	Needle Shield Rubber	Net to Net
			4	Plunger Stoppers Rubber	Net + 11.55% wastage
			5	Plunger Rods Plastic	Net + 2.5% wastage
			6	Preventis Plastic	Net to Net
			7	Anti Factor Xa Test Kits	Consumables,<br>Accessories,<br>etc. not allowed under policy
			8	Anti Factor IIa Test Kits	Consumables,<br>Accessories,<br>etc. not allowed under policy
			9	Analytical Columns Kits	Consumables,<br>Accessories,<br>etc. not allowed under policy
			10	Analytical Guard Columns<br>Kits	Consumables,<br>Accessories,<br>etc. not allowed under policy
			11	Medical Grade Paper Paper	Consumables,<br>Accessories,<br>etc. not allowed under policy
			12	Tubing Plastic	Consumables,<br>Accessories,<br>etc. not allowed under policy
			13	Anti Factor Xa Kits	Consumables,<br>Accessories,<br>etc. not allowed under policy
			14	Anti Factor IIa Kits	Consumables,<br>Accessories,<br>etc. not allowed under policy
			15	N.M.R. Standard Kits	Consumables,<br>Accessories,<br>etc. not allowed under policy

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			16	Mol. Wt. Standard Kits	Consumables,<br>Accessories,<br>etc. not allowed under policy
2	Enoxaparin Sodium Injection<br>60mg Pre filled Syringes<br>Injectable	<br> <br>1 Number	1	Heparin Sodium Powder	119.187 mg
			2	Barrel Syringes Glass	Net + 5% wastage
			3	Needle Shield Rubber	Net to Net
			4	Plunger Stoppers Rubber	Net + 10.85% wastage
			5	Plunger Rods Plastic	Net + 1.65% wastage
			6	Preventis Plastic	Net to Net
			7	Anti Factor Xa Test Kits	Consumables,<br>Accessories,<br>etc. not allowed under policy
			8	Anti Factor IIa Test Kits	Consumables,<br>Accessories,<br>etc. not allowed under policy
			9	Analytical Columns Kits	Consumables,<br>Accessories,<br>etc. not allowed under policy
			10	Analytical Guard Columns<br>Kits	Consumables,<br>Accessories,<br>etc. not allowed under policy
			11	Medical Grade Paper Paper	Consumables,<br>Accessories,<br>etc. not allowed under policy
			12	Tubing Plastic	Consumables,<br>Accessories,<br>etc. not allowed under policy
			13	Anti Factor Xa Kits	Consumables,<br>Accessories,<br>etc. not allowed under policy
			14	Anti Factor IIa Kits	Consumables,<br>Accessories,<br>etc. not allowed under policy
			15	N.M.R. Standard Kits	Consumables,<br>Accessories,<br>etc. not allowed under policy

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16 Mol. Wt. Standard Kits Consumables, Accessories, etc. not allowed under policy RA concerned may take further necessary action as per above decision of NC.

Case No.	3 / NC/3/MEET/Sep/202223/7
Case Status	Case Approved
Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM REVIW00166244AM22
RA File Number	082404000397 AM15
Licence No and Date	0810134800/13/03/2015
Norms Committee Decision:<br>Shri Anil Jain, CEO, Shri Ketan Doshi, General Manager (R&C) and Shri D.K. Singh, A.R. ; attended the Personal<br>Hearing and explained their case. The Committee after deliberation decided to revise adhoc norms as under:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>p-HYDROXY BENZALDEHYDE (LIGHT<br>YELLOW<br>CRYSTALLINE<br>POWDER),<br>PARA HYDROXY BENZALDEHYDE, 4-<br>HYDROXY BENZALDEHYDE<br>1.69 kg<br>2<br>ACETONE (COLORLESS LIQUID)<br>1.50 kg<br>RASPBERRY KETONE/ 4-(4-<br>HYDROXYPHYENYL)<br>BUTANE - 2 - ONE WHITE<br>CRYSTALLINE POWDER<br>(Assay NLT 99%)<br>1 kg<br>3<br>G2PAC ASSEMBLY 700 LITER / 250 KGS<br>(35 inch x 35 inch x 35 inch polyprpelene<br>woven fabric bags)<br>Relevant as per<br>packing policy<br>RA concerned may take further necessary action as per above decision of NC.

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Case No.	4 / NC/3/MEET/Sep/202223/7
Case Status	Case Approved
Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM REVIW00166233AM22
RA File Number	082404000104 AM17
Licence No and Date	0810138218/28/06/2016
Norms Committee Decision:<br>Shri Anil Jain, CEO, Shri Ketan Doshi, General Manager (R&C) and Shri D.K. Singh, A.R. ; attended the Personal<br>Hearing and explained their case. The Committee after deliberation decided to revise adhoc norms as under:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>p-HYDROXY BENZALDEHYDE (LIGHT<br>YELLOW<br>CRYSTALLINE<br>POWDER),<br>PARA HYDROXY BENZALDEHYDE, 4-<br>HYDROXY BENZALDEHYDE<br>1.69 kg<br>2<br>ACETONE (COLORLESS LIQUID)<br>1.50 kg<br>RASPBERRY KETONE/ 4-(4-<br>HYDROXYPHYENYL)<br>BUTANE - 2 - ONE WHITE<br>CRYSTALLINE POWDER<br>(Assay NLT 99%)<br>1 kg<br>3<br>G2PAC ASSEMBLY 700 LITER / 250 KGS<br>(35 inch x 35 inch x 35 inch polyprpelene<br>woven fabric bags)<br>Relevant as per<br>packing policy<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	5 / NC/3/MEET/Sep/202223/7
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM REVIW00001184AM23
RA File Number	092404000181 AM19
Licence No and	0910066442/11/07/2018

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Date

Norms Committee Decision:

Shri M. Ravi Kumar, DGFT (Exim) and Shri V. Jaya Prakash, Manager (Impex) attended the Personal Hearing and explained their case. The Committee after deliberation decided to call for following information from the firm:

i. Details on import item - Clavulanate Potassium +Syloid for kg Activity is not given as per discussion in PH.
ii. Consumption coefficient for 1 kg Amoxycilin Trihydrate Bulk.

(iii) Wastage applied on Tablets / Capsules from API.

Case No.	6 / NC/3/MEET/Sep/202223/7
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM REVIW00001185AM23
RA File Number	092404000345 AM19
Licence No and<br>Date	0910066762/25/10/2018
Norms Committee Decision:<br>Shri M. Ravi Kumar, DGFT (Exim) and Shri V. Jaya Prakash, Manager (Impex) attended the Personal Hearing and<br>explained their case. The Committee after deliberation decided to call for following information from the firm:<br>Details on import item - Clavulanate Potassium +Syloid for kg Activity is not given as per discussion in<br>PH.<br>i.<br>Consumption coefficient for 1 kg Amoxycilin Trihydrate Bulk.<br>ii.<br>(iii) Wastage applied on Tablets / Capsules from API.

Case No.	7 / NC/3/MEET/Sep/202223/7
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM REVIW00001186AM23
RA File Number	092404000386 AM19

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Licence No and<br>Date	0910066874/20/11/2018
Norms Committee Decision:<br>Shri M. Ravi Kumar, DGFT (Exim) and Shri V. Jaya Prakash, Manager (Impex) attended the Personal Hearing and<br>explained their case. The Committee after deliberation decided to call for following information from the firm:<br>Details on import item - Clavulanate Potassium +Syloid for kg Activity is not given as per discussion in<br>PH.<br>i.<br>Consumption coefficient for 1 kg Amoxycilin Trihydrate Bulk.<br>ii.<br>(iii) Wastage applied on Tablets / Capsules from API.

Licence No and Date

0910066874/20/11/2018

Norms Committee Decision: Shri M. Ravi Kumar, DGFT (Exim) and Shri V. Jaya Prakash, Manager (Impex) attended the Personal Hearing and explained their case. The Committee after deliberation decided to call for following information from the firm: Details on import item - Clavulanate Potassium +Syloid for kg Activity is not given as per discussion in PH. i. Consumption coefficient for 1 kg Amoxycilin Trihydrate Bulk. ii. (iii) Wastage applied on Tablets / Capsules from API.

