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List of Drug Master Files (DMF) for 33199 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 ISOSULFAN BLUE (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
33199
Active
2018-09-28
Complete
2019-09-04
2019-07-31
II
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Looking for Drug Master Files (DMF) for 33199 of Emcure Pharmaceuticals Ltd

Looking for Drug Master Files (DMF) for 33199 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 ISOSULFAN BLUE, with a corresponding US DMF Number 33199.

Remarkably, this DMF maintains an Active status since its submission on September 28, 2018, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 04, 2019, and payment made on July 31, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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