IN FORCE Advance Authorisation

DGFT Minutes

Reliability

In force — no superseding record on file.

Document text

Government of India / भारत सरकार

Ministry of Commerce and Industry / वािणज्य और उद्योग मंत्रालय Department of Commerce / वािणज्य िवभाग

Directorate General of Foreign Trade, Delhi / िवदेश व्यापार महािनदेशालय, िदल्ली VANIJYA BHAWAN, AKBAR ROAD, CENTRAL DELHI, DELHI, 110011 / वािणज्य भवन, अकबर रोड, नई िदल्ली Email Office : dgft@nic.in , Phone Office : 011-23062777

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Dec/202324/19 DATED: 05/01/2024

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/Dec/202324/19 dated 05/01/2024 of Norms Committee - III for the year 2023-24 was held on 05/01/2024 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:-

cations 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:-

	Name and Designation of Representatives
1	UTTAM SARKAR,Assistant Section Officer	DGFT(HQ)
2	Raman Kumar,Deputy DGFT	DGFT(HQ)
3	NAND Lal,Technical Consultant	DPIIT
4	SHAISH KUMAR,Technical Consultant	DGFT
5	DINESHNARAIN MATHUR,Technical<br>Consultant	DGFT
6	Nand Lal,Technical Consultant	DGFT

1 This document has been digitally signed by Raman Kumar, Deputy DGFT on 06-02-2024 11:34:01.

UDIN00469829AM24

Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Dec/202324/19
Case Status	Case Rejected
Party Name	CYKLO PHARMA CHEM PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00003200AM24
RA File Number	032404000318 AM04
Licence No and<br>Date	0310204913/29/05/2003
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm has not
provided any technical justification / information for enhancement. Hence, it was decided torejectthe case
maintaining thestatus quo.

Case No.	2 / NC/3/MEET/Dec/202324/19
Case Status	Case Rejected
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00006970AM24
RA File Number	039404000337 AM12
Licence No and<br>Date	0310646104/03/08/2011
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and it was observed that the there is no
justification for enhancement. Hence, it was decided torejectthe case maintaining thestatus quo.

e request of firm for review of ad-hoc norms and it was observed that the there is no|| |justification for enhancement. Hence, it was decided torejectthe case maintaining thestatus quo.||

Case No.	3 / NC/3/MEET/Dec/202324/19	3 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	MOREPEN LABORATORIES LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00006470AM23
RA File Number	052404000420 AM14
Licence No and Date	0510378413/05/02/2014
Norms Committee Decision:
Decision:The Committee	considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-
hoc 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. allowed.

This document has been digitally signed by Raman Kumar, Deputy DGFT on 06-02-2024 11:34:01.

UDIN00469829AM24

|Export Product|Qty.|Sl. No.|Import Items|Qty. allowed.||

This document has been digitally signed by Raman Kumar, Deputy DGFT on 06-02-2024 11:34:01.

UDIN00469829AM24

(4R-CIS)-1, 1-DIMETHYLETHYL-6-[2-	1	4-Fluoro-alpha-[2-methyl-1-	No import made.
[2-(4-FLUOROPHENYL) -5-(1-		oxopropyl]-gamma-oxo-N-beta-
ISOPROPYL)-3-PHENYL-4-		diphenyl benzene butanamide
[(PHENYLAMINO)(CARBONYL]-1H-
PYRROLE-1-YL]ETHYL]-2,2-
DIMETHYL-1,3-DIOXANE-4-	2	(4R-Cis)-1,1-Dimethylethyl-6-	903 kg.
ACETATE/ATORVASTAIN		cyanomethyl-2,2-dimethyl-1,3-
		dioxane -4-Acetate
CALCIUM INTERMEDIATE)
	3	ISOPROPYL ALCOHOL	No import made
	4	CYCLOHEXANE	No import made
	5	METHANOL	No import made
	6	SODIUM BICARBONATE	No import made

Note: The above norms are for regularization and closure purpose only. No repeat Licence may be allowed by RA on above norms.

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

Case No.	4 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	SATYAJIT CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005534AM24
RA File Number	NA
Licence No and<br>Date	0310786462/07/07/2014
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

er|HQRNORM APPLY 00005534AM24| |RA File Number|NA| |Licence No and Date|0310786462/07/07/2014| |Norms Committee Decision:|| |The case is under|consideration for want of comments of TE.|

Case No.	5 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	ROYAL PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00006808AM24
RA File Number	039504000958 AM15
Licence No and<br>Date	0310793866/12/02/2015

UDIN00469829AM24

Norms Committee Decision:

Decision: Shri Padmakant Pandya, Manager (Exports), Shri Rutvij Purohit, Asstt. Manager (Exports) and Shri P.J. Gandhi, Technical Consultant of the firm had attended the Personal Hearing and explained the case. The Committee heard the explanation of Representative of the firm and after due deliberation the committee has considered for review of ad-hoc norms on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under, or as applied whichever is less: -

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
BICALUTAMIDE SULFIDE<br>CHEMICAL NAME: N-[4-CYANO-3-<br>(TRIFLUORO METHYL)PHENYL]-3-<br>[(4-FLUOROPHENYL THIO)] -2-<br>HYDROXY-2-METHYL<br>PROPIONALIDE	1 kg.	1	N-[4-CYANO-3-<br>(TRIFLUORO<br>METHYL)PHENYL]<br>METHACRYLAMIDE<br>MATERIAL<br>FORMULA<br>C12H9ON2F3 AND MATERIAL<br>WEIGHT 254	<br> <br> <br>0.750 kg.
		2	4-FLUOROTHIOPHENOL<br>MATERIAL FORMULA C6H5F5<br>AND MATERIAL WEIGHT 128	<br>0.344 kg.

ETHACRYLAMIDE MATERIAL FORMULA C12H9ON2F3 AND MATERIAL WEIGHT 254| 0.750 kg.| |||2|4-FLUOROTHIOPHENOL MATERIAL FORMULA C6H5F5 AND MATERIAL WEIGHT 128| 0.344 kg.|

Case No.	Case No.	6 / NC/3/MEET/Dec/202324/19	6 / NC/3/MEET/Dec/202324/19	6 / NC/3/MEET/Dec/202324/19	6 / NC/3/MEET/Dec/202324/19	6 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		MOREPEN LABORATORIES LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM REVIW00006437AM23
RA File Number		052404000073 AM16
Licence No and Date		0510394342/25/05/2015
Norms Committee Decision:<br>Decision:The Committee considered the case<br>of HBP Vol. I as per details given below or as<br>Export Product<br>Qty.<br>SITAGLIPTIN PHOSPHATE<br>MONOHYDRATE<br>1 kg.				as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>applied by the firm, whichever is less:-
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	SITAGLIPTIN PHOSPHATE<br>MONOHYDRATE		1 kg.	1	2,4,5-TRIFLUOROPHENYL ACETIC<br>ACID	0.667 kg.
				2	1,3-DIOXANE-4,6-DIONE-2,2-<br>DIMETHYL / 2,2-DIMETHYL-1,3-<br>DIOXANE-4,6-DIONE	0.667 kg.

UDIN00469829AM24

3	3-(TRIFLUOROMETHYL)-5,6,7,8-	0.80 kg.
	TETRAHYDRO-[1,2,4] TRIAZOLO[4,3-
	A]PYRAZINE HYDROCHLORIDE
4	D-(-) MANDELIC ACID / R-(-)	0.667 kg.
	MANDELIC ACID

M24

3	3-(TRIFLUOROMETHYL)-5,6,7,8-	0.80 kg.
	TETRAHYDRO-[1,2,4] TRIAZOLO[4,3-
	A]PYRAZINE HYDROCHLORIDE
4	D-(-) MANDELIC ACID / R-(-)	0.667 kg.
	MANDELIC ACID

Above norms based on Actual Import or by comparison is for closure and regularization purpose only.

Case No.	7 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00006509AM24
RA File Number	039504000267 AM18
Licence No and<br>Date	0310814547/11/07/2017
Norms Committee Decision:<br>Decision :Shri Kunal Sikchi, Director and Shri Nitin Vyas,Sr. Executive of the firm had attended the Personal<br>Hearing and explained firm’s case. The Committee heard the explanation of Representative of the firm and after<br>due deliberation the committee has considered for review of ad-hoc norms on the basis of information provided by<br>the firm, it was decided to revise ad-hoc norms as under, or as applied whichever is less:-<br>Export Product<br>Qty<br>S.No.<br>Import Item<br>Qty. allowed<br>1<br>Fatty Acid Distillate Deoderised<br>Distillate<br>30.00 kg<br>2<br>Methenol 99%<br>9.18 kg<br>3<br>S-Heptane<br>2.94 kg<br>D Alpha Tocopherol having Net<br>content of Fatty Acid<br>Distillate/Deoderised Distillate<br>727000.00 kgs. Methenol 99 Percent<br>222400.00 kg. S Heptane 71200.00<br>kg.

S-Heptane 2.94 kg D Alpha Tocopherol having Net content of Fatty Acid Distillate/Deoderised Distillate 727000.00 kgs. Methenol 99 Percent 222400.00 kg. S Heptane 71200.00 kg. Acetone 29000.00 kg. 1 Kg. 4 Acetone 1.20 kg Note: The above norms are for regularization and closure purpose only. No repeat Licence may be allowed by RA on above norms. RA concerned may take further necessary action as per above decision of NC.||

UDIN00469829AM24

Case No.	8 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	ROYAL PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00006805AM24
RA File Number	039504000424 AM18
Licence No and<br>Date	0310815337/23/08/2017
Norms Committee Decision:<br>Decision:Shri Padmakant Pandya, Manager (Exports), Shri Rutvij Purohit, Asstt. Manager (Exports) and Shri P.J.<br>Gandhi, Technical Consultant of the firm had attended the Personal Hearing and explained the case. The<br>Committee heard the explanation of Representative of the firm and after due deliberation the committee has<br>considered for review of ad-hoc norms on the basis of information provided by the firm, it was decided to revise<br>ad-hoc norms as under, or as applied whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

information provided by the firm, it was decided to revise ad-hoc norms as under, or as applied whichever is less: - Export Product Qty. Sl. No. Import Items Qty. allowed. 1 N-[4-CYANO-3- (TRIFLUORO METHYL)PHENYL] METHACRYLAMIDE MATERIAL FORMULA C12H9ON2F3 AND MATERIAL WEIGHT 254 0.750 kg. BICALUTAMIDE SULFIDE CHEMICAL NAME: N-[4-CYANO-3- (TRIFLUORO METHYL)PHENYL]-3- [(4-FLUOROPHENYL THIO)] -2- HYDROXY-2-METHYL PROPIONALIDE 1 kg. 2 4-FLUOROTHIOPHENOL MATERIAL FORMULA C6H5F5 AND MATERIAL WEIGHT 128 0.344 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	9 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00002756AM23
RA File Number	522404000085 AM18
Licence No and<br>Date	5210042570/20/03/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/May/202223/4 dated 17/06/2022against advance

UDIN00469829AM24

authorization No.5210042570 dated 20/03/2018 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

9AM24

authorization No.5210042570 dated 20/03/2018 , it was decided to fix ad-hoc 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. allowed.
TERT-<br>BUTYL<br>1-PIPERAZINE<br>CARBOXYLATE<br>(1-BOC<br>PIPERAZINE)	<br> <br>1 kg.	1	DI- Tert Butyl Dicarbonate	2.00 kg.
		2	PIPERAZINE ANHYDROUS	0.80 kg.

Case No.	10 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	SHREE BANKEY BEHARI LAL FLAVORS
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00006890AM24
RA File Number	052404000067 AM19
Licence No and<br>Date	0510406412/10/05/2018
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Production/Consumption data for the year 2018-19 certified by GST.

rm for review/fixation of ad-hoc norms and it was decided to call for following information/documents from the firm:- Production/Consumption data for the year 2018-19 certified by GST.||

Case No.	11 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00001184AM23
RA File Number	092404000181 AM19
Licence No and<br>Date	0910066442/11/07/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.12/82-ALC4/2019 dated 17/01/2020against advance authorizationNo.<br>0910065450 dated 11/09/2017, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-

UDIN00469829AM24

5450** dated 11/09/2017, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||

UDIN00469829AM24

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Amoxycillin & Clavulanate Potassium OS<br>200/28.5mg per 5ml -50ml((The relevant Bulk<br>Drug content in the Export Product is:<br>Amoxycillin Trihydrate 100.00 Kgs + Syloid<br>14.25 KgA))	1000<br>Bottles	1	6-APA	1192.80 gm.
		2	Clavulanate Potassium + Syloid /<br>Clavulanate Potassium Diluted<br>with Silicon Dioxide (1:1)	<br> <br>707.00 gm.
Amoxycillin & Clavulanate Potassium OS<br>200/28.5mg per 5ml-75ml((The relevant Bulk<br>Drug content in the Export Product is:<br>Amoxycillin Trihydrate 90.00Kgs + Syloid<br>12.825 KgA))	1000<br>Bottles	3	6-APA	1789.2 gm.
		4	Clavulanate Potassium + Syloid /<br>Clavulanate Potassium Diluted<br>with Silicon Dioxide (1:1)	<br> <br>1060.50 gm.
Amoxycillin & Clavulanate Potassium OS<br>200/28.5mg per 5 ml-100ml((The relevant Bulk<br>Drug content in the Export Product is:<br>Amoxycillin Trihydrate 176.00 Kgs + Syloid<br>25.080 KgA ))	1000<br>Bottles	5	6-APA	2385.6 gm.
		6	Clavulanate Potassium + Syloid /<br>Clavulanate Potassium Diluted<br>with Silicon Dioxide (1:1)	<br> <br>1414.00 gm.
Amoxycillin & Clavulanate Potassium OS<br>400/57mg per 5ml-50ml((The relevant Bulk Drug<br>content in the Export<br>Product is : Amoxycillin Trihydrate 240.00Kgs +<br>Syloid 34.20 KgA))	<br>1000<br>Bottles	7	6-APA	2385.60 gm.

otassium OS 400/57mg per 5ml-50ml((The relevant Bulk Drug content in the Export Product is : Amoxycillin Trihydrate 240.00Kgs + Syloid 34.20 KgA))| 1000 Bottles|7|6-APA|2385.60 gm.| ||||8|Clavulanate Potassium + Syloid / Clavulanate Potassium Diluted with Silicon Dioxide (1:1)| 1414.0 gm.| ||Amoxycillin & Clavulanate Potassium OS 400/57mg per 5ml-75ml((The relevant Bulk Drug content in the Export Product is: Amoxycillin Trihydrate 720.00 Kgs + Syloid 102.60 KgA))| 1000 Bottles|9|6-APA|3578.40 gm.| ||||10|Clavulanate Potassium + Syloid / Clavulanate Potassium Diluted with Silicon Dioxide (1:1)| 2121.00 gm.| ||Amoxycillin & Clavulanate Potassium OS 400/57mg per 5ml-100ml((The relevant Bulk Drug content in the Export Product is: Amoxycillin Trihydrate 1760.00Kgs + Syloid 250.80 KgA))|1000 Bottles|11|6-APA|4771.20 gm.| ||||12|Clavulanate Potassium + Syloid / Clavulanate Potassium Diluted with Silicon Dioxide (1:1)| 2828.00 gm.| ||Amoxycillin & Clavulanate Potassium Os 600/42.9mg per 5ml-75ml((The relevant Bulk Drug content in the Export Product is: Amoxycillin Trihydrate 1890.00Kgs + Syloid 135.135 KgA))|1000 Bottles|13|6-APA|5367.60 gm.| ||||14|Clavulanate Potassium + Syloid / Clavulanate Potassium Diluted with Silicon Dioxide (1:1)| 1596.54 gm.|

UDIN00469829AM24

135 KgA))|1000 Bottles|13|6-APA|5367.60 gm.| ||||14|Clavulanate Potassium + Syloid / Clavulanate Potassium Diluted with Silicon Dioxide (1:1)| 1596.54 gm.|

UDIN00469829AM24

15<br>6-APA<br>8946.00 gm.<br>Amoxycillin & Clavulanate Potassium OS<br>600/42.9mg per 5ml-125ml((The relevant Bulk<br>Drug content in the Export Product is:<br>Amoxycillin Trihydrate 1650.00Kgs + Syloid<br>117.975 KgA))<br>1000<br>Bottles<br>16<br>Clavulanate Potassium + Syloid /<br>Clavulanate Potassium Diluted<br>with Silicon Dioxide (1:1)<br>2660.91 gm.<br>17<br>6-APA<br>14313.6 gm.<br>Amoxycillin & Clavulanate Potassium OS<br>600/42.9mg per 5ml-200ml((The relevant Bulk<br>Drug content in the Export Product is:<br>Amoxycillin Trihydrate 1200.00Kgs + Syloid<br>85.80 KgA))<br>1000<br>Bottles<br>18<br>Clavulanate Potassium + Syloid /<br>Clavulanate Potassium Diluted<br>with Silicon Dioxide (1:1)<br>4257.46 gm.<br>RA concerned may take further necessary action as per above decision of NC.	Amoxycillin & Clavulanate Potassium OS<br>600/42.9mg per 5ml-125ml((The relevant Bulk<br>Drug content in the Export Product is:<br>Amoxycillin Trihydrate 1650.00Kgs + Syloid<br>117.975 KgA))	1000<br>Bottles	15	6-APA	8946.00 gm.
			16	Clavulanate Potassium + Syloid /<br>Clavulanate Potassium Diluted<br>with Silicon Dioxide (1:1)	<br> <br>2660.91 gm.