Case No.	Case No.	Case No.	8 / NC/3/MEET/Sep/202223/7	8 / NC/3/MEET/Sep/202223/7	8 / NC/3/MEET/Sep/202223/7	8 / NC/3/MEET/Sep/202223/7	8 / NC/3/MEET/Sep/202223/7
Case Status			Case Approved
Party Name			GLAND PHARMA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number			HQRNORM REVIW00000283AM23
RA File Number			092404000491 AM19
Licence No and<br>Date			0910067225/27/02/2019
Norms Committee Decision:<br>Shri N. Prabhakar Rao, GM Commercial and Shri A. Jayateerth, DGM – Production attended the Personal Hearing<br>and explained their case. The Committee after deliberation decided to revise adhoc norms as under:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>Heparin Sodium<br>59.6 mg<br>2<br>0.5ml Barrel Syringes<br>Net + 5% wastage<br>3<br>0.5ml Needle Shield<br>Net to Net<br>4<br>0.5ml Plunger Stoppers<br>Net + 12% wastage<br>5<br>0.5ml Plunger Rods<br>Net + 2.5% wastage<br>1<br>Enoxaparin Sodium Injection<br>30mg/0.3ml,<br>Pre-filled<br>Syringes<br>1 Number
	Sl.<br>No.	Export Product		Qty.	Sl.<br>No.	Import items	Qty.
	1	Enoxaparin Sodium Injection<br>30mg/0.3ml,<br>Pre-filled<br>Syringes		<br> <br>1 Number	1	Heparin Sodium	59.6 mg
					2	0.5ml Barrel Syringes	Net + 5% wastage
					3	0.5ml Needle Shield	Net to Net
					4	0.5ml Plunger Stoppers	Net + 12% wastage
					5	0.5ml Plunger Rods	Net + 2.5% wastage

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			6	0.5ml<br>Preventis<br>Needle<br>shielding System	<br>Net + 3% wastage
2	Enoxaparin Sodium Injection<br>100mg/1.0ml<br>Pre-filled<br>Syringes	<br> <br>1 Number	7	Heparin Sodium	198.664 mg
			8	1ml Barrel Syringes	Net + 5% wastage
			9	1ml Needle Shield	Net to Net
			10	1ml Plunger Stoppers	Net + 12% wastage
			11	1ml Plunger Rods	Net + 2.5% wastage
			12	1ml<br>Preventis<br>Needle<br>shielding System	<br>Net + 3% wastage

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

Case No.	Case No.	9 / NC/3/MEET/Sep/202223/7	9 / NC/3/MEET/Sep/202223/7	9 / NC/3/MEET/Sep/202223/7	9 / NC/3/MEET/Sep/202223/7	9 / NC/3/MEET/Sep/202223/7
Case Status		Case Deferred
Party Name		GLAND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number		HQRNORM REVIW00000141AM23
RA File Number		092404000043 AM20
Licence No and<br>Date		0910067519/14/05/2019
Norms Committee Decision:<br>Shri N. Prabhakar Rao, GM Commercial and Shri A. Jayateerth, DGM – Production attended the Personal Hearing<br>and explained their case. The Committee after deliberation decided to revise adhoc norms as under:<br>Sl. No.<br>Export Product<br>Qty<br>Sl. No. Import Items<br>Qty<br>1<br>Heparin Sodium<br>39.733 mg<br>Enoxaparin<br>Sodium 1 Number<br>1
	Export Product		Qty	Sl. No.	Import Items	Qty
	Enoxaparin<br>Sodium		1 Number	1	Heparin Sodium	39.733 mg

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	Injection 20mg Pre-filled<br>Syringes		2	Barrel Syringes	Net + 5% wastage
			3	Needle Shield	Net to Net
			4	Plunger Stoppers	Net + 12% wastage
			5	Plunger Rods	Net + 2.5% wastage
			6	Preventis Needle Shielding System	Net + 3% wastage
2	Enoxaparin<br>Sodium<br>Injection 30mg Pre-filled<br>Syringes	<br> <br>1 Number	1	Heparin Sodium	59.6 mg
			2	Barrel Syringes	Net + 5% wastage
			3	Needle Shield	Net to Net
			4	Plunger Stoppers	Net + 12% wastage
			5	Plunger Rods	Net + 2.5% wastage
			6	Preventis Needle Shielding System	Net + 3% wastage
3	Enoxaparin<br>Sodium<br>Injection 40mg Pre-filled<br>Syringes	<br> <br>1 Number	1	Heparin Sodium	79.466 mg
			2	Barrel Syringes	Net + 5% wastage
			3	Needle Shield	Net to Net
			4	Plunger Stoppers	Net + 11.55% wastage
			5	Plunger Rods	Net + 2.5% wastage
			6	Preventis Needle Shielding System	Net + 3% wastage
4	Enoxaparin<br>Sodium<br>Injection 60mg Pre-filled<br>Syringes	<br> <br>1 Number	1	Heparin Sodium	119.187 mg
			2	Barrel Syringes	Net + 5% wastage
			3	Needle Shield	Net to Net

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			4	Plunger Stoppers	Net + 10.85% wastage
			5	Plunger Rods	Net + 1.65% wastage
			6	Preventis Needle Shielding System	Net + 3% wastage
5	Enoxaparin<br>Sodium<br>Injection 80mg Pre-filled<br>Syringes	<br> <br>1 Number	1	Heparin Sodium	158.93 mg
			2	Barrel Syringes	Net + 4.65% wastage
			3	Needle Shield	Net to Net
			4	Plunger Stoppers	Net + 12% wastage
			5	Plunger Rods	Net + 2.5% wastage
			6	Preventis Needle Shielding System	Net + 3% wastage
6	Enoxaparin<br>Sodium<br>Injection 100mg Pre-filled<br>Syringes	<br> <br>1 Number	1	Heparin Sodium	198.664 mg
			2	Barrel Syringes	Net + 5% wastage
			3	Needle Shield	Net to Net
			4	Plunger Stoppers	Net + 12% wastage
			5	Plunger Rods	Net + 2.5% wastage
			6	Preventis Needle Shielding System	Net + 3% wastage
7	Enoxaparin<br>Sodium<br>Injection 120mg Pre-filled<br>Syringes	<br> <br>1 Number	1	Heparin Sodium	238.40 mg
			2	Barrel Syringes	Net + 5% wastage
			3	Needle Shield	Net to Net
			4	Plunger Stoppers	Net + 12% wastage

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		5	Plunger Rods	Net + 2.5% wastage
		6	Preventis Needle Shielding System	Net + 3% wastage
Enoxaparin<br>Sodium<br>Injection 150mg Pre-filled<br>Syringes	<br> <br>1 Number	1	Heparin Sodium	298.00 mg
		2	Barrel Syringes	Net + 5% wastage
		3	Needle Shield	Net to Net
		4	Plunger Stoppers	Net + 12% wastage
		5	Plunger Rods	Net + 2.5% wastage
		6	Preventis Needle Shielding System	Net + 3% wastage

Case No.	Case No.	Case No.	10 / NC/3/MEET/Sep/202223/7	10 / NC/3/MEET/Sep/202223/7	10 / NC/3/MEET/Sep/202223/7	10 / NC/3/MEET/Sep/202223/7	10 / NC/3/MEET/Sep/202223/7
Case Status			Case Approved
Party Name			PIRAMAL ENTERPRISES LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number			018205000182AM20
RA File Number			039504000143 AM20
Licence No and<br>Date			0310829108/17/05/2019
Norms Committee Decision:<br>Shri Devesh Desai, Associate Vice President, Shri Sunil Kumar Jain, General Manager – Production and Shri<br>Prashant Khilare, Manager Commercial; attended the Personal Hearing and explained their case. The Committee<br>after deliberations decided to ratify adhoc 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>Sl. No. Export Product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.
	Sl. No.	Export Product		Qty.	Sl. No.	Import items	Qty.

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1	Atorvastatin Calcium Tablets USP 10mg<br>(Net wt. of Import Sr. No. 1 is 1180.35 kgs,<br>Sl. No. 2 is 8152.45 kg, Sr. No. 3 is<br>2272.66 kg, Sr. No. 4 is 1190000 Nos., Sr.<br>No. 8 is 1190000 Nos.)	<br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene Glycol Solvate<br>USP	<br> <br>11.415 mg
			2	Microcrystalline<br>Cellulose<br>(MCC) NF (Avicel PH 102)	<br>64.578 mg
			3	Calcium Acetate	18.049 mg
			4	PLASTIC BOTTLES 75CC<br>WHITE<br>HDPE<br>ROUND<br>38MM	<br> <br>Relevant as per<br>packing policy
			8	PLASTIC<br>CAPS<br>/<br>CLOSURES PP 38MM-400<br>BLUE CR	<br> <br>Relevant as per<br>packing policy
2	Atorvastatin Calcium Tablets USP 10mg<br>(Net wt. of Import Sr. No. 1 is 826.50kgs,<br>Sr. No. 2 is 5709 kg, Sr. No. 3 is 1591.50<br>kg, Sr. No. 5 is 750000 Nos., Sr. No. 9 is<br>75000 Nos.)	<br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene Glycol Solvate<br>USP	<br> <br>11.415 mg
			2	Microcrystalline<br>Cellulose<br>(MCC) NF (Avicel PH 102)	<br>64.578 mg
			3	Calcium Acetate	18.049 mg
			5	PLASTIC BOTTLES 250CC<br>WHITE<br>HDPE<br>ROUND<br>38MM	<br> <br>Relevant as per<br>packing policy
			9	PLASTIC<br>CAPS<br>/<br>CLOSURES PP 53MM –<br>400 BLUE PP	<br> <br>Relevant as per<br>packing policy
3	Atorvastatin Calcium Tablets USP 20mg<br>(Net wt. of Import Sr. No. 1 is 3041.13 kgs,<br>Sr. No. 2 is 20865.2 kgs, Sr. No. 3 is<br>5818.19 kg, Sr. No. 4 is 1533000 Nos., Sr.<br>No. 8 is 1533000 Nos.)	<br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene Glycol Solvate<br>USP	<br> <br>22.830 mg
			2	Microcrystalline<br>Cellulose<br>(MCC) NF (Avicel PH 102)	<br>129.427 mg
			3	Calcium Acetate	36.090 mg
			4	PLASTIC BOTTLES 75CC	Relevant as per

