CORPORATE OVERVIEW

WHO WE ARE

WHO WE ARE

• Small Scale Development

• Scale-up and Technology Transfer

• Clinical Manufacturing and Packaging

• Commercial Manufacturing and Packaging

• Quality Control and Stability Testing

We are a full-service, cGMP-compliant manufacturing and packaging services company serving the pharmaceutical industry in the areas of:

OUR PHILOSOPHY

We seek to maximize our production capacity and our customer’s market share.

We will provide flexible cost-effective

manufacturing services.

We will seek to maximize growth opportunities and profitability for both companies

OUR HERITAGE

Constructed by G.D. Searle (1971 – 1997)

• 101,000 ft2 facility

• 40 Products, 80 SKU’s manufactured at Oakville Site

• Transferred 3 ANDA powder and semisolid products

• Segregated suite produced ¾ billion tablets

• Designated as world-wide clinical supply site

Roberts/Shire (1997 – 2001)

• 20 products, 75 SKU's transferred in 8 months

• Transferred 3 complete manufacturing and packaging work centers

• Designated as outsourcing partner for all North American operations

WellSpring Pharmaceutical/Pharma Services (2001 – Present)

• Establish Contract Manufacturing Services

• 26 products - NDA/ANDA’s /OTC’s

• Solid and Semisolid Development Projects Executed

EXPANDED BUSINESS FOCUS

• Expanded directly scalable capabilities in smaller development scale equipment

• Expertise (Process Development and Clinical Manufacture Phase I & Phase II) that complement our larger scale commercial manufacturing

• Expanded capabilities into specialized dosage forms such as bilayer tablets or “tablet within a tablet”

• Support potential high potency compound manufacturing

• Expand capabilities into larger scale commercial manufacturing

Recent Equipment Acquisition Provide For:

MAJOR CAPITAL EXPANSION PROGRAM

3- Year Capital Investments Include: • Alexanderwerk Roller Compactor

• IMA Precisa Capsule Weight Checker

• 400 kg O’Hara Tray Drying Oven

• Korsch XL400 Tablet Press with Bilayer Module

• Glatt GPCG 2/5 Fluid Bed Processor

• O’Hara Aqueous Film Coating with 18” and 30” Interchangeable Pans

• 5L Becomix Counter Sweep Vessel

Future Initiatives: • Manesty Novapress Tablet Press

• Explosion Resistant Manufacturing Upgrades

• 30-50L Counter Sweep Vessel

• Large 2000-4000 L Counter Sweep Vessel

OUR DEEP EXPERIENCE

• Designated as exclusive North American supply site for major product lines

• Experience with a wide range of products

• cGMP compliant facility FDA & HC approved, EMA accepted

Over 80 client audits since 2001

Extensive experience in providing manufacturing outsourcing services for major product lines to large pharmaceutical companies

2014 Health Canada Inspection

2014 Saudi Arabia Health Authority Inspection

2014 FDA General Inspection

2012 Health Canada Inspection

2010 Health Canada Inspection

2009 FDA General Inspection and PAI

2009 Health Canada Inspection

2007 FDA General Inspection and PAI

2006 Health Canada Inspection

2004 Health Canada Inspection

2002 FDA Systems Based Inspection

OUTSTANDING COMPLIANCE HISTORY

OUR PEOPLE

Total of 122 Employees

Manager, IT Peter Lunde

Chief Financial Officer

Matthew Griffiths

Controller, Pharma Services

Darren Jolley

Director, Quality & Regulatory Affairs

Charles Chee

Manager, Laboratory Services

Dragan Pupovac

Director, Plant Operations

Aaron Polesky

Manager, Maintenance

Pierre Pitre

Manager, Materials Management Mike Rowland

Manager, Manufacturing

Trevor Curry

President, Pharma Services David Mayers

Vice President, Business Development

Sam Ricchezza

Manager, Human Resources Sarah Roth

Executive Director, Business

Development Lonnie Barish

Technical Director, Pharma Services

David Watt

Director, Program Management Dara Caratao

CEO Wendy Shusko

MANUFACTURING STRUCTURE

Processing Operator Basil Bilal

Joel Firmin Winston Malabre

Jose Jessie Dela Cruz Rene Molina

Uldarico Maramo Danta Mangilaya Narendra Pandit Daljeet Panesar

Nesan Nagaretnam Leo Sia

Sunny Joseph Waran Arasaratnam

Dennis Baja Branislav Sesum (c) Leonardo Jocson (c)

Pablo Milanes (c)

Production Mechanic Denis Guite

Kevin Marchand Shawn Cook

Director, Plant Operations

Aaron Polesky

Plant Operations Coordinator

Laurie McIntyre

Manager, Manufacturing

Trevor Curry

Group Leader Cindy McMillan

Packaging Operator Mary Latincic

Denise McDonald Louise McDonald

Claudette McKernan Antonio Omay

Wieslawa Przeracka Vijitha Sivayoganatha

Marg Sobik Astrid Szczesna

Agata Szwed Sangeeta Modgil

Manjula Patel Taruna Lad

Kalpana Vashee Rosalia Tolentino Ewa Cieslicka (c) Jennifer Davis (c) Hanna Pustul (c) Shahnaz Hadi (c) Harjeet Lall (c)