.975 KgA))|1000 Bottles|15|6-APA|8946.00 gm.| |---|---|---|---|---|---| ||||16|Clavulanate Potassium + Syloid / Clavulanate Potassium Diluted with Silicon Dioxide (1:1)| 2660.91 gm.| ||Amoxycillin & Clavulanate Potassium OS 600/42.9mg per 5ml-200ml((The relevant Bulk Drug content in the Export Product is: Amoxycillin Trihydrate 1200.00Kgs + Syloid 85.80 KgA))|1000 Bottles|17|6-APA|14313.6 gm.| ||||18|Clavulanate Potassium + Syloid / Clavulanate Potassium Diluted with Silicon Dioxide (1:1)| 4257.46 gm.|

Case No.	Case No.	12 / NC/3/MEET/Dec/202324/19	12 / NC/3/MEET/Dec/202324/19	12 / NC/3/MEET/Dec/202324/19	12 / NC/3/MEET/Dec/202324/19	12 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		ROYAL PHARMA
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM REVIW00006804AM24
RA File Number		039504000720 AM19
Licence No and<br>Date		0310824487/17/10/2018
Norms Committee Decision:<br>Shri Padmakant Pandya, Manager (Exports), Shri Rutvij Purohit, Asstt. Manager (Exports) and Shri P.J. Gandhi,<br>Technical Consultant of the firm had attended the Personal Hearing and explained the case.

Padmakant Pandya, Manager (Exports), Shri Rutvij Purohit, Asstt. Manager (Exports) and Shri P.J. Gandhi, Technical Consultant of the firm had attended the Personal Hearing and explained the case. The Committee heard the explanation of Representative of the firm and after due deliberation the committee has considered for review of ad-hoc norms on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under, or as applied whichever is less: - Export Product Qty. Sl. No. Import Items Qty. allowed. 1 N-[4-CYANO-3- (TRIFLUORO METHYL)PHENYL] METHACRYLAMIDE MATERIAL FORMULA C12H9ON2F3 AND MATERIAL WEIGHT 254 0.750 kg. BICALUTAMIDE SULFIDE CHEMICAL NAME: N-[4-CYANO-3- (TRIFLUORO METHYL)PHENYL]-3- [(4-FLUOROPHENYL THIO)] -2- HYDROXY-2-METHYL PROPIONALIDE 1 kg. 2 4-FLUOROTHIOPHENOL MATERIAL FORMULA C6H5F5 AND MATERIAL WEIGHT 128 0.344 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||BICALUTAMIDE SULFIDE CHEMICAL NAME: N-[4-CYANO-3- (TRIFLUORO METHYL)PHENYL]-3- [(4-FLUOROPHENYL THIO)] -2- HYDROXY-2-METHYL PROPIONALIDE||1 kg.|1|N-[4-CYANO-3- (TRIFLUORO METHYL)PHENYL] METHACRYLAMIDE MATERIAL FORMULA C12H9ON2F3 AND MATERIAL WEIGHT 254| 0.750 kg.| |||||2|4-FLUOROTHIOPHENOL MATERIAL FORMULA C6H5F5 AND MATERIAL WEIGHT 128| 0.344 kg.| ||||||||

UDIN00469829AM24

A C12H9ON2F3 AND MATERIAL WEIGHT 254| 0.750 kg.| |||||2|4-FLUOROTHIOPHENOL MATERIAL FORMULA C6H5F5 AND MATERIAL WEIGHT 128| 0.344 kg.| ||||||||

UDIN00469829AM24

Case No.	13 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	VINS BIOPRODUCTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00007011AM24
RA File Number	092404000363 AM19
Licence No and<br>Date	0910066851/14/11/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case toDeptt. of Bio-Technologyfor<br>obtaining their comments.

Case No.	14 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	RUBICON RESEARCH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00007177AM24
RA File Number	039504000889 AM19
Licence No and<br>Date	0310825587/11/12/2018
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Copy of Master Batch Formula still not given for each export items.

m for review/fixation of ad-hoc norms and it was decided to call for following information/documents from the firm:- Copy of Master Batch Formula still not given for each export items.||

Case No.	15 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	ROYAL PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00006812AM24
RA File Number	039504000945 AM19
Licence No and<br>Date	0310825646/13/12/2018
Norms Committee Decision:<br>Decision:Shri Padmakant Pandya, Manager (Exports), Shri Rutvij Purohit, Asstt. Manager (Exports) and Shri P.J.

10 This document has been digitally signed by Raman Kumar, Deputy DGFT on 06-02-2024 11:34:01.

UDIN00469829AM24

Gandhi, Technical Consultant of the firm had attended the Personal Hearing and explained the case. The Committee heard the explanation of Representative of the firm and after due deliberation the committee has considered for review of ad-hoc norms on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under, or as applied whichever is less: -

beration the committee has considered for review of ad-hoc norms on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under, or as applied whichever is less: -

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
BICALUTAMIDE SULFIDE<br>CHEMICAL NAME: N-[4-CYANO-3-<br>(TRIFLUORO METHYL)PHENYL]-3-<br>[(4-FLUOROPHENYL THIO)] -2-<br>HYDROXY-2-METHYL<br>PROPIONALIDE	1 kg.	1	N-[4-CYANO-3-<br>(TRIFLUORO<br>METHYL)PHENYL]<br>METHACRYLAMIDE<br>MATERIAL<br>FORMULA<br>C12H9ON2F3 AND MATERIAL<br>WEIGHT 254	<br> <br> <br>0.750 kg.
		2	4-FLUOROTHIOPHENOL<br>MATERIAL FORMULA C6H5F5<br>AND MATERIAL WEIGHT 128	<br>0.344 kg.

Case No.	Case No.	16 / NC/3/MEET/Dec/202324/19	16 / NC/3/MEET/Dec/202324/19	16 / NC/3/MEET/Dec/202324/19	16 / NC/3/MEET/Dec/202324/19	16 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM REVIW00000817AM24
RA File Number		082404000026 AM20
Licence No and<br>Date		0810145127/30/04/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Dec/202324/17 dated 20/12/2023against advance<br>authorizationNo.0810145127 dated 30/04/2019, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

uct in meetingNo.NC/3/MEET/Dec/202324/17 dated 20/12/2023against advance authorizationNo.0810145127 dated 30/04/2019, it was decided to fix ad-hoc 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. allowed. 1 Imidazole 0.712 kg. 2 SODIUM METHOXIDE POWDER 1.00 kg. N-(3-AMINOPROPYL) IMIDAZOLE WHITE OR OFF WHITE CRYSTAL 1 kg. 3 ACRYLONITRILE 0.500 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||N-(3-AMINOPROPYL) IMIDAZOLE WHITE OR OFF WHITE CRYSTAL||1 kg.|1|Imidazole|0.712 kg.| |||||2|SODIUM METHOXIDE POWDER|1.00 kg.| |||||3|ACRYLONITRILE|0.500 kg.|

UDIN00469829AM24

Case No.	17 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00007489AM24
RA File Number	092404000172 AM20
Licence No and<br>Date	0910067749/03/07/2019
Norms Committee Decision:<br>Dr. Suresh Reddy Childipudi, R&D Head, and Shri T. Ram Prasad of the firm had attended the Personal Hearing<br>and explained firm’s case.

Date|0910067749/03/07/2019| |Norms Committee Decision: Dr. Suresh Reddy Childipudi, R&D Head, and Shri T. Ram Prasad of the firm had attended the Personal Hearing and explained firm’s case. The Committee heard the explanation of Representative of the firm and after due deliberation the committee has considered for fixation of ad-hoc norms on the basis of information provided by the firm, it was decided to fix ad-hoc norms as under, or as applied whichever is lower: - Export Product Qty. Sl. No. Import Items Qty. allowed (1R,2R)-2-amino-6-(4-nitrophenyl)-1- phenylhex-5-yn-1-ol hydrochloride of Aminoalcohol 1 kg. 1 KRED LYOPHILIZED ENZYME POWDER 0.0118 kg. RA concerned may take further necessary action as per above decision of Norms Committee.||

Case No.	18 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00007504AM24
RA File Number	092404000275 AM20
Licence No and<br>Date	0910067938/27/08/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Dec/202324/17 dated 20.12.2023against advance<br>authorizationNo. 0911000023 dated 15/12/2020, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I

UDIN00469829AM24

Dec/202324/17 dated 20.12.2023against advance authorizationNo.** 0911000023 dated 15/12/2020, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I||

UDIN00469829AM24

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Sodium(S)-4-oxo-4,6,7,8-<br>tetrahydropyrrolo[1,2-a]pyrimidine-6-<br>carboxylate	1 kg.	1	NORBORNADIENE TECH	2.00 kg.

Case No.	19 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00004718AM24
RA File Number	052404000296 AM20
Licence No and<br>Date	0510411778/06/09/2019
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>HYPE<br>0.905 kg.<br>TESA-1-(3-CHLOROPYRIDIN-2YL)-3-[5-<br>(TRIFLUOROMETHYL)-2H TETRAZOL-<br>2YLMETHYL-1H- PYRAZOLE -5-<br>CARBOXYLIC ACID<br>1 kg.<br>2<br>TFMT-NA<br>(28% solution in Acetone)<br>1.91 kg.<br>RA concerned may take further necessary action as per above decision of NC.

2YLMETHYL-1H- PYRAZOLE -5- CARBOXYLIC ACID 1 kg. 2 TFMT-NA (28% solution in Acetone) 1.91 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	20 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	VINS BIOPRODUCTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00006988AM24
RA File Number	092404000410 AM20

UDIN00469829AM24

Licence No and 0910068189/15/11/2019 Date Norms Committee Decision: The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following information/documents from the firm:- 1. Batch Manufacturing record and material reconciliation sheet duly signed by dealing executive/manager from the applicant.

Case No.	21 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00004716AM24
RA File Number	052404000445 AM20
Licence No and<br>Date	0510412564/21/11/2019
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

REVIW00004716AM24| |RA File Number|052404000445 AM20| |Licence No and Date|0510412564/21/11/2019| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	Case No.	Case No.	22 / NC/3/MEET/Dec/202324/19	22 / NC/3/MEET/Dec/202324/19	22 / NC/3/MEET/Dec/202324/19
Case Status			Case Approved
Party Name			RUBICON RESEARCH PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number			HQRNORM REVIW00007128AM24
RA File Number			039504000793 AM20
Licence No and<br>Date			0310833193/04/12/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. 3/82-ALC4/2020 dated 07.08.2020against advance authorization No.<br>0310830404 dated 18.07.2019, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Cyclobenzaprine Tablet 5MG<br>1 Number<br>1<br>Anhydrous Lactose USP<br>- NF (Super Tab 21 AN)<br>95.00 mg / 5<br>mg tablet<br>2<br>Cyclobenzaprine Tablet10 MG<br>1 Number<br>1<br>Anhydrous Lactose USP<br>- NF (Super Tab 21 AN)<br>90.00 mg / 10<br>mg tablet
	Sl. No.	Export product		Qty.	Sl.

00 mg / 5 mg tablet 2 Cyclobenzaprine Tablet10 MG 1 Number 1 Anhydrous Lactose USP - NF (Super Tab 21 AN) 90.00 mg / 10 mg tablet|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|Cyclobenzaprine Tablet 5MG||1 Number|1|Anhydrous Lactose USP - NF (Super Tab 21 AN)|95.00 mg / 5 mg tablet| ||2|Cyclobenzaprine Tablet10 MG||1 Number|1|Anhydrous Lactose USP - NF (Super Tab 21 AN)|90.00 mg / 10 mg tablet|

UDIN00469829AM24

Case No.	23 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	RUBICON RESEARCH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00007129AM24
RA File Number	039504001166 AM20
Licence No and<br>Date	0310835813/24/04/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. 3/82-ALC4/2020 dated 07.08.2020against advance authorization No.<br>0310830404 dated 18.07.2019, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Sl. No. Export product<br>Qty.<br>Sl. No.

8.07.2019**, it was decided to fix ad-hoc 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. No. Import items Qty. 1 Cyclobenzaprine Tablet 5MG 1 Number 1 Supertab 21 AN Anhydrous Lactose Ph .Eur Anhydrous lactose USP-NF,JP 95.00 mg / 5 mg tablet 2 Cyclobenzaprine Tablet 7.5 mg 1 Number 1 Supertab 21 AN Anhydrous Lactose Ph .Eur Anhydrous lactose USP-NF,JP 92.5 mg / 7.5 mg tablet 3 Cyclobenzaprine Tablet10 MG 1 Number 1 Supertab 21 AN Anhydrous Lactose Ph .Eur Anhydrous lactose USP-NF,JP 90.00 mg / 10 mg tablet RA concerned may take further necessary action as per above decision of NC.||

Case No.	24 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	RUBICON RESEARCH PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024

UDIN00469829AM24

and Date
HQ File Number	HQRNORM REVIW00007125AM24
RA File Number	039504000025 AM21
Licence No and<br>Date	0310835832/25/04/2020
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>1. Drug Manufacturing Licence (DML) for each export item.<br>2. Master Batch Formula for each item.

s and it was decided to call for following information/documents from the firm:- 1. Drug Manufacturing Licence (DML) for each export item. 2. Master Batch Formula for each item.||

Case No.	25 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	RUBICON RESEARCH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00007123AM24
RA File Number	039504000062 AM21
Licence No and<br>Date	0310836183/13/05/2020
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>1. Get the license amended to show content of API in each export.

Case No.	Case No.	26 / NC/3/MEET/Dec/202324/19	26 / NC/3/MEET/Dec/202324/19	26 / NC/3/MEET/Dec/202324/19	26 / NC/3/MEET/Dec/202324/19	26 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		SRF LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM REVIW00004717AM24
RA File Number		052404000258 AM21
Licence No and<br>Date		0510415088/02/09/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl.

-hoc norms and it was decided to fix ad-hoc 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. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

UDIN00469829AM24

1<br>HYPE<br>0.905 kg.<br>TESA -1-(3-CHLOROPYRIDIN-2YL)-3-<br>[5-(TRIFLUOROMETHYL)-2H<br>TETRAZOL-2YLMETHYL-1H-<br>PYRAZOLE-5-CARBOXYLIC ACID<br>1 kg.<br>2<br>TFMT-Na<br>(28% solutions in Acetone)<br>1.91 kg.<br>RA concerned may take further necessary action as per above decision of NC.	TESA -1-(3-CHLOROPYRIDIN-2YL)-3-<br>[5-(TRIFLUOROMETHYL)-2H<br>TETRAZOL-2YLMETHYL-1H-<br>PYRAZOLE-5-CARBOXYLIC ACID	1 kg.	1	HYPE	0.905 kg.
			2	TFMT-Na<br>(28% solutions in Acetone)	1.91 kg.

Case No.	27 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	ROYAL PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00006811AM24
RA File Number	039504000439 AM21
Licence No and<br>Date	0310838908/15/10/2020
Norms Committee Decision:<br>Shri Padmakant Pandya, Manager (Exports), Shri Rutvij Purohit, Asstt. Manager (Exports) and Shri P.J. Gandhi,<br>Technical Consultant of the firm had attended the Personal Hearing and explained the case.

Padmakant Pandya, Manager (Exports), Shri Rutvij Purohit, Asstt. Manager (Exports) and Shri P.J. Gandhi, Technical Consultant of the firm had attended the Personal Hearing and explained the case. The Committee heard the explanation of Representative of the firm and after due deliberation the committee has considered for review of ad-hoc norms on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under, or as applied whichever is less: - Export Product Qty. Sl. No. Import Items Qty. allowed. 1 N-[4-CYANO-3- (TRIFLUORO METHYL)PHENYL] METHACRYLAMIDE MATERIAL FORMULA C12H9ON2F3 AND MATERIAL WEIGHT 254 0.750 kg. BICALUTAMIDE SULFIDE CHEMICAL NAME: N-[4-CYANO-3- (TRIFLUORO METHYL)PHENYL]-3- [(4-FLUOROPHENYL THIO)] -2- HYDROXY-2-METHYL PROPIONALIDE 1 kg. 2 4-FLUOROTHIOPHENOL MATERIAL FORMULA C6H5F5 AND MATERIAL WEIGHT 128 0.344 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No. 28 / NC/3/MEET/Dec/202324/19

UDIN00469829AM24

ULA C6H5F5 AND MATERIAL WEIGHT 128 0.344 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No. 28 / NC/3/MEET/Dec/202324/19

UDIN00469829AM24

Case Status	Case Approved
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005163AM24
RA File Number	NA
Licence No and<br>Date	0310839717/25/11/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in MeetingNo. NC/3/MEET/May/202223/3 dated 27.05.2022against advance authorization<br>No. 0311005861 dated 04.08.2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Eastman ( TM) Cellulose<br>Acetate ( CA 398-10NF/EP)<br>4.40 mg<br>Carbamazepine Extended Relase Tablets USP<br>100mg,(Each Tablet Contains ( 1 ) Eastman (<br>TM ) Cellulose Acetate ( CA<br>398-10NF/EP)-35.04mg,<br>2)<br>Cellulose<br>Acetate ( CA -320S)-Eastman 5.28mg. Net<br>content (i) 3650.010 (ii) 550.000)<br>1 Number<br>2<br>Cellulose Acetate ( CA-320S<br>Eastman)<br>29.20 mg<br>RA concerned may take further necessary action as per above decision of NC.

