EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Reset all filters
01 1EUROAPI
Reset all filters
01 1NALTREXONE HYDROCHLORIDE
Reset all filters
01 1France
Reset all filters
01 1Active
Reset all filters
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-17
Pay. Date : 2013-03-11
DMF Number : 20623
Submission : 2007-06-20
Status : Active
Type : II
20
Francopia A Euroapi Co, 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 NALTREXONE HYDROCHLORIDE, with a corresponding US DMF Number 20623.
Remarkably, this DMF maintains an Active status since its submission on June 20, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 17, 2013, and payment made on March 11, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II