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List of Drug Master Files (DMF) for 6492 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 PENTAMIDINE ISETHIONATE (1)

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01 Canada (1)

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01 Active (1)

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01 Complete (1)

6492
Active
1986-07-23
Complete
2014-03-31
2013-09-17
II
Minakem Delmar

BePharma 2024

Not Confirmed

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Looking for Drug Master Files (DMF) for 6492 of Delmar Chemicals Inc

Looking for Drug Master Files (DMF) for 6492 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 PENTAMIDINE ISETHIONATE, with a corresponding US DMF Number 6492.

Remarkably, this DMF maintains an Active status since its submission on July 23, 1986, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 31, 2014, and payment made on September 17, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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