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List of Drug Master Files (DMF) for 32308 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 AMORPHOUS (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
32308
Active
2018-01-19
Complete
2018-04-13
2018-01-18
II
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Looking for Drug Master Files (DMF) for 32308 of Dipharma Francis Srl

Looking for Drug Master Files (DMF) for 32308 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 DEXLANSOPRAZOLE AMORPHOUS, with a corresponding US DMF Number 32308.

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 April 13, 2018, and payment made on January 18, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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