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List of Drug Master Files (DMF) for 32397 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 DEXLANSOPRAZOLE ANHYDROUS (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
32397
Active
2018-01-19
Complete
2018-03-09
2018-01-18
II
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Looking for Drug Master Files (DMF) for 32397 of Dipharma Francis Srl

Looking for Drug Master Files (DMF) for 32397 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 DEXLANSOPRAZOLE ANHYDROUS, with a corresponding US DMF Number 32397.

Remarkably, this DMF maintains an Active status since its submission on January 19, 2018, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 09, 2018, and payment made on January 18, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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