01 1Chemi SpA
01 1OXIRACETAM
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8272
Submission : 1989-10-24
Status : Inactive
Type : II
A Oxiracetam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxiracetam, including repackagers and relabelers. The FDA regulates Oxiracetam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxiracetam 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 Oxiracetam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxiracetam supplier is an individual or a company that provides Oxiracetam active pharmaceutical ingredient (API) or Oxiracetam finished formulations upon request. The Oxiracetam suppliers may include Oxiracetam API manufacturers, exporters, distributors and traders.
click here to find a list of Oxiracetam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxiracetam DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxiracetam active pharmaceutical ingredient (API) in detail. Different forms of Oxiracetam DMFs exist exist since differing nations have different regulations, such as Oxiracetam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxiracetam DMF submitted to regulatory agencies in the US is known as a USDMF. Oxiracetam USDMF includes data on Oxiracetam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxiracetam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxiracetam suppliers with USDMF on PharmaCompass.
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