Nycomed
Global Contract
Manufacturing
Nycomed Global Contract Manufacturing Brochure 2011
Our Global Contract Manufacturing Team
As one of the world’s leading pharmaceutical companies, Nycomed not only discovers, develops, manufactures and markets
its own products; it also provides contract
manufacturing services to third parties
throughout the world. In this new brochure
for 2010, we provide an overview of the
company and explain our understanding
of partnership. We also introduce our 8
state-of-the-art plants worldwide offering
contract manufacturing and present our
wide range of technologies and services.
Nycomed’s policy has always been to provide patients with the very best in terms
of quality, reliability and responsiveness.
With its contract manufacturing services,
Nycomed also shares this approach with
its customers - who expect a strong and
economically sound partnership with us. We
offer the highest level of customer focus
in terms of reliable communication; this is
why our clients are directly linked to the
operational managers at the various manufacturing sites.
Austria/Linz
Austria/Linz
Austria/Linz
Belgium/Brussels
Brazil/Jaguariuna
Brazil/Jaguariuna
Denmark/Roskilde
Denmark/Roskilde
Germany/Oranienburg
Germany/Singen
Mexico/Mexico City
Mexico/Mexico City
Mexico/Mexico City
Norway/Elverum
Norway/Elverum
Poland/ Łyskowice
Contents
About Nycomed
5
Nycomed at a glance
Manufacturing
Contract manufacturing
Global Presence
11
Global presence in manufacturing
Nycomed plants providing contract
manufacturing services
Technologies
17
Overview of pharmaceutical
technologies
Solids
Semi-solids
Non-sterile liquids
Sterile / special preparations
Services
23
Packaging
Development
Overview of quality standards
Contact
27
Contacts for building up partnerships
Nycomed Global Contract Manufacturing Brochure 2011
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An innovative pharmaceutical
company with a solid product
portfolio, promising pipeline
and global reach, particularly in
emerging markets.
About Nycomed
Nycomed - a global market-driven
growth company
Nycomed at a glance
Nycomed is a privately-owned global pharmaceutical company with a differentiated
portfolio focused on branded medicines in
the areas of gastroenterology, respiratory and
inflammatory diseases, pain, osteoporosis and
tissue management. An extensive range of
OTC products completes the portfolio.
company generated total sales of € 3.2 billion
and an adjusted EBITDA of € 1.1 billion in
2009. Nycomed ranks 28th among global
pharmaceutical companies and is the 16th
largest provider of OTC medicines.
Research and development is conducted at
three sites in Europe and one in India. New
products are sourced from our own internal
discovery organisation and in-licensed from
external companies such as small biotech organisations. Establishing long-term partnerships is
a cornerstone of Nycomed´s growth strategy.
Our mission
Our mission is to bring medicines that matter
to patients and healthcare providers.
Nycomed has 15 manufacturing sites and two
joint-ventures in 13 countries. 5 centres of
competence for global products are located
in Europe and 10 production sites for regional
products in fast-growing markets such as Brazil
and Mexico. A major investment is currently
being made in a new pharmaceutical plant in
Russia, at present Nycomed’s biggest single
market.
For more information visit www.nycomed.com
Our vision
Our vision is to become the preferred pharmaceutical company by being responsive,
reliable and focusing on results.
Company values
Nycomed people are encouraged to think for
themselves along with the company. Our
inherent values “Empathy, Courage, Trust and
Motivation” help us create an environment,
where highly motivated and committed employees deliver results.
Nycomed employs 12,000 people worldwide
and has affiliates in more than 50 countries.
It has a strong presence in Europe and in the
emerging markets in Russia/Commonwealth
of Independent States, Asia and Latin America. Headquartered in Zurich, Switzerland, the
Nycomed Global Contract Manufacturing Brochure 2011
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Competence is more
than the sum of individual skills.
