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Athena Athena

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List of Drug Master Files (DMF) for 20853 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 AmbioPharm (1)

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01 BIVALIRUDIN, NON-STERILE BULK DRUG SUBSTANCE (1)

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01 U.S.A (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
20853
Active
2007-09-14
Complete
2013-05-30
2013-05-16
II
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Looking for Drug Master Files (DMF) for 20853 of Ambiopharm Inc

Looking for Drug Master Files (DMF) for 20853 of Ambiopharm Inc 1

20

Ambiopharm Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

They are recognized for The FDA-inspected, USA-based Peptide Manufacturer with the Largest Worldwide Capacity.

One of their notable products is BIVALIRUDIN, NON-STERILE BULK DRUG SUBSTANCE, with a corresponding US DMF Number 20853.

Remarkably, this DMF maintains an Active status since its submission on September 14, 2007, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 30, 2013, and payment made on May 16, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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