Contract Manufacturing Network

Excellence in
Pharmaceutical
Services
Excellence in
Pharmaceutical Services
Business success requires strong, quality-conscious partners.
We, the Contract Manufacturing Network, are on hand to
support you at all times. Our experience and hard work can
help you to achieve your goals while allowing you to concentrate
fully on your core business and ideas.
 3

Aiming to fulfil your expectations.

By exceeding them.
Excellence in Pharmaceutical Services

More than 8 billion tablets and capsules. 180 million packs. 160 million liquid units. More
than 2,300 employees. Deliveries to more than 100 countries. Customers on 5 continents.
Four sites in Europe. And just one goal: to give you, with the Contract Manufacturing Net-
work, the best possible opportunity for putting your entrepreneurial vision into practice.
Excellence in Pharmaceutical Services – that is our commitment to you. A commitment that
we back up with special values.

Uniqueness
We provide a unique range of services from
the product through to packaging. Take ad-
vantage of our state-of-the-art production
technologies and you too can benefit from
optimized manufacturing processes and
our many years of experience in the ma-
nufacture of various solid formulations and
sterile and non-sterile liquids as well as the
corresponding individualized packaging.
Quality
We guarantee quality. As a part of the Ba-
yer Group, we naturally work to the high-
est standards – from careful planning via
transparent processes through to seamless
communication. On delivery, you can ex-
pect a high-quality, flawless product right
on time.
Perspectives
We create room to maneuver. The expertise
and dedication of our experts and specialists
help to markedly reduce the burden on you,
allowing you to devote your energy com-
pletely to your corporate objectives and new
business ideas.
Protection
We protect your intellectual property. We
know from our own experience that the
findings of research and development are a
company‘s greatest capital. Your know-how
is in safe hands with us – and comprehen-
sively protected.
Profitability competencies
5 Solids &
Money well spent: you can expect a compre- Semi-Solids
hensive package of services at a reasonable,
7 Liquids &
competitive price that’s worth every penny.
Parenterals
You benefit from professional production and
the expert skills of our process specialists
9 Packaging
who can leverage optimum quality for you.

10 Germany
Kiel
Leverkusen

11 Finland
locations

Torku

11 Spain
Alcalá
Partnership and perfection.
Our contribution to your success.
Solids & Semi-Solids
Our services go beyond conventional tablets: for our own products, we
have already developed numerous protected solutions – in particular in
the field of sustained-release formulations. The protection of intellectual
property is therefore a matter that is fundamentally close to our heart:
Your product knowledge and our process information are the foundation
on which successful projects are built.

