For a pain free world - CEPiA A team specialized in chemical synthesis and ... FRANCOPIA _THE OPIATE...

FRANCOPIA - THE OPIATE EXPERT

For a pain free world

2FRANCOPIA_THE OPIATE EXPERT For a pain free world

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


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.

A fully integrated activity from poppy seeds to active pharmaceutical ingredients

OUR STRENGTH

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

Francopia, a subsidiary of the Sanofi Group, member of the CEPiA networkThe 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 solu-tions for the 7 billion people who live in the world.In 2008, Sanofi created “CEPiA”, a unit to develop commercial and external partnerships in indus-trial affairs. This new entity was to herald a new direction for the Group through the restructuring and promotion of its huge portfolio of active phar-maceutical ingredients. In addition to this, its si-gnificant production capacity and time-tested know-how in the development of custom synthe-sis solutions were made available to third parties. Today, Francopia combines the Group’s in-dustrial power with the far-reaching CEPiA network and its historically rooted exper-tise 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.

A TEAM OF OVER

200 OPIATES EXPERTS

ON HAND

Natural derivatives and Synthetic opiates


Für eine welt ohne schmerzЗа мир без боли 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

FRANCOPIA, A WORLDWIDE NETWORK ON YOUR DOORSTEP

Local CEPiA commercial teams

Local Francopia network

Francopia headquarters


Thanks to a global presence with strong local representa-tion, 75% of our sales are achie-ved through export. Francopia currently distributes its range of active pharmaceutical ingre-dients* in over 80 countries:

Tailor-made solutions driven by customers’ needs…

Working for you worldwide…

nCustom built services (e.g.: packaging, labelling, sieving, milling, micronization, specific analysis)nOperational responsiveness and reliability in the supply chain nA fully dedicated team (commercial, supply chain, quality and regulatory)

… Aiming at developing and maintaining long term partnerships

* 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 esta-blished in 1968 in accordance with the Single Convention on Narcotic Drugs, 1961. Each member state must declare its total drug produc-tion, 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 en-forcement agencies.

PRESENT IN OVER

80COUNTRIES

FRANCOPIA, A WORLDWIDE NETWORK ON YOUR DOORSTEP


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, ma-naged to identify and subse-quently 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 suffe-ring. 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 be-came 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 prin-ciple active ingredients are not only used to bring pain relief but are also used to create drug-weaning medication for drug addicts.


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 commitment400 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 methodsn Seed productionn Phytosanitary product approval

In connection with all the major organizations

AGRONOMIC RESEARCH

R&D FRANCOPIA

The French Ministry of Environment

Public and private research organizations

The sanitary and safety organizations and control agencies

Poppy growers

Phytosanitary companies

The French Medicines and Healthcare products

Regulatory Agency


Getting the best out of a fragile crop

AGRICULTURAL PRODUCTION

Crop sowing techniques

Phytosanitary treatment choices

Development of specialized agricultural machinery

Harvesting organization

Crop yield analysis

Dehydration processing

Production of granulated poppy straw

Controlled environment storage

With its thorough tracking sys-tem and its complete control of logistics, Francopia’s agricul-tural team guarantees highly reliable product lines.

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.


+120 TONS OF ACTIVE INGREDIENTS

ARE DISTRIBUTED EVERY YEAR


Manufacturingfor the entire globe…

INDUSTRIAL PRODUCTION

The industrial power of SanofiFrancopia relies on a stong network of manufactu-ring 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 7 000 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 num-ber of different packaging requirements through the latest technology including closed-system environ-ment 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 synthe-tic 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 bestn Adapting international standards to local regulationn 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 develop-ment 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 envi-ronmental issues. Careful waste disposal and energy saving mea-sures have been introduced and integrated throughout the site.Our sites are ISO 140001 certified..


For a pain free worldFrancopia is a world leader in the production of a wide range of active pharmaceutical ingre-dients 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 traditio-nal molecules to the very latest in synthetic opioids.

3 molecules pushing the boundaries of pain relief solutions

MorphineDiscovered in 1804, this legendary molecule has become the leading pain relief solution.

OxycodoneThis widely taken opioid analgesic de-rived from thebaine offers a reliable alternative to morphine for the relief of severe pain.

FentanylA potent synthetic analgesic, it is 100 times stronger than morphine. With its fast-acting properties, its use be-came increasingly widespread during the last decade. Through new delivery forms it has become a major alterna-tive to other molecules.


For a pain free world

SYNTHETICOPIOIDS

THEBAINE DERIVATIVES

MORPHINEDERIVATIVES

OtherTreatments

MethadoneLevomethadone(Anti-addictive)

NaloxoneNaltrexone

(antidote,management of alcohol dependence)

Apomorphine(Parkinson’s Disease/Erectile dysfunction)

Moderate painLevel 2*

Severe painLevel 3*

FentanylTramadol

OxycodoneBuprenorphine

Nalbuphine

Morphine, Hydromorphone

Codeine,DihydrocodeineEthylmorphine

Pain management

* World Health Organization pain ladder

A CHOICE OF

30 ACTIVE INGREDIENTS AND INTERMEDIATES


A complete range of 30 active ingredients and intermediates

Product name CEP USDMF JMF EDMF (ASMF) OTHERS*

Apomorphine Hydrochloride

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


Product name CEP USDMF JMF EDMF (ASMF) OTHERS*

Morphine Base

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

* Other DMF types or technical information

Different particle size specifications available on demand

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Für eine welt ohne schmerz

За мир без боли 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

Contacts

France+33 1 55 71 27 34

United States+1 908 981 5767

Eastern Europe+421 33 736 2809

India+91 98 33 77 44 68

Japan+81 3 6301 3450

Rest of the World+33 1 55 71 27 34

20, avenue Raymond Aron F-92165 Antony Cedex - [email protected]

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

For a pain free world - CEPiA A team specialized in chemical synthesis and ... FRANCOPIA _THE OPIATE...

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