01 1F. Hoffmann-La Roche
01 1DECLINAX (DEBRISOQUIN SULFATE) TABS 10MG
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5997
Submission : 1985-08-08
Status : Inactive
Type : II
A Debrisoquin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Debrisoquin, including repackagers and relabelers. The FDA regulates Debrisoquin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Debrisoquin 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 Debrisoquin supplier is an individual or a company that provides Debrisoquin active pharmaceutical ingredient (API) or Debrisoquin finished formulations upon request. The Debrisoquin suppliers may include Debrisoquin API manufacturers, exporters, distributors and traders.
click here to find a list of Debrisoquin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Debrisoquin DMF (Drug Master File) is a document detailing the whole manufacturing process of Debrisoquin active pharmaceutical ingredient (API) in detail. Different forms of Debrisoquin DMFs exist exist since differing nations have different regulations, such as Debrisoquin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Debrisoquin DMF submitted to regulatory agencies in the US is known as a USDMF. Debrisoquin USDMF includes data on Debrisoquin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Debrisoquin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Debrisoquin suppliers with USDMF on PharmaCompass.
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