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THE OPIATE EXPERT FOR A PAIN FREE WORLD AGRICULTURAL RESEARCH ALKALOID EXTRACTION TRACEABILITY SECURITY AGRICULTURAL PRODUCTION SANOFI GROUP

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THE OPIATE EXPERTFOR A PAIN FREE WORLD

AGRICULTURALRESEARCH

ALKALOID EXTRACTION

TRACEABILITY

SECURITY

AGRICULTURAL PRODUCTION

S A N O F I G R O U P

80 YEARS OF ALKALOID EXTRACTION

40 YEARS OF INDUSTRIAL SCALE POPPY CULTIVATION

30 YEARS OF EXPORT EXPERTISE

A MAJOR OPIATE PLAYERIN THE WORLD

FRANCOPIA

2FRANCOPIA_THE OPIATE EXPERT - For a pain free world

Created in 1932, Francopia is today one of the world’s major opiate producers. Specialist in the supply of active ingredients, the company is a key player involved in pain and addiction treatment.

3FRANCOPIA_THE OPIATE EXPERT - For a pain free world

1 - AGRICULTURAL RESEARCH Creating varieties and producing seeds

2 - AGRICULTURAL PRODUCTION Using a dedicated team to provide the narcotic raw material

3 - INDUSTRIAL PRODUCTION Manufacturing 20 active pharmaceutical ingredients

and intermediates

4 - DISTRIBUTION Applying the highest security standards, adapted to each country, to deliver to customers worldwide

Security and quality at each step of the process

Francopia, a Sanofi company, within the CEPiA network Within the Industrial Affairs Division of Sanofi, CEPiA (Commercial & External Partnership, Industrial Affairs) is an organisation exclusively dedicated to third party sales. CEPiA offers a wide range of solutions, including:• A portfolio of 200 intermediate

and active ingredients • Custom Synthesis • Toll manufacturing3 TYPES OF

PRODUCTS

Morphine Derivatives

Thebaine Derivatives

Synthetic Opioids

A FULLY INTEGRATED ACTIVITYFROM POPPY SEEDS TO ACTIVE PHARMACEUTICAL INGREDIENTS

4FRANCOPIA_THE OPIATE EXPERT - For a pain free world

RESEARCH FOCUSING ONPRODUCTIVITY

The main steps in genotype creation:• Crossing between elite lines• Evaluation of the chemical and agricultural

potential • Multiplication of progeny.

Once these steps are complete, the new variety can move to agricultural production scale production.

AGRICULTURAL RESEARCH

For more than 40 years, Francopia has focused its research on breeding alkaloid rich plants suitable for industrial scale cultivation.

Investing in the future: a strong commitment1000 poppy genotypes are tested each year by a team of agriculture engineers. Thus, more than 40 new varieties have already progressed to agricultural scale production.The role of this team of highly qualified researchers includes:

Genotype hybridisation

Research of innovative genotypes

Identification of genes of interest

Chemical analysis and genetic tagging

Variety selection by statistical and genomic methods

Certification of phytosanitary products

1000 "GENOTYPES" TESTED EVERY YEAR

5FRANCOPIA_THE OPIATE EXPERT - For a pain free world

COLLABORATION WITH KEY PLAYERS

R&D FRANCOPIA

French Ministry ofthe Environment

French Agency for Medicine Security

(ANSM)

Phytosanitary companies

Poppy growers

Sanitary and safety organisations and control agencies

Private and public research

6FRANCOPIA_THE OPIATE EXPERT - For a pain free world

SECURING POPPY CULTIVATION

The Francopia agricultural team controls the whole supply chain, ensuring the traceability and safety of products.

