KEY PRODUCTS
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI
01 1PREDNISOLONE ACETATE
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 : 2023-02-01
Pay. Date : 2023-01-30
DMF Number : 3529
Submission : 1979-05-30
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 PREDNISOLONE ACETATE, with a corresponding US DMF Number 3529.
Remarkably, this DMF maintains an Active status since its submission on May 30, 1979, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 01, 2023, and payment made on January 30, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
