capabilities overview

CATALENT PHARMA SOLUTIONS

Catalyst + Talent.
Our name combines these ideas. From drug and biologic development to delivery technologies to supply solutions, we are the catalyst for your success.

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Whether you are looking for a single, tailored solution or multiple answers throughout your products lifecycle, we can improve the total value of your treatmentsfrom discovery to market and beyond. Catalent. More products. Better treatments. Reliably supplied.

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WHY CATALENT? Unrivaled experience, deepest expertise, and a track record of market success on a global scale. We serve 49 of the top 50 pharmaceutical and 36 of the top 50 biotech companies as the worlds #1 delivery, development and supply partner
*

We operate 20+ global sites across 100+ markets We create expert solutions from over 1,000 scientists We support 40% of recent new U.S. drug approvals We manufacture or package 100 billion units annually We are the industry leader in drug delivery technology We use a multi-faceted approach to improve bioavailability, therapeutic profiles and patient adherence We provide end-to-end biologics technologies, from gene expression to fill/finish
01 AUG 2011 4 * source: United Nations World Investment Report, 2011

We Have a History of Providing Unique Offerings

Seven decades of oral dose form innovation Three decades of packaging innovation Two decades of serving biotech Over 1,000 current patents and patent applications Deepest and broadest delivery and development expertise Global manufacturing supply network

BUILDING WITHIN CARDINAL HEALTH

STANDING UP AT CATALENT

TRANSFORMING

DRIVING GROWTH

1996 - 2006

2007 - 2009

2009 - 2010

2011 +

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Our Solutions Serve a Diverse Customer Group

Trademarks above are the property of their respective owners 01 AUG 2011 6

Our Expertise Spans Multiple Markets

Pharmaceuticals (Brand & Generic)

Biologics

Consumer Health (VMS & OTC)

Veterinary Medicine

Cosmetics
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We Reliably Supply More Products and Better Treatments Worldwide

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Capabilities by Site

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Our Leadership Combines Talent and Experience

JOHN CHIMINSKI PRESIDENT & CEO

MATTHEW WALSH SVP & CFO

LANCE MIYAMOTO SVP, HUMAN RESOURCES

DAVID HEYENS PRESIDENT, SOFTGEL TECHNOLOGIES

IAN MUIR PRESIDENT, MODIFIED RELEASE TECHNOLOGIES

BARRY LITTLEJOHNS PRESIDENT, MEDICATION DELIVERY SOLUTIONS

SCOTT HOULTON PRESIDENT, DEVELOPMENT & CLINICAL SERVICES

STEVE LEONARD SVP, GLOBAL OPERATIONS

KURT NIELSEN SVP, INNOVATION & GROWTH

WILL DOWNIE SVP, GLOBAL SALES & MARKETING

SHARON JOHNSON SVP, GLOBAL QUALITY & REGULATORY AFFAIRS

SAMRAT KHICHI Chief Administrative Officer & GENERAL COUNSEL

ROY SATCHELL SVP, INFORMATION TECHNOLOGY & CIO

CORNELL STAMORAN VP, CORPORATE DEVELOPMENT & STRATEGY .

CHARLES SILVEY VP, INTERNAL AUDIT

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DEVELOPMENT

more products.

With our broad range of expert services we drive more efficient development timelines to help you bring more compounds and better products to market faster.

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DEVELOPMENT

BIOLOGICS
GPEX CELL LINE ENGINEERING BIOMANUFACTURING

PHARMACEUTICAL & BIOPHARMACEUTICAL LAB SERVICES

COMPENDIAL, RELEASE, POTENCY & MICROBIOLOGY TESTING METHOD DEVELOPMENT & VALIDATION PHYSICAL, MATERIAL & BIOPHYSICAL CHARACTERIZATION STABILITY TESTING & STORAGE IMPURITY & STRUCTURAL CHARACTERIZATION FACILITY & PROCESS VALIDATION VIRAL CLEARANCE & VIRAL SAFETY PK & IMMUNOGENICITY

PRE-FORMULATION & FORMULATION

ORAL DOSE FORMS: SOFTGEL, CONTROLLED RELEASE, IMMEDIATE RELEASE, ORALLYDISINTEGRATING TABLETS INHALATION PARENTERAL

OPTIFORM TECHNOLOGY & SOLID STATE SERVICES REGULATORY CONSULTING

EARLY STAGE DEVELOPMENT SERVICES LATE STAGE DEVELOPMENT SERVICES COMPLETE LIFE-CYCLE MANAGEMENT CUSTOMIZED EDUCATION PROGRAMS

