Minakem is manufacturing small molecules APIs including corticosteroids
01 1Minakem (formerly Delmar Chemicals)
01 1MIRABEGRON
01 1Canada
01 1Active
01 1Complete
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-03
Pay. Date : 2018-07-09
DMF Number : 32929
Submission : 2018-09-14
Status : Active
Type : II
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Delmar Chemicals Inc, based in Canada, is a pharmaceutical company.
They are recognized for Minakem is manufacturing small molecules APIs including corticosteroids
One of their notable products is MIRABEGRON, with a corresponding US DMF Number 32929.
Remarkably, this DMF maintains an Active status since its submission on September 14, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 03, 2020, and payment made on July 09, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
