01 1Shionogi
01 1CERULETIDE DIETHYLAMINE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4661
Submission : 1982-09-30
Status : Inactive
Type : II
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A Takus manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Takus, including repackagers and relabelers. The FDA regulates Takus manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Takus 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 Takus supplier is an individual or a company that provides Takus active pharmaceutical ingredient (API) or Takus finished formulations upon request. The Takus suppliers may include Takus API manufacturers, exporters, distributors and traders.
click here to find a list of Takus suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Takus DMF (Drug Master File) is a document detailing the whole manufacturing process of Takus active pharmaceutical ingredient (API) in detail. Different forms of Takus DMFs exist exist since differing nations have different regulations, such as Takus USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Takus DMF submitted to regulatory agencies in the US is known as a USDMF. Takus USDMF includes data on Takus's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Takus USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Takus suppliers with USDMF on PharmaCompass.
