IN FORCE Advance Authorisation

DGFT Minutes

Reliability

In force — no superseding record on file.

Document text

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Government of India/HRTGRPR Ministry of Commerce and Industry/@ UNAS a TAATea Department ofCommerce/aifsorsaaHrt Directorate General ofForeignTrade, Delhi aeReaORAe Aes faecht VANUYA BHAWAN, AKBAR ROAD,CENTRAL DELHI, DELHI,11001 1/4[USTHEH,] HRS Afgaceh Email Office : dgft@nic.in, Phone Office :011-23062777

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Minutes of Meeting Meeting Date -25/04/2025

Meeting No -NC/3/MEET/Apr/202526/1

Minutes of the Norms Committee-3 Meeting No.NC/3/MEET/Apr/202526/1 dated 25/04/2025, 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 Chapter 29 and 30.

The following members were present in the Meeting:-

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||||||
|---|---|---|---|---|
|Sl. No.||Name &|[ Designation]|Department|
|atl|Shri Dinesh Narain Mathur, Technical Expert|Consultant (Pharma)|
|Shri Shaish Kumar,|Technical Expert|Consultant|(Chemical)|
|Shri Nand Lal,|Technical|Expert|Consultant|(Chemical)|
|ae|Shri Raman Kumar, Deputy DGFT|DGFT (HQ)|
|Shri Uttam Dey|Sarkar, ASO|DGFT (HQ)|

----- End of picture text -----

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

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.

3 RAs shall also ensure that authorization is issued or redeemed based on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less. In this regard, full compliance with the provisions of Para 4.12 of FTP, Para 4.16, Para 4.21, and Para 4.51 of HBP shall be made. RAMAN KUMArrade sseesBonenpoms STSin Ministy a AIT, New O°

RAFileNumber:<br>[NA<br>[LicenseNumber:<br>[NA<br>Dateof<br>aneNA<br>Issued:	i.	ee
ic ee<br>te ed ot		ee<br>eee<br>oe<br>eea
eirrcc:<br>[sooo		_
ee<br>eee ee<br>ee
observed that the firm vide e-mail	dated	24/04/2025 has informed that their purchase order was cancelled
andrequested towithdrawathe applicationfrom portal. Therefore, it wasdecided to closetheapplicationof<br>efirm.

24/04/2025 has informed that their purchase order was cancelled| |andrequested towithdrawathe applicationfrom portal. Therefore, it wasdecided to closetheapplicationof efirm.|||

092404000573AM18a Me Biea Authorisation 16/02/2018 Issued: Chemical and Allied Products Sa ca ac EE ar Decision: The Committee considered the request of firm for fixationCreof ad-hoc norms andCERESit 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:allowed. Teed 4 Dimethyl Aminopyridine |hd1kg. [2|ied1 |[Cp[4-Cyanopyridine] ac? HCI33%) |i| 1.0 kg.“3 [4 |[Dimethylamine] eee[6 2[Toluene =:40% SolutionS|:| _1.5 0.2Kkg. RA concerned may take further necessary action as per above decision of NC.

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|||
|---|---|
|HQRNORMREV1W00005058AM25|
|Authorisation|04/05/2018|
|Issued:|
|"llce,|
|AppliatonBass|
|Manufacturer|Exporter|
|Private|Limited|

----- End of picture text -----

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e|Limited|


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Decision: The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. | as per details given below or as applied by the firm, whichever is less:- 

**==> picture [434 x 111] intentionally omitted <==**

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```text
||||||
|---|---|---|---|---|
|No.|
|4|Dimethyl|Aminopyridine|-|
|60%|solution|
|Solution|
|||6|[Toluene|||~—sO.12kg|

----- End of picture text -----

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

MeetingNo:NC/3/MEET/Apr/202526/1

Date:25/04/2025 |CaseNo:4/NC/3/MEET/Apr/202526/1

|HQFileNumber:|HQRNORMREVIW00005226AM25|||||
|---|---|---|---|---|---|
|RAFileNumber:||052404000616AM20||:|-||
|LicenseNumber:|/|0510413195|||||
|Dateof||.||||
|Authorisation|03/01/2020|||||
|Issued:||||||
||Office oftheAdditional Director General|ofForeign Trade,CLADelhi||||
||0599018461|||||
||TOJO VIKAS INTERNATIONAL PRIVATE LIMITED|||||
||4,ADCHINI,,DELHI,1 10017.|||||
||10017|||||
|TypeofLicense:||Advance LicencewithAUCondition|||||
|ApplicationBasis:||Export Order|||||
|ExporterType||||||
|ExportProdut<br>Group:|| cjeenicelandiAllied Products||||:|
|CIF'Valucofthe<br>License:|34512000|||||
|CIFFCC:|480000|||||
|FOBValue:|50330000|||-||
|FOBFCC:||||||
|Decision:<br>TheCommitteeconsidered thecaseas perthe agenda.

jeenicelandiAllied Products||||:|
|CIF'Valucofthe<br>License:|34512000|||||
|CIFFCC:|480000|||||
|FOBValue:|50330000|||-||
|FOBFCC:||||||
|Decision:<br>TheCommitteeconsidered thecaseas perthe agenda. Afterdeliberation,|||deliberation, thecommitteedecided|||
|to seek information from the firm on use ofexport product with all details.||||||
|||ye<br>-||R||
|||i>!VES 98?<br>ee<br>eigenod?<br>Atego ore 6ot&OAS SI<br>oPetoCONTSoreae<br>ae<br>Cae,en||||

|HQFileNumber:<br>|HQRNORMREVIW00005059AM25||
|---|---|
|RAFileNumber: _ |092404000306AM21|E|
|LicenseNumber:<br>[0910069226||
|"nwESS<br>Authorisation<br>21/09/2020<br>Issued:||
|ee<br>al.<br>ee||
|Private Limited||
|ChemicalandAlliedProducts||

Decision: The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

No. allowed. Solution

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

	094A04000085AM22
	0911000683
Authorisation<br>Issued:	Res<br>15/04/2021	aes
ie	ee	ee ee	ee
	Chemical and Allied Products
			=
38795500<br>aneTaeOR

Decision: The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. | as per details given below or as applied by the firm, whichever is less:-

dered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. | as per details given below or as applied by the firm, whichever is less:-

|4Dimethyl Aminopyridine|Dimethyl Aminopyridine|1|kg.|No.<br> ae|eS Sec|eS Sec|
|---|---|---|---|---|---|---|
||||||Solution||
|||||[6|[Toluene|S|.2kg|

	09AA04002898AM22
[LicenseNumber:[0911000881<br>Dateof<br>pcan<br>Issued:	[0911000881<br>20/05/2021	Seg ley eeSe<br>NE<br>= ee<br>eer ieetLi
re	aa		a	OSSa
	Chemical and Allied Products
		‘
	77591000

| Export Product___—| Qty. [SLNo.| _Importltems _| Qty. allowed. | Solution | 6 |[Toluene] —s || O.2ke

|HQRNORMREVIW00004581AM25<br>jRAFileNumber:<br>|034AX04000276AM23||7|-|
|---|---|---|---|
|Dateof||||
|Issued:||||
|Decision: TheCommitteeconsidered therequest offirm for fixation of ad-hoc normsand itwas||||
|ad-hoc norms under Para 4.07 ofHBP Vol. I asper details given below orasapplied||by|the|
|hichever is less:-||||
|SULPHONIC ACID|BENZALDEHYDE|||
||BISULPHITE(SMBS)|||

Decision: The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, hichever is less:-

dered the request of firm for fixation of ad-hoc norms and it was decided to ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, hichever is less:-

[MeetingNo:NC/3/MEET/Apr/202526/ 1

[Date:25/04/2025 [CaseNo:9/NC/3/MEET/Apr/202526/ ]

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|||||
|---|---|---|---|
|08/12/2022|
|Issued:|
|<2Authorisation ane:See|eee|
|Plot NoSSand4STSIIC,MEDAK,502279.|
|502279|
|Advance|Licence|with AU|Condition|

----- End of picture text -----

Decision: The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:No. 60 mg / ml (300 mg / 5 ml camelsolution A A es: Tobramycin for Inhalation | Number 2 Tobramycin Sulfate | 466.49 mg. ml Sa 4 = RA concerned may take further necessary action as per above decision of NC.

|Dateof<br>Simin * <br>Issued:|fa|||\|
|---|---|---|---|
|Be|OfficeoftheAdditionalDirectorGeneralofForeign Trade, Hyderabad<br>eeee ee|ee||
||69,HYDERABAD,500033.|||

Co i a ae a Gl aes) Decision: The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:No. METHYL ESTER ETHYL BENZENEAMINE PENTONOATE eeSodium Sulfite ae oe

	0411065084
Authorisation	21/03/2023
Issued:
	Chemical and Allied Products
		7
	89745232

. METHYL ESTER ETHYL BENZENEAMINE PENTONOATE eeSodium Sulfite ae oe

	0411065084
Authorisation	21/03/2023
Issued:
	Chemical and Allied Products
		7
	89745232

|Para 4.07 ofHBP Vol. | as per details given below orasapplied|bythe firm, whichever is less:-|
|---|---|
|| _ExportProducts| Qty. |SLNo. |<br>Aeee<br>et|_ImportItems _| Qty.allowed. ||

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|||||
|---|---|---|---|
|03AX04006291AM23|
|0311022549|
|Dateof|eo eeone|=|et|
|29/03/2023|,|
|Issued:|
|SSCSCSCS~SSSC*d|
|[StausofEporer|[ManuowerEwporer|
|Chemical|and|Allied|Products|
|2409121|

----- End of picture text -----

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:-

Sanaa i No.a ee eallow e d.s

==> picture [478 x 344] intentionally omitted <==

Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Sanaa i No.a ee eallow e d.s

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||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|_||Authorisation|31/03/2023|
|Issued:|
|arrcc:___|ari559|3|
|ofinformation|provided|by|the|firm|and|it|has|been|observed|by|the|committee|that|export|product|
|“Ambroxan”|(Perfumery|Compound)|as|applied|by|the|firm|appears|to|fall|under|para|4.11(b)|of|FTP,|
|2023,|and|the|said|para|states|that|“For|export|of|perfumes,|perfumery|compounds|and|various|feeding|
|redients|containing|vitamins,|no|authorisation|shall|be|issued|by|Regional|Authority|under|para|4.07|of|
|HBP.|The|applicant|firm|is|requested|to|clarify|how|this|application|comes|under|Para|4.07|of HBP,|and|
|the RA|concerned|is|also|directed|to|provide|their|comments|on|the|same.|

