About Siegfried. Company Portrait

Transcription

1 About Siegfried ompany Portrait

2 Headquartered in Zofingen, Switzerland, Siegfried operates worldwide in life sciences with production facilities in Switzerland, USA, Malta, hina, Germany and France. Siegfried provides longstanding pharma and chemical experience, which offers customers the benefit of an integrated partner with more synergy, expertise and value. Siegfried is active in both the primary and secondary production of drugs. The group develops and produces active pharmaceutical ingredients (API) and intermediates for the research-based pharmaceutical industry, as well as controlled substances. In addition, Siegfried offers both development and manufacturing services for finished dosage forms, including sterile filling. Explore more about how Siegfried s broad range of custom development services, drug substance and drug product manufacturing capabilities, together with an existing product portfolio, can help you achieve greater value. Dear reader, Dr. Rudolf Hanko, hief Executive fficer Selecting the right outsourcing partner is critical in a competitive market environment. This ideal partner needs industrial experience coupled with reliability and flexibility. Beyond expertise, customers need a partner with broad technological capabilities and sufficient production capacity to reduce the complexity of a project, especially when deadlines are tight. As an experienced, international outsourcing partner, Siegfried provides products and customized services that integrate seamlessly into our customers value chain. Siegfried offers a wide range of services for the pharmaceuticals industry: development services for active pharmaceutical ingredients, intermediates and finished drug products, registration activities, production, packaging and shipping. As a former, fully integrated pharmaceutical company, Siegfried is one of the few exclusive suppliers worldwide that has extensive skills in both API manufacturing and in the production of finished drug products. This is a rare combination of experience and knowhow. With Siegfried as your preferred partner, you can expect real added value for your business. Whether your needs are in custom development and manufacture of APIs, intermediates or drug products, controlled substances, high potency products or the manufacture of demanding formulations, Siegfried delivers more benefits than you expect. Dr. Rudolf Hanko, E Siegfried 3

3 History 2012 Acquisition of Alliance Medical Products (AMP) in Irvine (USA) Foundation of Siegfried in Zofingen (H) Start of operation at facility in antong () Acquisition of Hameln Pharma in Hameln (DE) Foundation of Ganes hemical Works, Inc. in ew Jersey (USA) Acquisition of segments of BASF s pharmaceutical supply business in Minden (DE), Evionnaz (H) and St. Vulbas (FR) 1973 Listing on the Swiss Stock Exchange (SWX) 2005 Acquisition of Penick orporation in ew Jersey (USA) 2007 Launch of a pharmaceutical production facility in Hal Far (ML)

4 Your Preferred Integrated Partner Siegfried, a worldwide integrated ontract Development and Manufacturing rganization, spans the eastern and western hemispheres. Siegfried provides development and manufacturing services, and offers intermediates, active pharmaceutical ingre dients and finished dosage forms. Exclusive synthesis APIs and Intermediates ontrolled substances hemical Process Development Pharmaceutical Development Services hemistry hemical Production Pharmaceutical Production Siegfried has extensive experience in both chemical and pharmaceutical production. Its diverse background sets Siegfried apart from other suppliers, bringing more value to customers both in product development and within the transition from production of APIs to finished dosage forms. Pharmaceutics Solid dosage forms Liquid dosage forms Sterile fillings 6 7

5 Active Pharmaceutical Ingredients and Intermediates Siegfried is the ideal partner for both cgmp and non-cgmp intermediates and active pharmaceutical ingredients. Whether by optimizing processes already in operation or by implementing complex procedures, our chemists have extensive know-how and a wide range of experience in the development and production of customized APIs and intermediates. Siegfried offers special technologies and manufacturing processes, including phosgenation, Azide chemistry, isolator technology, microreactors, spray drying and controlled substances, as described on the following pages. ur expertise includes the scale-up in compliance with cgmp requirements as well as the manufacture of clinical pilot samples during the entire product life cycle. reative life cycle approaches and professional project management ensure more value for our customers. Locations Zofingen, Evionnaz H antong Saint-Vulbas FR Minden DE Pennsville USA 8

6 Broad Portfolio of Generic APIs Selection of controlled substances H H H H Me H H H H BU Buprenorphine xymorphone xycodone Hydromorphone H H H H Thebaine Morphine ripavine Me Me H H H 2 H H H H H Hydrocodone odeine altrexone aloxone Siegfried offers a broad portfolio of active pharmaceutical ingredients (APIs) from its locations in both the eastern and western hemispheres. The portfolio focuses on anesthetics, pain/addiction treatment applications, central nervous and respiratory diseases as well as caffeine for human health and nutrition. Siegfried procures raw materials from long-standing and reliable suppliers. As a recognized expert in the production of APIs, Siegfried has all authorizations and approvals required for the produc tion and worldwide distribution of these substances. Highest quality specifications as well as regulatory and technical support for our customers are standard at Siegfried. Locations Zofingen, Evionnaz H Pennsville USA Minden DE 10 11

