Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1Coral Drugs Private Limited
03 1Gonane Pharma
04 1Sanofi
05 1Avik Pharmaceutical Limited
06 1Bristol Myers Squibb
07 1Chemos
08 1Conscientia Industrial
09 1J&H CHEM
10 1Molcan Corporation
11 1SIMS Srl
01 1Canada
02 2China
03 1France
04 2Germany
05 3India
06 1Italy
07 1U.S.A
01 2Active
02 3Inactive
03 6Blank
01 2Valid
02 9Blank
01 11Blank
01 1WC-0169
02 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17758
Submission : 2004-10-15
Status : Active
Type : II
Certificate Number : CEP 2018-282 - Rev 03
Issue Date : 2024-07-25
Type : Chemical
Substance Number : 867
Status : Valid
NDC Package Code : 46439-8728
Start Marketing Date : 2008-05-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37346
Submission : 2022-08-04
Status : Active
Type : II
Certificate Number : R0-CEP 2021-078 - Rev 00
Issue Date : 2022-03-28
Type : Chemical
Substance Number : 867
Status : Valid
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
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 : 8329
Submission : 1989-12-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6958
Submission : 1987-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9847
Submission : 1992-08-28
Status : Inactive
Type : II
Date of Issue : 2019-06-27
Valid Till : 2022-07-02
Written Confirmation Number : WC-0169
Address of the Firm :
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