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