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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 : 2022-03-01

Pay. Date : 2022-02-11

DMF Number : 35412

Submission : 2021-11-15

Status : Active

Type : II

EUROAPI Compnay Banner

Looking for Drug Master Files (DMF) for 35412 of Euroapi Hungary Ltd

Looking for Drug Master Files (DMF) for 35412 of Euroapi Hungary Ltd 1

20

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 CARBOPROST TROMETHAMINE, with a corresponding US DMF Number 35412.

Remarkably, this DMF maintains an Active status since its submission on November 15, 2021, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 01, 2022, and payment made on February 11, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II