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List of Drug Master Files (DMF) for 32151 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 ISOPROTERENOL HYDROCHLORIDE 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
32151
Active
2017-10-18
Complete
2018-02-14
2018-01-18
II
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Looking for Drug Master Files (DMF) for 32151 of Emcure Pharmaceuticals Ltd

Looking for Drug Master Files (DMF) for 32151 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 ISOPROTERENOL HYDROCHLORIDE USP, with a corresponding US DMF Number 32151.

Remarkably, this DMF maintains an Active status since its submission on October 18, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 14, 2018, and payment made on January 18, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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