Technology
and equipment
Rapid blending and fluidized bed
granulation
• High-speed mixer granulators
• Fluidized bed granulators
• Pearlmilling
Dry granulation
• Roller compactor
High-speed tablet presses
• Single or double-sided rotary presses
• Standard and oblong formats
• Bi-layer tableting
Aqueous and organic coating
• Aqueous coating drum coaters
• Organic solvent coating drum coaters
• Extensive experience in coating pellets with a very narrow particle size
oblong tablets and mechanically
unstable formulations as well as
processing functional coatings
Manufacturing of ointments & pastes
• Batch sizes from 100 to 1,000 liters
• Vessels with cooling and heating
systems
• Partly explosion proof areas
Filling of applicators and tubes
• Filling of applicators from 5 to 60 g
• Filling of tubes from 30 to 150 ml
Formulation and filling of powders
• Filling in several different primary
packaging materials, e.g. bottles,
sachets, cans, etc
Soft gelatine capsules
• Forms of: oval, oblong, round, oval twist off,
oblong twist off, special forms
• Batch size from 100 to 2,000 liters
• Dedicated lines for different types of uses:
pharmaceutical, food supplements and
cosmetics
Hard gelatine capsules
5
Special
technologies
and services
Coat-core tablets. The ideal delivery form
for targeted and controlled release of
the active ingredient or for processing
incompatible actives
• More than ten years of development and
production experience
• Various concepts for delayed release
Bi-Layer Tablets. Utilizing Bi-Layer
technology, modified release of the
active ingredient can be realized
• We draw from extensive experience in the
application of functional coatings
• Tablet printing technology available
Lacquer-coated pellets. Continuous
fluidized bed agglomeration produces
distribution
• High drug contents can be
incorporated
• Wurster coating
Vacuum fluidized bed granulation.
Robust process for manufacturing granu-
lates with amorphous active ingredient
• Manufacture of coprecipitates to
improve the solubility of poorly
soluble drug forms
Injection Moulding
Technological support in
• Improved quality and costs competencies
5 Solids &
• Support for scale changes Semi-Solids
Technological support for commercial
products
7 Liquids &
Parenterals
• Optimization of primary and secondary
packaging materials for quality and price
9 Packaging
• Developing and optimizing
manufacturing processes for
commercial products
• Transfer to new technologies 10 Germany
Kiel
• Own staff ensure support in qualifying
Leverkusen
and validating process parameters
11 Finland
locations
Torku
11 Spain
Alcalá
We are experts in liquids.
So the best know-how can flow in.
Liquids & Parenterals
Quality has many facets. For example, the high purity standards that
govern the production of our sterile and aseptic products naturally apply
equally to our numerous non-sterile liquids. You too can benefit from
our well-trained teams whose skills and dedication ensure that these high
standards are maintained every day.
 7
Special
technologies
and services
Technology Internal siliconization for infusion
bottles up to 250 ml

and equipment
Filling of aqueous and oily solutions
• Product-specific, dedicated
equipment possible
• Vessels with cooling and heating
systems
• Batch sizes from 12.5 to 5000 liters
Filling of small vials, ampoules up to
large-volume injection and infusion
bottles, div. kind of plastic bottles
& containers, drop dispenser
• Filling of injection and infusion glass
bottles from 25 to 1,000 ml
• Filling of vials from 6 to 10 ml
• Filling of ampoules from 0,5 to 20 ml
• Filling of tubes from 0,23 – 8 ml
• Filling of bottles / containers from
5 ml to 20 l
• Filling of Armados-bottles
High-speed machines for visual
examination of parenterals
• Combination of visual and automatic
controls achieves optimum quality
in terms of appearance and particle
detection
• Manual inspection for lyophilized
products and opaque solutions
Hot-water spray sterilizing systems
• Ensure rapid heating and cooling of
sensitive products
• Temperatures can be adjusted in all
ranges for specific heat treatment of
sensitive products
• Reliable prevention of interactions
between glass and solution
• Silicone emulsion can be annealed
to the inside of the glass bottles
• Very cost-effective process
Technological support for commercial
products
• Optimization of primary packaging
materials for quality and price
• Development of improved processes for
commercial products
• Own staff ensure support in qualifying
and validating process parameters
Manufacture and filling of oxygen-/light
sensitive products
• Efficient gassing technology and
measuring techniques
• Light protected areas
Aseptic manufacture of parenteral
solutions
• Large clean room area with various
separated filling lines
• Full support including in-house
microbiology lab
• Over 50 years of experience in filling
aseptic products
• Clean-room concept audited by
authorities and customers
5 Solids &
competencies
• FDA approved
Semi-Solids
Partly explosion proof areas
7 Liquids &
Aerosols Parenterals
9 Packaging

Lyophilization
10 Germany
• Freeze-drying of ampoules and vials
Kiel
• Freeze-drying shelf areas up to Leverkusen
10 m² available
11 Finland
locations

Torku

11 Spain
Alcalá
When it comes to packaging,
we guarantee top quality.
Packaging
When it comes to packaging, our possibilities are almost unlimited. Our
specialists will therefore help you find the best solution for your product
in each individual case. We are also delighted to support you if you
have special requirements or want to develop a new feature, whether a
child-proof seal, hospital pack or an innovative wallet packaging, as the
answer to your marketing needs.

