Sanofi Active Ingredient Solutions API Supply, Custom Synthesis, API and Pharma Contract Manufacturing Solutions
Within the industrial affairs of Sanofi Active Ingredient Solutions is an organisation fully dedicated to third-party activities.
The mission of Sanofi Active Ingredient Solutions’ sales activity is to promote the use of Sanofi’s industrial network for active pharmaceutical ingredients (API) sales and custom synthesis.
Supply of intermediates and active pharmaceutical ingredients
Sanofi has high-performance quality units, including 16 chemistry, biochemistry and biotechnical facilities, for the production of high-quality APIs and advanced intermediates.
Sanofi manufactures and offers through Sanofi Active Ingredient Solutions’ regular product list (about 200 intermediates and API), including:
- Fermentation derivatives
Sanofi Active Ingredient Solutions’ commercial offer also includes a dedicated quality assurance and regulatory affairs support. Our manufacturing plants are frequently inspected by health authorities, with good manufacturing practice (GMP) customer audits being performed regularly.
Custom synthesis and API contract manufacturing
Sanofi Active Ingredient Solutions also provides custom synthesis and API contract manufacturing services, offering both toll manufacturing and tailor-made synthesis of API ingredients, or multistep cGMP intermediates.
Exclusive synthesis often concerns compounds that are still in the clinical development stage. Sanofi Active Ingredient Solutions offers tailored services, working on process development for ensuring:
- Identification of industrial synthetic route, taking into account all of the parameters required for future industrialisation, such as existing patents, HSE, quality and cost
- Process optimisation
- Physical quality studies
- Process safety studies
- Process chemical engineering studies
- Scaling-up with the production of batches in pilot workshops, including technical, clinical, primary stability and registration
- Development and validation of analytical methods
- Necessary regulatory support for drafting the CMC sections of the dossiers
Toll manufacturing commonly involves molecules that are pending registration or those that have already been marketed. After the transfer of your manufacturing process, toll manufacturing can be applied, in accordance with the specifications provided, without modification of the necessary quantities. Alterations to the process will only be made with your consent.
Quality assurance and regulatory affairs support
A dedicated quality assurance and regulatory affairs support is part of the Sanofi Active Ingredient Solutions offer.
Quality is one of the pillars of Sanofi Active Ingredient Solutions’ commercial strategy. The products we market are manufactured in Sanofi facilities and all comply with the same high-quality standards as those applied for the Sanofi branded products.
All our manufacturing plants are frequently inspected by health authorities (ANSM, FDA, PMDA, KFDA, ANVISA, etc.) and many GMP customer audits are performed regularly without any concern.
Our core are of expertise includes:
- Multi-steps chemistry
- Opiates and opïoids
- High active products (taxanes)
- Therapeutic proteins
- Monoclonal antibodies
- Viral vectors
Products and Services
Sanofi’s Vaccine Manufacturing Facility, Toronto, Ontario, Canada
Sanofi – Lonza Biologics Production Facility, Visp
Ash Stevens Riverview Facility
Sanofi CEPiA has announced that the company will now be known as Sanofi Active Ingredient Solutions.Read more
The Life Science Leader magazine has awarded CEPiA-Sanofi as a worldwide CMO Leader for the third year running.Read more
CEPIA-Sanofi has been awarded the CMO leadership award within the categories quality, reliability, productivity and innovation by Life Science Leader.Read more
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