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Athena Athena

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List of Drug Master Files (DMF) for 30175 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Sun Pharmaceutical Industries Limited (1)

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01 ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS) (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
30175
Active
2016-05-31
Complete
2016-07-28
2016-05-04
II
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Looking for Drug Master Files (DMF) for 30175 of Sun Pharmaceutical Industries Ltd

Looking for Drug Master Files (DMF) for 30175 of Sun Pharmaceutical Industries Ltd 1

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Sun Pharmaceutical Industries 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 ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS), with a corresponding US DMF Number 30175.

Remarkably, this DMF maintains an Active status since its submission on May 31, 2016, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 28, 2016, and payment made on May 04, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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