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List of Drug Master Files (DMF) for 13810 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 DEXMEDETOMIDINE HYDROCHLORIDE (1)

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01 Finland (1)

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01 Active (1)

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01 Complete (1)

Looking for Drug Master Files (DMF) for 13810 of Fermion Oy

Looking for Drug Master Files (DMF) for 13810 of Fermion Oy 1

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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 DEXMEDETOMIDINE HYDROCHLORIDE, with a corresponding US DMF Number 13810.

Remarkably, this DMF maintains an Active status since its submission on October 30, 1998, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 31, 2021, and payment made on August 26, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II

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