01 1GW Pharmaceutical
01 1EPIDIOLEX
01 1United Kingdom
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27824
Submission : 2013-12-11
Status : Inactive
Type : II
A Trimethadione manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trimethadione, including repackagers and relabelers. The FDA regulates Trimethadione manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trimethadione 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 Trimethadione supplier is an individual or a company that provides Trimethadione active pharmaceutical ingredient (API) or Trimethadione finished formulations upon request. The Trimethadione suppliers may include Trimethadione API manufacturers, exporters, distributors and traders.
click here to find a list of Trimethadione suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trimethadione DMF (Drug Master File) is a document detailing the whole manufacturing process of Trimethadione active pharmaceutical ingredient (API) in detail. Different forms of Trimethadione DMFs exist exist since differing nations have different regulations, such as Trimethadione USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trimethadione DMF submitted to regulatory agencies in the US is known as a USDMF. Trimethadione USDMF includes data on Trimethadione's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trimethadione USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trimethadione suppliers with USDMF on PharmaCompass.
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