01 1Procos
01 1DIMIRACETAM
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25123
Submission : 2011-07-11
Status : Inactive
Type : II
A Dimiracetam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dimiracetam, including repackagers and relabelers. The FDA regulates Dimiracetam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dimiracetam 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 Dimiracetam supplier is an individual or a company that provides Dimiracetam active pharmaceutical ingredient (API) or Dimiracetam finished formulations upon request. The Dimiracetam suppliers may include Dimiracetam API manufacturers, exporters, distributors and traders.
click here to find a list of Dimiracetam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dimiracetam DMF (Drug Master File) is a document detailing the whole manufacturing process of Dimiracetam active pharmaceutical ingredient (API) in detail. Different forms of Dimiracetam DMFs exist exist since differing nations have different regulations, such as Dimiracetam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dimiracetam DMF submitted to regulatory agencies in the US is known as a USDMF. Dimiracetam USDMF includes data on Dimiracetam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dimiracetam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dimiracetam suppliers with USDMF on PharmaCompass.
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