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List of Drug Master Files (DMF) for 26947 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Emcure Pharmaceuticals (1)

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01 ENOXAPARIN SODIUM USP (1)

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01 India (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
26947
Active
2013-03-31
Complete
2014-07-25
2013-12-13
II
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Looking for Drug Master Files (DMF) for 26947 of Emcure Pharmaceuticals Ltd

Looking for Drug Master Files (DMF) for 26947 of Emcure Pharmaceuticals Ltd 1

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Emcure Pharmaceuticals Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is ENOXAPARIN SODIUM USP, with a corresponding US DMF Number 26947.

Remarkably, this DMF maintains an Active status since its submission on March 31, 2013, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 25, 2014, and payment made on December 13, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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