Sanofi CEPiA - API Supply, Custom Synthesis, API and Pharma Contract Manufacturing Solutions

Within the industrial affairs of Sanofi, CEPiA (Commercial and External Partnership, Industrial Affairs) is an organisation fully dedicated to third-party activities.

The mission of the CEPiA sales activity is to promote the use of Sanofi's industrial network for active pharmaceutical ingredients (APIs) sales, custom synthesis and API and pharmaceutical contract manufacturing services.

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 CEPiA a regular product list (about 200 intermediates and APIs), including:

• Steroids
• Cobalamins
• Antibiotics
• Prostaglandins
• Opiates
• Opioids
• Fermentation derivatives

CEPiA's commercial offer also includes a dedicated quality assurance and regulatory affairs support. Our manufacturing plants are frequently inspected by health authorities, with GMP customer audits being performed regularly.

Custom synthesis and API contract manufacturing

CEPiA 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. CEPiA 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.

Pharmaceutical contract manufacturing

CEPiA provides drug product contract manufacturing, with our offer based on different key elements such as:

• Access to the Sanofi worldwide and diversified industrial network
• A wide range of technologies - from classical to innovative or niche technologies
• Quality and regulatory support, in compliance with the highest standards
• An offer from development starting at Phase 3, until industrialisation

Quality assurance and regulatory affairs support

A dedicated quality assurance and regulatory affairs support is part of the CEPiA offer.

Quality is one of the pillars of the CEPiA 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:

• Corticosteroids
• Hormones
• Multi-steps chemistry
• Opiates and opïoids
• Prostaglandins
• High active products (taxanes)
• Oligosaccharides
• Peptides
• Oligonucleotides
• Biotechnologies
• Therapeutic proteins
• Monoclonal antibodies
• Viral vectors
• Plasmids