. Net content (i) 3650.010 (ii) 550.000) 1 Number 2 Cellulose Acetate ( CA-320S Eastman) 29.20 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	29 / NC/3/MEET/Dec/202324/19	29 / NC/3/MEET/Dec/202324/19	29 / NC/3/MEET/Dec/202324/19	29 / NC/3/MEET/Dec/202324/19	29 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM REVIW00004711AM24
RA File Number		039404000659 AM21
Licence No and<br>Date		0310839748/26/11/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>DIISOPROPYL ETHER<br>DIISOPROPYL ETHER<br>1 kg.<br>1<br>1.25 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	DIISOPROPYL ETHER		1 kg.	1	DIISOPROPYL ETHER	1.25 kg.

UDIN00469829AM24

(Purity more than 99.21%)			(Purity not more than 95%)
(Moisture less than 1000 PPM)

SOPROPYL ETHER||1 kg.|1|DIISOPROPYL ETHER|1.25 kg.|

UDIN00469829AM24

(Purity more than 99.21%)			(Purity not more than 95%)
(Moisture less than 1000 PPM)

Case No.	30 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	MAC-CHEM PRODUCTS (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00005491AM24
RA File Number	NA
Licence No and<br>Date	0311000185/17/12/2020
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>1. Complete Chemistry, Molecular weight, Percentage Yield and Material Balance for Lyophilised sterile Bulk.

Case No.	Case No.	31 / NC/3/MEET/Dec/202324/19	31 / NC/3/MEET/Dec/202324/19	31 / NC/3/MEET/Dec/202324/19	31 / NC/3/MEET/Dec/202324/19	31 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM REVIW00006917AM24
RA File Number		09AA04002675 AM21
Licence No and<br>Date		0911000050/18/12/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>**Sl. No.

the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Methyl L-pyroglutamate 2.70 kg. 2 Triethyl amine 2.27 kg. Pyrimidinone acid, sodium salt sodium((S)-4-oxo- 4,6,7,8-tetrahydropyrrolo [1,2-a]pyrimidine-6- carboxylate) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Pyrimidinone acid, sodium salt sodium((S)-4-oxo- 4,6,7,8-tetrahydropyrrolo [1,2-a]pyrimidine-6- carboxylate)||1 kg.|1|Methyl L-pyroglutamate|2.70 kg.| |||||2|Triethyl amine|2.27 kg.|

UDIN00469829AM24

3<br>2,5 Norbornadiene<br>2.00 kg.<br>4<br>Chloro sulfonyl isocyanate<br>2.778 kg.<br>5<br>Isopropyl alcohol<br>4.02 kg.<br>RA concerned may take further necessary action as per above decision of NC.			3	2,5 Norbornadiene	2.00 kg.
			4	Chloro sulfonyl isocyanate	2.778 kg.
			5	Isopropyl alcohol	4.02 kg.

take further necessary action as per above decision of NC.			3	2,5 Norbornadiene	2.00 kg.
			4	Chloro sulfonyl isocyanate	2.778 kg.
			5	Isopropyl alcohol	4.02 kg.

Case No.	32 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	RUBICON RESEARCH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00007127AM24
RA File Number	039504000557 AM21
Licence No and<br>Date	0311000313/22/12/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. 3/82-ALC4/2020 dated 07.08.2020against advance authorization No.<br>0310830404 dated 18.07.2019, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Cyclobenzaprine Tablet 5MG<br>1 Number<br>1<br>Supertab 21 AN Anhydrous<br>Lactose Ph .Eur Anhydrous<br>lactose USP-NF,JP<br>95.00 mg / 5<br>mg tablet<br>2<br>Cyclobenzaprine Tablet 7.5 mg<br>1 Number<br>1<br>Supertab 21 AN Anhydrous<br>Lactose Ph .Eur Anhydrous<br>lactose USP-NF,JP<br>92.5 mg / 7.5<br>mg tablet<br>3<br>Cyclobenzaprine Tablet10 MG<br>1 Number<br>1<br>Supertab 21 AN Anhydrous<br>Lactose Ph .Eur Anhydrous<br>lactose USP-NF,JP<br>90.00 mg / 10<br>mg tablet<br>RA concerned may take further necessary action as per above decision of NC.

1 Supertab 21 AN Anhydrous Lactose Ph .Eur Anhydrous lactose USP-NF,JP 90.00 mg / 10 mg tablet RA concerned may take further necessary action as per above decision of NC.||

UDIN00469829AM24

Case No.	33 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	SV PLASTOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00007423AM24
RA File Number	31AA04007148 AM21
Licence No and<br>Date	3111000400/14/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.14/82-ALC4/2019 dated 06/03/2020against advance authorization<br>No.3110067406 dated 02/05/2019, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>TIN INGOTS<br>0.122 kg.<br>TRI BUTYL TIN OXIDE (TBTO)<br>1 kg.<br>2<br>TETRA BUTYL TIN TBT<br>0.969 kg.<br>RA concerned may take further necessary action as per above decision of NC.

.** 1 TIN INGOTS 0.122 kg. TRI BUTYL TIN OXIDE (TBTO) 1 kg. 2 TETRA BUTYL TIN TBT 0.969 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>	Case No.<br>	34 / NC/3/MEET/Dec/202324/19	34 / NC/3/MEET/Dec/202324/19	34 / NC/3/MEET/Dec/202324/19	34 / NC/3/MEET/Dec/202324/19	34 / NC/3/MEET/Dec/202324/19
Case Status<br>		Case Approved
Party Name<br>		VARTIKA CHEMICALS AND PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date<br>		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number<br>		HQRNORM APPLY 00002099AM23
RA File Number<br>		NA
Licence No and<br>Date<br>		1311000462/22/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>MEROPENEM STERILE IP<br>(Sterile Powder for injection<br>1 kg.<br>1<br>Meropenem Trihydrate<br>(Non-sterile)<br>0.8968 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	MEROPENEM STERILE IP<br>(Sterile Powder for injection		1 kg.	1	Meropenem Trihydrate<br>(Non-sterile)	0.8968 kg.

UDIN00469829AM24

(Antibiotic))

.**|Import Items|Qty. allowed.| ||MEROPENEM STERILE IP (Sterile Powder for injection||1 kg.|1|Meropenem Trihydrate (Non-sterile)|0.8968 kg.|

UDIN00469829AM24

(Antibiotic))

Case No.	Case No.	35 / NC/3/MEET/Dec/202324/19	35 / NC/3/MEET/Dec/202324/19	35 / NC/3/MEET/Dec/202324/19	35 / NC/3/MEET/Dec/202324/19	35 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM APPLY 00148419AM22
RA File Number		31AA04021097 AM22
Licence No and<br>Date		3111000476/27/07/2021
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc 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. allowed. Radicate Spot on 12 (For small dog) (6 Pipettes Pack)) 0.5 ml. 180.0 Number 1 Selamectin BP 66.096 gm. Radicate Spot on 12 (For medium dog) (6 Pipettes Pack)) 1 ml. 150.0 Number 2 Selamectin BP 110.16 gm. Radicate Spot on 12(Radicate Spot on 12 (For large dog) (6 Pipettes Pack)) 2 ml. 100.0 Number 3 Selamectin BP 146.88 gm. Radicate Spot on 12(Radicate Spot on 12 (For Extra large dog) (6 Pipettes Pack)) 3 ml. 100.0 Number 4 Selamectin BP 220.32 gm. Radicate Spot on 12(Radicate Spot on 12 (For Cat) (6 Pipettes Pack)) 0.75 ml. 2500.0 Number 5 Selamectin BP 708.75 gm. Radicate Spot on 12(Radicate Spot on 12 (For small dog) (1 Pipettes Pack)) 0.5 ml. 2000.0 Number 6 Selamectin BP 122.40 gm. Radicate Spot on 12(Radicate Spot on 12 (For medium dog) (1 Pipettes Pack)) 1 ml 2000.0 Number 7 Selamectin BP 244.80 gm.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|**Qty.

t on 12(Radicate Spot on 12 (For medium dog) (1 Pipettes Pack)) 1 ml 2000.0 Number 7 Selamectin BP 244.80 gm.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Radicate Spot on 12 (For small dog) (6 Pipettes Pack)) 0.5 ml.|| 180.0 Number|1|Selamectin BP|66.096 gm.| ||Radicate Spot on 12 (For medium dog) (6 Pipettes Pack)) 1 ml.|| 150.0 Number|2|Selamectin BP|110.16 gm.| ||Radicate Spot on 12(Radicate Spot on 12 (For large dog) (6 Pipettes Pack)) 2 ml.|| 100.0 Number|3|Selamectin BP|146.88 gm.| ||Radicate Spot on 12(Radicate Spot on 12 (For Extra large dog) (6 Pipettes Pack)) 3 ml.|| 100.0 Number|4|Selamectin BP|220.32 gm.| ||Radicate Spot on 12(Radicate Spot on 12 (For Cat) (6 Pipettes Pack)) 0.75 ml.|| 2500.0 Number|5|Selamectin BP|708.75 gm.| ||Radicate Spot on 12(Radicate Spot on 12 (For small dog) (1 Pipettes Pack)) 0.5 ml.|| 2000.0 Number|6|Selamectin BP|122.40 gm.| ||Radicate Spot on 12(Radicate Spot on 12 (For medium dog) (1 Pipettes Pack)) 1 ml|| 2000.0 Number|7|Selamectin BP|244.80 gm.|

UDIN00469829AM24

0.0 Number|6|Selamectin BP|122.40 gm.| ||Radicate Spot on 12(Radicate Spot on 12 (For medium dog) (1 Pipettes Pack)) 1 ml|| 2000.0 Number|7|Selamectin BP|244.80 gm.|

UDIN00469829AM24

Radicate Spot on 12(Radicate Spot on 12 (For large dog)<br>(1 Pipettes Pack)) 2 ml.	<br>1000.0 Number	8	Selamectin BP	244.80 gm.
Radicate Spot on 12(Radicate Spot on 12 (For Extra large<br>dog) (1 Pipettes Pack)) 3 ml.	<br>250.0 Number	9	Selamectin BP	91.80 gm.
Petmedin 1.25 mg Tablets(Petmedin 1.25 mg Tablets)	1 Number each	10	Selamectin BP	1.275 mg.
Petmedin 2.5 mg Tablets(Petmedin 2.5 mg Tablets)	1 Number each	11	Selamectin BP	2.55 mg.
Petmedin 5 mg Tablets(Petmedin 5 mg Tablets)	1 Number each	12	Selamectin BP	5.10 mg.

ectin BP|1.275 mg.| ||Petmedin 2.5 mg Tablets(Petmedin 2.5 mg Tablets)|1 Number each|11|Selamectin BP|2.55 mg.| ||Petmedin 5 mg Tablets(Petmedin 5 mg Tablets)|1 Number each|12|Selamectin BP|5.10 mg.| ||Petmedin 10 mg Tablets(Petmedin 10 mg Tablets)|1 Number each|13|Selamectin BP|10.20 mg.|

Case No.	36 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	RAJASTHAN ANTIBIOTICS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00150875AM22
RA File Number	05AA04055660 AM22
Licence No and<br>Date	0511003910/30/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>KETOPROFEN<br>BP<br>(STERILE<br>POWDER) (32.3 Percentage TO 39.5<br>Percentage W/W)<br>1 kg.<br>1<br>KETOPROFEN BP<br>0.363 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	37 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	HARMAN FINOCHEM LIMITED

UDIN00469829AM24

rther necessary action as per above decision of NC.||

Case No.	37 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	HARMAN FINOCHEM LIMITED

UDIN00469829AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00164102AM22
RA File Number	03AA04065031 AM22
Licence No and<br>Date	0311006216/17/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case alongwith relevant documents.		Personal Hearing

Case No.	38 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00165403AM22
RA File Number	05AA04062260 AM22
Licence No and<br>Date	0511004178/18/08/2021
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Complete Chemistry, Molecular Weight and Percentage Yield on molar basis for each export products.

norms and it was decided to call for following information/documents from the firm:- Complete Chemistry, Molecular Weight and Percentage Yield on molar basis for each export products.||

Case No.	Case No.	39 / NC/3/MEET/Dec/202324/19	39 / NC/3/MEET/Dec/202324/19	39 / NC/3/MEET/Dec/202324/19	39 / NC/3/MEET/Dec/202324/19	39 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		CHEMPLAST SANMAR LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM REVIW00006805AM23
RA File Number		04AA04015436 AM22
Licence No and<br>Date		0411001511/22/09/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Hydrogen Cyanamide 30 Percent<br>1.48 kg.<br>Phenyl Guanidine Carbonate<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Phenyl Guanidine Carbonate		1 kg.	1	Hydrogen Cyanamide 30 Percent	1.48 kg.

yl Guanidine Carbonate 1 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Phenyl Guanidine Carbonate||1 kg.|1|Hydrogen Cyanamide 30 Percent|1.48 kg.|

Case No.	Case No.	39 / NC/3/MEET/Dec/202324/19	39 / NC/3/MEET/Dec/202324/19	39 / NC/3/MEET/Dec/202324/19	39 / NC/3/MEET/Dec/202324/19	39 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		CHEMPLAST SANMAR LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM REVIW00006805AM23
RA File Number		04AA04015436 AM22
Licence No and<br>Date		0411001511/22/09/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Hydrogen Cyanamide 30 Percent<br>1.48 kg.<br>Phenyl Guanidine Carbonate<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Phenyl Guanidine Carbonate		1 kg.	1	Hydrogen Cyanamide 30 Percent	1.48 kg.

UDIN00469829AM24

2 Aniline 0.682 kg.

t Product**||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Phenyl Guanidine Carbonate||1 kg.|1|Hydrogen Cyanamide 30 Percent|1.48 kg.|

UDIN00469829AM24

2 Aniline 0.682 kg.

Case No.	40 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	AMARA LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00211472AM22
RA File Number	09AA04016055 AM22
Licence No and<br>Date	0911001711/13/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Deferiprone<br>1 kg.<br>1<br>Maltol<br>1.26 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Qty. Sl. No. Import Items Qty. allowed. Deferiprone 1 kg. 1 Maltol 1.26 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	41 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	LUPIN LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00005265AM24
RA File Number	03AA040109357 AM22
Licence No and<br>Date	0311007760/18/10/2021
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Copy of Drug Manufacturing Licence (DML) for export items.<br>1.<br>Complete chemistry, Molecular Weight, Percentage Yield on molar basis for API.<br>2.

UDIN00469829AM24

Case No.	42 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	BHAGWATI INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00219420AM22
RA File Number	08AA04033013 AM22
Licence No and<br>Date	0811002934/21/10/2021

|Meeting Number and Date|NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024| |HQ File Number|HQRNORM APPLY 00219420AM22| |RA File Number|08AA04033013 AM22| |Licence No and Date|0811002934/21/10/2021| |Norms Committee Decision: The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following information/documents from the firm:- Chemistry of the export item giving molecular weight of both reactant and the products. 1. Yield of the reaction with justification and to indicate by-product formed with value, if any. 2.||

Case No.	43 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00239769AM22
RA File Number	09AA04001389 AM22
Licence No and<br>Date	0911001808/02/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case to Deptt. ofBio-Technologyfor<br>obtaining their comments.

1808/02/11/2021| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to refer the case to Deptt. ofBio-Technologyfor obtaining their comments.||

Case No.	Case No.	44 / NC/3/MEET/Dec/202324/19	44 / NC/3/MEET/Dec/202324/19	44 / NC/3/MEET/Dec/202324/19	44 / NC/3/MEET/Dec/202324/19	44 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM APPLY 00253270AM22
RA File Number		05AA04099135 AM22
Licence No and<br>Date		0511006147/15/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00469829AM24

Tretinoin Microspheres,2%	1 kg.	1	Tretinoin USP	0.021 kg.
Placebo Tretinoin Microspheres,2%	1 kg.	2	Tretinoin USP	0.021 kg.

*Qty. allowed.**|

UDIN00469829AM24

Tretinoin Microspheres,2%	1 kg.	1	Tretinoin USP	0.021 kg.
Placebo Tretinoin Microspheres,2%	1 kg.	2	Tretinoin USP	0.021 kg.

