IN FORCE Advance Authorisation

DGFT Minutes

Reliability

In force — no superseding record on file.

Document text

UDIN00156044AM26

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/May/202526/3 DATED: 04/06/2025

Minutes of the Norms Committee–3 Meeting No.NC/3/MEET/Apr/202526/3 dated 04/06/2025, under the Chairmanship of Shri Rakesh Kumar, Addl. DGFT for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of the Foreign Trade Policy, 2023 pertaining to Chemical and Allied products falling under Chapters 29 and 30.

    The following members were present in the Meeting:-

Sl. No.	Name & Designation	Department
1	Shri Dinesh Narain Mathur, Technical Expert	Consultant (Pharma)
2	Shri Shaish Kumar, Technical Expert	Consultant (Chemical)
3	Shri Nand Lal, Technical Expert	Consultant (Chemical)
In attendance:
1	Shri Raman Kumar, Deputy DGFT	DGFT (HQ)

    The Norms Committee has taken decisions only with respect to technical aspect / wastage

Signature Not Verified Signature Not Verified Digitally Signed. Digitally signa, Name: RAMAN KUMAR( Deputy Name: RAMAN KUJAAR( Deputy DGFT ) DGFT ) Date: 20-Jun-2025 10:15:38 Date: 20-Jun-2 10:15:38 Reason: ramankumar@nic.in Reason: ramankumar@nic.in Location: DGFT(HQ) Location: DGFTTHQ)

This document has been digitally signed by Raman Kumar, Deputy DGFT,DGFT(HQ) on 20-Jun-2025.

UDIN00156044AM26

ankumar@nic.in Reason: ramankumar@nic.in Location: DGFT(HQ) Location: DGFTTHQ)

This document has been digitally signed by Raman Kumar, Deputy DGFT,DGFT(HQ) on 20-Jun-2025.

UDIN00156044AM26

norms. While redeeming the application, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure, including those in notifications, public notices and policy circulars issued from time to time or any other provisions under FTP/HBP for issuance of Advance Authorization and regularisation of the case.

    RAs shall ensure compliance with SION, General Notes and Chapter Notes wherever applicable.

    RAs shall also ensure that authorization is issued or redeemed based on the wastages/consumption asratified by the Committee or as per wastages claimed in the application, whichever is less. In this regard full compliance of the provisions of Para 4.12 or the relevant para of the applicable FTP, Para 4.16, Para 4.21,and Para 4.51 or the relevant paras of the applicable HBP shall be made

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Case Details and Decision(s):

Case No.	Case No.	Case No.	1 / NC/3/MEET/May/202526/3	1 / NC/3/MEET/May/202526/3
Case Status			Case Approved
Party Name			ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number			HQRNORM APPLY 00004369AM25
RA File Number			NA
Licence No and<br>Date			NA
Norms Committee Decision:<br>Decision:The Committee considered the request of firm for fixation of ad-hoc norms to enable them to<br>obtain Advance Authorization from concerned RA and it was decided to fix ad-hoc norms as per details<br>given below or as applied by the firm, whichever is less:<br>Sl. No.<br>Export Product<br>Qty.<br>1<br>CHOLESTYRAMINE FOR ORAL SUSPENSION USP POWDER 4<br>GRAMS (9 GRAMS POUCH PACK) (EACH POUCH OF 9 GRAMS<br>CONTAIN 4 GRAMS OF CHOLESTYRAMINE RESIN USP) ((ACTIVE<br>INGREDIENT: CHOLESTYRAMINE RESIN USP -NET WT. 30232.800<br>KGS))<br>1 Number<br>2<br>CHOLESTYRAMINE FOR ORAL SUSPENSION USP POWDER 4<br>GRAMS (378 GRAMS JAR/BOTTLE PACK) (EACH JAR / BOTTLE<br>OF 378 GRAMS EQUVIVALENT TO 42 POUCHES OF 9 GRAMS<br>AND EACH 9 GRAMS CONTAIN 4 GRAMS OF CHOLESTYRAMINE<br>RESIN USP) ((ACTIVE INGREDIENT: CHOLESTYRAMINE RESIN<br>USP - NET WT. 23033.808 KGS))<br>1 Number<br>3<br>CHOLESTYRAMINE FOR ORAL SUSPENSION USP LIGHT<br>POWDER 4 GRAMS (5.5 GRAMS POUCH PACK) (EACH POUCH OF<br>5.5 GRAMS CONTAIN 4 GRAMS OF CHOLESTYRAMINE RESIN<br>USP) ((ACTIVE INGREDIENT: CHOLESTYRAMINE RESIN USP -<br>NET WT.

AL SUSPENSION USP LIGHT POWDER 4 GRAMS (5.5 GRAMS POUCH PACK) (EACH POUCH OF 5.5 GRAMS CONTAIN 4 GRAMS OF CHOLESTYRAMINE RESIN USP) ((ACTIVE INGREDIENT: CHOLESTYRAMINE RESIN USP - NET WT. 21593.520 KGS)) 1 Number CHOLESTYRAMINE FOR ORAL SUSPENSION USP LIGHT POWDER 4 GRAMS (231 GRAMS JAR / BOTTLE PACK) (EACH JAR /BOTTLE OF 231 GRAMS EQUVIVALENT TO 42 POUCHES OF 5.5 GRAMS AND EACH 5.5 GRAMS CONTAIN 4 GRAMS OF 4 1 Number||||| ||Sl. No.|Export Product||Qty.| ||1|CHOLESTYRAMINE FOR ORAL SUSPENSION USP POWDER 4 GRAMS (9 GRAMS POUCH PACK) (EACH POUCH OF 9 GRAMS CONTAIN 4 GRAMS OF CHOLESTYRAMINE RESIN USP) ((ACTIVE INGREDIENT: CHOLESTYRAMINE RESIN USP -NET WT. 30232.800 KGS))||1 Number| ||2|CHOLESTYRAMINE FOR ORAL SUSPENSION USP POWDER 4 GRAMS (378 GRAMS JAR/BOTTLE PACK) (EACH JAR / BOTTLE OF 378 GRAMS EQUVIVALENT TO 42 POUCHES OF 9 GRAMS AND EACH 9 GRAMS CONTAIN 4 GRAMS OF CHOLESTYRAMINE RESIN USP) ((ACTIVE INGREDIENT: CHOLESTYRAMINE RESIN USP - NET WT. 23033.808 KGS))||1 Number| ||3|CHOLESTYRAMINE FOR ORAL SUSPENSION USP LIGHT POWDER 4 GRAMS (5.5 GRAMS POUCH PACK) (EACH POUCH OF 5.5 GRAMS CONTAIN 4 GRAMS OF CHOLESTYRAMINE RESIN USP) ((ACTIVE INGREDIENT: CHOLESTYRAMINE RESIN USP - NET WT. 21593.520 KGS))||1 Number| ||4|CHOLESTYRAMINE FOR ORAL SUSPENSION USP LIGHT POWDER 4 GRAMS (231 GRAMS JAR / BOTTLE PACK) (EACH JAR /BOTTLE OF 231 GRAMS EQUVIVALENT TO 42 POUCHES OF 5.5 GRAMS AND EACH 5.5 GRAMS CONTAIN 4 GRAMS OF||1 Number|

AL SUSPENSION USP LIGHT POWDER 4 GRAMS (231 GRAMS JAR / BOTTLE PACK) (EACH JAR /BOTTLE OF 231 GRAMS EQUVIVALENT TO 42 POUCHES OF 5.5 GRAMS AND EACH 5.5 GRAMS CONTAIN 4 GRAMS OF||1 Number|

Case No.	Case No.	Case No.	1 / NC/3/MEET/May/202526/3	1 / NC/3/MEET/May/202526/3
Case Status			Case Approved
Party Name			ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number			HQRNORM APPLY 00004369AM25
RA File Number			NA
Licence No and<br>Date			NA
Norms Committee Decision:<br>Decision:The Committee considered the request of firm for fixation of ad-hoc norms to enable them to<br>obtain Advance Authorization from concerned RA and it was decided to fix ad-hoc norms as per details<br>given below or as applied by the firm, whichever is less:<br>Sl. No.<br>Export Product<br>Qty.<br>1<br>CHOLESTYRAMINE FOR ORAL SUSPENSION USP POWDER 4<br>GRAMS (9 GRAMS POUCH PACK) (EACH POUCH OF 9 GRAMS<br>CONTAIN 4 GRAMS OF CHOLESTYRAMINE RESIN USP) ((ACTIVE<br>INGREDIENT: CHOLESTYRAMINE RESIN USP -NET WT. 30232.800<br>KGS))<br>1 Number<br>2<br>CHOLESTYRAMINE FOR ORAL SUSPENSION USP POWDER 4<br>GRAMS (378 GRAMS JAR/BOTTLE PACK) (EACH JAR / BOTTLE<br>OF 378 GRAMS EQUVIVALENT TO 42 POUCHES OF 9 GRAMS<br>AND EACH 9 GRAMS CONTAIN 4 GRAMS OF CHOLESTYRAMINE<br>RESIN USP) ((ACTIVE INGREDIENT: CHOLESTYRAMINE RESIN<br>USP - NET WT.

(EACH JAR / BOTTLE OF 378 GRAMS EQUVIVALENT TO 42 POUCHES OF 9 GRAMS AND EACH 9 GRAMS CONTAIN 4 GRAMS OF CHOLESTYRAMINE RESIN USP) ((ACTIVE INGREDIENT: CHOLESTYRAMINE RESIN USP - NET WT. 23033.808 KGS)) 1 Number 3 CHOLESTYRAMINE FOR ORAL SUSPENSION USP LIGHT POWDER 4 GRAMS (5.5 GRAMS POUCH PACK) (EACH POUCH OF 5.5 GRAMS CONTAIN 4 GRAMS OF CHOLESTYRAMINE RESIN USP) ((ACTIVE INGREDIENT: CHOLESTYRAMINE RESIN USP - NET WT. 21593.520 KGS)) 1 Number CHOLESTYRAMINE FOR ORAL SUSPENSION USP LIGHT POWDER 4 GRAMS (231 GRAMS JAR / BOTTLE PACK) (EACH JAR /BOTTLE OF 231 GRAMS EQUVIVALENT TO 42 POUCHES OF 5.5 GRAMS AND EACH 5.5 GRAMS CONTAIN 4 GRAMS OF 4 1 Number||||| ||Sl. No.|Export Product||Qty.| ||1|CHOLESTYRAMINE FOR ORAL SUSPENSION USP POWDER 4 GRAMS (9 GRAMS POUCH PACK) (EACH POUCH OF 9 GRAMS CONTAIN 4 GRAMS OF CHOLESTYRAMINE RESIN USP) ((ACTIVE INGREDIENT: CHOLESTYRAMINE RESIN USP -NET WT. 30232.800 KGS))||1 Number| ||2|CHOLESTYRAMINE FOR ORAL SUSPENSION USP POWDER 4 GRAMS (378 GRAMS JAR/BOTTLE PACK) (EACH JAR / BOTTLE OF 378 GRAMS EQUVIVALENT TO 42 POUCHES OF 9 GRAMS AND EACH 9 GRAMS CONTAIN 4 GRAMS OF CHOLESTYRAMINE RESIN USP) ((ACTIVE INGREDIENT: CHOLESTYRAMINE RESIN USP - NET WT. 23033.808 KGS))||1 Number| ||3|CHOLESTYRAMINE FOR ORAL SUSPENSION USP LIGHT POWDER 4 GRAMS (5.5 GRAMS POUCH PACK) (EACH POUCH OF 5.5 GRAMS CONTAIN 4 GRAMS OF CHOLESTYRAMINE RESIN USP) ((ACTIVE INGREDIENT: CHOLESTYRAMINE RESIN USP - NET WT.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

CHOLESTYRAMINE RESIN USP) ((ACTIVE INGREDIENT: CHOLESTYRAMINE RESIN USP - NET WT. 16797.312 KGS))

CHOLESTYRAMINE RESIN USP) ((ACTIVE INGREDIENT:<br>CHOLESTYRAMINE RESIN USP - NET WT. 16797.312 KGS))<br>For export of 1 pouch of<br>Sl. No.<br>Import Items<br>9 gm<br>5.5 gm<br>1<br>CHOLESTYRAMINE RESIN USP<br>4.08 gm<br>4.08 gm<br>2<br>SUCROSE NF (COMPRESSUC PS)<br>4.461 gm<br>Nil<br>3<br>MANNITOL USP (PEARLITOL SD 200)<br>Nil<br>1.1575 gm<br>4<br>ANHYDROUS CITRIC ACID USP (POWDER GRADE)<br>0.100 gm<br>0.060 gm<br>5<br>PROPYLENE GLYCOL ALGINATE NF<br>(KELCOLOID S)<br>0.225 gm<br>0.050 gm<br>RA concerned may take further necessary action as per above decision of NC.		CHOLESTYRAMINE RESIN USP) ((ACTIVE INGREDIENT:<br>CHOLESTYRAMINE RESIN USP - NET WT. 16797.312 KGS))

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

OLESTYRAMINE RESIN USP) ((ACTIVE INGREDIENT: CHOLESTYRAMINE RESIN USP - NET WT. 16797.312 KGS))|| |---|---|---|---|

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

Case No.	2 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00006271AM25
RA File Number	NA
Licence No and<br>Date	NA
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 item in meeting No. NC/3/MEET/Sep/202324/14 dated 27/09/2023 against Hq.File No.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

HQRNORMAPPLY00005754AM24 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

Norms recommended for OMEPRAZOLE DELAYED RELEASE CAPSULE USP 10 mg 20 mg and 40 mg.

Sl.No.	Import Item	10 mg capsule	20 mg capsule	40 mg capsule
1	OMEPRAZOLE USP	10.2 mg	20.4 mg	40.8 mg
2	HYPROMELLOSE 3 CPS 2910 USP	4.68 mg	9.36 mg	18.6 mg
3	HYPROMELLOSE PHTHALATE NF	8.555 mg	17.110 mg	31.0 mg
4	SUGAR SPHERES NF (PHARMA-	47.50 mg	95.0 mg	190.0 mg
	SPHERES, 710-850 MICRON)
5	TALC PH. E/USP/JP	4.78 mg	9.56 mg	19.12 mg
6	TRIETHYL CITRATE NF	1.285 mg	2.570 mg	4.65 mg




Case No	3 / NC/3/MEET/May/202526/3
.
Case Status	Case Deferred
P N	INCHEM LABORATORIES PRIVATE LIMITED
arty ame
Mi Nb
eetng umer<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025

HQ File Number	HQRNORM REVIW00002300AM25
RA Fil Nb	092404000413 AM12
e umer
Li N d	0910050238/15/12/2011
cence o an

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Date

Norms Committee Decision:

The firm was called for Personal Hearing on 05.06.2025 through Video Conference, but the firm could not appear before Norms Committee. It was decided to grant one more opportunity to the firm for Personal Hearing with relevant documents/information.

Case No.	4 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	WEXFORD LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM REVIW00003783AM25
RA File Number	072404000382 AM14
Licence No and<br>Date	0710101548/23/01/2014
Norms Committee Decision:
The Committee considered the case as per agenda and it has been observed that export product and		import
item are same. Therefore, it was decided that the firm may call for attendingPersonal Hearing		before
Norms Committee to explain its case along with following information / documents from the firm:
Copy of Drug Manufacturing Licence (DML)<br>I.
Copy of Certificate of Analysis (CoA) of import item.<br>II.
Wastage claimed.<br>III.
Copy of Shipping Bill of export product.<br>IV.

Case No.	5 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	WEXFORD LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM REVIW00003782AM25
RA File Number	072404000120 AM18
Licence No and<br>Date	0710111992/09/08/2017
Norms Committee Decision:

/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025| |HQ File Number|HQRNORM REVIW00003782AM25| |RA File Number|072404000120 AM18| |Licence No and Date|0710111992/09/08/2017| |Norms Committee Decision:||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

The Committee considered the case as per agenda and it has been observed that export product and import item are confusing. Therefore, it was decided that the firm may call for attending Personal Hearing before Norms Committee to explain its case along with following information / documents from the firm:

I. Copy of Drug Manufacturing Licence (DML)
II. Copy of Certificate of Analysis (CoA) of import item.
III. Wastage claimed.
IV. Copy of Shipping Bill of export product.

Case No.<br>6 / NC/3/MEET/May/202526/3
Case Status<br>Case Approved
Party Name<br>SUPERMINT EXPORTS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number<br>HQRNORM REVIW00003665AM25
RA File Number<br>052404000340 AM21
Licence No and<br>Date<br>0510415463/09/10/2020
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import item in meeting No. NC/3/MEET/Feb/202425/17 dated 25/02/2025 against advance
authorization No.2910025424 dated 19/08/2019, it was decided to fix ad-hoc norms under Para 4.07 of
HBP Vol.

t item in meeting No. NC/3/MEET/Feb/202425/17 dated 25/02/2025 against advance||| |authorization No**.**2910025424 dated 19/08/2019, 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.|| |Dihydromyrcenol 1 kg. 1 Dihydromyrcene (91% Purity)|1.13 kg.|| |RA concerned may take further necessary action as per above decision of NC.|||

Case No.	7 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	KRUNAL INDUSTRIES PRIVATE LIMITED

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00301989AM22
RA File Number	08AX04000162 AM22
Licence No and<br>Date	0811003592/30/12/2021
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<br>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>1<br>NITRO METHANE<br>0.3216 Kg<br>2 BROMO 2 NITRO 1,3<br>PROPANEDIOL<br>(BRONOPOL)<br>1 kg.<br>2<br>LIQUID BROMINE<br>1.14 Kg<br>RA concerned may take further necessary action as per above decision of NC.

