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