Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 2Sanofi
02 1Nuray Chemicals Private Limited
03 1Moehs Iberica
04 1HRV Global Life Sciences
05 1Cambrex Corporation
06 1Enomark
07 1Erregierre SpA
08 1Hikal
09 1Lusochimica
10 1Quimica Sintetica
11 2Blank
01 2France
02 4India
03 2Italy
04 2Spain
05 1U.S.A
06 2Blank
01 2Active
02 8Inactive
03 3Blank
01 2Withdrawn by Holder
02 11Blank
01 13Blank
01 1WC-0094
02 1WC-0416
03 11Blank
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9382
Submission : 1991-10-23
Status : Inactive
Type : II
Certificate Number : R1-CEP 1998-136 - Rev 03
Issue Date : 2016-07-08
Type : Chemical
Substance Number : 871
Status : Withdrawn by Holder
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-06-16
Pay. Date : 2021-04-30
DMF Number : 35857
Submission : 2021-04-30
Status : Active
Type : II
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm :
NDC Package Code : 58159-081
Start Marketing Date : 2020-10-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-10-05
Pay. Date : 2020-09-29
DMF Number : 14420
Submission : 1999-09-22
Status : Active
Type : II
NDC Package Code : 68069-0009
Start Marketing Date : 2009-10-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9957
Submission : 1992-11-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8874
Submission : 1990-12-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9442
Submission : 1991-11-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9376
Submission : 1991-10-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7990
Submission : 1989-03-28
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4141
Submission : 1981-03-24
Status : Inactive
Type : II
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