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ABOUT THIS PAGE
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.
Urate Oxidase Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Urate Oxidase GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Urate Oxidase GMP manufacturer or Urate Oxidase GMP API supplier for your needs.
A Urate Oxidase CoA (Certificate of Analysis) is a formal document that attests to Urate Oxidase's compliance with Urate Oxidase specifications and serves as a tool for batch-level quality control.
Urate Oxidase CoA mostly includes findings from lab analyses of a specific batch. For each Urate Oxidase CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Urate Oxidase may be tested according to a variety of international standards, such as European Pharmacopoeia (Urate Oxidase EP), Urate Oxidase JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Urate Oxidase USP).
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