FRANCOPIA - THE OPIATE EXPERT. For a pain free world

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1 FRANCOPIA - THE OPIATE EXPERT For a pain free world

2 FRANCOPIA, LEADING THE WAY IN FRANCE AND THROUGHOUT THE WORLD 80 YEARS IN ALKALOID EXTRACTION 40 YEARS OF INDUSTRIAL SCALE POPPY CULTIVATION 30 YEARS OF EXPORT EXPERTISE 2 FRANCOPIA_THE OPIATE EXPERT For a pain free world

3 Founded in 1932, Francopia is now one of the major international players in opiates production. Being a world leader in the supply of controlled substance, Francopia is at the forefront of the global fight against pain. OUR STRENGTH A fully integrated activity from poppy seeds to active pharmaceutical ingredients 1 - AGRONOMIC RESEARCH Developing new poppy breeding programs thereby creating new plant varieties 2 - AGRICULTURAL PRODUCTION Cultivating poppy fields 3 - INDUSTRIAL PRODUCTION Manufacturing close to 30 active pharmaceutical ingredients and intermediates 4 - DISTRIBUTION Exportation of materials to over 80 different countries Guaranteeing safe, reliable products at every stage of our operation Natural derivatives and Synthetic opiates A TEAM OF OVER 200 OPIATES EXPERTS ON HAND Francopia, a subsidiary of the Sanofi Group, member of the CEPiA network The Sanofi Group (a world leader in health care) is continually working towards finding new ways of protecting people, to improving the quality of human life and to providing better healthcare solutions for the 7 billion people who live in the world. In 2008, Sanofi created CEPiA, a unit to develop commercial and external partnerships in industrial affairs. This new entity was to herald a new direction for the Group through the restructuring and promotion of its huge portfolio of active pharmaceutical ingredients. In addition to this, its significant production capacity and time-tested know-how in the development of custom synthesis solutions were made available to third parties. Today, Francopia combines the Group s industrial power with the far-reaching CEPiA network and its historically rooted expertise in the field of opiates. All together, they make Francopia a world class partner with a unique capacity to meet the ever changing market needs and expectations. 3

4 For a pain free world За мир без боли Para un mundo sin dolor 痛みのない世界のために Für eine welt ohne schmerz Pour un monde sans douleur FRANCOPIA, A WORLDWIDE NETWORK ON YOUR DOORSTEP Francopia headquarters Local CEPiA commercial teams Local Francopia network 4 FRANCOPIA_THE OPIATE EXPERT For a pain free world

5 Working for you worldwide Thanks to a global presence with strong local representation, 75% of our sales are achieved through export. Francopia currently distributes its range of active pharmaceutical ingredients* in over 80 countries: Tailor-made solutions driven by customers needs n Custom built services (e.g.: packaging, labelling, sieving, milling, micronization, specific analysis) n Operational responsiveness and reliability in the supply chain n A fully dedicated team (commercial, supply chain, quality and regulatory) Aiming at developing and maintaining long term partnerships PRESENT IN OVER 80 COUNTRIES * Refer to product list on page 14 A highly controlled and regulated activity The International Narcotics Control Board (INCB) is the monitoring body for the implementation of the United Nations international drug control conventions. It was established in 1968 in accordance with the Single Convention on Narcotic Drugs, Each member state must declare its total drug production, import, export, consumption, manufacture and stockpiles. In France, Francopia works hand in hand on security matters and administrative flow with the French Ministry of Interior and the law enforcement agencies. 5

6 400 "GENOTYPES" TESTED EVERY YEAR Once upon a time, the poppy The poppy (Papaver somniferum - botanic name) was used by many ancient civilisations to alleviate pain. However, it was not until 1804, that a German pharmacist, F.W. Sertürner, managed to identify and subsequently isolate the principle active ingredient morphine. The name is a reference to the Greek myth, whereby Morpheus, the god of dreams, was said to use poppy flowers to bring relief from suffering. Throughout the 19th century, doctors viewed morphine as a miracle medicine and prescribed it for any number of uses. With the invention of the hypodermic syringe circa 1850 its use became increasingly widespread. However, it soon transpired that morphine was not the innocuous remedy that it was first thought to be. It became clear that it was a highly addictive drug, which led to it being an extremely sought after substance. Morphine was no longer the panacea of the ill but a staple of the criminal underworld. That said, thanks to tight legislative control, the opium poppy has been reclaimed by the pharmaceutical laboratories and the principle active ingredients are not only used to bring pain relief but are also used to create drug-weaning medication for drug addicts. 6 FRANCOPIA_THE OPIATE EXPERT For a pain free world

7 AGRONOMIC RESEARCH Focusing our agronomic research on optimizing our productivity For over 40 years, Francopia has been committed to breeding a poppy with a maximum morphine and thebaine yield suited to industrial scale cultivation. Absolute commitment 400 poppy genotypes are tested every year resulting in 40 new varieties in current crop production. A wide range of R&D projects are overseen by our highly skilled team of researchers: n Establishment and control of agronomic protocols n Chemical and genetic analysis of newly modified varieties n Variety selection through the use of statistical methods n Seed production n Phytosanitary product approval In connection with all the major organizations Phytosanitary companies The French Medicines and Healthcare products Regulatory Agency The sanitary and safety organizations and control agencies R&D FRANCOPIA The French Ministry of Environment Public and private research organizations Poppy growers 7

