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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 : 2013-01-28

Pay. Date : 2013-01-03

DMF Number : 3535

Submission : 1979-06-04

Status : Active

Type : II

EUROAPI Compnay Banner

Looking for Drug Master Files (DMF) for 3535 of Euroapi France

Looking for Drug Master Files (DMF) for 3535 of Euroapi France 1

20

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, with a corresponding US DMF Number 3535.

Remarkably, this DMF maintains an Active status since its submission on June 04, 1979, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 28, 2013, and payment made on January 03, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II