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List of Drug Master Files (DMF) for 10006 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 CROMOLYN SODIUM (1)

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01 Finland (1)

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01 Active (1)

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01 Complete (1)

10006
Active
1992-12-15
Complete
2018-06-13
2018-02-08
II

Looking for Drug Master Files (DMF) for 10006 of Fermion Oy

Looking for Drug Master Files (DMF) for 10006 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 CROMOLYN SODIUM, with a corresponding US DMF Number 10006.

Remarkably, this DMF maintains an Active status since its submission on December 15, 1992, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 13, 2018, and payment made on February 08, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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