01 1Katsura Chemical
01 1BTA
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12867
Submission : 1998-02-13
Status : Inactive
Type : II
37
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A BTA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BTA, including repackagers and relabelers. The FDA regulates BTA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BTA 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 BTA supplier is an individual or a company that provides BTA active pharmaceutical ingredient (API) or BTA finished formulations upon request. The BTA suppliers may include BTA API manufacturers, exporters, distributors and traders.
click here to find a list of BTA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A BTA DMF (Drug Master File) is a document detailing the whole manufacturing process of BTA active pharmaceutical ingredient (API) in detail. Different forms of BTA DMFs exist exist since differing nations have different regulations, such as BTA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A BTA DMF submitted to regulatory agencies in the US is known as a USDMF. BTA USDMF includes data on BTA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BTA USDMF is kept confidential to protect the manufacturer’s intellectual property.
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