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Cepia Sanofi IN HOUSE API MANUFACTURING WORLDWIDE COMMERCIAL NETWORK SUSTAINABLE DEVELOPMENT QUALITY & REGULATORY SUPPORT SANOFI QUALITY STANDARDS CEPiA SALES BIOTECH & CHEMICAL SUPPLY INTERMEDIATES & APIs CEPiA Within the Industrial Affairs Division of Sanofi , CEPiA (Commercial & External Partnership, Industrial Affairs) is an organization fully dedicated to third party activities. One of the key activities of CEPiA is to offer a broad range of innovative solutions including: • Intermediates and Active Pharmaceutical Ingredients (APIs) supply • Custom Synthesis & API Contract Manufacturing • Pharma Contract Manufacturing CEPiA SALES AT A GLANCE • Around 200 APIs on catalogue… • …sold in more than 80 countries… • …manufactured in 16 Sanofi chemical & biotech sites • 200 CEPiA collaborators close to you CEPiA Sales is a Sanofi activity dedicated to manufacturing and supply of a broad range of of Biotech & Chemical Intermediates and APIs available on a catalogue basis. By employing Sanofi exhaustive industrial capabilities and other resources expected of large pharma, CEPiA offers high quality pharmaceutical intermediates and APIs: • From traditional chemistry to biotechnology • From small scale to large scale production • Various grades of physical quality 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 CEPiA guarantees REACH compliance. OPIATES & OPIOIDS (FRANCOPIA) CORTICOSTEROIDS & HORMONES FERMENTATION & BIOTECHNOLOGY Five chemical and biotech Business Units at your service. CEPiA SALES Each Business Unit focuses on a specifi c expertise and offers dedicated Quality & Regulatory support. SYNTHESIS PROSTAGLANDINS FACILITIES AND TECHNOLOGIES EUROPE FOCUS Frankfurt Elbeuf Vitry Prague Framingham Ujpest Amilly Vertolaye Garessio Mourenx Ankleshwar Sisteron Brindisi Aramon Jurong FERMENTATION & BIOTECHNOLOGY CORTICOSTEROIDS & HORMONES PROSTAGLANDINS • Vitamin B12 & derivatives • 30 corticosteroids manufactured • Supply of natural & modifi ed • Antibiotics & Antituberculosis on a ton scale Prostaglandins APIs • Packaging customization • Sustainable process for a long term • Continuous evolution of product portfolio • Customized product grade presence • Process development and scale-up of new • Fully back integrated manufacturing chemical entities • Jet milling expertise • Multipurpose production lines, batch sizes SYNTHESIS up to 10 Kg API • A portfolio of more than 60 APIs covering • cGMP compliance for all operations, various therapeutic areas OPIATES & OPIOIDS (FRANCOPIA) with proven record of seamless regular • 12 Sanofi manufacturing sites involved to • From poppy seeds to APIs FDA inspections and customer audits support this broad offer • World number 1 Codeine producer • From mass production (Metamizol, & exporter Ketoprofen) to medium and small scale • 30 Narcotics & Antagonists in portofolio production • 80 years experience in Alkaloid extraction CEPiA A WORLDWIDE COMMERCIAL NETWORK CEPiA EASTERN CEPiA EUROPE & TURKEY PRAGUE CEPiA JAPAN HEADQUARTERS (CZECH REPUBLIC) PARIS (FRANCE) TOKYO CEPiA CHINA CEPiA NORTH AMERICA SHANGHAI BRIDGEWATER, NJ (USA) CEPiA INDIA MUMBAI CEPiA Headquarters TO CONTACT US CEPiA local commercial organization PLEASE VISIT OUR WEBSITE : http://cepia.sanofi .com CEPiA local representative March 2014 449 792 290 00024 - T. 02 76 30 58 70 - © photos : SANOFI - Document imprimé par un imprimeur labellisé Imprim'Vert, sur papier FSC recyclé avec des encres végétales. sur papier FSC recyclé avec des encres végétales. SANOFI - Document imprimé par un imprimeur labellisé Imprim'Vert, 02 76 30 58 70 - © photos : T. 449 792 290 00024 - 20, avenue Raymond Aron F-92165 Antony Cedex - France - Tel: +33 1 55 71 42 82 Communication: catherine.ortet@sanofi .com | www.cepia-sanofi .com FULLY INTEGRATED OFFER 1960 STRAINS OWNER Vitamin B12 production in Romainville site (Roussel- VITAMIN B12 Uclaf), France 1966 ANTIBIOTICS Vitamin B12 production in Saint-Aubin-lès-Elbeuf site BIOTECHNOLOGY (Rhône-Poulenc), France 1972 Rifampicin (Rifadin®) production in Brindisi site (Gruppo Lepetit), Italy BIOENGINEERING 1987 Teicoplanin (Targocid®) production in Brindisi site (Gruppo Lepetit), Italy 1995 Defl azacort (Calcort®) production in Brindisi site LONG TERM Aramon, France EXPERTISE (Hoechst Marion Roussel), Italy Sanofi Biotechnology exper- tise is based on a large vo- 2007 lume fermentation technolo- Artesunate (Coarsucam®) gy used to produce complex production in Garessio site APIs in Europe in a backward (Sanofi ), Italy integrated manner, i.e. wit- hout intermediates from va- 2012 rious origins. Launch of the semi- Sanofi inherited its know-how synthetic Artemisinin in fermentation from its roots