KEY PRODUCTS
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 1Minakem
01 1VINBLASTINE 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 : 2018-03-27
Pay. Date : 2017-11-27
DMF Number : 5335
Submission : 1984-04-13
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 VINBLASTINE SULFATE, with a corresponding US DMF Number 5335.
Remarkably, this DMF maintains an Active status since its submission on April 13, 1984, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 27, 2018, and payment made on November 27, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