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Nycomed Global Contract Manufacturing Brochure 2011
About Nycomed
Manufacturing “Operational excellence in mastering the
supply chain”
Our manufacturing operations provide a
competitive advantage for the whole company
through an innovative, global supply chain
network. This network is constantly reviewed
and optimised in the interests of increasing
the utilisation of its capacity, enhancing supply
chain performance, maintaining a high level
of customer service and decreasing the cost of
goods sold (COGS). Thus, it delivers Nycomed’s
products and services to its customers with the
right balance of quality, reliability, responsiveness and costs. Ensuring the availability of
Nycomed products and services for customers
in the most efficient manner possible requires
an integratedapproach. Nycomed’s operational activities are part of the company's value
stream. A significant volume of contract manufacturing further optimises the utilisation of
the manufacturing network. Currently, we operate 15 manufacturing facilities in 11 countries.
These meet the highest international quality
standards. Our combination of central and
regional manufacturing ensures rapid response
when opening up new and expanding existing
markets. Partnership plays a vital role in all of
our operational activities. Close cross-functional collaboration and seamless processing
between internal teams and external partners
help us to respond quickly and accurately to
market demand.
Competence centres
As a part of the continuous optimisation
programme for our production network, we
have established competence centres for certain technologies and/or pharmaceutical business areas. This helps us to increase capability
in our core competence areas.
CENTRES OF COMPETENCE FOR GLOBAL PRODUCTS
Asker, Norway: solid forms of calcium
Linz, Austria: sterile ampoules, biologicals and packaging
Lyszkowice, Poland: OTC products in solid and non-sterile liquid forms
Oranienburg, Germany: development, production and packaging of solid
dosage formulations; and niche technologies, such as pellets and stick packs
Singen, Germany: liquids (including sterile liquids in ampoules, vials and
syringes), semi-liquids, stick packs and ointments
“Partnerships are the key to our success“
Partnerships play an essential role at Nycomed.
Wherever we operate, we offer our research,
development, regulatory, manufacturing, marketing and sales expertise to our partners. And,
where we are not present, we are willing and
ready to cooperate. Around the world, we are
currently working with up to a hundred partners; this allows us to adapt our capabilities to
meet market needs. Identifying good partners
and managing long-term relationships is part of
our company philosophy.
Nycomed Global Contract Manufacturing Brochure 2011
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About Nycomed
Contract manufacturing “Part of Nycomed's Operations Strategy.“
Subsequent to initiating
the concept of production
network optimisation in
2007, Nycomed established a global organisation
for contract manufacturing
based on a broad range of
technologies, services and
incorporating the competence of a successful
mid-sized pharmaceutical
company.
Local responsibility
With the know-how and the capacity of our
plants throughout the world, we at Nycomed
are close to our customers in all important
markets. Being near to our clients is part of
our understanding of providing full service. As
every client and every task has quite specific
requirements, Nycomed has to approach each
situation as if it were unique. We thus tailor
our services towards specific customers and
tasks. In this way, we can provide the service that is needed. Certificated by the most
stringent and demanding authorities, Nycomed
delivers its services worldwide. It also provides
its expertise not only in scientific matters but
also by supplementing our clients' understanding of their target markets for the supply and
distribution of products.
Operational Excellence (OpEx)
Nycomed has placed high priority on continuous improvement throughout the whole
organisation by focusing on the needs of their
customers, empowering its employees and
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Nycomed Global Contract Manufacturing Brochure 2011
optimizing existing production processes.
Our production site in Elverum, Norway is a
good example. In 2009, the site received a
company award for optimising the production
of a fluoride dental rinse. In a separate initiative, a nasal spray production line was reengineered based on direct input from
employees and the help of our ‘green belts’
– with a resulting 50% improvement in two key
process steps.
Furthermore, this site has also received several
awards for supplier excellence from a
well-known pharmaceutical company.
