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01 1Fermion Oy

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWith Fermion, start the journey of your innovative API.

GDUFA

DMF Review : Complete

Rev. Date : 2019-03-26

Pay. Date : 2018-12-20

DMF Number : 33361

Submission : 2019-01-02

Status : Active

Type : II

fermion

Looking for Drug Master Files (DMF) for 33361 of Fermion Oy

Looking for Drug Master Files (DMF) for 33361 of Fermion Oy 1

20

Fermion Oy, based in Finland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for With Fermion, start the journey of your innovative API.

One of their notable products is NINTEDANIB ESYLATE, with a corresponding US DMF Number 33361.

Remarkably, this DMF maintains an Active status since its submission on January 02, 2019, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 26, 2019, and payment made on December 20, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II