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List of Drug Master Files (DMF) for 31073 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 BULK EVEROLIMUS (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
31073
Active
2016-10-27
Complete
2017-03-30
2016-10-24
II
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Looking for Drug Master Files (DMF) for 31073 of Apotex Pharmachem Inc

Looking for Drug Master Files (DMF) for 31073 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 BULK EVEROLIMUS, with a corresponding US DMF Number 31073.

Remarkably, this DMF maintains an Active status since its submission on October 27, 2016, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 30, 2017, and payment made on October 24, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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