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