METHANE 0.3216 Kg 2 BROMO 2 NITRO 1,3 PROPANEDIOL (BRONOPOL) 1 kg. 2 LIQUID BROMINE 1.14 Kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	8 / NC/3/MEET/May/202526/3
Case Status	Case Rejected
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM REVIW00003341AM25
RA File Number	05AX04000760 AM23
Licence No and<br>Date	0511013171/13/06/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Hence, it was decided to<br>rejectthe case maintaining thestatus quo.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Case No.	9 / NC/3/MEET/May/202526/3
Case Status	Case Rejected
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM REVIW00006414AM24
RA File Number	09AX04000207 AM23
Licence No and<br>Date	0911003443/05/08/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Hence, it was decided to<br>rejectthe case maintaining thestatus quo.

ms and it was observed that the firm has not provided any technical justification / information for enhancement. Hence, it was decided to rejectthe case maintaining thestatus quo.||

Case No.	Case No.	10 / NC/3/MEET/May/202526/3	10 / NC/3/MEET/May/202526/3	10 / NC/3/MEET/May/202526/3	10 / NC/3/MEET/May/202526/3	10 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00003389AM23
RA File Number		08AX04001054 AM23
Licence No and<br>Date		0811006114/26/09/2022
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<br>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>Vardenafil Tablets 5 Mg (Each Film<br>Coated Tablet Contains: Vardenafil<br>(As Vardenafil Hydrochloride<br>Trihydrate Ph.Eur.) 5 Mg)<br>540000<br>Numbers<br>1<br>Vardenafil Hydrochloride<br>Trihydrate EP / BP / IP /<br>USP / PH. EUR<br>3.049 kg<br>Vardenafil Tablets 10 Mg (Each Film 180000<br>Vardenafil Hydrochloride<br>2<br>2.033 kg
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

IP / USP / PH. EUR 3.049 kg Vardenafil Tablets 10 Mg (Each Film 180000 Vardenafil Hydrochloride 2 2.033 kg||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Vardenafil Tablets 5 Mg (Each Film Coated Tablet Contains: Vardenafil (As Vardenafil Hydrochloride Trihydrate Ph.Eur.) 5 Mg)||540000 Numbers|1|Vardenafil Hydrochloride Trihydrate EP / BP / IP / USP / PH. EUR|3.049 kg| ||Vardenafil Tablets 10 Mg (Each Film||180000|2|Vardenafil Hydrochloride|2.033 kg|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

|Coated Tablet Contains: Vardenafil (As Vardenafil Hydrochloride Trihydrate Ph.Eur.) 10 Mg) Numbers Trihydrate EP / BP / IP / USP / PH. EUR. Vardenafiltablets 20mg (Each Film Coated Tablet Contains: Vardenafil (As Vardenafil Hydrochloride Trihydrate Ph.Eur.) 20 Mg [In Which Active Ingredient Vardenafil Hydrochloride Trihydrate Used Is 5.520 Kgs.]) 51000 Numbers 3 Vardenafil Hydrochloride Trihydrate EP / BP / IP / USP / PH. EUR 1.162 kg RA concerned may take further necessary action as per above decision of NC.|Coated Tablet Contains: Vardenafil (As Vardenafil Hydrochloride Trihydrate Ph.Eur.) 10 Mg)|Numbers||Trihydrate EP / BP / IP / USP / PH.

further necessary action as per above decision of NC.	Coated Tablet Contains: Vardenafil<br>(As Vardenafil Hydrochloride<br>Trihydrate Ph.Eur.) 10 Mg)	Numbers		Trihydrate EP / BP / IP /<br>USP / PH. EUR.
	Vardenafiltablets 20mg (Each Film<br>Coated Tablet Contains: Vardenafil<br>(As Vardenafil Hydrochloride<br>Trihydrate Ph.Eur.) 20 Mg [In Which<br>Active Ingredient Vardenafil<br>Hydrochloride<br>Trihydrate Used Is 5.520 Kgs.])	51000<br>Numbers	3	Vardenafil Hydrochloride<br>Trihydrate EP / BP / IP /<br>USP / PH. EUR	1.162 kg

Case No.	Case No.	11 / NC/3/MEET/May/202526/3	11 / NC/3/MEET/May/202526/3	11 / NC/3/MEET/May/202526/3	11 / NC/3/MEET/May/202526/3	11 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		NECTAR LIFE SCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00003987AM23
RA File Number		302404000100 AM20
Licence No and<br>Date		3011002766/01/11/2022
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 item in meeting No. NC/3/MEET/Mar/202425/19 dated 27/03/2025 against advance<br>authorization No.3011005168 dated 13/05/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>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.

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 GHYH 2.977 kg. 2 Ethyl-4-chloroacetoacetate 1.82 kg. Ceftibuten Hydrate 1 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Ceftibuten Hydrate||1 kg|1|GHYH|2.977 kg.| |||||2|Ethyl-4-chloroacetoacetate|1.82 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

3	Methylene Chloride	85.60 kg.
4	Triethylamine	3.214 kg
5	Isopropyl acetate	7.99 kg.
6	DL Malic acid	7.18 kg.
7	Methanol	52.50 kg.
8	Prenol (Prenyl alcohol)	3.114 kg.
9	Methyl 3-methoxyacrylate	1.62 kg.
10	Dimethylformamide (DMF)	4.82 kg.
11	Toluene	0.38 kg.
12	Acetone	2.13 kg.

|7|Methanol|52.50 kg.| ||||8|Prenol (Prenyl alcohol)|3.114 kg.| ||||9|Methyl 3-methoxyacrylate|1.62 kg.| ||||10|Dimethylformamide (DMF)|4.82 kg.| ||||11|Toluene|0.38 kg.| ||||12|Acetone|2.13 kg.|

Case No.	12 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
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 Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Secnidazole Taste Masked Pellets	1 kg	1	Secnidazole IH	0.478 kg

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

port Items**|Qty. allowed.| |---|---|---|---|---| |Secnidazole Taste Masked Pellets|1 kg|1|Secnidazole IH|0.478 kg|

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

Case No.	13 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
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 Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>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>Secnidazole Taste Masked Pellets<br>1 kg<br>1<br>Secnidazole IH<br>0.478 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	14 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	SCL LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

e|NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

HQ File Number	HQRNORM APPLY 00006594AM23
RA File Number	30AX04000547 AM23
Licence No and<br>Date	3011003202/24/02/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	15 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	MAHARASHTRA ALDEHYDES AND CHEMICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00006735AM23
RA File Number	03AX04004601 AM23
Licence No and<br>Date	0311021876/03/03/2023
Norms Committee Decision:<br>The Committee considered the case and firm is requested to amend the export item as Triethyl Citate and<br>furnish the copy of the amended authorization.

Case No.	16 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	ATUL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM REVIW00006563AM24
RA File Number	08AX04001977 AM23
Licence No and<br>Date	0811007532/10/03/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No. 17 / NC/3/MEET/May/202526/3

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

s.**||

Case No. 17 / NC/3/MEET/May/202526/3

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Case Status	Case Approved
Party Name	S KANT CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00000218AM24
RA File Number	03AX04000033 AM24
Licence No and<br>Date	0311022832/17/04/2023
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<br>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.<br>allowed.<br>9,11 B - Expoxide Triamcinolone<br>(5TR)<br>1 kg<br>1<br>3,20-Dioxopregna-1,4,9 (11),16-<br>Tetraen-21-Yl Acetate (3tr)<br>1.05 kg<br>RA concerned may take further necessary action as per above decision of NC.

de Triamcinolone (5TR) 1 kg 1 3,20-Dioxopregna-1,4,9 (11),16- Tetraen-21-Yl Acetate (3tr) 1.05 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	18 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00000292AM24
RA File Number	03AX04000045 AM24
Licence No and<br>Date	0311022935/19/04/2023
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 item in meeting No. NC/3/MEET/Apr/202526/1 dated 25/04/2025 against advance<br>authorization No.0311029682 dated 27/12/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

as applied by the firm, whichever is less:-||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Export Product	Export Product			Qty.	Sl	. No.	Import Items	Qty. allowed.
Tylosin Bolus 200 mg. ((Each		Bolus		1 Number		1	Tylosin Tartrate	204.00 mg.
Contains Tylosin 200mg)
Tylosin Injection 5% - 50 ml. ((Each<br>l i li			1 Number		2		Tylosin Tartrate	3.056 gm.
M Contans Tyosn Tartrate Eq. To<br>Tylosin Base 50mg)
Tylosin Injection 5% - 100 ml. ((Each			1 Number		3		Tylosin Tartrate	6.111 gm.
Ml Contains	Tylosin Tartrate Eq. To
Tylosin Base	50mg)


Tylosin Tartr<br>ml ((Each M	ate Injection 20% - 50<br>l Contains Tylosin		1 Number		4		Tylosin Tartrate	12.222 gm.
.<br>Tartrate Eq.	<br>To Tylosin 200mg)

Tylosin Tartr	ate Injection 20%-100		1 Number		5		Tylosin Tartrate	24.444 gm.
ml. ((Each Ml Contains Tylosin<br>Tartrate Eq. To Tylosin 200mg)
Tylosin Tartrate Powder 100% -100<br>gm. Sachet ((Each Gram Contains<br>Tylosin Tartrate 100%)			1 Number		6		Tylosin Tartrate	101 gm.

Tylosin Tartrate Powder<br>gm.

)||||||||||| ||Tylosin Tartrate Powder 100% -100 gm. Sachet ((Each Gram Contains Tylosin Tartrate 100%)||||1 Number||6||Tylosin Tartrate||101 gm.| ||||||||||||| ||Tylosin Tartrate Powder gm. Sachet ((Each Gram Tlosin Tartrate 100%)||100% - 500 Contains|||1 Number||7|Tylosin Tartrate||505 gm.| ||y||||||||||| ||Tylosin Tartrate Powder Jar ((Each Gram Contai Tartrate 100%)||100% -1 kg ns Tylosin|||1 Number||8|Tlosin Tartrate||1010 m| ||||||||||y||g.| ||||||||||||| ||Tylosin Tartrate Powder 20% -5 gm.||||1 Number||9||Tylosin Tartrate||1.1756 gm.| ||((Each Gram Contains Tylosin Tartrate Eq. To Tylosin 20%)||||||||||| ||Tylosin Tartrate Powder 20% -100||||1 Number||10||Tylosin Tartrate||23513 gm| || gm. ((Each G| ram Contains Tylosin|||||||||. .| |||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

|Tartrate Eq. To Tylosin 20%) Tylosin Tartrate Powder 20% - 500 gm. ((Each Gram Contains Tylosin Tartrate Eq. To Tylosin 20%) 1 Number 11 Tylosin Tartrate 117.564 gm. Tylosin Tartrate Powder 20% -1kg Jar ((Each Gram Contains Tylosin Tartrate Eq.

Tartrate Eq. To Tylosin 20%)
Tylosin Tartrate Powder 20% - 500<br>gm. ((Each Gram Contains Tylosin<br>Tartrate Eq. To Tylosin 20%)	1 Number	11	Tylosin Tartrate	117.564 gm.
Tylosin Tartrate Powder 20% -1kg Jar<br>((Each Gram Contains Tylosin<br>Tartrate Eq. To Tylosin 20%)	<br>1 Number	12	Tylosin Tartrate	235.128 gm.
Tylosin Tartrate Powder 99% - 100<br>gm Sachet ((Each Gram Contains<br>Tylosin Tartrate 99%)	1 Number	13	Tylosin Tartrate	100 gm.
Tylosin Tartrate Powder 99% - 500<br>gm Sachet ((Each Gram Contains<br>Tylosin Tartrate 99%)	1 Number	14	Tylosin Tartrate	500 gm.
Tylosin Tartrate Powder 99% -1 kg<br>Jar ((Each Gram Contains Tylosin<br>Tartrate 99%)	1 Number	15	Tylosin Tartrate	1000 gm.

ains Tylosin Tartrate 99%)|1 Number|14|Tylosin Tartrate|500 gm.| ||Tylosin Tartrate Powder 99% -1 kg Jar ((Each Gram Contains Tylosin Tartrate 99%)|1 Number|15|Tylosin Tartrate|1000 gm.|

Case No.	19 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00000325AM24
RA File Number	03AX04000169 AM24
Licence No and<br>Date	0311022998/21/04/2023
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 item in meeting No. NC/3/MEET/Apr/202526/1 dated 25/04/2025 against advance

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

authorization No . 0311029682 dated 27/12/2023, 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:-

AM26

authorization No . 0311029682 dated 27/12/2023, 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:-

|authorization No**.0311029682 dated 27/12/2023, 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:-|authorization No.0311029682 dated 27/12/2023, 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:-|authorization No.0311029682 dated 27/12/2023, 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:-|authorization No.0311029682 dated 27/12/2023, 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:-|authorization No.0311029682 dated 27/12/2023, 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:-|authorization No.0311029682 dated 27/12/2023, 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:-|authorization No.**0311029682 dated 27/12/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

BP Vol. I as per details given below or as applied by the firm, whichever is less:-|authorization No**.**0311029682 dated 27/12/2023, 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|roduct|Qty.|Sl. No.|Import Items|Qty. allowed.| |||||||| ||Tylosin Bolu|s 200 mg. ((Each Bolus|1 Number|1|Tylosin Tartrate|204.00 mg.| || Contains Tyl| osin 200 Mg)||||| |||||||| ||Tylosin Injec |tion 5% - 50 ml. ((Each Ml | 1 Number|2|Tylosin Tartrate|3.056 gm.| ||Contains Tylosin Tartrate Eq. To Tylosin Base 50 mg.)|||||| |||||||| ||Tylosin Injection 5% - 100 ml. ((Each Ml Contains Tylosin Tartrate Eq. To Tylosin Base 50 mg)||1 Number|3|Tylosin Tartrate|6.111 gm.| |||||||| ||Tylosin Tartr|ate Injection 20% - 50 ml.|1 Number|4|Tylosin Tartrate|12.222 gm.| ||((Each Ml Co|ntains Tylosin Tartrate Eq.||||| ||To Tylosin 2|00mg)||||| |||||||| |||||||| ||Tylosin Tartr |ate Injection 20% - 100 ml. |1 Number|5|Tylosin Tartrate|24.444 gm.| ||((Each Ml C T Tli 2|ntains Tylosin Tartrate Eq. 0 M||||| ||o yosn|g)||||| |||||||| ||Tylosin Tartrate Powder 100% - 100 gm. Sachet ((Each Gram Contains Tylosin Tartrate 100%)||1 Number|6|Tylosin Tartrate|101 gm.| ||Tylosin Tartrate Powder 100% - 500 gm.

n|g)||||| |||||||| ||Tylosin Tartrate Powder 100% - 100 gm. Sachet ((Each Gram Contains Tylosin Tartrate 100%)||1 Number|6|Tylosin Tartrate|101 gm.| ||Tylosin Tartrate Powder 100% - 500 gm. Sachet ((Each Gram Contains Tylosin Tartrate 100%)||1 Number|7|Tylosin Tartrate|505 gm.| |||||||| ||Tylosin Tartrate Powder 100% - 1 kg. Jar ((Each Gram Contains Tylosin Tartrate 100%)||1 Number|8|Tylosin Tartrate|1010 gm.| |||||||| |||||||| ||Tylosin Tartr |ate Powder 20% - 5 gm. |1 Number|9|Tylosin Tartrate|1.1756 gm.| ||((Each Gram Eq. To Tylos|Contains Tylosin Tartrate in 20%)||||| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Tylosin Tartrate Powder 20% -100 gm.	1 Number	10	Tylosin Tartrate	23.513 gm.
((Each Gram Contains Tylosin Tartrate
Eq. To Tylosin 20%)
Tylosin Tartrate Powder 20% -500 gm.	1 Number	11	Tylosin Tartrate	117.564 gm.
((Each Gram Contains Tylosin Tartrate
Eq. To Tylosin 20%)
Tylosin Tartrate Powder 20% - 1 kg. Jar	1 Number	12	Tylosin Tartrate	235.128 gm.
((Each Gram Contains Tylosin Tartrate
Eq.

Each Gram Contains Tylosin Tartrate||||| |Eq. To Tylosin 20%)||||| |Tylosin Tartrate Powder 20% - 1 kg. Jar|1 Number|12|Tylosin Tartrate|235.128 gm.| |((Each Gram Contains Tylosin Tartrate||||| |Eq. To Tylosin 20%)||||| |Tylosin Tartrate Powder 99% - 100 gm.|1 Number|13|Tylosin Tartrate|100 gm.| |Sachet ((Each Gram Contains Tylosin||||| |Tartrate 99%)||||| |Tylosin Tartrate Powder 99% - 500 gm.|1 Number|14|Tylosin Tartrate|500 gm.| |Sachet ((Each Gram Contains Tylosin||||| |Tartrate 99%)||||| |Tylosin Tartrate Powder 99% - 1 kg Jar|1 Number|15|Tylosin Tartrate|1000 gm.| |((Each Gram Contains Tylosin Tartrate||||| |99%)|||||

Case No.	20 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	SATYADEVA PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00000775AM24
RA File Number	09AX04000090 AM24
Licence No and<br>Date	0911005025/11/05/2023
Norms Committee Decision:

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

The committee considered the request of the firm for fixation of ad-hoc norms, and as per the advice of the TE, it was decided to call for following information/documents from the firm:-

Percentage on molar basis as per the present data of production.
Production/consumption data for the last three years certified by Chartered Accountant.

ormation/documents from the firm:-

Percentage on molar basis as per the present data of production.
Production/consumption data for the last three years certified by Chartered Accountant.

Case No.<br>21 / NC/3/MEET/May/202526/3
Case Status<br>Case Approved
Party Name<br>SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number<br>HQRNORM APPLY 00000897AM24
RA File Number<br>05AX04000410 AM24
Licence No and<br>Date<br>0511018871/17/05/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import item in meeting No. NC/3/MEET/Apr/202425/2 dated 30/04/2024	against advance
authorization No.0511019270 dated 09/06/2023, 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. allowed.
Kombinil-DUO<br>Eye/Ear<br>925926<br>1<br>Dexamethasone Micronised PH	4.72 kg
Drops 5ml Vial<br>Vials<br>EUR USP JP
RA concerned may take further necessary action as per above decision of NC.

Case No.	22 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

g Number and Date|NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

HQ File Number	HQ File Number	HQRNORM APPLY 00000920AM24	HQRNORM APPLY 00000920AM24	HQRNORM APPLY 00000920AM24	HQRNORM APPLY 00000920AM24	HQRNORM APPLY 00000920AM24	HQRNORM APPLY 00000920AM24
RA File Number		08AX04000086 AM24
Licence No and<br>Date		0811008233/18/05/2023
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<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-


	Export	roduct	Qty.	Sl. No.	Import Items		Qty. allowed.

	PREGABAL	IN CAPSULES	<br>1 Number	1	PREGABALIN		25.50 mg
	25<br>MG<br>(	EACH<br>HARD
	<br>GELATIN	<br>CAPSULES			EP / BP / IP / USP / PH. EUR.
	CONTAINS:<br>25 MG)	PREGABALIN

					HARD GELATIN CAPSULE		Relevant, As per<br>packing policy<br>and General<br>Notes.
	PREGABALIN CAPSULES<br> <br> <br> <br>		<br> <br>1 Number	2	PREGABALIN		51.00 mg
	50<br>MG<br>(EACH<br>HARD<br>GELATIN<br>CAPSULES<br>CONTAINS: PREGABALIN		<br> <br>		E	P / BP / IP / USP / PH.

