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List of Drug Master Files (DMF) for 14534 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 BUPROPION HCL (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
14534
Active
1999-11-11
Complete
2015-03-09
2015-03-04
II
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Looking for Drug Master Files (DMF) for 14534 of Dipharma Francis Srl

Looking for Drug Master Files (DMF) for 14534 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 BUPROPION HCL, with a corresponding US DMF Number 14534.

Remarkably, this DMF maintains an Active status since its submission on November 11, 1999, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 09, 2015, and payment made on March 04, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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