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List of Drug Master Files (DMF) for 18910 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 BUDESONIDE (1)

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01 Germany (1)

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01 Active (1)

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01 Complete (1)

18910
Active
2005-10-26
Complete
2013-05-16
2013-05-03
II
Axplora CB

Biotechgate Digital

Not Confirmed

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Looking for Drug Master Files (DMF) for 18910 of Farmabios Spa

Looking for Drug Master Files (DMF) for 18910 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 BUDESONIDE, with a corresponding US DMF Number 18910.

Remarkably, this DMF maintains an Active status since its submission on October 26, 2005, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 16, 2013, and payment made on May 03, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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