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List of Drug Master Files (DMF) for 9043 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 ALPRAZOLAM (1)

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01 Finland (1)

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01 Active (1)

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01 Complete (1)

9043
Active
1991-04-04
Complete
2020-12-30
2020-12-23
II

Looking for Drug Master Files (DMF) for 9043 of Fermion Oy

Looking for Drug Master Files (DMF) for 9043 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 ALPRAZOLAM, with a corresponding US DMF Number 9043.

Remarkably, this DMF maintains an Active status since its submission on April 04, 1991, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of December 30, 2020, and payment made on December 23, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II

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