01 1TOKO PHARMACEUTICAL INDUSTRIES CO LTD
01 1TAMIBAROTENE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25008
Submission : 2011-06-01
Status : Inactive
Type : II
A Tamibarotene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tamibarotene, including repackagers and relabelers. The FDA regulates Tamibarotene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tamibarotene 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 Tamibarotene supplier is an individual or a company that provides Tamibarotene active pharmaceutical ingredient (API) or Tamibarotene finished formulations upon request. The Tamibarotene suppliers may include Tamibarotene API manufacturers, exporters, distributors and traders.
click here to find a list of Tamibarotene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tamibarotene DMF (Drug Master File) is a document detailing the whole manufacturing process of Tamibarotene active pharmaceutical ingredient (API) in detail. Different forms of Tamibarotene DMFs exist exist since differing nations have different regulations, such as Tamibarotene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tamibarotene DMF submitted to regulatory agencies in the US is known as a USDMF. Tamibarotene USDMF includes data on Tamibarotene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tamibarotene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tamibarotene suppliers with USDMF on PharmaCompass.
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