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14 

```text
||Dateof||||
|---|---|---|---|---|
|||15/05/2023|||
|||Office oftheAdditional Director GeneralofForeign Trade,Hyderabad|||
||Re|69, HYDERABAD,500033.<br>OO|ee|ok<br>en|
|||||||
||eirece:<br>[1106558<br>140926000<br>a yes<br>ee<br>ee ee<br>Decision: TheCommitteeconsideredthe request offirm forreview ofad-hoc norms andonthe basisof||||
||information provided bythe firm, itwas decided to revisead-hoc norms as under:-||||
|||||allowed.|
||ESTER||ETHYLBENZENEAMINE||
||||PENTONOATE<br>[4 [Methanol<br>«1133<br>kg||
||||[6|SodiumNitrite<br>|0.94kg||

	5211005254
		sie
Authorisation	25/07/2023
Issued:

a ene__. Se cane

Chemical and Allied Products 91295309

SE | Ss ae ane Ae 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. | SI.No. |ImportItems ——_—'| Qty. allowed. | Aminopropy]]-1-Hmethylethyl) carbamate Pyrazole-3-yl}-2Chlorobenzonitrile)

==> picture [476 x 378] intentionally omitted <==

Product__[ Qty. | SI.No. |ImportItems ——_—'| Qty. allowed. | Aminopropy]]-1-Hmethylethyl) carbamate Pyrazole-3-yl}-2Chlorobenzonitrile)

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||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|LicenseNumber:|{0511020026|
|Authorisation|25/07/2023|
|Issued:|
|it|ee|
|ae|We|
|ofinformation|provided|by|the|firm|and|it|has|been|observed|by|the|committee|that|export|product|
|“Ambroxide”|(Perfumery|Compound)|as|applied|by|the|firm|appears|to|fall|under|para|4.11(b)|of FTP,|
|2023,|and|the|said|para|states|that|“For|export|of perfumes,|perfumery|compounds|and|various|feeding|
|redients|containing|vitamins,|no|authorisation|shall|be|issued|by|Regional|Authority|under|para|4.07|of|
|HBP.|The|applicant|firm|is|requested|to|clarify|how|this|application|comes|under|Para|4.07|of HBP|and|
|the RA concerned|is|also|directed|to|provide|its|comments|on|the|same.|

----- End of picture text -----

MeetingNo:NC/3/MEET/Apr/202526/1

Date:25/04/2025 _|CaseNo:17/NC/3/MEET/Apr/202526/1

|HQFileNumber:||HQRNORMAPPLY00004732AM24|||
|---|---|---|---|
|RAFileNumber:<br>|05AX04001031AM24<br>LicenseNumber-_ [0511019800<br>Dateof||:|;|
|Authorisation|31/07/2023|||
|Issued:||||
||Office oftheAdditional Director General ofForeign Trade,CLADelhi|||
||KELVINNATURAL MINTPRIVATELIMITED|||
||KHASRANO.225-226,Bareilly,243123.|||
|TypeofLicense:|Advance Licence withAUCondition|||
|ApplicationBasis:||ExportOrder|||
||Manufacturer Exporter|||
|ro||||
|Expose |heaiioal<br>Group:|heaiioal anidAlliad Proaaete|||
|License:||||
|CIFFCC:|381916|||
|FOBValue:<br>36748800<br>ie<br>a<br>ee<br>lee ee amar<br>Decision:The firm was called for a Personal Hearing through Video Conference, but the firm could not||||
|appear before the Norms Committee. It was decided to grant one more opportunity to the <br>PersonalHearingwithrelevantdocuments/information.|||firm for a|

LicenseNumber: {0911005577	LicenseNumber: {0911005577
Authorisation	04/08/2023
Issued:

Decision: The representative of the firm had attended the Personal Hearing through Video Concerence and explained the case. The Committee heard the explanation of Representative of the firm and after due deliberation 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:a 65 Grams of Everolimus jrooConsists OR Bd No.haem Bane 28 RA concerned may take further necessary action as per above decision of NC.

given below or as applied by the firm, whichever is less:a 65 Grams of Everolimus jrooConsists OR Bd No.haem Bane 28 RA concerned may take further necessary action as per above decision of NC.

	52AX04000128AM24
	5211005508
Dateof
	21/08/2023
Issued:

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	No.			allowed.
Aminopropy]]-1-H-		1- methylethyl) carbamate
Chlorobenzonitrile)		azodicarboxy	late

	05AX04002297AM24
LicenseNumber: <br>Dateof	[0511022013<br>Th Soe. es oe	nae<br>ae
Issued:
	ChemicalandAlliedProducts

| |Chlorobenzonitrile)||azodicarboxy|late||

	05AX04002297AM24
LicenseNumber: <br>Dateof	[0511022013<br>Th Soe. es oe	nae<br>ae
Issued:
	ChemicalandAlliedProducts

of information provided by the firm and it has been observed by the committee that export product “Ambroxan” (Perfumery Compound) as applied by the firm appears to fall under para 4.11(b) of FTP, 2023, and the said para states that “For export of perfumes, perfumery compounds and various feeding redients containing vitamins, no authorisation shall be issued by Regional Authority under para 4.07 of HBP. The applicant firm is requested to clarify how this application comes under Para 4.07 of HBP and the RA concerned is also directed to provide its comments on the same.

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|||||
|---|---|---|---|
|HQRNORMAPPL|Y00007173AM24|
|LicenseNumber:|[0511022438|—|ar|
|Authorisation|04/12/2023|
|Issued:|
|eee|

----- End of picture text -----

and explained the case. The Committee observed that the representative of the firm could not explain their case due to non availability of technical expert of the firm. Therefore, it was decided that the firm may be called again for Personal Hearing.

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----- Start of picture text ----- [LicenseNumber: [0911006354 Dateof : 18/12/2023 Issued: ap a a ee ----- End of picture text -----

133] intentionally omitted <==**

----- Start of picture text ----- [LicenseNumber: [0911006354 Dateof : 18/12/2023 Issued: ap a a ee ----- End of picture text -----

aa we ee 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:-

No. allowed. Diatrizoate Meglumine And | 1 Number Diatrizoate Sodium Solution USP Sours (Each ML of aqueous, USP flavoured solution provides Diatrizoate Meglumine USP 660 mg & _ Diatrizoate Sodium USP 100 mg Diatrizoate Meglumine And | 1 Number Diatrizoate Sodium Solution Usp ML of aqueous, flavoured USP solution provides Diatrizoate Meglumine USP 660 mg & Diatrizoate Sodium USP 100 meimg 9 aes 5 RA concerned may take further necessary action as per above decision of NC.

23 i

HQRNORMAPPL Y00007500AM24<br>parianeoeoR	HQRNORMAPPL Y00007500AM24<br>parianeoeoR
Saat <br>Authorisation<br>Issued:	one SE aly a ae<br>20/12/2023
	PublicLimited

ision: 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:-

No. Peroxide Gel 1%/5% (Pack Phosphate USP Clindamycin & Benzoyl | 1 Number i ees. ee «| Import Item Sr. No. 1 is 8.75 Peroxide USP Kgs. & Sr. No. 2 is 43.75 Kgs. Peroxide Gel 1%/5% (Pack Phosphate USP Size 35gm) ((Net Wt. of Import Item Sr. No. 1 is 17.50 Hydrous Benzoyl | 1837.50 mg. Kgs. & Sr. No. 2 is 87.50 Peroxide USP Peroxide Gel 1%/5% (Pack Phosphate USP Size S50gm) ((Net Wt. of

|Import Item Sr. No. 1 is 17.50|Hydrous|Benzoyl | 2625.00 mg.|Benzoyl | 2625.00 mg.|
|---|---|---|---|
|Kgs. &<br>Sr.<br>No.<br>2<br>is<br>87.50|Peroxide USP|||
|Kgs.))||||
|Satin a||||
|1% (Pack<br>Size 30gm)<br>(Net|Phosphate USP|||
|Wt. ofImport Item Sr. No. | is||||
|10.50 Kgs.<br>oticatae Bi caer<br>1% (Pack<br>Size 60gm)<br>(Net<br>Phosphate USP<br>Wt. of Import Item Sr. No. | is<br>210.00 Kgs.<br>Adapalene<br>&<br>Benzoyl | 1 Number<br>HYDROUS|||1181.25 mg.|
|Peroxide<br>Gel<br>0.1%/2.5%|BENZOYL|||
|(Pack Size 45gm) (Net Wt. of|PEROXIDE|USP||
|Import<br>Item<br>Sr.<br>No.<br>2<br>is||||
|112.50Kgs.||||

==> picture [472 x 300] intentionally omitted <==

l 0.1%/2.5%|BENZOYL||| |(Pack Size 45gm) (Net Wt. of|PEROXIDE|USP|| |Import Item Sr. No. 2 is|||| |112.50Kgs.||||





25 

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```text
||||||||
|---|---|---|---|---|---|---|
|Authorisation|[21/12/2023|
|Issued:|.|
|a)|
|a|7:|a|
|Decision:The committee considered the request of firm and|it was|decided to|call|for|following|information|
|/documents|from|the|firm:-|
|The commercial value ofbyproducts formed|during the|reaction with evidence (a copy ofinvoice)|

----- End of picture text -----

Note: The committee also decided to hold decision of NC regarding the norms fixed in respect of AA No 0411007898/dated 26/07/2024 in the meeting dated 17.03.2025 for the same export product till further order RA is requested to take action accordingly.

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----- Start of picture text -----

|||||||
|---|---|---|---|---|---|
|0811010331|
|Authorisation|22/12/2023|
|Issued:|
|fee|ee|ee|ee|oe|
|St|aaa|ae|a|ae|ee|
|oe|eae|ee|
|ee tae|

----- End of picture text -----

MeetingNo:NC/3/MEET/Apr/202526/1

Date:25/04/2025 |CaseNo:26/NC/3/MEET/Apr/202526/1

| |fee|ee|ee|ee|oe| |St|aaa|ae|a|ae|ee| |oe|eae|ee| |ee tae|


**----- End of picture text -----**<br>


27 

MeetingNo:NC/3/MEET/Apr/202526/1 

Date:25/04/2025 |CaseNo:26/NC/3/MEET/Apr/202526/1 

```text
|Dateof||||||||
|---|---|---|---|---|---|---|---|
|Authorisation<br>27/12/2023|||||||‘|
|Issued:||||||||
|Office oftheAdditionalDirectorGeneralofForeign||||Trade, Mumbai||||
|0305081002||||||||
|ASHISH LIFESCIENCE PRIVATE LIMITED||||||||
|PLOTJ-137MIDCTARAPUR,PALGHAR,401501.||||||||
|#01501||||||||
|Advance Licence withAU Condition||||||||
|MerchantCum Manufacturer|Exporter|||||||
|tua rT<br>Group:||||||||
|License:||||||||
|9092<br>FOBValue:<br>[6803706<br>FOBFCC:<br>82269||||||||
|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/202425/18 dated 17/03/2025 against||||||||
|advance authorization No.0311025742 dated 25/07/2023,|||it was decided to fix ad-hoc||norms under Para|||
|4.07 ofHBP Vol. I as per details given below or asapplied by thefirm, whichever is less:-||||||||
|Export Product||||||Qty.

5742 dated 25/07/2023,|||it was decided to fix ad-hoc||norms under Para|||
|4.07 ofHBP Vol. I as per details given below or asapplied by thefirm, whichever is less:-||||||||
|Export Product||||||Qty. allowed.||
|TYLOSIN BOLUS 200MG (EACH|<br>BOLUS<br>CONTAINS<br>TYLOSIN|| Number|||TYLOSINTARTRATE||204.00 gm.||
|200MG||||||||
|TYLOSIN INJECTION 5%-50 ML|<br>(EACH ML CONTAINS TYLOSIN|| Number||2|TYLOSINTARTRATE||3.056 gm.||
|TARTRATE<br>EQ.<br>TO<br>TYLOSIN||||||||
|BASE 50MG||||||||
|TYLOSIN INJECTION 5%-100ML||1 Number||3|TYLOSINTARTRATE||||
|(EACH ML CONTAINS TYLOSIN|||||||6.111 gm.||
|TARTRATE<br>EQ.<br>TO<br>TYLOSIN||||||||
|BASE 50MG||||||||
|TYLOSIN TARTRATE INJECTION|<br>20%-50 ML (EACH MLCONTAINS|| Number|||TYLOSINTARTRATE||12.222 gm.||
|TYLOSIN<br>TARTRATE<br>EQ.<br>TO||||||||
|TYLOSIN 200 MG||||||||
|TYLOSIN TARTRATE INJECTION||1 Number||5|TYLOSINTARTRATE||||
|20%-100<br>ML<br>(EACH<br>ML||||||24.444 gm.||
|CONTAINS TYLOSIN TARTRATE||||||||
|EQ. TO TYLOSIN 200MG||||||||
|TYLOSIN TARTRATE POWDER |a<br>100%-100GM_<br>_SACHET<br>(EACH|a|Soe TYLOSINTARTRATE||||101 gm.||
||||28|||||