REGABALIN CAPSULES || 1 Number|||2|PREGABALIN|||51.00 mg| |||50 MG (EACH HARD GELATIN CAPSULES CONTAINS: PREGABALIN|| ||||E|P / BP / IP / USP / PH. EUR||| |||50 MG)|||||||||| ||||||||||HARD GELATIN CAPSULE||Relevant As per| ||||||||||||, packing policy and General Notes.| |||PREGABALIN CAPSULES 75 MG (EACH HARD GELATIN CAPSULES || 1 Number|||3|PREGABALIN EP / BP / IP / USP / PH. EUR.|||76.5 mg| |||CONTAINS: 5 MG|PREGABALIN||||||||| |||7 )|||||||||| ||||||||||||| |||||||||HARD GELATIN|||Relevant, As per| |||||||||||| packing policy and General| |||||||||||| Notes.| ||||||||||||| |||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

	PREGABALIN CAPSULES<br>100 MG (EACH HARD<br>GELATIN<br>CAPSULES<br>CONTAINS: PREGABALIN<br>100 MG)	<br> <br> <br> <br>1 Number	4	PREGABALIN<br>EP / BP / IP / USP / PH. EUR .	102.00 mg
				HARD GELATIN CAPSULE	Relevant, As per<br>packing policy<br>and General<br>Notes.
	PREGABALIN CAPSULES<br>150 MG (EACH HARD<br>GELATIN<br>CAPSULES<br>CONTAINS: PREGABALIN<br>150 MG)	<br> <br> <br> <br>1 Number	5	PREGABALIN<br>EP / BP / IP / USP / PH.

icy and General Notes.| ||PREGABALIN CAPSULES 150 MG (EACH HARD GELATIN CAPSULES CONTAINS: PREGABALIN 150 MG)| 1 Number|5|PREGABALIN EP / BP / IP / USP / PH. EUR.|153.00 mg| |||||HARD GELATIN CAPSULE|Relevant, As per packing policy and General Notes.| ||PREGABALIN CAPSULES 200 MG (EACH HARD GELATIN CAPSULES CONTAINS: PREGABALIN 200 MG)| 1 Number|6|PREGABALIN EP / BP / IP / USP / PH. EUR.|204.00 mg| |||||HARD GELATIN CAPSULE|Relevant, As per packing policy and General Notes.| ||PREGABALIN CAPSULES 225 MG (EACH HARD GELATIN CAPSULES CONTAINS: PREGABALIN 225 MG)| 1 Number|7|PREGABALIN EP / BP / IP / USP / PH. EUR.|229.50 mg| |||||HARD GELATIN CAPSULE|Relevant, As per packing policy and General Notes.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

r packing policy and General Notes.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

PREGABALIN<br>EP / BP / IP / USP / PH. EUR.<br>306.00 mg<br>PREGABALIN CAPSULES<br>300 MG (EACH HARD<br>GELATIN CAPSULES<br>CONTAINS: PREGABALIN<br>300 MG [IN WHICH<br>ACTIVE INGREDIENT<br>PREGABALIN USED IS<br>3450.000 KGS.])<br>1 Number<br>8<br>HARD GELATIN CAPSULE<br>Relevant, As per<br>packing policy<br>and General<br>Notes.<br>RA concerned may take further necessary action as per above decision of NC.	PREGABALIN CAPSULES<br>300 MG (EACH HARD<br>GELATIN CAPSULES<br>CONTAINS: PREGABALIN<br>300 MG [IN WHICH<br>ACTIVE INGREDIENT<br>PREGABALIN USED IS<br>3450.000 KGS.])	<br>1 Number	8	PREGABALIN<br>EP / BP / IP / USP / PH. EUR.	306.00 mg
				HARD GELATIN CAPSULE	Relevant, As per<br>packing policy<br>and General<br>Notes.

0.000 KGS.])| 1 Number|8|PREGABALIN EP / BP / IP / USP / PH. EUR.|306.00 mg| |---|---|---|---|---|---| |||||HARD GELATIN CAPSULE|Relevant, As per packing policy and General Notes.|

Case No.	Case No.	23 / NC/3/MEET/May/202526/3	23 / NC/3/MEET/May/202526/3	23 / NC/3/MEET/May/202526/3	23 / NC/3/MEET/May/202526/3	23 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		HINDYS LAB PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00001037AM24
RA File Number		09AX04001157 AM23
Licence No and<br>Date		0911005091/23/05/2023
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<br>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>Tertiarybutyl-[2-((4R,6S)-6-<br>(Acetyloxy) Methyl-2,2-<br>Dimethyl-1,3-Dioxane-4-yl]<br>Acetate(Heterocyclic<br>Compounds With Nitrogen<br>Hetero-atom(s)<br>1.136 kg<br>N-[5-(bromomethyl)-4-(4-<br>Diloxanide furoate, Cimetidine,<br>Oxyclozanide, Famotidine: Other<br>(Tert-Butyl-2-((4R,6S)-6-((E)-2-<br>(4-(4-Flurophenyl)-6- Isopropyl-2-<br>(N-Methyl methane sulfonamido)<br>Pyrimidin-5-Yl) vinyl)-2,2-<br>Dimethyl-1,3-Dioxane-4-Yl-)<br>Acetate)<br>1 kg<br>2<br>1.44 kg
	Export Product		Qty.	Sl. No.	Import Items	Qty.

sopropyl-2- (N-Methyl methane sulfonamido) Pyrimidin-5-Yl) vinyl)-2,2- Dimethyl-1,3-Dioxane-4-Yl-) Acetate) 1 kg 2 1.44 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Diloxanide furoate, Cimetidine, Oxyclozanide, Famotidine: Other (Tert-Butyl-2-((4R,6S)-6-((E)-2- (4-(4-Flurophenyl)-6- Isopropyl-2- (N-Methyl methane sulfonamido) Pyrimidin-5-Yl) vinyl)-2,2- Dimethyl-1,3-Dioxane-4-Yl-) Acetate)||1 kg|1|Tertiarybutyl-[2-((4R,6S)-6- (Acetyloxy) Methyl-2,2- Dimethyl-1,3-Dioxane-4-yl] Acetate(Heterocyclic Compounds With Nitrogen Hetero-atom(s)|1.136 kg| |||||2|N-[5-(bromomethyl)-4-(4-|1.44 kg|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

fluorophenyl)-6-isopropyl pyrimidin-2-yl]-N-methyl methane sulphonamide (Salts of formic acid: Other)

Case No.	24 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	AGRO SOLVENT PRODUCTS PVT LTD
Meeting Number	NC/ 3/ MEET/ Ma/ 202526/ 3 and 04/06/2025
and Date	y
HQ File Number	HQRNORM APPLY 00001107AM24
RA File Number	56AX04000449 AM23
Licence No and	5611001909/25/05/2023
Date
Norms Committee	Decision:
The case is unde	r consideration and TE was requested to expedite his comments.

mber|56AX04000449 AM23| |Licence No and|5611001909/25/05/2023| |Date|| |Norms Committee|Decision:| |The case is unde|r consideration and TE was requested to expedite his comments.| ||| |||

Case No.	Case No.	25 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		INTIGREAT CONSULTING SERVICES LLP
Meeting Number an	d Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00001324AM24
RA File Number		03AX04000737 AM24
Licence No and Da	te	0311024265/06/06/2023
Norms Committee	Decision:

The Committee<br>	considered the case as per agenda and taking cue from the earlier decision for same export<br>
product/import<br>authorization N<br>	item in meeting No. NC/3/MEET/Apr/202526/2 dated 08/05/2025 against advance<br>o.0311017790 dated 12/09/2022, it was decided to fix ad-hoc norms under Para 4.07 of<br>
HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

lied by the firm, whichever is less:-||| ||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Export Product	Qty.	Sl. No.	Import Items	Qty.
				allowed.
Tablets / Capsules(REMURES ULTRA	<br>1 Number	1	Diosmin/Hesparidine	510 mg.
( Diosmin 450 mg + Hesparidine 50 mg<br>) coated tablets Pack 2 x 15 tablets = 30			(90/10)
Tablets in one Pack, (NET CONTENT
=<br>225.00<br>KGS),TOTAL<br>GROSS
CONTENT (MFG OVERAGES 5% +
2% MFG LOSS) = 240.75 KGS)
Tablets / Capsules(REMURES ULTRA	<br>1 Number	2	Diosmin/Hesparidine	510 mg.
( Diosmin 450 mg + Hesparidine 50 mg<br>) coated tablets Pack 4 x 15 tablets = 60			(90/10)
Tablets in one Pack. (NET CONTENT
= 255.00 KGS) ,TOTAL GROSS
CONTENT (MFG OVERAGES 5% +
2% MFG LOSS) = 272.85 KGS)

Case No.	26 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	SHILPA PHARMA LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00001330AM24
RA File Number	07AX04000315 AM24
Licence No and<br>Date	0711007735/06/06/2023
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:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Gemcitabine HCL	1 kg	1	2 Deoxy 2 2 Difluoro D Erythro<br>Pentafuranous 1 Ulose 3 5 Dibenzoate	4.78 kg
		2	Tetra Hydro Furan	4.60 kg
		3	Methylene Dichloride	6.20 kg
		4	N Acetyl Cytosine	2.92 kg
		5	Trimethyl Silyl Trifluoromethane<br>Sulfonate	4.23 kg
		6	Methanol	6.20 kg

4.78 kg| ||||2|Tetra Hydro Furan|4.60 kg| ||||3|Methylene Dichloride|6.20 kg| ||||4|N Acetyl Cytosine|2.92 kg| ||||5|Trimethyl Silyl Trifluoromethane Sulfonate|4.23 kg| ||||6|Methanol|6.20 kg|

Case No.	27 / NC/3/MEET/May/202526/3
Case Status	Case Rejected
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM REVIW00003342AM25
RA File Number	05AX04001798 AM24
Licence No and<br>Date	0511021104/22/09/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Hence, it was decided to<br>rejectthe case maintaining thestatus quo.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Case No.	28 / NC/3/MEET/May/202526/3
Case Status	Case Rejected
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM REVIW00003344AM25
RA File Number	05AX04002118 AM24
Licence No and<br>Date	0511021548/16/10/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Hence, it was decided to<br>rejectthe case maintaining thestatus quo.

ms and it was observed that the firm has not provided any technical justification / information for enhancement. Hence, it was decided to rejectthe case maintaining thestatus quo.||

Case No.	29 / NC/3/MEET/May/202526/3
Case Status	Case Rejected
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM REVIW00003345AM25
RA File Number	05AX04003290 AM24
Licence No and<br>Date	0511023265/15/01/2024
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Hence, it was decided to<br>rejectthe case maintaining thestatus quo.

Case No.	30 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	PRASOL CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00008287AM24
RA File Number	03AX04004987 AM24

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Licence No and 0311030614/01/02/2024 Date

Norms Committee Decision:

The committee considered the request of the firm for fixation of ad-hoc norms, and as per the advice of the TE, it was decided to call for following information/documents from the firm:-

Percentage Yield of reaction not given.
Quantity and value of by-product MPD

s, and as per the advice of the TE, it was decided to call for following information/documents from the firm:-

Percentage Yield of reaction not given.
Quantity and value of by-product MPD

Case No.	31 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	YELLOWSTONE FINE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00008613AM24
RA File Number	03AX04005249 AM24
Licence No and<br>Date	0311031269/16/02/2024
Norms Committee Decision:<br>The committee considered the request of the firm for fixation of ad-hoc norms, and as per the advice of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Justification of 55% Yield.<br>1.

Case No.	32 / NC/3/MEET/May/202526/3
Case Status	Case Rejected
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM REVIW00003346AM25
RA File Number	05AX04003839 AM24
Licence No and<br>Date	0511024393/07/03/2024
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Hence, it was decided to<br>rejectthe case maintaining thestatus quo.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

ctthe case maintaining thestatus quo.**||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Case No.	33 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00009209AM24
RA File Number	03AX04005812 AM24
Licence No and<br>Date	0311032330/19/03/2024
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<br>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>Ferrous<br>Fumarate<br>USP/BP/FCC/IP<br>1 kg<br>1<br>Fumaric Acid 99 %<br>0.725 kg<br>Note: NC also decided to make a new SION on the above export product.<br>RA concerned may take further necessary action as per above decision of NC.

1 Fumaric Acid 99 % 0.725 kg Note: NC also decided to make a new SION on the above export product. RA concerned may take further necessary action as per above decision of NC.||

Case No.	34 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00009219AM24
RA File Number	03AX04005814 AM24
Licence No and<br>Date	0311032351/20/03/2024
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<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Export	Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Ferrous	Fumarate	<br>1 kg	1	Maleic Anhydride	0.65 kg
USP/BP/FCC/IP

Note: NC also decided to make a new SION on the above export product.

Case No.	Case No.	35 / NC/3/MEET/May/202526/3	35 / NC/3/MEET/May/202526/3	35 / NC/3/MEET/May/202526/3	35 / NC/3/MEET/May/202526/3	35 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		USV PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00009247AM24
RA File Number		03AX04005861 AM24
Licence No and<br>Date		0311032405/21/03/2024
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 item in meeting No. NC/3/MEET/May/202425/4 dated 06.06.2024 against advance<br>authorization No.0311016913 dated 05.08.2022, it was decided to fix ad-hoc norms under Para 4.07 of<br>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. Doxycycline Hyclate DR Tablets USP 200 mg 60 S((2,333 Bottles X 60 Per Bottles = 1,39,980 Tablets) (Total Weight of Export Product = 27.996 Kgs) (Net Content weight of Import Product = 38.290 kgs)) 1 Number 1 Doxycycline Hyclate 230.80 mg. Doxycycline Hyclate DR Tablets USP 100 mg , 100 S US ((9,900 Bottles X 100 Per Bottles = 9,90,000 Tablets) (Total Weight of Export Product = 99.000 Kgs) (Net Content weight of Import Product = 1 Number 2 Doxycycline Hyclate 115.40 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Doxycycline Hyclate DR Tablets USP 200 mg 60 S((2,333 Bottles X 60 Per Bottles = 1,39,980 Tablets) (Total Weight of Export Product = 27.996 Kgs) (Net Content weight of Import Product = 38.290 kgs))||1 Number|1|Doxycycline Hyclate|230.80 mg.| ||Doxycycline Hyclate DR Tablets USP 100 mg , 100 S US ((9,900 Bottles X 100 Per Bottles = 9,90,000 Tablets) (Total Weight of Export Product = 99.000 Kgs) (Net Content weight of Import Product =|| 1 Number|2|Doxycycline Hyclate|115.40 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

135.402 kgs))

ycycline Hyclate|115.40 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

135.402 kgs))


	135.402 kgs)	)


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

Case No.		36 / NC/3/MEET/May/202526/3
Cas	e Status	Case Approved
Part	y Name	GALAXY SURFACTANTS LTD
Me<br>and	tin Nmbr
	g ue<br>Date	NC/ 3/ MEET/ May/ 2		02526/ 3 an		d 04/06/2		025
HQ	File Number	HQRNORM APPLY 0		0009329A		M24
RA	File Number	03AX04005978 AM24
Lic<br>Dat	ence No and<br>e	0311032511/26/03/202		4
Nor<br>Th<br>pr<br>au<br>H<br>RA	ms Committee Decision:<br>e Committee considered the case a<br>oduct/import item in meeting N<br>thorization No.0311032511 dated<br>BP Vol. I as per details given below			s per age<br>o.NC/3/M<br>26.03.20<br>or as app
						nda and t<br>EET/Au<br>24 it		aking cue from the earlier decision fo<br>g/202425/8 dated 28.08.2024 ag<br>s decided to fix ad-hoc norms unde		r same export<br>ainst advance<br>Para 407 of
						, w<br>lied by t		<br>he firm, whichever is less:-		.

	Export Product		Qty.		Sl.		I	rt Itm	Qt lld
						o.		po es	**y.

ara 407 of| |||||||, w lied by t||| he firm, whichever is less:-||||.| ||||||||||||||| ||Export Product||Qty.||Sl.||I||rt Itm||Qt lld||| |||||||o.|||po es||y. aowe.||| ||Phenoxyethanol||1 kg||1||P||l||069||k| ||||||||||eno||.||g.| ||||||||E||hlene Oxide||032||k| ||||||||y||||. g.||| ||concerned may take further necessary actio|||||n as per above decision of NC.|||||||| |||||||||||||||

Case No.	37 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number
and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00009338AM24

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

RA File Number

08AX04002294 AM24

Licence No and Date

0811011115/27/03/2024

Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Apr/202526/1 dated 25/04/2025 against advance authorization No**.**0811011004 dated 13/03/2024, 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.

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. Magnesium Sulfate In Water for Injection (0.325 m Eq Mg++/mL) 40 mg/mL 2g Total 1 Number 1 Magnesium Sulfate Heptahydrate Ph Eur 2.00 gm. Magnesium Sulfate In Water for Injection (0.325 m Eq Mg++/mL) 40 mg/mL 4g Total 1 Number 2 Magnesium Sulfate Heptahydrate Ph Eur 4.00 gm. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	38 / NC/3/MEET/May/202526/3	38 / NC/3/MEET/May/202526/3	38 / NC/3/MEET/May/202526/3	38 / NC/3/MEET/May/202526/3	38 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		GALAXY SURFACTANTS LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00009360AM24
RA File Number		03AX04006006 AM24
Licence No and<br>Date		0311032575/27/03/2024
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<br>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.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Sodium	<br>Lauroyl	Methyl	1	Lauric Acid	0.614 kg
Taurate	(Galsoft SLT	(N) /
Galsoft	SLT (N) MB)		2	N-Methyl Taurine	0.728 kg
				Sodium Salt 62%.

Case No.	39 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	VENUS REMEDIES LIMITED
Meeting Number and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00000028AM25
RA File Number	30AX04000590 AM24
Licence No and Date	3011005003/02/04/2024
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<br>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>Sugammadex<br>solution<br>for<br>Injection 100 mg / ml (200 mg /<br>2 ml) (Each vial of 2ml<br>contains: Sugammadex Sodium<br>equivalent to sugammadex .......<br>.....

