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 around 200 intermediates and API through Sanofi Active Ingredient Solutions’ regular product list, which includes steroids, cobalamins, antibiotics, prostaglandins, opiates, opioids and fermentation derivatives.
The company’s commercial offer also includes a dedicated quality assurance (QA) and regulatory affairs support. Its 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 customised synthesis of API ingredients, or multistep current good manufacturing practice (cGMP) intermediates.
Exclusive synthesis often concerns compounds that are still in the clinical development stage. Sanofi Active Ingredient Solutions offers customised services, working on process development to ensure:
- Identification of industrial synthetic route, taking into account all of the parameters required for future industrialisation, such as existing patents, 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 chemistry, manufacturing, and control (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
Dedicated QA 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 it markets are manufactured in Sanofi facilities and all comply with the same high-quality standards as those applied for the Sanofi branded products.
The company’s manufacturing plants are frequently inspected by health authorities, including Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), the US Food and Drug Administration (FDA), the Pharmaceuticals and Medical Devices Agency (PMDA), Korea Food and Drug Administration (KFDA) and the Brazilian Health Regulatory Agency (ANVISA).
Many GMP customer audits are performed regularly without any concern.
Sanofi Active Ingredient Solutions’ core expertise includes:
- Multi-steps chemistry
- Opiates and opïoids
- High active products (taxanes)
- Therapeutic proteins
- Monoclonal antibodies
- Viral vectors
About Sanofi Active Ingredient Solutions
Sanofi Active Ingredient Solutions is the new branding of Sanofi API’s third-party business that was previously known as Sanofi CEPIA.
The company’s dedicated experts develop, manufacture and supply API and technological solutions. Through its catalogue of high-quality active ingredients and contract development and manufacturing services, the company delivers expertise and innovative, customised solutions that support customers in more than 80 countries worldwide.
Sanofi Active Ingredient Solutions’ products contribute to key therapeutic solutions that help millions of people. Its customers range from start-ups to big pharmaceutical companies