KEY PRODUCTS
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 1Minakem
01 1ESOMEPRAZOLE MAGNESIUM DIHYDRATE MICRONIZED AND NON MICRONIZED
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 : 2019-11-25
Pay. Date : 2019-10-16
DMF Number : 34026
Submission : 2019-10-04
Status : Active
Type : II
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Minakem, 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 ESOMEPRAZOLE MAGNESIUM DIHYDRATE MICRONIZED AND NON MICRONIZED, with a corresponding US DMF Number 34026.
Remarkably, this DMF maintains an Active status since its submission on October 04, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 25, 2019, and payment made on October 16, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
