2Technical Support 3Formulation Development 4Proof of Concept 5 GMP Services 6Advanced Drug Delivery 1EUDRAGIT Products Evonik. Power to create.

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1 GMP Services Solutions for Clinical Sample Manufacturing 1 EUDRAGIT Products 2 Technical Support 3 Formulation Development Proof of Concept 4 5 GMP Services 6 Advanced Drug Delivery Evonik. Power to create.

2 Introduction Production is a business line of the globally active Evonik Industries AG, the world s leader in specialty chemistry. With the EUDRAGIT product range, has positioned itself throughout the world as a market leader in functional polymers for pharmaceutical applications. These include polymers for modified drug release, taste masking and moisture protection formulations, which can be applied in matrix systems, film coatings or melt extrudates. As part of its technical services for customers, the company conducts development projects in close cooperation with international and local pharmaceutical companies. In 2001, in Darmstadt, Germany, opened a GMP area for manufacturing of clinical samples. It complies with EU GMP-guidelines and is prepared to fulfill FDA requirements. Human Resources The GMP team is fully staffed with highly qualified employees being controlled by a comprehensive health monitoring system. All positions as required by the EU GMP guidelines are available in house. Continuous Production Facilities The GMP area includes qualified work and storage areas where equipment can be set up and materials are prepared in an orderly and consistent manner. Our class D clean room GMP area has a total area of 135 m2 training based on yearly identified needs assessments ensure that all employees are kept up-to-date on GMP regulations, pharmaceutical technology and product specifics. including separate GMP storage rooms. A modern air conditioning system, with regular room and hygiene monitoring, together with pest control ensure that the GMP area meets highest quality standards. Production Equipment and Processes Project Management Our mission is to work closely with you and provide expert support for your product developments with EUDRAGIT products from the first feasibility studies to scale-up and production. By doing this we enable access to new process technologies which will add value to your projects or just 2 help you overcome capacity issues. We offer small- and medium-scale production of GMP bulk material or clinical samples in our in-house GMP area, an offering that rounds out our service-rich product development package by providing you with complete development services under one roof. From the moment you start working with us until the project has been completed, you will be assigned a specialist project manager who will be your main contact, and who will coordinate all interactions with other departments. Formulation development is done by a specialist team from our Technical Customer Service department. After the formu- lation and processes have been determined, product specific GMP documents are prepared. Transfer to the GMP area and production of bulk material or clinical samples are done in cooperation with the product specialists from Technical Customer Service, by which we ensure the highest quality in both the pharmaceutical technology and GMP sector. State-of-the-art equipment is available for film coating, granulation, pelletization, tabletting, and melt extrusion. All of the equipment is suitable and qualified for its intended use, regularly calibrated and maintained. All relevant software conforms to CFR 21 Part 11 and has been certified or validated, as required. All production equipment cleaning processes are validated. At, your project will get specialist expertise with fast and efficient service leading to shorter timelines and lower product development costs. Our mission is to make sure you are completely satisfied and to be successful together with you. 3

3 Production Equipment Tablett Press IMA/Kilian E 150plus MX 18 incl. Metal Detector, Online Tablet Tester and Dust Seperator Compression of: Round tablets Oblong tablets Capacity: 5,400-67,500 tablets/hour Perforated Pan Coater Glatt GMPC II with 4 Exchangeable Drums Coating of: Tablets Dragèes Capsules Capacity: kg High Shear Mixer Diosna P/VAC 10 Mixing and granulating of: Dry products Wet products Vacuum drying Capacity: liter Laboratory Blender Servolift Mixing of: Powders Granules Pellets Capacity: 5 or 10 liter conical vessel max. 30 kg Rotor Precision Granulator Alexanderwerk RFG 150 DA Leistritz Extruder Micro 18 GL-40D Pharma Granulation of: Dry products Wet products Capacity of up to 600 kg/hour Extrusion of powders and granules. Additional dosing of fluids is possible Capacity of kg/ hour Fluid Bed Coater Glatt GPCG 3.1 Caleva Extruder 20/ Spheronizer 250 Coating of: Pellets Crystals Granules Tablets Capsules 4 Capacity (product specific/bulk density): Insert Min.-Max. GPCG kg GPCG kg Wurster kg Manufacturing of strand extrudates by wet extrusion and pelletisation afterwards Capacity: Extruder up to 25 kg/hour Spheronizer up to 10 kg/ hour 5

