KEY PRODUCTS
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI
01 1HYDROXOCOBALAMIN ACETATE PH.EUR.,JP,PYROGEN-FREE
01 1France
01 1Active
01 1Complete
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-04
Pay. Date : 2013-02-27
DMF Number : 16152
Submission : 2002-09-25
Status : Active
Type : II
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Euroapi France, based in France, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
One of their notable products is HYDROXOCOBALAMIN ACETATE PH.EUR.,JP,PYROGEN-FREE, with a corresponding US DMF Number 16152.
Remarkably, this DMF maintains an Active status since its submission on September 25, 2002, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 04, 2014, and payment made on February 27, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