Case No.	45 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	ALEOR DERMACEUTICALS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00255297AM22
RA File Number	34AA04009240 AM22
Licence No and Date	3411001409/17/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>FOAM<br>(BETAMETHASONE<br>VALERATE FOAM, 0.12% (50G<br>CAN)<br>(net<br>content<br>of<br>active<br>ingredient 600gm))<br>1 Number<br>1<br>BETAMETHASONE VALERATE<br>(Micronized)<br>0.0612 gm.<br>FOAM<br>(BETAMETHASONE<br>VALERATE FOAM, 0.12% (100G<br>CAN)<br>(net<br>content<br>of<br>active<br>ingredient 900gm))<br>1 Number<br>2<br>BETAMETHASONE VALERATE<br>(Micronized)<br>0.1224 gm.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	46 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	NATCO PHARMA LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00004488AM24
RA File Number	09AX04000043 AM22
Licence No and Date	0911002121/21/12/2021

UDIN00469829AM24

Norms Committee Decision:

The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
NITROGLYCERIN SUBLINGUAL<br>TABLETS USP 0.3 mg Each Tablet contains<br>Nitroglycerin USP 0.3 mg<br>(2x1,80,000=3,60,000 Tablets)	1 Number	1	DILUTED<br>NITROGLYCERIN USP<br>1.95 percent	16.105 mg
		2	Glyceryl Monosterate<br>(Imwitor 491 powder)	1.255 mg
NITROGLYCERIN SUBLINGUAL<br>TABLETS USP 0.4mg Each Tablet contains<br>Nitroglycerin USP 0.4 mg<br>(4x12,00,000=48,00,000 Tablets)	1 Number	3	DILUTED<br>NITROGLYCERIN USP<br>1.95 percent	21.474 mg
		4	Glyceryl Monosterate<br>(Imwitor 491 powder)	1.255 mg
NITROGLYCERIN SUBLINGUAL<br>TABLETS USP 0.6 mg Each Tablet contains<br>Nitroglycerin USP 0.6 mg<br>(2x1,80,000=3,60,000 Tablets)	1 Number	5	DILUTED<br>NITROGLYCERIN USP<br>1.95 percent	32.21 mg
		6	Glyceryl Monosterate<br>(Imwitor 491 powder)	1.255 mg

contains Nitroglycerin USP 0.6 mg (2x1,80,000=3,60,000 Tablets)|1 Number|5|DILUTED NITROGLYCERIN USP 1.95 percent|32.21 mg| |||6|Glyceryl Monosterate (Imwitor 491 powder)|1.255 mg|

Case No.	47 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	SV PLASTOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00007424AM24
RA File Number	31AX04000016 AM22
Licence No and<br>Date	3111000805/21/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Feb/202223/20 dated 24/02/2023against advance

UDIN00469829AM24

authorization No.3111000540 dated 23/08/2021 , it was decided to fix ad-hoc 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. allowed.
MONO BUTYL TIN OXIDE (MBTO)	1 kg.	1	TIN INGOTS	0.496 kg.
		2	TETRA BUTYL TIN TBT	0.487 kg.

Case No.	48 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00299344AM22
RA File Number	07AA04038998 AM22
Licence No and<br>Date	0711002737/28/12/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00299344AM22| |RA File Number|07AA04038998 AM22| |Licence No and Date|0711002737/28/12/2021| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	Case No.	Case No.	49 / NC/3/MEET/Dec/202324/19	49 / NC/3/MEET/Dec/202324/19	49 / NC/3/MEET/Dec/202324/19	49 / NC/3/MEET/Dec/202324/19	49 / NC/3/MEET/Dec/202324/19
Case Status			Case Approved
Party Name			RUBICON RESEARCH PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number			HQRNORM REVIW00007179AM24
RA File Number			03AX04000191 AM22
Licence No and<br>Date			0311009972/31/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. 3/82-ALC4/2020 dated 07.08.2020against advance authorization No.<br>0310830404 dated 18.07.2019, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.
	Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.

UDIN00469829AM24

pplied by the firm, whichever is less:- Sl. No. Export product Qty. Sl. No. Import items Qty.|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.|

UDIN00469829AM24

1<br>Cyclobenzaprine Tablet 5MG<br>1 Number<br>1<br>Supertab 21 AN Anhydrous<br>Lactose Ph .Eur Anhydrous<br>lactose USP-NF,JP<br>95.00 mg / 5<br>mg tablet<br>2<br>Cyclobenzaprine Tablet 7.5 mg<br>1 Number<br>1<br>Supertab 21 AN Anhydrous<br>Lactose Ph .Eur Anhydrous<br>lactose USP-NF,JP<br>92.5 mg / 7.5<br>mg tablet<br>3<br>Cyclobenzaprine Tablet10 MG<br>1 Number<br>1<br>Supertab 21 AN Anhydrous<br>Lactose Ph .Eur Anhydrous<br>lactose USP-NF,JP<br>90.00 mg / 10<br>mg tablet<br>RA concerned may take further necessary action as per above decision of NC.	1	Cyclobenzaprine Tablet 5MG	1 Number	1	Supertab 21 AN Anhydrous<br>Lactose Ph .Eur Anhydrous<br>lactose USP-NF,JP	95.00 mg / 5<br>mg tablet
	2	Cyclobenzaprine Tablet 7.5 mg	1 Number	1	Supertab 21 AN Anhydrous<br>Lactose Ph .Eur Anhydrous<br>lactose USP-NF,JP	92.5 mg / 7.5<br>mg tablet
	3	Cyclobenzaprine Tablet10 MG	1 Number	1	Supertab 21 AN Anhydrous<br>Lactose Ph .Eur Anhydrous<br>lactose USP-NF,JP	90.00 mg / 10<br>mg tablet

lactose USP-NF,JP|92.5 mg / 7.5 mg tablet| ||3|Cyclobenzaprine Tablet10 MG|1 Number|1|Supertab 21 AN Anhydrous Lactose Ph .Eur Anhydrous lactose USP-NF,JP|90.00 mg / 10 mg tablet|

Case No.	Case No.	50 / NC/3/MEET/Dec/202324/19	50 / NC/3/MEET/Dec/202324/19	50 / NC/3/MEET/Dec/202324/19	50 / NC/3/MEET/Dec/202324/19	50 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		AUROBINDO PHARMA LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM APPLY 00326841AM22
RA File Number		09AA04016329 AM22
Licence No and<br>Date		0911002348/21/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Meropenem Trihydrate<br>(Non-Sterile) I.P<br>0.8968 kg.<br>2<br>Acetone<br>2.64 kg.<br>3<br>Methanol (Methyl Alcohol)<br>0.80 kg.<br>Meropenem for Injection<br>(Sterile Bulk) USP<br>1 kg.<br>4<br>Aluminium Canister 14 Ltr.(5Kg) with<br>Inner and Outer Lids<br>Relevant, as per<br>Packing Policy
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

Bulk) USP 1 kg. 4 Aluminium Canister 14 Ltr.(5Kg) with Inner and Outer Lids Relevant, as per Packing Policy||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Meropenem for Injection (Sterile Bulk) USP||1 kg.|1|Meropenem Trihydrate (Non-Sterile) I.P|0.8968 kg.| |||||2|Acetone|2.64 kg.| |||||3|Methanol (Methyl Alcohol)|0.80 kg.| |||||4|Aluminium Canister 14 Ltr.(5Kg) with Inner and Outer Lids|Relevant, as per Packing Policy|

Case No.	Case No.	50 / NC/3/MEET/Dec/202324/19	50 / NC/3/MEET/Dec/202324/19	50 / NC/3/MEET/Dec/202324/19	50 / NC/3/MEET/Dec/202324/19	50 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		AUROBINDO PHARMA LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM APPLY 00326841AM22
RA File Number		09AA04016329 AM22
Licence No and<br>Date		0911002348/21/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc 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. allowed. 1 Meropenem Trihydrate (Non-Sterile) I.P 0.8968 kg. 2 Acetone 2.64 kg. 3 Methanol (Methyl Alcohol) 0.80 kg. Meropenem for Injection (Sterile Bulk) USP 1 kg. 4 Aluminium Canister 14 Ltr.(5Kg) with Inner and Outer Lids Relevant, as per Packing Policy||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Meropenem for Injection (Sterile Bulk) USP||1 kg.|1|Meropenem Trihydrate (Non-Sterile) I.P|0.8968 kg.| |||||2|Acetone|2.64 kg.| |||||3|Methanol (Methyl Alcohol)|0.80 kg.| |||||4|Aluminium Canister 14 Ltr.(5Kg) with Inner and Outer Lids|Relevant, as per Packing Policy|

UDIN00469829AM24

Case No.	51 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00345828AM22
RA File Number	09AX04000205 AM22
Licence No and<br>Date	0911002465/07/02/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00345828AM22| |RA File Number|09AX04000205 AM22| |Licence No and Date|0911002465/07/02/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	52 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00346268AM22
RA File Number	34AX04000204 AM22
Licence No and<br>Date	3411001767/07/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case alongwith relevant documents.		Personal Hearing

Case No.	53 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00350237AM22
RA File Number	05AX04000943 AM22
Licence No and<br>Date	0511008753/10/02/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No. 54 / NC/3/MEET/Dec/202324/19

31 This document has been digitally signed by Raman Kumar, Deputy DGFT on 06-02-2024 11:34:01.

UDIN00469829AM24

eration for want of comments of TE.**||

Case No. 54 / NC/3/MEET/Dec/202324/19

31 This document has been digitally signed by Raman Kumar, Deputy DGFT on 06-02-2024 11:34:01.

UDIN00469829AM24

Case Status	Case Deferred
Party Name	GANGWAL HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00356909AM22
RA File Number	03AX04001205 AM22
Licence No and<br>Date	0311011422/16/02/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	55 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00371441AM22
RA File Number	09AX04000232 AM22
Licence No and<br>Date	0911002575/01/03/2022
Norms Committee Decision:<br>The firm has informed that they have surrendered their above license. In view of the information from the firm, the<br>Committee decided towithdrawthe case.

Case No.	56 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00386056AM22
RA File Number	08AX04000650 AM22
Licence No and<br>Date	0811004377/14/03/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00386056AM22| |RA File Number|08AX04000650 AM22| |Licence No and Date|0811004377/14/03/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	57 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	PROEC ENERGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00005029AM24
RA File Number	05AX04001262 AM22

32 This document has been digitally signed by Raman Kumar, Deputy DGFT on 06-02-2024 11:34:01.

UDIN00469829AM24

Licence No and 0511010975/14/03/2022 Date Norms Committee Decision:

The case is under consideration for want of comments of TE.

Case No.	Case No.	Case No.	58 / NC/3/MEET/Dec/202324/19	58 / NC/3/MEET/Dec/202324/19	58 / NC/3/MEET/Dec/202324/19	58 / NC/3/MEET/Dec/202324/19	58 / NC/3/MEET/Dec/202324/19
Case Status			Case Approved
Party Name			CIPLA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number			HQRNORM REVIW00000257AM24
RA File Number			03AX04001590 AM22
Licence No and<br>Date			0311013222/22/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Jan/202122/13 dated 21/01/2022against advance<br>authorizationNo.0311005784 dated 01/08/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

uct in meetingNo.NC/3/MEET/Jan/202122/13 dated 21/01/2022against advance authorizationNo.0311005784 dated 01/08/2021, it was decided to fix ad-hoc 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. No. Import items Qty. allowed 1 Telmisartan Granules 68.034 mg 1 Telmisartan and Amlodipine Tablets 40/10mg / Each uncoated tablets contains :(Telmisartan 40 mg Telmisartan 40 mg equivalent to Telmisartan granules 67.36mg Amlodipine Besilate equivalent to Amlodipine USP 10mg Net wt of Telmisartan Granules is 2020.800 Kgs. Net wt of Amlodipine Besilate is 300.000 Kgs.) 1 Number 2 Amlodipine Besilate 10.20 mg 3 Telmisartan Granules 136.07 mg 2 Telmisartan and Amlodipine Tablets 80/10mg / Each uncoated tablets contains : Telmisartan 80 mg(Telmisartan 80 mg equivalent to Telmisartan granules 134.72mg Amlodipine Besilate equivalent to Amlodipine USP 10mg Net wt of Telmisartan Granules is 10777.600 Kgs. Net wt of Amlodipine Besilate is 800.000 Kgs.) 1 Number 4 Amlodipine Besilate 10.20 mg 5 Telmisartan Granules 68.034 mg 3 Telmisartan and Amlodipine Tablets 40/5mg / Each uncoated tablets contains : Telmisartan 40 mg(Telmisartan 40 mg equivalent to Telmisartan granules 67.36mg Amlodipine Besilate equivalent to Amlodipine USP 5mg Net wt of Telmisartan Granules is 6286.933 Kgs.

: Telmisartan 40 mg(Telmisartan 40 mg equivalent to Telmisartan granules 67.36mg Amlodipine Besilate equivalent to Amlodipine USP 5mg Net wt of Telmisartan Granules is 6286.933 Kgs. Net wt of Amlodipine Besilate is 466.667 Kgs.) 1 Number 6 Amlodipine Besilate 5.10 mg|||||||| ||**Sl. No. **|Export product||Qty.|**Sl. No. **|Import items|Qty. allowed| ||1|Telmisartan and Amlodipine Tablets 40/10mg / Each uncoated tablets contains :(Telmisartan 40 mg Telmisartan 40 mg equivalent to Telmisartan granules 67.36mg Amlodipine Besilate equivalent to Amlodipine USP 10mg Net wt of Telmisartan Granules is 2020.800 Kgs. Net wt of Amlodipine Besilate is 300.000 Kgs.)|| 1 Number|1|Telmisartan Granules|68.034 mg| ||||||2|Amlodipine Besilate|10.20 mg| ||2|Telmisartan and Amlodipine Tablets 80/10mg / Each uncoated tablets contains : Telmisartan 80 mg(Telmisartan 80 mg equivalent to Telmisartan granules 134.72mg Amlodipine Besilate equivalent to Amlodipine USP 10mg Net wt of Telmisartan Granules is 10777.600 Kgs. Net wt of Amlodipine Besilate is 800.000 Kgs.)|| 1 Number|3|Telmisartan Granules|136.07 mg| ||||||4|Amlodipine Besilate|10.20 mg| ||3|Telmisartan and Amlodipine Tablets 40/5mg / Each uncoated tablets contains : Telmisartan 40 mg(Telmisartan 40 mg equivalent to Telmisartan granules 67.36mg Amlodipine Besilate equivalent to Amlodipine USP 5mg Net wt of Telmisartan Granules is 6286.933 Kgs.

Case No.	Case No.	Case No.	58 / NC/3/MEET/Dec/202324/19	58 / NC/3/MEET/Dec/202324/19	58 / NC/3/MEET/Dec/202324/19	58 / NC/3/MEET/Dec/202324/19	58 / NC/3/MEET/Dec/202324/19
Case Status			Case Approved
Party Name			CIPLA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number			HQRNORM REVIW00000257AM24
RA File Number			03AX04001590 AM22
Licence No and<br>Date			0311013222/22/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Jan/202122/13 dated 21/01/2022against advance<br>authorizationNo.0311005784 dated 01/08/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>**Qty.