Global presence
As a global company, Nycomed can provide a
supply chain anywhere in the world, making
sure that your products will be available when
and where they are needed. Customers from all
parts of the world, from small, emerging and
large pharmaceutical companies already use
these services. We are confident that you will
benefit from our services too.
Global CM organisation dedicated to the
management of
external partners.
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Trust, versatility,
competence, reliability at your service throughout
the world.
Global Presence
Global presence in manufacturing.
under construction
Europe
Manufacturing sites
Argentinia
Austria
Belgium
Brazil
Denmark
Estonia
Germany
Mexico
Norway
Poland
USA
Joint ventures
China
Site under construction
India
Russia
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Global Presence
Nycomed plants providing contract manufacturing services
- An international team
of more than 550
- Located in Linz, upper
Austria
- Production area of
7,543 m2
- Approved by EMA, ANVISA and local authorities
- Accredited by the
Japanese authorities
AUSTRIA/LINZ Competence centre for sterile ampoules and biological products with vast expertise
in the processing of biologics (animal or human origin) and authorised to handle narcotic drugs and
drug substances.
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BELGIUM/BRUSSELS Manufacturing site for solid dosage forms and liquids focusing on the supply of
medium-sized batches and with the flexibility to operate in highly competitive markets.
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A highly motivated
team of 90
Located in Brussels, in
the heart of Belgium
and Europe
Production area of
8,100 m2
Approved by EMA
Nycomed Global Contract Manufacturing Brochure 2011
Global Presence
Brazil/Jaguariúna Manufacturing site for solid, liquid and semi-solid forms. One of the largest
and most modern plants in Latin America complying with global standards.
- An international team
of 400
- Located 130 km south
west of Sao Paulo
- 3 state-of-the-art
production facilities with
a production area of
14,050 m2
- Approved by FDA, EMA
and local authorities
Germany/Oranienburg Competence centre for the development, production and packaging
of solid dosage forms. Supplies the pharmaceutical markets in more than 100 countries, from
Europe to the US and Japan. Large-scale production focusing on high throughput.
- An international team
of 430
- Located in the heart of
Europe, 30 km northwest
of Berlin, Germany
- Two state-of-the-art production plants covering
12,900 m2
- Approved by FDA, EMA
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Global Presence
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An international team
of 750
Located in Singen,
Germany (close to the
Lake of Constance)
State-of-the-art plant
with a production area
of 30,000 m2
Approved by FDA,
EMA, ANVISA and local
authorities
- An international team of
342
- Located in the suburb of
Naucalpan, in the western
part of the Greater
Mexico City Metropolitan
Area
- Two state-of-the-art
facilities with a production
area of 4,019 m2
- Approved by local authorities
(SSA Mexico & INVIMA
Colombia)
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Germany/Singen Competence centre for sterile dosage forms processed aseptically or terminally
sterilised and including freeze-dried vials. As one of Nycomed's largest production plants, Singen
manufactures non-sterile liquids, semi-solids and special preparations such as nasal sprays.
Mexico/Naucalpan Manufacturing site for solid dosage forms of OTC and RX products. Supply
of the local market as well as Central America, the Caribbean, Venezuela, Peru, Colombia, Ecuador
and Chile.
Nycomed Global Contract Manufacturing Brochure 2011
Global Presence
Norway/Elverum Manufacturing site specialised in the production of liquids, mainly sterile
liquids, filled in plastic ampoules (BFS) as well as non-sterile liquids filled in plastic ampoules, spray
pump vials and bottles.
- An experienced team
of 170
- Located 100 km north of
Oslo Airport Gardermoen
- Compact manufacturing
unit covering a production
area of 3,400 m2
- Approved by EMA
Poland/Łyskowice Competence centre for our solid and non-sterile liquid OTC products.
Produces a wide variety of pharmaceutical, dietary, nutritional and cosmetic products with a focus on
quality and efficiency. Special expertise in the processing of vitamins.
