01 1Ajinomoto OmniChem N.V.
01 1NEFAZODONE II
01 1Belgium
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9218
Submission : 1991-05-15
Status : Inactive
Type : II
A Nefazodone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nefazodone, including repackagers and relabelers. The FDA regulates Nefazodone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nefazodone 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 Nefazodone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nefazodone supplier is an individual or a company that provides Nefazodone active pharmaceutical ingredient (API) or Nefazodone finished formulations upon request. The Nefazodone suppliers may include Nefazodone API manufacturers, exporters, distributors and traders.
click here to find a list of Nefazodone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nefazodone DMF (Drug Master File) is a document detailing the whole manufacturing process of Nefazodone active pharmaceutical ingredient (API) in detail. Different forms of Nefazodone DMFs exist exist since differing nations have different regulations, such as Nefazodone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nefazodone DMF submitted to regulatory agencies in the US is known as a USDMF. Nefazodone USDMF includes data on Nefazodone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nefazodone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nefazodone suppliers with USDMF on PharmaCompass.
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