-hoc 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. No. Import items Qty. allowed 1 Telmisartan Granules 68.034 mg 1 Telmisartan and Amlodipine Tablets 40/10mg / Each uncoated tablets contains :(Telmisartan 40 mg Telmisartan 40 mg equivalent to Telmisartan granules 67.36mg Amlodipine Besilate equivalent to Amlodipine USP 10mg Net wt of Telmisartan Granules is 2020.800 Kgs. Net wt of Amlodipine Besilate is 300.000 Kgs.) 1 Number 2 Amlodipine Besilate 10.20 mg 3 Telmisartan Granules 136.07 mg 2 Telmisartan and Amlodipine Tablets 80/10mg / Each uncoated tablets contains : Telmisartan 80 mg(Telmisartan 80 mg equivalent to Telmisartan granules 134.72mg Amlodipine Besilate equivalent to Amlodipine USP 10mg Net wt of Telmisartan Granules is 10777.600 Kgs. Net wt of Amlodipine Besilate is 800.000 Kgs.) 1 Number 4 Amlodipine Besilate 10.20 mg 5 Telmisartan Granules 68.034 mg 3 Telmisartan and Amlodipine Tablets 40/5mg / Each uncoated tablets contains : Telmisartan 40 mg(Telmisartan 40 mg equivalent to Telmisartan granules 67.36mg Amlodipine Besilate equivalent to Amlodipine USP 5mg Net wt of Telmisartan Granules is 6286.933 Kgs. Net wt of Amlodipine Besilate is 466.667 Kgs.) 1 Number 6 Amlodipine Besilate 5.10 mg|||||||| ||**Sl. No. **|Export product||Qty.|**Sl. No.

isartan Granules is 6286.933 Kgs. Net wt of Amlodipine Besilate is 466.667 Kgs.) 1 Number 6 Amlodipine Besilate 5.10 mg|||||||| ||**Sl. No. **|Export product||Qty.|**Sl. No. **|Import items|Qty. allowed| ||1|Telmisartan and Amlodipine Tablets 40/10mg / Each uncoated tablets contains :(Telmisartan 40 mg Telmisartan 40 mg equivalent to Telmisartan granules 67.36mg Amlodipine Besilate equivalent to Amlodipine USP 10mg Net wt of Telmisartan Granules is 2020.800 Kgs. Net wt of Amlodipine Besilate is 300.000 Kgs.)|| 1 Number|1|Telmisartan Granules|68.034 mg| ||||||2|Amlodipine Besilate|10.20 mg| ||2|Telmisartan and Amlodipine Tablets 80/10mg / Each uncoated tablets contains : Telmisartan 80 mg(Telmisartan 80 mg equivalent to Telmisartan granules 134.72mg Amlodipine Besilate equivalent to Amlodipine USP 10mg Net wt of Telmisartan Granules is 10777.600 Kgs. Net wt of Amlodipine Besilate is 800.000 Kgs.)|| 1 Number|3|Telmisartan Granules|136.07 mg| ||||||4|Amlodipine Besilate|10.20 mg| ||3|Telmisartan and Amlodipine Tablets 40/5mg / Each uncoated tablets contains : Telmisartan 40 mg(Telmisartan 40 mg equivalent to Telmisartan granules 67.36mg Amlodipine Besilate equivalent to Amlodipine USP 5mg Net wt of Telmisartan Granules is 6286.933 Kgs. Net wt of Amlodipine Besilate is 466.667 Kgs.)|| 1 Number|5|Telmisartan Granules|68.034 mg| ||||||6|Amlodipine Besilate|5.10 mg|

sartan Granules is 6286.933 Kgs. Net wt of Amlodipine Besilate is 466.667 Kgs.)|| 1 Number|5|Telmisartan Granules|68.034 mg| ||||||6|Amlodipine Besilate|5.10 mg|

UDIN00469829AM24

	4	Telmisartan and Amlodipine Tablets 80/5mg / Each<br>uncoated<br>tablets<br>contains<br>:<br>Telmisartan<br>80<br>mg(Telmisartan 80 mg equivalent to Telmisartan<br>granules 134.72mg Amlodipine Besilate equivalent to<br>Amlodipine USP 5mg Net wt of Telmisartan<br>Granules is 10777.600 Kgs. Net wt of Amlodipine<br>Besilate is 400.000 Kgs.)	Telmisartan and Amlodipine Tablets 80/5mg / Each<br>uncoated<br>tablets<br>contains<br>:<br>Telmisartan<br>80<br>mg(Telmisartan 80 mg equivalent to Telmisartan<br>granules 134.72mg Amlodipine Besilate equivalent to<br>Amlodipine USP 5mg Net wt of Telmisartan<br>Granules is 10777.600 Kgs. Net wt of Amlodipine<br>Besilate is 400.000 Kgs.)	<br> <br> <br> <br> <br> <br>1 Number	7	Telmisartan Granules	136.07 mg

Case No.			59 / NC/3/MEET/Dec/202324/19
Case Status			Case Deferred
Party Name			ARENE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number			HQRNORM APPLY 00000197AM23
RA File Number			09AX04000016 AM23
Licence No and<br>Date			0911002850/12/04/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

|RA File Number|||09AX04000016 AM23||||| |Licence No and Date|||0911002850/12/04/2022||||| |Norms Committee Decision: The case is under consideration for want of comments of TE.||||||||

Case No.	60 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00000485AM23
RA File Number	03AX04000399 AM23
Licence No and<br>Date	0311014263/29/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case alongwith relevant documents.		Personal Hearing

Case No.	61 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00005291AM24
RA File Number	31AX04000028 AM23
Licence No and<br>Date	3111001358/17/05/2022
Norms Committee Decision:

34 This document has been digitally signed by Raman Kumar, Deputy DGFT on 06-02-2024 11:34:01.

UDIN00469829AM24

The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:-

UDIN00469829AM24

The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
DNOVO BP818	1 kg.	1	OCP 50	1.100 kg.
		2	Paraformaldehyde	0.141 kg.
		3	Methanol	0.66 kg.
		4	Katalco 71 5	0.004 kg.

Case No.	Case No.	62 / NC/3/MEET/Dec/202324/19	62 / NC/3/MEET/Dec/202324/19	62 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		NATCO PHARMA LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM REVIW00004490AM24
RA File Number		09AX04000174 AM23
Licence No and Date		0911003150/08/06/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of<br>by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>NITROGLYCERIN SUBLINGUAL<br>TABLETS USP 0.3 mg-Each Tablet<br>contains Nitroglycerin USP 0.3 mg<br>(1 x 1,80,000 = 1,80,000 Tabs)<br>1 Number<br>NITROGLYCERIN SUBLINGUAL<br>TABLETS USP 0.4 mg-Each Tablet<br>1 Number				ad-hoc norms and on the basis of information provided
	Export Product		Qty.	**Sl.

= 1,80,000 Tabs) 1 Number NITROGLYCERIN SUBLINGUAL TABLETS USP 0.4 mg-Each Tablet 1 Number||||ad-hoc norms and on the basis of information provided||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||NITROGLYCERIN SUBLINGUAL TABLETS USP 0.3 mg-Each Tablet contains Nitroglycerin USP 0.3 mg (1 x 1,80,000 = 1,80,000 Tabs)||1 Number|1|DILUTED NITROGLYCERIN USP 1.95 %| 16.105 mg.| |||||2|Glyceryl Monosterate (Imwitor 491 powder)| 1.60 mg.| ||NITROGLYCERIN SUBLINGUAL TABLETS USP 0.4 mg-Each Tablet||1 Number|3|DILUTED NITROGLYCERIN USP| 21.474 mg.|

UDIN00469829AM24

contains Nitroglycerin USP 0.4 mg		1.95 %
(3 x12,00,000= 36,00,000 Tabs)
	4	Glyceryl	Monosterate	<br>1.60 mg.
		(Imwitor 491 powder)

Case No.	63 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	NASENSE LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00001297AM23
RA File Number	09AX04000213 AM23
Licence No and<br>Date	0911003160/09/06/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00001297AM23| |RA File Number|09AX04000213 AM23| |Licence No and Date|0911003160/09/06/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	Case No.	64 / NC/3/MEET/Dec/202324/19	64 / NC/3/MEET/Dec/202324/19	64 / NC/3/MEET/Dec/202324/19	64 / NC/3/MEET/Dec/202324/19	64 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		ROYAL PHARMA
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM REVIW00006658AM24
RA File Number		03AX04001263 AM23
Licence No and<br>Date		0311015473/13/06/2022
Norms Committee Decision:<br>Shri Padmakant Pandya, Manager (Exports), Shri Rutvij Purohit, Asstt. Manager (Exports) and Shri P.J. Gandhi,<br>Technical Consultant of the firm had attended the Personal Hearing and explained the case. The Committee heard<br>the explanation of Representative of the firm and after due deliberation the committee has considered for review of<br>ad-hoc norms on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under, or<br>as applied whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>BICALUTAMIDE SULFIDE<br>CHEMICAL NAME: N-[4-CYANO-3-<br>(TRIFLUORO METHYL)PHENYL]-3-<br>N-[4-CYANO-3-<br>(TRIFLUORO<br>METHYL)PHENYL]<br>METHACRYLAMIDE<br>1 kg.<br>1<br>0.750 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

br>(TRIFLUORO METHYL)PHENYL]-3- N-[4-CYANO-3- (TRIFLUORO METHYL)PHENYL] METHACRYLAMIDE 1 kg. 1 0.750 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||BICALUTAMIDE SULFIDE CHEMICAL NAME: N-[4-CYANO-3- (TRIFLUORO METHYL)PHENYL]-3-||1 kg.|1|N-[4-CYANO-3- (TRIFLUORO METHYL)PHENYL] METHACRYLAMIDE| 0.750 kg.|

UDIN00469829AM24

	MATERIAL<br>FORM<br>C12H9ON2F3 AND MATER	<br>
	WEIGHT 254

2	4-FLUOROTHIOPHENOL<br>MATERIAL FORMULA C6H5F5<br>AND MATERIAL WEIGHT 128	<br>0.344 kg.


Case No.	65 / NC/3/MEET/Dec/202324/19

Case Status	Case Deferred

Party Name	SRF LIMITED

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024

HQ File Number	HQRNORM REVIW00007068AM24

RA File Number	05AX04001017 AM23

Licence No and<br>Date	0511013648/07/07/2022

Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

4| ||| |RA File Number|05AX04001017 AM23| ||| |Licence No and Date|0511013648/07/07/2022| ||| |Norms Committee Decision: The case is under consideration for want of comments of TE.|| |||


Case No.	66 / NC/3/MEET/Dec/202324/19

Case Status	Case Deferred

Party Name	SRF LIMITED

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024

HQ File Number	HQRNORM REVIW00007056AM24

RA File Number	05AX04001011 AM23

Licence No and<br>Date	0511013749/13/07/2022

Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	67 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	DEEPAK NITRITE LIMITED
Meeting Number<br>and Date
	NC/ 3/ MEET/ De	c/ 202324/ 19	and 05/01	/2024
HQ File Number	HQRNORM REV	IW00007416	AM24
RA File Number	34AX04000357 AM23

Case No.	67 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	DEEPAK NITRITE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00007416AM24
RA File Number	34AX04000357 AM23

UDIN00469829AM24

Licence No and 3411002528/13/07/2022 Date Norms Committee Decision:

The case is under consideration for want of comments of TE.

Case No.	68 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	SRF LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00007032AM24
RA File Number	05AX04001131 AM23
Licence No and Date	0511013929/22/07/2022
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>2.2 AZOBISISOBUTYRONITRILE(AIBN)<br>0.0176 kg<br>2<br>BENZOTRIFLUORIDE (BTF)<br>0.0684 kg.<br>2,2-difluoro-1,3-<br>benzodioxole(DFBD)<br>1 kg.<br>3<br>1,3-BENZODIOXOLE<br>0.898 kg.<br>RA concerned may take further necessary action as per above decision of NC.

ORIDE (BTF) 0.0684 kg. 2,2-difluoro-1,3- benzodioxole(DFBD) 1 kg. 3 1,3-BENZODIOXOLE 0.898 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	69 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004780AM24
RA File Number	NA
Licence No and<br>Date	0311016601/26/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Nov/202324/16 dated 17/11/2023against advance<br>authorization No. 0311009090 No. dated 02/12/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP

UDIN00469829AM24

Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty.<br>allowed.
DIISOPROPYL ETHER<br>(Purity more than 99.21%)<br>(Moisture less than 1000 PPM)	1 kg.	1	CRUDE DIISOPROPYL ETHER<br>(Purity not more than 95%)	1.25 kg.

.** allowed.| |---|---|---|---|---| |DIISOPROPYL ETHER (Purity more than 99.21%) (Moisture less than 1000 PPM)|1 kg.|1|CRUDE DIISOPROPYL ETHER (Purity not more than 95%)|1.25 kg.|

Case No.	70 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00005227AM24
RA File Number	31AX04000141 AM23
Licence No and<br>Date	3111001623/17/08/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>OCP 50<br>1.100 kg.<br>2<br>Paraformaldehyde<br>0.141 kg.<br>3<br>Methanol<br>0.66 kg.<br>DNOVO BP818<br>(Tetra Methyl Bisphenol F)<br>1 kg.<br>4<br>Katalco 71 5<br>0.004 kg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00469829AM24

g. DNOVO BP818 (Tetra Methyl Bisphenol F) 1 kg. 4 Katalco 71 5 0.004 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00469829AM24

Case No.	71 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	SHREE MAHADEV INTERMEDIATE
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00005358AM24
RA File Number	34AX04000640 AM23
Licence No and<br>Date	3411002862/04/10/2022
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>“Complete chemical reactions with molecular and structural formula and molecular weights along with stage<br>wise percentage yields on molar basis.”

Case No.	72 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00005140AM24
RA File Number	08AX04001050 AM23
Licence No and<br>Date	0811006214/10/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case alongwith relevant documents.		Personal Hearing

he Committee considered the case as per agenda and it was decided to call the firm for attending before Norms Committee to explain its case alongwith relevant documents.||Personal Hearing|

Case No.	73 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00007058AM24
RA File Number	05AX04002096 AM23
Licence No and<br>Date	0511015534/31/10/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	74 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
PartyName	MAXTAR BIO GENICS

40 This document has been digitally signed by Raman Kumar, Deputy DGFT on 06-02-2024 11:34:01.

UDIN00469829AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004225AM23
RA File Number	05AX04002243 AM23
Licence No and<br>Date	0511015686/09/11/2022
Norms Committee Decision:<br>The committee considered the request of the firm for fixation of ad-hoc norms and it was decided that the firm<br>may be advised to get their Advance Authorization amended for complete description of export product as per<br>their DML

The committee considered the request of the firm for fixation of ad-hoc norms and it was decided that the firm may be advised to get their Advance Authorization amended for complete description of export product as per their DML

est of the firm for fixation of ad-hoc norms and it was decided that the firm may be advised to get their Advance Authorization amended for complete description of export product as per their DML**

Case No.	75 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	RAJASTHAN ANTIBIOTICS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004250AM23
RA File Number	05AX04002186 AM23
Licence No and<br>Date	0511015716/09/11/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	Case No.	76 / NC/3/MEET/Dec/202324/19	76 / NC/3/MEET/Dec/202324/19
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number			HQRNORM APPLY 00004256AM23
RA File Number			03AX04004034 AM23
Licence No and<br>Date			0311019116/10/11/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>Sl.No<br>Export Product<br>Quantity<br>(i)<br>Medical Creams & Ointments(SECURA EXTRA PROTECTIVE CREAM 3.25 Oz 92 GM<br>Tot wt: 4210.66 Kgs(Net Cont: Pet 1718.78Kgs, Ceto 257.69Kgs, Methyl 214.74Kgs,<br>Akucell 128.84Kgs, Karaya 300.64kgs,Diaz 8.42 Kgs))<br>1 Number
	Sl.No	Export Product		Quantity

r>Tot wt: 4210.66 Kgs(Net Cont: Pet 1718.78Kgs, Ceto 257.69Kgs, Methyl 214.74Kgs, Akucell 128.84Kgs, Karaya 300.64kgs,Diaz 8.42 Kgs)) 1 Number||||| ||Sl.No|Export Product||Quantity| ||(i)|Medical Creams & Ointments(SECURA EXTRA PROTECTIVE CREAM 3.25 Oz 92 GM Tot wt: 4210.66 Kgs(Net Cont: Pet 1718.78Kgs, Ceto 257.69Kgs, Methyl 214.74Kgs, Akucell 128.84Kgs, Karaya 300.64kgs,Diaz 8.42 Kgs))|| 1 Number|

UDIN00469829AM24

(ii)	Medical Creams & Ointments(SECURA EXTRA PROTECTIVE CREAM 7.75 Oz 219.70	<br>1 Number
	GM Tot wt: 7792.10Kgs (Net Cont: White Pet 3180.74Kgs, Ceto 476.88Kgs, Methyl
	397.40Kgs, Akucell 238.44 Kgs, Karaya 556.36kgs,Diaz 15.58 Kgs))
(iii)	Medical Creams & Ointments(SECURA ANTIFUNGAL EXTRA THICK PROTECTIVE	<br>1 Number
	CREAM 3.25 Oz 92 GM Tot wt: 5883.40 Kgs (Net Cont: White Pet 2353.36Kgs, Ceto
	353Kgs, Methyl 294.17Kgs, Akucell 176.50 Kgs, Karaya 411.84kgs,Diaz 11.77Kgs))
(iv)	Medical Creams & Ointments(SECURA EXTRA PROTECTIVE CREAM 90 GMS TUBE	<br>1 Number
	Tot wt: 1918.17Kgs (Net Cont: White Pet 783Kgs, Ceto 117.39Kgs, Methyl 97.83Kgs,
	Akucell 58.70 Kgs, Karaya 136.96kgs,Diaz 3.84 Kgs))

Sl.No	Import Product	Quantity
1	Relevant Bulk Drugs	Net content in the export product plus 3% wastage.
2	Relevant Excipients	Net content in the export product plus 3% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy

Note:

1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments solely for export to US.
1.02 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments for the export to other than US.
The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption.

Case No.	77 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004258AM23
RA File Number	03AX04003990 AM23
Licence No and<br>Date	0311019120/10/11/2022
Norms Committee Decision:

42 This document has been digitally signed by Raman Kumar, Deputy DGFT on 06-02-2024 11:34:01.

UDIN00469829AM24

The case is under consideration for want of comments of TE.

Case No.	78 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	BOTANIC HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004273AM23
RA File Number	09AX04000641 AM23
Licence No and<br>Date	0911003939/10/11/2022
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Manufacturing process indicating stage wise wastage of raw materials.<br>1.<br>Chemistry of the reaction giving molecular weight of reactant and product.<br>2.<br>CoA report (indicating composition) of both import and export items and to give calculation for the<br>requirement of raw materials both imported and indigenously indicating.<br>3.

CoA report (indicating composition) of both import and export items and to give calculation for the requirement of raw materials both imported and indigenously indicating.

ting.** 3.||

CoA report (indicating composition) of both import and export items and to give calculation for the requirement of raw materials both imported and indigenously indicating.

Case No.	Case No.	79 / NC/3/MEET/Dec/202324/19	79 / NC/3/MEET/Dec/202324/19	79 / NC/3/MEET/Dec/202324/19	79 / NC/3/MEET/Dec/202324/19	79 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM APPLY 00004284AM23
RA File Number		04AX04000700 AM23
Licence No and<br>Date		0411004428/11/11/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jun/202324/8 dated 30.06.2023against advance authorization<br>No. 0411005200 dated 06/04/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>ISOBUTYL<br>ACETOPHENONE<br>1.110 kg.<br>2<br>SODIUM METAL<br>0.235 kg.<br>IBUPROFEN<br>1 Kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	IBUPROFEN		1 Kg.	1	ISOBUTYL<br>ACETOPHENONE	1.110 kg.
				2	SODIUM METAL	0.235 kg.