|||||24.444 gm.|| |CONTAINS TYLOSIN TARTRATE|||||||| |EQ. TO TYLOSIN 200MG|||||||| |TYLOSIN TARTRATE POWDER |a 100%-100GM_ _SACHET (EACH|a|Soe TYLOSINTARTRATE||||101 gm.|| ||||28|||||




```text
|Eee<br>a<br>TYLOSIN<br>TARTRATE<br>POWDER|<br>| Number<br>7<br>100%<br>-500GM SACHET<br>(EACH|Eee<br>a<br>TYLOSIN<br>TARTRATE<br>POWDER|<br>| Number<br>7<br>100%<br>-500GM SACHET<br>(EACH|Eee<br>a<br>TYLOSIN<br>TARTRATE<br>POWDER|<br>| Number<br>7<br>100%<br>-500GM SACHET<br>(EACH|Eee<br>a<br>TYLOSIN<br>TARTRATE<br>POWDER|<br>| Number<br>7<br>100%<br>-500GM SACHET<br>(EACH|TYLOSINTARTRATE|505 gm.|
|---|---|---|---|---|---|
|GRAM<br>CONTAINS’<br>TYLOSIN||||||
|TARTRATE 100%||||||
|TYLOSIN<br>TARTRATE<br>POWDER|<br>100% -IKG JAR (EACH GRAM|||Number|8|TYLOSINTARTRATE|1010 gm.|
|CONTAINS TYLOSIN TARTRATE<br>100%|||||||
|TYLOSIN<br>TARTRATE<br>POWDER|<br>20%-5GM (EACH<br>GRAM|||Number||TYLOSINTARTRATE|1.1756gm.|
|CONTAINS TYLOSIN TARTRATE||||||
|EQ. TO TYLOSIN 20%||||||
|TYLOSIN<br>TARTRATE<br>POWDER|<br>20%<br>-100GM<br>(EACH<br>GRAM|||Number||TYLOSINTARTRATE|23.513 gm.|
|CONTAINS TYLOSIN TARTRATE||||||
|EQ. TO TYLOSIN 20%||||||
|TYLOSIN<br>TARTRATE<br>POWDER|<br>20%<br>-500GM<br>(EACH<br>GRAM|| Number|||TYLOSINTARTRATE|117.564 gm.|
|CONTAINSTYLOSINTARTRATE||||||
|EQ. TO TYLOSIN 20%||||||
|TYLOSIN<br>TARTRATE<br>POWDER|<br>20% -IKG JAR (EACH GRAM|| Number||12|TYLOSINTARTRATE|235.128 gm.|
|CONTAINS TYLOSIN TARTRATE||||||
|EQ.

m.|
|CONTAINSTYLOSINTARTRATE||||||
|EQ. TO TYLOSIN 20%||||||
|TYLOSIN<br>TARTRATE<br>POWDER|<br>20% -IKG JAR (EACH GRAM|| Number||12|TYLOSINTARTRATE|235.128 gm.|
|CONTAINS TYLOSIN TARTRATE||||||
|EQ. TOTYLOSIN 20%||||||
|TYLOSIN<br>TARTRATE<br>POWDER|<br>99%<br>-100GM<br>SACHET<br>(EACH|| Number||13|TYLOSINTARTRATE|100 gm.|
|GRAM<br>CONTAINS’<br>TYLOSIN||||||
|TARTRATE 99%||||||
|TYLOSIN<br>TARTRATE<br>POWDER|<br>99% -500 GM SACHET (EACH||| Number||TYLOSINTARTRATE|500 gm.|
|GRAM<br>CONTAINS’<br>TYLOSIN||||||
|TARTRATE 99%||||||
|TYLOSIN<br>TARTRATE<br>POWDER|<br>99% -IKG JAR (EACH GRAM||| Number||TYLOSINTARTRATE|1000 gm.|
|CONTAINS TYLOSIN TARTRATE||||||
|99%||||||

==> picture [473 x 238] intentionally omitted <==

----- Start of picture text ----- Issued: ee ee a a eee Group: License: ee Se Sn FOB Value: 1485979 1000 ----- End of picture text -----

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. | as per details given below or as applied by the firm, whichever is less:ee ASHOXY 20% LA / OXYVET 20% 543.0 kg. 2 PYRROLIDONE 570.57 kg. LA (OXYTETRACYCLINE INJECTABLE SOLUTION 20% LONG ACTING) PackSOML 2-pyrrolidone) (Nett Wt. of EXEMPTED MATERIAL IS 543.40 KGS) (27500 NOS vial(EACH VIALCONTAINS 19MLHe ASHOXY 20% LA / OXYVET 20% 1343.0 kg. 2 |2PYRROLIDONE | 1410.86 kg. LA (OXYTETRACYCLINE INJECTABLE SOLUTION 20% LONG ACTING) Pack100ML vial(EACH VIAL CONTAINS 38ML 2-pyrrolidone) (Nett Wt.

INS 19MLHe ASHOXY 20% LA / OXYVET 20% 1343.0 kg. 2 |2PYRROLIDONE | 1410.86 kg. LA (OXYTETRACYCLINE INJECTABLE SOLUTION 20% LONG ACTING) Pack100ML vial(EACH VIAL CONTAINS 38ML 2-pyrrolidone) (Nett Wt. of EXEMPTED MATERIAL IS 1343.68 KGS) (34000 NOS ASHOXY 20% LA / OXYVET 20% 494.0 kg. 3. | 2 PYRROLIDONE 518.7 kg. INJECTABLE SOLUTION 20% LONG ACTING) Pack250ML vial((EACH VIAL CONTAINS 95ML 2-pyrrolidone) (Nett Wt. of

EXEMPTED MATERIAL IS 494 KGS) (5000 NOS

==> picture [477 x 249] intentionally omitted <==

----- Start of picture text ----- 01/01/2024 Issued: anAuthorisation aSRe ny eS ee ----- End of picture text -----

No. allowed. USP 50 MG 100 S((54,000 (Monohydrate) Bottles X 100 Per Bottles = 54,00,000 Tablets) (Total Weight of Export Product = 270.00 Kgs) (Net Content weight of Import Product = 298.16 kg USP 100 MG 50 (Monohydrate) S((1,68,000 Bottles X 50 Per Bottles = 84,00,000 Tablets) (Total Weight of Export Product = 840.00 Kgs) (Net Content weight of Import Product = 927.61 kgs

||09AX04000875AM24|
|---|---|
||0911006481|
||||
|Authorisation|03/01/2024|
|Issued:||
|a.ee||
||Chemical and Allied Products|
||111840374|
|2|nteC|

appear before Norms Committee. It was decided to grant one more opportunity to the firm for Personal Hearing with relevant documents/information.

Allied Products| ||111840374| |2|nteC|




appear before Norms Committee. It was decided to grant one more opportunity to the firm for Personal Hearing with relevant documents/information. 

33 

```text
||09AX04000867AM24||||
|---|---|---|---|---|
||0911006493||||
|Authorisation|05/01/2024||||
|Issued:|||||
|Oe|ee|ee|eee ||Oe|
||Chemical and Allied Products||||
||31491512||||
|acas|||||

Decision: The Committee considered the case as per agenda and it was decided to call the firm for attending Personal Hearing before Norms Committee to explain its case along with following information / documents from the firm:

(i) All inputs including packing materials, dyes etc. are in kg. activity which is incorrect (ii) Copy ofMaster Batch Formual showing net content of inputs. (iii) Amended Advance Authorisation to show correct unit of measurement.

	3011004726
Dateof			laa =<br>IO
	29/01/2024
Issued:
Rane	[SCLUIFESCENGESUMTED
aeee<br>ie<br>eel
ae	ChemicalandAllied	AlliedProducts
saa<br>ee	25891710<br>ee	ee	eeee

==> picture [192 x 14] intentionally omitted <==

----- Start of picture text ----- No. allowed. ----- End of picture text -----

as applied by the firm, whichever is less:-

==> picture [192 x 14] intentionally omitted <==

----- Start of picture text ----- No. allowed. ----- End of picture text -----

QUETI-VII-R (Crude quetiapine fumarate)[2-[2-(4-dibenzo [b,f] [1,4] thiazepin-11-yl-1-piperazinyl) ethoxy] ethanolfumarate (2(QUETI-VII-R (Crude quetiapine fumarate) 2-[2-(4dibenzo [b,f] [1,4]thiazepin-11-yl-1piperazinyl) | ethoxy]ethanolfumarate :

==> picture [473 x 285] intentionally omitted <==

----- Start of picture text -----

|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|Authorisation|30/01/2024|
|Issued:|
|es|ee|ee|ee|
|Group:|Chemical and Allied Products|
|ee|
|ge|
|ee|ee|
|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:-|

----- End of picture text -----

To give balance chemical reaction indicating molecular weight of all the reactants and product with stage wise yield of the reaction.
To indicate where Alumino Silicate catalyst, Denatured Ethyl alcohol and methanol are used in the chemical reaction, giving their application/use.
Calculation of the requirement of all the chemicals with justification of low yield, if any. 4. In chemical reaction Ethyl acetate has been shown as one of the reactants whereas the same has neither been shown in import nor in indigenous inputs.

ith justification of low yield, if any. 4. In chemical reaction Ethyl acetate has been shown as one of the reactants whereas the same has neither been shown in import nor in indigenous inputs.

	3411004560
Authorisation	30/01/2024
Issued:
eee	OO		ee	ee
	Chemical and	Allied Products
	63062105
a	ee	oo Lo ea,Se ee
advice oftheTE,	TE, it was decided to call for		following information/documents	from thefirm:-

Copy of Master Batch Formula.

Issued: A RO Se eS Group: License: Saal. a ee "ET WS [4478750 Decision: a ee oe a ae | 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. 3411003884 dated 13/07/2023, 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:ee Acetonide Ointment USP, 1,00,000 oe UNITS / GM; 0.1% - 15 gm Tube Nystatin and Triamcinolone 1 Number 2 Nystatin USP 477.30 mg. SeeUNITS/ GM; 0.1% - 30 gm tube Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 60 gm tube Acetonide Cream USP, 1,00,000 UNITS / GM; 0.1% - 15 gm tube Acetonide Cream USP, 1,00,000 UNITS / GM; 0.1% - 30 gm tube Cream USP, 1,00,000 UNITS / GM: 0.1% - 60 gm tube owesAcetonide | | | | RA concerned may take further necessary action as per above decision of NC.

==> picture [475 x 279] intentionally omitted <==

1,00,000 UNITS / GM: 0.1% - 60 gm tube owesAcetonide | | | | RA concerned may take further necessary action as per above decision of NC.

==> picture [475 x 279] intentionally omitted <==

----- Start of picture text -----

|||
|---|---|
|Authorisation|_|31/01/2024|
|Issued:|
|TEea|
|478293207|
|5677070|
|SER|
|ee|oe|

----- End of picture text -----

. |

==> picture [473 x 223] intentionally omitted <==

----- Start of picture text -----

||||
|---|---|---|
|05AX04003478AM24|
|0511023580|p|
|:|
|Authorisation|01/02/2024|
|Issued:|
|eee|
|ee|se|ee|
|—|Chemical and Allied Products|

----- End of picture text -----

basis ofinformation provided by the firm and it has been observed by the committee that export product “Ambrox/Ambroxide” (Perfumery Compound) as applied by the firm appears to fall under para 4.11(b) of FTP, 2023, and the said para states that “For export of perfumes, perfumery compounds and various feeding redients containing vitamins, no authorisation shall be issued by Regional Authority under para 4.07 of HBP. The applicant firm is requested to clarify how this application comes under Para 4.07 of HBP and the RA concerned is also directed to provide its comments on the same.

==> picture [120 x 67] intentionally omitted <==

----- Start of picture text ----- R wi ET raw New De ----- End of picture text -----

ide its comments on the same.

==> picture [120 x 67] intentionally omitted <==

----- Start of picture text ----- R wi ET raw New De ----- End of picture text -----

Dateof
Authorisation	01/02/2024
	Office oftheAdditional Director GeneralofForeignTrade,Ahmedabad
Group:
cyano	[anizrr
heme (ee<br>Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 ofHBP Vol. I as per details given below or as applied by the firm, whichever is
less:-

No. 100000 units / gm, 15gm | Numbers statin Micronized (15gm Tube) (Each gram 2 | ALUMINUM TUBES[|][As][per][packing] Contains: 100,000 USP AND CAPS FOR| policy and Nystatin Units in an NYSTATIN CREAM| General Notes. aqueous, cream base. Net USP 100000 15G content of Nystatin should not be less than 84.270 Kg and Each finish products contain ALUMINUM TUBES AND CAPS not Numbers in export item 100000 units / gm, 30gm | Numbers (Nystatin Micronized[)] ee Contains: 100,000 USP AND CAPS FOR| policy and Nystatin Units in an NYSTATIN CREAM[|][General][Notes.] aqueous, creambase. Net USP 100000 30G

;

content of Nystatin should not be less than 529.696 Kg and Each finish products contain ALUMINUM TUBES AND CAPS not be less than 1100000 Numbers in export item

aaee ee Director 5 toll 5 Bac ‘ Trade Directorate General of Foreign Trade meeery of Commerce & industry Vanijya 6haw New Delhi

==> picture [477 x 199] intentionally omitted <==

aaee ee Director 5 toll 5 Bac ‘ Trade Directorate General of Foreign Trade meeery of Commerce & industry Vanijya 6haw New Delhi

==> picture [477 x 199] intentionally omitted <==

----- Start of picture text -----

||||||
|---|---|---|---|---|
|Dateof|
|Issued:|
|hos|tee|ee|ee|ee|
|renroiiet|chemi and Allied Products|

----- End of picture text -----

==> picture [452 x 56] intentionally omitted <==

----- Start of picture text -----

|||||||||
|---|---|---|---|---|---|---|---|
|[Export Product|[Qty.|||SLNo.|||Importitems|_—__—|_ Qty.|allowed._||
|GRADE|96%|

----- End of picture text -----

==> picture [160 x 77] intentionally omitted <==

----- Start of picture text -----

|||
|---|---|
|HQFiieNumber|
|03AX04004941AM24|
|0311030679|
|Authorisation|05/02/2024|
|Issued:|

