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List of Drug Master Files (DMF) for 28612 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 FEXOFENADINE HYDROCHLORIDE USP FORM l (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
28612
Active
2014-11-05
Complete
2015-01-05
2014-10-09
II
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Looking for Drug Master Files (DMF) for 28612 of Dipharma Francis Srl

Looking for Drug Master Files (DMF) for 28612 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 FEXOFENADINE HYDROCHLORIDE USP FORM l, with a corresponding US DMF Number 28612.

Remarkably, this DMF maintains an Active status since its submission on November 05, 2014, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 05, 2015, and payment made on October 09, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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