01 1Finar
01 1ACETONITRILE HIGH PURITY GRADE (HP)
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26612
Submission : 2012-11-08
Status : Active
Type : IV
A Acetonitrile manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acetonitrile, including repackagers and relabelers. The FDA regulates Acetonitrile manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acetonitrile 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 Acetonitrile manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Acetonitrile supplier is an individual or a company that provides Acetonitrile active pharmaceutical ingredient (API) or Acetonitrile finished formulations upon request. The Acetonitrile suppliers may include Acetonitrile API manufacturers, exporters, distributors and traders.
click here to find a list of Acetonitrile suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Acetonitrile DMF (Drug Master File) is a document detailing the whole manufacturing process of Acetonitrile active pharmaceutical ingredient (API) in detail. Different forms of Acetonitrile DMFs exist exist since differing nations have different regulations, such as Acetonitrile USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acetonitrile DMF submitted to regulatory agencies in the US is known as a USDMF. Acetonitrile USDMF includes data on Acetonitrile's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acetonitrile USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Acetonitrile suppliers with USDMF on PharmaCompass.
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