01 1Taiho Pharmaceutical
01 1TAC-101 DRUG SUBSTANCE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21314
Submission : 2008-02-06
Status : Inactive
Type : II
A Tac 101 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tac 101, including repackagers and relabelers. The FDA regulates Tac 101 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tac 101 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 Tac 101 supplier is an individual or a company that provides Tac 101 active pharmaceutical ingredient (API) or Tac 101 finished formulations upon request. The Tac 101 suppliers may include Tac 101 API manufacturers, exporters, distributors and traders.
click here to find a list of Tac 101 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tac 101 DMF (Drug Master File) is a document detailing the whole manufacturing process of Tac 101 active pharmaceutical ingredient (API) in detail. Different forms of Tac 101 DMFs exist exist since differing nations have different regulations, such as Tac 101 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tac 101 DMF submitted to regulatory agencies in the US is known as a USDMF. Tac 101 USDMF includes data on Tac 101's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tac 101 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tac 101 suppliers with USDMF on PharmaCompass.
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