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