01 1CARDIOME DEVELOPMENT AG
01 1RSD1235 DRUG SUBSTANCE
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19171
Submission : 2006-03-14
Status : Inactive
Type : II
A Vernakalant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vernakalant, including repackagers and relabelers. The FDA regulates Vernakalant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vernakalant 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 Vernakalant supplier is an individual or a company that provides Vernakalant active pharmaceutical ingredient (API) or Vernakalant finished formulations upon request. The Vernakalant suppliers may include Vernakalant API manufacturers, exporters, distributors and traders.
click here to find a list of Vernakalant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vernakalant DMF (Drug Master File) is a document detailing the whole manufacturing process of Vernakalant active pharmaceutical ingredient (API) in detail. Different forms of Vernakalant DMFs exist exist since differing nations have different regulations, such as Vernakalant USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vernakalant DMF submitted to regulatory agencies in the US is known as a USDMF. Vernakalant USDMF includes data on Vernakalant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vernakalant USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vernakalant suppliers with USDMF on PharmaCompass.
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