Items** Qty. allowed. Sugammadex solution for Injection 100 mg / ml (200 mg / 2 ml) (Each vial of 2ml contains: Sugammadex Sodium equivalent to sugammadex ....... ..... 200 mg Hydrochloric acid 3.7% (to adjust pH) and /or Sodium hydroxide (to adjust pH) Water for Injections..................................... q.s Containing 4.000 Kg of Sugammadex Sodium) 1 Number 1 Sugammadex Sodium 239.326 mg RA concerned may take further necessary action as per above decision of NC||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Case No.	40 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00000065AM25
RA File Number	09AX04001116 AM24
Licence No and Date	0911007027/03/04/2024
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<br>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. 1 2-Fluoro-6-methoxy pyridine (FMP) 1.975 kg Atinvicitinib (or) 1-[(3R,4S)-4- Cyanotetrahydropyran-3-yl]-3-[(2- fluoro-6-methoxy-4-pyridyl) amino]pyrazole-4-Carboxamid ((L-005251026-Form-I)) 1 kg 2 4,5-bis (Diphenylphosphino)- 9,9-dimethylxanthane (Xantphos) 0.125 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	41 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	PLASTIBLENDS INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00000067AM25
RA File Number	03AX04006127 AM24
Licence No and<br>Date	0311032797/03/04/2024
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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

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

Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

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.
Addtive Masterbatch<br>(ITC(HS) Code 29420090)<br>NET CONTENT:1)<br>Relevant polymer such as<br>Hydrocarbon Resin:<br>86625.00KGS(2) Additive<br>namely Antioxidant:<br>173.250KGS 3) Relevant<br>polymers such as<br>BOPP:86451.750 KGS)	173250 kg.	1	Relevant polymer such as<br>Hydrocarbon Resin	89223.75 kg.
		2	Additive namely<br>Antioxidant	178.448 kg.
		3	Hompopolymer of PP	89045 kg.

Case No.	Case No.	42 / NC/3/MEET/May/202526/3	42 / NC/3/MEET/May/202526/3	42 / NC/3/MEET/May/202526/3	42 / NC/3/MEET/May/202526/3	42 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		LIVMORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00000105AM25
RA File Number		34AX04000777 AM24
Licence No and Date		3411004764/05/04/2024
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<br>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.

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. SABAM HCL (S-(+)-2- AMINOBUTYRAMIDE HYDROCHLORIDE (SABAM HCL) CAS Bulk Drug (Levetiracetam IH/USP/BP/EP (Net Content Of Input In Export Product Is 2000 Kgs.)) 1 kg 1 0.95 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Bulk Drug (Levetiracetam IH/USP/BP/EP (Net Content Of Input In Export Product Is 2000 Kgs.))||1 kg|1|SABAM HCL (S-(+)-2- AMINOBUTYRAMIDE HYDROCHLORIDE (SABAM HCL) CAS|0.95 kg|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

NO.7682-20-4)

Case No.	43 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	LIVMORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00000106AM25
RA File Number	34AX04000776 AM24
Licence No and Date	3411004765/05/04/2024
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<br>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.

se 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. Rosuvastatine Calcium IH/USP/BP/EP (Rosuvastatin Calcium Monohydrate IH/USP/BP/EP (Net Content of Input In Export Product is 1000 Kgs)) 1 kg 1 Bulk Drug Intermediates (Tert- Butyl 6-[(1e)-2-[4-(4- Fluoromethl1)-6(1-Methyl (Methyl (Methylsulphony1) Amino)-5-Pyrimidiny1) Etheny1) 2-2-Dimethy1- 1,3dioxanecasno.289042-12-2) 1.30 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	44 / NC/3/MEET/May/202526/3
Case Status	Case Approved

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Party Name	UMEDICA LABORATORIES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00000145AM25
RA File Number	03AX04000009 AM25
Licence No and Date	0311032889/08/04/2024
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<br>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>Rosuvastatin Tablet BP/ USP<br>10 MG. ((Each Tablet contains<br>Rosuvastatin Calcium 10.400<br>mg) Eq.

rm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Rosuvastatin Tablet BP/ USP 10 MG. ((Each Tablet contains Rosuvastatin Calcium 10.400 mg) Eq. to Rosuvastatin 10 mg. (Net wt of import material is 490.474 kg.)) 1 Number 1 Tert-butyl 2-((4R,6S)-6-((E)-2- (4-(4-fluorophenyl)-6-isopropyl- 2-(N-methylmethylsulfonamido) pyrimidin-5-yl)vinyl)-2,2- dimethyl-1,3-dioxan-4-yl) acetate 10.608 mg/Tablet RA concerned may take further necessary action as per above decision of NC.||

Case No.	45 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	VINCIT LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00000334AM25
RA File Number	05AX04004078 AM24
Licence No and<br>Date	0511025080/19/04/2024
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 item in meeting No. NC/3/MEET/Apr/202526/1 dated 25/04/2025 against advance<br>authorization No.0311031186 dated 14/02/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

as applied by the firm, whichever is less:-||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Levofloxacin Q Acid Or Levofloxacin<br>Carboxylic Acid)<br>0.856 kg.<br>Levofloxacin<br>Hemihydrate<br>1 kg<br>2<br>N Methyl Piperazine<br>0.432 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	Levofloxacin<br>Hemihydrate	1 kg	1	Levofloxacin Q Acid Or Levofloxacin<br>Carboxylic Acid)	0.856 kg.
			2	N Methyl Piperazine	0.432 kg.

Case No.	Case No.	46 / NC/3/MEET/May/202526/3	46 / NC/3/MEET/May/202526/3	46 / NC/3/MEET/May/202526/3	46 / NC/3/MEET/May/202526/3	46 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00000476AM25
RA File Number		08AX04000132 AM25
Licence No and<br>Date		0811011403/29/04/2024
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 item in meeting No. NC/3/MEET/Dec/202425/12 dated 10/12/2024 against advance<br>authorization No.0811011676 dated 28/05/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol.

ort item in meeting No. NC/3/MEET/Dec/202425/12 dated 10/12/2024 against advance authorization No**.**0811011676 dated 28/05/2024, 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 (R)-3-[(tert-butoxycarbonyl) amino-4- (2,4,5-trifluorophenyl)] butanoic acid 0.953 kg. 2 3-(trifluoromethyl)-5,6,7,8-tetrahydro [1,2,4] triazolo [4,3-a] pyrazine hydrochloride 0.686 kg. Sitagliptin Free Base 1 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Sitagliptin Free Base||1 kg|1|(R)-3-[(tert-butoxycarbonyl) amino-4- (2,4,5-trifluorophenyl)] butanoic acid|0.953 kg.| |||||2|3-(trifluoromethyl)-5,6,7,8-tetrahydro [1,2,4] triazolo [4,3-a] pyrazine hydrochloride|0.686 kg.|

Case No.	Case No.	46 / NC/3/MEET/May/202526/3	46 / NC/3/MEET/May/202526/3	46 / NC/3/MEET/May/202526/3	46 / NC/3/MEET/May/202526/3	46 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00000476AM25
RA File Number		08AX04000132 AM25
Licence No and<br>Date		0811011403/29/04/2024
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 item in meeting No.

0811011403/29/04/2024||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Dec/202425/12 dated 10/12/2024 against advance authorization No**.**0811011676 dated 28/05/2024, 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 (R)-3-[(tert-butoxycarbonyl) amino-4- (2,4,5-trifluorophenyl)] butanoic acid 0.953 kg. 2 3-(trifluoromethyl)-5,6,7,8-tetrahydro [1,2,4] triazolo [4,3-a] pyrazine hydrochloride 0.686 kg. Sitagliptin Free Base 1 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Sitagliptin Free Base||1 kg|1|(R)-3-[(tert-butoxycarbonyl) amino-4- (2,4,5-trifluorophenyl)] butanoic acid|0.953 kg.| |||||2|3-(trifluoromethyl)-5,6,7,8-tetrahydro [1,2,4] triazolo [4,3-a] pyrazine hydrochloride|0.686 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

[4,3-a] pyrazine hydrochloride|0.686 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

3<br>O-(Benzotriazol-1-yl)-N,N,N',N'-<br>tetramethyluronium<br>0.936 kg.<br>4<br>Isopropyl Alcohol (Solvent))<br>6.80 kg.<br>5<br>Methanol<br>5.25 kg.<br>RA concerned may take further necessary action as per above decision of NC.			3	O-(Benzotriazol-1-yl)-N,N,N',N'-<br>tetramethyluronium	0.936 kg.
			4	Isopropyl Alcohol (Solvent))	6.80 kg.
			5	Methanol	5.25 kg.

Case No.	47 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00000737AM25
RA File Number	34AX04000120 AM25
Licence No and<br>Date	3411004931/15/05/2024
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 item in meeting No. NC/3/MEET/Apr/202526/1 dated 25/04/2025 against advance<br>authorization No.3411005383 dated 09/09/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>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>Aldehyde<br>C10 (Capric<br>Aldehyde)<br>1 kg.<br>1<br>Fatty Alcohol C10 (98% Purity)<br>1.40 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Qty. allowed. Aldehyde C10 (Capric Aldehyde) 1 kg. 1 Fatty Alcohol C10 (98% Purity) 1.40 kg. RA concerned may take further necessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Case No.	48 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	APTRA SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00000952AM25
RA File Number	26AX04000006 AM25
Licence No and<br>Date	2611001464/28/05/2024
Norms Committee Decision:<br>The firm was called for Personal Hearing on 05.06.2025 through Video Conference, but the firm could not<br>appear before Norms Committee. It was decided to grant one more opportunity to the firm forPersonal<br>Hearing<br> with relevant documents/information

Case No.	49 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	AARTI PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00001028AM25
RA File Number	03AX04000079 AM25
Licence No and<br>Date	0311034279/31/05/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

|RA File Number|03AX04000079 AM25| |Licence No and Date|0311034279/31/05/2024| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	50 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	CLARIANT INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00001120AM25
RA File Number	03AX04001111 AM25
Licence No and	0311034385/05/06/2024

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Date

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.
Piroctone Olamine Or Vipirox<br>(Octopirox Plus)	<br>1 kg	1	Dimethyl Acrylic Acid Ester	0.770 kg
		2	Hydroxyl ammonium sulfate	1.628 kg
		3	Isononyl Acid Chloride	1.515 kg
		4	Mono Ethanol Amine	0.372 kg

ne Or Vipirox (Octopirox Plus)| 1 kg|1|Dimethyl Acrylic Acid Ester|0.770 kg| |||2|Hydroxyl ammonium sulfate|1.628 kg| |||3|Isononyl Acid Chloride|1.515 kg| |||4|Mono Ethanol Amine|0.372 kg|

Case No.	Case No.	51 / NC/3/MEET/May/202526/3	51 / NC/3/MEET/May/202526/3	51 / NC/3/MEET/May/202526/3	51 / NC/3/MEET/May/202526/3	51 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		MOREPEN LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00001122AM25
RA File Number		05AX04000723 AM25
Licence No and<br>Date		0511025891/05/06/2024
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<br>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.<br>allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty.<br>allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

1	5-Bromo-2-Chloro-4'-<br>ethoxydiphenylmethane (DP01)	1.233 kg
2	2,3,4,6-Tetra-O-trimethylsilyl-B-D-<br>glucolactone (DPS01) or 2,3,4,6-<br>Tetrakis-O-trimethylsilyl-D-<br>gluconolactone (DPS01)	2.120 kg
3	(S)-(+) -1,2-Propanediol	0.200 kg
4	Acetonitrile	3.16 kg
5	Tetrahydrofuran	3.80 kg
6	N,N Diisopropyl ethyl amine	3.667 kg

imethylsilyl-D- gluconolactone (DPS01)|2.120 kg| ||||3|(S)-(+) -1,2-Propanediol|0.200 kg| ||||4|Acetonitrile|3.16 kg| ||||5|Tetrahydrofuran|3.80 kg| ||||6|N,N Diisopropyl ethyl amine|3.667 kg|

Case No.	Case No.	52 / NC/3/MEET/May/202526/3	52 / NC/3/MEET/May/202526/3	52 / NC/3/MEET/May/202526/3	52 / NC/3/MEET/May/202526/3	52 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		MOREPEN LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00001123AM25
RA File Number		05AX04000722 AM25
Licence No and<br>Date		0511025892/05/06/2024
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<br>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.<br>allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty.<br>allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

1	5-Bromo-2-Chloro-4'-<br>ethoxydiphenylmethane (DP01)	1.233 kg
2	2,3,4,6-Tetra-O-trimethylsilyl-B-D-<br>glucolactone (DPS01) or 2,3,4,6-<br>Tetrakis-O-trimethylsilyl-D-<br>gluconolactone (DPS01)	2.120 kg
3	(S)-(+) -1,2-Propanediol	0.200 kg
4	Acetonitrile	3.16 kg
5	Tetrahydrofuran	3.80 kg
6	N,N Diisopropyl ethyl amine	3.667 kg

imethylsilyl-D- gluconolactone (DPS01)|2.120 kg| ||||3|(S)-(+) -1,2-Propanediol|0.200 kg| ||||4|Acetonitrile|3.16 kg| ||||5|Tetrahydrofuran|3.80 kg| ||||6|N,N Diisopropyl ethyl amine|3.667 kg|

Case No.	53 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00001242AM25
RA File Number	05AX04000783 AM25
Licence No and<br>Date	0511026035/11/06/2024
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 item in meeting No. NC/3/MEET/Mar/202324/26 dated 22/03/2024 against advance<br>authorization No.0511023848 dated 08/02/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

as applied by the firm, whichever is less:-||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Tri Ethyl Citrate (Tec)<br>(Packed In 2,000 Nos. of Hm-<br>HDPE Drums Made of Hdpe<br>Granules (17,000.000 Kgs.<br>Without Wastage)) (Each<br>Drum Shall Weight 8.5 Kg<br>and Storage Capacity<br>250.000 Kgs.))	1 kg	1	Citric Acid	0.726 kg.
		2	Denatured Ethyl Alcohol	0.526 kg.
		3	HDPE Granules<br>(Total Weight = 17,850.000<br>Kgs.)	Relevant, as per<br>packing policy<br>and General<br>Notes.

s.))|1 kg|1|Citric Acid|0.726 kg.| ||||2|Denatured Ethyl Alcohol|0.526 kg.| ||||3|HDPE Granules (Total Weight = 17,850.000 Kgs.)|Relevant, as per packing policy and General Notes.|

Case No.	Case No.	54 / NC/3/MEET/May/202526/3	54 / NC/3/MEET/May/202526/3	54 / NC/3/MEET/May/202526/3	54 / NC/3/MEET/May/202526/3	54 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		ALCHEMIE FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00001248AM25
RA File Number		03AX04001154 AM25
Licence No and<br>Date		0311034547/12/06/2024
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<br>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>Aniline<br>0.533 kg<br>2<br>Benzyl Chloride<br>0.621 kg<br>3<br>Caustic Soda Lye<br>0.196 kg<br>N Ethyl N Benzyl Aniline Sulphonic<br>Acid (N,Ethyl-N-(3 Sulfobenzyl<br>Aniline<br>1 kg
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	N Ethyl N Benzyl Aniline Sulphonic<br>Acid (N,Ethyl-N-(3 Sulfobenzyl<br>Aniline		1 kg	1	Aniline	0.533 kg
				2	Benzyl Chloride	0.621 kg
				3	Caustic Soda Lye	0.196 kg

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

e|0.621 kg| |||||3|Caustic Soda Lye|0.196 kg|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

4<br>Ethyl Alcohol and other<br>Spirits Denatured of any<br>Strength Denatured Ethyl<br>Alcohol<br>0.260 kg<br>RA concerned may take further necessary action as per above decision of NC.			4	Ethyl Alcohol and other<br>Spirits Denatured of any<br>Strength Denatured Ethyl<br>Alcohol	0.260 kg

Case No.	55 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00001292AM25
RA File Number	03AX04001135 AM25
Licence No and<br>Date	0311034573/13/06/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal<br>Hearing<br> before Norms Committee to explain its case along with sample of exort product/import item from<br>the firm.

enda and it was decided to call the firm for attendingPersonal Hearing before Norms Committee to explain its case along with sample of exort product/import item from the firm.|||

Case No.	56 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00001293AM25
RA File Number	03AX04001186 AM25
Licence No and<br>Date	0311034574/13/06/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal<br>Hearing<br> before Norms Committee to explain its case along with sample of exort product/import item from<br>the firm.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Case No.	57 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	LINCOLN PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00001296AM25
RA File Number	08AX04000313 AM25
Licence No and<br>Date	0811011811/13/06/2024
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 item in meeting No.

ate|0811011811/13/06/2024| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Nov/202425/10 dated 22/11/2024 against advance authorization No**.**0811007126 dated 31/01/2023, 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. Alendronate Sodium Tablets Usp 70 Mg (Packing1x4 = 4 Nos In Each Pack.) ((Total Sodium Alendronate Trihydrate Used I.E. 400000 X 91.37 / 1000000= 36.55 Kg Net)) 1 Number Tablet 1 Sodium Alendronate Trihydrate ((This License Issued In Terms Of P.C No:9(Re-2003)2002- 2007dt: 30.6.03.License will comply with all conditions of the said circular read with conditions mentioned in P.C.No:15(RE- 2003)2002-2007dt:17.9.03)) 93.197 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	58 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	LEBEN LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00001309AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

| |HQ File Number|HQRNORM APPLY 00001309AM25|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

RA File Number	RA File Number	03AX04001212 AM25
Licence No and<br>Date		0311034498/13/06/2024
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 item in meeting No. NC/3/MEET/Mar/202425/19 dated 27/03/2025 against advance<br>authorization No.0311036028 dated 05/08/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>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>Alclox-250 Capsule . Cloxacillin<br>Sodium Capsules USP 250mg.<br>((Each Capsule Containing<br>Cloxacillin Sodium BP Equivalent<br>To 250mg of Cloxacillin)<br>1069377<br>Numbers<br>1<br>Cloxacillin Sodium<br>BP Compacted<br>297.22 kg.
	oduct/import item in m<br>thorization No.03110360<br>BP Vol.

quivalent To 250mg of Cloxacillin) 1069377 Numbers 1 Cloxacillin Sodium BP Compacted 297.22 kg.|||||||||||||||| ||oduct/import item in m thorization No**.**03110360 BP Vol. I as per details gi||eting No. 28 dated 0 ven below||NC/3/MEE 5/08/2024, i or as applied||||T/Mar/202425/19 dated 27/03/2 t was decided to fix ad-hoc norm by the firm, whichever is less:-|||||25 against advance s under Para 4.07 of|| ||||||||||||||||| ||Export Product|||||Qty.||||Sl. No.|Import Items||||Qty. allowed.| ||Alclox-250 Capsule . Cl Sodium Capsules USP 2||oxacillin 50mg.|||106937 Number|||7 s|1|Cloxacillin Sodium BP Compacted||||297.22 kg.| ||((Each Capsule Containing Cloxacillin Sodium BP Equivalent To 250mg of Cloxacillin)||||||||||||||| ||||||||||||||||| ||Alclox-500 Capsule . Cloxacillin Sodium Capsules USP 500 mg. ((Each Capsule Containing|||||3256772 Numbers||||2|Cloxacillin Sodium BP Compacted||||1810.43 kg.| ||Cloxacillinsodium BP E||quivalent To||||||||||||| ||500 mg of cloxacillin).||||||||||||||| ||||||||||||||||| ||||||||||||||||| ||Ampicillin and Cloxacill||in Capsules|||3000000||||3|Cloxacillin Sodium||||83385 kg| || (250 mg +250 mg) (Each|| capsule||| Numbers||||| BP Compacted||||. .| || contains Ampicillin Trih|| ydrate||||||||||||| || equivalent to 250mg (La|| mpyklox||||||||||||| |RA| Capsule. Cloxacillin Cap (250 mg+250 mg) (Each Cap Containing Cloxacillin sodium Equi to 250 Mg of Cloxacillin )||||||||||||||| ||Alclox -125 Syrup.

