01 1MSN Laboratories
02 1UBE Industries
01 1CS-747 DRUG SUBSTANCE
02 1PRASUGREL [ROUTE CODE - 'LP']
01 1India
02 1Japan
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27571
Submission : 2013-09-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15058
Submission : 2000-09-22
Status : Inactive
Type : II
A Prasugrel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prasugrel, including repackagers and relabelers. The FDA regulates Prasugrel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prasugrel 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 Prasugrel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prasugrel supplier is an individual or a company that provides Prasugrel active pharmaceutical ingredient (API) or Prasugrel finished formulations upon request. The Prasugrel suppliers may include Prasugrel API manufacturers, exporters, distributors and traders.
click here to find a list of Prasugrel suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prasugrel DMF (Drug Master File) is a document detailing the whole manufacturing process of Prasugrel active pharmaceutical ingredient (API) in detail. Different forms of Prasugrel DMFs exist exist since differing nations have different regulations, such as Prasugrel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prasugrel DMF submitted to regulatory agencies in the US is known as a USDMF. Prasugrel USDMF includes data on Prasugrel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prasugrel USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prasugrel suppliers with USDMF on PharmaCompass.
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