Minakem is manufacturing small molecules APIs including corticosteroids
01 1Minakem (formerly Delmar Chemicals)
01 1SORAFENIB HEMITOSYLATE
01 1Canada
01 1Active
01 1Complete
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-27
Pay. Date : 2018-01-19
DMF Number : 32140
Submission : 2017-12-20
Status : Active
Type : II
20
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 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