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				WHITE<br>HDPE<br>ROUND<br>38MM	<br>packing policy
			8	PLASTIC<br>CAPS<br>/<br>CLOSURES PP 38MM-400<br>BLUE CR	<br> <br>Relevant as per<br>packing policy
4	Atorvastatin Calcium Tablets USP 40mg<br>(Net wt. of Import Sr. No. 1 is 5717.25kgs,<br>Sr. No. 2 is 39891.35kg, Sr. No. 3 is<br>11123.51kg, Sr. No. 4 is 1441000 Nos., Sr.<br>No. 8 is 1441000 Nos.)	<br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene Glycol Solvate<br>USP	<br> <br>45.595 mg
			2	Microcrystalline<br>Cellulose<br>(MCC) NF (Avicel PH 102)	<br>258.08 mg
			3	Calcium Acetate	71.963 mg
			4	PLASTIC BOTTLES 75CC<br>WHITE<br>HDPE<br>ROUND<br>38MM	<br> <br>Relevant as per<br>packing policy
			8	PLASTIC<br>CAPS<br>/<br>CLOSURES PP 38MM-400<br>BLUE CR	<br> <br>Relevant as per<br>packing policy
5	Atorvastatin Calcium Tablets USP 80mg<br>(Net wt. of Import Sr. No. 1 is 3062.96kgs,<br>Sr. No. 2 is 20801.62 kg, Sr. No. 3 is<br>5800.89 kg, Sr. No. 6 is 386000 Nos., Sr.<br>No. 8 is 386000 Nos.)	<br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene Glycol Solvate<br>USP	<br> <br>91.20 mg
			2	Microcrystalline<br>Cellulose<br>(MCC) NF (Avicel PH 102)	<br>518.206 mg
			3	Calcium Acetate	144.929 mg
			6	PLASTIC BOTTLES 120CC<br>WHITE<br>HDPE<br>ROUND<br>38MM	<br> <br>Relevant as per<br>packing policy
			8	PLASTIC<br>CAPS<br>/<br>CLOSURES PP 38MM-400<br>BLUE CR	<br> <br>Relevant as per<br>packing policy
6	Atorvastatin<br>Calcium<br>Tablets<br>USP<br>80mg(Net wt. of Import Sr. No. 1 is<br>1763.36kgs, Sr. No. 2 is 11975.60 kgs, Sr.	<br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene Glycol Solvate<br>USP	<br> <br>91.20 mg

UDIN00232628AM23

	2	Microcrystalline<br>Cellulose<br>(MCC) NF (Avicel PH 102)	<br>518.206 mg
	3	Calcium Acetate	144.929 mg
	7	PLASTIC<br>BOTTLES<br>1500CC<br>WHITE<br>HDPE<br>ROUND 38MM	<br> <br>Relevant as per<br>packing policy
	10	PLASTIC<br>CAPS<br>/<br>CLOSURES PP 89MM –<br>400 WHITE PLAIN	<br> <br>Relevant as per<br>packing policy
Note: The above norms are valid only for subject to fulfillment of following conditions:<br>Export Product being Patented Medicine, be filed with USFDA filing ANDA (A New Drug Application) of Apotex<br>Corp, US. Agent for Apotex Inc., Candada.<br>1.<br>Export to USA only.<br>2.<br>Firm holding Certificate of Manufacturing Exclusivity.<br>3.

Case No.	Case No.	Case No.	11 / NC/3/MEET/Sep/202223/7	11 / NC/3/MEET/Sep/202223/7	11 / NC/3/MEET/Sep/202223/7	11 / NC/3/MEET/Sep/202223/7	11 / NC/3/MEET/Sep/202223/7
Case Status			Case Approved
Party Name			PIRAMAL ENTERPRISES LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number			HQRNORM REVIW00001325AM23
RA File Number			039504001121 AM20
Licence No and<br>Date			0310835077/26/02/2020
Norms Committee Decision:<br>Shri Devesh Desai, Associate Vice President, Shri Sunil Kumar Jain, General Manager – Production and Shri<br>Prashant Khilare, Manager Commercial; attended the Personal Hearing and explained their case. The Committee<br>after deliberations decided to revise adhoc norms as under:<br>Sl. No. Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.
	Sl. No.	Export Product		Qty.	Sl. No.	Import items	Qty.

UDIN00232628AM23

1	Atorvastatin Calcium Tablets USP<br>10mg (Pack Size 90 tabs)((Net wt.<br>of Import Sr. No. 1 is 629.53kgs,<br>Sr. No. 2 is 3486.56kg, Sr. No. 3 is<br>990.08kg, Sr. No. 4 is 634680 Nos.,<br>Sr. No. 8 is 634680 Nos.))	<br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>11.415 mg
			2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>64.578 mg
			3	Calcium Acetate	18.049 mg
			4	Plastic Bottles 75CC white HDPE<br>Round 38mm	<br>Relevant as per<br>packing policy
			5	CR38400APJT865<br>BLUE<br>PP465<br>1400 (Plastics Caps/Closures PP<br>38MM-400 Blue CR)	<br> <br>Relevant as per<br>packing policy
2	Atorvastatin Calcium Tablets USP<br>10mg (Pack Size 1000 tabs)((Net<br>wt. of Import Sr. No. 1 is<br>157.38kgs, Sr. No. 2 is 871.62kg,<br>Sr. No. 3 is 247.52kg, Sr. No. 5 is<br>14280 Nos., Sr. No. 9 is 14280<br>Nos.))	<br> <br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>11.415 mg
			2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>64.578 mg
			3	Calcium Acetate	18.049 mg
			4	250cc Rnd White 53/400 Hdpe Sclair<br>58a (Plastic Bottles 250CC white<br>HDPE Round 38mm)	<br> <br>Relevant as per<br>packing policy
			5	Blue 53mm Pp Cap Lp-E & Triseal<br>F217hy (Plastics Caps/Closures PP<br>53MM-400 Blue PP)	<br> <br>Relevant as per<br>packing policy
3	Atorvastatin Calcium Tablets USP<br>20mg (Pack Size 90 tabs)((Net wt.<br>of Import Sr. No. 1 is 787.01kgs,<br>Sr. No. 2 is 4374.12kg, Sr. No. 3 is<br>1241.46kg, Sr. No. 4 is 396720<br>Nos., Sr. No. 8 is 396720 Nos.))	<br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin Calcium Propylene<br>Glycol Solvate USP	22.830 mg
			2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>129.427 mg
			3	Calcium Acetate	36.090 mg
			4	Plastic Bottles 75CC white HDPE<br>Round 38mm	Relevant as per<br>packing policy

UDIN00232628AM23

			5	CR38400APJT865 BLUE PP465<br>1400 (Plastics Caps/Closures PP<br>38MM-400 Blue CR)	Relevant as per<br>packing policy
4	Atorvastatin Calcium Tablets USP<br>40mg (Pack Size 90 tabs)((Net wt.<br>of Import Sr. No. 1 is 1836.07kgs,<br>Sr. No. 2 is 10169.51kg, Sr. No. 3<br>is 2887.80kg, Sr. No. 4 is 462770<br>Nos., Sr. No. 8 is 462770 Nos.))	<br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>45.595 mg
			2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>258.08 mg
			3	Calcium Acetate	71.963 mg
			4	Plastic Bottles 75CC white HDPE<br>Round 38mm	<br>Relevant as per<br>packing policy
			5	CR38400APJT865<br>BLUE<br>PP465<br>1400 (Plastics Caps/Closures PP<br>38MM-400 Blue CR)	<br> <br>Relevant as per<br>packing policy
5	Atorvastatin Calcium Tablets USP<br>80mg (Pack Size 90 tabs)((Net wt.<br>of Import Sr. No. 1 is 1049.18kgs,<br>Sr. No. 2 is 5839.10kg, Sr. No. 3 is<br>1656.89kg, Sr. No. 6 is 132220<br>Nos., Sr. No. 8 is 132220 Nos.))	<br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>91.20 mg
			2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>518.206 mg
			3	Calcium Acetate	144.929 mg
			4	Plastic Bottles 120CC white HDPE<br>Round 38mm	<br>Relevant as per<br>packing policy
			5	CR38400APJT865<br>BLUE<br>PP465<br>1400 (Plastics Caps/Closures PP<br>38MM-400 Blue CR)	<br> <br>Relevant as per<br>packing policy
6	Atorvastatin Calcium Tablets USP<br>80mg (Pack Size 1000 tabs)((Net<br>wt. of Import Sr. No. 1 is<br>786.90kgs, Sr. No. 2 is 4379.40kg,<br>Sr. No. 3 is 1242.69kg, Sr. No. 7 is<br>8925 Nos., Sr. No. 10 is 8925<br>Nos.))	<br> <br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>91.20 mg
			2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>518.206 mg
			3	Calcium Acetate	144.929 mg
			4	1500cc Round Extrusion 89/400 Neck<br>White (Plastic Bottles 1500CC white	<br> <br>Relevant as per<br>packing policy

UDIN00232628AM23

HDPE Round 38mm)<br>5<br>CC8940AFS837 WHITE PP551 CT<br>89 400SP (Plastics Caps/Closures PP<br>89MM-400 White Plain)<br>Relevant as per<br>packing policy<br>Note: The above norms are valid only for subject to fulfillment of following conditions:<br>Export Product being Patented Medicine, be filed with USFDA filing ANDA (A New Drug Application) of Apotex<br>Corp, US. Agent for Apotex Inc., Candada.<br>1.<br>Export to USA only.<br>2.<br>Firm holding Certificate of Manufacturing Exclusivity.<br>3.<br> RA concerned may take further necessary action as per above decision of NC.					HDPE Round 38mm)
				5	CC8940AFS837 WHITE PP551 CT<br>89 400SP (Plastics Caps/Closures PP<br>89MM-400 White Plain)	<br> <br>Relevant as per<br>packing policy
	Note: The above norms are valid only for subject to fulfillment of following conditions:<br>Export Product being Patented Medicine, be filed with USFDA filing ANDA (A New Drug Application) of Apotex<br>Corp, US. Agent for Apotex Inc., Candada.<br>1.<br>Export to USA only.<br>2.<br>Firm holding Certificate of Manufacturing Exclusivity.<br>3.

