EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI
02 1Sanofi
03 1HRV Global Life Sciences
04 1H. Lundbeck AS
05 2R L Fine Chem
06 1Teva API
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.
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
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Status : Withdrawn by Holder
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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