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01 1Tayca
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01 1MICRO TITANIUM DIOXIDE MT-100TV DRUG SUBSTANCE
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01 1Japan
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01 1Inactive
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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 12767-65-6 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 12767-65-6, including repackagers and relabelers. The FDA regulates 12767-65-6 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 12767-65-6 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 12767-65-6 supplier is an individual or a company that provides 12767-65-6 active pharmaceutical ingredient (API) or 12767-65-6 finished formulations upon request. The 12767-65-6 suppliers may include 12767-65-6 API manufacturers, exporters, distributors and traders.
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A 12767-65-6 DMF (Drug Master File) is a document detailing the whole manufacturing process of 12767-65-6 active pharmaceutical ingredient (API) in detail. Different forms of 12767-65-6 DMFs exist exist since differing nations have different regulations, such as 12767-65-6 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 12767-65-6 DMF submitted to regulatory agencies in the US is known as a USDMF. 12767-65-6 USDMF includes data on 12767-65-6's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 12767-65-6 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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