01 2JenKem Technology
02 1Morton Salt
01 1MALEIMIDE-PEG2-SUCCINIMIDYL PROPIONATE, MW 425.4
02 1N-(2 METHYL-1-NAPHTHYL) MALEIMIDE.
03 1Y-SHAPE (MPEG20K)2-PEG10K MALEIMIDE, MW 50000
01 2China
02 1U.S.A
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37470
Submission : 2022-09-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36582
Submission : 2021-12-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5606
Submission : 1984-10-18
Status : Inactive
Type : II
A N-Maleimide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N-Maleimide, including repackagers and relabelers. The FDA regulates N-Maleimide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N-Maleimide 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 N-Maleimide supplier is an individual or a company that provides N-Maleimide active pharmaceutical ingredient (API) or N-Maleimide finished formulations upon request. The N-Maleimide suppliers may include N-Maleimide API manufacturers, exporters, distributors and traders.
click here to find a list of N-Maleimide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A N-Maleimide DMF (Drug Master File) is a document detailing the whole manufacturing process of N-Maleimide active pharmaceutical ingredient (API) in detail. Different forms of N-Maleimide DMFs exist exist since differing nations have different regulations, such as N-Maleimide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A N-Maleimide DMF submitted to regulatory agencies in the US is known as a USDMF. N-Maleimide USDMF includes data on N-Maleimide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The N-Maleimide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of N-Maleimide suppliers with USDMF on PharmaCompass.
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