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Athena Athena

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List of Drug Master Files (DMF) for 22319 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Axplora (1)

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01 MOMETASONE FUROATE (1)

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01 Germany (1)

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01 Active (1)

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01 Complete (1)

22319
Active
2008-12-18
Complete
2014-03-31
2014-03-20
II
Axplora CB

Biotechgate Digital

Not Confirmed

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Looking for Drug Master Files (DMF) for 22319 of Farmabios Spa

Looking for Drug Master Files (DMF) for 22319 of Farmabios Spa 1

20

Farmabios Spa, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

They are recognized for Axplora- The partner of choice for complex APIs.

One of their notable products is MOMETASONE FUROATE, with a corresponding US DMF Number 22319.

Remarkably, this DMF maintains an Active status since its submission on December 18, 2008, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 31, 2014, and payment made on March 20, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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