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List of Drug Master Files (DMF) for 29190 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 ROSUVASTATIN CALCIUM (1)

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01 Canada (1)

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01 Active (1)

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01 Complete (1)

29190
Active
2015-12-03
Complete
2016-04-08
2015-09-25
II
Minakem Delmar

Swiss Biotech Day

Not Confirmed

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Looking for Drug Master Files (DMF) for 29190 of Delmar Chemicals Inc

Looking for Drug Master Files (DMF) for 29190 of Delmar Chemicals Inc 1

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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 ROSUVASTATIN CALCIUM, with a corresponding US DMF Number 29190.

Remarkably, this DMF maintains an Active status since its submission on December 03, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 08, 2016, and payment made on September 25, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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