01 1CHEMO IBERICA SA
02 1Changzhou Pharmaceutical Factory
03 1Jubilant Generics
04 1MSN Laboratories
01 3ALISKIREN HEMIFUMARATE
02 1ALISKIREN HEMIFUMARATE [ROUTE CODE - "AF"]
01 1China
02 2India
03 1Spain
01 2Active
02 2Inactive
01 1Complete
02 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24755
Submission : 2011-03-10
Status : Inactive
Type : II
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 : 28050
Submission : 2014-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-23
Pay. Date : 2015-09-18
DMF Number : 26975
Submission : 2013-04-29
Status : Active
Type : II
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.
A Aliskiren DMF (Drug Master File) is a document detailing the whole manufacturing process of Aliskiren active pharmaceutical ingredient (API) in detail. Different forms of Aliskiren DMFs exist exist since differing nations have different regulations, such as Aliskiren USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aliskiren DMF submitted to regulatory agencies in the US is known as a USDMF. Aliskiren USDMF includes data on Aliskiren's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aliskiren USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aliskiren suppliers with USDMF on PharmaCompass.
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