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Catalent Biologics: From Gene to Clinic

Our GPEx technology is a proprietary technology that generates stable mammalian cell lines for expression of biopharmaceuticals in record time. Catalent enables you to speed your drug development to clinic by providing a robust GPEx technology platform and a customized service solutions to meet your needs. Integrated analytical services and commercial supply of sterile fill and finish solutions in pre-filled syringes and innovative delivery devices

CELL LINE DEVELOPMENT

BIOASSAY DEVELOPMENT

cGMP API MANUFACTURE PHASE I/II

BIOSAFETY TESTING

FORMULATION DEVELOPMENT

FILL/FINISH, STABILITY & PACKAGING

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DELIVERY

better treatments.

We are a world leader in drug delivery solutions with a proven track record of helping our customers create better treatments.

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DELIVERY

SOFTGEL TECHNOLOGIES
SOFTGEL CAPSULES VEGICAPS CAPSULES

INHALATION
PRESSURIZED METERED-DOSE INHALERS DRY POWDER INHALERS NASAL SPRAYS NEBULIZED SOLUTIONS/SUSPENSIONS

ZYDIS & LYOPAN FAST-DISSOLVE TECHNOLOGIES

INJECTABLES
FORMULATION DEVELOPMENT PREFILLED SYRINGES CLICK-IN SAFETY DEVICE PROTECTOR SAFETY SHIELD SYSTEM ASI AUTOINJECTOR PHASE I/II VIALS

CONTROLLED RELEASE TECHNOLOGIES

OSDrC OPTIDOSETM COMPLEX TABLETS COATED PELLETS & BEADS ADVANCED CAPSULES INNOVATIVE API SOLUTIONS COMBINATION SOLID PHARMACEUTICALS FIXED DOSE COMBINATIONS

CONSUMER HEALTH

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Bioavailability Challenges. Softgel Solutions.

Catalent Softgel is the drug delivery solution of choice that helps delivery more products and better treatments by reliably solving complex bioavailability, solubility, formulation and development challenges Deliver more products to market with our proven drug delivery solution and over 75 years of global manufacturing expertise

Poor aqueous solubility Liquid, paste or semi-solid formulation Highly potent Poor stability Scalability issues

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Vegicaps Capsules Deliver More APIs

Tailoring softgel technologies to the evolving needs of our customers, our efforts have led us to develop an alternative to gelatin capsules. Vegicaps capsules are an easy-to-swallow, plant-based shell, free from animal derivatives, gluten, and modified sugars. Support a wide range of APIs:

Higher melting points Wider range of pH values Semisolid formulations

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CR Technologies Improve Treatment Outcomes

Broadest selection of technologies and deepest expertise to help bring better treatments to market with optimized therapeutic, delivery and release profiles, improved bioavailability and patient adherence As the innovator of coated multi-particulate dosage forms and a leader in the production of coated beads and tablets, we bring years of experience to empower your controlled-release success on every level Catalents controlled-release technologies and oral solids capability offers formulation, development, and manufacturing services for:

Oral Solid Tablets and Hard-shell Capsules Powders, Pellets, Beads, Granules Hot Melt Extrusion OSDrC OptidoseTM

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OSDrC OPTIDOSETM Technology: Flexibility to Improve Your Treatments

OSDrC OPTIDOSETM technology

the broadest range: controlled release, combination products (tabletwithin-a-tablet and pellets-within-a-tablet) and direct compression orally disintegrating tablets optimized dosing, therapeutic, and plasma release profiles to meet patient needs in a high quality, one step manufacturing process.

Broad Range of Tablet Options:

Pulsatile Release Tablets Bi-Layer Tablets Combination Products (multiple API in single tablets) Dividable Tablets IR/ER Combination Tablets Direct Compression Orally Disintegrating Tablets (ODT)

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Patient Preferred Zydis Fast-Dissolve Helps Improve Therapeutic Profile and Patient Adherence

Zydis Fast-Dissolve is a unique, freeze-dried oral solid dosage:

Disperses instantly in the mouth - usually in about 3 seconds Taken without water, meeting the needs of patients who cannot or will not swallow oral medications

Zydis Fast- Dissolve provides valuable product differentiation for Branded OTC and Rx products:

Fastest dispersion dosage form on the market today combines with an elegant and smooth mouth-feel to create product and brand loyalty for OTC products Immediate dispersion of API in the oral cavity supports buccal delivery for an improved therapeutic profile Shown to help drive market share and brand growth gains Improved compliance in multiple therapeutic areas

