01 1Mallinckrodt Pharmaceuticals
01 1SELENOMETHIONINE
01 1Ireland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2653
Submission : 1976-04-19
Status : Inactive
Type : II
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A MSE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MSE, including repackagers and relabelers. The FDA regulates MSE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MSE 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 MSE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A MSE supplier is an individual or a company that provides MSE active pharmaceutical ingredient (API) or MSE finished formulations upon request. The MSE suppliers may include MSE API manufacturers, exporters, distributors and traders.
click here to find a list of MSE suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A MSE DMF (Drug Master File) is a document detailing the whole manufacturing process of MSE active pharmaceutical ingredient (API) in detail. Different forms of MSE DMFs exist exist since differing nations have different regulations, such as MSE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MSE DMF submitted to regulatory agencies in the US is known as a USDMF. MSE USDMF includes data on MSE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MSE USDMF is kept confidential to protect the manufacturer’s intellectual property.
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