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SANOFI - CEPiA

SANOFI CEPiA

CEPiA (Commercial & External Partnership, Industrial Affairs) is an organization fully dedicated to third party activities within the Industrial Affairs of Sanofi.

One of the key activities of CEPiA is to offer a broad range of innovative solutions including:

  • Supply of Active Pharmaceutical Ingredients (APIs) and Intermediates
  • Custom Synthesis & API Contract Manufacturing
  • Pharma Contract Manufacturing

CEPiA Sales is a Sanofi activity dedicated to manufacturing and supply of a broad range of APIs available on a catalogue basis.

By employing its exhaustive industrial capabilities, facilities and expertise​ expected of large pharma, CEPiA provides its clients with «fast to market» solutions.

We offer API Contract Manufacturing & Custom Synthesiscompetences​ from small molecules to biologics, from lab scale to commercial quantities. Additionally, we offer our extensive drug product facilities.

To handle complex industrial projects, CEPiA relies on the wide Sanofi Industrial network.

Roughly 16 Chemical & Biotech sites located in 6 countries (mainly in Europe) manufacture intermediates and APIs for third party projects.

About 38 pharmaceutical sites located in 25 countries worlwide offer their production capacities for third party market.

In total, more than 50 Sanofi sites​ are in support of CEPiA activity.

 

Products

1/ Intermediates and Active Pharmaceutical Ingredients (API) supply:

We manufacture and supply a broad range of biotech & chemical intermediates and APIs. Customers in pharmaceutical industry can have access to almost 200 high quality APIs, manufactured in our 16 chemical and biotech sites.

  • From traditional chemistry to biotechnology
  • From small scale to large scale production
  • Various grades of APIs (sieving, milling, micronization…)
  • Knowledge & expertise sharing from Sanofi network
  • Sustainable Development and Ethical Chart
  • From Sanofi sites regularly inspected by international Health Authorities with success
  • Regulatory & Quality standards
  • Regulatory & Quality support with dedicated team

 

FERMENTATION & BIOTECHNONOGY

  • Vitamin B12 & derivatives
  • Antibiotics & Antituberculosis
  • Packaging customization
  • Customized product grade

SYNTHESIS

  • Analgesics & Nonsteroidal anti-inflammatory drugs (NSAIDs)
  • CNS for Oral & Injectable applications
  • Human recombinant insulin for cells culture (Tamsulosine)
  • Anaesthetics (articaine)
  • Systemic & cardiovascular
  • Metabolic disorders & anti-allergics

CORTICOSTEROIDS & HORMONES

  • Non fluorinated glucocorticoids and derivatives (Hydrocortisone, prednisone...)
  • Fluorinated glucocorticoids and derivatives (dexamethasone, triamcinolone…)
  • Minearlocorticoids (spironolactone, canrenone..)

PROSTAGLANDIN

  • World number 1
  • Development of pulmonary arterial hypertension (PAH) portfolio (Epoprostenol, Iloprost…)
  • Development of Ophthalmology portfolio (Latanoprost, Travoprost…)
  • Around 17 prostagladin APis on catalogue
  • Process development & scale-up of new chemical entities.

OPIATES & OPIOIDS (FRANCOPIA)

  • World number 1 in Codeine producer & exporter
  • From poppy seeds to APIs
  • 30 Narcotics & Antagonists in Portfolio
    • Morphine derivatives
    • Thebaine derivatives
    • Synthtic Opioids
  • 80 year experience in Alkaloid extraction

2/ Custom Synthesis & API CMO

We are a Contract Manufacturing Organization (CMO) in Chemistry and Biotechnology.

We offer our customers and partners Sanofi’s experience and know-how from Process Development to industrial scale production.
We offer custom synthesis & API Contract Manufacturing under cGMP conditions for API and multistep intermediates.

  • Toll manufacturing​ most often concerns molecules pending registration or those already marketed. Following transfer of your manufacturing process, it can be applied without modification for the production of the necessary quantities in accordance with the specifications provided. Any changes to the process are made with your agreement.
  • Exclusive synthesis​often concerns compounds that are still in the clinical development stage. According to customer's requirements, this involves working on process development to offer alternative synthetic route implementation via:
    • Chemical and biotechnological development
    • Analytical development
    • Physical quality studies
    • Clinical supplies
  • Pilot plant production from technical /engineering runs to clinical supplies
    • Process Engineering and scale-up
    • Process safety
  • Commercial supply at industrial scale
  • Quality & regulatory support

Our expertise fields cover:

Chemistry:

 

  • Oligosaccharides
  •   Peptides
  • Oligonucleotides
  • Corticosteroids and Hormones
  • Prostaglandins
  • Opiates and opioids
  • Highly Active Products (HAP)
  • Multi-step heterocyclic chemistry

Biotechnology:

  • Plasmids
  • Therapeutic proteins (Production / Extraction / Purification)
  • Extractive proteins
  • Recombinant proteins
  • Monoclonal antibodies
  •   Viral vectors

3/ Pharmaceutical Contract manufacturing:

We manufacture more than 800SKu’s in 15 galenic forms. Customers can have access to almost 38 sites located in 25 countries and benefit from our know-how from Toll manufacturing to full range of Services including API, at the quality standards of Sanofi. You can rely on our expertise and adequate resources, if Technology transfer and scaling-up from Phase III to Industrialization are required.

We offer you one of the most extensive variety of technologies available:

  • Sterile:
    • Injectable
      • Pre-filled syringes, Freeze-dying of ampoules and vials, Bio Products filling, etc.
      • Non Injectable
        • Drops, Aerosols and Sprayx, Tubes, etc.
  • Non Sterile:
    • Solids ans Semi-Solids
      • Granulation and coating, multi-layer tablets, tab in tab, etc.
  • Segretated Workshops:
    • Penicillins, Cephalosporins,, High Potent Actives, Cytotoxics

Related resource

PEPTIDES & OLIGONUCLEOTIDES

PEPTIDES & OLIGONUCLEOTIDES

SANOFI - CEPiA | 09-Nov-2015 | Technical / White Paper

From a unique state-of-the-art platform for development and scale-up of Peptides and Oligonucleotides in Frankfurt (Germany), CEPiA offers customized services...