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List of Drug Master Files (DMF) for 27637 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Alkem Laboratories (1)

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01 DALFAMPRIDINE 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
27637
Active
2013-11-01
Complete
2014-01-24
2013-11-19
II
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Looking for Drug Master Files (DMF) for 27637 of Alkem Laboratories Ltd

Looking for Drug Master Files (DMF) for 27637 of Alkem Laboratories Ltd 1

20

Alkem Laboratories 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 DALFAMPRIDINE USP, with a corresponding US DMF Number 27637.

Remarkably, this DMF maintains an Active status since its submission on November 01, 2013, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 24, 2014, and payment made on November 19, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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