Stephen McMillan (c) Quentin Lendvoy (c)

Lall, Harjeet (c)

Manager, Maintenance Pierre Pitre

Maintenance Mechanic

Gardner Walker

Building Mechanic Stephen Thomas

Sr. Production Mechanic

Gary Knights

Production Mechanic Doug McMullen

Production & Demand Planner

Sandy Clappa

Senior Procurement Specialist

Branka McBride

Manager, Materials Management Mike Rowland

Warehouse Operator Wayne Quinlan Dan Maloney

Bronson Lendvoy (c)

James McKeating (Agency Temp)

Student (Part-Time) Michelle Mesce

Processing Operator Trainee

Nebojsa Papic Nikola Papic (c)

Group Leader Rod Dean

Christian Jimenez Sean Lendvoy Arturo Micu

Processing Operator (Senior)

Balford Grant James Small

Igor Radunovic Scott Everingham

Supervisor, Manufacturing Tanya Madill Sanjoy Datta

QUALITY SERVICES STRUCTURE

Senior Chemist Lauro Carreon

Supervisor, QC Mark Stiene

Chemist Sasha Knezev Mirjana IIic

Carol Shi Magdalena Piekarczyk Tatjana Stojanovic (c)

Hetal Bilimoria (c) Andrea Ma (c) Raajvi Tailor (c)

Microbiologist Hannah Chen

Microbiology Lab Assistant

Kim Miller (c)

Research Chemist Chris Moore

Data Reviewer Hong Zhai

Stability Program Associate

Isabelle Lambinicio

Lab Documentation Specialist

Paul Andersch (c)

Laboratory Systems Specialist

Vladimir IIic

Chemist Ronnie Lu

Nataliya Gorban Ying Zhang

Compliance Coordinator Saido Sheikh

Frances Clarke (PT) Jennifer Nguyen

QS Documentation Coordinator Laura Birch

QA Sampler Pallavi Kolekar

Manager, Laboratory Services

Dragan Pupovac

Administrative Coordinator

Natalie Baricevic

Directory, Quality & Regulatory Affairs

Charles Chee

Senior QA Associate Irene Mesce

QA Associate

Donna Mamaradlo Yasleidy Hernandez-Morales

Ottis Brown (c) Fatemeh Darvish (c)

Group Leader, Quality Assurance

Lorraine Harkness

Laboratory Assistant Lynnette Mangilaya (c)

BUSINESS DEVELOPMENT STRUCTURE

Executive Director, Business Development

Lonnie Barish

Regional Director, Business Development

VACANT

Technical Director David Watt

Director, Program Management Dara Caratao

Vice President, Business Development Sam Ricchezza

Technical Transfer Manager

Norman Fong

Project Manager Michelle Puglielli

Krystyna Chiaravalle

Technical Services Coordinator (c)

Matthew Lambinico-Tieng

Senior Validation Specialist

Barry Knox

Validation Engineer Zhan Yang

MANUFACTURING AND PACKAGING SERVICES

Warehouse

Utilities & Services

Topicals & Liquids Manufacturing

Topicals & Liquids Packaging

Quality Control

Solid Dose Manufacturing

Solid Dose Packaging Hall

Quality Control

Admin

Clinical Services

Narcotics Vault

OUR FACILITY

Admin

Technical Services

Algeria Australia Belarus Canada Czech Republic France Germany Mexico

New Zealand Romania Russia Spain Sweden UK USA

PRODUCT DISTRIBUTION

Distribution Countries

WORK CENTER CAPACITY UTILIZATION

% Utilization Based on Current Single Shift Operation

WORK CENTER CAPACITY UTILIZATION

% Utilization Based on Current Single Shift Operation

SMALL SCALE DEVELOPMENT

• 5L Beco-Mini Lab (manufacture of small scale semi-solids)

• Small scale kettles with mixing capabilities (solutions)

• ILC Dover Containment Hood for working with potent compounds

• T.K. Fielder SP65 High Shear Granulator (small scale high shear granulations)

• Glatt GPCG-2 Fluid Bed Granulator (6L and 12L spray granulation bowls)

• O’Hara Labcoat II Film Coater (18 and 30” interchangeable pans)

SOLID DOSE MANUFACTURING

• Pharma Matrix High Shear Granulators TK Fielder PMA250, SP400 and PMA600 Units

• Glatt Fluid Bed Processor WSG120 (220L & 525L bowls)

• Alexanderwerk WP200 Roller Compactor

• Glatt Bin Blending System 250L, 500L, 1200L and 1800L Bins

• V-Cone Blenders 1 cubic foot

3 cubic foot

10 cubic foot (with Intensifier Bar)

• Fitzmill and Comils

• Thomas Accela-Cota 48” Tablet Film Coater Aqueous Coating Only

SOLID DOSE MANUFACTURING

• O’Hara Tray Drying Oven (2)

• Manesty Tablet Presses Betapress: 16-station, "B" Tooling (2)

