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List of Drug Master Files (DMF) for 26291 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 EXEMESTANE MICRONIZED USP (1)

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01 Germany (1)

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01 Active (1)

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01 Complete (1)

26291
Active
2012-07-26
Complete
2014-03-15
2013-11-14
II
Axplora CB

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Not Confirmed

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Looking for Drug Master Files (DMF) for 26291 of Farmabios Spa

Looking for Drug Master Files (DMF) for 26291 of Farmabios Spa 1

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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 EXEMESTANE MICRONIZED USP, with a corresponding US DMF Number 26291.

Remarkably, this DMF maintains an Active status since its submission on July 26, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 15, 2014, and payment made on November 14, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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