EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI
02 1Sanofi
03 1HRV Global Life Sciences
04 1TAPI Technology & API Services
05 1H. Lundbeck AS
06 2R L Fine Chem
01 1Denmark
02 2France
03 3India
04 1Israel
01 1Active
02 2Inactive
03 4Blank
01 2Valid
02 1Withdrawn by Holder
03 4Blank
01 1220MF10195
02 6Blank
01 1WC-0139A3
02 1WC-0445A4
03 5Blank
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Registration Number : 220MF10195
Registrant's Address : 82 Avenue Raspail 94250 Gentilly France
Initial Date of Registration : 2008-08-28
Latest Date of Registration : --
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 : 4078
Submission : 1981-02-18
Status : Inactive
Type : II
Certificate Number : CEP 2003-121 - Rev 04
Issue Date : 2024-02-02
Type : Chemical
Substance Number : 534
Status : Valid
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17665
Submission : 2004-09-10
Status : Inactive
Type : II
Certificate Number : R0-CEP 2005-075 - Rev 00
Issue Date : 2009-10-05
Type : Chemical
Substance Number : 534
Status : Withdrawn by Holder
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-23
Pay. Date : 2013-02-21
DMF Number : 5900
Submission : 1985-04-22
Status : Active
Type : II
Certificate Number : R1-CEP 2011-329 - Rev 00
Issue Date : 2018-01-24
Type : Chemical
Substance Number : 534
Status : Valid
NDC Package Code : 45562-1739
Start Marketing Date : 2012-07-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
Date of Issue : 2021-08-06
Valid Till : 2022-07-28
Written Confirmation Number : WC-0445A4
Address of the Firm :
Date of Issue : 2019-08-05
Valid Till : 2022-07-21
Written Confirmation Number : WC-0139A3
Address of the Firm :
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