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