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List of Drug Master Files (DMF) for 30583 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 TEDUGLUTIDE NON-STERILE (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
30583
Active
2016-08-12
Complete
2016-11-04
2016-08-01
II
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Looking for Drug Master Files (DMF) for 30583 of Ambiopharm Inc

Looking for Drug Master Files (DMF) for 30583 of Ambiopharm Inc 1

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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 TEDUGLUTIDE NON-STERILE, with a corresponding US DMF Number 30583.

Remarkably, this DMF maintains an Active status since its submission on August 12, 2016, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 04, 2016, and payment made on August 01, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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