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List of Drug Master Files (DMF) for 30682 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 METHYLPHENIDATE 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
30682
Active
2016-07-29
Complete
2016-10-30
2016-08-03
II
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Looking for Drug Master Files (DMF) for 30682 of Alkem Laboratories Ltd

Looking for Drug Master Files (DMF) for 30682 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 METHYLPHENIDATE HYDROCHLORIDE USP, with a corresponding US DMF Number 30682.

Remarkably, this DMF maintains an Active status since its submission on July 29, 2016, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 30, 2016, and payment made on August 03, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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