- A dedicated international
expert team of 280
- Located in the heart of
Poland
- State-of-the-art plant
with a production area of
2,918 m2
- Approved by EMA and
local authorities
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Achieving the highest
possible quality is a matter of
course - our maxim is safety
and convenience.
Pharmaceutical Technologies
Overview of
pharmaceutical technologies
By using our contract manufacturing services
you can access Nycomed's comprehensive
technology portfolio for pharmaceuticals and
the competence we have built up over decades.
Knowledge, modern technology and creativity
combined with clear and well-defined communication procedures between our teams of
experts and customers are the key factors for
achieving optimum solutions that will surely
exceed your expectations.
Solids
Semi-solids
Non-sterile liquids
Steriles
▪
Austria / Linz
Belgium / Brussels
▪
Germany / Oranienburg
▪
▪
Germany / Singen
Norway / Elverum
▪
▪
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▪
Poland / Łyskowice
▪
▪
Brazil / Jagúariuna
▪
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▪
Mexico / Mexico City
▪
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▪
HIGHLIGHTS
Austria / Linz: Expertise in processing biologics (human or animal origin)
Belgium / Brussels: Small-/ mid-sized products, organic coating
Germany / Oranienburg: Pellet/ granule technology (minimum filling
weight of 100 mg), organic solvents in granulation, coating, wallet packaging
Norway / Elverum: Blow-Fill-Seal technology (BFS)
Poland / Łyskowice: OTC and food supplements, vitamin products, sachet
filling, organic coating
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Pharmaceutical Technologies
Solids
Our technology portfolio for the bulk production of solids comprises:
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Granulation (wet, fluid bed with aqueous and organic solvents)
Roller compaction
Pellet production (non-pairelles, extrusion, Wurster coating)
Tableting (cores for various tablet types, e.g. bi-layer, micro- or controlled-release tablets)
- Encapsulation (hard shell)
- Coating (aqueous, organic, sugar or double-layer coating)
- Imprinting
Whatever you need in the way of solid dosage
forms - tablets, coated tablets, pellets or capsules - you can trust Nycomed with your
projects and products. Nycomed provides both
basic and specialised technologies for bulk
clinical supplies, bulk production and packaging.
Pellets/granules
Film-coated Tablets
Belgium / Brussels
▪
▪
▪
Germany / Oranienburg
▪
▪
▪
Poland / Łyskowice
▪
▪
Brazil / Jagúariuna
▪
▪
▪
▪
Mexico / Mexico City
▪
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▪
Solids are the dominant
dosage forms and are subject to constantly changing
requirements. Nycomed
has invested in the most
advanced technologies
available.
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Nycomed Global Contract Manufacturing Brochure 2011
Sugar-coated Tablets
Capsules
Pharmaceutical Technologies
Semi-solids
Elverum has a key competence in BFS technology, in this case for the filling of gels.
Filling capacities for local markets are also
available in the plants in Brazil and Mexico.
Several Nycomed sites are capable of manufacturing semi-solids: Singen, one of the major
sites, covers the whole portfolio from gels to
suppositories. Filling into stick packs for gels
is unique here within our operations network.
Creams
Ointments
Suppositories
Germany / Singen
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▪
Brazil / Jagúariuna
▪
▪
▪
Mexico / Mexico City
▪
▪
Nycomed has proven
technologies and expertise in the manufacture of
a number of semi-solid
products.
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Pharmaceutical Technologies
Non-sterile liquids
Nycomed has substantial product expertise in
the production of both sterile and non-sterile
liquids. With our comprehensive general and
niche technologies, our production capabilities
for non-sterile liquids range from nutritinal and
vitamin products to state-of-the-art prescription drugs. The majority of the vitamin products and nutritionals provided to our clients
are manufactured at Lyszkowice in Poland.
