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Siegfried Brochure

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Siegfried Brochure

  1. 1. Vision «To be a world-class partner in developing and manufacturing drugs that improve human life.» 2 Siegfried is a leading provider of high value added development and manufacturing solutions for pharmaceutical companies seeking to optimize their drug development and supply activities by enhancing their access to both the active pharma- ceutical ingredient as well as the formulated drug.
  2. 2. Corporate Profile Siegfried is a globally active independent Swiss company with facilities in Switzerland, Germany, Malta, the United States, as well as China where a professional sourcing organization is located. As a supplier and service provider to the worldwide pharmaceutical industry, we focus on the development and production of active pharmaceutical ingredients, cGMP and non-cGMP intermediates, controlled subtances for analgesics, finished dosage forms and the provision of related services. We aim to provide products and services that fit smoothly into our customers’ value chain. This is ensured by our specific know- how in process development, in chemical and pharmaceutical production, and through the professional management of complex outsourcing projects. This enables us to realize tech- nology transfers in very short time. In this way and as a strategic partner, we make a significant contribution to the success of our customers. «Thanks to the rapid technology transfer and professional project management, we are an internationally renowned outsourcing partner.»
  3. 3. Corporate Development 1873 Founded by Benoni Siegfried in Zofingen, Switzerland 1904 Conversion into a joint stock corporation 1937 Launch of a manufacturing joint venture in the United States 1973 Listing on the Swiss Stock Exchange (SWX: SFZN) 1991 Realignment of company activities to focus on cGMP and non-cGMP intermediates, active pharmaceutical ingredients and complex generics The Siegfried Group consists of two business units 2005 Acquisition of Penick Corporation, U.S.A., Siegfried Actives a company specialized in active pharmaceutical ingredients for analgesics Custom synthesis of APIs and intermediates, as well as production of standard substances. 2007 Inauguration of the pharmaceutical production site in Malta Siegfried Generics Sale of the Sidroga Division Development and production of complex generic dossiers and finished dosage forms, including dry powder inhaler Building up of an entity for inhalation technology technology. in Munich 4
  4. 4. Principles Speed Time is a key factor for our customers. We have teams of specialists and high-performance production systems in order to meet aggressive timelines. This way, we further simplify and accelerate the outsourcing process for our customers. By com- bining speed and uncompromising quality, we have gained an international reputation as an efficient partner when addressing production bottlenecks. Reliability Consistency, in terms of quality and robustness of processes, is of utmost importance to Siegfried. To guarantee these standards, we leverage the best available raw materials, pro- cesses, plants, employees and market partners. Flexibility We know our customers – and they know us. Simple organiza- tional structures, an emphasis on teamwork, direct communica- tion and an intensive exchange of experience and knowledge allow us to respond quickly and effectively to customer requests. 5 Speed Reliability Flexibility
  5. 5. Siegfried Actives Siegfried Actives focuses on the development, scale-up and pro- duction of cGMP and non-cGMP intermediates, finished APIs and standard products . We are a world leader in production and delivery of controlled substances including opiates for use in analgesics. Our production plants are located in Zofingen (Switzerland) and Pennsville (U.S.A.). 6 «Siegfried – the right partner for cGMP and non-cGMP intermediates as well as finished APIs.»
  6. 6. Our strengths, your benefits • Fast technology transfer, efficient project management • Process development, scale-up and optimization • cGMP / non-cGMP manufacture • Extensive know-how in physical operations • Full regulatory support (DMF and CEP) • Analytical services (validation, stability studies, purity profiles) • Premier customer service and technical assistance We help our customers to avoid production bottlenecks and to enter their products into the market on time. 7