Unipress: 27-station, "B" Tooling

Novapress: 37-station, "D" Tooling

• Bosch H&K 1500 Capsule Filler

• IMA Precisa Capsule Weight Checker

• Capsugel Ultra II 8 Capsule Filling Machine

SOLID DOSE MANUFACTURING

• High Shear Granulation and Fluid Bed Granulation/Drying

Batch Sizes: 50 kg to 250 kg*

• Tray Drying Batch Sizes: 5 kg to 400 kg*

• Blending Batch Sizes: 5 kg to 450 kg*

• Tablet Coating Batch Sizes: 90-140 kg (48” pan)*

* Based on a 0.5 bulk density

SOLID DOSE PACKAGING

• Glass and plastic bottles

• PVC/foil and foil/foil blisters

• Induction Seal & C/R Caps

• Fully automated, validated lines

Bottle Descramblers

Slat fillers

Desiccant Placers

Cotton Inserter

Induction Sealers

Cappers

Torquers

Cartoners/Labelers/Shrink wrappers

• Flexible lines

For small scale packaging needs

SEMI-SOLIDS

• Batch size: 120 kg to 500 kg if vacuum required

• Batch Size: 2 to 500 kg if no vacuum required

• Equipment: Molto Mat Universal 500L Mixer

Jacketed Vessels equipped with Prop Mixers

SEMI-SOLIDS & LIQUIDS MANUFACTURING

NON-STERILE LIQUIDS/SUSPENSIONS

• Batch sizes: 30 L to 2,000 L (2 x 1000L)

• Equipment: 70 L – 1000L Jacketed Vessels

2,000 L Liquids Process Tank

100 & 250 L Mixing Tanks

Light Sensitive Products

SEMI-SOLIDS & LIQUIDS PACKAGING

• Tube Filling Line Romaco Unipac Tube Filler

Plastic (Laminate) and metal tubes

Fill Range: 2 g to 227 g

SEMISOLIDS & LIQUIDS PACKAGING

• Jar Filling Line

Fill Range: 25 g to 450 g

• Liquid Filling Line

Fill Range: 6 mL to 1000 mL

Bottle Filing in Glass or Plastic Bottles

Neck-banding and Induction-sealing (most formats and sizes)

QUALITY ASSURANCE AND QUALITY CONTROL

QUALITY CONTROL TESTING

• Testing Capabilities

USP Compendial & Non-Compendial Chemistry Testing

Microbial Testing

BP/EP testing available

• Analytical Method Development, Validations and Transfer

• Support of Plant Activities

Cleaning Validation

Process and Packaging Validation

Environmental Monitoring Program

QUALITY CONTROL TESTING CAPABILITIES

• Equipment Capabilities

HPLC (UV / DAD & RI)

HPLC Conductivity

Infra-Red Spectrophotometry

UV / Visible Spectrophotometry

GC-FID

Dissolution Apparatus Type 1 & 2

• Chromatographic Data Software

WatersTM Empower 3

ALL MAJOR LAB EQUIPMENT FULLY PART 11 COMPLIANT

STABILITY TESTING

• ICH Compliant Stability Programs

• Room Temperature and Accelerated Chambers

25°C/60%RH

30°C/65%RH

40°C/75%RH

Validated, Alarmed and on Back-up power

• Photostability

• Protocol and Report generation

QUALITY ASSURANCE

eQMS System Change Control System

Control and Issuance of Master Documents • SOP’s, Test Methods and Specifications, Master Processing

and Packaging Records

CAPA System

GMP Training Records • SOP’s, Test Methods, MPF/P’s

Manual System Non-Conformance Reporting System

Vendor Auditing and Approval

Customer Complaints

Product Release (BPCS)

GMP Training

Quality Control

TECHNICAL TRANSFER PHILOSOPHY

• Project management oversight

• Full analysis of technical package

• Establish technical transfer team

• Create timelines with client input

• Weekly progress meetings

• Technical project plans, protocols and reports generated

• Full client approval of master documents

• Analytical testing support

• Project is considered transferred when validation is completed

CLIENTS WELCOME TO OVERSEE TRANSFER!

INDUSTRY LEADING CLIENT FOCUS

• We know the CMO business and what it takes to be successful

• Strong cGMP compliance record

• Long history of product quality

• Provide responsive personalized service

• Reliable production flexibility and capacity

• Help develop full commercial potential and value pricing

• Continuous improvement culture

WE WILL BUILD A LONG LASTING PARTNERSHIP WITH YOU!

KEY CONTACTS

LONNIE BARISH, MBA Executive Director, Business Development

130 Market Place #244 San Ramon, CA 94583 USA

Office: +1 925-803-1080 Cell: +1 510-305-8910

SAM RICCHEZZA Vice President,Business Development

400 Iroquois Shore Rd Oakville, ON L6H 1M5 CANADA

Office: +1 905-337-4518 Cell: +1 905-334-2478

DAVID WATT Technical Director 400 Iroquois Shore Rd

Oakville, ON L6H 1M5 CANADA

Office: +1 905-337-4519 Cell: +1 647-330-6415