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List of Drug Master Files (DMF) for 26682 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 SAPROPTERIN DIHYDROCHLORIDE (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
26682
Active
2012-12-06
Complete
2014-03-04
2013-09-23
II
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Looking for Drug Master Files (DMF) for 26682 of Dipharma Sa

Looking for Drug Master Files (DMF) for 26682 of Dipharma Sa 1

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

One of their notable products is SAPROPTERIN DIHYDROCHLORIDE, with a corresponding US DMF Number 26682.

Remarkably, this DMF maintains an Active status since its submission on December 06, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 04, 2014, and payment made on September 23, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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