7FRANCOPIA_THE OPIATE EXPERT - For a pain free world

AROUND

10,000 ha

Crop sowing techniques

Selection of phytosanitary treatments

Development of specific agricultural machinery

Organisation of harvesting

Field geolocalisation for traceability and registration with police

Dehydration

Production of poppy straw pellets

Storage under controlled atmosphere

GETTING THE BESTOUT OF A FRAGILE CROP

AGRICULTURAL PRODUCTION

Francopia produces a high yielding poppy using a network of contracted farmers and agriculture related organisations.A dedicated team ensures the perpetuation of the highly technical know-how throughout all stages of the production, such as :

The power of the Group Francopia relies on the strong network of Sanofi manufacturing sites, each with its own expertise and tailored skills to ensure customer supply.

A vegetal extraction site• Expert in alkaloid extraction since 1963• Production of 150 metric tons of active ingredients annually• Packaging and logistics within closed units

The second site• The largest chemical and biotechnological site

of the Sanofi Group in Europe • Specialised in the manufacturing of synthetic

opioids

Unmatched experienceWith over 80 years of solid experience in vegetalextraction and chemical synthesis, Francopia industrial teams have fine tuned their manufacturing processes in line with the need to produce the very safest, highest quality products. The industrial sites are continually audited and checked by the major regulatory bodies such as the FDA (US), ANSM (France), PMDA (Japan), ANVISA (Brazil)…

Francopia meeting customers' specific needs• Adaptation of regulatory documents to local

regulations• Physical quality on demand: sieving, milling and

micronisation• Chemical and physical analyses with cutting edge

technology (NRM, LC-MS…), allowing to respond to specific demands

• Development team dedicated to toll manufacturing responding to the need for changing processes or specifications and developing new molecules

SANOFI’SINDUSTRIAL EXPERTISE

INDUSTRIAL PRODUCTION

MORE THAN

150 METRIC TONSOF ACTIVE INGREDIENTS SHIPPEDEACH YEAR

8FRANCOPIA_THE OPIATE EXPERT - For a pain free world

ACTING FOR SUSTAINABLE DEVELOPMENT

The development of Francopia is based on a continuous drive to improve processes and minimise environmental impacts. Our principal plant has implemented and constructed a waste and energy recovery treatment unit. The large solar panels, installed in 2012, produce the equivalent of the annual energy consumption of 350 households.Our sites are certified ISO 14001 and 50001.

9FRANCOPIA_THE OPIATE EXPERT - For a pain free world

PRODUCINGUNDER TIGHT CONTROL

10FRANCOPIA_THE OPIATE EXPERT - For a pain free world

The International Narcotics Control Board (ONU-INCB) monitors the worldwide narcotics market.

In accordance with the 1961 Single Convention on Narcotic Drugs, each country is obliged to declare all production, import, export, consumption, manufacturing and stock.

Francopia ensures the safety of all movements, under the control of the Ministry of Interior and the French Police.Francopia is AEO certified (Authorised Economic Operator)*.

* Global certification that recognises the high quality of different regulations, practices, and procedures in terms of customs compliance and security of the supply chain for the administration of international trade operations.

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Working with you worldwideThanks 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.

Meeting customer needs…• Tailor made services (packaging, labelling, sieving, milling,

micronisation, specific analyses...)• Operational responsiveness and reliability in the supply chain• A fully dedicated team (commercial, logistics, quality and

regulatory support)

… towards a long term partnershipFRANCOPIA_THE OPIATE EXPERT - For a pain free world

CEPiA Offices

Local Francopia representatives

Francopia headquarter and manufacturing site

FRANCOPIA A GLOBAL NETWORK CLOSE TO ITS CUSTOMERS

SELLING IN MORE THAN

80 COUNTRIES

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Für eine Welt ohne Schmerz

За мир без боли

致力于无痛世界

P a r a u n m u n d o s i n d o l o r

For a pa in f ree world

痛みのない世界のために

Pou r u n monde sa ns dou leu r

[email protected]

Francopia, a subsidiary of the Sanofi Group, member of the CEPiA network

Contacts

France+33 1 55 71 27 34

United States+1 908 981 55 18

Eastern Europe +421 2 33 100 700

India+91 98 33 77 44 68

Japan+81 3 6301 3450

China+86 21 22 266 032

Rest of the World+33 1 55 71 27 34