01 1Abbott Laboratories
01 1DIMETHADIONE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 413
Submission : 1960-11-28
Status : Inactive
Type : II
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A DMO manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DMO, including repackagers and relabelers. The FDA regulates DMO manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DMO 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 DMO supplier is an individual or a company that provides DMO active pharmaceutical ingredient (API) or DMO finished formulations upon request. The DMO suppliers may include DMO API manufacturers, exporters, distributors and traders.
click here to find a list of DMO suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A DMO DMF (Drug Master File) is a document detailing the whole manufacturing process of DMO active pharmaceutical ingredient (API) in detail. Different forms of DMO DMFs exist exist since differing nations have different regulations, such as DMO USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DMO DMF submitted to regulatory agencies in the US is known as a USDMF. DMO USDMF includes data on DMO's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DMO USDMF is kept confidential to protect the manufacturer’s intellectual property.
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