7 Development and ommercial Production of Finished ral Dosage Forms In our Swiss and Maltese facilities, Siegfried offers a wide selection in the formulation of pharmaceutical products, including production based on closed and high-containment principles. With its extensive experience and the application of numerous different technologies, Siegfried develops sophisticated products in solid oral dosage forms. ur strengths include the scale-up in accordance with cgmp requirements and the production of clinical pilot samples, commercial batches and packaging. reative life cycle approaches ensure more value for our customers. Siegfried stands out when it comes to exceptional quality and worldwide regulatory compliance. Locations D M P Zofingen H * Hal Far ML D: Development, M: linical trial material, P: ommercial prodcution * orphan drugs, niche products 13

8 Aseptic and Sterile Filling of Sterile Dosage Forms At the Irvine (USA) and Hameln (Germany) facilities, Siegfried provides contract development and manufacturing services specializing in difficult to manufacture injectables, ophthalmics, and combination devices. ur cgmp scalable aseptic fill/finish suites support clinical through commercial sterile manufacturing of vials, ampoules, squeeze tubes, cartridges, PFS and ophtalmic droppers. Vials and ampoules are filled in aseptic conditions and terminally sterilized if needed. ur formulation expertise ranges from solutions, suspensions, emulsions, ointments and gels to sterile drug delivery devices. ur inhouse, state-of-the-art, development, microbiology and chemistry laboratories ensure quality of product and process from incoming materials to finished products. Both facilities have been inspected and approved by the European and US authorities. Locations Hameln DE Irvine USA A V PS ST PB M P A: Ampoules, V: Vials, : artridges, PS: Pre-filled syringes, ST: Squeeze tube, PB: Plastic bottle (BT), M: linical trial material, P: ommercial prodcution 14

9 Highest Safety, Health and Environmental Protection Standards In the life sciences industry, sustainability is more than a wish or aspiration. The activities of all market participants are under continuous review by boards of health, customers and consumers. As a result, safety and environmental awareness is a top priority at Siegfried. orporate sustainability is at the center of all of Siegfried s endeavors and processes, and is rooted in its mission. Accident prevention is an integral element of all corporate processes and is reviewed periodically to ensure compliance with the latest safety and environmen tal standards. Besides quality standards and efficiency, safety and environmental protection are key success factors of our company. Siegfried s safety, health and environmental policy (SHE) is practiced at all levels. The high cgmp standard (current Good Manufacturing Practice) and quality aspects implemented by Siegfried enjoy international recognition. We constantly strive to maintain these standards worldwide in order to maintain our reputation as a reliable and quality-conscious partner over the long term. Siegfried is a member of the Science Industries Switzerland trade organization and co-signed the bligation to Maintain Responsible are in Based on these principles, internal safety, health and environmental protection guidelines have been developed and were incorporated into a global SHE policy in The operational responsibility for Siegfried s safety, health and environmental policy is the department of compliance. However, individual responsibility is expected of all Siegfried employees, contractors and suppliers at all worldwide sites. bservance of international guidelines: cgmp (current Good Manufacturing Practice) IH (International onference on Harmonization): WH (World Health rganization):

10 Siegfried Worldwide Siegfried operates worldwide in six countries on three continents. Headquartered in Zofingen, Switzerland, Siegfried has facilities in Switzerland, USA, Malta, hina, Germany and France. Siegfried AG HQ Untere Bruehlstrasse Zofingen Switzerland Finished oral dosage forms; controlled substances; APIs, intermediates Siegfried USA, LL 33 Industrial Park Road Pennsville, J USA ontrolled substances; APIs, intermediates, drug product intermediates Siegfried Malta Ltd HHF070 Hal Far Industrial Estate Hal Far BBG 3000 Malta Finished oral dosage forms Siegfried Irvine 9342 Jeronimo Road Irvine, A USA Sterile and aseptic filling Siegfried (antong) Pharmaceuticals o. Ltd. o. 5, Tongshun Road, ETDA antong ity, Jiangsu Province P.R. (post code: ) hina APIs, intermediates Siegfried Hameln Langes Feld Hameln Germany Sterile and aseptic filling Minden Deutschland Hameln Deutschland Evionnaz Schweiz Zofingen Schweiz Irvine USA Pennsville USA Saint-Vulbas Frankreich Hal Far Malta antong hina Siegfried Pharmahemikalien Minden GmbH Karlstrasse Minden Germany APIs, intermediates, custom synthesis, controlled substances Siegfried Evionnaz SA Route du Simplon 1, Evionnaz Switzerland APIs, intermediates Siegfried St. Vulbas SAS Parc Industriel de la Plaine de l Ain 530 Allée de la Luye Saint Vulbas France APIs, intermediates 18 19

11 Professionalism and Passion Innovation and Sustainability ompliance and Flexibility 2016 Siegfried AG Siegfried Holding AG Untere Bruehlstrasse 4 H-4800 Zofingen