UDIN00469829AM24

kg. IBUPROFEN 1 Kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||IBUPROFEN||1 Kg.|1|ISOBUTYL ACETOPHENONE|1.110 kg.| |||||2|SODIUM METAL|0.235 kg.|

UDIN00469829AM24

3<br>MONOCHLORO ACETIC<br>ACID<br>0.919 kg.<br>4<br>ISO PROPYL ALCOHOL 0.500 kg.<br>5<br>SODIUM DICHROMATE 0.630 kg.<br>RA concerned may take further necessary action as per above decision of NC.		3	MONOCHLORO ACETIC<br>ACID	<br>0.919 kg.
		4	ISO PROPYL ALCOHOL	0.500 kg.
		5	SODIUM DICHROMATE	0.630 kg.

Case No.	80 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	HONOUR LAB LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004335AM23
RA File Number	09AA04002473 AM22
Licence No and<br>Date	0911003950/14/11/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jun/202122/2 dated 02/07/2021 against advance authorization<br>No. 0911000974 dated 31/05/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.

ed** 31/05/2021, it was decided to fix ad-hoc 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. 1 N,N-Dimethyl formamide 56,000 kg 2 Hexamethyl disilazane 1,41,600 kg 3 Cytosine 86,800 kg (1R,2S,5R)-2-Isopropyl-5- methylcyclohexyl-(2R,5S)-5-(4-amino-2- oxopyrimidin-1-(2H)-yl)-1,3-oxathiolane- 2-carboxylate.((1R,2S,5R)-2-Isopropyl-5- methylcyclohexyl-(2R,5S)-5-(4-amino-2- oxopyrimidin-1-(2H)-yl)-1,3- oxathiolane- 2-carboxylate. (OR) Cyclohexyl Ester (PE) (OR) Cyclohexyl Ester HN) 200000 kg 4 Triphosgene 1,00,000 kg RA concerned may take further necessary action as per above decision of NC.||

UDIN00469829AM24

Case No.	Case No.	81 / NC/3/MEET/Dec/202324/19	81 / NC/3/MEET/Dec/202324/19	81 / NC/3/MEET/Dec/202324/19	81 / NC/3/MEET/Dec/202324/19	81 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		SRF LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM APPLY 00004336AM23
RA File Number		05AX04002273 AM23
Licence No and Date		0511015796/14/11/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc 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. allowed. 1 2.2 AZOBISISOBUTYRONITRILE(AIBN) 0.0176 kg. 2 BENZOTRIFLUORIDE (BTF) 0.0684 kg. 2,2-difluoro-1,3- benzodioxole(DFBD) 1 kg. 3 1,3-BENZODIOXOLE 0.898 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||2,2-difluoro-1,3- benzodioxole(DFBD)||1 kg.|1|2.2 AZOBISISOBUTYRONITRILE(AIBN)|0.0176 kg.| |||||2|BENZOTRIFLUORIDE (BTF)|0.0684 kg.| |||||3|1,3-BENZODIOXOLE|0.898 kg.| |||||action as per above decision of NC.|||

Case No.	Case No.	82 / NC/3/MEET/Dec/202324/19	82 / NC/3/MEET/Dec/202324/19	82 / NC/3/MEET/Dec/202324/19	82 / NC/3/MEET/Dec/202324/19	82 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM APPLY 00004383AM23
RA File Number		08AX04001342 AM23
Licence No and<br>Date		0811006452/16/11/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting**No.

006452/16/11/2022||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo. NC/3/MEET/Nov/202324/16 dated 17/11/2023against advance authorizationNo. 0811004640 dated 13/04/2022, it was decided to fix ad-hoc 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. allowed. METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS: METHOTREXATE 1 Number Vial 1 61.87 mg/vial||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS:||1 Number Vial|1|METHOTREXATE|61.87 mg/vial|

Case No.	Case No.	82 / NC/3/MEET/Dec/202324/19	82 / NC/3/MEET/Dec/202324/19	82 / NC/3/MEET/Dec/202324/19	82 / NC/3/MEET/Dec/202324/19	82 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM APPLY 00004383AM23
RA File Number		08AX04001342 AM23
Licence No and<br>Date		0811006452/16/11/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting**No.

UDIN00469829AM24

	METHOTREXATE PH. EUR. 25MG)			EP / BP / IP / USP / PH. EUR.<br>(Moisture and Residual Solvents<br>content not less than 12.49 % in<br>API)
	METHOTREXATE INJECTION BP 100MG/ML<br>[5 ML VIAL](EACH ML CONTAINS:<br>METHOTREXATE PH. EUR. 100 MG)	1 Number<br>Vial	2	METHOTREXATE<br>EP / BP / IP / USP / PH. EUR.<br>(Moisture and Residual Solvents<br>content not less than 12.49 % in<br>API)	618.70 mg/vial
	METHOTREXATE INJECTION BP 100MG/ML<br>[10ML VIAL](EACH ML CONTAINS:<br>METHOREXATE PH. EUR. 100MG)	1 Number<br>Vial	3	METHOTREXATE<br>EP / BP / IP / USP / PH.

han 12.49 % in API)|618.70 mg/vial| ||METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR. 100MG)|1 Number Vial|3|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49 % in API)|1237.39 mg/vial| ||METHOTREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG)|1 Number Vial|4|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49 % in API)|306.867 mg/vial| ||METHOTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)|1 Number Vial|5|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49 % in API)|590.57 mg/vial| ||METHOTREXATE INJECTION BP 25MG/ML [40ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)|1 Number Vial|6|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49 % in API)|1181.15 mg/vial| ||METHOTREXATE INJECTION BP 100MG/ML [50ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100MG [IN WHICH ACTIVE INGREDIENT METHOTREXATE USED IS 8.175 KGS.])|1 Number Vial|7|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49 % in API)|5737.00 mg/vial|

UDIN00469829AM24

UDIN00469829AM24

Case No.	83 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004409AM23
RA File Number	03AX04003954 AM23
Licence No and<br>Date	0311019281/17/11/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	84 / NC/3/MEET/Dec/202324/19	84 / NC/3/MEET/Dec/202324/19	84 / NC/3/MEET/Dec/202324/19	84 / NC/3/MEET/Dec/202324/19	84 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		GRANULES INDIA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM APPLY 00004411AM23
RA File Number		09AX04000695 AM23
Licence No and<br>Date		0911003896/17/11/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

f ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Guaifenesin 1.05 kg. 2 Sodium Methoxide Powder 0.005 kg. 3 Dimethyl Carbonate 0.500 kg. 4 Ammonium Chloride 0.015 kg. 5 Ammonia Gas 0.250 kg. Methocarbamol 1 Kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Methocarbamol||1 Kg.|1|Guaifenesin|1.05 kg.| |||||2|Sodium Methoxide Powder|0.005 kg.| |||||3|Dimethyl Carbonate|0.500 kg.| |||||4|Ammonium Chloride|0.015 kg.| |||||5|Ammonia Gas|0.250 kg.|

Case No.	Case No.	84 / NC/3/MEET/Dec/202324/19	84 / NC/3/MEET/Dec/202324/19	84 / NC/3/MEET/Dec/202324/19	84 / NC/3/MEET/Dec/202324/19	84 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		GRANULES INDIA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM APPLY 00004411AM23
RA File Number		09AX04000695 AM23
Licence No and<br>Date		0911003896/17/11/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

UDIN00469829AM24

6<br>Toluene<br>0.300 kg.<br>7<br>Methanol<br>0.700 kg.<br>8<br>Activated carbon<br>0.005 kg.<br>RA concerned may take further necessary action as per above decision of NC.			6	Toluene	0.300 kg.
			7	Methanol	0.700 kg.
			8	Activated carbon	0.005 kg.

Case No.	85 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	ENVEE DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004428AM23
RA File Number	34AX04000741 AM23
Licence No and<br>Date	3411003006/17/11/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00004428AM23| |RA File Number|34AX04000741 AM23| |Licence No and Date|3411003006/17/11/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	86 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004437AM23
RA File Number	03AX04003955 AM23
Licence No and<br>Date	0311019320/18/11/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	87 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004468AM23
RA File Number	34AX04000711 AM23
Licence No and	3411003022/18/11/2022

UDIN00469829AM24

Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. NC/3/MEET/Jul/202324/9 dated 28/07/2023 against advance authorization No. 3411000924 dated 02/08/2021 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

dvance authorization No. 3411000924 dated 02/08/2021 , it was decided to fix ad-hoc 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.
Hexyl Salicylate<br>(n-Hexyl-ortho-Hydroxy Benzoate)	1 kg.	1	n-Hexanol (Lorol C 6/ Nacol 6)	0.510 kg.
		2	Salicylic Acid	0.682 kg.

Case No.	88 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004509AM23
RA File Number	09AX04000587 AM23
Licence No and<br>Date	0911003994/21/11/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	89 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004510AM23
RA File Number	04AX04000675 AM23
Licence No and<br>Date	0411004400/21/11/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Apr/202324/1 dated 28/04/2023against advance authorization<br>No. 0411004581 dated 07/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details

UDIN00469829AM24

ted 28/04/2023**against advance authorization No. 0411004581 dated 07/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details||

UDIN00469829AM24

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
IBUPROFEN	1 kg.	1	Isobutyl Acetophenone	1.11 kg.
		2	Sodium Metal	0.235 kg.
		3	Monochloro Acetic Acid	0.919 kg.
		4	Isopropyl Alcohol	0.50 kg.
		5	Sodium Dichromate	0.630 kg.

Case No.	90 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	BIOLOGICAL E. LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004512AM23
RA File Number	09AX04000684 AM23
Licence No and<br>Date	0911003996/21/11/2022
Norms Committee Decision:<br>The case is under consideration for want of comments from Deptt. of Bio-Technology.

Case No.	91 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004522AM23
RA File Number	08AX04001395 AM23
Licence No and<br>Date	0811006510/22/11/2022

UDIN00469829AM24

Norms Committee Decision:

The case is under consideration for want of comments of TE.

Case No.	92 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004528AM23
RA File Number	03AX04003867 AM23
Licence No and<br>Date	0311019424/22/11/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case alongwith relevant documents.		Personal Hearing

Case No.	Case No.	93 / NC/3/MEET/Dec/202324/19	93 / NC/3/MEET/Dec/202324/19	93 / NC/3/MEET/Dec/202324/19	93 / NC/3/MEET/Dec/202324/19	93 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM APPLY 00004554AM23
RA File Number		05AX04002424 AM23
Licence No and<br>Date		0511015979/23/11/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc 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. allowed. 1 2-n-propyl-4-methyl-6-(1- methylbenzimidazol-2-yl) 0.621 kg. 2 2-Cyano-4-Methyl Biphenyl (OTBN) 0.650 kg. 3 Acetic acid 0.90 kg. 4 Toluene 1.71 kg. TELMISARTAN USP/EP(POWDER) 1 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||TELMISARTAN USP/EP(POWDER)||1 kg.|1|2-n-propyl-4-methyl-6-(1- methylbenzimidazol-2-yl)|0.621 kg.| |||||2|2-Cyano-4-Methyl Biphenyl (OTBN)|0.650 kg.| |||||3|Acetic acid|0.90 kg.| |||||4|Toluene|1.71 kg.|

UDIN00469829AM24

	5	Methylene Chloride	1.34	kg.
	6	Methanol	1.25	kg.

Case No.	94 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004555AM23
RA File Number	09AX04000691 AM23
Licence No and<br>Date	0911004009/23/11/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

br>Tablet|1|Desipramine Hydrochloride USP|76.50 mg| |||||2|Croscarmellose Sodium (Ac-di-sol)|26.25 mg| |||||3|Microcrystalline cellulose (Avicel PH102)|100.60 mg|

UDIN00469829AM24

4<br>Hydroxypropyl Cellulose (Klucel LF)<br>2.10 mg<br>5<br>Citric Acid Monohydrate (Powder<br>Emprove)<br>5.00 mg<br>kgs))<br>6<br>Magnesium Stearate<br>1.05 mg<br>1<br>Desipramine Hydrochloride USP<br>102.00 mg<br>2<br>Croscarmellose Sodium (Ac-di-sol)<br>35.00 mg<br>3<br>Microcrystalline<br>cellulose<br>(Avicel<br>PH102)<br>134.13 mg<br>4<br>Hydroxypropyl Cellulose (Klucel LF)<br>2.80 mg<br>5<br>Citric Acid Monohydrate (Powder<br>Emprove)<br>6.67 mg<br>5 Desipramine HCL Tab<br>USP 100 mg<br>(Desipramine HCL Tab<br>USP 100 mg (net content<br>of active ingredients =<br>50.00<br>kgs))<br>1 Number<br>Tablet<br>6<br>Magnesium Stearate<br>1.40 mg<br>1<br>Desipramine Hydrochloride USP<br>153.00 mg<br>2<br>Croscarmellose Sodium (Ac-di-sol)<br>52.50 mg<br>3<br>Microcrystalline<br>cellulose<br>(Avicel<br>PH102)<br>201.20 mg<br>4<br>Hydroxypropyl Cellulose (Klucel LF)<br>4.20 mg<br>5<br>Citric Acid Monohydrate (Powder<br>Emprove)<br>10.00 mg<br>6 Desipramine HCL Tab<br>USP 150 mg<br>(Desipramine HCL Tab<br>USP 150 mg (net content<br>of active ingredients =<br>60.000<br>kgs))<br>1 Number<br>Tablet<br>6<br>Magnesium Stearate<br>2.10 mg<br>RA concerned may take further necessary action as per above decision of NC.		kgs))		4	Hydroxypropyl Cellulose (Klucel LF)	2.10 mg

	kgs))		4	Hydroxypropyl Cellulose (Klucel LF)	2.10 mg
			5	Citric Acid Monohydrate (Powder<br>Emprove)	5.00 mg
			6	Magnesium Stearate	1.05 mg
5	Desipramine HCL Tab<br>USP 100 mg<br>(Desipramine HCL Tab<br>USP 100 mg (net content<br>of active ingredients =<br>50.00<br>kgs))	1 Number<br>Tablet	1	Desipramine Hydrochloride USP	102.00 mg
			2	Croscarmellose Sodium (Ac-di-sol)	35.00 mg
			3	Microcrystalline<br>cellulose<br>(Avicel<br>PH102)	134.13 mg
			4	Hydroxypropyl Cellulose (Klucel LF)	2.80 mg
			5	Citric Acid Monohydrate (Powder<br>Emprove)	6.67 mg
			6	Magnesium Stearate	1.40 mg
6	Desipramine HCL Tab<br>USP 150 mg<br>(Desipramine HCL Tab<br>USP 150 mg (net content<br>of active ingredients =<br>60.000<br>kgs))	1 Number<br>Tablet	1	Desipramine Hydrochloride USP	153.00 mg
			2	Croscarmellose Sodium (Ac-di-sol)	52.50 mg
			3	Microcrystalline<br>cellulose<br>(Avicel<br>PH102)	201.20 mg
			4	Hydroxypropyl Cellulose (Klucel LF)	4.20 mg
			5	Citric Acid Monohydrate (Powder<br>Emprove)	10.00 mg
			6	Magnesium Stearate	2.10 mg

Case No. 115 / NC/3/MEET/Dec/202324/19

UDIN00469829AM24

yl Cellulose (Klucel LF)|4.20 mg| |||||5|Citric Acid Monohydrate (Powder Emprove)|10.00 mg| |||||6|Magnesium Stearate|2.10 mg|

Case No. 115 / NC/3/MEET/Dec/202324/19

UDIN00469829AM24

Case Status	Case Status	Case Approved	Case Approved	Case Approved	Case Approved	Case Approved
Party Name		HETERO LABS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM APPLY 00004723AM23
RA File Number		09AX04000639 AM23
Licence No and<br>Date		0911004062/30/11/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Sep/202324/14 dated 27.09.2023 against advance authorization No.<br>0911005462 dated 21.07.2023,it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.1 as per details given<br>below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

d to fix ad-hoc norms under Para 4.07 of HBP Vol.1 as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed 1 Glyoxylic acid 50% 0.69 kg 2 Sodium bisulphite 0.55 kg 3 2,5-dihydroxy-1,4-dithiane 0.28 kg 4 Formaldehyde 0.46 kg 5 N-Hexane 0.44 kg 6 Toluene 0.22 kg 7 Cyclohexane 0.55 kg 5-Hydroxy-1,3-oxathiolane-2-carboxylicacid (1R,2S,5R) menthyl ester 1 kg 8 L-(-) Menthol 99% 0.725 kg RA concerned may take further necessary action as per above decision of NC||||from earlier decision for same export product / **27.09.2023 **against advance authorization No. s under Para 4.07 of HBP Vol.1 as per details given||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed| ||5-Hydroxy-1,3-oxathiolane-2-carboxylicacid (1R,2S,5R) menthyl ester||1 kg|1|Glyoxylic acid 50%|0.69 kg| |||||2|Sodium bisulphite|0.55 kg| |||||3|2,5-dihydroxy-1,4-dithiane|0.28 kg| |||||4|Formaldehyde|0.46 kg| |||||5|N-Hexane|0.44 kg| |||||6|Toluene|0.22 kg| |||||7|Cyclohexane|0.55 kg| |||||8|L-(-) Menthol 99%|0.725 kg|

