01 2Daiichi Sankyo
01 1CETRAXATE HCl CAPSULES
02 1CETRAXATE HYDROCHLORIDE
01 2Japan
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4443
Submission : 1982-02-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4448
Submission : 1982-02-05
Status : Inactive
Type : II
A Cetraxate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cetraxate, including repackagers and relabelers. The FDA regulates Cetraxate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cetraxate 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 Cetraxate supplier is an individual or a company that provides Cetraxate active pharmaceutical ingredient (API) or Cetraxate finished formulations upon request. The Cetraxate suppliers may include Cetraxate API manufacturers, exporters, distributors and traders.
click here to find a list of Cetraxate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cetraxate DMF (Drug Master File) is a document detailing the whole manufacturing process of Cetraxate active pharmaceutical ingredient (API) in detail. Different forms of Cetraxate DMFs exist exist since differing nations have different regulations, such as Cetraxate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cetraxate DMF submitted to regulatory agencies in the US is known as a USDMF. Cetraxate USDMF includes data on Cetraxate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cetraxate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cetraxate suppliers with USDMF on PharmaCompass.
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