01 1Dishman Carbogen Amcis
01 1HEXETIDINE
01 1India
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24162
Submission : 2010-09-07
Status : Inactive
Type : II
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A Duranil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Duranil, including repackagers and relabelers. The FDA regulates Duranil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Duranil API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Duranil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Duranil supplier is an individual or a company that provides Duranil active pharmaceutical ingredient (API) or Duranil finished formulations upon request. The Duranil suppliers may include Duranil API manufacturers, exporters, distributors and traders.
click here to find a list of Duranil suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Duranil DMF (Drug Master File) is a document detailing the whole manufacturing process of Duranil active pharmaceutical ingredient (API) in detail. Different forms of Duranil DMFs exist exist since differing nations have different regulations, such as Duranil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Duranil DMF submitted to regulatory agencies in the US is known as a USDMF. Duranil USDMF includes data on Duranil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Duranil USDMF is kept confidential to protect the manufacturer’s intellectual property.
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