----- End of picture text -----

==> picture [473 x 118] intentionally omitted <==

----- Start of picture text -----

|||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Chemical|and|Allied|Products|
|121023311|
|a|<a|a|eS|
|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:-|

ion:|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:-|


**----- End of picture text -----**<br>


1. Compostion of export item duly approved by Department of Ayush. 2. Copy of Master Batch Formula for each export. 

44 

|Authorisation|06/02/2024|
|---|---|
|Issued:||
|**e**e|e<br>eee ee|
||98575048|
||Tat|



45 

**==> picture [471 x 277] intentionally omitted <==**

**----- Start of picture text -----**<br>
Issued:<br>Office ofthe Additional Director General of Foreign Trade,CLADelhi<br>EE CC ae ee Te<br>Group:<br>leirrcc: [54800<br>a eee 9 ee<br>ne i i acres<br>Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is<br>less:-<br>**----- End of picture text -----**<br>


|___ExportProduct_ | Qty. | SLNo. | _ImportItems | Qty. allowed. | Amoxicillin for Oral 75000 Amoxicillin 221.1 kg. Suspension USP | Numbers Trihydrate USP 125MG/SML, 100ML (Each Bottle Contain Amoxicillin Trihydrate USP is 2.948 Gram. Total Qty of Amoxicillin Trihydrate USP is 221.10 Kgs Suspension USP | Numbers Trihydrate USP 12SMG/SML, 60ML (Each Bottle Contain Amoxicillin Trihydrate USP is 1.768 Gram. Total Qty of Amoxicillin Trihydrate USP is 283.06 Kgs Suspension USP | Numbers Trihydrate USP 250MG/SML, 60ML (Each Bottle Contain Amoxicillin aed 

46

ain Amoxicillin Trihydrate USP is 1.768 Gram. Total Qty of Amoxicillin Trihydrate USP is 283.06 Kgs Suspension USP | Numbers Trihydrate USP 250MG/SML, 60ML (Each Bottle Contain Amoxicillin aed 

46 

Trihydrate USP is 3.537 Gram. Total Qty of Amoxicillin Trihydrate USP is 594.04 Kgs 


47 

: 

**==> picture [474 x 301] intentionally omitted <==**

**----- Start of picture text -----**<br>
```text
|||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|06/02/2024|
|Issued:|
|aAuthorisation|ESeo|
|eS|
|a?|a|
|—|Chemical and Allied Products|
|nS|ee|eee ee|
|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:-|

----- End of picture text -----

Complete Technical details as per Annexure to Appendix 4E.
Production/ Comsuption Data duly certified by Chatered Accountant.

0711010455 Dateof Se ee, eee Issued: Chemical and Allied P roducts avemoe, aeSpo ee ee me ee ee 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. 0711011646 dated 25/06/2024, 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:-

==> picture [355 x 91] intentionally omitted <==

024, 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:-

==> picture [355 x 91] intentionally omitted <==

----- Start of picture text -----

|||||||
|---|---|---|---|---|---|
|No.|
|(as|Ascorbic|Acid)|-60mg (248.500|DC|97 Percentage|
|KGS) +Iron|(From|Ferrous|SF|I.H|
|Bisglycinate|Chelate-|24mg|(441.000|
|KGS)|With|Other Essential|Vitamins|BISGLYCINATE|
|&|Minerals|(No|of Tabs-3500000|

----- End of picture text -----

Leman Oa<br>ee<br>ee<br>a ee<br>Authorisation<br>08/02/2024<br>Issued:
a<br>verR GaSe
——<br>ChemicalandAlliedProducts
base<br>95667282<br>eae"ee

Decision: The Committee considered the case as per the agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Mar/202425/8 dated 17/03/2025 against advance authorization No. 5211003710 dated 07/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:No. Aminopropyl]-1-Hmethylethyl)carbamate 0.826 kg. Pyrazole-3-yl}-2-Consens ari) Bie2 StamnesisDiisopropy] azodicarboxylate a = ==(1.237 kg RA concerned may take further necessary action as per above decision of NC.

Qn pias

Dateof
Issued:
ime	a		ee	i
Se:	ee	ee	a i		eS!
Group:

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

Qn pias

Dateof
Issued:
ime	a		ee	i
Se:	ee	ee	a i		eS!
Group:

No. allowed. Lapox ARD-12 (Reactive Diluents) | | kg. (4-ter-Butylphenol glycidyl ether)

=a<br>Authorisation<br>Issued:	cele<br>14/02/2024	ern	ee

Chemical and Allied Products ogee ae oe ae PRO OPN OT a a ee ad 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: -

No.

Levofloxacin USP/EP/BP

MeetingNo:NC/3/MEET/Apr/202526/1

Date:25/04/2025 |CaseNo:47/NC/3/MEET/Apr/202526/1

==> picture [489 x 609] intentionally omitted <==

----- Start of picture text -----

||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|HQFileNumber:|HQRNORMAPPLY0000866 1AM24|
|RAFileNumber:|07AX04001821AM24|
|O71101059|
|Date|ofAuthorisation|
|Issued:|
|Office|of|the Additional|Director General|of|Foreign|Trade,Bengaluru|
|0788016849|
|,|GLOBAL CALCIUM|PRIVATE|LIMITED|
|882Calcium|House 6"|Cross|6th|Block,Bangalore,560095.|
|560095|
|TypeofLicense:|Advance|Licence with AU|Condition|
|ApplicationBasis:|Export Order|
|Manufacturer Export|
|ExporerType|
|An-oeeeaaaala|Chemical and Allied Products|
|Group:|
|CiFValucofthe|29784060|
|License:|
|CIFFCC:|354150|
|FOBFOBFCC: Value:|Roh36165096|ee|ree aie|oe|
|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.|||SI. No. ||Import Items|Qty.|allowed.|
|Calcium|Citrate|Malate|USP|1|kg.|Citric|Acid|0.500|kg.|
|DL-Malic|Acid|0.477|kg.|
|Calcium|Carbonate|0.720|kg.|
|RA|concerned|may|take|further|necessary|action|as|per|above|decision|of NC.|

----- End of picture text -----

==> picture [474 x 248] intentionally omitted <==

ate|0.720|kg.| |RA|concerned|may|take|further|necessary|action|as|per|above|decision|of NC.|


**----- End of picture text -----**<br>


53 

**==> picture [474 x 248] intentionally omitted <==**

**----- Start of picture text -----**<br>
```text
|||||
|---|---|---|---|
|Authorisation|21/02/2024|
|Issued:|
|St a|See ee|
|License:|
|Sell a|a|i|eS|
|Gee se|ee|ee|||

----- End of picture text -----

Issued:
		Officeofthe Joint DirectorGeneral ofForeign Trade,Indore
me		eee
Group:
License:
eee<br>Decision:	The	ee<br>Committeeconsideredthecaseasperagendaanditwas

ision: 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:-

allowed. Sodium Dichloroisocyanurate | 1 Number 1 Sodium 3.57 mg. Dichloroisocyanurate Tablets 3.5 mg Tablets 33 mg (Sodium Dichloroisocyanurate Dichloroisocyanurate Tablets 33 mg Stat Tablets 67 mg (Sodium Dichloroisocyanurate Dichloroisocyanurate Tablets 67 mg Sodium Dichloroisocyanurate 1 Number 4 Sodium 170.34 mg. Tablets 167 mg (Sodium Dichloroisocyanurate 167 mg Tablets 1.67 gm (Sodium Dichloroisocyanurate Dichloroisocyanurate Tablets a1.67 gm | |

Sodium Dichloroisocyanurate | 1 Number Tablets 2.5 gm (Sodium Dichloroisocyanurate Tablets 2.5 gm

Sodium 2.55 gm. Dichloroisocyanurate

RAMAn KUMAR <A gar! TIE orelonATT S co aaa ore eoreist a- ore eat Sarco &

Dateof , Issued: 5 Sal, Sa a LO ee aE TORREY WE ee a ee 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:-

|RAFIleNumber. _|03AX0400S401AM24<br>LicsseNumber_ 0311031303<br>Dateof|>,|
|---|---|
|Authorisation<br>27/02/2024||
|Issued:ee<br>ee<br>en<br>ee||
|EAD<br>|<br>sesnioalsaAltiedProducts<br>Group:||
|CIFValueofthe<br>139534968<br>License:||

er_ 0311031303<br>Dateof	>,
Authorisation<br>27/02/2024
Issued:ee<br>ee<br>en<br>ee
EAD<br>	<br>sesnioalsaAltiedProducts<br>Group:
CIFValueofthe<br>139534968<br>License:




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:- 

No. Clindamycin & Benzoyl | 1 Number Clindamycin 262.50 mg. Peroxide Gel 1%/5% (Pack Size Phosphate USP 25gm ) ((Net Wt. of Import Item 2 Hydrous_ _ Benzoy! 1312.50 mg. Sr. No. 1 is 17.50 Kgs. & Peroxide USP Sr. No. 2 is 87.50 Kgs.)) Clindamycin & Benzoyl | 1 Number 3 Clindamycin 367.50 mg. Peroxide Gel 1%/5% (Pack Size Phosphate USP 35gm ) ((Net Wt. of Import Item Sr. No. | is 22.75 Kgs. & 4 |Hydrous Benzoyl! 1837.50 mg. Clindamycin & Benzoyl! | 1 Number 5 Clindamycin 525.00 mg. Peroxide Gel 1%/5% (Pack Size Phosphate USP 50gm ) ((Net Wt. of Import Item Sr. No. 2 is 162.50 Kgs.)) oa lemacter 

58

nzoyl! 1837.50 mg. Clindamycin & Benzoyl! | 1 Number 5 Clindamycin 525.00 mg. Peroxide Gel 1%/5% (Pack Size Phosphate USP 50gm ) ((Net Wt. of Import Item Sr. No. 2 is 162.50 Kgs.)) oa lemacter 

58 

```text
|Clindamycin Phosphate Gel|1%||||1|Number|7|Clindamycin|315.0 mg.|
|---|---|---|---|---|---|---|---|
|(Pack Size 30gm) ((Net Wt. of||||||Phosphate USP||
|Import Item Sr. No.<br>1<br>is|3.00|||||||
|Kgs.||||||||
|Clindamycin Phosphate Gel|1%||||1|Number||Clindamycin|630.0 mg.|
|(Pack Size 60gm) ((Net Wt. of||||||Phosphate USP||
|Import Item Sr. No.<br>1<br>is|6.00|||||||
|Kgs.||.||||||
|Adapalene & Benzoyl Peroxide||||1|Number||Hydrous __Benzoy!|1181.25 mg.|
|Gel<br>0.1%/2.5%<br>(<br>Pack|Size|||||Peroxide USP||
|45gm ) ((Net Wt. ofImport|Item|||||||
|Sr.No.2is11.25Kgs.||||||||

RA concernedmay take further necessary actionas per above decision ofNC.

==> picture [474 x 90] intentionally omitted <==

----- Start of picture text -----

|||
|---|---|
|0311031507|
|Authorisation|27/02/2024|
|Issued:|
|se|
|(RRs0rT|PON|

----- End of picture text -----

==> picture [113 x 57] intentionally omitted <==

----- Start of picture text -----

|||||
|---|---|---|---|
|Chemical|and|Allied|Products|
|258355200|
|3079323|

----- End of picture text -----

entionally omitted <==**

----- Start of picture text -----

|||||
|---|---|---|---|
|Chemical|and|Allied|Products|
|258355200|
|3079323|

----- End of picture text -----

basis ofinformation provided by the firm and it has been observed by the committee that export product “Galaxmusk Pure” (Perfumery Compound) as applied by the firm appears to fall under para 4.11(b) of FTP, 2023, and the said para states that “For export of perfumes, perfumery compounds and various feeding redients containing vitamins, no authorisation shall be issued by Regional Authority under para 4.07 of HBP. The applicant firm is requested to clarify how this application comes under Para 4.07 of HBP and the RA concerned is also directed to provide its comments on the same.

==> picture [148 x 43] intentionally omitted <==

----- Start of picture text ----- 20 c~x —_aphts aesWA ----- End of picture text -----

|<a neseee<br>ere<br>Authorisation<br>01/03/2024<br>Issued:|
|---|
|me<br>eee<br>ee<br>eee|
|Chemical and Allied Products|
|5325364|
|toooYee<br>eee|
|Decision: TheCommitteeconsideredthecaseas peragendaand it was decided to fixad-hoc norms<br>under Para4.07ofHBP Vol. I asper details given below or asapplied by the firm, whichever is less:-|
|[ExportProduct<br>___—=*(|.Qty. | SLNo.| ImportItems_| Qty.allowed._|<br>oe<br>ee<br>15ml (604.72mg/ml) (Net Content<br>ofGadobutrol - 90.708 kg|





61 

Authorisation 01/03/2024 Issued: Se ee Chemical and Allied Products B07 e **e** Decision:e eee es 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._| for Injection 10000 KIU / VIAL and Sodium Chloride Injection BP 0.9% W/V, 2 ML (Combi pack of Aprotinin for Injection 10000 KIU / VIAL and Sodium Chloride Injection BP 0.9% W/V, 2 ML = ie RA concerned may take further necessary action as per above decision of NC. 

62 

