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List of Drug Master Files (DMF) for 5717 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 DILTIAZEM HCL (1)

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01 Finland (1)

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01 Active (1)

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01 Complete (1)

5717
Active
1985-02-06
Complete
2017-02-01
2016-12-29
II

Looking for Drug Master Files (DMF) for 5717 of Fermion Oy

Looking for Drug Master Files (DMF) for 5717 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 DILTIAZEM HCL, with a corresponding US DMF Number 5717.

Remarkably, this DMF maintains an Active status since its submission on February 06, 1985, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 01, 2017, and payment made on December 29, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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