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List of Drug Master Files (DMF) for 5408 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Fermion Oy (1)

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01 AZATHIOPRINE (1)

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01 Finland (1)

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01 Active (1)

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01 Complete (1)

5408
Active
1984-03-19
Complete
2016-09-14
2016-08-29
II

Looking for Drug Master Files (DMF) for 5408 of Fermion Oy

Looking for Drug Master Files (DMF) for 5408 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 AZATHIOPRINE, with a corresponding US DMF Number 5408.

Remarkably, this DMF maintains an Active status since its submission on March 19, 1984, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 14, 2016, and payment made on August 29, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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