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 : 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 : 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 : 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
A Aliskiren manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aliskiren, including repackagers and relabelers. The FDA regulates Aliskiren manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aliskiren API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Aliskiren manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aliskiren supplier is an individual or a company that provides Aliskiren active pharmaceutical ingredient (API) or Aliskiren finished formulations upon request. The Aliskiren suppliers may include Aliskiren API manufacturers, exporters, distributors and traders.
click here to find a list of Aliskiren suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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