01 1F. Hoffmann-La Roche
01 1TROCINATE 100MG & 400MG
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4738
Submission : 1982-11-29
Status : Inactive
Type : II
A Thiphenamil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Thiphenamil, including repackagers and relabelers. The FDA regulates Thiphenamil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Thiphenamil 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 Thiphenamil supplier is an individual or a company that provides Thiphenamil active pharmaceutical ingredient (API) or Thiphenamil finished formulations upon request. The Thiphenamil suppliers may include Thiphenamil API manufacturers, exporters, distributors and traders.
click here to find a list of Thiphenamil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Thiphenamil DMF (Drug Master File) is a document detailing the whole manufacturing process of Thiphenamil active pharmaceutical ingredient (API) in detail. Different forms of Thiphenamil DMFs exist exist since differing nations have different regulations, such as Thiphenamil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Thiphenamil DMF submitted to regulatory agencies in the US is known as a USDMF. Thiphenamil USDMF includes data on Thiphenamil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Thiphenamil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Thiphenamil suppliers with USDMF on PharmaCompass.
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