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CEP/COS
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JDMF
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EU WC
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KDMF
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NDC API
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API SUPPLIERS
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USDMF
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Urokinase manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Urokinase, including repackagers and relabelers. The FDA regulates Urokinase manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Urokinase 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 Urokinase manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Urokinase supplier is an individual or a company that provides Urokinase active pharmaceutical ingredient (API) or Urokinase finished formulations upon request. The Urokinase suppliers may include Urokinase API manufacturers, exporters, distributors and traders.
click here to find a list of Urokinase suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Urokinase DMF (Drug Master File) is a document detailing the whole manufacturing process of Urokinase active pharmaceutical ingredient (API) in detail. Different forms of Urokinase DMFs exist exist since differing nations have different regulations, such as Urokinase USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Urokinase DMF submitted to regulatory agencies in the US is known as a USDMF. Urokinase USDMF includes data on Urokinase's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Urokinase USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Urokinase suppliers with USDMF on PharmaCompass.
Urokinase 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 Urokinase 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 Urokinase GMP manufacturer or Urokinase GMP API supplier for your needs.
A Urokinase CoA (Certificate of Analysis) is a formal document that attests to Urokinase's compliance with Urokinase specifications and serves as a tool for batch-level quality control.
Urokinase CoA mostly includes findings from lab analyses of a specific batch. For each Urokinase 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.
Urokinase may be tested according to a variety of international standards, such as European Pharmacopoeia (Urokinase EP), Urokinase JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Urokinase USP).
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