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 Hextril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hextril, including repackagers and relabelers. The FDA regulates Hextril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hextril 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 Hextril manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Hextril supplier is an individual or a company that provides Hextril active pharmaceutical ingredient (API) or Hextril finished formulations upon request. The Hextril suppliers may include Hextril API manufacturers, exporters, distributors and traders.
click here to find a list of Hextril suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Hextril DMF (Drug Master File) is a document detailing the whole manufacturing process of Hextril active pharmaceutical ingredient (API) in detail. Different forms of Hextril DMFs exist exist since differing nations have different regulations, such as Hextril USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hextril DMF submitted to regulatory agencies in the US is known as a USDMF. Hextril USDMF includes data on Hextril's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hextril USDMF is kept confidential to protect the manufacturer’s intellectual property.
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