Your Boutique for [niche] APIs

Via delle Arti 33, 20863 Concorezzo (Italy)

Tel +39.039.6040836 www.icrom.com

Email: info@icrom.com

Our History1969 – ICROM was established by a French entrepreneur, JeanEpuran, as chemical industry for the manufacturing of ActiveIngredients for Synthelabo (subsequently merged with Sanofi)

1996 – ICROM was acquired by Protex International, now ProxisDéveloppement SA, a multinational, specialty chemical companyheadquartered in Paris. A fruitful period of consistently grothstarted, with a significant diversification of API portfolio.

Over more than 40 years ICROM is serving the Pharmaceuticalsegment providing high quality and tailored made products andservices

Proxis Développement groupProxis Development SA (www.proxis-developpement.com) is aFrench industrial group with an international presence which offersproducts, services and solutions to a wide range of marketsincluding the water treatment, perfumes and agro-food sectors.

This diversification constitutes a major asset for the Group and itscustomers: capitalising on its know-how, sharing in-houseresources, the complementary nature of various skills and forms ofexpertise.

Proxis Development holding is an affiliate of Protex international,an independent French Industrial Group, founded in 1932. ProtexInternational has been run by the Moor family for 3 generations,currently leading a group of 160 million €.

ICROM TodayA 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

ICROM TURNOVER 2003-2015 (K€)

5

Markets – by value (2015)EU 47 % MENA 10% NorthAm 8 % FarEast 21%LatAm 7 % INDIAs 7%

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

Units and processes

FlexibleDiversified

Qualified

Integrated

Multipurpose plant of 70 cubic meter capacity divided in 4 Workshops

Industrial plant20 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) andcan operate in the range 0.05 to 0.5 Bar and from –20 °C to 150°C with dedicatedpurified 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 10-200 g/batch To handle potent compounds down to 0.1 µg/m3.

(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 & RegulatoryQuality 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 – being small, ICROM is a fast and responsiveorganisation. Project decisions are made locally, not burdened by large committees nor by multiple management levels.

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 [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)