Technology
and equipment
Manufacture of PVC/PVDC, PP and
Alu-Alu blisters, perforated and
unperforated
Processing of special film types
• Pigmented and opaque deep-drawn films
• Preprinted, colored and/or paper-backed
push-through foils
• Experienced in child-resistance
packaging
In-line printing of push-through foils,
including unit-dose details, for highly
flexible blister design
Various blister types and sizes can
be produced
Packaging in various folding box designs
Pasting of folding boxes to provide
proof of originality
More then 14 different blistering lines
to choose from
• High-performance blistering lines com-
bined with high-flexibility packaging lines
• Packaging up to shipping container stage
and palleting
Packaging of tubes granules/powers
into Pouches
Packaging of small tubes, etc. into
blisters
9
Special
technologies
and services
Fully automated packaging in Wallets.
Wallet packaging is a high quality tech-
nique that incorporates direct and lasting
communication with the customer
• Child-resistant packaging available
• Wallets can be upgraded by adding more
product information and additional items
Blisters can be combined with
accessories and medicinal products
(creams, applicators etc.)
Hospital packs (bulk packs) can be
produced with special layouts
Development of modern packaging
and materials
• Production of designs for supplying
samples to the USA and other
countries
• Development of child-resistant
packaging
Production of sample packs with
various information leaflets,
instructions for use and reply cards
Electronic document workflow for
approval processes
Data matrix code handling implemented
Coordination/packaging of initial
supply quantities following marketing competencies
5 Solids &
authorization Semi-Solids
Formulation, filling and packaging for
7 Liquids &
stability testing and Follow up Studies
Parenterals
Support in formulation and packaging
9 Packaging
development
Worldwide direct delivery
10 Germany
Toxic goods handling and warehousing
Kiel
Packaging and shipping for all Leverkusen
continents
11 Finland
locations
Torku
11 Spain
Alcalá
Our standard is Excellence. Our
locations are Kiel, Leverkusen,
Turku and Alcalá.
Network
Kiel - Germany
KVP Pharma + Veterinär
Produkte GmbH
KVP Pharma + Veterinär Produkte GmbH
is one of BHC core production sites
with approximately 460 employees.
We use state of the art equipment and
machinery in our plant and draw on a highly
qualified team. Pharmaceutical products are
manufactured on site and dispatched from
Kiel to over 100 countries.
Our range is comprised of medicine in
practically every conceivable application.
The breadth of this range constitutes a major
challenge for KVP and requires the greatest
flexibility with regard to plant, machinery and
technologies.
Efficiency, quality assurance and acute
environmental awareness are the guiding
principles behind our daily work. It is our
obligation to meet international principles
of “good manufacturing practice for
medicines” (the so-called GMP Guidelines),
the demands of the FDA (US Food and Drug
Administration), as well as Bayer HealthCare
AG’s high quality standards.
Kiel
Leverkusen
Alcalá
Leverkusen -
Germany
Bayer Schering Pharma AG
Supply Center Leverkusen
With approximately 1,000 highly qualified
employees, Leverkusen is one of Bayer
HealthCare’s major production sites. We
produce, package, and distribute high quality
medicinal products for all international
pharmaceutical markets. We have over
100 years of experience in this field.
Our manufacturing facilities produce over 100
different products and many different types of
packaging. In 2008, for example, the solids
facility in Leverkusen manufactured more than
seven billion tablets. These were packaged
by the solids packaging facility into over
260 million blister packs.
At the same time, the parenteral facility in
Leverkusen produced more than 21 million
infusion and injection bottles and vials and
nearly one million ampoules. These were turned
into more than 19 million packaging units.
Our quality management system has been
approved by national and international
authorities and numerous customers. As a
global supplier of medicinal products we have
of course been audited by the U.S. regulatory
body FDA (Food and Drug Administration).

