01 4UCB Pharma S.A
01 2PIRACETAM
02 1PIRACETAM (NOOTROPIL)
03 1PIRACETAM TABLETS 80 MG AND 1200 MG
01 4Belgium
01 4Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11885
Submission : 1996-02-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3868
Submission : 1981-06-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2875
Submission : 1977-02-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11886
Submission : 1996-02-28
Status : Inactive
Type : II
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A 2-Pyrrolidone-N-Acetamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 2-Pyrrolidone-N-Acetamide, including repackagers and relabelers. The FDA regulates 2-Pyrrolidone-N-Acetamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 2-Pyrrolidone-N-Acetamide 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 2-Pyrrolidone-N-Acetamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A 2-Pyrrolidone-N-Acetamide supplier is an individual or a company that provides 2-Pyrrolidone-N-Acetamide active pharmaceutical ingredient (API) or 2-Pyrrolidone-N-Acetamide finished formulations upon request. The 2-Pyrrolidone-N-Acetamide suppliers may include 2-Pyrrolidone-N-Acetamide API manufacturers, exporters, distributors and traders.
click here to find a list of 2-Pyrrolidone-N-Acetamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A 2-Pyrrolidone-N-Acetamide DMF (Drug Master File) is a document detailing the whole manufacturing process of 2-Pyrrolidone-N-Acetamide active pharmaceutical ingredient (API) in detail. Different forms of 2-Pyrrolidone-N-Acetamide DMFs exist exist since differing nations have different regulations, such as 2-Pyrrolidone-N-Acetamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 2-Pyrrolidone-N-Acetamide DMF submitted to regulatory agencies in the US is known as a USDMF. 2-Pyrrolidone-N-Acetamide USDMF includes data on 2-Pyrrolidone-N-Acetamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 2-Pyrrolidone-N-Acetamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
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