01 1Tayca
01 1MICRO TITANIUM DIOXIDE MT-100TV DRUG SUBSTANCE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12195
Submission : 1996-10-31
Status : Inactive
Type : II
64
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A Tronox manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tronox, including repackagers and relabelers. The FDA regulates Tronox manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tronox 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 Tronox manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Tronox supplier is an individual or a company that provides Tronox active pharmaceutical ingredient (API) or Tronox finished formulations upon request. The Tronox suppliers may include Tronox API manufacturers, exporters, distributors and traders.
click here to find a list of Tronox suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Tronox DMF (Drug Master File) is a document detailing the whole manufacturing process of Tronox active pharmaceutical ingredient (API) in detail. Different forms of Tronox DMFs exist exist since differing nations have different regulations, such as Tronox USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tronox DMF submitted to regulatory agencies in the US is known as a USDMF. Tronox USDMF includes data on Tronox's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tronox USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tronox suppliers with USDMF on PharmaCompass.