Solutions
Suspensions
Austria / Linz
▪
▪
Germany / Singen
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Norway / Elverum
▪
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Poland / Łyskowice
▪
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▪
▪
Brazil / Jagúariuna
▪
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▪
▪
▪
Mexico / Mexico City
▪
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▪
Applications for non-sterile liquids:
- Nasal applications
(drops, sprays, rinsing fluids)
- Eye drops
- Oral drops
- Vitamin syrups
- Ethanolic solutions
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Nycomed Global Contract Manufacturing Brochure 2011
Gels
Syrups
Ethanolic liquids
▪
Pharmaceutical Technologies
Steriles
handle hazardous goods such as psychotropic
substances. We supply liquid sterile products
aseptically filled as well as terminally sterilized.
Elverum applies its Blow-Fill-Seal technology
for filling sterile products.
Whether semi-solids or liquids, Nycomed
offers a broad range of sterile products in any
required form based on a variety of ingredients,
including biologics. Among our European sites,
Singen and Linz are competence centres for
sterile dosage forms and are authorised to
Injectables
Austria / Linz
▪
Germany / Singen
▪
Norway / Elverum
▪
Infusion solutions
Gels
▪
▪
Special Preparations
Complementary to our portfolio of sterile products, Nycomed has special
expertise in the niche technologies of preparation of sterile powders and
sterile suspensions.
- Aseptic spray-drying of sterile powders and aseptic filling into bottles
- Preparation of sterile suspensions by multi-step dissolution of single
compounds, sterile filtration and precipitation under aseptic conditions in
a final step.
Nycomed Global Contract Manufacturing Brochure 2011
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Our primary goal is to contribute to the success of our
customers; we thus stay close
to them from development to
delivery.
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Services
Packaging
Nycomed provides the entire range of packaging technologies for solids, semi-solids and
liquids and for sterile and non-sterile products.
We also assist our clients in designing the right
package to enhance users' understanding of the
product and hence also improve compliance.
Our innovative packaging designs have won
several design awards. In 2006, Nycomed introduced wallet packaging at our plant in
Oranienburg. At Nycomed we constantly continue to strengthen our ability to support our
customers with innovative packaging concepts.
Our technology portfolio for packaging of:
Solids
- Blisters in various formats
(PVC, PVC/PVDC, PVC/Alu,
Alu/Alu, Aclar, Triplex, COC)
- Bottles (glass, PE)
- Sachets (Alu/Alu)
- Stick packs
- Wallet packaging
Liquids
- Ampoules (glass, plastic)
- Bottles (glass, plastic)
- Flaconettes (glass, plastic)
- Pre-filled Syringes (glass,
plastic)
- Sachets
- Thermo-shaped units
- Vials (glass, plastic)
Packaging development:
- Design of packaging format
- Development
- Material research
Semi-solids
- Sachets (Alu/Alu)
- Stick packs
- Thermo-shaped units
- Tubes (Alu)
For primary packaging in
plastics we apply "BlowFill-Seal" technology using
a plastic granulate as well
as so-called "ThermoShaped-Units", shaped
from two plastic foils and
fused together. For all kinds
of primary packaging we
supply secondary packaging including leaflets
and bundling, if applicable.
Our glass ampoules are
packaged in plastic trays
formed by a deep-drawing
process.
Liquid preparations in
- Blow-Fill-Seal (gels, liquids)
- Pump sprays
Nycomed Global Contract Manufacturing Brochure 2011
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Services
Development
A team of selected experts provides development services to foster product transfer
to the Nycomed operations network.
Whether you need assistance in process optimisation, scale-up, optimisation of analytics or
CMC-documentation, Nycomed can be of help.
With our qualified and dedicated professional
staff and excellent laboratory facilities, you
can trust us with your development projects,
starting with effective product transfer
management.
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Nycomed Global Contract Manufacturing Brochure 2011
Product development services
- Effective transfer management
- Optimisation of formulations
- Scale-up and optimization of production processes
- Optimization of analytical methods
- Bulk clinical supplies
- Stability testing
- Regulatory support (CMC dossier)
- Market form design (bulk & packaging)
Services
Overview of quality standards
We fulfil the highest of international
quality standards.