0mg (La|| mpyklox||||||||||||| |RA| Capsule. Cloxacillin Cap (250 mg+250 mg) (Each Cap Containing Cloxacillin sodium Equi to 250 Mg of Cloxacillin )||||||||||||||| ||Alclox -125 Syrup. Cloxacillin||||||21000|||4|Cloxacillin Sodium BP Compacted||||58.48 kg.| ||Socium for Oral Solution USP ((Each 5 Ml Contains Cloxacil sodium BP Equivalent To 125 Of Cloxacillin||| lin Mg|||Nu|mbers|||BP Co|mpacted|||| ||||||||||||||||| ||concerned may take further ne|||cessary a|||||||||||| ||||||||ctio|n as per above decision of||||NC.||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Case No.	59 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	CHEMPLAST SANMAR LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00001314AM25
RA File Number	04AX04000189 AM25
Licence No and<br>Date	0411007575/13/06/2024
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 item in meeting No. NC/3/MEET/Mar/202425/18 dated 17/03/2025 against advance<br>authorization No.0411007898 dated 26/07/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>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.

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 D-Serine ((R)-2-amino-3- hydroxypropanoic acid 1.073 kg. (4R)-2-oxooxazolidine-4- carboxylic acid (COX)((4R)-2- oxooxazolidine-4-carboxylic acid (COX)) 1 kg 2 Potassium methoxide 32% in methanol 2.240 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	60 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00001396AM25
RA File Number	09AX04000130 AM25
Licence No and<br>Date	0911007445/18/06/2024
Norms Committee Decision:

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

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.
Sotagliflozin	1 kg	1	4-chloro-ethoxybenzyl hydroxy methanone	1.70 kg

as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Sotagliflozin	1 kg	1	4-chloro-ethoxybenzyl hydroxy methanone	1.70 kg

Case No.	61 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	STERIL-GENE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00001488AM25
RA File Number	04AX04001003 AM24
Licence No and<br>Date	0411007616/21/06/2024
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 item in meeting No. NC/3/MEET/Dec/202425/13 dated 07/01/2025 against advance<br>authorization No.0311039223 dated 02/12/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>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>Tamoxifen 20 Mg Tablets<br>1 Number<br>1<br>Tamoxifen Citrate<br>30.4 mg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	62 / NC/3/MEET/May/202526/3
Case Status	Case Rejected

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

2526/3| |---|---| |Case Status|Case Rejected|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00001489AM25
RA File Number	03AX04001452 AM25
Licence No and<br>Date	0311034818/21/06/2024
Norms Committee Decision:<br>The firm was called for Personal Hearing on 05/06/2025 through Video Conference, but the firm could not<br>appear before Norms Committee. Hence, it was decided torejectthe application of the firm.

Case No.	63 / NC/3/MEET/May/202526/3
Case Status	Case Rejected
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00001490AM25
RA File Number	03AX04001450 AM25
Licence No and<br>Date	0311034819/21/06/2024
Norms Committee Decision:<br>The firm was called for Personal Hearing on 05/06/2025 through Video Conference, but the firm could not<br>appear before Norms Committee. Hence, it was decided torejectthe application of the firm.

rm was called for Personal Hearing on 05/06/2025 through Video Conference, but the firm could not appear before Norms Committee. Hence, it was decided torejectthe application of the firm.||

Case No.	64 / NC/3/MEET/May/202526/3
Case Status	Case Rejected
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00001491AM25
RA File Number	03AX04001449 AM25
Licence No and<br>Date	0311034820/21/06/2024
Norms Committee Decision:<br>The firm was called for Personal Hearing on 05/06/2025 through Video Conference, but the firm could not<br>appear before Norms Committee. Hence, it was decided torejectthe application of the firm.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Case No.	65 / NC/3/MEET/May/202526/3
Case Status	Case Rejected
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00001493AM25
RA File Number	03AX04001447 AM25
Licence No and<br>Date	0311034821/21/06/2024
Norms Committee Decision:<br>The firm was called for Personal Hearing on 05/06/2025 through Video Conference, but the firm could not<br>appear before Norms Committee. Hence, it was decided torejectthe application of the firm.

rm was called for Personal Hearing on 05/06/2025 through Video Conference, but the firm could not appear before Norms Committee. Hence, it was decided torejectthe application of the firm.||

Case No.	66 / NC/3/MEET/May/202526/3
Case Status	Case Rejected
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00001494AM25
RA File Number	03AX04001441 AM25
Licence No and<br>Date	0311034822/21/06/2024
Norms Committee Decision:<br>The firm was called for Personal Hearing on 05/06/2025 through Video Conference, but the firm could not<br>appear before Norms Committee. Hence, it was decided torejectthe application of the firm.

Case No.	67 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00001507AM25
RA File Number	09AX04000202 AM25
Licence No and	0911007468/24/06/2024

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Date

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:-

ion:

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.
Fesoterodine Fumarate Extended –		1 Number	1	Fesoterodine Fumarate	4.08 mg
release Tablets 4 mg (Consists of
Fesoterodine Fumarate 16.31 Kgs)
Fesoterodine<br>Fumarate<br>Extended	-	<br>1 Number	2	Fesoterodine Fumarate	8.16 mg
release Tablets 8 mg (Consists	of
Fesoterodine Fumarate 43.49 Kgs)

Case No.	68 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	PANACEA BIOTEC PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00001565AM25
RA File Number	05AX04000957 AM25
Licence No and<br>Date	0511026325/26/06/2024
Norms Committee Decision:
The case is under consideration and TE was requested to expedite his comments.

Case No.	69 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	LEBEN LABORATORIES PRIVATE LIMITED

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

arty Name|LEBEN LABORATORIES PRIVATE LIMITED|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ May	/ 202526	/ 202526	/ 3 an	d 04/06/2025	d 04/06/2025	d 04/06/2025
HQ	File Number	HQRNORM APPL	Y 000035		71A	M25
RA	File Number	03AX04003210 A	M25

Lic<br>Dat	ence No and<br>e	0311037768/09/10/	2024
Nor<br>Th<br>pr<br>au<br>H	ms Committee Decision:									decision for same export<br>3/2025 against advance<br>orms under Para 4.07 of<br>-
	e Committee considered the ca<br>oduct/import item in meeting<br>thorization No.0311036028 da<br>BP Vol. I as per details given be		se as per<br>No. N<br>ted 05/0<br>low or a		age<br>C/3/<br>8/20	nda and taking cue from th<br>MEET/Mar/202425/19 da<br>24, it was decided to fix			e earlier<br>ted 27/0<br>ad-hoc n
					s app	lied by the firm, whichev			er is less:

	Export Product			Qty.			Sl. No.	Import Ite	ms		Qty. allowed.
	Alclox-250 Capsule. Cloxacill<br>Sodium Capsules USP 250mg.<br>((Each Capsule Containing<br>Cloxacillin Sodium BP<br>Equivalent To 250 Mg of<br>Cloxacillin).		in<br>	1376<br>Num	235<br>bers	<br>	1	Cloxacilli<br>Compacte	n Sodium<br>d	BP	382.52 kg.

	Alclox-500 Capsule .

ng Cloxacillin Sodium BP Equivalent To 250 Mg of Cloxacillin).||in |1376 Num|235 bers| |1|Cloxacilli Compacte|n Sodium d|BP|382.52 kg.| ||||||||||||| ||Alclox-500 Capsule . Cloxacill Sodium Capsules USP 500 Mg ((Each Capsule Containing Cloxacillinsodium BP Equival To 500 Mg of Cloxacillin).||in . ent| 1169 Num|831 bers|3 |2|Cloxacilli Compacte|n Sodium d|BP|6503.09 kg.| ||||||||||||| ||Lampyklox Capsule. Cloxacill Capsule (250+250 mg) ((Each Capsule Containg Cloxacillin Sodium Equivalent To 250 mg Cloxacillin)||in of|2000 Num|000 bers| |3|Cloxacilli Compacte|n Sodium d|BP|555.9 kg.| ||||||||||||| ||Alclox -125 Syrup. Cloxacillin Socium For Oral Solution USP ((Each 5ml Contains Cloxacillin sodium BP Equival To 125 Mg of Cloxacillin).|| ent| 2100 Num|0 bers||4|Cloxacilli Compacte|n Sodium d|BP|58.48 kg.| ||||||||||||| |||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Case No.	70 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	PI INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003572AM25
RA File Number	13AX04000225 AM25
Licence No and<br>Date	1311003391/09/10/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

|RA File Number|13AX04000225 AM25| |Licence No and Date|1311003391/09/10/2024| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	Case No.	71 / NC/3/MEET/May/202526/3	71 / NC/3/MEET/May/202526/3	71 / NC/3/MEET/May/202526/3	71 / NC/3/MEET/May/202526/3	71 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00003592AM25
RA File Number		05AX04002138 AM25
Licence No and<br>Date		0511028223/10/10/2024
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 item in meeting No. NC/3/MEET/Dec/202425/12 dated 10/12/2024 against advance<br>authorization No.0511026265 dated 21/06/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>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>Brinzolamide Ophthalmic<br>Brinzolamide<br>1 Number<br>1<br>51.00 mg/Vial
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Brinzolamide Ophthalmic		1 Number	1	Brinzolamide	51.00 mg/Vial

ide Ophthalmic Brinzolamide 1 Number 1 51.00 mg/Vial||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Brinzolamide Ophthalmic||1 Number|1|Brinzolamide|51.00 mg/Vial|

Case No.	Case No.	71 / NC/3/MEET/May/202526/3	71 / NC/3/MEET/May/202526/3	71 / NC/3/MEET/May/202526/3	71 / NC/3/MEET/May/202526/3	71 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00003592AM25
RA File Number		05AX04002138 AM25
Licence No and<br>Date		0511028223/10/10/2024
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 item in meeting No. NC/3/MEET/Dec/202425/12 dated 10/12/2024 against advance<br>authorization No.0511026265 dated 21/06/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>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>Brinzolamide Ophthalmic<br>Brinzolamide<br>1 Number<br>1<br>51.00 mg/Vial
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Brinzolamide Ophthalmic		1 Number	1	Brinzolamide	51.00 mg/Vial

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

almic||1 Number|1|Brinzolamide|51.00 mg/Vial|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Suspension, 1% w/v 5ml (			(Micronized and Sterile)
Sterile Eye Drops)((Each ml
contains Brinzolamide 10 mg
(Equivalent to 1150.000 Gm
of Bulk Drug))
Brinzolamide Ophthalmic	1 Number	2	Brinzolamide	102.00 mg/Vial
Suspension, 1% w/v 10ml (<br>Sterile Eye Drops)((Each ml			(Micronized and Sterile)
contains Brinzolamide 10 mg
(Equivalent to 1500.000 Gm
of Bulk Drug))
Brinzolamide Ophthalmic	1 Number	3	Brinzolamide	153.00 mg/Vial
Suspension, 1% w/v 15ml (<br>Sterile Eye Drops)( (Each ml			(Micronized and Sterile)
contains Brinzolamide 10 mg
(Equivalent to 2250.000 Gm
of Bulk Drug)(Total 4900.000
Gm of Bulk Drug)

Case No.	72 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	BVC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003593AM25
RA File Number	34AX04000557 AM25
Licence No and<br>Date	3411005529/10/10/2024
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:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>n-Hexanol (Lorol C6/ Nacol 6)<br>0.782 kg<br>Hexyl Acetate<br>1 kg<br>2<br>Acetic Acid<br>0.463 kg<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	Hexyl Acetate	1 kg	1	n-Hexanol (Lorol C6/ Nacol 6)	0.782 kg
			2	Acetic Acid	0.463 kg

Case No.	Case No.	Case No.	73 / NC/3/MEET/May/202526/3	73 / NC/3/MEET/May/202526/3	73 / NC/3/MEET/May/202526/3
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number			HQRNORM APPLY 00003605AM25
RA File Number			03AX04003421 AM25
Licence No and<br>Date			0311037850/11/10/2024
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to fix ad-hoc norms as under:-<br>Sl. No<br>Export Product<br>Quantity<br>1<br>Medical Cream and Ointments(Glycerine Vaseline and Paraffin Cream 250gm<br>[Total Wt.

firm, it was decided to fix ad-hoc norms as under:- Sl. No Export Product Quantity 1 Medical Cream and Ointments(Glycerine Vaseline and Paraffin Cream 250gm [Total Wt. 750000 Kgs(Net Cont:Gly112500Kgs,Vase 60000 Kgs, Para Liq 15000 Kgs, Ste 50% 15750Kgs, Ste95% 6750 Kgs, Cyclo18750Kgs,Sili3750 Kgs,Mac37500Kgs,Trie3750 Kgs)]) 1 Number S. No Import Product Quantity allowed. 1 Relevant Bulk Drugs Net content in the export product plus 2% wastage.|||||| ||Sl. No|Export Product |||Quantity| ||1|Medical Cream and Ointments(Glycerine Vaseline and Paraffin Cream 250gm [Total Wt. 750000 Kgs(Net Cont:Gly112500Kgs,Vase 60000 Kgs, Para Liq 15000 Kgs, Ste 50% 15750Kgs, Ste95% 6750 Kgs, Cyclo18750Kgs,Sili3750 Kgs,Mac37500Kgs,Trie3750 Kgs)]) ||| 1 Number| ||||||| ||S. No|Import Product||Quantity allowed.|| ||1|Relevant Bulk Drugs||Net content in the export product plus 2% wastage.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

2	Relevant Excipients	Net content in the export product plus 2% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy & General Notes.

Note:

i. The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption.

Case No.	Case No.	74 / NC/3/MEET/May/202526/3	74 / NC/3/MEET/May/202526/3	74 / NC/3/MEET/May/202526/3	74 / NC/3/MEET/May/202526/3	74 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00003610AM25
RA File Number		03AX04002821 AM25
Licence No and Date		0311037863/11/10/2024
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 item in meeting No. NC/3/MEET/Apr/202526/1 dated 25/04/2025 against advance<br>authorization No.0311037160 dated 16/09/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>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.

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 Meropenem Non-Sterile (Meropenem Trihydrate Non-Sterile) 0.8968 kg. Meropenem For Injection (Meropenem Buffered Sterile (Containing NLT 84% Sterile Meropenem) 1 kg. 2 Packing Material:Aluminium Canister (5kg) /Aluminium Bottle Anodized 2m (20l000t.8020xy) (Oneset Contains One Canister/Aluminium Bottle Anodized+Inlid+Outlid+Bromo Butyl Gasket / Chloro Butyl Plug 802 / 2t.802 And Tear Off Alu Cap) As per packing policy and General Notes.||||||| ||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:Aluminium Canister (5kg) /Aluminium Bottle Anodized 2m (20l000t.8020xy) (Oneset Contains One Canister/Aluminium Bottle Anodized+Inlid+Outlid+Bromo Butyl Gasket / Chloro Butyl Plug 802 / 2t.802 And Tear Off Alu Cap)|As per packing policy and General Notes.|

t Contains One Canister/Aluminium Bottle Anodized+Inlid+Outlid+Bromo Butyl Gasket / Chloro Butyl Plug 802 / 2t.802 And Tear Off Alu Cap)|As per packing policy and General Notes.|

Case No.	Case No.	74 / NC/3/MEET/May/202526/3	74 / NC/3/MEET/May/202526/3	74 / NC/3/MEET/May/202526/3	74 / NC/3/MEET/May/202526/3	74 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00003610AM25
RA File Number		03AX04002821 AM25
Licence No and Date		0311037863/11/10/2024
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 item in meeting No. NC/3/MEET/Apr/202526/1 dated 25/04/2025 against advance<br>authorization No.0311037160 dated 16/09/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>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.

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 Meropenem Non-Sterile (Meropenem Trihydrate Non-Sterile) 0.8968 kg. Meropenem For Injection (Meropenem Buffered Sterile (Containing NLT 84% Sterile Meropenem) 1 kg. 2 Packing Material:Aluminium Canister (5kg) /Aluminium Bottle Anodized 2m (20l000t.8020xy) (Oneset Contains One Canister/Aluminium Bottle Anodized+Inlid+Outlid+Bromo Butyl Gasket / Chloro Butyl Plug 802 / 2t.802 And Tear Off Alu Cap) As per packing policy and General Notes.||||||| ||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:Aluminium Canister (5kg) /Aluminium Bottle Anodized 2m (20l000t.8020xy) (Oneset Contains One Canister/Aluminium Bottle Anodized+Inlid+Outlid+Bromo Butyl Gasket / Chloro Butyl Plug 802 / 2t.802 And Tear Off Alu Cap)|As per packing policy and General Notes.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

per packing policy and General Notes.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Case No.	Case No.	75 / NC/3/MEET/May/202526/3	75 / NC/3/MEET/May/202526/3	75 / NC/3/MEET/May/202526/3	75 / NC/3/MEET/May/202526/3	75 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00003617AM25
RA File Number		05AX04002239 AM25
Licence No and Date		0511028273/14/10/2024
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<br>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>Tobramycin<br>3150 gm.<br>Tobramycin and<br>Dexamethasone Ophthalmic<br>Suspension 5ml ((Each ml<br>contains Tobramycin 3 mg. &<br>Dexamethasone 1mg<br>(Equivalent to 3000 gm<br>Tobramycin Bulk Drug and<br>1000 gm Dexamethasone Bulk<br>Drug))<br>200000<br>Numbers<br>2<br>Dexamethasone ( Micronised )<br>1050 gm.<br>3<br>Tobramycin (Raw Material /<br>Standard Grade)<br>2835 gm.<br>Tobramycin and<br>Dexamethasone Ophthalmic<br>Suspension 3ml ((Each ml<br>contains Tobramycin 3 mg.

one ( Micronised ) 1050 gm. 3 Tobramycin (Raw Material / Standard Grade) 2835 gm. Tobramycin and Dexamethasone Ophthalmic Suspension 3ml ((Each ml contains Tobramycin 3 mg. & Dexamethasone 1mg (Equivalent to 2700 gm Tobramycin Bulk Drug and 900 gm Dexamethasone Bulk Drug)) 300000 Numbers 4 Dexamethasone ( Micronised ) 945 gm. 5 Tobramycin 5670 gm. Tobramycin and Dexamethasone Ophthalmic 180000 Numbers||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Tobramycin and Dexamethasone Ophthalmic Suspension 5ml ((Each ml contains Tobramycin 3 mg. & Dexamethasone 1mg (Equivalent to 3000 gm Tobramycin Bulk Drug and 1000 gm Dexamethasone Bulk Drug))||200000 Numbers|1|Tobramycin|3150 gm.| |||||2|Dexamethasone ( Micronised )|1050 gm.| ||Tobramycin and Dexamethasone Ophthalmic Suspension 3ml ((Each ml contains Tobramycin 3 mg. & Dexamethasone 1mg (Equivalent to 2700 gm Tobramycin Bulk Drug and 900 gm Dexamethasone Bulk Drug))||300000 Numbers|3|Tobramycin (Raw Material / Standard Grade)|2835 gm.| |||||4|Dexamethasone ( Micronised )|945 gm.| ||Tobramycin and Dexamethasone Ophthalmic||180000 Numbers|5|Tobramycin|5670 gm.| ||Suspension 10ml ((Each ml||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

n|5670 gm.| ||Suspension 10ml ((Each ml||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

contains Tobramycin 3mg. &<br>Dexamethasone1mg<br>(Equivalent to 5400gm<br>Tobramycin Bulk Drug and<br>1800gm Dexamethasone Bulk<br>Drug) (Total Equivalent to<br>11100gm Tobramycin Bulk<br>Drug and 3700gm<br>Dexamethasone Bulk Drug))<br>6<br>Dexamethasone ( Micronised )<br>1890 gm.<br>RA concerned may take further necessary action as per above decision of NC.	contains Tobramycin 3mg. &<br>Dexamethasone1mg<br>(Equivalent to 5400gm<br>Tobramycin Bulk Drug and<br>1800gm Dexamethasone Bulk<br>Drug) (Total Equivalent to<br>11100gm Tobramycin Bulk<br>Drug and 3700gm<br>Dexamethasone Bulk Drug))		6	Dexamethasone ( Micronised )	1890 gm.

