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List of Drug Master Files (DMF) for 15174 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 1Fermion Oy

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

GDUFA

DMF Review : Complete

Rev. Date : 2020-06-12

Pay. Date : 2020-06-05

DMF Number : 15174

Submission : 2000-12-04

Status : Active

Type : II

fermion

Looking for Drug Master Files (DMF) for 15174 of Fermion Oy

Looking for Drug Master Files (DMF) for 15174 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 GLIPIZIDE, with a corresponding US DMF Number 15174.

Remarkably, this DMF maintains an Active status since its submission on December 04, 2000, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 12, 2020, and payment made on June 05, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II