8 8 FRANCOPIA_THE OPIATE EXPERT For a pain free world

9 AGRICULTURAL PRODUCTION Getting the best out of a fragile crop Working alongside with Farmers, Francopia produces a high yielding poppy. This partnership puts all its joint know-how into ensuring reliability with efficiency right down the entire manufacturing line. Crop sowing techniques Phytosanitary treatment choices Development of specialized agricultural machinery Harvesting organization With its thorough tracking system and its complete control of logistics, Francopia s agricultural team guarantees highly reliable product lines. Crop yield analysis Dehydration processing Production of granulated poppy straw Controlled environment storage 9

10 +120 TONS OF ACTIVE INGREDIENTS ARE DISTRIBUTED EVERY YEAR 10 FRANCOPIA_THE OPIATE EXPERT For a pain free world

11 INDUSTRIAL PRODUCTION Manufacturing for the entire globe The industrial power of Sanofi Francopia relies on a stong network of manufacturing plants within the Sanofi Group, each with its own expertise and able to provide a reliable supply for its customers. n One of the site is expert in alkaloid extraction since 1962, processes tons of granules, resulting in 120 tons of active ingredients, every year. With 3 separate workshops, production capacity and flexibility are all guaranteed. A state of the art packaging unit allows to further adapt to any number of different packaging requirements through the latest technology including closed-system environment cells and work flow management procedures. n The second site is an absolute hub of scientific and industrial development. This site bolsters Francopia s product lines by offering an extensive range of synthetic opiates. The power of unmatched experience With over 80 years of solid experience in vegetal extraction and chemical synthesis, Francopia has fine tuned its manufacturing processes in line with the need to produce the very safest, highest quality products. The various sites are continually audited and checked by the major regulatory bodies such as the FDA (US), ANSM (France the new name for the AFSSAPS), PMDA (Japan), ANVISA (Brazil) Francopia customer centric service at its best n Adapting international standards to local regulation n Adaptation of physical product forms: sieving, milling, micronization n On demand, specific analysis capitalizing on highly advanced chemical and physical techniques such as chromatography, laser granulometry n A team specialized in chemical synthesis and able to adapt to your needs: specification changes or procedures, new molecule development Environmental sustainability strategy The very future of our development lies in finding the means to reduce our carbon footprint and thereby counteracting our impact on the environment. 25% of the industrial investment is ploughed into addressing environmental issues. Careful waste disposal and energy saving measures have been introduced and integrated throughout the site. Our sites are ISO certified.. 11

12 For a pain free wo 3 molecules pushing the boundaries of pain relief solutions Francopia is a world leader in the production of a wide range of active pharmaceutical ingredients used for the treatment of both moderate and severe pain. Long years of experience allow Francopia to offer a wide range of active principles from traditional molecules to the very latest in synthetic opioids. Morphine Discovered in 1804, this legendary molecule has become the leading pain relief solution. Oxycodone This widely taken opioid analgesic derived from thebaine offers a reliable alternative to morphine for the relief of severe pain. Fentanyl A potent synthetic analgesic, it is 100 times stronger than morphine. With its fast-acting properties, its use became increasingly widespread during the last decade. Through new delivery forms it has become a major alternative to other molecules. 12 FRANCOPIA_THE OPIATE EXPERT For a pain free world

13 A CHOICE OF 30 ACTIVE INGREDIENTS AND INTERMEDIATES rld Pain management Moderate pain Level 2* Severe pain Level 3* Other Treatments MORPHINE DERIVATIVES Codeine, Dihydrocodeine Ethylmorphine Morphine, Hydromorphone Apomorphine (Parkinson s Disease/ Erectile dysfunction) THEBAINE DERIVATIVES Buprenorphine Nalbuphine Oxycodone Naloxone Naltrexone (antidote,management of alcohol dependence) SYNTHETIC OPIOIDS Tramadol Fentanyl Methadone Levomethadone (Anti-addictive) * World Health Organization pain ladder 13

14 A complete range of 30 active ingredients and intermediates Product name CEP USDMF JMF Apomorphine Hydrochloride EDMF (ASMF) OTHERS* Buprenorphine Hydrochloride Codeine Base In progress Codeine Camphosulfonate Codeine Phosphate Hemihydrate Codeine Resinate Concentrate of Poppy Straw (Morphine) Concentrate of Poppy Straw (Thebaine) Dihydrocodeine Hydrogen Tartrate Ethylmorphine Hydrochloride In progress Fentanyl Citrate Hydromorphone Hydrochloride In progress Levomethadone Hydrochloride (under conditions / restricted access) Methadone Hydrochloride * Other DMF types or technical information 14 FRANCOPIA_THE OPIATE EXPERT For a pain free world

15 Product name CEP USDMF JMF Morphine Base EDMF (ASMF) OTHERS* Morphine Hydrochloride Morphine Sulfate Nalbuphine hydrochloride Naloxone Hydrochloride Naltrexone Hydrochloride In progress Opium Crude Opium Powder Oxycodone Hydrochloride Pethidine Hydrochloride Phenyltoloxamine Resinate Thebaine Base Tramadol Hydrochloride Different particle size specifications available on demand * Other DMF types or technical information 15

16 For a pain free world Contacts Pour un monde sans douleur France United States 痛みのない世界のために Eastern Europe India Japan Rest of the World Para un mundo sin dolor За мир без боли Für eine welt ohne schmerz Francopia, a subsidiary of the Sanofi Group, member of the CEPiA network arcangelegroupe.com March photos: Sanofi, X - front page : NicolasBroquedis.com This document was printed by an eco-friendly printing company (working under the French label Imprim vert ), on FSC recycled paper and using vegetable based inks. 20, avenue Raymond Aron F Antony Cedex - France francopia@sanofi.com

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