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List of Drug Master Files (DMF) for 31159 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 MSN Laboratories (1)

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01 APREMILAST (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
31159
Active
2016-12-23
Complete
2018-03-20
2017-10-10
II
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Looking for Drug Master Files (DMF) for 31159 of Msn Life Sciences Private Ltd

Looking for Drug Master Files (DMF) for 31159 of Msn Life Sciences Private Ltd 1

20

Msn Life Sciences Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is APREMILAST (AMORPHOUS), with a corresponding US DMF Number 31159.

Remarkably, this DMF maintains an Active status since its submission on December 23, 2016, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 20, 2018, and payment made on October 10, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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