Case No.	Case No.	Case No.	12 / NC/3/MEET/Sep/202223/7	12 / NC/3/MEET/Sep/202223/7	12 / NC/3/MEET/Sep/202223/7	12 / NC/3/MEET/Sep/202223/7	12 / NC/3/MEET/Sep/202223/7
Case Status			Case Approved
Party Name			PIRAMAL ENTERPRISES LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number			HQRNORM REVIW00001324AM23
RA File Number			039504001215 AM20
Licence No and<br>Date			0310835591/11/04/2020
Norms Committee Decision:<br>Shri Devesh Desai, Associate Vice President, Shri Sunil Kumar Jain, General Manager – Production and Shri<br>Prashant Khilare, Manager Commercial; attended the Personal Hearing and explained their case. The Committee<br>after deliberations decided to revise adhoc norms as under:<br>Sl. No. Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP<br>11.415 mg<br>2<br>Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)<br>64.578 mg<br>Atorvastatin Calcium Tablets USP<br>10mg (Pack Size 90 tabs)((Net wt.<br>of Import Sr. No. 1 is 406.67kgs,<br>Sr. No. 2 is 2252.30kg, Sr. No. 3 is<br>639.59kg, Sr. No. 4 is 410000 Nos.,<br>1<br>1 Number<br>Tablet
	Sl. No.	Export Product		Qty.	Sl. No.	Import items	Qty.
	1	Atorvastatin Calcium Tablets USP<br>10mg (Pack Size 90 tabs)((Net wt.<br>of Import Sr. No. 1 is 406.67kgs,<br>Sr. No. 2 is 2252.30kg, Sr. No. 3 is<br>639.59kg, Sr. No. 4 is 410000 Nos.,		<br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>11.415 mg
					2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>64.578 mg

UDIN00232628AM23

	Sr. No. 8 is 410000 Nos.))		3	Calcium Acetate	18.049 mg
			4	Plastic Bottles 75CC white HDPE<br>Round 38mm	<br>Relevant as per<br>packing policy
			5	CR38400APJT865<br>BLUE<br>PP465<br>1400 (Plastics Caps/Closures PP<br>38MM-400 Blue CR)	<br> <br>Relevant as per<br>packing policy
2	Atorvastatin Calcium Tablets USP<br>10mg (Pack Size 1000 tabs)((Net<br>wt. of Import Sr. No. 1 is<br>2733.21kgs,<br>Sr.<br>No.<br>2<br>is<br>15137.42kg,<br>Sr.<br>No.<br>3<br>is<br>4298.58kg, Sr. No. 5 is 248000<br>Nos., Sr. No. 9 is 248000 Nos.))	<br> <br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>11.415 mg
			2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>64.578 mg
			3	Calcium Acetate	18.049 mg
			4	250cc Rnd White 53/400 Hdpe Sclair<br>58a (Plastic Bottles 250CC white<br>HDPE Round 38mm)	<br> <br>Relevant as per<br>packing policy
			5	Blue 53mm Pp Cap Lp-E & Triseal<br>F217hy (Plastics Caps/Closures PP<br>53MM-400 Blue PP)	<br> <br>Relevant as per<br>packing policy
3	Atorvastatin Calcium Tablets USP<br>20mg (Pack Size 90 tabs)((Net wt.<br>of Import Sr. No. 1 is 1031.57kgs,<br>Sr. No. 2 is 5733.37kg, Sr. No. 3 is<br>1627.24kg, Sr. No. 4 is 520000<br>Nos., Sr. No. 8 is 520000 Nos.))	<br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>22.830 mg
			2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>129.427 mg
			3	Calcium Acetate	36.090 mg
			4	Plastic Bottles 75CC white HDPE<br>Round 38mm	<br>Relevant as per<br>packing policy
			5	CR38400APJT865<br>BLUE<br>PP465<br>1400 (Plastics Caps/Closures PP<br>38MM-400 Blue CR)	<br> <br>Relevant as per<br>packing policy
4	Atorvastatin Calcium Tablets USP<br>40mg (Pack Size 90 tabs)((Net wt.	<br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>45.595 mg

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	of Import Sr. No. 1 is 3967.56kgs,<br>Sr. No. 2 is 21975.30kg, Sr. No. 3<br>is 6240.24kg, Sr. No. 4 is 1000000<br>Nos., Sr. No. 8 is 1000000 Nos.))	<br> <br>	2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>258.08 mg
			3	Calcium Acetate	71.963 mg
			4	Plastic Bottles 75CC white HDPE<br>Round 38mm	<br>Relevant as per<br>packing policy
			5	CR38400APJT865<br>BLUE<br>PP465<br>1400 (Plastics Caps/Closures PP<br>38MM-400 Blue CR)	<br> <br>Relevant as per<br>packing policy
5	Atorvastatin Calcium Tablets USP<br>80mg (Pack Size 90 tabs)((Net wt.<br>of Import Sr. No. 1 is 2444.02kgs,<br>Sr. No. 2 is 13601.90kg, Sr. No. 3<br>is 3859.65kg, Sr. No. 6 is 308000<br>Nos., Sr. No. 8 is 308000 Nos.))	<br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>91.20 mg
			2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>518.206 mg
			3	Calcium Acetate	144.929 mg
			4	Plastic Bottles 120CC white HDPE<br>Round 38mm	<br>Relevant as per<br>packing policy
			5	CR38400APJT865<br>BLUE<br>PP465<br>1400 (Plastics Caps/Closures PP<br>38MM-400 Blue CR)	<br> <br>Relevant as per<br>packing policy
6	Atorvastatin Calcium Tablets USP<br>80mg (Pack Size 1000 tabs)((Net<br>wt. of Import Sr. No. 1 is<br>793.51kgs, Sr. No. 2 is 4416.20kg,<br>Sr. No. 3 is 1253.13kg, Sr. No. 7 is<br>9000 Nos., Sr. No. 10 is 9000<br>Nos.))	<br> <br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>91.20 mg
			2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>518.206 mg
			3	Calcium Acetate	144.929 mg
			4	1500cc Round Extrusion 89/400 Neck<br>White (Plastic Bottles 1500CC white<br>HDPE Round 38mm)	<br> <br>Relevant as per<br>packing policy
			5	CC8940AFS837 WHITE PP551 CT<br>89 400SP (Plastics Caps/Closures PP<br>89MM-400 White Plain)	<br> <br>Relevant as per<br>packing policy
Note: The above norms are valid only for subject to fulfillment of following conditions:

UDIN00232628AM23

Export Product being Patented Medicine, be filed with USFDA filing ANDA (A New Drug Application) of Apotex Corp, US. Agent for Apotex Inc., Candada.
Export to USA only.
Firm holding Certificate of Manufacturing Exclusivity.

Case No.	Case No.	Case No.	13 / NC/3/MEET/Sep/202223/7	13 / NC/3/MEET/Sep/202223/7	13 / NC/3/MEET/Sep/202223/7	13 / NC/3/MEET/Sep/202223/7	13 / NC/3/MEET/Sep/202223/7
Case Status			Case Approved
Party Name			PIRAMAL ENTERPRISES LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number			HQRNORM REVIW00001326AM23
RA File Number			039504000075 AM21
Licence No and<br>Date			0310836467/01/06/2020
Norms Committee Decision:<br>Shri Devesh Desai, Associate Vice President, Shri Sunil Kumar Jain, General Manager – Production and Shri<br>Prashant Khilare, Manager Commercial; attended the Personal Hearing and explained their case. The Committee<br>after deliberations decided to revise adhoc norms as under:<br>Sl. No. Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP<br>11.415 mg<br>2<br>Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)<br>64.578 mg<br>3<br>Calcium Acetate<br>18.049 mg<br>4<br>Plastic Bottles 75CC white HDPE<br>Round 38mm<br>Relevant as per<br>packing policy<br>1<br>Atorvastatin Calcium Tablets USP<br>10mg (Pack Size 90 tabs)((Net wt.<br>of Import Sr. No. 1 is 2281.35kgs,<br>Sr. No. 2 is 12634.87kg, Sr. No. 3<br>is 3587.93kg, Sr. No. 4 is 2300000<br>Nos., Sr. No. 8 is 2300000 Nos.))<br>1 Number<br>Tablet<br>5<br>CR38400APJT865<br>BLUE<br>PP465<br>1400 (Plastics Caps/Closures PP<br>38MM-400 Blue CR)<br>Relevant as per<br>packing policy
	Sl. No.	Export Product		Qty.	Sl. No.	Import items	Qty.
	1	Atorvastatin Calcium Tablets USP<br>10mg (Pack Size 90 tabs)((Net wt.<br>of Import Sr. No. 1 is 2281.35kgs,<br>Sr. No. 2 is 12634.87kg, Sr. No. 3<br>is 3587.93kg, Sr. No. 4 is 2300000<br>Nos., Sr. No. 8 is 2300000 Nos.))		<br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>11.415 mg
					2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>64.578 mg
					3	Calcium Acetate	18.049 mg
					4	Plastic Bottles 75CC white HDPE<br>Round 38mm	<br>Relevant as per<br>packing policy
					5	CR38400APJT865<br>BLUE<br>PP465<br>1400 (Plastics Caps/Closures PP<br>38MM-400 Blue CR)	<br> <br>Relevant as per<br>packing policy

