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List of Drug Master Files (DMF) for 26489 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 GLATIRAMER ACETATE (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
26489
Active
2012-09-27
Complete
2015-01-05
2014-06-09
II
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Looking for Drug Master Files (DMF) for 26489 of Ambiopharm Inc

Looking for Drug Master Files (DMF) for 26489 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 GLATIRAMER ACETATE, with a corresponding US DMF Number 26489.

Remarkably, this DMF maintains an Active status since its submission on September 27, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 05, 2015, and payment made on June 09, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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