Minakem is manufacturing small molecules APIs including corticosteroids
01 1Minakem (formerly Delmar Chemicals)
01 1APIXABAN
01 1Canada
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-15
Pay. Date : 2016-03-28
DMF Number : 30336
Submission : 2016-03-14
Status : Active
Type : II
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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 APIXABAN, with a corresponding US DMF Number 30336.
Remarkably, this DMF maintains an Active status since its submission on March 14, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 15, 2016, and payment made on March 28, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
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