Turku
Turku - Finland
Bayer Schering Pharma Oy
Bayer Schering Pharma Oy is located in Turku
in the southwest corner of Finland.
Bayer Schering Pharma Oy has long experience
in solid forms production, providing reliable
deliveries, efficiency and punctuality. The first-
rate expertise of our personnel and the well-
functioning manufacturing equipment and
quality assurance ensure consistently high
quality products.
At the plant in Turku, Bayer Schering Pharma Oy
manufactures high quality specialty products
for worldwide distribution by the global Group.
96% of the products manufactured in Turku are
being exported. Products are sold in about 120
countries from the US to the Far East.
The history of export activities by Bayer
Schering Pharma Oy already spans 50 years: the
company was established in 1946 and it started
to export products in 1952. Our long experience
in manufacturing tablets and capsules led to co-
operation with big international pharmaceutical
companies and Bayer Schering Pharma
started contract manufacturing in 1950s. Our
production capacity is high, giving us the
flexibility to meet the needs of our contract
manufacturing customers.
As all Bayer sites and companies also Bayer
Schering Pharma Oy is committed to social
responsibility to care for our environment
and follows the principles laid out in the
Responsible Care program. For our sustained
efforts in environmental protection and safety,
we have been awarded with the ISO 14001
environmental certificate.
Bayer Schering Pharma employs about 650
people and about 450 of the personnel work
for production.
11
Alcalá - Spain
BerliMed, S.A.
BerliMed is located in Alcalá de Henares, one
of the oldest cities in Spain in the geographic
center of the Iberian Peninsula, 25 km to the
east of Madrid. The supply center has good
logistical connections, being positioned di-
rectly on the highway between Madrid and
Barcelona, Spain’s two economic centers,
and just a few kilometers away from the Ma-
drid airport.
BerliMed was founded as a joint venture in
1996. The factory was built and production
begun in less than two years time, from No-
vember 1996 until August 1998.
Since May 2009 BerliMed is wholly owned by
Bayer. The site is a part of the Bayer Health-
Care supply center network. BerliMed emplo-
ys a workforce of approximately 300.
The site supplies customers all over the world.
The focus of production is on the markets in
the EU (Spain, Germany, Italy, etc.) as well as
Japan an the United States.
Key areas of focus are the production of sterile/
non-sterile liquids and soft gelatin capsules
with state-of-the-art manufacturing technolo-
gies and including an own R&D facility.
BerliMed has a Quality Management System 5 Solids &
competencies
meeting the international GMP (Good Manuf- Semi-Solids
acturing Practices) Guidelines. Our Quality
System has been approved by national and 7 Liquids &
international authorities and customers, in- Parenterals
cluding the FDA (U.S. Food and Drug Admini-
9 Packaging
stration). The facility also holds an ISO 14001
environmental certificate.
10 Germany
Kiel
Leverkusen
11 Finland
locations
Torku
11 Spain
Alcalá
Contact &
Imprint
Bayer HealthCare AG

Product Supply - Supply Center Leverkusen

Contract Manufacturing Network

Harald Milzarek
Building D305
51368 Leverkusen, Germany

Tel. +49 (0)2 14 30 - 5 66 43

Fax +49 (0)2 14 30 - 9 65 66 43

harald.milzarek@bayerhealthcare.com
www.contractmanufacturing.bayerhealthcare.com

Leverkusen, Germany, September 2009

FORWARD-LOOKING STATEMENTS

This brochure may contain forward-looking statements based on current assumptions and
forecasts made by Bayer Group or subgroup management. Various known and unknown risks,
uncertainties and other factors could lead to material differences between the actual future
results, fi nancial situation, development or performance of the company and the estimates given
here. These factors include those discussed in Bayer’s public reports which re available on the
Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these
forward-looking statements or to conform them to future events or developments. Product names
are mostly registered trademarks. All trademarks are printed in italics.

Photo page 2: ©Mikael Damkier/ fotolia.de