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List of Drug Master Files (DMF) for 31132 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 AMINOCAPROIC ACID (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
31132
Active
2016-12-14
Complete
2017-09-21
2017-07-25
II
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Looking for Drug Master Files (DMF) for 31132 of Dipharma Francis Srl

Looking for Drug Master Files (DMF) for 31132 of Dipharma Francis Srl 1

20

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 AMINOCAPROIC ACID, with a corresponding US DMF Number 31132.

Remarkably, this DMF maintains an Active status since its submission on December 14, 2016, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 21, 2017, and payment made on July 25, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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