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01 1URATE OXIDASE ("URICOZYME")
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3498
Submission : 1978-10-15
Status : Inactive
Type : II
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PharmaCompass offers a list of Urate Oxidase API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Urate Oxidase manufacturer or Urate Oxidase supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Urate Oxidase manufacturer or Urate Oxidase supplier.
A Rasburicase manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rasburicase, including repackagers and relabelers. The FDA regulates Rasburicase manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rasburicase 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 Rasburicase manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Rasburicase supplier is an individual or a company that provides Rasburicase active pharmaceutical ingredient (API) or Rasburicase finished formulations upon request. The Rasburicase suppliers may include Rasburicase API manufacturers, exporters, distributors and traders.
click here to find a list of Rasburicase suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Rasburicase DMF (Drug Master File) is a document detailing the whole manufacturing process of Rasburicase active pharmaceutical ingredient (API) in detail. Different forms of Rasburicase DMFs exist exist since differing nations have different regulations, such as Rasburicase USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rasburicase DMF submitted to regulatory agencies in the US is known as a USDMF. Rasburicase USDMF includes data on Rasburicase's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rasburicase USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rasburicase suppliers with USDMF on PharmaCompass.
