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01 1EUROAPI

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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

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Looking for Drug Master Files (DMF) for 20623 of Francopia A Euroapi Co

Looking for Drug Master Files (DMF) for 20623 of Francopia A Euroapi Co 1

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