```text
||RAFileNumber:||05AX04003809AM24|
|---|---|
|LicenseNumber:||0511024175<br>||
||||
|Authorisation|01/03/2024|
|Issued:||
|eee||
|rome|(ee|
|alsodecidedto|examineallSIONsrelatedtotheexportproduct,Menthol.|

MeetingNo:NC/3/MEET/Apr/202526/1

Date:25/04/2025 |CaseNo:56/NC/3/MEET/Apr/202526/1

2024| |Issued:|| |eee|| |rome|(ee| |alsodecidedto|examineallSIONsrelatedtotheexportproduct,Menthol.|




63 

MeetingNo:NC/3/MEET/Apr/202526/1 

Date:25/04/2025 |CaseNo:56/NC/3/MEET/Apr/202526/1 

```text
|HQFileNumber:||HQRNORMAPPLY000088994M24||
|---|---|---|
|RAFileNumber:||03A4X04005541AM24|pare|
|Dateof|||
|Authorisation|05/03/2024||
|Issued:|||
||OfficeoftheAdditional DirectorGeneralofForeign Trade, Mumbai||
||ASTEC LIFESCIENCES LIMITED||
|GODREJONE,3®” FLOOR,PIROJSHA NAGAR,MUMBAI,400079.<br>ee**e**<br>e<br>Advance Licence withAU Condition|||
|ApplicationBasis:||Export Order<br>.||
||ManuticturerExporer||
||Public Limited||
|Group:|ChemicalandAlliedProducts||
|CTPValucofthe<br>License:|134388562||
|CIFFCC:|409875||
|FOB Value:|49977600||
|FOBFCC|||

==> picture [435 x 108] intentionally omitted <==

----- Start of picture text ----- Export Product Qty. __| SLNo. | Import Items Qty. allowed. 2-@.4-Diluoroephenyl | 1 kg. 0.733 kg 3-Trimethylsilyl-2-I(1 H-1,2,4-Triazole-1YL)- 2 | Chloromethy! 0.788 kg. Propanol (F69) trimethylTriazole- sodiumsilane- salt 0.470 kg. Dimethyl acetamide 0.238 kg. Methyl Cyclo Hexane 0.993 kg. ----- End of picture text -----

==> picture [476 x 309] intentionally omitted <==

umsilane- salt 0.470 kg. Dimethyl acetamide 0.238 kg. Methyl Cyclo Hexane 0.993 kg. ----- End of picture text -----

==> picture [476 x 309] intentionally omitted <==

----- Start of picture text -----

|||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|0911006881|
|Issued:|:|
|cat ee|
|mentioned|in|the|application|is|not|clear.|Therefore,|it was|decided|that|the|firm|may|be|advised|to|correct|
|the name of export|item|in Annexure|to Appendix-4E|as well|as|in Advance|Authorisation.|

----- End of picture text -----

Authorisation, {06/03/2024 Issued: Malakpet, HYDERABAD,500078. eee — Chemical and Allied Products | payee ON 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. __—‘| SI.No. |ImportItems __| Qty. allowed. _| (Orphenadrine Citrate, Aspirin Citrate USP : i oo (Orphenadrine Citrate USP 50 starch cotains mg + Aspirin USP 770 mg + Asprin 90% USP Caffeine USP 60mg) starch 10% he Orphenadrine Citrate, Aspirin | 1 Number and Caffeine Tablets USP USP (Orphenadrine Citrate USP 25 mg + Aspirin USP 385 mg + starch cotains Caffeine USP 30 mg) Asprin 90% USP starch 10% | 6 [Caffeine | 30.6 mg. Ci

	0911006884
			3
Authorisation	06/03/2024
Issued:
2 eS aS		a	TT,
	Chemical andAllied Products
ee	ee	ee	ee

; |

0% | 6 [Caffeine | 30.6 mg. Ci

	0911006884
			3
Authorisation	06/03/2024
Issued:
2 eS aS		a	TT,
	Chemical andAllied Products
ee	ee	ee	ee

; |

==> picture [412 x 243] intentionally omitted <==

----- Start of picture text -----

|||||
|---|---|---|---|
|LicenseNumber:|{0311031972|
|Authorisation|11/03/2024|
|Issued:|
|ee|et|ees|te|
|Chemical|and Allied|Products|
|Fame|are|

----- End of picture text -----

Note: NC has also decided to make a new SION of above export product.

|0311032047|
|---|
|Authorisation<br>12/03/2024|
|Issued:<br>,|
|Chemical and Allied Products|
|156198728|
|.|
|Le . Eee<br>Seer<br>Sareearal<br>Decision: TheCommitteeconsidered thecaseas peragenda and it was decided to fix ad-hoc norms|
|under Para4.07 ofHBP Vol. I as per details givenbelow or as applied by the firm, whichever is less:-|
|[Export Product | Qty. | SI.No. |ImportItems __—————|_—(Qty.allowed.__|<br>P|eee<br>Pyrimidine (DCMP|





69 

| 

||Authorisation<br>13/03/2024|;||||
|---|---|---|---|---|---|
||Issued:|||||
||V||*-|||
|,||||||
||cams|||||
||Decision: TheCommittee considered the case as per theagenda andtakingcuefrom 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. 0811009216 dated 28/08/2023, it was decided to fix ad-hoc norms|||||
||under Para 4.07ofHBP Vol.|I as per details given below or asapplied by the firm, whichever is less:-||||
||a2)<br>for<br>Injection<br>(0.325<br>mEq<br>Mg++/mL)<br>40<br>mg/mL<br>2g<br>Total||No.|Heptahydrate phEur, USP|allowed.|
||for<br>Injection<br>(0.325|mEq||Heptahydrate phEur, USP||
||Mg++/mL)<br>40<br>mg/mL|4g||||
||Total|||||



Decision: The Committee considered the case as per the 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. 0811009216 dated 28/08/2023, 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:- 


70 

2 

|lLicenseNumber: [0311032149<br>Dateof<br>fscrain<br>Issued:||||
|---|---|---|---|
|es|aS, coe a|a|eSme|
|RE:|Gis:a||eoaSEs|



71 

i

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


70 

2 

|lLicenseNumber: [0311032149<br>Dateof<br>fscrain<br>Issued:||||
|---|---|---|---|
|es|aS, coe a|a|eSme|
|RE:|Gis:a||eoaSEs|



71 

i 

|LicenseNumber: <br>Dateof|[0311032677<br>Sl|Mpegs Seki<br>et|= einen|
|---|---|---|---|
|Issued:||||
|SESs<br>onal ae ee,||||
|ine|Chemical andAlliedProducts|||
|aa|156198728|||



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. | SI.No. [Importitems =i Qty allowed. | DCMP Pb ee RA concerned may take further necessary action as per above decision of NC. 

72 

is 

```text
||LicenseNumber:<br>[0711012278|
|---|---|
||:|
||Dateof<br>06/09/2024<br>zi|
||Issued:|
||ee<br>ne,<br>ee|
|~~|ee **e**ee<br>e<br>|License:<br>feee<br>ee<br>ae|
||meee<br>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/Sep/202425/9 dated 10/10/2024<br>against<br>advance authorization No. 0811006828 dated 23/12/2022, it was decided to fix ad-hoc norms under Para|
||4.07 ofHBP Vol. I as per details given below or as appliedbythe firm, whichever is less:-|
||coe<br>|<br>eee|<br>SODIUM<br>PHOSPHATE<br>SODIUM<br>IML INJECTION<br>PHOSPHATE USP<br>(Net Content 10 kg.))|

MeetingNo:NC/3/MEET/Apr/202526/1

Date:25/04/2025 |[CaseNo:66/NC/3/MEET/Apr/202526/1]

|HQFileNumber:<br>HQRNORMAPPLY00002896AM25||||
|---|---|---|---|
|OAX04000873AM25||||
|Date ofAuthorisation<br>|06/09/2024||||
|Issued:||||
|OfficeoftheAdditional DirectorGeneral ofForeign Trade,Ahmedabad||||
|TORRENTPHARMACEUTICALS|LTD|||
|TORRENTHOUSE,,AHMEDABAD,<br>380009.||||
|Advance Licence with AU Condition||||
|ApplicationBasis:<br>ExportOrder||||
|MerchantCumManufacturer Exporter||||
|ExporterType:<br>Public Limited||||
|Chemical andAllied Products<br>Group:||||
|CIE'Valucofine<br>48485446<br>License:||||
|CIFFCC:<br>571425||||
|FoBFcC:<br>[1502160<br>:<br>Decision: TheCommittee consideredthecaseas per agendaand it was decided to fix ad-hoc norms under||||
|Para4.07 ofHBP Vol. I as per details givenbelow|oras appliedby the firm, whichever is less:-|||
|Export Product|||Qty. allowed.|
|Nystatin Cream USP, 100000 |<br>120000<br>units/gm,15gm<br>(15gmTube) |Numbers||Nystatin<br>statin Micronized|29.48|
|(Each<br>gram<br>Contains:100,000USP<br>;<br>Nystatin<br>Units<br>in<br>anaqueous,cream<br>base.<br>Net|2|Aluminum Tubes And<br>Caps ForNystatin<br>CreamUSP 100000 15G|As perpacking<br>policyand<br> | GeneralNotes.|
|content ofNystatin should not||||
|be less than 28.893 Kg and||||
|Each finish products contain||||
|Aluminum Tubes And Caps||||
|not<br>be<br>less<br>than<br>120000||||
|Numbers in export item||||

|content ofNystatin should not||||
|be less than 28.893 Kg and||||
|Each finish products contain||||
|Aluminum Tubes And Caps||||
|not<br>be<br>less<br>than<br>120000||||
|Numbers in export item||||
|Nystatin Cream USP, 100000 | 780000<br>units /gm, 30gm (30 gmTube) |Numbers<br>(Each<br>gram<br>—_—Contains:<br>100,000USP Nystatin Units in<br>anaqueous,cream<br>base.<br>Net<br>content ofNystatin should not|3|Nystatin<br>(Nystatin Micronized<br>AiuminumTubesAnd<br>Caps ForNystatin<br>Cream USP 10000030G|383.124 kg<br>Asperpacking<br>policyand<br> | General Notes.|
|be less than 375.603 Kg and||||
|Each<br>finish products contain||||
|Aluminum Tubes And Caps||||
|not<br>be<br>less<br>than<br>780000||||
|Numbersinexportitem||||

==> picture [477 x 262] intentionally omitted <==

----- Start of picture text -----

||||||
|---|---|---|---|---|
|LicenseNumber:|[0911007890|
|Dateof|Soe|Ge|gees|ee|
|ScreenIssued:|:|;|
|a|
|ce|eee|ee|||

----- End of picture text -----

==> picture [442 x 83] intentionally omitted <==

----- Start of picture text -----

|||||||||
|---|---|---|---|---|---|---|---|
|[Export Product|||Qty.|_||SLNo.|| ImportItems|____||Qty. allowed. ||
|Nitrobenzoic|Acid|Ortho|Chloro|Benzoic|
|Acid|
|ee|es|

----- End of picture text -----

---|---|---|---|---| |[Export Product|||Qty.|||SLNo.|| ImportItems|___||Qty. allowed. || |Nitrobenzoic|Acid|Ortho|Chloro|Benzoic| |Acid| |ee|es|


