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Athena Athena

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List of Drug Master Files (DMF) for 29329 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Dipharma (1)

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01 MIGLUSTAT (1)

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01 Italy (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
29329
Active
2015-06-09
Complete
2015-10-14
2015-05-07
II
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Looking for Drug Master Files (DMF) for 29329 of Dipharma Sa

Looking for Drug Master Files (DMF) for 29329 of Dipharma Sa 1

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Dipharma Sa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is MIGLUSTAT, with a corresponding US DMF Number 29329.

Remarkably, this DMF maintains an Active status since its submission on June 09, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 14, 2015, and payment made on May 07, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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