01 1Nissan Chemical
01 1PAROGRELIL
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21093
Submission : 2007-11-20
Status : Inactive
Type : II
A Parogrelil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Parogrelil, including repackagers and relabelers. The FDA regulates Parogrelil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Parogrelil API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Parogrelil supplier is an individual or a company that provides Parogrelil active pharmaceutical ingredient (API) or Parogrelil finished formulations upon request. The Parogrelil suppliers may include Parogrelil API manufacturers, exporters, distributors and traders.
click here to find a list of Parogrelil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Parogrelil DMF (Drug Master File) is a document detailing the whole manufacturing process of Parogrelil active pharmaceutical ingredient (API) in detail. Different forms of Parogrelil DMFs exist exist since differing nations have different regulations, such as Parogrelil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Parogrelil DMF submitted to regulatory agencies in the US is known as a USDMF. Parogrelil USDMF includes data on Parogrelil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Parogrelil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Parogrelil suppliers with USDMF on PharmaCompass.
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