Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 1Minakem
02 1CHEMO
03 1CHEMO IBERICA SA
04 1Changzhou Pharmaceutical Factory
05 1Globalchem
06 1Jubilant Generics
07 1Jubilant Pharmova
08 1MSN Laboratories
01 1China
02 1France
03 4India
04 2Spain
01 2Active
02 2Inactive
03 4Blank
01 8Blank
01 8Blank
01 1WC-0021n
02 1WC-0092
03 1WC-0092A
04 5Blank
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-23
Pay. Date : 2015-09-18
DMF Number : 26975
Submission : 2013-04-29
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
NDC Package Code : 14501-0062
Start Marketing Date : 2010-11-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28050
Submission : 2014-03-31
Status : Active
Type : II
Date of Issue : 2021-12-02
Valid Till : 2024-11-04
Written Confirmation Number : WC-0092A
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26776
Submission : 2012-12-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24755
Submission : 2011-03-10
Status : Inactive
Type : II
Date of Issue : 2022-09-01
Valid Till : 2024-11-04
Written Confirmation Number : WC-0092
Address of the Firm :
NDC Package Code : 65372-1178
Start Marketing Date : 2014-03-04
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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