01 1Cipla
01 1TRIOXSALEN, PROCEDS.FOR THE
01 1India
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4351
Submission : 1981-12-11
Status : Inactive
Type : II
A Trioxsalen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trioxsalen, including repackagers and relabelers. The FDA regulates Trioxsalen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trioxsalen 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 Trioxsalen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trioxsalen supplier is an individual or a company that provides Trioxsalen active pharmaceutical ingredient (API) or Trioxsalen finished formulations upon request. The Trioxsalen suppliers may include Trioxsalen API manufacturers, exporters, distributors and traders.
click here to find a list of Trioxsalen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trioxsalen DMF (Drug Master File) is a document detailing the whole manufacturing process of Trioxsalen active pharmaceutical ingredient (API) in detail. Different forms of Trioxsalen DMFs exist exist since differing nations have different regulations, such as Trioxsalen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trioxsalen DMF submitted to regulatory agencies in the US is known as a USDMF. Trioxsalen USDMF includes data on Trioxsalen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trioxsalen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trioxsalen suppliers with USDMF on PharmaCompass.
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