01 1H. Lundbeck AS
01 1ETHOTOIN
01 1Denmark
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25673
Submission : 2012-04-10
Status : Inactive
Type : II
A Ethotoin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ethotoin, including repackagers and relabelers. The FDA regulates Ethotoin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ethotoin 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 Ethotoin supplier is an individual or a company that provides Ethotoin active pharmaceutical ingredient (API) or Ethotoin finished formulations upon request. The Ethotoin suppliers may include Ethotoin API manufacturers, exporters, distributors and traders.
click here to find a list of Ethotoin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ethotoin DMF (Drug Master File) is a document detailing the whole manufacturing process of Ethotoin active pharmaceutical ingredient (API) in detail. Different forms of Ethotoin DMFs exist exist since differing nations have different regulations, such as Ethotoin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ethotoin DMF submitted to regulatory agencies in the US is known as a USDMF. Ethotoin USDMF includes data on Ethotoin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ethotoin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ethotoin suppliers with USDMF on PharmaCompass.
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