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Siegfried Brochure
1.
2. Vision
«To be a world-class
partner in developing
and manufacturing
drugs that improve
human life.»
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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.
3. 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.»
4. 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
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5. 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.
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Speed
Reliability
Flexibility
6. 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.).
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«Siegfried – the right partner
for cGMP and non-cGMP
intermediates as well as
finished APIs.»
7. 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.
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8. 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.
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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.
9. 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.
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10. 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.
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11. «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.
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«At Siegfried, quality,
safety and environmental
management go hand
in hand.»
