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List of Drug Master Files (DMF) for 26059 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Amphastar Pharmaceuticals (1)

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01 SEMI-PURIFIED HEPARIN SODIUM (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
26059
Active
2012-05-25
Complete
2014-06-10
2012-12-12
II
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Looking for Drug Master Files (DMF) for 26059 of Amphastar Nanjing Pharmaceuticals Inc

Looking for Drug Master Files (DMF) for 26059 of Amphastar Nanjing Pharmaceuticals Inc 1

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Amphastar Nanjing Pharmaceuticals Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is SEMI-PURIFIED HEPARIN SODIUM, with a corresponding US DMF Number 26059.

Remarkably, this DMF maintains an Active status since its submission on May 25, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 10, 2014, and payment made on December 12, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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