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List of Drug Master Files (DMF) for 32140 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 SORAFENIB HEMITOSYLATE (1)

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01 Canada (1)

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01 Active (1)

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01 Complete (1)

32140
Active
2017-12-20
Complete
2018-07-27
2018-01-19
II
Minakem Delmar

CPhI Japan

Not Confirmed

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Looking for Drug Master Files (DMF) for 32140 of Delmar Chemicals Inc

Looking for Drug Master Files (DMF) for 32140 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 SORAFENIB HEMITOSYLATE, with a corresponding US DMF Number 32140.

Remarkably, this DMF maintains an Active status since its submission on December 20, 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 January 19, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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