**----- End of picture text -----**<br>



75 

**==> picture [404 x 296] intentionally omitted <==**

**----- Start of picture text -----**<br>
```text
||||||||
|---|---|---|---|---|---|---|
|Dateof|
|Issued:|
|Office of|the Additional|Director|General of|Foreign|Trade,CLADelhi|-|
|:|12501|hae|tee|aT|as|
|Deptt.|of Bio-Technology|for|obtaining|their|comments.|

----- End of picture text -----

==> picture [475 x 284] intentionally omitted <==

----- Start of picture text -----

|||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Authorisation|09/09/2024|
|Issued:|
|al—_eee|e|
|CIFFCC:|3534167|:|
|[—|
|per|the|advice|of|the TE,|it|was|decided|to|call|for|following|information/documents|from|the|firm:-|

----- End of picture text -----

Commercial value of Low Boiler and High Boiler with residue.

‘

|Dateof|||=|a||
|---|---|---|---|---|---|
|Authorisation.|09/09/2024|||||'|
|Issued:||||||
||OfficeoftheJoint|Joint|DirectorGeneral ofForeign|Trade,Vadodara||
|ge<br>se cg ele||||||
||43528050|||t||
|CIFFCC:|513000||:|‘||

---|---|---| |Authorisation.|09/09/2024|||||'| |Issued:|||||| ||OfficeoftheJoint|Joint|DirectorGeneral ofForeign|Trade,Vadodara|| |ge se cg ele|||||| ||43528050|||t|| |CIFFCC:|513000||:|‘||




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/Aug/202425/8 dated 28/08/2024 against advance authorization No. 3411004867 dated 26/04/2024, 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:(CAPRIC ALDEHYDE) C10 (98% puri Semen |" |) (eee | 

Note: NC has also decided to make a new SION of above said decision.. 


78 

|Se Set<br>Authorisation<br>09/09/2024<br>Issued:<br>Office oftheAdditional Director GeneralofForeign Trade,CLADelhi|
|---|
|Agea**e**te<br>e|



; 

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/202425/13 dated 07/01/2025 against advance authorization No. 0511026672 dated 15/07/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. | as per details given below or as applied by the firm, whichever is less:- 

||||||No.|
|---|---|---|---|---|---|
|Percent) Eye Drops 5 ml|||Vial|Vial||
|(Each<br>ml|contains|3mg|of|||
|Tobramycin||||||




79 

, 

|ee<br>Authorisation<br>10/09/2024<br>Issued:|de ee|
|---|---|
|PLOTNO.440/4,5&6,and8206/B,,SA<br>CHIN,394230.|:|
|99328804||



**==> picture [1 x 1] intentionally omitted <==**

||||||




79 

, 

|ee<br>Authorisation<br>10/09/2024<br>Issued:|de ee|
|---|---|
|PLOTNO.440/4,5&6,and8206/B,,SA<br>CHIN,394230.|:|
|99328804||



**==> picture [1 x 1] intentionally omitted <==**

**----- Start of picture text -----**<br>
|<br>**----- End of picture text -----**<br>


Decision: The Committee considered the case as per the agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Mar/202425/8 dated 17/03/2025 against advance authorization No. 5211003710 dated 07/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- 

No. allowed. Pyrazole-3-yl}-2co peel ib Bl - = ielinmethyl **e** thyl)c **a** rbamatetrnaans0.8261.237ST kg.keg 8 ETE RA concerned may take further necessary action as per above decision of NC. eect 

80 

: 

|lLicenseNumber:|{0311037933|~|
|---|---|---|
|Dateof|||
||10/09/2024||
|Issued:|||
||ChemicalandAlliedProducts||

ned may take further necessary action as per above decision of NC. eect 

80 

: 

|lLicenseNumber:|{0311037933|~|
|---|---|---|
|Dateof|||
||10/09/2024||
|Issued:|||
||ChemicalandAlliedProducts||



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:Forte (15 ml). (Each |Numbers Hydrochloride Spray bottle contains (i) Benzydamine Hydrochloride 45 mg. NetSpraycontentcontains(i) 58.083Benzydaminekg.) (Each : =inflammatoryHydrochloride -255 mcg neNo. inflammatory (30 ml). (Each Spray |Numbers Hydrochloride bottle contains (i) Benzydamine Hydrochloride 44.85 mg. Net content (i) 39.216 kg.) (Each Spray contains Benzydamine Hydrochloride -255 mcg 


81 

Authorisation 10/09/2024 Issued: OO ee a ee ee —— 3663567 CIFFCC: 43176 * aa ee ee ee ee 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. | as per details given below or as applied by the firm, whichever is less:USP 325 MG 60s us| Capsule Hydrochloride (Ris((8,751 Bottles X 60 Capsules Per Bottles = 5,25,060 Capsules ) (Total Weight of Export Product = 170.645 Kgs) (Net Content weight of Import Product = 187.726 kgs ceeCapsules |||No. allowed. RA concerned may take further necessary action as per above decision of NC. 

82 

MeetingNo:NC/3/MEET/Apr/202526/1 

CaseNo:75/NC/3/MEET/Apr/202526/1 

, 

-

87.726 kgs ceeCapsules |||No. allowed. RA concerned may take further necessary action as per above decision of NC. 

82 

MeetingNo:NC/3/MEET/Apr/202526/1 

CaseNo:75/NC/3/MEET/Apr/202526/1 

, 

- 

```text
|HQFileNumber:||HQRNORMAPPLY00002968AM25||
|---|---|---|
|RAFileNumber:||09AX04000457AM25||
||0911007920||
|Dateof|||
|Authorisation|10/09/2024<br>'||
|Issued:|||
||Office ofthe Additional Director GeneralofForeign Trade,Hyderabad||
||0500067654||
||JODAS EXPOIM PRIVATE LIMITED||
|i|PlotNoSSand45TSIIC,MEDAK,502279.<br>ee<br>aa<br>Advance Licence withAU Condition|ee|
||MerchantCum Manufacturer Exporter||
|Group:|Chemical andAllied Products||
|License:|es<br>wre||

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/Sep/202324/14 dated 27/09/2023 against advance authorization No. 0911005567 dated 03/08/2023, 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:-

Note: NC has also decided to make a new SION of above export product.

| |

lation of Solution for | Numbers Injection Bulk Intramuscular and Sterile Intravenous administration 1000 mg

Note: NC has also decided to make a new SION of above export product.

| |

Daieof Authorisation 10/09/2024 ee i ee ee Group: oR ae ae aa ae ET SS cea ee eee a Ua. a 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/E/MEET/Feb/202324/23 dated 19/02/2024 against advance authorization No. 0311002623 dated 19/03/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:SELAMECTIN No. allowed. nelierda6% SPOT wii.ON 0.25 ML 90912 SELAMECTIN| 1.39 gm. mg Brand Name : Catch One. Net Quantity of Selamectin Consumed Including Wastages & Overages : 1.500 Kgs. (Net Content of Selamectin is 1.3637 kg SELAMECTIN 6% SPOT ON 0.50 ML | 181836 2 SELAMECTIN | 5.56 gm TUBE(Each ml Contains Selamectin 60 | Numbers mg Brand Name : Catch One. Net Quantity of Selamectin Consumed Including Wastages & Overages : 6.000 Kgs.(Net Content of Selamectin is 5.4551 kg TUBE(Each ml Contains Selamectin 60 | Numbers mg Brand Name : Catch One. Net Quantity of Selamectin Consumed Including Wastages & Overages : 11.500 Kgs. (Net

Content of Selamectin is 5.4551 kg TUBE(Each ml Contains Selamectin 60 | Numbers mg Brand Name : Catch One. Net Quantity of Selamectin Consumed Including Wastages & Overages : 11.500 Kgs. (Net

[Content of Selamectinis 10.4547kg)) = | | | SELAMECTIN 6% SPOT ON 1 ML| 113640 SELAMECTIN | 6.95 gm. TUBE(Each ml Contains Selamectin 60 | Numbers mg Brand Name : Catch One. Net Quantity of Selamectin Consumed Including Wastages & Overages : 7.500 Kgs. (Net Content of Selamectin is 6.8184 kg “= SELAMECTIN 6% SPOT ON 2° ML 60609 5 SELAMECTIN| © 7.41 gm. TUBE(Each tml Contains Selamectin 60 | Numbers mg Brand Name : Catch One. Net Quantity of Selamectin Consumed Including Wastages & Overages : 8.000 Kgs.(Net Content of Selamectin is 7.2731 kg SELAMECTIN 6% SPOT ON 4 ML 18942 SELAMECTIN | 4.63 gm. TUBE(Each ml Contains Selamectin 60 | Numbers mg Brand Name : Catch One. Net Quantity of Selamectin Consumed Including Wastages & Overages : 5.000 Kgs(Net Content of Selamectin is 4.5461 kg

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

LicenseNumber:	{0311037052	sites
Authorisation	10/09/2024
Issued:
Group:	Chemical and Allied Products

further necessary actionas per above decision of NC.

LicenseNumber:	{0311037052	sites
Authorisation	10/09/2024
Issued:
Group:	Chemical and Allied Products

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:No. 0.03% 30 mil(Ipratropium |Numbers 2 15 ML MYSTA As per packing ml (Net content’ of BOTTLES General Notes. Ipratropium Bromide USP PUMP -70-CLAAs per packing API is 11.32 kg and Packing THREAD 18MM 57 policy and metrial of Platsic Bottle & 5MM General Notes. PumpIpratropiumas per Bro.export Nasal Spraygq Heer(= ee Ipratropium Bro. Nasal Spray | 1150000 ae 10.557 kg. | Bro. Nasal Spray 0.06% 15 PLASTIC BOTTLES) _| policy and ml (Net content of General Notes. API is 10.62 kg and Packing THREAD 18MM 57 policy and metrial of Platsic Bottle & 5MM General Notes. Pump as per export ¢ sree a a,

ae:

MeetingNo:NC/3/MEET/Apr/202526/1	MeetingNo:NC/3/MEET/Apr/202526/1
	HQRNORMAPPLY00002984AM25
IRAFileNumber: — <br>LicenseNumber:	}09AX04000283AM25<br> [0911007924 ~~	mete,<br>Conner	7	ae	EA<br>Re
Authorisation	11/09/2024
Issued:
isc.Ve	Ve	ea				ee
ee	ee	ee		ee

LicenseNumber:	LicenseNumber:	{0311037072		*
Authorisation		11/09/2024
Issued:			:
Re			a	ee
		Chemical and Allied Products
lecome		100128547
		1179370
A	NN		ee	ee

att

311037072||*| |---|---|---|---|---| |Authorisation||11/09/2024||| |Issued:|||:|| |Re|||a|ee| |||Chemical and Allied Products||| |lecome||100128547||| |||1179370||| |A|NN||ee|ee|

att

==> picture [474 x 117] intentionally omitted <==

----- Start of picture text -----

|||
|---|---|
|Dateof|
|Issued:|
|ee|
|ee|eee|

----- End of picture text -----

==> picture [468 x 170] intentionally omitted <==

----- Start of picture text -----

||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|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/202425/13|dated|07/01/2025|against|
|advance|authorization|No.|0511026674|dated|15/07/2024,|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:-|
|No.|
|Brinera|(Brinzolamide|Opthalmic|Micronized|Sterile|
|Suspension|1%)-|Sml|(Each|ml|
|eeecontains|10|mg|of Brinzolamideers,|||ee|
|RA concerned|may|take|further|necessary|action as|per|above|decision|of|NC.|

----- End of picture text -----

)-|Sml|(Each|ml| |eeecontains|10|mg|of Brinzolamideers,|||ee| |RA concerned|may|take|further|necessary|action as|per|above|decision|of|NC.|


**----- End of picture text -----**<br>


89 

: 

_ 

```text
||03AX04002898AM25<br>LiceuseNumber:<br>[0311037113<br>Authorisation<br>12/09/2024<br>Issued:|ts<br>eee<br>A<br>—<br>:<br>Seen<br>ai<br>| ae ae|ts<br>eee<br>A<br>—<br>:<br>Seen<br>ai<br>| ae ae|ts<br>eee<br>A<br>—<br>:<br>Seen<br>ai<br>| ae ae|
|---|---|---|---|---|
||Bi<br>ee||ee|ee, ee|
||=<br>Chemical andAlliedProducts||||
|||||)|
||aeaes<br>10891551||||
||[286||||
||EE<br>air gansae<br>Decision: The Committee considered the case as per agenda and|||ayaeRO<br> taking cue from the earlier decision for|
||Same export product/import item in meeting <br>advance authorization No. 0311017630 dated|No. NC/3/MEET/Jan/202223/18 dated 23/01/2023 against<br> 03/09/2022, it was decided to fix ad-hoc norms under Para|||
||4.07 ofHBP Vol. I as per details givenbelow or as applied bythe firm, whichever is less:-||||
|||No.|||
|'|hee<br>(Pack 30 Gms) (Net wt. of<br>Ciclopirox USP<br>is 20.790<br>Kgs.<br>Ciclopirox Gel 0.77percent | 1 Number<br>(Pack 45 Gms) (Net wt. of|2|eed eas<br>Ciclopirox USP<br>352.967mg/ pack||
||Kgs.||||
||(Pack 100 Gms) (Net wt. of||||
||Ciclopirox<br>USP<br>is<br>50.05||||
||Kgs.||||

==> picture [476 x 228] intentionally omitted <==

USP 352.967mg/ pack|| ||Kgs.|||| ||(Pack 100 Gms) (Net wt. of|||| ||Ciclopirox USP is 50.05|||| ||Kgs.||||




| 


90 

ae 

a 

**==> picture [476 x 228] intentionally omitted <==**

**----- Start of picture text -----**<br>
```text
||||||||
|---|---|---|---|---|---|---|
|03AX04002839AM25|
|LicenseNumber:|[031103711S~|~~|NE|=|RANE|dere|
|Authorisation|12/09/2024|
|Issued:|
|ANDPHARMACEUTICALSUIMITED|
|Rane:|J|BCHEMICALS|
|ee|up|tee|
|womrestet|chemia and Allied Products|

