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High Potency Active Pharmaceutical Ingredients

Innovation made. Easy.

2 2 High Potency Active Pharmaceutical Ingredients

Umicore is a global materials technology and recycling company. We focus on application areas where our expertise in chemistry, materials science, metallurgy and recycling makes a real difference. Our business philosophy is centered on the creation of tailor-made solutions for a wide range of high tech materials. We have a proud history of more than 100 years of expertise in fully integrated metal processing. We distinguish ourselves by recycling products that contain our materials and by doing so, we complete the metals loop contributing to the efficient usage of scarce natural resources.

The Precious Metals Chemistry business unit focuses on understanding your rapidly changing needs. We provide:

» innovative metal-based chemistry and applications

» commercial-scale manufacturing and» supply chain expertise to enable your

current and future technologies.

Innovation and progress are our steady companions. We offer an integrated, long-term collaborative partnership approach to research, development and commercial manufacturing that offers customers continued support through-out the product’s life cycle.

The key to our success is our deep understanding of customer-specific applications. This enables us to translate conceptual ideas into solid chemistry solutions that work for our customers.

Our production naturally benefits from our longstanding experience in the platinum group metals chemistry: a fully integrated precious metal stream from metal refining and purifi-cation down to the in-house production of key starting materials and recycling of all metal containing production residues. This allows an outstanding advantage when transforming high value platinum metal.

This professional and accurate precious metal management is naturally part of our services to customers.

High potency APIs are our passion

Umicore Precious Metals Chemistry is one of the world’s largest producers of platinum APIs for anti-cancer treatment. We pride ourselves in having over 50 years of experience in the platinum group metals chemistry and over 20 years in organometallics.

▾ Dissolution unit in cGMP production area ▾ Evaporation equipment

Innovation made. Easy. 33

Opened in 2009 in Buenos Aires, Argentina, our new, state-of-the-art hAPI facility produces according to cGMP requirements for global markets and has been inspected and endorsed by a variety of health agencies and customers. Additionally, the high standards of these facili-ties and systems have been verified by an inde-pendent third party audit according to ISO/IEC 17020 standards in 2014.

Managed under European standards and values, the Argentinian hAPI manufacturing site offers our customers an advantageous cost competitive-ness, as well as unique and innovative options to develop launch strategies for generic molecules.

We offer contract development and manufactur-ing services for your metal- based and organic highly potent molecules.

All research & development work is performed by our dedicated R&D group in Hanau-Wolfgang, Germany. Products and processes developed in Germany are transferred to our Argentinean hAPI plant for GMP production of clinical or commercial batches.

Our quality control teams in Argentina and Germany apply the latest analytical techniques and methodologies. Our in-house facilities and close cooperation with external contract laboratories allow us to also offer quality control services beyond standard analytics. We go the extra mile to offer our clients a constant, superior product quality!

Reliable partner – reliable quality

Umicore has been producing and marketing high potency APIs (hAPIs) for more than 20 years – complying with cGMP requirements, ICH guidelines and all applicable regulations in the pharmaceutical industry.

◂ Umicore Argentina plant:

» cGMP production

of APIs

» Manufacturing of key

starting materials

» Precious metal refining

Quality Control

CustomerSales &

Marketing Services

R & D Production

Regulatory Affairs

Quality Assurance

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We are truly globalWe serve clients all over the globe – including Europe, USA, Japan, Asia-Pacific, India and Latin America.

Our regulatory affairs group offers professional services to the generic as well as research based pharmaceutical industry. This includes, but is not limited to, filing and maintenance of DMFs, CEPs and documentation in paper or eCTD format. We also support the clinical development of inno-vative drug substances, for example with the preparation of CMC sections. Where appropriate we engage country specific,external regulatory advisors to ensure a smooth and efficient filing strategy.

▴ The Argentinian team: Your team for success!

Innovation made. Easy. 55

Our passion is APIs.Our commitment is to you.

Customer needs are our focus. Everything we do at Umicore is with the customer in mind.

We have won the trust of our customers and, in return, our customers have made us a major player in the platinum API market over the last decades. Our product portfolio does not only include:

» Cisplatin» Carboplatin» Oxaliplatin

but also various exclusive metal-based hAPIs.

The market success, as well as the experience in R&D, production and marketing of these highly potent molecules, triggered our decision to expand our portfolio into products with similar requirements.

Our capabilities include contract research and manufacturing services from pre- clinical process R&D to commercialization, for both NCEs and generics.

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O

O

O

O

Pt

NH3

NH3

NH3Pt

NH3

Cl

Cl

H2N O O

O ONH2

Pt

▴ Cisplatin ▴ Carboplatin ▴ Oxaliplatin

Working with us makes you benefit from:» Professional and dedicated project

management» Full support from pre-clinical to commercial

phase, including tech-transfer to our cGMP production facility in Argentina

» Strict protection of your IP » Expertise in global IP strategy» Close cooperation with our regulatory affairs

department

Today, our technological expertise includes:» Chemical synthesis of highly potent APIs» Inorganic, organic and metal-organic chemistry

» R&D in high containment facilities: isolators, laminar-flow boxes

» Process and product handling under highly inert atmosphere

» Handling of high purity products and pyrophoric materials

» Expertise in analytical method development as well as in process and method validation

At Umicore our values are transparent: teamwork, respect, openness, innovation and commitment, as well as trust and reliability reflect our basic business principles. Contact us to see for yourself.

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The information and statements contained herein are provided free of charge. They are believed to be accurate at the time of publication, but Umicore makes no warranty with respect thereto, including, but not limited to, any results to be obtained or the infringement of any proprietary rights. Use or application of such information or statements is at the user’s sole discretion, without any liability on the part of Umicore. Nothing herein shall be construed as a license or recommendation for use, which infringes upon any proprietary rights. All sales are subject to Umicore’s General Conditions of Sale and Delivery.

© 2015 Umicore AG & Co. KG. Version 09/2015. Printed in the Federal Republic of Germany.

Umicore AG & Co. KGPrecious Metals ChemistryRodenbacher Chaussee 463457 Hanau-WolfgangGermany

For inquiries and additional information please contact

Tel.: +49 (6181) 59 2471Fax: +49 (6181) 59 2970Email: api@umicore.com

Website: www.chemistry.umicore.com www.umicore.com