Case No.	116 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	HETERO LABS LIMITED
Meeting Number	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024

UDIN00469829AM24

Case No.	116 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	HETERO LABS LIMITED
Meeting Number	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024

UDIN00469829AM24

and Date
HQ File Number	HQRNORM APPLY 00004725AM23
RA File Number	09AX04000586 AM23
Licence No and<br>Date	0911004061/30/11/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Sep/202324/14 dated 27.09.2023 against advance authorization No.<br>0911005462 dated 21.07.2023,it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.1 as per details given<br>below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>1<br>Glyoxylic acid 50%<br>0.69 kg<br>2<br>Sodium bisulphite<br>0.55 kg<br>3<br>2,5-dihydroxy-1,4-dithiane<br>0.28 kg<br>4<br>Formaldehyde<br>0.46 kg<br>5<br>N-Hexane<br>0.44 kg<br>6<br>Toluene<br>0.22 kg<br>7<br>Cyclohexane<br>0.55 kg<br>5-Hydroxy-1,3-oxathiolane-2-carboxylicacid<br>(1R,2S,5R) menthyl ester<br>1 kg<br>8<br>L-(-) Menthol 99%<br>0.725 kg<br>RA concerned may take further necessary action as per above decision of NC

Case No.	117 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	ASTEC LIFESCIENCES LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004726AM23
RA File Number	03AX04004382 AM23

UDIN00469829AM24

Licence No and Date 0311019654/01/12/2022

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Jul/202324/9 dated 28.07.2023 against advance authorization No. 0311014646 dated 11.05.2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.1 as per details given below or as applied by the firm, whichever is less:-

Licence No and Date

0311019654/01/12/2022

Norms Committee Decision: The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Jul/202324/9 dated 28.07.2023against advance authorization No. 0311014646 **dated 11.05.2022,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.1 as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items **Qty.

d to fix ad-hoc norms under Para 4.07 of HBP Vol.1 as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 2 FLURO A NILINE 0.66 kg. 2 ETHYL CHLOROFORMATE 0.55 kg. 3 DI METHYL FORMAMIDE Deleted (not given in production/consumption data & also not a main reactant 4 ETHYL 3 AMINO 4 4 4 TRIFLUROCROTONATE 0.66 kg. PDSH(PDSH TECHNICAL) 1 kg. 5 POTASSIUM CARBONATE 0.31 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	118 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004728AM23
RA File Number	03AX04004201 AM23
Licence No and<br>Date	0311019658/01/12/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	119 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	SOLARA ACTIVE PHARMA SCIENCES LIMITED

UDIN00469829AM24

ration for want of comments of TE.**||

Case No.	119 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	SOLARA ACTIVE PHARMA SCIENCES LIMITED

UDIN00469829AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004745AM23
RA File Number	04AX04000794 AM23
Licence No and<br>Date	0411004556/01/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jun/202324/8 dated 30.06.2023against advance authorization<br>No. 0411005200 dated 06/04/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed<br>1<br>ISOBUTYL ACETOPHENONE<br>1.110 kg.<br>2<br>SODIUM METAL<br>0.235 kg.<br>3<br>MONOCHLORO ACETIC ACID<br>0.919 kg.<br>4<br>ISO PROPYL ALCOHOL<br>0.500 kg.<br>IBUPROFEN<br>1 Kg.<br>5<br>SODIUM DICHROMATE<br>0.630 kg.<br>RA concerned may take further necessary action as per above decision of NC.

D 0.919 kg. 4 ISO PROPYL ALCOHOL 0.500 kg. IBUPROFEN 1 Kg. 5 SODIUM DICHROMATE 0.630 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	120 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004771AM23
RA File Number	03AX04004397 AM23
Licence No and<br>Date	0311019716/02/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Mar/202223/22 dated 24/03/2023against advance authorizationNo.<br>0311019716 dated 02/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:

UDIN00469829AM24

Export product	Qty.	Sl. No.	Import items	Qty. allowed
FLUTICASONE LOTION 0.05%	50000	1	Fluticasone Propionate USP	1.53 kg
(Fluticasoen Propinate Lotion 0.05%)	Numbers
(Pack 60 ML)((Net wt. of Fluticasone
Propionate USP is 1.50 Kgs.))

UTICASONE LOTION 0.05%|50000|1|Fluticasone Propionate USP|1.53 kg| |(Fluticasoen Propinate Lotion 0.05%)|Numbers|||| |(Pack 60 ML)((Net wt. of Fluticasone||||| |Propionate USP is 1.50 Kgs.))|||||

Case No.	121 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	FDC LIMITED
Meeting Number and	Date NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004788AM23
RA File Number	03AX04004005 AM23
Licence No and Date	0311019730/02/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc 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>Qty.		Sl. No.	Import Items	Qty.
				allowed.
CHLORAMPHENICOL EYE DROPS 10<br>552000.0		1	CHLORAMPHENICOL	28.152 kg
ML((EACH	VIAL<br>CONTAINS		MICRONIZED
CHLORAMPHENICOL MICRONIZED<br>Numbers
0.050GM NET	WT OF BULK DRUG IS
27.600 KGS))
RA concerned may take further necessary action as per above decision of			NC.

Case No.	122 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004798AM23
RA File Number	03AX04004191 AM23

UDIN00469829AM24

Licence No and 0311019737/03/12/2022 Date Norms Committee Decision:

The case is under consideration for want of comments of TE.

Case No.	123 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004807AM23
RA File Number	03AX04004440 AM23
Licence No and<br>Date	0311019755/05/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case alongwith relevant documents.		Personal Hearing

Case No.	124 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	RAVOO'S LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004812AM23
RA File Number	09AX04000761 AM23
Licence No and<br>Date	0911004086/05/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. Allowed<br>Ciprofloxacin Hydrochloride Taste<br>Masked Pellets (Ciprofloxacin HCL<br>USP NET CONTENT 10991.20<br>KG)<br>50000 kg.<br>1<br>Ciprofloxacin HCL USP<br>10991.20 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 125 / NC/3/MEET/Dec/202324/19

UDIN00469829AM24

kg. 1 Ciprofloxacin HCL USP 10991.20 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No. 125 / NC/3/MEET/Dec/202324/19

UDIN00469829AM24

Case Status	Case Approved
Party Name	INDO AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00001065AM24
RA File Number	03AX04004219 AM23
Licence No and<br>Date	0311019745/05/12/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed<br>SORBITAN MONO OLEATE OR IAL SMO<br>1 Kg.<br>1<br>SORBITOL 70%<br>0.50 Kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	126 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004828AM23
RA File Number	09AX04000798 AM23
Licence No and<br>Date	0911004095/06/12/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00004828AM23| |RA File Number|09AX04000798 AM23| |Licence No and Date|0911004095/06/12/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	127 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004836AM23
RA File Number	03AX04004351 AM23
Licence No and<br>Date	0311019783/06/12/2022
Norms Committee Decision:

UDIN00469829AM24

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Sep/202223/8 dated 23.09.2022 against advance authorization No. 0311007434 dated 03.10.2021 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

dvance authorization No. 0311007434 dated 03.10.2021 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

|The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23.09.2022against advance authorization No. 0311007434 dated 03.10.2021, it was decided to fix ad-hoc 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. Import items Qty. allowed 1 FLUCORT N SKIN CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 322660 Packs 2 FLUCORT SKIN CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 322660 Packs 3 FLUCORT SKIN CREAM 0.025% (Pack Size 10 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.) 242000 Packs 4 FLUCORT SKIN CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 968000 Packs 5 FLUOCINOLONE CREAM (TDR) ET 0.025% (Pack Size 10 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 96800 Packs 6 CYNOZET CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs 7 CYNOZET CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 64532 Packs 8 SUPRICORT CREAM 0.

CINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs 7 CYNOZET CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 64532 Packs 8 SUPRICORT CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 580800 Packs 9 SUPRICORT CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 193596 Packs 10 SUPRICORT CREAM 0.025% (Pack Size 250 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 3873 Packs 11 SUPRICORT N CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs FLUOCINOLONE ACETONIDE BP 9.10 kg|The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23.09.2022against advance authorization No. 0311007434 dated 03.10.2021, it was decided to fix ad-hoc 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. Import items **Qty.

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. Import items Qty. allowed 1 FLUCORT N SKIN CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 322660 Packs 2 FLUCORT SKIN CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 322660 Packs 3 FLUCORT SKIN CREAM 0.025% (Pack Size 10 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.) 242000 Packs 4 FLUCORT SKIN CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 968000 Packs 5 FLUOCINOLONE CREAM (TDR) ET 0.025% (Pack Size 10 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 96800 Packs 6 CYNOZET CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs 7 CYNOZET CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 64532 Packs 8 SUPRICORT CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 580800 Packs 9 SUPRICORT CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 193596 Packs 10 SUPRICORT CREAM 0.025% (Pack Size 250 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 3873 Packs 11 SUPRICORT N CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs FLUOCINOLONE ACETONIDE BP

ONE ACETONIDE BP is 0.242 Kgs.) 3873 Packs 11 SUPRICORT N CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs FLUOCINOLONE ACETONIDE BP 9.10 kg|The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23.09.2022against advance authorization No. 0311007434 dated 03.10.2021, it was decided to fix ad-hoc 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. Import items Qty. allowed 1 FLUCORT N SKIN CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 322660 Packs 2 FLUCORT SKIN CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 322660 Packs 3 FLUCORT SKIN CREAM 0.025% (Pack Size 10 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.) 242000 Packs 4 FLUCORT SKIN CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 968000 Packs 5 FLUOCINOLONE CREAM (TDR) ET 0.025% (Pack Size 10 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 96800 Packs 6 CYNOZET CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs 7 CYNOZET CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 64532 Packs 8 SUPRICO

.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs 7 CYNOZET CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 64532 Packs 8 SUPRICORT CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 580800 Packs 9 SUPRICORT CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 193596 Packs 10 SUPRICORT CREAM 0.025% (Pack Size 250 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 3873 Packs 11 SUPRICORT N CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs FLUOCINOLONE ACETONIDE BP 9.10 kg|The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23.09.2022against advance authorization No. 0311007434 dated 03.10.2021, it was decided to fix ad-hoc 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. Import items **Qty.

ONE ACETONIDE BP is 0.242 Kgs.) 3873 Packs 11 SUPRICORT N CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs FLUOCINOLONE ACETONIDE BP 9.10 kg| |---|---|---|---|---|---| ||Sl. No.|Export Product|Qty.|Import items|Qty. allowed| ||1|FLUCORT N SKIN CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)| 322660 Packs|FLUOCINOLONE ACETONIDE BP|9.10 kg| ||2|FLUCORT SKIN CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)| 322660 Packs||| ||3|FLUCORT SKIN CREAM 0.025% (Pack Size 10 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.)| 242000 Packs||| ||4|FLUCORT SKIN CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)| 968000 Packs||| ||5|FLUOCINOLONE CREAM (TDR) ET 0.025% (Pack Size 10 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)| 96800 Packs||| ||6|CYNOZET CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)| 193600 Packs||| ||7|CYNOZET CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)| 64532 Packs||| ||8|SUPRICORT CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.)| 580800 Packs||| ||9|SUPRICORT CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.)| 193596 Packs||| ||10|SUPRICORT CREAM 0.025% (Pack Size 250 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)| 3873 Packs|||

ms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.)| 193596 Packs||| ||10|SUPRICORT CREAM 0.025% (Pack Size 250 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)| 3873 Packs||| ||11|SUPRICORT N CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)| 193600 Packs|||

UDIN00469829AM24

12<br>SUPRICORT N CREAM 0.025% (Pack Size 15 gms) (Net<br>Wt.of FLUOCINOLONE ACETONIDE BP is 0.242Kgs.)<br>64532 Packs<br>13<br>Flucort C Cream 0.01% (Pack Size 15 gms) (Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.095 Kgs)<br>63332 Packs<br>14<br>FLUCORT C OINTMENT 0.025% (Pack Size 15 gms) (Net<br>Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.)<br>161330 Packs<br>15<br>GLENCORT GEL 0.025% (Pack Size 5 gms) (Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.452 Kgs.)<br>361600 Packs<br>16<br>GLENCORT GEL 0.025% (Pack Size 30 gms) (Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.484 Kgs.)<br>64535 Packs<br>17<br>FLUCORT MZ SKIN OINTMENT 0.01% (Pack Size 15 gms)<br>(Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.145 Kgs.)<br>96798 Packs<br> <br>RA concerned may take further necessary action as per above decision of NC	12	SUPRICORT N CREAM 0.025% (Pack Size 15 gms) (Net<br>Wt.of FLUOCINOLONE ACETONIDE BP is 0.242Kgs.)	<br>64532 Packs
	13	Flucort C Cream 0.01% (Pack Size 15 gms) (Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.095 Kgs)	<br>63332 Packs
	14	FLUCORT C OINTMENT 0.025% (Pack Size 15 gms) (Net<br>Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.)	<br>161330 Packs

) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.095 Kgs)| 63332 Packs||| ||14|FLUCORT C OINTMENT 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.)| 161330 Packs||| ||15|GLENCORT GEL 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.452 Kgs.)| 361600 Packs||| ||16|GLENCORT GEL 0.025% (Pack Size 30 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.484 Kgs.)| 64535 Packs||| ||17|FLUCORT MZ SKIN OINTMENT 0.01% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.145 Kgs.)| 96798 Packs|||

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

Case No.	Case No.	128 / NC/3/MEET/Dec/202324/19	128 / NC/3/MEET/Dec/202324/19	128 / NC/3/MEET/Dec/202324/19	128 / NC/3/MEET/Dec/202324/19	128 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		TRANSPEK INDUSTRY LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM APPLY 00004865AM23
RA File Number		34AX04000797 AM23
Licence No and<br>Date		3411003093/07/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>NEODECANOYL CHLORIDE<br>1 kg.<br>1<br>N-DECANOIC ACID<br>0.950 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

br>Sl. No. Import Items Qty. allowed. NEODECANOYL CHLORIDE 1 kg. 1 N-DECANOIC ACID 0.950 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||NEODECANOYL CHLORIDE||1 kg.|1|N-DECANOIC ACID|0.950 kg.| ||||||||

UDIN00469829AM24

Case No.	129 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00005141AM24
RA File Number	08AX04001419 AM23
Licence No and<br>Date	0811006678/07/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case alongwith relevant documents.		Personal Hearing

Case No.	130 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00004943AM23
RA File Number	03AX04004593 AM23
Licence No and<br>Date	0311019936/12/12/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00004943AM23| |RA File Number|03AX04004593 AM23| |Licence No and Date|0311019936/12/12/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	131 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	B G P HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005000AM23
RA File Number	34AX04000827 AM23
Licence No and<br>Date	3411003121/15/12/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	132 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
PartyName	AURORE LIFE SCIENCES PRIVATE LIMITED

75 This document has been digitally signed by Raman Kumar, Deputy DGFT on 06-02-2024 11:34:01.

UDIN00469829AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005018AM23
RA File Number	09AX04000828 AM23
Licence No and<br>Date	0911004164/15/12/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00005018AM23| |RA File Number|09AX04000828 AM23| |Licence No and Date|0911004164/15/12/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	Case No.	Case No.	133 / NC/3/MEET/Dec/202324/19	133 / NC/3/MEET/Dec/202324/19
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number			HQRNORM APPLY 00005075AM23
RA File Number			03AX04004710 AM23
Licence No and<br>Date			0311020115/19/12/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>Sl.No<br>Export Product<br>Quantity<br>(i)<br>Medical Creams & Ointments(Clindamycin Phosphate Topical Solution USP 1 % ( 60 ML)<br>Tot Wt: 2455.20 Kgs (Net Cont: CLINDA 31.43Kgs, 2 Oz. HDPE 440000Nos, 24-400<br>WHITE PP 440000Nos, DAB-O-MATIC 440000Nos.) )<br>1 Number<br>(ii)<br>Medical Creams & Ointments(Clindamycin Phosphate Topical Solution USP 1 % ( 30 ML)<br>Tot Wt: 1227.60Kgs (Net Cont: CLINDA 15.71Kgs, 1 Oz.

