siegfried brochure
TRANSCRIPT
Vision
Siegfried is a leading provider of high value added developmentand manufacturing solutions for pharmaceutical companiesseeking 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.
«To be a world-class partner in developing and manufacturing drugs that improve human life.»
2
Corporate Profile
Siegfried is a globally active independent Swiss company withfacilities in Switzerland, Germany, Malta, the United States, as well as China where a professional sourcing organization islocated. As a supplier and service provider to the worldwidepharmaceutical 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 intoour customers’ value chain. This is ensured by our specific know-how in process development, in chemical and pharmaceuticalproduction, 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 projectmanagement, we are an internationally renowned outsourcing partner.»
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 theUnited States
1973 Listing on the Swiss Stock Exchange (SWX: SFZN)
1991 Realignment of company activities to focus oncGMP and non-cGMP intermediates, active pharmaceutical ingredients and complex generics
2005 Acquisition of Penick Corporation, U.S.A., a company specialized in active pharmaceuticalingredients for analgesics
2007 Inauguration of the pharmaceutical production sitein Malta
Sale of the Sidroga Division
Building up of an entity for inhalation technologyin Munich
The Siegfried Group consists of two business units
Siegfried Actives
Custom synthesis of APIs and intermediates, as well as production of standard substances.
Siegfried Generics
Development and production of complex generic dossiers and finished dosage forms, including dry powder inhaler technology.
4
Principles
SpeedTime is a key factor for our customers. We have teams of specialists and high-performance production systems in orderto meet aggressive timelines. This way, we further simplify andaccelerate the outsourcing process for our customers. By com-bining speed and uncompromising quality, we have gained aninternational reputation as an efficient partner when addressingproduction bottlenecks.
ReliabilityConsistency, 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.
FlexibilityWe 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 knowledgeallow us to respond quickly and effectively to customerrequests.
SpeedReliabilityFlexibility
5
Siegfried Actives
«Siegfried – the right partnerfor cGMP and non-cGMP intermediates as well as finished APIs.»
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 controlledsubstances including opiates for use in analgesics.
Our production plants are located in Zofingen (Switzerland) andPennsville (U.S.A.).
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 toenter their products into the market on time.
7
Siegfried Generics
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.
Siegfried Generics develops and produces demanding genericdossiers and various pharmaceutical dosage forms for the worldmarket. 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 patentexpiry. Our production facilities are located in Malta; additional-ly, we collaborate with qualified partners throughout Europe.
8
Inhaler technology
Siegfried focuses on the development, registration and manu-facture of medicines for pulmonary applications.
An innovative dry powder inhaler (DPI), registered and patentedunder the name of PulmoJet®, serves as technology platform.PulmoJet was developed with the goals to obtain a simple touse and robust device with excellent performance and patientfeedback features, while retaining simplicity in construction andcost-effectiveness in manufacture.
The company envisions being a leading provider of generic andinnovative inhalation drug products for world-wide markets.Distribution will be based on partnering and licensing activities.
PulmoJet® Key features
PulmoJet® is a multi-dose DPI with a 3-gram reservoir. It is athree step inhaler (open, inhale, close) and can be used in anyorientation. Double dosing is not possible. It is equipped with aunique direct dose indicator and has excellent moisture protec-tion.
9
Compliance
Quality management
The safety of the consumer is given highest priority. Therefore,products and work processes are subject to the most rigorousrequirements in development, production and marketing.
The management and the employees of Siegfried are commit-ted to complying fully with all quality guidelines in force. Weassure that all processes at Siegfried observe the guidelines andrequirements of our customers. Our first-class performancerecord resulting from audits carried out by the authorities andby customers speaks for itself.
The Siegfried Compliance Board, led by a former inspector ofthe United States Food and Drug Administration (FDA), ensuresthat guidelines are observed and harmonized within the com-pany worldwide.
10
«We take our obligationstoward customers, employeesand the environment seriously.»
«At Siegfried, quality, safety and environmental management go hand in hand.»
Safety, health and the environment
Siegfried feels a responsibility to both its employees and theenvironment and thus pays great attention to this sensitivearea. Over the past few years alone, we have invested morethan 100 million Swiss francs in a new, environmentally friendlyinfrastructure, refurbished existing buildings and equiped allinstallations to comply with legal requirements.
Awareness for safety, health and environmental protection isactively promoted among all employees. Within the parametersof the “Responsible Care” initiative implemented worldwide bythe chemical industry, Siegfried has enacted concrete programsthat have had positive results, such as reducing water andpower consumption and preventing accidents.
Therefore, we have launched the Siegfried Safety Program(SSP). It focuses on sensitizing our employees to becomingmore aware of safety. Siegfried has achieved considerableimprovements since.
11
Siegfried (USA) Inc.
Headquarters U.S.A.Production facility for APIs and controlled substances
33 Industrial Park RoadPennsville, NJ 08070USAPhone +1 877 763 8630Fax +1 856 678 [email protected]
Siegfried Ltd
Headquarters and Center of ExcellenceDevelopment Production facility for intermediates and APIs
Untere Brühlstrasse 44800 ZofingenSchweizPhone +41 62 746 1212Fax +41 62 746 [email protected]
Siegfried Shanghai
Sourcing and Asia Business Development
12A, Pu Fa Tower588 South Pudong RoadPudong, Shanghai 200120ChinaPhone +8621 5876 5019Fax +8621 5840 [email protected]
SCI Pharmtech, Inc.
Production facility for intermediates and APIs
186-2, Hai-Hu-Tsun Lu-Chu-Hsiang338 TaoyuanTaiwanPhone + 886 3 3541 700
Siegfried Generics (Malta) Ltd
Pharmaceutical production facility
HHF070 Hal Far Industrial Estate P.O. Box 14, Hal Far BBG 07 MaltaPhone +356 222 777 11 Fax +356 222 777 [email protected]
Siegfried Pharma Development GmbHSiegfried Inhalation Development GmbH
Center of Excellence Inhalation Technology
Staffelseestrasse 481477 MünchenDeutschlandPhone + 49 89 724 6948 10Fax + 49 89 724 6948 11 [email protected]
1 2
2
3
4
4
5
5
6
6
31
© S
iegf
ried
Ltd
09/2
007/
2500