Lyopan Fast-Dissolve formulation offers increased:

Taste masking capabilities Increased API dosing

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Safe & Reliable Fill Finish Solutions

Catalents specialty sterile solutions brand acts as the catalyst to improve the total performance of your aseptic fill-finish products

Pre-filled syringes Bulk syringes Dual-Chamber Flexible bags Blow/Fill/Seal Innovative delivery and safety devices

Ensure patients safety and accurate dosing Cost effective, customized manufacturing options for your complex treatments

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Broadest Inhaled Drug Development Capabilities

Catalent enables you to improve speed to market and value of your product treatment with our broadest range of services across all inhaled dose forms and a proven track record advancing inhalation products to market. Capabilities include:

Pre-formulation Formulation Product development CMC development Manufacturing Regulatory consulting

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SUPPLY

reliably supplied.

We offer global, tailored clinical supply, oral, inhalation, biologic, and parenteral manufacturing and packaging solutions to take your product from design, to clinical trial, to plant, and to pharmacy.

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SUPPLY

CLINICAL SUPPLY
GLOBAL COMPARATOR SOURCING MANUFACTURING & BLINDING PACKAGING & LABELING ANALYTICAL SERVICES DISTRIBUTION & WAREHOUSING

COMMERCIAL PACKAGING
BOTTLING BLISTER PACKAGING CUSTOMIZED BLISTERS/WALLETING INJECTABLE PACKAGING & KITTING SPECIALTY PRODUCT HANDLING

MANUFACTURING
SOFTGEL & VEGICAPS CAPSULES CONTROLLED RELEASE TABLETS ZYDIS & LYOPAN FAST-DISSOLVE TABLETS STERILE: BLOW/FILL/SEAL, IV BAGS, INJECTABLES

PACKAGING DELIVERY SOLUTIONS

INTEGRATED SUPPLY CHAIN LATE-STAGE CUSTOMIZATION PRODUCT LIFECYCLE MANAGEMENT ANTI-COUNTERFEITING DESIGN SOLUTIONS PATIENT ADHERENCE SOLUTIONS DELPOUCH UNIT DOSE DELIVERY SYSTEM MEDIA ENHANCED PACKAGING TECHNOLOGY

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Reduce Timelines with Clinical Supply Services

Deeper industry experience and technical expertise Integrated and innovative services Broader analytical capabilities Global sourcing and distribution network Proven project management and supply chain solutions

COMPARATOR SOURCING

BLINDING & MANUFACTURING

ANALYTICAL SERVICES

LABELING & PACKAGING

DISTRIBUTION & WAREHOUSING

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Supply Chain Solutions For Your Success

Extensive expertise and specialized capabilities:

Industry leaders in bottle and blister packaging Unmatched expertise in biotech and cold chain solutions Controlled drug storage and anti-counterfeiting capabilities Tangible benefits through integrated supply chain solutions Customized packaging to drive dosage and patient compliance

DelPouch, RxBarrier, HingePak and more

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Reliably Supplied: Our Foundation for Growth

We deliver reliable supply through:

Safe operations Regulatory compliance Quality right first time Predictable, on time delivery Clear, timely communication Excellent service Sustainability

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Compliance: The Foundation for Reliably Supplied

PEOPLE

Engaged, capable, committed, accountable

PROCESS

Simple, standard, transparent

CULTURE

Model the behaviors and values live the code

Knowledge + Accountability + Engagement = Compliance

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Excellence in EHS

Culture of discipline Root cause, corrective action GMP foundation Sustainability Leading performance indicator

3.0

2.0

1.23
1.0

50% in 12 months!

0.0 Nov Jan Mar May Jul S ep Nov Jan Mar

RECORDABLE INCIDENT RATE

Our Employees Deserve It Our Customers Expect It

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Reliably Supplied: Beyond Delivering On Time

Sustainable regulatory compliance Safe operations Business continuity Environmental sustainability Supplier management Depth and breadth of resources Access to capital Ability to partner and innovate Global footprint No critical observations in over 50 regulatory inspections globally over last year*

Our Foundation for Growth!

*(FY11 June 1, 2010 - June 30, 2011 01 AUG 2011 30

discover more.
CATALENT PHARMA SOLUTIONS 14 SCHOOLHOUSE ROAD SOMERSET, NJ 08873 + 1 866 720 3148 www.catalent.com