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List of Drug Master Files (DMF) for 23582 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Alkaloida Chemical Company Zrt (1)

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01 HYDROXYCHLOROQUINE SULFATE USP (1)

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01 Hungary (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
23582
Active
2010-03-25
Complete
2018-05-11
2018-04-04
II
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Looking for Drug Master Files (DMF) for 23582 of Alkaloida Chemical Co Zrt

Looking for Drug Master Files (DMF) for 23582 of Alkaloida Chemical Co Zrt 1

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Alkaloida Chemical Co Zrt, based in Hungary, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is HYDROXYCHLOROQUINE SULFATE USP, with a corresponding US DMF Number 23582.

Remarkably, this DMF maintains an Active status since its submission on March 25, 2010, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 11, 2018, and payment made on April 04, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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