01 1Apothecon Pharmaceuticals
02 1CorMedix
01 2TAUROLIDINE
01 1India
02 1U.S.A
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24498
Submission : 2010-12-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31155
Submission : 2017-02-10
Status : Active
Type : II
A Taurolidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Taurolidine, including repackagers and relabelers. The FDA regulates Taurolidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Taurolidine 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 Taurolidine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Taurolidine supplier is an individual or a company that provides Taurolidine active pharmaceutical ingredient (API) or Taurolidine finished formulations upon request. The Taurolidine suppliers may include Taurolidine API manufacturers, exporters, distributors and traders.
click here to find a list of Taurolidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Taurolidine DMF (Drug Master File) is a document detailing the whole manufacturing process of Taurolidine active pharmaceutical ingredient (API) in detail. Different forms of Taurolidine DMFs exist exist since differing nations have different regulations, such as Taurolidine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Taurolidine DMF submitted to regulatory agencies in the US is known as a USDMF. Taurolidine USDMF includes data on Taurolidine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Taurolidine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Taurolidine suppliers with USDMF on PharmaCompass.
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