Case No.	Case No.	76 / NC/3/MEET/May/202526/3	76 / NC/3/MEET/May/202526/3	76 / NC/3/MEET/May/202526/3	76 / NC/3/MEET/May/202526/3	76 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00003619AM25
RA File Number		08AX04001094 AM25
Licence No and<br>Date		0811012932/14/10/2024
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 item in meeting No.

0811012932/14/10/2024||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Mar/202425/19 dated 27/03/2025 against advance authorization No**.**0811010468 dated 09/01/2024, 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. Isosorbide Mononitrate Extended Release Tablets USP 60 Mg (Each Film Coated Extended Release Tablets Contains: Diluted Isosorbide Mononitrate (50% Diluted with L Actose Monohydrate) USP equivalent to Isosorbide Mononitrate 60 mg 1 Number 1 Isosorbide Mononitrate 50 percent Assay. Diluted ISMN (50% diluted with lactose monohydrate) 122.40 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Isosorbide Mononitrate Extended Release Tablets USP 60 Mg (Each Film Coated Extended Release Tablets Contains: Diluted Isosorbide Mononitrate (50% Diluted with L Actose Monohydrate) USP equivalent to Isosorbide Mononitrate 60 mg|| 1 Number|1|Isosorbide Mononitrate 50 percent Assay. Diluted ISMN (50% diluted with lactose monohydrate)| 122.40 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

==> picture [464 x 160] intentionally omitted <==

ally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

==> picture [464 x 160] intentionally omitted <==

----- Start of picture text ----- Isosorbide Mononitrate Extended 1 Number Isosorbide Mononitrate 50 244.80 mg. Release Tablets USP 120 Mg (Each percent Assay. Diluted ISMN Film Coated Extended Release (50% diluted with lactose Tablets Contains : Diluted Isosorbide monohydrate) Mononitrate (50% Diluted With Lactose Monohydrate) USP equivalent to Isosorbide Mononitrate 120 mg ----- End of picture text -----

Case No.	Case No.	77 / NC/3/MEET/May/202526/3	77 / NC/3/MEET/May/202526/3	77 / NC/3/MEET/May/202526/3	77 / NC/3/MEET/May/202526/3	77 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00003620AM25
RA File Number		08AX04001096 AM25
Licence No and<br>Date		0811012933/14/10/2024
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 item in meeting No. NC/3/MEET/Dec/202425/12 dated 10/12/2024 against advance<br>authorization No.0811011769 dated 07/06/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol.

ort item in meeting No. NC/3/MEET/Dec/202425/12 dated 10/12/2024 against advance authorization No**.**0811011769 dated 07/06/2024, 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. Bisoprolol Fumarate Tablets 1.25 Mg (Each Film Coated Tablet Contains: Bisoprolol Fumarate USP 1.25 mg.) 1 Number Tablet 1 Bisoprolol Fumarate USP 1.275 mg/1.25 mg Tablet Bisoprolol Fumarate Tablets 2.5 Mg (Each Film Coated 1 Number Tablet 2 Bisoprolol Fumarate USP 2.55 mg/2.5 mg Tablet||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Bisoprolol Fumarate Tablets 1.25 Mg (Each Film Coated Tablet Contains: Bisoprolol Fumarate USP 1.25 mg.)||1 Number Tablet|1|Bisoprolol Fumarate USP|1.275 mg/1.25 mg Tablet| ||Bisoprolol Fumarate Tablets 2.5 Mg (Each Film Coated||1 Number Tablet|2|Bisoprolol Fumarate USP|2.55 mg/2.5 mg Tablet|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

br>Import Items Qty. allowed. Azithromycin Dihydrate 1 kg 1 Azithromycin Amine 0.9434 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	87 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	BVC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003672AM25
RA File Number	34AX04000597 AM25
Licence No and<br>Date	3411005544/16/10/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Personal Hearing before Norms Committee to explain its case along with sampel of the products.

Case No.	88 / N	C/3/MEET/May/202526/3
Case Status	Case A	pproved
Party Name	FDC L	IMITED
Meeting Number<br>and Date	NC/ 3/	MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRN	ORM APPLY 00003680AM25
RA File Number	03AX0	4003229 AM25
Licence No and	03110	7995/16/10/2024
Date

MEET/ May/ 202526/ 3 and 04/06/2025||||||| |HQ File Number||HQRN|ORM APPLY 00003680AM25||||||| |RA File Number||03AX0|4003229 AM25||||||| |Licence No and||03110|7995/16/10/2024||||||| |Date|||||||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Mar/202324/26 dated 22/03/2024 against advance authorization No**.**0311030712 dated 06/02/2024, 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. Sodium Cromoglicate Eye Drops 13.5 Ml ((Each 13.5 Ml Vial Contains Sodium Cromoglicate 0.270 gm Net Wt of Bulk 89.910 Kgs)) 1 Vial 1 Sodium Cromoglicate 0.2754 gm/13.5 ml vial Sodium Cromoglicate Eye Drops 10 Ml ( Allercrom Eye Drops 10 Ml) ((Each 10 Ml Vil Cti Sdi 1 Vial 2 Sodium Cromoglicate 0.204 gm./10 ml. vial|||||||||| ||||||||||| ||Export Product|||Qty.|**Sl. No. **|Imp|ort Items|Qty.|allowed.| ||||||||||| ||Sodium Cromoglicate Eye Drops 13.5 Ml ((Each 13.5 Ml Vial Contains Sodium Cromoglicate 0.270 gm Net Wt of Bulk 89.910 Kgs))|||1 Vial|1|Sodi|um Cromoglicate|0.275 vial|4 gm/13.5 ml| ||||||||||| ||||||||||| ||Sodium Cromoglicate Eye Drops 10 Ml ( Allercrom Eye Drops 10 Ml) ((Each 10 Ml Vil Cti Sdi|||1 Vial|2|Sodium Cromoglicate||0.204 gm./10 ml.

275 vial|4 gm/13.5 ml| ||||||||||| ||||||||||| ||Sodium Cromoglicate Eye Drops 10 Ml ( Allercrom Eye Drops 10 Ml) ((Each 10 Ml Vil Cti Sdi|||1 Vial|2|Sodium Cromoglicate||0.204 gm./10 ml. vial|| ||a onans oum Cromoglicate 0.200 gm Net Wt of Bulk 84.534 Kgs))||||||||| ||||||||||| ||Sodium Crom |oglicate Eye ||1 Vial|3|Sodium Cromoglicate||0.102 gm./5 ml. vial|| ||Drops 5 Ml ( |Allercrom Eye |||||||| ||Drops 5 Ml A |nd Cromolyn |||||||| ||Sodium Eye ((Each 5 Ml |Drops 5 Ml) Vial Contains |||||||| ||Sodium Crom |oglicate 0.100 |||||||| ||gm Net Wt o|f Bulk 7.800|||||||| |||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Kgs))

Case No.	89 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	SV PLASTOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003682AM25
RA File Number	31AX04000348 AM24
Licence No and<br>Date	3111003982/16/10/2024
Norms Committee Decision:<br>The committee considered the request of the firm for fixation of ad-hoc norms, and as per the advice of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Chemical name of export product.<br>1.<br>Complete chemistry with material balance Moler weight of export and import.<br>2.<br>Percentage Yield and stichiometric balance.<br>3.

rom the firm:- Chemical name of export product. 1. Complete chemistry with material balance Moler weight of export and import. 2. Percentage Yield and stichiometric balance. 3.||

Case No.	90 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	LITMUS ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003683AM25
RA File Number	03AX04003302 AM25
Licence No and<br>Date	0311037996/16/10/2024
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<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
TCD Emulsifier	20000 kg.	1	Hexahydro Phthalic Anhydride	12336 kg.
			HHPA
		2	TCD Alcohol DM	7868 kg.

4AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
TCD Emulsifier	20000 kg.	1	Hexahydro Phthalic Anhydride	12336 kg.
			HHPA
		2	TCD Alcohol DM	7868 kg.

Case No.	91 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	SV PLASTOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003691AM25
RA File Number	31AX04000043 AM22
Licence No and<br>Date	3111003987/17/10/2024
Norms Committee Decision:
The committee considered the request of the firm for fixation of ad-hoc norms, and as per the advice of
the TE, it was decided to call for following information/documents from the firm:-
Complete chemistry with material balance molecular weight of export and import<br>1.
Percentage Yield and stichometric balance.<br>2.

Case No.	92 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003714AM25
RA File Number	03AX04003488 AM25
Licence No and<br>Date	0311038037/17/10/2024
Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

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:-

|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:-|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:-|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:-|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:-|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:-|The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

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 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 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 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 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 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 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.|| |||||||||||| ||Diclofenac G|el 3% 25g DE ((Net|| 1 Number||1||Sodium Hyaluronate|1.6|1 gm| ||Wt.

d.**||||||||||| ||Export Product|||Qty.||**Sl. No. **||Import Items|Qty. allowed.|| |||||||||||| ||Diclofenac G|el 3% 25g DE ((Net|| 1 Number||1||Sodium Hyaluronate|1.6|1 gm| ||Wt. of Sod|ium Hyaluronate is||||||||| ||7.93 Kgs.))|||||||||| |||||||||||| ||ilf|l|| ||||i l||| ||Dcoenac Wt f Sd|e 3% 50g DE ((Net i Hlt i|| 1 Number||2||Sodum Hyauronate|1.6|gm| ||. o o 349 Ks))|um yauronae s||||||||| ||. g.|||||||||| |||||||||||| ||Diclofenac Gel 3% 90g DE ((Net Wt. of Sodium Hyaluronate is 6.35 Kgs.))||| 1 Number||3||Sodium Hyaluronate|1.6|2 gm| ||DICLOFENAC GEL 3% 50g UK||| 1 Number||4||Sodium Hyaluronate|0.30|9 gm| || ((Net Wt. of Sodium Hyaluronate is 11.90 Kgs.))||| ||||||| ||||| ||||||| ||DICLOFENAC G UK ((Nt Wt||L 3% 100g f Sdi| 1 Number||5||Sodium Hyaluronate|3.60 gm|| || e . Haluronate is 635||o oum Ks))|||||||| ||y .||g.|||||||| ||Diclofenac Gel 3%||60g ES ((Net| 1 Number||6||Sodium Hyaluronate|8.41 gm|| ||Wt. of Sodium||Hyaluronate is|||||||| ||61.89 Kgs.))|||||||||| |||||||||||| |||||||||||| |RA|Diclofenac Gel 3% 90g ES ((Net Wt. of Sodium Hyaluronate is 2.86 Kgs.))||| 1 Number||7||Sodium Hyaluronate|0.481 gm|| ||concerned may take further necessary action as per above decision of NC.|||||||||| |||||||||||| |||||||||||| |||||||||||| |Cas|e No.|93 / NC/3/MEET/May/2||02526/3|||||||

Case No. 93 / NC/3/MEET/May/202526/3

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

C/3/MEET/May/2||02526/3|||||||

Case No. 93 / NC/3/MEET/May/202526/3

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Case Status<br>Case Approved
Party Name<br>NEOGEN CHEMICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number<br>HQRNORM APPLY 00003723AM25
RA File Number<br>03AX04003562 AM25
Licence No and<br>Date<br>0311038044/18/10/2024
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import item in meeting No. NC/3/MEET/Mar/202425/19 dated 27/03/2025 against advance
authorization No.0311034124 dated 27/05/2024, 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. allowed.
Ethyl Isobutyrate<br>1 kg.<br>1	Isobutyric Acid	0.948 kg
RA concerned may take further necessary action as per above decision of NC.

.** Sl. No.|Import Items|Qty. allowed.|| |Ethyl Isobutyrate 1 kg. 1|Isobutyric Acid|0.948 kg|| |RA concerned may take further necessary action as per above decision of NC.||||

Case No.	94 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003724AM25
RA File Number	03AX04003565 AM25
Licence No and<br>Date	0311038045/18/10/2024
Norms Committee Decision:
The Committee	considered the case as per agenda and it was decided to call the firm for attending
Personal Hearing<br> before Norms Committee to explain its case along with relevant information /
documents from the firm:

Case No.	95 / NC/3/MEET/May/202526/3
Case Status	Case Approved

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

2526/3| |---|---| |Case Status|Case Approved|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Par	ty Name	JUBILANT GENERI	CS LIMITED	CS LIMITED
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ May/	202526/ 3 and		04/06/2025

HQ	File Number	HQRNORM APPLY	00003727AM2		5
RA	File Number	05AX04002287 AM	25
Lic<br>Dat	ence No and<br>e	0511028382/18/10/2	024
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<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-	ms Committee Decision:<br>e Committee considered the case		as per agenda		and it was dec		ided to fix ad-hoc norms	under Para 4.07 of

	Export Product			Qty.		Sl. No.	Import Items	Qty. allowed.
	Cyclobenzaprine<br>Hydrochloride<br>			<br>1 Number		1	Cyclobenzaprine<br>	5.10 mg
	Tablets 5 Mg						Hydrochloride


	Cyclobenzap	rine<br>Hydrochloride		<br>1 Number		2	Cyclobenzaprine	7	.65 mg
	Tablets 7.5 M	g					Hydrochloride
		<br>		<br>
	Cyclobenzap<br>	rine<br>Hydrochloride<br>		<br>1 Number		3	Cyclobenzaprine<br>	1	.20 mg
	Tablets 10 M	g					Hydrochloride

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

|| 1 Number||3|Cyclobenzaprine |1|.20 mg| ||Tablets 10 M|g|||||Hydrochloride||| ||||||||||| |RA concerned may take further necessary action as per above decision of NC.|||||||||| |||||||||||

Case No.	96 / NC/3/MEET/May/202526/3

Case Status	Case Approved

Party Name	MANKIND PHARMA LIMITED

Meeting Number
<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003735AM25

RA File Number	05AX04002293 AM25

Licence No and
Date	0511028402/18/10/2024
Norms Committee	Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

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.
Doxepin Hydrochloride Capsules	<br>1 Number	1	Doxepin HCL	11.353 mg
USP 10 mg.
Doxepin Hydrochloride Capsules	<br>1 Number	2	Doxepin HCL	28.384 mg
USP 25 mg.
Doxepin Hydrochloride Capsules	<br>1 Number	3	Doxepin HCL	56.766 mg
USP 50 mg.
Doxepin Hydrochloride Capsules	<br>1 Number	4	Doxepin HCL	85.152 mg
USP 75 mg.
Doxepin Hydrochloride Capsules	<br>1 Number	5	Doxepin HCL	113.538 mg
USP 100 mg.

g| |USP 50 mg.||||| |Doxepin Hydrochloride Capsules| 1 Number|4|Doxepin HCL|85.152 mg| |USP 75 mg.||||| |Doxepin Hydrochloride Capsules| 1 Number|5|Doxepin HCL|113.538 mg| |USP 100 mg.|||||

Case No.	97 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	ACUTAAS CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003737AM25
RA File Number	52AX04000217 AM25
Licence No and<br>Date	5211010354/18/10/2024
Norms Committee Decision:
The committee considered the request of the firm for fixation of ad-hoc norms, and as per the advice of
the TE, it was decided to call for following information/documents from the firm:-
Please furnish complete chemistry with molecular weight and percentage yield on molar basis for<br>1.
manufacture of DARO-III from its basic stage.

Please furnish complete chemistry with molecular weight and percentage yield on molar basis for manufacture of DARO-III from its basic stage.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

manufacture of DARO-III from its basic stage.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Case No.	98 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003746AM25
RA File Number	03AX04003569 AM25
Licence No and<br>Date	0311038096/21/10/2024
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<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. allowed.<br>Aminowel 5% Infusion 250ml<br>310000<br>Numbers<br>1<br>Glycine EP<br>284.81 kg<br>RA concerned may take further necessary action as per above decision of NC.

ort Items** Qty. allowed. Aminowel 5% Infusion 250ml 310000 Numbers 1 Glycine EP 284.81 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	99 / NC/3/MEET/May/202526/3	99 / NC/3/MEET/May/202526/3	99 / NC/3/MEET/May/202526/3	99 / NC/3/MEET/May/202526/3	99 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		UMEDICA LABORATORIES PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00003748AM25
RA File Number		03AX04003491 AM25
Licence No and Date		0311038102/21/10/2024
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<br>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.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

. No. **|Import Items|Qty. allowed.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Rosuvastatin Tablet<br>BP /USP10 mg.<br>1 Number<br>1<br>Tert-butyl2-((4R,6S)-6-((E)-2-(4-(4-<br>fluorophenyl)-6-isopropyl-2-(N-<br>methylmethylsulfonamido)<br>pyrimidin-5-yl)vinyl)-2,2-dimethyl-<br>1,3-dioxan-4-yl) acetate)<br>10.608 mg.	Rosuvastatin Tablet<br>BP /USP10 mg.	1 Num	ber	1		Tert-but<br>fluoroph<br>methylm<br>pyrimidi	yl2-((4R,6S)-6-((E)-2-(4-(4-<br>enyl)-6-isopropyl-2-(N-<br>ethylsulfonamido)<br>n-5-yl)vinyl)-2,2-dimethyl-		10.608 mg.
						1,3-dioxan-4-yl) acetate)
RA concerned may take further necessary action as per above decision of NC.



