KEY PRODUCTS
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 1Minakem
01 1VINCRISTINE SULFATE
01 1France
01 1Active
01 1Complete
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-25
Pay. Date : 2021-10-21
DMF Number : 4932
Submission : 1983-06-01
Status : Active
Type : II
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Minakem High Potent, based in France, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
One of their notable products is VINCRISTINE SULFATE, with a corresponding US DMF Number 4932.
Remarkably, this DMF maintains an Active status since its submission on June 01, 1983, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 25, 2021, and payment made on October 21, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
