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List of Drug Master Files (DMF) for 4246 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 METHOTREXATE (1)

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01 Finland (1)

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01 Active (1)

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01 Complete (1)

4246
Active
1981-08-06
Complete
2013-06-08
2013-05-23
II

Looking for Drug Master Files (DMF) for 4246 of Fermion Oy

Looking for Drug Master Files (DMF) for 4246 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 METHOTREXATE, with a corresponding US DMF Number 4246.

Remarkably, this DMF maintains an Active status since its submission on August 06, 1981, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 08, 2013, and payment made on May 23, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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