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List of Drug Master Files (DMF) for 28065 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Apotex Fermentation Inc. (1)

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01 TACROLIMUS USP (1)

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01 Canada (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
28065
Active
2014-03-17
Complete
2014-07-14
2014-03-13
II
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Looking for Drug Master Files (DMF) for 28065 of Apotex Pharmachem Inc

Looking for Drug Master Files (DMF) for 28065 of Apotex Pharmachem Inc 1

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Apotex Pharmachem Inc, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is TACROLIMUS USP, with a corresponding US DMF Number 28065.

Remarkably, this DMF maintains an Active status since its submission on March 17, 2014, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 14, 2014, and payment made on March 13, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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