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List of Drug Master Files (DMF) for 26294 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Viatris (1)

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01 MIGLUSTAT (1)

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01 U.S.A (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
26294
Active
2013-03-08
Complete
2014-01-24
2013-01-28
II
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Looking for Drug Master Files (DMF) for 26294 of Mylan Laboratories Ltd

Looking for Drug Master Files (DMF) for 26294 of Mylan Laboratories Ltd 1

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Mylan Laboratories Ltd, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is MIGLUSTAT, with a corresponding US DMF Number 26294.

Remarkably, this DMF maintains an Active status since its submission on March 08, 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 January 28, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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