4 Quality Control Certification Quality Control In-house Analysis Chemical and physical analysis Dissolution testing Chromatography (HPLC, GC) IR spectroscopy Release of active ingredients Storage for stability testing as specified in ICH Q1A (R2) (If desired, special climatic zones can be set up) Analysis Available from Contract Laboratories Microbiological testing Other specific methods on request The GMP area has a comprehensive quality control system which ensures the quality of starting materials, intermediate and finished products as well as of packaging materials. Starting materials and primary packaging materials are ordered from qualified suppliers only, which are requalified on a regular basis to ensure continuing high quality. If a product requires special analytical testing, we can develop a separate Our QC staff has extensive analytical expertise in testing pharmaceutical products. Thanks to our expertise in polymers and pharmaceutical formulations, we can process orders efficiently and on time from development to the release of clinical trial samples Quality, Certification, and Auditing specification to perform the analysis. Analytical testing is conducted in our QC department using European Pharmacopoeia or other standard methods. Qualified external laboratories under contract can be used for microbiological or other special tests. Regular complete audits of the company s laboratories and contracted external service providers ensure compliance with regulatory requirements. while meeting the highest quality standards. A LIMS system is used to document all analytical data in confor mity to GMP. It is validated and conforms to CFR 21 Part 11, and as such ensures the secure administration and documentation of analytical results. Implementation of all key functions in house, GMP documentation, having the ability to trace all batches, comprehen sive self-inspection, and training measures are the keys to successfully ensuring that our system is of the highest quality which translates into successful development of your product. An electronic document ma nagement system (XERI) is used to author, update, link, and manage documents and manuals, and for training purposes. The system is validated and conforms to CFR 21 Part 11 and as such ensures secure company-wide access to valid documents. To monitor the use of and compliance with GMP procedures we perform extensive company-run inspections and audits of contract partners. We are committed to continually improving our operations through appropriate and efficient planning, and by analyzing our processes and operations. Together with our process based organizational structure, these elements form the basis of our effective quality assurance system. You can be confident that our best resources will be used to handle your project in an effective and efficient manor. Certifications, Manufacturing Authorization, and Guidelines Evonik Röhm GmbH is certified according to: DIN EN 9001 DIN EN ISO has a Manufacturing Authori zation Manu facturing Operations of Human Investigational Medicinal Products for Clinical Trials issued by the German authorities. Our GMP system complies with EU GMP guidelines and is prepared to meet FDA requirements on a short-term basis. Other In-house Analytical Methods Used for Development Purposes GC-MS NMR SEM GPC DSC Raman spectroscopy and IR microscopy 6 7

5 Further information is available from the following addresses: Germany Evonik Röhm GmbH Kirschenallee Darmstadt phone fax USA Evonik Degussa Corporation 2 Turner Place, PO Box 365 Piscataway, NJ phone fax [email protected] India Evonik Degussa India Pvt. Ltd. Research Centre Saki Vihar Road, Saki Naka Mumbai phone fax [email protected] China Evonik Degussa (China) Co., Ltd. 55 Chungdong Road Xinzhuang Industry Park Shanghai phone fax [email protected] Japan Evonik Degussa Japan Co. Ltd. Shinjuku Monolith 12F 2-3-1, Nishi-Shinjuku Shinjuku-ku Tokyo phone fax [email protected] This information and all further technical advice is based on our present knowledge and experience. However, it implies no liability or other legal responsibility on our part, including with regard to existing third party intellectual property rights, especially patent rights. In particular, no warranty,whether express or implied, or guarantee of pro-duct properties in the legal sense is intended or implied. We reserve the right to make any changes according to technological progress or further developments. The customer is not released from the obligation to conduct careful inspection and testing of incoming goods. Performance of the product described herein should be verified by testing, which should be carried out only by qualified experts in the sole responsibility of a customer. Reference to trade names used by other companies is neither a recommendation, nor does it imply that similar products could not be used. Evonik Röhm GmbH is the owner of patent rights covering the use of EUDRAGIT polymers in compositions, procedures and/or applications which may be subject to license agreements. Compositions, procedures and/or applications falling within the claims of patents related to EUDRACOL and EUDRAPULSE and EUDRAMODE will always require separate license agreements. = registered trademark EUDRAGIT = reg. Trademark of Evonik Röhm GmbH, Darmstadt, Germany Evonik Röhm GmbH Kirschenallee Darmstadt Germany phone fax Evonik. Power to create.