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01 1Sanofi

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

GDUFA

DMF Review : Complete

Rev. Date : 2025-10-01

Pay. Date : 2025-09-29

DMF Number : 3452

Submission : 1979-02-08

Status : Active

Type : II

Sanofi Company Banner

Looking for Drug Master Files (DMF) for 3452 of Euroapi France

Looking for Drug Master Files (DMF) for 3452 of Euroapi France 1

20

Euroapi France, based in France, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

They are recognized for Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

One of their notable products is METHYLPREDNISOLONE ACETATE, with a corresponding US DMF Number 3452.

Remarkably, this DMF maintains an Active status since its submission on February 08, 1979, 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 29, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II