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List of Drug Master Files (DMF) for 11148 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 BUSPIRONE HYDROCHLORIDE (1)

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01 Finland (1)

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01 Active (1)

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01 Complete (1)

11148
Active
1994-10-21
Complete
2016-07-28
2016-07-21
II

Looking for Drug Master Files (DMF) for 11148 of Fermion Oy

Looking for Drug Master Files (DMF) for 11148 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 BUSPIRONE HYDROCHLORIDE, with a corresponding US DMF Number 11148.

Remarkably, this DMF maintains an Active status since its submission on October 21, 1994, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 28, 2016, and payment made on July 21, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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