UDIN00232628AM23

2	Atorvastatin Calcium Tablets USP<br>10mg (Pack Size 1000 tabs)((Net<br>wt. of Import Sr. No. 1 is<br>440.84kgs, Sr. No. 2 is 2441.52kg,<br>Sr. No. 3 is 693.32kg, Sr. No. 5 is<br>40000 Nos., Sr. No. 9 is 40000<br>Nos.))	<br> <br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>11.415 mg
			2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>64.578 mg
			3	Calcium Acetate	18.049 mg
			4	250cc Rnd White 53/400 Hdpe Sclair<br>58a (Plastic Bottles 250CC white<br>HDPE Round 38mm)	<br> <br>Relevant as per<br>packing policy
			5	Blue 53mm Pp Cap Lp-E & Triseal<br>F217hy (Plastics Caps/Closures PP<br>53MM-400 Blue PP)	<br> <br>Relevant as per<br>packing policy
3	Atorvastatin Calcium Tablets USP<br>20mg (Pack Size 90 tabs)((Net wt.<br>of Import Sr. No. 1 is 1031.57kgs,<br>Sr. No. 2 is 5733.37kg, Sr. No. 3 is<br>1627.24kg, Sr. No. 4 is 520000<br>Nos., Sr. No. 8 is 520000 Nos.))	<br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>22.830 mg
			2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>129.427 mg
			3	Calcium Acetate	36.090 mg
			4	Plastic Bottles 75CC white HDPE<br>Round 38mm	<br>Relevant as per<br>packing policy
			5	CR38400APJT865<br>BLUE<br>PP465<br>1400 (Plastics Caps/Closures PP<br>38MM-400 Blue CR)	<br> <br>Relevant as per<br>packing policy
4	Atorvastatin Calcium Tablets USP<br>40mg (Pack Size 90 tabs)((Net wt.<br>of Import Sr. No. 1 is 3174.05kgs,<br>Sr. No. 2 is 17580.24kg, Sr. No. 3<br>is 4992.19kg, Sr. No. 4 is 800000<br>Nos., Sr. No. 8 is 800000 Nos.))	<br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>45.595 mg
			2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>258.08 mg
			3	Calcium Acetate	71.963 mg
			4	Plastic Bottles 75CC white HDPE<br>Round 38mm	<br>Relevant as per<br>packing policy

UDIN00232628AM23

	5				5	CR38400APJT865<br>BLUE<br>PP465<br>1400 (Plastics Caps/Closures PP<br>38MM-400 Blue CR)	CR38400APJT865<br>BLUE<br>PP465<br>1400 (Plastics Caps/Closures PP<br>38MM-400 Blue CR)	<br> <br>Relevant as per<br>packing policy
		Atorvastatin Calcium Tablets USP<br>80mg (Pack Size 90 tabs)((Net wt.<br>of Import Sr. No. 1 is 396.76kgs,<br>Sr. No. 2 is 2208.10kg, Sr. No. 3 is<br>626.57kg, Sr. No. 6 is 50000 Nos.,<br>Sr. No. 8 is 50000 Nos.))		<br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP		<br>91.20 mg
					2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)		<br>518.206 mg

					3	Calcium Acetate		144.929 mg


					4	Plastic Bottles 120CC white HDPE		<br>Relevant as per
						Round 38mm		packing policy

					5	CR38400APJT865<br>BLUE<br>PP465		<br>Relevant as per
						1400 (Plastics Caps/Closures PP		<br> <br>packing policy
						38MM-400 Blue CR)

	6	Atorvastatin Calcium Tablets USP<br>80mg (Pack Size 1000 tabs)((Net<br>wt. of Import Sr. No. 1 is<br>3526.72kgs,<br>Sr.<br>No.<br>2<br>is<br>19627.56kg,<br>Sr.<br>No.<br>3<br>is<br>5569.48kg, Sr. No. 7 is 40000 Nos.,<br>Sr. No. 10 is 40000 Nos.))		<br> <br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP		<br>91.20 mg
					2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)		<br>518.206 mg
					3	Calcium Acetate		144.929 mg
					4	1500cc Round Extrusion 89/400<br>White (Plastic Bottles 1500CC<br>HDPE Round 38mm)	Neck<br>white	<br> <br>Relevant as per<br>packing policy
					5	CC8940AFS837 WHITE PP551 CT<br>89 400SP (Plastics Caps/Closures PP<br>89MM-400 White Plain)		<br> <br>Relevant as per<br>packing policy

	Note: The above nor		ms are valid only for subject to fulfillment of following conditions:
	Export Product<br>1.		being Patented Medicine, be filed with USFDA filing ANDA (A New Drug Application) of Apotex
	Corp, US. Agent<br> <br>		for Apotex Inc., Candada.<br>
	Export to USA o<br>2.<br>Firm holding Ce<br>3.		nly.<br>rtificate of Manufacturing Exclusivity.



RA concerned			a take further necessar action as er above decision of NC
y y p .

UDIN00232628AM23

Case No.	Case No.	Case No.	14 / NC/3/MEET/Sep/202223/7	14 / NC/3/MEET/Sep/202223/7	14 / NC/3/MEET/Sep/202223/7	14 / NC/3/MEET/Sep/202223/7	14 / NC/3/MEET/Sep/202223/7
Case Status			Case Approved
Party Name			PIRAMAL ENTERPRISES LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number			HQRNORM REVIW00001327AM23
RA File Number			039504000288 AM21
Licence No and<br>Date			0310837797/20/08/2020
Norms Committee Decision:<br>Shri Devesh Desai, Associate Vice President, Shri Sunil Kumar Jain, General Manager – Production and Shri<br>Prashant Khilare, Manager Commercial; attended the Personal Hearing and explained their case. The Committee<br>after deliberations decided to revise adhoc norms as under:<br>Sl. No. Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP<br>11.415 mg<br>2<br>Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)<br>64.578 mg<br>3<br>Calcium Acetate<br>18.049 mg<br>4<br>Plastic Bottles 75CC white HDPE<br>Round 38mm<br>Relevant as per<br>packing policy<br>5<br>CR38400APJT865<br>BLUE<br>PP465<br>1400 (Plastics Caps/Closures PP<br>38MM-400 Blue CR)<br>Relevant as per<br>packing policy<br>1<br>Atorvastatin Calcium Tablets USP<br>10mg (Pack Size 90 tabs) (Net wt.<br>of Import Sr. No. 1(is 1454.336<br>kgs, Sr. No. 2 is 8054.601 kg, Sr.<br>No. 3 is 2287.27 kg, Sr. No. 4 is<br>1466227 Nos., Sr. No. 8 is 1466227<br>Nos.))<br>1 Number<br>Tablet<br>6<br>Strippax<br>Sorbent<br>50<br>C<br>&<br>50<br>SG<br>1<br>gm<br>(Silica<br>gel<br>desiccants)<br>Relevant as per<br>packing policy<br>1<br>Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP<br>11.415 mg<br>Atorvastatin Calcium Tablets USP<br>10mg (Pack Size 1000 tabs) (Net<br>2<br>1 Number<br>Tablet
	Sl. No.	Export Product		Qty.	Sl. No.	Import items	Qty.
	1	Atorvastatin Calcium Tablets USP<br>10mg (Pack Size 90 tabs) (Net wt.<br>of Import Sr. No. 1(is 1454.336<br>kgs, Sr. No. 2 is 8054.601 kg, Sr.<br>No. 3 is 2287.27 kg, Sr. No. 4 is<br>1466227 Nos., Sr. No. 8 is 1466227<br>Nos.))		<br> <br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>11.415 mg
					2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>64.578 mg
					3	Calcium Acetate	18.049 mg
					4	Plastic Bottles 75CC white HDPE<br>Round 38mm	<br>Relevant as per<br>packing policy
					5	CR38400APJT865<br>BLUE<br>PP465<br>1400 (Plastics Caps/Closures PP<br>38MM-400 Blue CR)	<br> <br>Relevant as per<br>packing policy
					6	Strippax<br>Sorbent<br>50<br>C<br>&<br>50<br>SG<br>1<br>gm<br>(Silica<br>gel<br>desiccants)	<br> <br>Relevant as per<br>packing policy
	2	Atorvastatin Calcium Tablets USP<br>10mg (Pack Size 1000 tabs) (Net		<br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>11.415 mg

