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List of Drug Master Files (DMF) for 32224 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 PIRFENIDONE (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
32224
Active
2018-04-24
Complete
2018-11-13
2018-10-11
II
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Looking for Drug Master Files (DMF) for 32224 of Dipharma Francis Srl

Looking for Drug Master Files (DMF) for 32224 of Dipharma Francis Srl 1

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

One of their notable products is PIRFENIDONE, with a corresponding US DMF Number 32224.

Remarkably, this DMF maintains an Active status since its submission on April 24, 2018, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 13, 2018, and payment made on October 11, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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