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List of Drug Master Files (DMF) for 32949 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 FULVESTRANT (1)

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01 Germany (1)

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01 Active (1)

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01 Complete (1)

32949
Active
2018-07-27
Complete
2020-12-29
2020-07-17
II
Axplora CB

2024 ACI Convention

Not Confirmed

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Looking for Drug Master Files (DMF) for 32949 of Farmabios Spa

Looking for Drug Master Files (DMF) for 32949 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 FULVESTRANT, with a corresponding US DMF Number 32949.

Remarkably, this DMF maintains an Active status since its submission on July 27, 2018, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of December 29, 2020, and payment made on July 17, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II

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