UDIN00232628AM23

	wt. of Import Sr. No. 1(is 1869.856<br>kgs, Sr. No. 2 is 10355.890 kg, Sr.<br>No. 3 is 2940.769 kg, Sr. No. 5 is<br>169663 Nos., Sr. No. 9 is 169663<br>Nos.))	<br> <br> <br>	2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>64.578 mg
			3	Calcium Acetate	18.049 mg
			4	250cc Rnd White 53/400 Hdpe Sclair<br>58a (Plastic Bottles 250CC white<br>HDPE Round 38mm)	<br> <br>Relevant as per<br>packing policy
			5	Blue 53mm Pp Cap Lp-E & Triseal<br>F217hy (Plastics Caps/Closures PP<br>53MM-400 Blue PP)	<br> <br>Relevant as per<br>packing policy
			6	Strippax<br>Sorbent<br>50<br>C<br>&<br>50<br>SG<br>1<br>gm<br>(Silica<br>gel<br>desiccants)	<br> <br>Relevant as per<br>packing policy
3	Atorvastatin Calcium Tablets USP<br>20mg (Pack Size 90 tabs) (Net wt.<br>of Import Sr. No. 1(is 301.168 kgs,<br>Sr. No. 2 is 1673.870 kg, Sr. No. 3<br>is 475.075 kg, Sr. No. 4 is 151815<br>Nos., Sr. No. 8 is 151815 Nos.))	<br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>22.830 mg
			2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>129.427 mg
			3	Calcium Acetate	36.090 mg
			4	Plastic Bottles 75CC white HDPE<br>Round 38mm	<br>Relevant as per<br>packing policy
			5	CR38400APJT865<br>BLUE<br>PP465<br>1400 (Plastics Caps/Closures PP<br>38MM-400 Blue CR)	<br> <br>Relevant as per<br>packing policy
			6	Strippax<br>Sorbent<br>50<br>C<br>&<br>50<br>SG<br>1<br>gm<br>(Silica<br>gel<br>desiccants)	<br> <br>Relevant as per<br>packing policy
4	Atorvastatin Calcium Tablets USP<br>40mg (Pack Size 90 tabs) (Net wt.<br>of Import Sr. No. 1(is 8102.726<br>kgs, Sr. No. 2 is 44878.925 kg, Sr.<br>No. 3 is 12744.093 kg, Sr. No. 4 is<br>2042244 Nos., Sr. No. 8 is 2042244<br>Nos.))	<br> <br> <br> <br> <br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>45.595 mg
			2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>258.08 mg
			3	Calcium Acetate	71.963 mg

UDIN00232628AM23

				4	Plastic Bottles 75CC white HDPE<br>	<br>Relevant as per<br>
					Round 38mm	packing policy
				5	CR38400APJT865<br>BLUE<br>PP465<br>	<br> <br>Relevant as per<br>
					1400 (Plastics Caps/Closures PP<br>38MM-400 Blue CR)	<br>packing policy

					<br> <br> <br> <br> <br>	<br>
				6	Strippax<br>Sorbent<br>50<br>C<br>&<br>50<br>SG<br>1<br>m<br>(Silica<br>el	<br> <br>Relevant as per<br>ackin olic
					<br> <br>g<br> <br>g<br>desiccants)	<br>pg py
			<br>		<br> <br>	<br>
5	Atorvasta<br>80mg (P	tin Calcium Tablets USP<br>ck Size 90 tabs) (Net wt	<br> <br>1 Number<br>Tablet	1	Atorvastatin<br>Calcium<br>Propylene<br>Glycol Solvate USP	<br>91.20 mg
	<br>of Impor<br>kgs, Sr.	.<br>t Sr. No. 1(is 3324.196<br>No. 2 is 18500.438 kg, Sr.	<br> <br> <br>

	No. 3 is 5249.650 kg, Sr. No. 6 is<br>418922 Nos., Sr. No. 8 is 418922<br>Nos.))		<br>	2	Microcrystalline Cellulose (MCC) NF<br>(Avicel PH 102)	<br>518.206 mg
				3	Calcium Acetate	144.929 mg


				4	Plastic Bottles 120CC white HDPE	<br>Relevant as per
					Round 38mm	packing policy


				5	CR38400APJT865<br>BLUE<br>PP465<br>1400 (Plastics Caps/Closures PP	<br> <br>Relevant as per<br>packing policy
					38MM-400 Blue CR)


				6	Strippax<br>Sorbent<br>50<br>C<br>&<br>50<br>SG<br>1<br>gm<br>(Silica<br>gel<br>	<br> <br>Relevant as per<br>packing policy
					desiccants)
6	Atorvastatin Calcium Tablets USP<br>		<br> <br>1 Number<br>	1	Atorvastatin<br>Calcium<br>Propylene<br>	<br>91.20 mg
	80mg (Pack Size 1000 tabs) (Net<br>t f Imrt Sr N 1(i 3843596		<br> <br>Tablet		Glycol Solvate USP
	w. o<br>kgs, Sr.	po . o. s .<br>No. 2 is 21391.096 kg, Sr.	<br>

	<br>No. 3 is	<br>6069.90kg, Sr. No. 7 is	<br>	2	Microcrystalline Cellulose (MCC) NF<br>	<br>518.206 mg
	43594 N<br>	os., Sr. No. 10 is 43594			(Avicel PH 102)
	Nos.))
				3	Calcium Acetate	144.929 mg


				4	1500cc Round Extrusion 89/400 Neck	<br>Relevant as per
					<br>White (Plastic Bottles 1500CC white<br>HDPE Round 38mm)	<br> <br> <br>packing policy

				5	CC8940AFS837 WHITE PP551 CT<br>89 400SP (Plastics Caps/Closures PP	<br> <br>Relevant as per<br>packing policy

UDIN00232628AM23

89MM-400 White Plain)<br>6<br>Strippax<br>Sorbent<br>50<br>C<br>&<br>50<br>SG<br>1<br>gm<br>(Silica<br>gel<br>desiccants)<br>Relevant as per<br>packing policy<br>Note: The above norms are valid only for subject to fulfillment of following conditions:<br>Export Product being Patented Medicine, be filed with USFDA filing ANDA (A New Drug Application) of Apotex<br>Corp, US. Agent for Apotex Inc., Candada.<br>1.<br>Export to USA only.<br>2.<br>Firm holding Certificate of Manufacturing Exclusivity.<br>3.<br> RA concerned may take further necessary action as per above decision of NC.					89MM-400 White Plain)
				6	Strippax<br>Sorbent<br>50<br>C<br>&<br>50<br>SG<br>1<br>gm<br>(Silica<br>gel<br>desiccants)	<br> <br>Relevant as per<br>packing policy
	Note: The above norms are valid only for subject to fulfillment of following conditions:<br>Export Product being Patented Medicine, be filed with USFDA filing ANDA (A New Drug Application) of Apotex<br>Corp, US. Agent for Apotex Inc., Candada.<br>1.<br>Export to USA only.<br>2.<br>Firm holding Certificate of Manufacturing Exclusivity.<br>3.

Case No.	Case No.	15 / NC/3/MEET/Sep/202223/7	15 / NC/3/MEET/Sep/202223/7	15 / NC/3/MEET/Sep/202223/7	15 / NC/3/MEET/Sep/202223/7	15 / NC/3/MEET/Sep/202223/7
Case Status		Case Approved
Party Name		GLAND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number		HQRNORM REVIW00000277AM23
RA File Number		09AA04000173 AM22
Licence No and<br>Date		0911000784/07/05/2021
Norms Committee Decision:<br>Shri N. Prabhakar Rao, GM Commercial and Shri A. Jayateerth, DGM – Production attended the Personal Hearing<br>and explained their case. The Committee after deliberation decided to revise adhoc norms as under:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Heparin Sodium<br>357.60 kg<br>2<br>Barrel Syringes<br>Net + 5% wastage<br>3<br>Plunger Stoppers<br>Net + 11.55% wastage<br>Low Molecular Weight Heaprin Enoxaparin<br>Sodium Injection USP 40mg in 0.4ml Pre-<br>filled<br>Syringe(Composition<br>per<br>syringe,<br>Enoxaparin Sodium USP 40mg, Water for<br>Injection USP q.s. to 0.4ml)<br>4500000<br>Numbers
	Export Product		Qty.	Sl. No.	Import items	Qty.
	Low Molecular Weight Heaprin Enoxaparin<br>Sodium Injection USP 40mg in 0.4ml Pre-<br>filled<br>Syringe(Composition<br>per<br>syringe,<br>Enoxaparin Sodium USP 40mg, Water for<br>Injection USP q.s. to 0.4ml)		4500000<br>Numbers	1	Heparin Sodium	357.60 kg
				2	Barrel Syringes	Net + 5% wastage
				3	Plunger Stoppers	Net + 11.55% wastage

Case No.	Case No.	15 / NC/3/MEET/Sep/202223/7	15 / NC/3/MEET/Sep/202223/7	15 / NC/3/MEET/Sep/202223/7	15 / NC/3/MEET/Sep/202223/7	15 / NC/3/MEET/Sep/202223/7
Case Status		Case Approved
Party Name		GLAND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number		HQRNORM REVIW00000277AM23
RA File Number		09AA04000173 AM22
Licence No and<br>Date		0911000784/07/05/2021
Norms Committee Decision:<br>Shri N. Prabhakar Rao, GM Commercial and Shri A. Jayateerth, DGM – Production attended the Personal Hearing<br>and explained their case. The Committee after deliberation decided to revise adhoc norms as under:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Heparin Sodium<br>357.60 kg<br>2<br>Barrel Syringes<br>Net + 5% wastage<br>3<br>Plunger Stoppers<br>Net + 11.55% wastage<br>Low Molecular Weight Heaprin Enoxaparin<br>Sodium Injection USP 40mg in 0.4ml Pre-<br>filled<br>Syringe(Composition<br>per<br>syringe,<br>Enoxaparin Sodium USP 40mg, Water for<br>Injection USP q.s. to 0.4ml)<br>4500000<br>Numbers
	Export Product		Qty.	Sl. No.	Import items	Qty.
	Low Molecular Weight Heaprin Enoxaparin<br>Sodium Injection USP 40mg in 0.4ml Pre-<br>filled<br>Syringe(Composition<br>per<br>syringe,<br>Enoxaparin Sodium USP 40mg, Water for<br>Injection USP q.s. to 0.4ml)		4500000<br>Numbers	1	Heparin Sodium	357.60 kg
				2	Barrel Syringes	Net + 5% wastage
				3	Plunger Stoppers	Net + 11.55% wastage

