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List of Drug Master Files (DMF) for 6505 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 NIFEDIPINE USP (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
6505
Active
1986-07-23
Complete
2016-03-25
2016-02-25
II
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Looking for Drug Master Files (DMF) for 6505 of Dipharma Francis Srl

Looking for Drug Master Files (DMF) for 6505 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 NIFEDIPINE USP, with a corresponding US DMF Number 6505.

Remarkably, this DMF maintains an Active status since its submission on July 23, 1986, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 25, 2016, and payment made on February 25, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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