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