production in Garessio site in Roussel Uclaf, Rhône-Pou- (Sanofi ), Italy lenc, Gruppo Lepetit and Brindisi, Italy S a n o fi . Production of vitamin B12 started in of antituberculosis and antibiotics which the 1960’s with Roussel Uclaf and has started 40 years ago with Gruppo expanded with Rhône-Poulenc. This Lepetit. strong industrial background makes Specifi c biotechnology projects are CEPiA today one of the world’s leading also developed. Thanks to in-house suppliers and Sanofi the only Western expertise and capacity in bio-manu- producer of vitamin B12. facturing, high tech APIs are produced CEPiA industrial footprint is also cha- through recombinant technologies, racterized by an integrated production cell culture, protein engineering… BIOTECHNOLOGY INTEGRATED OFFER A comprehensive offer from production by fermentation to delivery of APIs 2 major poles dedicated to integrated productions of traditional compounds. The total industrial fermentation capacity is more than 6 000 m3 with a fully computerized control system and state-of-the-art downstream equipment (fi ltration, concentration, crystallization, chromatography…). VITAMIN B12 & DERIVATIVES 2 sites in France: • Saint-Aubin-lès-Elbeuf • Aramon ANTIBIOTICS & ANTITUBERCULOSIS 1 site in Italy: • Brindisi BIOTECHNOLOGY Purifi cation of recombinant proteins in a controlled environment as well as biochemical synthesis. 2 sites focused on specifi c biotech projects: • Aramon / France • Garessio / Italy All sites are certifi ed FDA, cGMP, ISO 14001 and benefi t from regional and specialized certifi cations such as ANSM (France), AIFA (Italy), ANVISA (Brazil), KFDA (Korea)… BIOTECHNOLOGY CUSTOMER ORIENTED OFFER • Packaging customization • Customized number of batches to minimize quality control and avoid extra costs • Specifi c certifi cations (e.g. Hallal, Kosher) • Customized product grades (particle size distribution, impurity profi le…) 15 APIs out of which 9 are suitable for injection More than 5 CEP 280 customers 2 EDMF in 62 countries 5 JMF 4 USDMF CONTACT Isabelle Messager +33 (1) 5571-2915 isabelle.messager@sanofi .com March 2014 449 792 290 00024 - T. 02 76 30 58 70 - © photos : SANOFI - Document imprimé par un imprimeur labellisé Imprim'Vert, sur papier FSC recyclé avec des encres végétales. sur papier FSC recyclé avec des encres végétales. SANOFI - Document imprimé par un imprimeur labellisé Imprim'Vert, 02 76 30 58 70 - © photos : T. 449 792 290 00024 - 20, avenue Raymond Aron F-92165 Antony Cedex - France - Tel: +33 1 55 71 42 82 Communication: catherine.ortet@sanofi .com | www.cepia-sanofi .com PROFESSIONAL RELIABLE 1980 PGF2 α production DEDICATED 1998 PROSTAGLANDIN PGE1 & PGE2 production EXPERTISE Since 2000 Leading generic Prostaglandin supplier CHINOIN of Japan APIs: Beraprost Sodium and Limaprost Alfadex Since 2005 Development of pulmonary arterial hypertension (PAH) portfolio HISTORY APIs: Epoprostenol, Iloprost, Treprostinil OF CHINOIN The tradition of chemical and Since 2008 pharmaceutical academic Development sciences in Hungary provi- of Ophthalmology portfolio ded a stable background APIs: Latanoprost, for the foundation of several Travoprost, Bimatoprost pharmaceutical companies. Amongst these, Chinoin’s more than hundred year tra- 2012 dition is unique. 17 Prostaglandin APIs Chinoin has been the foun- available from regular tain of innovation since its es- production tablishment in 1910, owning numerous patents worldwide and pro- Until today, the Prostaglandin Business viding new drugs to patients and high- Unit has successfully developed and tech solutions for its partners. industrialized several synthesis routes for The dedication to the discovery of new natural and modifi ed Prostaglandins. therapeutical fi elds resulted in an intense Thanks to the high level of expertise research and development activity on and diverse portfolio, we are now sup- Prostaglandins in the late 1970s. plying high quality Prostaglandin APIs in Chinoin was acquired by Sanofi in the 5 continents, in partnership with more mid 1990s. than 50 companies. The Prostaglandin activity is managed by a dedicated "Prostaglandins Busi- ness Unit" within CEPiA. THE PROSTAGLANDIN OFFER For many years, we have produced one of the most complicated entities nature has ever created with industrial state-of-the-art chemistry. Our production is based on our own intermediate tree, so we are totally broad from external sources or suppliers. STRENGTHS • Anticipation of market needs by continuous overview of worldwide marketed Prostaglandin APIs status • High level service of individual customer needs • Flexible, quick supply of broad range of Prostaglandin APIs • Worldwide
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