440000Nos, DAB-O-MATIC 440000Nos.) ) 1 Number (ii) Medical Creams & Ointments(Clindamycin Phosphate Topical Solution USP 1 % ( 30 ML) Tot Wt: 1227.60Kgs (Net Cont: CLINDA 15.71Kgs, 1 Oz. HDPE 44000Nos, 24-400 WHITE PP 44000Nos, DAB-O-MATIC 44000Nos.) ) 1 Number (iii) Medical Creams & Ointments(Clindamycin Phosphate & Benzoyl Peroxide Gel, 1.2%/5% (45 Gm) Tot Wt: 45 Kgs (Net Cont: CLINDA 0.54 Kgs, HYDROUS BENZ 2.25 Kgs.Tubes 1000Nos ) ) 1 Number (iv) Medical Creams & Ointments(Clindamycin Phosphate Top. Lot. 1% 60ML Tot Wt: 55.80 Kgs (Net Cont: CLINDA 0.66 Kgs, STEARIC ACID 1.12 Kgs, KOLLIWAX CSA 1.40Kgs, LDPE BOTTLE 1000 Nos) ) 1 Number Medical Creams & Ointments(Clindamycin Phosphate Gel 30 Gm Tot Wt: 30 Kgs (Net (v) 1 Number||||| ||Sl.No|Export Product||Quantity| ||(i)|Medical Creams & Ointments(Clindamycin Phosphate Topical Solution USP 1 % ( 60 ML) Tot Wt: 2455.20 Kgs (Net Cont: CLINDA 31.43Kgs, 2 Oz. HDPE 440000Nos, 24-400 WHITE PP 440000Nos, DAB-O-MATIC 440000Nos.) )||1 Number| ||(ii)|Medical Creams & Ointments(Clindamycin Phosphate Topical Solution USP 1 % ( 30 ML) Tot Wt: 1227.60Kgs (Net Cont: CLINDA 15.71Kgs, 1 Oz. HDPE 44000Nos, 24-400 WHITE PP 44000Nos, DAB-O-MATIC 44000Nos.) )|| 1 Number| ||(iii)|Medical Creams & Ointments(Clindamycin Phosphate & Benzoyl Peroxide Gel, 1.2%/5% (45 Gm) Tot Wt: 45 Kgs (Net Cont: CLINDA 0.54 Kgs, HYDROUS BENZ 2.25 Kgs.Tubes 1000Nos ) )||1 Number| ||(iv)|Medical Creams & Ointments(Clindamycin Phosphate Top. Lot.

oyl Peroxide Gel, 1.2%/5% (45 Gm) Tot Wt: 45 Kgs (Net Cont: CLINDA 0.54 Kgs, HYDROUS BENZ 2.25 Kgs.Tubes 1000Nos ) )||1 Number| ||(iv)|Medical Creams & Ointments(Clindamycin Phosphate Top. Lot. 1% 60ML Tot Wt: 55.80 Kgs (Net Cont: CLINDA 0.66 Kgs, STEARIC ACID 1.12 Kgs, KOLLIWAX CSA 1.40Kgs, LDPE BOTTLE 1000 Nos) )||1 Number| ||(v)|Medical Creams & Ointments(Clindamycin Phosphate Gel 30 Gm Tot Wt: 30 Kgs (Net||1 Number|

Case No.	Case No.	Case No.	133 / NC/3/MEET/Dec/202324/19	133 / NC/3/MEET/Dec/202324/19
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number			HQRNORM APPLY 00005075AM23
RA File Number			03AX04004710 AM23
Licence No and<br>Date			0311020115/19/12/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>Sl.No<br>Export Product<br>Quantity<br>(i)<br>Medical Creams & Ointments(Clindamycin Phosphate Topical Solution USP 1 % ( 60 ML)<br>Tot Wt: 2455.20 Kgs (Net Cont: CLINDA 31.43Kgs, 2 Oz. HDPE 440000Nos, 24-400<br>WHITE PP 440000Nos, DAB-O-MATIC 440000Nos.) )<br>1 Number<br>(ii)<br>Medical Creams & Ointments(Clindamycin Phosphate Topical Solution USP 1 % ( 30 ML)<br>Tot Wt: 1227.60Kgs (Net Cont: CLINDA 15.71Kgs, 1 Oz.

UDIN00469829AM24

	Cont: CLINDA 0.36Kgs, Tubes 1000Nos.) )
(vi)	Medical Creams & Ointments(Clindamycin Phosphate Gel 60 Gm Tot Wt: 60 Kgs (Net	1 Number
	Cont: CLINDA 0.71Kgs, Tubes 1000 Nos.) )
(vii)	Medical Creams & Ointments(Clindamycin 10mg/g + Benzoyl Peroxide 50mg/g Gel 30Gm	<br>1 Number
	Tot Wt: 30 Kgs (Net Cont: CLINDA 0.30 Kgs, BENZOYL 1.50 Kgs, Tubes 1000 Nos) )
(viii)	Medical Creams & Ointments(Clindamycin 10mg/g + Benzoyl Peroxide 50mg/g Gel 60	1 Number
	Gm Tot Wt: 60 Kgs (Net Cont: CLINDA 0.60 Kgs, BENZOYL 4.28 Kgs, Tubes 1000 Nos)
	)

Sl.No	Import Product	Quantity
1	Relevant Bulk Drugs	Net content in the export product plus 3% wastage.
2	Relevant Excipients	Net content in the export product plus 3% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy

Note:

1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments solely for export to US.
1 .02 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments for the export to other than US.
The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption.

Case No.	134 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	SHARON BIO-MEDICINE LIMITED

77 This document has been digitally signed by Raman Kumar, Deputy DGFT on 06-02-2024 11:34:01.

UDIN00469829AM24

Meeting Number and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005222AM23
RA File Number	03AX04004798 AM23
Licence No and Date	0311020213/22/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc 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. allowed. 1 PHARMABURST B1 184.00 mg DIARRHOEA RELIEF INSTANT 2MG ORODISPERSIBLE TABLETS / LOPERAMIDE 2MG FAST MELT TABLETS 6's (DIARRHOEA RELIEF INSTANT 2MG(ORODISPERSIBLE TABLETS / LOPERAMIDE 2MG FAST MELT TAB 6's) Each Tablets contains PHARMABURST B1 184 Kgs for One Batch equal to 10,00,000 Tablets) (PHARMABURST B1 1075.22 Kgs equal to 5843592 Tablets) NET WT. LOPERAMIDE HYDROCHLORIDE PH EUR 11.69 KGS) 1 NUMBER 2 LOPERAMIDE HYDROCHLORIDE PH EUR 2.04 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	135 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005247AM23
RA File Number	08AX04001457 AM23
Licence No and<br>Date	0811006828/23/12/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	136 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	KAVALIFE PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024

UDIN00469829AM24

No.	136 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	KAVALIFE PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024

UDIN00469829AM24

and Date
HQ File Number	HQRNORM APPLY 00005283AM23
RA File Number	07AX04001408 AM23
Licence No and<br>Date	0711006001/26/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting1/82-ALC4/2019 dated 03/06/2019against advance authorizationNo.<br>0710113301 dated 17/05/2018, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Natural Caffeine Anhydrous<br>(Not less than 98.5%)<br>1 kg.<br>1<br>Natural Caffeine Powder<br>98.5%<br>1.186 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	137 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005300AM23
RA File Number	09AX04000869 AM23
Licence No and<br>Date	0911004207/26/12/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00005300AM23| |RA File Number|09AX04000869 AM23| |Licence No and Date|0911004207/26/12/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	138 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005311AM23
RA File Number	03AX04004688 AM23
Licence No and<br>Date	0311020288/27/12/2022
Norms Committee Decision:

UDIN00469829AM24

|T i 0 g RA|he Committee considered the case as per agenda and taking cue from earlier decision for same export product / mport item in Meeting No.NC/3/MEET/Oct/202324/15dated 13/10/2023against advance authorization No. 311004745dated 19/06/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details iven below or as applied by the firm, whichever is less:|he Committee considered the case as per agenda and taking cue from earlier decision for same export product / mport item in Meeting No.NC/3/MEET/Oct/202324/15dated 13/10/2023against advance authorization No. 311004745dated 19/06/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

mport item in Meeting No.NC/3/MEET/Oct/202324/15dated 13/10/2023against advance authorization No. 311004745dated 19/06/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details iven below or as applied by the firm, whichever is less:|he Committee considered the case as per agenda and taking cue from earlier decision for same export product / mport item in Meeting No.NC/3/MEET/Oct/202324/15dated 13/10/2023against advance authorization No. 311004745dated 19/06/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details iven below or as applied by the firm, whichever is less:|he Committee considered the case as per agenda and taking cue from earlier decision for same export product / mport item in Meeting No.NC/3/MEET/Oct/202324/15dated 13/10/2023against advance authorization No. 311004745dated 19/06/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details iven below or as applied by the firm, whichever is less:|he Committee considered the case as per agenda and taking cue from earlier decision for same export product / mport item in Meeting No.NC/3/MEET/Oct/202324/15dated 13/10/2023against advance authorization No. 311004745dated 19/06/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details iven below or as applied by the firm, whichever is less:| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|**Qty.

under Para 4.07 of HBP Vol. I as per details iven below or as applied by the firm, whichever is less:| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|Qty. allowed.| ||MEROPENEM FOR INJECTION (MEROPENEM BUFFERED STERILE) [Containing NLT 84% Sterile Meropenem]|1 kg.|1|MEROPENEM NON STERILE MEROPENEM TRIHYDRATE NON STERILE| 0.8968 kg.| ||||2|Packing Material|Relevant, as per Packing Policy| ||concerned may take further necessary action as per above decision of NC.|||||

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Oct/202324/15 dated 13/10/2023 against advance authorization No. 0311004745 dated 19/06/2021 , it was decided to fix ad-hoc 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.	139 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	ADCOCK INGRAM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005317AM23
RA File Number	07AX04001362 AM23
Licence No and<br>Date	0711006024/27/12/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00005317AM23| |RA File Number|07AX04001362 AM23| |Licence No and Date|0711006024/27/12/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	140 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	CANPEX CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005335AM23
RA File Number	31AX04000284 AM23
Licence No and<br>Date	3111001917/27/12/2022
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-

UDIN00469829AM24

1. Complete CoA of import item from Foreign Supplier

Case No.	Case No.	141 / NC/3/MEET/Dec/202324/19	141 / NC/3/MEET/Dec/202324/19	141 / NC/3/MEET/Dec/202324/19	141 / NC/3/MEET/Dec/202324/19	141 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		INDIA GLYCOLS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM APPLY 00005340AM23
RA File Number		05AX04002859 AM23
Licence No and<br>Date		0511016572/27/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/May/202324/5 dated 08/06/2023against advance<br>authorizationNo. 0511013942 dated 25/07/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Denatured Ethyl Alcohol<br>1.123 kg.<br>2<br>Silver Catalyst<br>(Activity 17% to 18%)<br>0.000228 kg.<br>Mono Ethylene Glycol (MEG)<br>1 kg.<br>3<br>Alumina Catalyst<br>0.000362 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

1 kg. 3 Alumina Catalyst 0.000362 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Mono Ethylene Glycol (MEG)||1 kg.|1|Denatured Ethyl Alcohol|1.123 kg.| |||||2|Silver Catalyst (Activity 17% to 18%)|0.000228 kg.| |||||3|Alumina Catalyst|0.000362 kg.| |||||as per above decision of NC.|||

Case No.	142 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	MEDREICH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005381AM23
RA File Number	07AX04001433 AM23
Licence No and<br>Date	0711006048/28/12/2022
Norms Committee Decision:

UDIN00469829AM24

The case is under consideration for want of comments of TE.

Case No.	143 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005387AM23
RA File Number	05AX04002796 AM23
Licence No and<br>Date	0511016607/28/12/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	144 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005401AM23
RA File Number	34AX04000903 AM23
Licence No and<br>Date	3411003211/29/12/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	145 / NC/3/MEET/Dec/202324/19	145 / NC/3/MEET/Dec/202324/19	145 / NC/3/MEET/Dec/202324/19	145 / NC/3/MEET/Dec/202324/19	145 / NC/3/MEET/Dec/202324/19
Case Status		Case Approved
Party Name		VINYL PRODUCTS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number		HQRNORM APPLY 00005409AM23
RA File Number		05AX04002878 AM23
Licence No and<br>Date		0511016621/29/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol.

|Licence No and Date||0511016621/29/12/2022||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc 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. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

UDIN00469829AM24

PVC Plasticizer	1 kg.	1	PHTHALIC ANHYDRIDE	0.400 kg.
(Phthalic, Non-Polymeric)
		2	2 ETHYL HEXANOL	0.700 kg.

Case No.	146 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	COHANCE LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005417AM23
RA File Number	09AX04000884 AM23
Licence No and<br>Date	0911004233/29/12/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	147 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	COHANCE LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005432AM23
RA File Number	09AX04000883 AM23
Licence No and<br>Date	0911004235/30/12/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00005432AM23| |RA File Number|09AX04000883 AM23| |Licence No and Date|0911004235/30/12/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	148 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005442AM23
RA File Number	05AX04002802 AM23
Licence No and<br>Date	0511016635/30/12/2022
Norms Committee Decision:

UDIN00469829AM24

The case is under consideration for want of comments of TE.

Case No.	149 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	BELCHEM INDUSTRIES (INDIA) PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005480AM23
RA File Number	03AX04004595 AM23
Licence No and<br>Date	0311020433/03/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jul/202324/9 dated 28.07.2023against advance authorization No.<br>0311016511 dt. 22.07.2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given<br>below or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>BELGUARD PBSA<br>(Phenyl benzimidazole Sulfonic Acid).<br>1 kg.<br>1<br>Ortho Phenylene Diamine<br>0.4925 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	150 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	MAYA BIOTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005487AM23
RA File Number	30AX04000416 AM23
Licence No and<br>Date	3011002973/03/01/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00005487AM23| |RA File Number|30AX04000416 AM23| |Licence No and Date|3011002973/03/01/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	151 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	RAKSHIT DRUGS PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024

UDIN00469829AM24

and Date
HQ File Number	HQRNORM APPLY 00005513AM23
RA File Number	09AX04000866 AM23
Licence No and<br>Date	0911004255/04/01/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	152 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005526AM23
RA File Number	09AX04000891 AM23
Licence No and<br>Date	0911004257/04/01/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	153 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005545AM23
RA File Number	07AX04001477 AM23
Licence No and<br>Date	0711006102/05/01/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00005545AM23| |RA File Number|07AX04001477 AM23| |Licence No and Date|0711006102/05/01/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	154 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	BIODEAL PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005558AM23
RA File Number	05AX04002932 AM23
Licence No and<br>Date	0511016743/05/01/2023
Norms Committee Decision:

85 This document has been digitally signed by Raman Kumar, Deputy DGFT on 06-02-2024 11:34:01.

UDIN00469829AM24

|Th I as RA|e Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. per details given below or as applied by the firm, whichever is less: -|e Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. per details given below or as applied by the firm, whichever is less: -|e Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. per details given below or as applied by the firm, whichever is less: -|e Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. per details given below or as applied by the firm, whichever is less: -|e Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. per details given below or as applied by the fi

ied by the firm, whichever is less: -|e Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. per details given below or as applied by the firm, whichever is less: -| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|Qty. allowed.| ||NASAL SPRAY(PUMP-90-APF- SNAP-20-26. 0-360 DEGREE NASAL ADAPTOR WITH CHEMICALS AS PER THE DRUG LICENSE)| 148500 pieces|1|NASAL ADAPTOR|Relevant on Net-to- Net basis with accountability.| ||concerned may take further necessary action as per above decision of NC.|||||

The Committee considered the case as per agenda and it was decided to fix adhoc 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.	155 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005568AM23
RA File Number	34AX04000926 AM23
Licence No and<br>Date	3411003231/05/01/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00005568AM23| |RA File Number|34AX04000926 AM23| |Licence No and Date|3411003231/05/01/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	156 / NC/3/MEET/Dec/202324/19
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM APPLY 00005588AM23
RA File Number	05AX04002947 AM23
Licence No and<br>Date	0511016763/06/01/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	157 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved

UDIN00469829AM24

Party Name<br>MICRO LABS LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number<br>HQRNORM APPLY 00005595AM23
RA File Number<br>07AX04001473 AM23
Licence No and Date<br>0711006137/06/01/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Nov/202324/16 dated 17.11.2023against advance authorization No.
0711004103 dt. 26.05.2022, it was decided to fix ad-hoc 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>Qty.<br>Sl. No. Import Items	**Qty.

ded to fix ad-hoc 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. allowed.|| |PHLOROGLUCINOL 160MG 1 Number 1 PHLOROGLUCINOL DIHYDRATE|163.20 mg|| |ODT||| |RA concerned may take further necessary action as per above decision of NC.|||

Case No.	158 / NC/3/MEET/Dec/202324/19
Case Status	Case Approved
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 19 and 05/01/2024
HQ File Number	HQRNORM REVIW00002991AM24
RA File Number	03AX04004890 AM23
Licence No and<br>Date	0311020522/06/01/2023
Norms Committee	Decision:
The Committee	considered the case as per agenda and taking cue from the earlier decision for same export
product/import	product in meetingNo.NC/3/MEET/Jan/202122/13 dated 21/01/2022against advance
authorizationNo.0311005784 dated 01/08/2021, it was		decided to fix ad-hoc		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. No.	Import items	Qty. allowed
Telmisartan and Amlodipine Tablets 40/10mg / Each<br>1		<br>1 Number	1	Telmisartan Granules	68.034 mg
uncoated	tablets contains :(Telmisartan 40 mg
Telmisartan 40 mg equivalent to Telmisartan granules
67.36mg	Amlodipine<br>Besilate<br>equivalent<br>to		2	Amlodipine Besilate	10.2

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

Analysis

No analysis generated for this document yet (analysis runs over brief docs + on-demand). Run build_analysis.py --ids 8045 --apply.