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List of Drug Master Files (DMF) for 27215 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 LIRAGLUTIDE, 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
27215
Active
2013-06-12
Complete
2018-07-06
2018-04-24
II
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Looking for Drug Master Files (DMF) for 27215 of Ambiopharm Inc

Looking for Drug Master Files (DMF) for 27215 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 LIRAGLUTIDE, NON-STERILE, BULK DRUG SUBSTANCE, with a corresponding US DMF Number 27215.

Remarkably, this DMF maintains an Active status since its submission on June 12, 2013, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 06, 2018, and payment made on April 24, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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