01 1Shionogi
01 1COMPOUND 7432-S
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6883
Submission : 1987-03-18
Status : Inactive
Type : II
22
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A Cedex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cedex, including repackagers and relabelers. The FDA regulates Cedex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cedex API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Cedex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Cedex supplier is an individual or a company that provides Cedex active pharmaceutical ingredient (API) or Cedex finished formulations upon request. The Cedex suppliers may include Cedex API manufacturers, exporters, distributors and traders.
click here to find a list of Cedex suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Cedex DMF (Drug Master File) is a document detailing the whole manufacturing process of Cedex active pharmaceutical ingredient (API) in detail. Different forms of Cedex DMFs exist exist since differing nations have different regulations, such as Cedex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cedex DMF submitted to regulatory agencies in the US is known as a USDMF. Cedex USDMF includes data on Cedex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cedex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cedex suppliers with USDMF on PharmaCompass.
