01 1Hamilton
01 1NEFIRACETAM DRUG SUBSTANCE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12951
Submission : 1998-04-17
Status : Inactive
Type : II
96
PharmaCompass offers a list of Nefiracetam API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Nefiracetam manufacturer or Nefiracetam supplier for your needs.
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PharmaCompass also assists you with knowing the Nefiracetam API Price utilized in the formulation of products. Nefiracetam API Price is not always fixed or binding as the Nefiracetam Price is obtained through a variety of data sources. The Nefiracetam Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A DMPPA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DMPPA, including repackagers and relabelers. The FDA regulates DMPPA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DMPPA 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 DMPPA supplier is an individual or a company that provides DMPPA active pharmaceutical ingredient (API) or DMPPA finished formulations upon request. The DMPPA suppliers may include DMPPA API manufacturers, exporters, distributors and traders.
click here to find a list of DMPPA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DMPPA DMF (Drug Master File) is a document detailing the whole manufacturing process of DMPPA active pharmaceutical ingredient (API) in detail. Different forms of DMPPA DMFs exist exist since differing nations have different regulations, such as DMPPA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DMPPA DMF submitted to regulatory agencies in the US is known as a USDMF. DMPPA USDMF includes data on DMPPA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DMPPA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DMPPA suppliers with USDMF on PharmaCompass.
