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List of Drug Master Files (DMF) for 20232 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 MIVACURIUM CHLORIDE (1)

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01 Germany (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
20232
Active
2007-01-31
Complete
2016-03-02
2016-02-23
II
Axplora CB

Biotechgate Digital

Not Confirmed

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Looking for Drug Master Files (DMF) for 20232 of Farmabios Spa

Looking for Drug Master Files (DMF) for 20232 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 MIVACURIUM CHLORIDE, with a corresponding US DMF Number 20232.

Remarkably, this DMF maintains an Active status since its submission on January 31, 2007, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 02, 2016, and payment made on February 23, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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