UDIN00232628AM23

	4	Plunger Rods		Net + 2.5% wastage
	5	Preventis	Needle	Net + 3% wastage
		Shielding System

Case No.	16 / NC/3/MEET/Sep/202223/7
Case Status	Case Approved
Party Name	GLAND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM REVIW00000276AM23
RA File Number	09AA04006940 AM21
Licence No and<br>Date	0911000856/18/05/2021
Norms Committee Decision:<br>Shri N. Prabhakar Rao, GM Commercial and Shri A. Jayateerth, DGM – Production attended the Personal Hearing<br>and explained their case. The Committee after deliberation decided to revise adhoc norms as under:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Heparin Sodium<br>329.25 kg<br>2<br>Barrel Syringes<br>Net + 5% wastage<br>3<br>Plunger Stoppers<br>Net + 11.55% wastage<br>4<br>Plunger Rods<br>Net + 2.5% wastage<br>Low Molecular Weight Heaprin Enoxaparin<br>Sodium Injection USP, 40mg in 0.4ml Pre-<br>filled Syringe(Composition per syringe,<br>Enoxaparin Sodium USP 40mg, Water for<br>Injection USP q.s. to 0.4ml)<br>4143333<br>Numbers<br>5<br>Preventis<br>Needle<br>Shielding System<br>Net + 3% wastage<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00232628AM23

Case No.	17 / NC/3/MEET/Sep/202223/7
Case Status	Case Approved
Party Name	GLAND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM REVIW00000270AM23
RA File Number	09AA04007005 AM21
Licence No and<br>Date	0911000882/20/05/2021
Norms Committee Decision:<br>Shri N. Prabhakar Rao, GM Commercial and Shri A. Jayateerth, DGM – Production attended the Personal Hearing<br>and explained their case. The Committee after deliberation decided to revise adhoc norms as under:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Heparin Sodium<br>405.27 kg<br>2<br>Barrel Syringes<br>Net + 4.65% wastage<br>3<br>Plunger Stoppers<br>Net + 12% wastage<br>4<br>Plunger Rods<br>Net + 2.5% wastage<br>Low Molecular Weight Heaprin Enoxaparin<br>Sodium Injection USP 80mg in 0.8ml Pre-<br>filled<br>Syringe(Composition<br>per<br>syringe,<br>Enoxaparin Sodium USP 80mg, Water for<br>Injection USP q.s. to 0.8ml)<br>2550000<br>Numbers<br>5<br>Preventis<br>Needle<br>Shielding System<br>Net + 3% wastage<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	18 / NC/3/MEET/Sep/202223/7
Case Status	Case Approved
Party Name	GLAND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022

UDIN00232628AM23

HQ File Number	HQRNORM REVIW00000275AM23
RA File Number	09AA04006941 AM21
Licence No and<br>Date	0911000880/20/05/2021
Norms Committee Decision:<br>Shri N. Prabhakar Rao, GM Commercial and Shri A. Jayateerth, DGM – Production attended the Personal Hearing<br>and explained their case. The Committee after deliberation decided to revise adhoc norms as under:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Heparin Sodium<br>329.25 kg<br>2<br>Barrel Syringes<br>Net + 5% wastage<br>3<br>Plunger Stoppers<br>Net + 11.55% wastage<br>4<br>Plunger Rods<br>Net + 2.5% wastage<br>Low Molecular Weight Heaprin Enoxaparin<br>Sodium Injection USP 40mg in 0.4ml Pre-<br>filled Syringe(Composition per syringe,<br>Enoxaparin Sodium USP 40mg, Water for<br>Injection USP q.s. to 0.4ml)<br>4143333<br>Numbers<br>5<br>Preventis Needle<br>Shielding System<br>Net + 3% wastage<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	19 / NC/3/MEET/Sep/202223/7
Case Status	Case Approved
Party Name	GLAND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM REVIW00000217AM23
RA File Number	09AA04006942 AM21
Licence No and<br>Date	0911000887/21/05/2021
Norms Committee Decision:<br>Shri N. Prabhakar Rao, GM Commercial and Shri A. Jayateerth, DGM – Production attended the Personal Hearing<br>and explained their case. The Committee after deliberation decided to revise adhoc norms as under:

UDIN00232628AM23

Export Product	Qty.	Sl. No.	Import items	Qty.
Low Molecular Weight Heaprin Enoxaparin<br>Sodium Injection USP 40mg in 0.4ml Pre-<br>filled Syringe(Composition per syringe,<br>Enoxaparin Sodium USP 40mg, Water for<br>Injection USP q.s. to 0.4ml)	4143333<br>Numbers	1	Heparin Sodium	329.25 kg
		2	Barrel Syringes	Net + 5% wastage
		3	Plunger Stoppers	Net + 11.55% wastage
		4	Plunger Rods	Net + 2.5% wastage
		5	Preventis Needle<br>Shielding System	Net + 3% wastage

Case No.	Case No.	Case No.	20 / NC/3/MEET/Sep/202223/7	20 / NC/3/MEET/Sep/202223/7	20 / NC/3/MEET/Sep/202223/7	20 / NC/3/MEET/Sep/202223/7	20 / NC/3/MEET/Sep/202223/7
Case Status			Case Approved
Party Name			GLAND PHARMA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number			HQRNORM REVIW00000143AM23
RA File Number			09AA04005477 AM21
Licence No and<br>Date			0911000482/24/05/2021
Norms Committee Decision:<br>Shri N. Prabhakar Rao, GM Commercial and Shri A. Jayateerth, DGM – Production attended the Personal Hearing<br>and explained their case. The Committee after deliberation decided to revise adhoc norms as under:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Enoxaparin Sodium<br>181 kg<br>Low<br>Molecular<br>Weight<br>Heaprin 4118180<br>1
	Sl.<br>No.	Export Product		Qty.	Sl. No.	Import items	Qty.
	1	Low<br>Molecular<br>Weight<br>Heaprin		4118180	1	Enoxaparin Sodium	181 kg

Case No.	Case No.	Case No.	20 / NC/3/MEET/Sep/202223/7	20 / NC/3/MEET/Sep/202223/7	20 / NC/3/MEET/Sep/202223/7	20 / NC/3/MEET/Sep/202223/7	20 / NC/3/MEET/Sep/202223/7
Case Status			Case Approved
Party Name			GLAND PHARMA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number			HQRNORM REVIW00000143AM23
RA File Number			09AA04005477 AM21
Licence No and<br>Date			0911000482/24/05/2021
Norms Committee Decision:<br>Shri N. Prabhakar Rao, GM Commercial and Shri A. Jayateerth, DGM – Production attended the Personal Hearing<br>and explained their case. The Committee after deliberation decided to revise adhoc norms as under:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Enoxaparin Sodium<br>181 kg<br>Low<br>Molecular<br>Weight<br>Heaprin 4118180<br>1
	Sl.<br>No.	Export Product		Qty.	Sl. No.	Import items	Qty.
	1	Low<br>Molecular<br>Weight<br>Heaprin		4118180	1	Enoxaparin Sodium	181 kg

UDIN00232628AM23

		Enoxaparin Sodium Injection USP,<br>40mg<br>in<br>0.4ml<br>Pre-filled	Enoxaparin Sodium Injection USP,<br>40mg<br>in<br>0.4ml<br>Pre-filled	Enoxaparin Sodium Injection USP,<br>40mg<br>in<br>0.4ml<br>Pre-filled	Numbers	2	Barrel Syringes	Net + 5% wastage	Net + 5% wastage
		Syringe(Composition<br>per<br>sy<br>Enoxaparin Sodium USP 40mg,<br>for Injection USP q.s. to 0.4ml)		ringe,<br>Water		3	Plunger Stoppers	Net + 11.5	5% wastage
						4	Plunger Rods	Net + 2.5%	wastage
							<br>
						5	Preventis<br>Needle<br>Shielding System	Net + 3%	wastage

	2	Low<br>Molecular<br>Weight<br>Heaprin<br>Enoxaparin Sodium Injection USP<br>60mg<br>in<br>0.6ml<br>Pre-filled<br>Syringe(Composition<br>per<br>syringe,<br>			1455841<br>Numbers	1	Enoxaparin Sodium	96 kg
						2	Barrel Syringes	Net + 5% wastage
		Enoxaparin Sodium USP 60mg, Water<br>for Injection USP s to 06ml)

			q.. .			3	Plunger Stoppers	Net + 10.85% wastage


						4	Plunger Rods	Net + 1.65% wastage

							<br>
						5	Preventis<br>Needle<br>Shielding System	Net + 3% wastage


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

Case No.			21 / NC/3/MEET/Sep/202223/7
Case Status			Case Approved
Part Name			GLAND PHARMA LIMITED
y
Mi Nb
eetng umer<br>and Date			NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022

HQ File Number			HQRNORM REVIW00000272AM23

RA File Number			09AA04007003 AM21

Licence No and<br>Date			0911000900/24/05/2021

Norms Committee			Decision:

Shri N. Prabhakar<br>and explained their			Rao, GM Commercial and Shri A. Jayateerth, DGM – Production attended the Personal Hearing<br>case. The Committee after deliberation decided to revise adhoc norms as under:

UDIN00232628AM23

Export Product	Qty.	Sl. No.	Import items	Qty.
Low Molecular Weight Heaprin Enoxaparin<br>Sodium Injection USP 60mg in 0.6ml Pre-<br>filled Syringe(Composition per syringe,<br>Enoxaparin Sodium USP 60mg, Water for<br>Injection USP q.s. to 0.6ml)	28,00,000<br>Numbers	1	Heparin Sodium	333.72 kg
		2	Barrel Syringes	Net + 5% wastage
		3	Plunger Stoppers	Net + 10.85% wastage
		4	Plunger Rods	Net + 1.65% wastage
		5	Preventis<br>Needle<br>Shielding System	Net + 3% wastage

Case No.	22 / NC/3/MEET/Sep/202223/7
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM REVIW00397057AM22
RA File Number	08AA04017921 AM22
Licence No and<br>Date	0811002234/04/08/2021
Norms Committee Decision:<br>Dr. Ajeet Singh, Vice President (R&D), Shri Sree Ram Kala, Vice President (Indirect Taxation) and Shri Keyur<br>Kayastha, Sr. General Manager, Unit Logistic; attended the Personal Hearing and explained their case. The<br>Representatives of firm in the Meeting stated that they will submit the hard copy of their reply. Reply is still awaited<br>from the firm.<br>Hence, it was decided to issue a Reminder<br> to firm to submit its reply.

