01 1Lonza Group
02 1Sumitomo Seika Chemicals
01 2KETOSULFONE
01 1Japan
02 1Switzerland
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15322
Submission : 2001-02-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15284
Submission : 2001-01-31
Status : Inactive
Type : II
A Ketosulfone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ketosulfone, including repackagers and relabelers. The FDA regulates Ketosulfone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ketosulfone 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 Ketosulfone supplier is an individual or a company that provides Ketosulfone active pharmaceutical ingredient (API) or Ketosulfone finished formulations upon request. The Ketosulfone suppliers may include Ketosulfone API manufacturers, exporters, distributors and traders.
click here to find a list of Ketosulfone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ketosulfone DMF (Drug Master File) is a document detailing the whole manufacturing process of Ketosulfone active pharmaceutical ingredient (API) in detail. Different forms of Ketosulfone DMFs exist exist since differing nations have different regulations, such as Ketosulfone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ketosulfone DMF submitted to regulatory agencies in the US is known as a USDMF. Ketosulfone USDMF includes data on Ketosulfone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ketosulfone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ketosulfone suppliers with USDMF on PharmaCompass.
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