KEY PRODUCTS
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI
01 1DINOPROSTONE (PROSTAGLANDIN E2)
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 : 2025-10-01
Pay. Date : 2025-09-26
DMF Number : 11563
Submission : 1995-07-06
Status : Active
Type : II
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Euroapi Hungary Ltd, 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 DINOPROSTONE (PROSTAGLANDIN E2), with a corresponding US DMF Number 11563.
Remarkably, this DMF maintains an Active status since its submission on July 06, 1995, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 01, 2025, and payment made on September 26, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