All our manufacturing sites in Europe are
regularly inspected by EMA and local health
authorities. Our competence centres in
Germany have been approved for supply to the
USA. Austria will be inspected by the FDA in
Solids
the near future.
We are an approved supplier for liquids and
semi-solids to Japan. In Latin- and South
America, we not only adhere to the strictest
local quality standards (ANVISA, INVIMA, etc.)
but also to global standards (FDA, EMA).
Semisolids
Liquids
Steriles
EMA
JAPAN
ANVISA
FDA approval ongoing
Austria / Linz
Belgium / Brussels
EMA
Germany / Oranienburg
EMA
ANVISA
FDA
INVIMA
EMA
EMA
FDA
ANVISA
JAPAN
Germany / Singen
Norway / Elverum
EMA
FDA
ANVISA
JAPAN
EMA
FDA
ANVISA
JAPAN
EMA
EMA
Poland / Łyskowice
EMA
INVIMA
Brazil / Jaguariuna
MERCOSUR
EMA
COLOMBIA
LOCAL AUTHORITIES
INVIMA
MERCOSUR
FDA
LOCAL AUTHORITIES
MERCOSUR
COLOMBIA
LOCAL AUTHORITIES
Mexico / Mexico City
CENTRAL AMERICA
LOCAL AUTHORITIES
INVIMA
CENTRAL AMERICA
LOCAL AUTHORITIES
CENTRAL AMERICA
LOCAL AUTHORITIES
EMA
CENTRAL AMERICA
LOCAL AUTHORITIES
Nycomed Global Contract Manufacturing Brochure 2011
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Close collaboration right from the start.
Contact
Contacts for building and furthering
partnerships
For further information please get in touch with us.
GLOBAL CONTRACT MANUFACTURING
Nycomed Denmark
Langebjerg 01
4000 Roskilde, Denmark
Phone: +45 4677 1462
Fax: +45 4675 6640
contract-manufacturing@nycomed.com
www.nycomed.com
Coordination office:
Nycomed Austria GmbH
St. Peter-Straße 25
4020 Linz, Austria
Phone: +43 70 6919 46 93
Fax: +43 73 2655 30 9
AUSTRIA
Nycomed Austria GmbH
St. Peter-Straße 25
4020 Linz, Austria
www.nycomed.at
GERMANY
Nycomed GmbH
Robert-Bosch-Straße 8
78224 Singen, Germany
www.nycomed.de
BELGIUM
Nycomed Christiaens SCA/CNA
Chaussée de Gand, 615
1080 Brussels, Belgium
www.nycomed.be
MEXICO
Nycomed México S.A. de C.V.
Av. I° de Mayo No 130 Col. Industrial Atoto
Naucalpan de Juarez,Naucalpan Edo. Mex., Mexico
www.nycomed.mx
BRAZIL
Nycomed Pharma Ltda.
Rodovia SP 340 Km 133,5
13 800 000 Jaguariuna, Brazil
www.nycomed.com.br
NORWAY
Nycomed Pharma AS
Solbrvegen 5
2418 Elverum, Norway
www.nycomed.no
GERMANY
Nycomed GmbH, Plant Oranienburg
Lehnitzstraße 70-98
16515 Oranienburg, Germany
www.nycomed.de
POLAND
Nycomed Pharma Sp. z.o.o.
Ul. Ksiestwa Lowickiego 12
99-420 Lyszkowice, Poland
www.nycomed.pl
Nycomed Denmark
Langebjerg 01
4000 Roskilde
Denmark
www.nycomed.com
Nycomed Global Contract Manufacturing Brochure 2011
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Nycomed Denmark
Langebjerg 01
4000 Roskilde
Denmark
www.nycomed.com