01 1AstraZeneca
01 1TOCAINIDE HCL. INJECTION
01 1United Kingdom
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5629
Submission : 1984-12-14
Status : Inactive
Type : II
A Tocainide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tocainide, including repackagers and relabelers. The FDA regulates Tocainide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tocainide 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 Tocainide supplier is an individual or a company that provides Tocainide active pharmaceutical ingredient (API) or Tocainide finished formulations upon request. The Tocainide suppliers may include Tocainide API manufacturers, exporters, distributors and traders.
click here to find a list of Tocainide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tocainide DMF (Drug Master File) is a document detailing the whole manufacturing process of Tocainide active pharmaceutical ingredient (API) in detail. Different forms of Tocainide DMFs exist exist since differing nations have different regulations, such as Tocainide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tocainide DMF submitted to regulatory agencies in the US is known as a USDMF. Tocainide USDMF includes data on Tocainide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tocainide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tocainide suppliers with USDMF on PharmaCompass.
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