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List of Drug Master Files (DMF) for 26389 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 STERILIZED MEDROXYPROGESTERONE ACETATE USP (MICRONIZED) (1)

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01 Germany (1)

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01 Active (1)

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01 Complete (1)

26389
Active
2012-09-04
Complete
2015-01-29
2014-09-03
II
Axplora CB

2024 ACI Convention

Not Confirmed

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Looking for Drug Master Files (DMF) for 26389 of Farmabios Spa

Looking for Drug Master Files (DMF) for 26389 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 STERILIZED MEDROXYPROGESTERONE ACETATE USP (MICRONIZED), with a corresponding US DMF Number 26389.

Remarkably, this DMF maintains an Active status since its submission on September 04, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 29, 2015, and payment made on September 03, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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