01 1MSN Laboratories
01 1FASORACETAM MONOHYDRATE
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34703
Submission : 2020-03-27
Status : Active
Type : II
A Fasoracetam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fasoracetam, including repackagers and relabelers. The FDA regulates Fasoracetam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fasoracetam 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 Fasoracetam supplier is an individual or a company that provides Fasoracetam active pharmaceutical ingredient (API) or Fasoracetam finished formulations upon request. The Fasoracetam suppliers may include Fasoracetam API manufacturers, exporters, distributors and traders.
click here to find a list of Fasoracetam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fasoracetam DMF (Drug Master File) is a document detailing the whole manufacturing process of Fasoracetam active pharmaceutical ingredient (API) in detail. Different forms of Fasoracetam DMFs exist exist since differing nations have different regulations, such as Fasoracetam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fasoracetam DMF submitted to regulatory agencies in the US is known as a USDMF. Fasoracetam USDMF includes data on Fasoracetam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fasoracetam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fasoracetam suppliers with USDMF on PharmaCompass.
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