Case No.	1	00 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		GLENMARK PHARMACEUTICALS LIMITED
Meeting Number and		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
Date

HQ File Number	HQRNORM APPLY 00003749AM25
RA File Number	03AX04003589 AM25
Licence No and Date	0311038089/21/10/2024
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<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. 1 Fenoterol Hydrobromide 510 gm Fenoterol Hydrobromide and Ipratropium Bromide Solution for Inhalation (0.5mg+0.25mg/ml) ( 20 ml ) ((Net Wt. of Fenoterol Hydrobromide is Qty. 500.00 Grams and Ipratropium Bromide is Qty. 250.00 Grams)) 50000 Numbers 2 Ipratropium Bromide 255 gm 3 Fenoterol Hydrobromide 2550 gm Fenoterol Hydrobromide and 50000|||||||||| ||||||||||| ||||||||||| ||Export Product|||||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Fenoterol Hydrobromide and Ipratropium Bromide Solution Inhalation (0.5mg+0.25mg/ml ml ) ((Net Wt. of Fenoterol Hydrobromide is Qty. 500.00 ||||for ) ( 20 |50000 Numbers|1|Fenoterol Hydrobromide|510 gm| ||||||||||| ||||||||2|Ipratropium Bromide|255 gm| ||Grams and Ipratropium Bromide is Qty. 250.00 Grams))||||||||| ||Fenoterol Hydrobromide and|||||50000|3|Fenoterol Hydrobromide|2550 gm| ||Ipratropium Bromide Solution for Inhalation (0.5mg+0.25mg/ml) ( 20 ml x 5 ) (Net Wt. of Fenoterol Hydrobromide is Qty. 2500.00 |||||Numbers|||| ||||||||4|Ipratropium Bromide|1275 gm| ||Grams and Ip|ratropium Bromide is|||||||| |||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Qty. 1250.00 Grams))

s|||||||| |||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Qty. 1250.00 Grams))


	Qty. 1250.00	Grams))
RA concerned m
		ay take further necessary action as per above decision of NC
		.



Case No.		101 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Par	ty Name	LEBEN LABORATORIES PRIVAT			E LIMITED
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ May/ 202526/ 3 and			04/06/2025
HQ	File Number	HQRNORM APPLY 00003757AM2			5
RA	File Number	03AX04003157 AM	25
Lic<br>Dat	ence No and<br>e	0311038087/21/10/2	024

Nor<br>Th<br>pr<br>au<br>H	ms Committee Decision:<br>e Committee considered the case<br>oduct/import item in meeting<br>thorization No.0311036037 date<br>BP Vol. I as per details given belo		as per agend<br>No. NC/3/ME<br>d 03/08/2024<br>w or as appli		and takin c	e from the earlier decisi		n for same exort
					g<br>ET/Mar/2024<br>, it was decid<br>ed by the firm,	<br>25/19 dated 27/03/2025<br>ed to fix ad-hoc norms u<br>whichever is less:-		p<br>against advance<br>nder Para 4.07 of
	Export Product			Q	ty.	Sl. No.	Import Items	**Qty.

r>25/19 dated 27/03/2025 ed to fix ad-hoc norms u whichever is less:-||p against advance nder Para 4.07 of||| ||Export Product|||||Q|ty.|||**Sl. No. **|Import Items|Qty. allowed.||| ||Moxileb Kid Tablet (Amoxicillin Tablet 125mg) (( Each Tablet Containing Amoxicillin Trihydrate Equivalent To 125 |||||1 Number|||1||Amoxicillin Trihydrate BP Compacted|146.32 mg.||| ||Mg of Amoxicillin) Net Content of Import/Exempt Material Used In Export Product 1) Amoxicillin Trihydrate BP (Compacted) -71.755 kgs (Excl 2% |||||||||||||| ||Wastage))|||||||||||||| |||||||||||||||| |||||||||||||||| ||Moxileb-250dt.Amoxicillin T||ablet 250 Mg|||1 Number|||2||Amoxicillin|292.639 mg.||| ||((Each Tablet Containing Am||oxicillin||||||||Trihydrate BP|||| ||Trihydrate Equivalent To 250||mg of||||||||Compacted|||| ||Amoxicillin ). Net Content of || |||||||||||| ||Import/Exempt Material Used ||In Export |||||||||||| ||Product 1)Amoxicillin Trihydrate BP (Compacted) -157.853 Kgs (Excl 2% Wastage))||||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

7.853 Kgs (Excl 2% Wastage))||||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Moxileb-250 Capsule. (Amoxicillin<br>Capsule 250 Mg) ((Each Capsule<br>Containing Amoxicillin Trihydrate	1 Number	3	Amoxicillin<br>Trihydrate BP<br>Compacted	Amoxicillin<br>Trihydrate BP<br>Compacted	Amoxicillin<br>Trihydrate BP<br>Compacted	292.639 mg.	292.639 mg.
Equovalent To 250mg of Amoxicillin). Net<br>Content of Import/Exempt Material Used In<br>Export Product 1) Amoxicillin Trihydrate<br>BP (Compacted) -1205.402 kgs (Excl 2%
<br>Wastage))
Moxileb-500 Capsule. (Amoxicillin<br>Capsule 500mg). ((Each Capsule<br>Containing Amoxicillin Trihydrate<br>Equivalent To 500 Mg of Amoxicillin). Net<br>Content of Import/Exempt Materialused In<br>Export Product 1) Amoxicillin Trihydrate<br>BP (Compacted) -5737.13 kgs (Excl 2%<br>Wastage))	1 Number	4	A<br>T<br>C	moxicil<br>rihydrat<br>ompact
					lin<br>e BP<br>	585.28 m	g.
					ed

Moxileb Oral Suspension Amoxicillin Oral<br>Suspension (Amoxicillin Syrup)<br>125mg/100 Ml Bottle. ((Each 5ml Contains<br>Amoxicillin Trihydrate Euqivalent To 125<br>Mg of Amoxicillin).

||||||||||| ||Moxileb Oral Suspension Amoxicillin Oral Suspension (Amoxicillin Syrup) 125mg/100 Ml Bottle. ((Each 5ml Contains Amoxicillin Trihydrate Euqivalent To 125 Mg of Amoxicillin). Net Content of Import/Exempt Material Used In Export Product 1) Amoxicillin Trihydrate BP - (Compacted) - 60.264 kgs (Excl 2% Wastage))|1 Number|5|A T C|moxicil rihydrat ompact|lin e BP||2625.00 m|g.|| ||||||| ed||||| |||||||||||| ||Moxileb Oral Suspension. Amoxicillin Oral Suspension (Amoxicillin Syrup) 250 Mg /100 Ml Bottle. ((Each 5ml Contains Amoxicillin Trihydrate Equivalent To 250 Mg of Amoxicillin). Net Content of Import/Exempt Material Used In Export Product 1) Amoxicillin Trihydrate BP (Compacted) - 120.54 Kgs (Excl 2% Wastage).)|1 Number|6|A T C|moxicil rihydrat ompact|lin ||5250.00 m|g.|| |||||||e BP ed||||| |||||||||||| ||A concerned may take further necessary action as per above decision o||||f NC.|||||| |||||||||||| ||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

n o||||f NC.|||||| |||||||||||| ||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Cas	e No.	102 / NC/3/MEET/May/202526/3	102 / NC/3/MEET/May/202526/3	102 / NC/3/MEET/May/202526/3	102 / NC/3/MEET/May/202526/3
Cas	e Status	Case Approved
Part	y Name	MALIK LIFESCIENCES PRIVATE LIMITED
Me<br>and	i Nb
	tng umer<br>Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ	File Number	HQRNORM APPLY 00003777AM25
RA	File Number	05AX04002054 AM25
Lic<br>Dat	ence No and<br>e	0511028020/22/10/2024
Nor<br>Th<br>pr<br>au<br>H<br>RA	ms Committee Decision:<br>e Committee considered the case as per agenda and taking cue from t<br>oduct/import item in meeting No. NC/3/MEET/Mar/202324/26 da<br>hii N0511024074 dd 26/02/2024 i didd fi					he earlier<br>ted 22/0<br>dh
							dec<br>3/2<br>	ision for same ex<br>024 against adv<br>d P 40		port<br>ance<br>7 f
	orzaton o.ate , t was ece to x<br>BP Vol. I as per details given below or as applied by the firm, whichev					a-oc<br>er is less	or<br>:-	s uner ara .		o

	Export Product		Qty.	Sl. No.	Imp	ort Item	s		**Qty.

er details given below or as applied by the firm, whichev|||||a-oc er is less|or :-|s uner ara .||o|| ||||||||||||| ||Export Product||Qty.|Sl. No.|Imp|ort Item|s||Qty. allowed|.|| ||Cefixime Tablets 200 mg (each tablet contains Cefixime USP (as Trihydrate) il Cfii 200|| 1 Number|1|Cefi Trih|xime US ydrate))|||||| ||||||||P (A|s|204.00 mg / Tablet||| ||equvaent to exme mg on anhydrous basis), Pack size:1, Strip = 10 Tablets))||||||||||| ||||||||||||| ||concerned may take further necessary action as per above decision of|||||NC.|||||| ||||||||||||| |||||||||||||

Case No.	103 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	BULI CHEMICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003786AM25
RA File Number	03AX04003625 AM25
Licence No and<br>	0311038141/22/10/2024
Date

Norms Committee<br>The Committee	Decision:<br>considered the case as per agenda and taking cue from the earlier decision for same export

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

rom the earlier decision for same export| |||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

| |product/import item in meeting No. NC/3/MEET/Mar/202425/19 dated 27/03/2025 against advance authorization No**.**0311036306 dated 13/08/2024, 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 Item Name-1:N-BUTYL LITHIUM IN HEXANE (n-butyl Lithium) 15% Qty:- 1 kg Import Items:|product/import item in meeting No. NC/3/MEET/Mar/202425/19 dated 27/03/2025 against advance authorization No.**0311036306 dated 13/08/2024, 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 Item Name-1:N-BUTYL LITHIUM IN HEXANE (n-butyl Lithium) 15% Qty:- 1 kg Import Items:|product/import item in meeting No. NC/3/MEET/Mar/202425/19 dated 27/03/2025 against advance authorization No.**0311036306 dated 13/08/2024, 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 Item Name-1:**N-BUTYL LITHIUM IN HEXANE (n-butyl Lithium) 15% Qty:- 1 kg Import Items:|product/import item in meeting No.

elow or as applied by the firm, whichever is less:- **Export Item Name-1:N-BUTYL LITHIUM IN HEXANE (n-butyl Lithium) 15% Qty:- 1 kg Import Items:|product/import item in meeting No. NC/3/MEET/Mar/202425/19 dated 27/03/2025 against advance authorization No.**0311036306 dated 13/08/2024, 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 Item Name-1:**N-BUTYL LITHIUM IN HEXANE (n-butyl Lithium) 15% Qty:- 1 kg Import Items:| |---|---|---|---|---| ||Sl.No.|Item description||Qty. recoomendation| ||1|Lithium Metal||0.0406 kg| ||2|Butyl Chloride||0.270 kg| ||3|Hexane||1.760 kg| ||**Export Item Name-2:**N-BUTYL LITHIUM IN HEXANE (n-butyl Lithium) 23% Qty:- 1 kg Import Items:|||| ||Sl.No.||Item description|Qty. recoomendation| ||1||Lithium Metal|0.0650 kg| ||2||Butyl Chloride|0.432 kg| ||3||Hexane|1.574 kg| ||**Export Item Name-3:**N-BUTYL LITHIUM IN HEXANE (n-butyl Lithium) 30% Qty:- 1 kg Import Items:|||| ||Sl.No.||Item description|Qty. recoomendation| ||1||Lithium Metal|0.0812 kg|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

2	Butyl Chloride	0.540 kg
3	Hexane	1.450 kg

. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

2	Butyl Chloride	0.540 kg
3	Hexane	1.450 kg

2<br>Butyl Chloride<br>0.540 kg<br>3<br>Hexane<br>1.450 kg<br>RA concerned may take further necessary action as per above decision of NC.	2	2	2	Butyl Chloride	Butyl Chloride	Butyl Chloride	Butyl Chloride	Butyl Chloride	Butyl Chloride	0.540 kg	0.540 kg	0.540 kg
	3			Hexane						1.450 kg
		concerned may take further nece			ssary action as		per above dec		ision of NC.


Case No.			104 / NC/3/MEET/May/202526/3
Case Status			Case Approved
Party Name			EAGLE CHEMICAL WORKS
Meeting Number<br>and Date			NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number			HQRNORM APPLY 00003795AM25
RA File Number			03AX04003055 AM25

Licence No and<br>D			0311038169/22/10/2024
ate
N Ci			ii
orms ommttee			ecson:
The Committee<br>of HBP Vol. I as			considered the case as per agenda and it was decided to fix ad-hoc norms under P<br>per details given below or as applied by the firm, whichever is less:-									ara 4.07


		Export Prod	uct		Qty.	Sl. No.		Import Items			**Qty.

r>per details given below or as applied by the firm, whichever is less:-||||||||||ara 4.07| ||||||||||||||| ||||||||||||||| |||Export Prod|uct||Qty.|Sl. No.||Import Items|||Qty. allo||wed.| ||||||||||||||| |Ferrous Fumarate BP/EP/FCC 1 kg 1 Fumaric Acid 0.727 kg RA concerned may take further necessary action as per above decision of NC.||Ferrous Fumarate BP/EP/FCC|||1 kg|1||Fumaric Acid|||0.727||kg| |||||||||||||||

Case No.	105 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	BHAGWATI ORGANICS PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ M/ 202526/ 3 nd 04/06/2025
and Date	ay a
HQ File Number	HQRNORM APPLY 00003824AM25
RA File Number	08AX04001178 AM25
Licence No and	0811012998/23/10/2024
Date
Norms Committee	Decision:

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

The committee considered the request of the firm for fixation of ad-hoc norms, and as per the advice of the TE, it was decided to call for following information/documents from the firm:-

A balanced chemical reaction indicating molecular weight of reactants and products with yield and justification.
The commercial value of the byproduct/s obtained during the process.
Calculation of the requirement of raw materials based on yield of the reaction.
A stoichiometric material balance on molar basis.

ial value of the byproduct/s obtained during the process.

Calculation of the requirement of raw materials based on yield of the reaction.
A stoichiometric material balance on molar basis.

The committee considered the request of the firm for fixation of ad-hoc norms, and as per the advice of<br>the TE, it was decided to call for following information/documents from the firm:-	The committee considered the request of the firm for fixation of ad-hoc norms, and as per the advice of<br>the TE, it was decided to call for following information/documents from the firm:-	The committee considered the request of the firm for fixation of ad-hoc norms, and as per the advice of<br>the TE, it was decided to call for following information/documents from the firm:-	The committee considered the request of the firm for fixation of ad-hoc norms, and as per the advice of<br>the TE, it was decided to call for following information/documents from the firm:-	The committee considered the request of the firm for fixation of ad-hoc norms, and as per the advice of<br>the TE, it was decided to call for following information/documents from the firm:-	The committee considered the request of the firm for fixation of ad-hoc norms, and as per the advice of<br>the TE, it was decided to call for following information/documents from the firm:-	The committee considered the request of the firm for fixation of ad-hoc norms, and as per the advice of<br>the TE, it was decided to call for following information/documents from the firm:-

red the request of the firm for fixation of ad-hoc norms, and as per the advice of the TE, it was decided to call for following information/documents from the firm:-| |---|---|---|---|---|---|---| |A balanced chemical reaction indicating molecular weight of reactants and products with yield and justification. 1. The commercial value of the byproduct/s obtained during the process. 2. Calculation of the requirement of raw materials based on yield of the reaction. 3.||||||| |A stoichio 4.||metric material balance on molar basis.||||| |||||||| |||||||| |||||||| |||||||| |||||||| |||||||| |Case No.||106 / NC/3/MEET/May/202526/3||||| |||||||| |Case Status||Case Approved||||| |Party Name||TIDE INDUSTRIES||||| |Meeting Number and Date||NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025||||| |HQ File Number||HQRNORM APPLY 00003840AM25||||| |RA File Number||34AX04000615 AM25||||| |Licence No and Date||3411005588/24/10/2024||||| |||||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Apr/202526/1 dated 25/04/2025 against advance||||||| |authorization N||o**.**3411005383 dated 09/09/2024, it was decided to fix ad-hoc norms under Para 4.07 of||||| |HBP Vol. I as p||er details given below or as applied by the firm, whichever is less:-||||| |||||||| |||||||| ||Export Prod|uct|Qty.|Sl. No.|Import Items|**Qty.

Para 4.07 of||||| |HBP Vol. I as p||er details given below or as applied by the firm, whichever is less:-||||| |||||||| |||||||| ||Export Prod|uct|Qty.|Sl. No.|Import Items|Qty. allowed.| |||||||| ||Aldehyde C1|0|1 kg.|1|Fatty Alcohol C10 (98% purity)|1.40 kg.| ||(Capric Alde|hyde)||||| |RA concerned may take further necessary action as per above decision of NC.||||||| ||||||||

Case No.	107 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Part Name	MEDICARE HYGIENE LIMITED
y
Meetin Number
g<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

HQ File Number	HQRNORM APPLY 00003843AM25
RA File Number	08AX04001190 AM25
Licence No and<br>Date	0811013002/24/10/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	108 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	PRACHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003845AM25
RA File Number	08AX04001204 AM25
Licence No and<br>Date	0811013007/24/10/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

|RA File Number|08AX04001204 AM25| |Licence No and Date|0811013007/24/10/2024| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	109 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	ACUTAAS CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003846AM25
RA File Number	52AX04000212 AM25
Licence No and<br>Date	5211010462/24/10/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	110 / NC/3/MEET/May/202526/3
Case Status	Case Deferred

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Party Name	LAZERHEAD LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003851AM25
RA File Number	09AX04000499 AM25
Licence No and<br>Date	0911008210/24/10/2024
Norms Committee Decision:
The case is under consideration and TE was requested to expedite his comments.

|RA File Number|09AX04000499 AM25| |Licence No and Date|0911008210/24/10/2024| |Norms Committee Decision:|| |The case is under consideration and TE was requested to expedite his comments.||

Case No.	111 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003868AM25
RA File Number	08AX04001241 AM25
Licence No and<br>Date	0811013030/25/10/2024
Norms Committee Decision:
The case is under consideration and TE was requested to expedite his comments.

