Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
KEY PRODUCTS
KEY SERVICES
KEY EXCIPIENTS
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01 1Minakem
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01 1ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
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01 1France
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01 1Active
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01 1Blank
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28462
Submission : 2014-07-08
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 TRIHYDRATE, with a corresponding US DMF Number 28462.
Remarkably, this DMF maintains an Active status since its submission on July 08, 2014, highlighting commitment to regulatory compliance.