Case No. 23 / NC/3/MEET/Sep/202223/7

UDIN00232628AM23

Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM REVIW00397079AM22
RA File Number	08AA04018916 AM22
Licence No and<br>Date	0811002280/09/08/2021
Norms Committee Decision:<br>:Dr. Ajeet Singh, Vice President (R&D), Shri Sree Ram Kala, Vice President (Indirect Taxation) and Shri Keyur<br>Kayastha, Sr. General Manager, Unit Logistic; attended the Personal Hearing and explained their case. The<br>Representatives of firm in the Meeting stated that they will submit the hard copy of their reply. Reply is still awaited<br>from the firm.<br>Hence, it was decided to issue a Reminder<br> to firm to submit its reply.

Case No.	24 / NC/3/MEET/Sep/202223/7
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM APPLY 00170502AM22
RA File Number	08AA04022482 AM22
Licence No and<br>Date	0811002393/25/08/2021
Norms Committee Decision:<br>Dr. Ajeet Singh, Vice President (R&D), Shri Sree Ram Kala, Vice President (Indirect Taxation) and Shri Keyur<br>Kayastha, Sr. General Manager, Unit Logistic; attended the Personal Hearing and explained their case. The<br>Representatives of firm in the Meeting stated that they will submit the hard copy of their reply. Reply is still awaited<br>from the firm.<br> Hence, it was decided to issue a Reminder<br> to firm to submit its reply.

Dr. Ajeet Singh, Vice President (R&D), Shri Sree Ram Kala, Vice President (Indirect Taxation) and Shri Keyur Kayastha, Sr. General Manager, Unit Logistic; attended the Personal Hearing and explained their case. The Representatives of firm in the Meeting stated that they will submit the hard copy of their reply. Reply is still awaited from the firm.

Case No.	25 / NC/3/MEET/Sep/202223/7
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED

34 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:50.

UDIN00232628AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM REVIW00397092AM22
RA File Number	08AA04023464 AM22
Licence No and<br>Date	0811002450/31/08/2021
Norms Committee Decision:<br>Dr. Ajeet Singh, Vice President (R&D), Shri Sree Ram Kala, Vice President (Indirect Taxation) and Shri Keyur<br>Kayastha, Sr. General Manager, Unit Logistic; attended the Personal Hearing and explained their case. The<br>Representatives of firm in the Meeting stated that they will submit the hard copy of their reply. Reply is still awaited<br>from the firm.<br> Hence, it was decided to issue a Reminder<br> to firm to submit its reply.

Case No.	26 / NC/3/MEET/Sep/202223/7
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM REVIW00397104AM22
RA File Number	08AA04025507 AM22
Licence No and<br>Date	0811002517/06/09/2021
Norms Committee Decision:<br>Dr. Ajeet Singh, Vice President (R&D), Shri Sree Ram Kala, Vice President (Indirect Taxation) and Shri Keyur<br>Kayastha, Sr. General Manager, Unit Logistic; attended the Personal Hearing and explained their case. The<br>Representatives of firm in the Meeting stated that they will submit the hard copy of their reply. Reply is still awaited<br>from the firm.<br> Hence, it was decided to issue a Reminder<br> to firm to submit its reply.

Case No.	27 / NC/3/MEET/Sep/202223/7
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022

35 This document has been digitally signed by AJAY KUMAR, Deputy Director on 14-10-2022 20:17:50.

UDIN00232628AM23

HQ File Number	HQRNORM REVIW00001475AM23
RA File Number	08AA04022429 AM22
Licence No and<br>Date	0811002501/06/09/2021
Norms Committee Decision:
Dr. Ajeet Singh, Vice President (R&D), Shri Sree Ram Kala, Vice President (Indirect Taxation) and Shri Keyur
Kayastha, Sr. General Manager, Unit Logistic; attended the Personal Hearing and explained their case. The
Representatives of	firm in the Meeting stated that they will	submit the hard copy of their reply. Reply is still awaited
from the firm.
Hence, it was decided to issue a Reminder<br>		to firm to submit its reply.

Case No.<br>28 / NC/3/MEET/Sep/202223/7
Case Status<br>Case Deferred
Party Name<br>INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number<br>HQRNORM REVIW00001473AM23
RA File Number<br>08AA04029213 AM22
Licence No and<br>Date<br>0811002696/27/09/2021
Norms Committee Decision:
Dr. Ajeet Singh, Vice President (R&D), Shri Sree Ram	Kala, Vice President (Indirect Taxation) and Shri Keyur
Kayastha, Sr. General Manager, Unit Logistic; attended the Personal Hearing and explained their case. The
Representatives of firm in the Meeting stated that they will submit the hard copy of their reply. Reply is still awaited
from the firm.
Hence, it was decided to issue a Reminder<br>	to firm to submit its reply.

Case No.	29 / NC/3/MEET/Sep/202223/7
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM REVIW00397111AM22
RA File Number	08AA04030678 AM22

UDIN00232628AM23

Licence No and Date

0811002770/04/10/2021

Norms Committee Decision: Dr. Ajeet Singh, Vice President (R&D), Shri Sree Ram Kala, Vice President (Indirect Taxation) and Shri Keyur Kayastha, Sr. General Manager, Unit Logistic; attended the Personal Hearing and explained their case. The Representatives of firm in the Meeting stated that they will submit the hard copy of their reply. Reply is still awaited from the firm. Hence, it was decided to issue a Reminder to firm to submit its reply.

Case No.	30 / NC/3/MEET/Sep/202223/7
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM REVIW00001209AM23
RA File Number	08AA04033169 AM22
Licence No and<br>Date	0811002929/20/10/2021
Norms Committee Decision:<br>Dr. Ajeet Singh, Vice President (R&D), Shri Sree Ram Kala, Vice President (Indirect Taxation) and Shri Keyur<br>Kayastha, Sr. General Manager, Unit Logistic; attended the Personal Hearing and explained their case. The<br>Representatives of firm in the Meeting stated that they will submit the hard copy of their reply. Reply is still awaited<br>from the firm.<br> Hence, it was decided to issue a Reminder<br> to firm to submit its reply.

Case No.	31 / NC/3/MEET/Sep/202223/7
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM REVIW00001474AM23
RA File Number	08AA04033170 AM22
Licence No and<br>Date	0811002920/20/10/2021

UDIN00232628AM23

Norms Committee Decision:

Hence, it was decided to issue a Reminder to firm to submit its reply.

Case No.	32 / NC/3/MEET/Sep/202223/7
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM REVIW00000529AM23
RA File Number	08AA04033768 AM22
Licence No and<br>Date	0811002982/26/10/2021
Norms Committee Decision:<br>Dr. Ajeet Singh, Vice President (R&D), Shri Sree Ram Kala, Vice President (Indirect Taxation) and Shri Keyur<br>Kayastha, Sr. General Manager, Unit Logistic; attended the Personal Hearing and explained their case. The<br>Representatives of firm in the Meeting stated that they will submit the hard copy of their reply. Reply is still awaited<br>from the firm.<br> Hence, it was decided to issue a Reminder<br> to firm to submit its reply.

Case No.	33 / NC/3/MEET/Sep/202223/7
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM REVIW00000528AM23
RA File Number	08AA04034748 AM22
Licence No and<br>Date	0811003137/15/11/2021
Norms Committee Decision:

UDIN00232628AM23

Hence, it was decided to issue a Reminder to firm to submit its reply.

Case No.	34 / NC/3/MEET/Sep/202223/7
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202223/ 7 and 16/09/2022
HQ File Number	HQRNORM REVIW00000530AM23
RA File Number	08AA04034735 AM22
Licence No and<br>Date	0811003139/15/11/2021
Norms Committee Decision:<br>Dr. Ajeet Singh, Vice President (R&D), Shri Sree Ram Kala, Vice President (Indirect Taxation) and Shri Keyur<br>Kayastha, Sr. General Manager, Unit Logistic; attended the Personal Hearing and explained their case. The<br>Representatives of firm in the Meeting stated that they will submit the hard copy of their reply. Reply is still awaited<br>from the firm.<br> Hence, it was decided to issue a Reminder<br> to firm to submit its reply.

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