Case No.	112 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	CALYX CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003874AM25
RA File Number	03AX04003742 AM25
Licence No and<br>Date	0311038273/27/10/2024
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import	item in meeting No. NC/3/MEET/Apr/202526/1 dated 25/04/2025 against advance
authorization No.0311037446 dated 26/09/2024, 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:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

as applied by the firm, whichever is less:-||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Export Product	Qty.			Sl. No.	Import Items	Qty. allowed.
Artemether		1	kg	1	Artemisinin	1.04 kg.

Note: NC also decided to make new SION on the above norms.


Case No.		113 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number		NC/ 3/ MEET/ M/ 202526/ 3 d 04/06/2025
and Date		ay an
HQ File Number		HQRNORM APPLY 00003896AM25
RA File Number		34AX04000632 AM25
Licence No and		3411005604/28/10/2024
Date
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<br>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.

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.|| ||Adapalene and BPO Topical Gel||78000|1|Benzoyl Peroxide|89.505 kg|| ||0.3% / 2.5%|- 45 Gm Pump|Numbers||Hydrous USP||| ||(Adapalene a|nd BPO Topical Gel|||||| ||0.3% / 2.5%|- 45 gm Pump|||||| ||Adapalene an Topical Gel 0|d Benzoyl Peroxide .3% / 2.5% Net|||||| ||content of of|Adapalene = 10.53|||||| ||kgs and Benz|oyl Peroxide Hydrous|||||| ||= 87.75 kgs.|)|||||| ||||||||| |RA concerned may take further necessary action as per above decision of NC.|||||||| |||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Case No.	Case No.	114 / NC/3/MEET/May/202526/3	114 / NC/3/MEET/May/202526/3	114 / NC/3/MEET/May/202526/3	114 / NC/3/MEET/May/202526/3	114 / NC/3/MEET/May/202526/3	114 / NC/3/MEET/May/202526/3	114 / NC/3/MEET/May/202526/3	114 / NC/3/MEET/May/202526/3	114 / NC/3/MEET/May/202526/3
Case Status		Case Approved

Party Name		MANKIND PHARMA LIMITED

Meeting Number<br>d D		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
an ate
H Fil Nb		HRNORM APPLY 00003908AM25
Q e umer		Q
RA File Number		05AX04002457 AM25

Licence No and<br>D		0511028610/28/10/2024
ate
N Ci		ii

NORM APPLY 00003908AM25||||||||| |Q e umer||Q||||||||| |RA File Number||05AX04002457 AM25||||||||| |||||||||||| |Licence No and D||0511028610/28/10/2024||||||||| |ate||||||||||| |N Ci||ii||||||||| |orms ommttee The Committee||ecson: considered the case as per agenda and taking cue from the earlier decision for same export||||||||| | product/import item in meeting No. NC/3/MEET/Sep/202425/9 dated 10/10/2024 against advance authorization No**.**0511016882 dated 17/01/2023, 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.| |||||||||||| |||||||||||| ||Formoterol|Fumarate Inhalation|| 3594000||1||Formoterol Fumarate||75.474 kg| ||Solution 20|mcg /2 mL (0.02 mg/2|| Numbers||||Dihydrate USP||| ||ml), ((filling number))|volume 2.1 ml in each||||||||| |||||||||||| |||||||||||| |RA concerned m||ay take further necessary action as per above decision of NC.||||||||| |||||||||||| |||||||||||| |Cas|e No.|115 / NC/3/MEET/May/202526/3||||||||| |||||||||||| |Cas|e Status|Case Approved||||||||| |Par|ty Name|WEST BENGAL CH|EMICAL IND||USTRIES LTD.|||||| |Me and|eting Number Date|NC/ 3/ MEET/ May/|202526/ 3 and||04/06/2025|||||| |HQ|File Number|HQRNORM APPLY|00003915AM2||5|||||| |RA|File Number|02AX04000478 AM|25|||||||| |||||||||||| |Lic Dat|ence No and e|0211007515/28/10/2|024||||||||

|202526/ 3 and||04/06/2025|||||| |HQ|File Number|HQRNORM APPLY|00003915AM2||5|||||| |RA|File Number|02AX04000478 AM|25|||||||| |||||||||||| |Lic Dat|ence No and e|0211007515/28/10/2|024|||||||| |Nor T 4|ms Committee Decision: he Committee considered the ca .07 of HBP Vol. I as per details g||se as per age iven below or||nda and it wa as applied by||s decided to fix ad-hoc n the firm, whichever is les||orms under Para s:-||

Case No.	115 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	WEST BENGAL CHEMICAL INDUSTRIES LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003915AM25
RA File Number	02AX04000478 AM25
Licence No and<br>Date	0211007515/28/10/2024
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:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Ferric Maltol	1 kg	1	Maltol	0.962 kg

umar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Ferric Maltol	1 kg	1	Maltol	0.962 kg

R	Export Product	Export Product	Qty.		Sl. No.		Import Ite	Import Ite	ms	Qty. a	llowed.
	Ferric Maltol		1 kg		1
							Maltol			0.96	2 kg
	A concerned may take further ne			cessary action		as per above			decision of NC.


Cas	e No.	116 / NC/3/MEET/M		ay/202526/3
Cas	e Status	Case Approved
Par	ty Name	LEBEN LABORAT		ORIES PRIVAT		E LIMITED
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ May/		202526/ 3 and		04/06/2025
HQ	File Number	HQRNORM APPLY		00003926AM2		5
RA	File Number	03AX04003723 AM		25
Licence No and<br>Date	ence No and<br>e	0311038315/29/10/2		024

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 item in meeting No. NC/3/MEET/Mar/202425/19 dated 27/03/2025 against advance
authorization No.0311036028 dated 05/08/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>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.
	Export Product				Qty.			Sl. No.	Import Items		**Qty.

y the firm, whichever is less:- Export Product Qty. Sl. No.Import Items Qty. allowed.||||||||||||| ||Export Product||||Qty.|||Sl. No.||Import Items||Qty. allowed.| |||||||||||||| |||||||||||||| ||Alclox-250 C |apsule. Cloxacillin |||1376235 |||1||Cloxacillin Sodium BP ||382.52 kg.| ||Sodium Caps ((Each Capsu |ules USP 250 mg. le Containing |||Numbers|||||Compacted||| ||Cloxacillin S |odium BP Equivalent ||||||||||| ||To 250 mg o |f Cloxacillin). Net ||||||||||| ||content of Im used|port/Exempt Material||||||||||| ||In Export Products 1) Cloxacillin Sodium BP (Compacted) -291.405 kgs (Excluding 2% Wastage).)|||| |||||||| ||Alclox-500 Capsule . Cloxacillin||||6389248|||2||Cloxacillin Sodium BP||3551.78 kg.| ||Sodium Capsules Usp 500 mg. ((Each Capsule Containing Cloxacillin sodium BP equivale|||nt|Numbe|rs||||Compacted||| ||||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

|||nt|Numbe|rs||||Compacted||| ||||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

to 500 mg of cloxacillin).Net<br>content of import/Exempt material<br>used in Export Products 1)<br>Cloxacillin Sodium Bp<br>(Compacted) -1774.941 kgs<br>(Excluding 2% Wastage).)<br>Alclox -125 Syrup. Cloxacillin<br>Socium for Oral Solution USP<br>((Each 5ml Contains Cloxacillin<br>sodium BP equivalent to 125 mg<br>of cloxacillin). Net content of<br>import/Exempt material used in<br>Export Product 1) Cloxacillin<br>Sodium Bp (Compacted) -57.33<br>Kgs (Excluding 2% Wastage ).)<br>21000<br>Numbers<br>3<br>Cloxacillin Sodium BP<br>Compacted<br>58.48 kg.<br>RA concerned may take further necessary action as per above decision of NC.	to 500 mg of cloxacillin).Net<br>content of import/Exempt material<br>used in Export Products 1)<br>Cloxacillin Sodium Bp<br>(Compacted) -1774.941 kgs<br>(Excluding 2% Wastage).)
	Alclox -125 Syrup. Cloxacillin<br>Socium for Oral Solution USP<br>((Each 5ml Contains Cloxacillin<br>sodium BP equivalent to 125 mg<br>of cloxacillin). Net content of<br>import/Exempt material used in<br>Export Product 1) Cloxacillin<br>Sodium Bp (Compacted) -57.33<br>Kgs (Excluding 2% Wastage ).)	21000<br>Numbers	3	Cloxacillin Sodium BP<br>Compacted	58.48 kg.

Case No.	Case No.	117 / NC/3/MEET/May/202526/3	117 / NC/3/MEET/May/202526/3	117 / NC/3/MEET/May/202526/3	117 / NC/3/MEET/May/202526/3	117 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00003937AM25
RA File Number		08AX04001290 AM25
Licence No and<br>Date		0811013104/29/10/2024
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 item in meeting No. NC/3/MEET/Mar/202324/26 dated 22/03/2024 against advance<br>authorization No.0311031277 dated 16/02/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>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>Indapamide SR 1.5 mg Tablets<br>(Indapamid heumann 1.5 Mg Tablets)<br>(Each Film Coated Sustained Release<br>1 Number<br>1<br>Indapamide EP<br>1.53 mg/Tablet
	Export Product		Qty.	Sl. No.	Import Items<br>	**Qty.

apamid heumann 1.5 Mg Tablets) (Each Film Coated Sustained Release 1 Number 1 Indapamide EP 1.53 mg/Tablet||||||| ||Export Product||Qty.|Sl. No.|Import Items |Qty. allowed.| ||Indapamide SR 1.5 mg Tablets (Indapamid heumann 1.5 Mg Tablets) (Each Film Coated Sustained Release||1 Number|1|Indapamide EP |1.53 mg/Tablet|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Tablet Contains: Indapamide PH.
EUR.1.5MG. Net Content of Active
Ingredient Indapamide EP Should Not
Be Less Than 84.00 Kgs.)
Indapamide Tablets 2.5 Mg	1 Number	2	Indapamide EP	2.55 mg./Tablet
(Indapamid heumann 2.5 Mg Tablets)
(Each Film Coated Tablet Contains :
Indapamide PH. EUR. 2.5 Mg
Equivalent to Indapamide In Net
Content of Active Ingredient
Indapamide EP Should Not Be Less
Than 112.050 Kgs.)

Case No.	118 / NC/3/MEET/May/202526/3
Case Status	Case Deferred
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003943AM25
RA File Number	09AX04000560 AM25
Licence No and<br>Date	0911008287/29/10/2024
Norms Committee Decision:
The case is under consideration and TE was requested to expedite his comments.

|RA File Number|09AX04000560 AM25| |Licence No and Date|0911008287/29/10/2024| |Norms Committee Decision:|| |The case is under consideration and TE was requested to expedite his comments.||

Case No.	119 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	KOPRAN LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003946AM25
RA File Number	03AX04003754 AM25
Licence No and<br>Date	0311038370/30/10/2024

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Dec/202425/12 dated 10/12/2024 against advance authorization No . 0711011477 dated 06/06/2024, 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 . 0711011477 dated 06/06/2024, 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.
Amoxicillin 250mg and Flucloxacillin<br>250 mg Capsules (Macropen 500 Mg<br>Capsules (Each Capsule Contains<br>Amoxicillin Trihydrate Equivalent to<br>250 mg of Amoxicillin and<br>Flucloxacillin Sodium Equivalent to<br>250mg of Anhydrous Flucloxacillin))	1 Number<br>Capsule	1	Amoxicillin Trihydrate	292.68 mg / Capsule
		2	Flucloxacillin Sodium	277.47 mg / Capsule
Amoxicillin 125 Mg and Flucloxacillin<br>125 Mg Oral Solution, 100 Ml Bottle<br>(Macropens 100 Ml Syrup) (Amoxicillin<br>125mg/5ml & Flucloxacillin 125mg/5ml<br>Oral Solution,100ml Bottle (Macropen S<br>100 ml syrup) (Each 5ml Contains<br>Amoxicillin Trihydrate Equivalent to<br>125 mg of Amoxicillin and<br>Flucloxacillin Sodium Equivalent to 125<br>mg of Anhydrous Flucloxacillin))	<br> <br> <br> <br>1 Number<br>Bottle	3	Amoxicillin Trihydrate	3012.83 mg/Bottle
		4	Flucloxacillin Sodium	2856.33 mg / Bottle

llin Sodium Equivalent to 125 mg of Anhydrous Flucloxacillin))| 1 Number Bottle|3|Amoxicillin Trihydrate|3012.83 mg/Bottle| |||4|Flucloxacillin Sodium|2856.33 mg / Bottle|

Case No.	120 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003948AM25
RA File Number	08AX04001293 AM25
Licence No and<br>Date	0811013115/30/10/2024
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 item in meeting No. NC/3/MEET/Aug/202425/8 dated 28/08/2024 against advance

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

authorization No . 0811011225 dated 04/04/2024, 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.
Metamizole Sodium,<br>Pitofenone Hydrochloride<br>&Fenpiverinium Bromide<br>Tablets. (Spasmalin Tablets<br>500mg). (Each coated tablet<br>contains 500 MG of<br>Metamizole Sodium B P mg<br>Excipients...as per q.s. Net<br>content of Metamizole Sodium<br>B P should not be less that<br>20000.00 kg in export item.)	1 Number	1	Metamizole Sodium B.<br>P.	510 mg/Tablet

Case No.	Case No.	121 / NC/3/MEET/May/202526/3	121 / NC/3/MEET/May/202526/3	121 / NC/3/MEET/May/202526/3	121 / NC/3/MEET/May/202526/3	121 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00003949AM25
RA File Number		08AX04001303 AM25
Licence No and<br>Date		0811013116/30/10/2024
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 item in meeting No. NC/3/MEET/Feb/202425/17 dated 25/02/2025 against advance<br>authorization No.0811009637 dated 11/10/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>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>Co-Careldopa Tablets 250 MG<br>+ 25 MG ( TIDOMET /<br>1 Number<br>1<br>LEVODOPA BP<br>255.0 mg./Tablet
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Co-Careldopa Tablets 250 MG<br>+ 25 MG ( TIDOMET /		1 Number	1	LEVODOPA BP	255.0 mg./Tablet

5.0 mg./Tablet||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Co-Careldopa Tablets 250 MG + 25 MG ( TIDOMET /||1 Number|1|LEVODOPA BP|255.0 mg./Tablet|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

TIDOMET FORTE, Levodopa 250 Mg + Carbidopa 25 mg Tablets) (Each uncoated tablet contains Levodopa BP 250 Mg

Case No.	122 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003950AM25
RA File Number	05AX04002498 AM25
Licence No and<br>Date	0511028660/30/10/2024
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 item in meeting No. NC/3/MEET/Aug/202425/8 dated 28/08/2024 against advance<br>authorization No.0511015566 dated 01/11/2022, it was decided to fix ad-hoc norms under Para 4.07 of<br>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>Mydrimax Eye Drops 5ml<br>Vials (Each ml contains<br>Tropicamide 0.8% )<br>1 Number<br>1<br>Tropicamide<br>40.8 mg / 5ml<br>Vial<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	123 / NC/3/MEET/May/202526/3
Case Status	Case Approved

picamide 40.8 mg / 5ml Vial RA concerned may take further necessary action as per above decision of NC.||

Case No.	123 / NC/3/MEET/May/202526/3
Case Status	Case Approved

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

Party Name	NEOGEN CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003959AM25
RA File Number	03AX04003719 AM25
Licence No and<br>Date	0311038388/30/10/2024
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 item in meeting No. NC/3/MEET/Mar/202425/19 dated 27/03/2025 against advance<br>authorization No.0311034124 dated 27/05/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>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>ETHYL ISOBUTYRATE<br>1 kg.<br>1<br>ISOBUTYRIC ACID<br>0.948 kg<br>RA concerned may take further necessary action as per above decision of NC.

l. No.** Import Items Qty. allowed. ETHYL ISOBUTYRATE 1 kg. 1 ISOBUTYRIC ACID 0.948 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	124 / NC/3/MEET/May/202526/3	124 / NC/3/MEET/May/202526/3	124 / NC/3/MEET/May/202526/3	124 / NC/3/MEET/May/202526/3	124 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00003962AM25
RA File Number		05AX04001685 AM25
Licence No and<br>Date		0511028475/30/10/2024
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 item in meeting No.NC/3/MEET/Jun/202324/6 dated 14.06.2023 against advance<br>authorization No.0511017678 dated 09.03.2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>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>1<br>CITRIC ACID<br>0.726 kg<br>TRI ETHYL CITRATE<br>1 kg
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	TRI ETHYL CITRATE		<br>1 kg	1	CITRIC ACID	0.726 kg

CITRIC ACID 0.726 kg TRI ETHYL CITRATE 1 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||TRI ETHYL CITRATE|| 1 kg|1|CITRIC ACID|0.726 kg|

Case No.	Case No.	124 / NC/3/MEET/May/202526/3	124 / NC/3/MEET/May/202526/3	124 / NC/3/MEET/May/202526/3	124 / NC/3/MEET/May/202526/3	124 / NC/3/MEET/May/202526/3
Case Status		Case Approved
Party Name		KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number		HQRNORM APPLY 00003962AM25
RA File Number		05AX04001685 AM25
Licence No and<br>Date		0511028475/30/10/2024
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 item in meeting No.NC/3/MEET/Jun/202324/6 dated 14.06.2023 against advance<br>authorization No.0511017678 dated 09.03.2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>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>1<br>CITRIC ACID<br>0.726 kg<br>TRI ETHYL CITRATE<br>1 kg
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	TRI ETHYL CITRATE		<br>1 kg	1	CITRIC ACID	0.726 kg

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

HYL CITRATE|| 1 kg|1|CITRIC ACID|0.726 kg|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 20-Jun-2025 10:15:38 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00156044AM26

(TEC)		2	DENATURED ETHYL	0.526	kg
			ALCOHOL

Case No.	125 / NC/3/MEET/May/202526/3
Case Status	Case Approved
Party Name	NEOGEN CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202526/ 3 and 04/06/2025
HQ File Number	HQRNORM APPLY 00003964AM25
RA File Number	03AX04003631 AM25
Licence No and<br>Date	0311038397/30/10/2024
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<br>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 I

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 8081 --apply.