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List of Drug Master Files (DMF) for 27325 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 METHYLPREDNISOLONE ACETATE STERILE (1)

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01 Germany (1)

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01 Active (1)

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01 Complete (1)

27325
Active
2013-07-19
Complete
2014-06-23
2013-12-31
II
Axplora CB

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Not Confirmed

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Looking for Drug Master Files (DMF) for 27325 of Farmabios Spa

Looking for Drug Master Files (DMF) for 27325 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 METHYLPREDNISOLONE ACETATE STERILE, with a corresponding US DMF Number 27325.

Remarkably, this DMF maintains an Active status since its submission on July 19, 2013, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 23, 2014, and payment made on December 31, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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