----- End of picture text -----

No. CB e tylpyridiniumnzydamine ChlorideHydrochlorideAnd | 1 Number al Chlorideapes We Antiseptic Lozenges Sugar Free. (Each lozenge contains (i) Hydrochloride Cetylpyridinium Chloride-1mg (ii) 3 Benzydamine Hydrochloride-3mg (iii) Isomalt ST-M-2471.285 mg. Net content (i) 8.621 Kg (ii) 25,862 Kgs. (iii) 21304.256 Kg.) - : |

Dateof	:
Issued:
wT: RSS		ee	eee		See
Licenses<br>eIrrcc:	{9031029<br>[63652			ce

) 8.621 Kg (ii) 25,862 Kgs. (iii) 21304.256 Kg.) - : |

Dateof	:
Issued:
wT: RSS		ee	eee		See
Licenses<br>eIrrcc:	{9031029<br>[63652			ce

|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/Jan/202324/20 dated 18/01/2024 against<br>advance authorization No. 0511018490 dated 25/04/2023, it was decided to fix ad-hoc norms under Para|
|4.07 ofHBP Vol. I as per details given below oras applied by the firm, whichever is less:-|
|a<br>eelee<br>allowed.<br>CAPSU**LES**USPIOMG |Namen | |_| DOXEPINCL | SASK)<br>CAPSU<br>USP 10 MG<br>Numbers|
|CAPSULES USP 25 MG<br>Numbers|
|CAPSULES USP 50 MG<br>Numbers|
|CAPSULES USP 75 MG<br>Numbers|
|CAPSULESUSP100MG<br>Numbers|

Note: The committee also decided to make a new SION for export product (10 mg) on the basis of above decision. RA concerned may take further necessary action as per above decision of NC.

Authorisation	13/09/2024
Issued:
	Office oftheAdditionalDirectorGeneralofForeign Trade, Hyderabad
Group:

observed that the firm has applied for import of intermediate (item No.2) and its raw material (item No.3) and since solvents are mix-up for import item No. | and 2, no norms can be worked out in the present form, therefore, as per the advice of the TE, it was decided to call the firm for attending Personal Hearing before Norms Committee with justification and details and documentary evidence of actual import.

erefore, as per the advice of the TE, it was decided to call the firm for attending Personal Hearing before Norms Committee with justification and details and documentary evidence of actual import.

|LicenseNumber:|||0511027729||
|---|---|---|---|
|Dateof|j|SS|eG eee Te Trey|
|Authorisation||13/09/2024||
|Issued:||||
|eg,<br>we, 1 ee a||||
|||ChemicalandAlliedProducts||

No. DIMETHYLADIPATE (DMA)| 1kg. |_1 |Adipic Acid -([0.925kg. (DIMETHYLADIPATE (DMA) (PACKED IN 852 NOS. OF 3 Hdpe Granules As per packing HM-HDPEDRUMSMADEOF (Total Weight = policy and HDPE GRANULES (7,242.000 7,604.100 KGS.) General Notes. KGS. WITHOUT WASTAGE)) (EACH DRUM SHALL WEIGHT 85 KG AND STORAGE CAPACITY 235.000 KGS. Some |

RA concerned may take further necessary action as per above decision

==> picture [117 x 42] intentionally omitted <==

----- Start of picture text ----- of NC. Pee KUMAR ----- End of picture text -----

==> picture [476 x 116] intentionally omitted <==

----- Start of picture text -----

|||||
|---|---|---|---|
|Dateof|
|Issued:|bsatesd|
|._ SAD.|Sa|te|eee:|

----- End of picture text -----

] intentionally omitted <==**

----- Start of picture text -----

|||||
|---|---|---|---|
|Dateof|
|Issued:|bsatesd|
|._ SAD.|Sa|te|eee:|

----- End of picture text -----

ae ee 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/Aug/202425/8 dated 28/08/2024 against advance authorization No. 0511024949 dated 10/04/2024, 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:-

a eeNo. allowed. Meropenem For Injection 1 kg. MEROPENEM NON0.8968 kg. (Containing NLT84% Sterile) TRIHYDRATE NONSTERILE (Meropenem Buffered Sterile) ert. packing policy and é General 2 Notes.

, |

16/09/2024 Issued: ~Authorisationillmeeecoe ee ee ee 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/202324/1 dated 28/04/2023 against advance authorization No. 0311020403 dated 02/01/2023, 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:tree ad? 2 ree berate: Fatty Acid (95% Active Content =| RA concerned may take further necessary action as per above decision ofNC.

“

given below or as applied by the firm, whichever is less:tree ad? 2 ree berate: Fatty Acid (95% Active Content =| RA concerned may take further necessary action as per above decision ofNC.

“

0311037200 Authorisation 17/09/2024 Issued: 7 eam Decision: The Committee considered the case as per agenda peand it was decidedeeeto 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. |Importitems | (Qty. allowed._| foesHYDROCHLORIDE eeeeee

Note: NC also decided to make a new SION for export product as per above decision.

==> picture [507 x 500] intentionally omitted <==

----- Start of picture text ----- Dateof Authorisation 17/09/2024 a SC ee 5 aa eS CIFFCC: MOO os ea ne ee eg Fae ee PONE ge ee ope acess 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:- No. allowed. Maropitant Injection 10 mg | 1 Number Maropitant Citrate 304.135 mg. / ml(Each ml contains : Monohydrate Maropitant Citrate 14.484 mg. Equivalent to Maropitant 10 mg Pack Maropitant Citrate Consumed along’ with wastages &overages - 5 Kg. Brand Name :Metonin Injection 10 mg es Es RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

verages - 5 Kg. Brand Name :Metonin Injection 10 mg es Es RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

imma<br>Dateof
Issued:
12105900	.
aoeee<br>Decision:TheCommitteeconsideredthecase	caseasperagendaand

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. 0711011479 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:ee eee MG (1005.00KGS)) SODIUM mg Capsule E.P/B.P/U.S.P. auction500 || | (ea lee RA concerned may take further necessary action as per above decision of NC.

==> picture [476 x 423] intentionally omitted <==

----- Start of picture text -----

||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|ioeeebe|
|18/09/2024|
|Issued:|
|ntAuthorisation|eeea|
|Seer eee|eke|eae|
|cIrrce:|[205|
|CS|a|ee|IN|
|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:-|
|allowed.|
|300mg/ 4ml|(Having|net|content|of|||[Numbers]|
|39.28|kg|of|Bulk|drug|(filling|
|volume|4.35ml|in|
|each|number|
|Tobramycin|Inhalation|Solution,|ees|ae|Tobramycin USP|

er|is|less:-| |allowed.| |300mg/ 4ml|(Having|net|content|of|||[Numbers]| |39.28|kg|of|Bulk|drug|(filling| |volume|4.35ml|in| |each|number| |Tobramycin|Inhalation|Solution,|ees|ae|Tobramycin USP|


**----- End of picture text -----**<br>



100 

3 

|Authorisation|18/09/2024|
|---|---|
|Issued:||
|ee<br>eeee||



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. 0511026076 dated 13/06/2024, 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:- 

on Sterile ae No. eee 


101 

**==> picture [473 x 285] intentionally omitted <==**

**----- Start of picture text -----**<br>
```text
||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Authorisation|19/09/2024|
|Issued:|
|See|
|ee|
|574399|
|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:-|

----- End of picture text -----

Percentage yield of reaction.

sre be“enttSac—

==> picture [482 x 298] intentionally omitted <==

g|information/documents|from the firm:-|


**----- End of picture text -----**<br>


1. Percentage yield of reaction. 

sre be“enttSac— 

% 

**==> picture [482 x 298] intentionally omitted <==**

**----- Start of picture text -----**<br>
```text
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|=|aa|-|—|-|
|Issued:|
|eee|
|ee|
|ae|
|ee|ee|
|||
|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:-|

----- End of picture text -----

Complete and balanced chemical reaction for each step showing molar requirement of each imported item with ther molecular weight.
Percentage Yield on molar basis for each step of API manufacturing.
Complete material balance for 16 inputs used in the process.

4, Requirement and recovery of solvants of each step. 5. Are you importing items of SI. No. 4,7,13 and 14 please give a copy of bill of entry.

Production/comsumption data for last 3 years duly certified by Company Auditor.

103

==> picture [473 x 335] intentionally omitted <==

,13 and 14 please give a copy of bill of entry.

Production/comsumption data for last 3 years duly certified by Company Auditor.

103

==> picture [473 x 335] intentionally omitted <==

----- Start of picture text -----

|||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Dateof|0511027868|cae|
|Issued:|
|a|SS|ee|a|
|Chemical|and|Allied|Products|
|IFV|
|s099|
|ee|
|Decision:|gee|ee|ee|Ce|ee|
|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/202223/24|dated|13/04/2023|against|
|advance|authorization|No.|0711003862|dated|26/04/2022,|it|was|decided|to|fix|ad-hoc|norms|under|Para|
|4.07|of HBP|Vol.|I|as|per|details|given|below|or as applied by the|firm,|whichever|is|less:-|

----- End of picture text -----

==> picture [439 x 95] intentionally omitted <==

----- Start of picture text -----

||||||||
|---|---|---|---|---|---|---|
|| __|Export Product____—[ Qty.|SLNo.|[Import|Items|__||Qty. allowed._|
|Ph.Eur|(UK|
|Ph.Eur|(UK|
|Ph.Eur|(UK|

----- End of picture text -----

(RA concerned may take further necessary «ction as per above decision ofNC.

104

==> picture [478 x 290] intentionally omitted <==

|(UK|


**----- End of picture text -----**<br>


(RA concerned may take further necessary «ction as per above decision ofNC. 

104 

: 

: 

