01 1CHEMSPEC CHEMICALS PVT LTD
01 1TRICLOCARBAN
01 1India
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25060
Submission : 2011-06-14
Status : Inactive
Type : II
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A Cutisan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cutisan, including repackagers and relabelers. The FDA regulates Cutisan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cutisan 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 Cutisan supplier is an individual or a company that provides Cutisan active pharmaceutical ingredient (API) or Cutisan finished formulations upon request. The Cutisan suppliers may include Cutisan API manufacturers, exporters, distributors and traders.
click here to find a list of Cutisan suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Cutisan DMF (Drug Master File) is a document detailing the whole manufacturing process of Cutisan active pharmaceutical ingredient (API) in detail. Different forms of Cutisan DMFs exist exist since differing nations have different regulations, such as Cutisan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cutisan DMF submitted to regulatory agencies in the US is known as a USDMF. Cutisan USDMF includes data on Cutisan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cutisan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cutisan suppliers with USDMF on PharmaCompass.
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