Your Boutique for [niche] APIs Via delle Arti 33, Concorezzo (Italy) Tel

Our History 1969 – ICROM was established by a French entrepreneur, Jean Epuran, as chemical industry for the manufacturing of Active Ingredients for Synthelabo (subsequently merged with Sanofi) 1996 – ICROM was acquired by Protex International, now Proxis Développement SA, a multinational, specialty chemical company headquartered in Paris. A fruitful period of consistently groth started, with a significant diversification of API portfolio. Over more than 40 years ICROM is serving the Pharmaceutical segment providing high quality and tailored made products and services

Proxis Développement group Proxis Development SA ( is a French industrial group with an international presence which offers products, services and solutions to a wide range of markets including the water treatment, perfumes and agro-food sectors. This diversification constitutes a major asset for the Group and its customers: capitalising on its know-how, sharing in-house resources, the complementary nature of various skills and forms of expertise. Proxis Development holding is an affiliate of Protex international, an independent French Industrial Group, founded in Protex International has been run by the Moor family for 3 generations, currently leading a group of 160 million €.

ICROM Today A fully integrated company, devoted to the development and manufacturing of active ingredients and advanced intermediates for pharmaceutical use. An API manufacturer delivering its products and services to more than 40 countries worldwide, both regulated and semi-regulated markets. A reliable partner with a strong know-how in API production and Custom Manufacturing services

5 Markets – by value (2015) EU47 %MENA10% NorthAm8 %FarEast21% LatAm7 %INDIAs7%

Core Activity & Services API sales by Portfolio  in house development of generic APIs Custom Synthesis and Contract Manufacturing  using newly developed or customer’s technology  processes optimization for industrial manufacturing Fine Chemical Manufacturing  Multi step GMP manufacturing of advanced intermediates, guaranteeing full regulatory compliance

Therapeutical categories

Units and processes Flexible Diversified Qualified Integrated Multipurpose plant of 70 cubic meter capacity divided in 4 Workshops

Industrial plant 20 reactors between stainless steel and glass lined, from 500 up to 6000 L. Divided in two workshops State-of-the-art line for small batch sizes and GMP pilot production, equipped with a dedicated centrifuge in clean room area, classified ISO 8 5 centrifuges working under laminar air flow Hydrogenation vessel 500 L working up to 100 °C and 10 atm Flow reactor for Ozonolysis Drying department in clean room area Internal biological waste water treatment and up to date systems for atmospheric pollution control

Kilogram Scale GMP unit - batch sizes from 0.5 kg to 2 kg - installed in a clean room area (ISO8, Class 100’000) The unit has 4 x 25 l glass reactors 2 vacuum buchners, 2 driers (120 L each) and can operate in the range 0.05 to 0.5 Bar and from –20 °C to 150°C with dedicated purified water production system, warehouses, HVAC and utilities. KILO PLANT Devoted to:  Small volume API  Pilot Productions  APIs for Clinical Trials

An highly-contained glove box GMP unit in a clean room GMP Production scales of g/batch To handle potent compounds down to 0.1 µg/m 3. (ISO 7 inside and ISO 8 outside) GMP unit devoted to:  Small Volume High-Potency APIs  HP APIs for Clinical Trials HP-API PLANT

Quality & Regulatory Quality System  All Icrom’s production UNITS work under cGMP (Eudralex Vol. 4, Part II) and are regularly inspected by the Italian Regulatory Agency (AIFA)  Last AIFA inspection: September2013  Agencies which have successfully qualified Icrom: US-FDA (last inspection Dec 2014; Self-Identified since 2013 according to GDUFA regulation) Japanese PMDA (site accreditation and DMF registration for 4 APIs) Korean FDA (twice, Jan ’11, registration for 3 APIs) Australian TGA (DMF registrastion for 1 API) Iranian FDA (DMF registrastion for 1 API)

Mission Our Mission is to be: a boutique for [niche] APIs by developing products with limited competition, particularly those which are: Highly technological (difficult-to-make chemistry) Highly valued and of small and medium volume Highly potent, innovative

Added Values High Speed High Speed – being small, ICROM is a fast and responsive organisation. Project decisions are made locally, not burdened by large committees nor by multiple management levels. High Quality High Quality - Our GMP Certifications demonstrate our ability to consistently meet the highest quality standards. This “quality culture” pervades all of our production UNITS Strongly Investing in [ Strongly Investing in [niche] APIs: Highly potent, Highly technological (difficult-to-make) and Highly valued and of small volume (niche)

Thank you for your attention Serving more than 200 Clients WW.. TEVA SEIYAKU (TAIYO)