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Biologics  

Enoxaparin benefits from a highly sophisticated set of quality assurance procedures relying on a multi-system approach, from the animal material origins to the final product1. Sanofi's quality assurance includes:

  • Periodic audits of its facilities and its suppliers of raw material
  • Comprehensive traceability from intestine mucosa collection to the final product
  • Screening (quantitative PCR) to exclude cross-animal species contamination
  • A manufacturing process enabled to eliminate and prevent potential viral and prion contamination

Sanofi leadership

The recent 2008 worldwide Heparins crisis that involved adulterated heparins illustrates the importance of a global dedicated organisation that has relentlessly improved its standards to meet patients’ needs and health authorities’ demands. In this regard during the OSCS (over sulphated chondroitin sulphate) contamination crisis, Sanofi in collaboration with regulatory agencies has not only ensured patients’ access to a life-saving antithrombotic without compromising safety, but has also been at the forefront of the analytical research to prevent the reoccurrence of similar issues in the future. As such, Sanofi can offer a sustained production of enoxaparin, matching the highest quality standards.

Sanofi patients’ safety first commitment

Sanofi is committed to patients’ safety first. As a responsible leader in the field of Heparins, Sanofi regularly interacts with regulatory agencies to improve patients’ access to the highest quality standard products.

 

 
 

1. Sanofi, data on file.

 

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