  7. 7. Siegfried Generics Siegfried Generics develops and produces demanding generic dossiers and various pharmaceutical dosage forms for the world market. Our product portfolio consists of leading generic pro- ducts in several therapeutic classes. Thanks to our know-how and reliability, we enable our custo- mers to enter important generic markets the day after patent expiry. Our production facilities are located in Malta; additional- ly, we collaborate with qualified partners throughout Europe. 8 Our strengths • EU registration files and technical files for ANDA applica- tions • Custom manufacturing of solid dosage forms • Regulatory support during the whole product life cycle • Intellectual property handling before and after market launch • Allocation of marketing licenses • Supply of quality products (PIC, WHO, FDA GMP) for the EU and the U.S.A.
  8. 8. Inhaler technology Siegfried focuses on the development, registration and manu- PulmoJet® Key features facture of medicines for pulmonary applications. PulmoJet® is a multi-dose DPI with a 3-gram reservoir. It is a An innovative dry powder inhaler (DPI), registered and patented three step inhaler (open, inhale, close) and can be used in any under the name of PulmoJet®, serves as technology platform. orientation. Double dosing is not possible. It is equipped with a PulmoJet was developed with the goals to obtain a simple to unique direct dose indicator and has excellent moisture protec- use and robust device with excellent performance and patient tion. feedback features, while retaining simplicity in construction and cost-effectiveness in manufacture. The company envisions being a leading provider of generic and innovative inhalation drug products for world-wide markets. Distribution will be based on partnering and licensing activities. 9
  9. 9. Compliance Quality management The safety of the consumer is given highest priority. Therefore, products and work processes are subject to the most rigorous requirements in development, production and marketing. The management and the employees of Siegfried are commit- ted to complying fully with all quality guidelines in force. We assure that all processes at Siegfried observe the guidelines and requirements of our customers. Our first-class performance record resulting from audits carried out by the authorities and by customers speaks for itself. The Siegfried Compliance Board, led by a former inspector of the United States Food and Drug Administration (FDA), ensures that guidelines are observed and harmonized within the com- pany worldwide. 10
  10. 10. «We take our obligations Safety, health and the environment toward customers, employees Siegfried feels a responsibility to both its employees and the environment and thus pays great attention to this sensitive and the environment seriously.» area. Over the past few years alone, we have invested more than 100 million Swiss francs in a new, environmentally friendly infrastructure, refurbished existing buildings and equiped all installations to comply with legal requirements. Awareness for safety, health and environmental protection is actively promoted among all employees. Within the parameters of the “Responsible Care” initiative implemented worldwide by the chemical industry, Siegfried has enacted concrete programs that have had positive results, such as reducing water and power consumption and preventing accidents. Therefore, we have launched the Siegfried Safety Program (SSP). It focuses on sensitizing our employees to becoming more aware of safety. Siegfried has achieved considerable improvements since. 11 «At Siegfried, quality, safety and environmental management go hand in hand.»
  11. 11. 3 2 1 4 5 6 1 Siegfried Ltd 2 Siegfried (USA) Inc. 3 Siegfried Pharma Development GmbH Siegfried Inhalation Development GmbH Headquarters and Center of Excellence Headquarters U.S.A. Development Production facility for APIs and Center of Excellence Inhalation Technology Production facility for intermediates controlled substances and APIs Untere Brühlstrasse 4 33 Industrial Park Road Staffelseestrasse 4 4800 Zofingen Pennsville, NJ 08070 81477 München Schweiz USA Deutschland Phone +41 62 746 1212 Phone +1 877 763 8630 Phone + 49 89 724 6948 10 Fax +41 62 746 1204 Fax +1 856 678 8201 Fax + 49 89 724 6948 11 info@siegfried.ch info@siegfried-usa.com info@siegfried.ch www.siegfried.ch www.siegfried-usa.com www.siegfried.ch 4 Siegfried Generics (Malta) Ltd 5 Siegfried Shanghai 6 SCI Pharmtech, Inc. Pharmaceutical production facility Sourcing and Production facility for intermediates Asia Business Development and APIs © Siegfried Ltd 09/2007/2500 HHF070 Hal Far Industrial Estate 12A, Pu Fa Tower 186-2, Hai-Hu-Tsun P.O. Box 14, Hal Far BBG 07 588 South Pudong Road Lu-Chu-Hsiang Malta Pudong, Shanghai 200120 338 Taoyuan Phone +356 222 777 11 China Taiwan Fax +356 222 777 01 Phone +8621 5876 5019 Phone + 886 3 3541 700 info@siegfried.ch Fax +8621 5840 4753 www.siegfried.ch ko-lin.feng@siegfried.ch

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