KEY PRODUCTS
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 1Minakem
01 1VINORELBINE TARTRATE
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 : 2016-04-23
Pay. Date : 2016-03-23
DMF Number : 14619
Submission : 1999-12-13
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 VINORELBINE TARTRATE, with a corresponding US DMF Number 14619.
Remarkably, this DMF maintains an Active status since its submission on December 13, 1999, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 23, 2016, and payment made on March 23, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
