01 1Ambrisentan
02 1Apixaban
03 1Apremilast
04 1Asenapine Maleate
05 1Bosentan Hydrate
06 1Cinacalcet Hydrochloride
07 1Darifenacin Hydrobromide
08 1Desvenlafaxine Succinate
09 2Donepezil
10 1Lurasidone Hydrochloride
11 2Memantine Hydrochloride
12 1Mirabegron
13 2Mirtazapine
14 1Paliperidone
15 1Prasugrel Hydrochloride
16 1Pyrantel Pamoate
17 2Quetiapine Hemifumarate
18 2Rivaroxaban
19 1Solifenacin Succinate
20 1Teriflunomide
21 1Venlafaxine Hydrochloride
22 2Vildagliptin
23 1Vortioxetine Hydrobromide
24 1Ziprasidone Hydrochloride
01 19Active
02 11Blank
01 9Valid
02 21Blank
01 1221MF10046
02 1222MF10164
03 1227MF10202
04 27Blank
01 22WC-0087-(Annexure-1)
02 2WC-0087-(Annexure-2)
03 5WC-0462
04 1Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-07
Pay. Date : 2013-09-26
DMF Number : 22379
Submission : 2008-12-25
Status : Active
Type : II
Certificate Number : CEP 2021-494 - Rev 00
Issue Date : 2024-02-22
Type : Chemical
Substance Number : 2582
Status : Valid
Registration Number : 222MF10164
Registrant's Address : Sethna 4th floor 55 Maharshi karve road Marine Lines,Mumbai-400002,INDIA
Initial Date of Registration : 2010-06-04
Latest Date of Registration :
Date of Issue : 2023-06-26
Valid Till : 2026-06-26
Written Confirmation Number : WC-0462
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20613
Submission : 2007-06-15
Status : Active
Type : II
Certificate Number : R1-CEP 2006-162 - Rev 02
Issue Date : 2023-02-15
Type : Chemical
Substance Number : 1680
Status : Valid
Registration Number : 221MF10046
Registrant's Address : Sethna 4th floor 55 Maharshi karve road Marine Lines,Mumbai-400002,INDIA
Initial Date of Registration : 2009-02-25
Latest Date of Registration :
Date of Issue : 2022-07-27
Valid Till : 2025-07-21
Written Confirmation Number : WC-0087-(Annexure-1)
Address of the Firm :
NDC Package Code : 22665-0002
Start Marketing Date : 2010-07-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-20
Pay. Date : 2013-09-26
DMF Number : 25354
Submission : 2011-09-30
Status : Active
Type : II
Registration Number : 227MF10202
Registrant's Address : Sethna 4th floor 55 Maharshi karve road Marine Lines,Mumbai-400002,INDIA
Initial Date of Registration : 2015-08-06
Latest Date of Registration :
Date of Issue : 2022-07-27
Valid Till : 2025-07-21
Written Confirmation Number : WC-0087-(Annexure-1)
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20570
Submission : 2007-05-28
Status : Active
Type : II
Certificate Number : R1-CEP 2008-214 - Rev 03
Issue Date : 2023-01-25
Type : Chemical
Substance Number : 2338
Status : Valid
Date of Issue : 2022-07-27
Valid Till : 2025-07-21