**==> picture [478 x 290] intentionally omitted <==**

**----- Start of picture text -----**<br>
```text
||||||||
|---|---|---|---|---|---|---|
|Authorisation|20/09/2024|
|Issued:|
|LicenseNumber:|{0311037289|Pet ee|
|oo|ae|ee|oe|ee|eee|
|Chemical|and Allied|Products|
|o|LS|ScGeeAeiss|aca|=|ais|a9|
|crvatonteLicense:||rraass|a.|.|
|frre:|20530|
|et Feeeeee|

----- End of picture text -----

105

ee<br>oe ee<br>Authorisation<br>20/09/2024<br>Issued:SoaE<br>a
Oe<br>OWeg
oe<br>41668921
Revie<br>(Oeeewnee<br>ee

|Export Product Qty. [SI.No. [Importitems———|Quy. allowed. | Levofloxacin Hemihydrate ee

106

{Authorisation	20/09/2024 . .<br>:<br>vite<br>.
Issued:
Ere	ee ee ee Se
oe<br>ee
pee	ee<br>e

107

owed. | Levofloxacin Hemihydrate ee

106

{Authorisation	20/09/2024 . .<br>:<br>vite<br>.
Issued:
Ere	ee ee ee Se
oe<br>ee
pee	ee<br>e

107

34A4X04000513AM25	’
3411005440
	=
Authorisation<br>20/09/2024
Issued:
ges<br>Chemical andAlliedProducts
ae<br>5251086
a aa
Decision: TheCommitteeconsidered thecase as peragendaand it was decided
under Para4.07 ofHBP Vol. I as per details givenbelow or as appliedby the
	No.
ee<br>Topical Gel USP 1 % - 30<br>gm<br>tube<br>(Clindamycin<br>Phosphate Topical Gel USP<br>1 %<br>- 30 gm tube (Net<br>content<br>of<br>active<br>ingredients 35.70 kg	Phosphate USP
Topical Gel USP<br>1 % - 60	PhosphateUSP
gm<br>tube<br>(Clindamycin
Phosphate Topical Gel USP
1 %<br>- 60 gm tube (Net
content<br>of<br>active
ingredients71.40kgs

108

LicenseNumber:<br>{0311037308
Dateof	oN Woe aeee ee eeiee
21/09/2024
Issued:
en<br>ee
ee Seee<br>eee
ae<br>aaa<br>Decision:TheCommitteeconsideredthecaseas	esreaeetal<br>peragendaandtakingcuefromtheearlierdecisionfor

of|oN Woe aeee ee eeiee| |21/09/2024|| |Issued:|| |en ee|| |ee Seee eee|| |ae aaa Decision:TheCommitteeconsideredthecaseas|esreaeetal peragendaandtakingcuefromtheearlierdecisionfor|

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. 0311004745 dated 19/06/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. | as per details given below or as applied by the firm, whichever is less:-

109

Authorisation	23/09/2024
Issued:
	(East),MUMBAI.400022.

Chemical and Allied Products a lcinrcc:____|eaeeao | 61323125 OR ee eh eee 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. | as per details given below or as applied by the firm, whichever is less:-

|__Export Product[ Qty. | Sl.No. |Importitems ———=«| Qty. allowed. = =Levofloxacin USP

110

==> picture [476 x 295] intentionally omitted <==

as applied by the firm, whichever is less:-

|__Export Product[ Qty. | Sl.No. |Importitems ———=«| Qty. allowed. = =Levofloxacin USP

110

==> picture [476 x 295] intentionally omitted <==

----- Start of picture text -----

|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|LicenseNumber:|{0911008005|
|Authorisation|23/09/2024|
|Issued:|
|ei ig|Chemical and Allied Products|.|
|eSLOE.__ Se|a|
|Decision:|The committee considered the request of|the|firm|for|fixation of|ad-hoc|norms,|and as|per the|

----- End of picture text -----

End use of the export item, Name of API, if Drug-intermediate. 2. Complete technical details as per Annexure to Appendix 4E.

111

=n aie

==> picture [474 x 132] intentionally omitted <==

----- Start of picture text -----

||||
|---|---|---|
|0311037335|
|Authorisation|23/09/2024|
|Issued:|'|
|—S—|
|oe|
|Se”|Ee|2|
|nl|
|aes|ig|

----- End of picture text -----

102248

No. USPRosuvastatin Tablet BP /| 1 Number _ | 5.304 5 MG.((Each Tablet en) mg/Tablet contains Rosuvastatin Calcium 5.200 mg) Eq. to of import material is 395.200 kg Rosuvastatin 5 mg. (Net wt =

RA concerned may iake further necessary action as per above decis/ oi of NC.

112

Dateof
Issued:
	Saee<br>ee<br>ee
	7052302

00 kg Rosuvastatin 5 mg. (Net wt =

RA concerned may iake further necessary action as per above decis/ oi of NC.

112

Dateof
Issued:
	Saee<br>ee<br>ee
	7052302

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/202324/25 dated 11/03/2024 against advance authorization No. 0311029092 dated 04/12/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. | as per details given below or as applied by the firm, whichever is less:-

allowed. banca bed lnc’ Gores O == — = RA concerned may take further tiecessary action as per above decision of NC. ”

113

saat <br>Authorisation<br>Issued:	>rece<br>25/09/2024<br>.
1060,CHANDIGARH,<br>160002.<br>[Ss<br>5 See<br>ne
	Chemical andAllied Products
	24281400

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 and Balanced chemical reaction, Molecular weight and percentage yield on moler basis.
Recovery of By-product and its sale value.

114

==> picture [479 x 413] intentionally omitted <==

te and Balanced chemical reaction, Molecular weight and percentage yield on moler basis.

Recovery of By-product and its sale value.

114

==> picture [479 x 413] intentionally omitted <==

----- Start of picture text -----

||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Authorisation|25/09/2024|
|Issued:|
|ee|
|ee, eee|
|'|License:|
|"i|a|ea TES|
|ee|(ee|ea|
|oom|ee|ee|ee|
|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:-|
|No.|
|Polyamines|
|||1 kg.|Mixture /|Higher Polyethylene|
|RA concerned|may|take|further|necessary|action|as|per above|decision|of|NC.|

----- End of picture text -----

115

os<br>Authorisation<br>Issued:	0811012739<br>26/09/2024

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:-

Yield of the reaction with justification of claiming quantity asked for.
Stoicheometric Material balance of the reaction on molar basis. 3. End use of the export item.

116

==> picture [475 x 122] intentionally omitted <==

----- Start of picture text ----- Authorisation 26/09/2024 Issued: . es sara aie geod ee eee he peaee oe ee es ----- End of picture text -----

tionally omitted <==**

----- Start of picture text ----- Authorisation 26/09/2024 Issued: . es sara aie geod ee eee he peaee oe ee es ----- End of picture text -----

No. allowed. Phenyl glycidly ether Ike [1 | Phenol | 0.660kg. |

117

|j Authorisation<br>26/09/2024|
|---|
|issued:|
|en 2 ee<br>ee<br>Ee|
|Decision: TheCommitteeconsidered thecaseas peragenda and it was decided to fix ad-hoc norms under|
|Para 4.07 ofHBP Vol. I as per details givenbelow or as applied by the firm, whichever is less:-<br>FE creel bt clbao<br>RD<br>allowed**.**<br>ARTEMETHER<br>[The[|_ARTEMISINN[1.08kg||

118

0711012421 Dateor : Issued: aie ee e ee e en 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:-

==> picture [441 x 78] intentionally omitted <==

----- Start of picture text -----

|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|[Export|Product|| _ Qty.|||SLNo.|||Importitems|||Qty. allowed.|_|
|[Magnesium Orotate|«| _—iikg.|||1|||OroticAcid|||0.990|kg.|
|Zine Orotate||Site. =||4|||Orotic Acid|| 0.890kg|

----- End of picture text -----

119

==> picture [475 x 310] intentionally omitted <==

ikg.|||1|||OroticAcid|||0.990|kg.| |Zine Orotate||Site. =||4|||Orotic Acid|| 0.890kg|


**----- End of picture text -----**<br>



119 

ae 

**==> picture [475 x 310] intentionally omitted <==**

**----- Start of picture text -----**<br>
```text
||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|0511028003|
|Dateof|
|Authorisation|27/09/2024|
|Issued:|
|ee|ee|||
|—|| 109121879|
|ee|i|
|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:-|

----- End of picture text -----

Complete and Balanced chemical reactions with Molecular weight and percentage yield on moler basis. 2. Material Balance for each step. 3. Requirement and Recovery of solvants of each step.

120

;

ys a

;

LicenseNumber: [0911008051	-
Dateof
Issued:
ee<br>ee<br>eee

4-Fluoro-a-2-Methyl-1Ikg. |_1No. |[AnilineOil] allowed. Oxopropyl)-g-Oxo-N-B-Diphenyl | 0.47 kg. Benzene Butaneamide (Diketone, Intermediate For Atorvastatin / | 4 | Methyl Aceto Acetate | 1.06kg. |

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

121

==> picture [464 x 409] intentionally omitted <==

r Atorvastatin / | 4 | Methyl Aceto Acetate | 1.06kg. |

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

121

==> picture [464 x 409] intentionally omitted <==

----- Start of picture text -----

||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Authorisation|27/09/2024|
|Issued:|
|_|pall|pe|aed|Ne|
|Ae.|a|ee|oe|Se|
|21218310|
|irrcc:|[essen|git|oS wie|et|
|Decision:|The|Committee|considered|the|case|as|per|agenda|and|it|was|decided|to|fix|ad-hoc|norms|
|under|Para|4.07|of HBP HBP|Vol.|I|as|per|details|given|below|or|as|applied|by|the|firm,|whichever|is|
|less:-|
|No.|
|4-Fluoro-alpha-[2-methyl-|-oxopropyl]-gamma-oxo-|||1kg.|||1  |AnilineOil| S47|
|N-beta-diphenyl|benzene|
|an|||4|| Methyl|Aceto|Acetate|||1.06kg.|

----- End of picture text -----

Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

122

“phe<br>Authorisation<br>27/09/2024<br>Issued:
a<br>ee ee<br>ee
iee<br>ee<br>ee
ae oaee<br>aeee

123

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

122

“phe<br>Authorisation<br>27/09/2024<br>Issued:
a<br>ee ee<br>ee
iee<br>ee<br>ee
ae oaee<br>aeee

123

|Authorisation<br>01/10/2024|
|---|
|Issued:|
|SScer<br>eae|
|[213953|
|Decision: TheCommitteeconsidered thecaseas peragenda and it was decided to fixad-hoc norms|
|under Para4.07 ofHBP Vol. I as per details givenbelow or as applied by the firm, whichever is less:-|
|1<br>NaturalRefinedPhytosterol95% ——~=~=“‘é‘idCOOOCWKSSSCCSC*~C*~C*”’|
|OE a AAR «LS<br>1 __| Fatty AcidDistillate/DeoderisedDistillate<br>=|9,21,250kg.<br>CS|
|CS55ree<br>||

Authorisation<br>18/11/2024<br>m<br>Issued:<br>:
fee ig ee ee<br>License:eg
Decision: The committee considered the request offirm for fixation of ad-hoc norms and as per the<br>adviceoftheTE,itwasdecidedtocallforfollowinginformation/documentsfromthefirm:-

Complete chemistry with Stichometric balance on molar basis with Molecular weight of export and import item and percentage of yield of reaction.

125

==> picture [475 x 310] intentionally omitted <==

mistry with Stichometric balance on molar basis with Molecular weight of export and import item and percentage of yield of reaction.

125

==> picture [475 x 310] intentionally omitted <==

----- Start of picture text -----

|||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|LicenseNumber:||0311039368|
|rene|
|Authorisation|06/12/2024|
|Issued:|
|iae|=|
|ee|eae|ne|ee!|ee|
|Shh|"(42888375|
|a|ee|
|ee|
|Decision:|The|committee|considered|the|request|of|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:-|

----- End of picture text -----

I. | Complete chemistry with Stichometric balance on molar basis with Molecular weight of export and import item and percentage of yield of reaction.

wet ; f RAMAN Corey ao ee i ek ce

126

Authorisation	06/12/2024
Issued:

Decision: The committee considered the request of 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:-

I. Complete chemistry with Stichometric balance on molar basis with Molecular weight of export and import item and percentage of yield of reaction.

127

		0311039397
Authorisation		[06/12/2024
Issued:
2	ES	ae	errE AT
		Chemical andAllied Products
		41053350

128

==> picture [476 x 259] intentionally omitted <==

1039397|| |---|---|---|---| |Authorisation||[06/12/2024|| |Issued:|||| |2|ES|ae|errE AT| |||Chemical andAllied Products|| |||41053350||

128

==> picture [476 x 259] intentionally omitted <==

----- Start of picture text -----

|||||||
|---|---|---|---|---|---|
|Authorisation|03/01/2025|
|Issued:|
|Bs|SANS <page|Se|ines ne|ee|a|

----- End of picture text -----

No. Omeprazole Sulphide | 1 kg. | 4 | Caustic Soda Lye Or Flakes | 1.36kg. [9eT [Para Anisdine |SItemA 10 [Methylene[Ammonium ChlorideSulphate | ‘124k038ke |

129

==> picture [475 x 456] intentionally omitted <==

----- Start of picture text -----

||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|0911008808|
|Authorisation|09/01/2025|
|Issued:|
|ee|
|ee|a,|a|a|ee|ee|
|Chemical|and|Allied|Products|
|ee|
|OO|
|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:-|
|No.|
|a:4 Dimethyl|Aminopyridine|||1kg.|__1||_[4-Cyanopyridine6|[TotnesOg=|||LO kg.=|
|RA|concerned|may|take|further|necessary|action|as|per above|decision|of|NC.|

----- End of picture text -----

és a—

130

Authorisation 09/01/2025 Issued: A

|||LO kg.=| |RA|concerned|may|take|further|necessary|action|as|per above|decision|of|NC.|


**----- End of picture text -----**<br>


és a— 

130 

? 

| 

: 

Authorisation 09/01/2025 Issued: A 

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:- 

No. 4 Dimethyl Aminopyridine | 1 kg. | Boe Solution ai Cees=: Ee: es ee 


Cee aez KUMAR Die sores, So wile ssn,nenereg eet, 

131 

Fé 

|Authorisation|20/01/2025|
|---|---|
|Issued:||
|A-68/3,GTKARNALROAD,NEWDELHI,1 10033.<br>eeeeee||



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

**==> picture [335 x 51] intentionally omitted <==**

**----- Start of picture text -----**<br>
No.<br>Dettol Plaster Antiseptik | 18990000<br>! Sensitive Adhesive<br>**----- End of picture text -----**<br>



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**==> picture [255 x 116] intentionally omitted <==**

**----- Start of picture text -----**<br>
ae<br>ee ie<br>pRAMANRace<br>owemepeiee wa orcs Sek,<br>ministre aon,<br>autye © New ON 132<br>**----- End of picture text -----**<br>

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