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List of Drug Master Files (DMF) for 32724 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Apotex Pharmachem (1)

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01 ELIGLUSTAT TARTRATE (1:0.5) (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
32724
Active
2018-05-01
Complete
2018-05-31
2018-04-20
II
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Looking for Drug Master Files (DMF) for 32724 of Apotex Pharmachem Inc

Looking for Drug Master Files (DMF) for 32724 of Apotex Pharmachem Inc 1

20

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

One of their notable products is ELIGLUSTAT TARTRATE (1:0.5), with a corresponding US DMF Number 32724.

Remarkably, this DMF maintains an Active status since its submission on May 01, 2018, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 31, 2018, and payment made on April 20, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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