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List of Drug Master Files (DMF) for 31791 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Minakem (formerly Delmar Chemicals) (1)

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01 ESLICARBAZEPINE ACETATE (1)

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01 Canada (1)

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01 Active (1)

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01 Complete (1)

31791
Active
2017-06-05
Complete
2018-07-27
2017-06-09
II
Minakem Delmar

Chinaplas 2024

Not Confirmed

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Looking for Drug Master Files (DMF) for 31791 of Delmar Chemicals Inc

Looking for Drug Master Files (DMF) for 31791 of Delmar Chemicals Inc 1

20

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

They are recognized for Minakem is manufacturing small molecules APIs including corticosteroids

One of their notable products is ESLICARBAZEPINE ACETATE, with a corresponding US DMF Number 31791.

Remarkably, this DMF maintains an Active status since its submission on June 05, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 27, 2018, and payment made on June 09, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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