Piramal Clinical Trial Services

Piramal Healthcare is a global pharmaceuticalcontract manufacturer whose key activities include Active Pharmaceutical Ingredient, Product Formulation and Packaging from development to full commercial scale.

Who are Piramal?

Piramal ClinicalTrial Services adds to our clinical trial manufacturing capabilities.

Piramal OverviewAnnualised revenues of $720m

Total employees ~ 8750

Sourcing office in China

Robust growth @26% (FY08)

Number 4 in the Indian domestic market

Top 10 global custom manufacturing player

On-going investment– Ahmedabad Facility

Investment of $10 Million over 2 Years

Combined Development and GMP CT manufacturing

– Bangalore Facility

Investment of $20 Million in sterile site

Two filling lines, one for CTM supply and one for commercial supply.

Strategic Acquisitions &

Alliances 2005 2008 2002 2000 19961990

•ICI Pharma, Cardiovascular portfolio

•ChennaiCentre of Excellence for Early phase API

•AhmedabadCentre of Excellence for Early phase Forms

•Global Bulk Drugs FDA approved API facility

•Avecia Pharma (UK & Canada) Global custom synthesis player

•Pfizer Morpeth, Dosage form and Logistics

•Haemaccel Brands Group of Plasma Select AG, Germany

•Minrad International Inc. manufacture of inhalation anaesthetics

Initial Indian Base Global Technical Capabilities

Building CMO Assets

•Nicholas labs entry pharmaceuticals

•Roche Products, ethical brands & vitamins

•Boehringer Mannheim, diagnsitics portfollio

•Sarabhai Piramal CNS & NSAIDS portfolio

•Khandelwal Labs, Cefixim based drugs

UNITED KINGDOM

1. MORPETH API & FormulationDevelopment & Manufacturing2. GRANGEMOUTHCytotoxic APIDevelopment & Manufacturing3. BILLINGHAMBiocatalysis & Fermentation

INDIA

1. MUMBAI R&D CENTRE API & Formulation Development2. CHENNAIAPI Development & Manufacturing3. HYDERABADAPI Manufacturing4. PITHAMPURCTM Manufacturing5. BANGALORECTM Manufacturing

CANADA

1. TORCAN API Development & Manufacturing

Where are Piramal ?

Morpeth History

1969 Established by G.D.Searle

1986 Monsanto acquisition of G.D.Searle Searle operated as a division

2000 Searle/Pharmacia merged Solutia/Monsanto spun off

2003 Pharmacia acquired by Pfizer

2005 Pfizer to sell Morpeth

2006 Site acquired by NPIL

2008 Name change to Piramal Healthcare and re-branding

People and Environment

Approximately 340 people employed

Succession planning and talent management

Learning resource centre

The site has been continuouslyrecognised as an “Investor In People”(the UK national standard for training &development) for over 16 years

ISO 14001 awarded September 2005

Licenses

MIA (IMP) 29595 Manufacturer's Authorisation Investigational Medicinal Products

MS 29595 Manufacturer's "Specials" Licence

MIA 29595 Manufacturer's/Importer's Licence

Certificate of GMP Compliance of a Manufacturer Certificate No: UK ManA 29595/18244 - This covers human and veterinary products.

QualityProven QC/QA organisational capabilities

QC sampling/testing/release activitiesStability testing per ICH requirementsMethod development & validationQA EU Import testing & Certification/releaseFour QP’s on Licence plus two 2 in training

Quality Management Systems in line with FDA guidelines, ICH and structured to FDA Quality Systems Inspection approach

Regulatory Compliance group to support site and customer activities

Facility Capabilities

Fully integrated siteAPI

Includes pilot plant and scale up capabilities

Pharmaceutical/drug productSupply to USA & Far East

Pre-formulation & Pilot capabilitiesClinical Trial Manufacturing

PackagingModern equipment and facilities

Clinical trial services

Distribution cGMP warehouse 7000 pallet locations

SAP systemCurrently distribute over 100 countries

Piramal Clinical Trial Services

• Packaging• Storage• Distribution• Reconciliation

As a specialised unit operating within the broader Piramal Healthcare organisation investigational drug supply process from comparator sourcing, manufacture, QP release and distribution through to patient kit returns and reconciliation

What can Piramal offer?

Primary Packaging

Fully Integrated Blister LineStandard tooling in different configurations reducing lead timesCustomised design software, machine creates the designThermoforming and cold forming3-D Blister tool design

Bottle fillingFull capability including HDPE, PP and glassDesiccant & cotton coil insertionIn-line induction sealing, Ink-jet coding & check weighing

Blister Card WalletingRotary heat sealers including child resistant capabilities

Over encapsulationMulti-Pharma MC100 machineCompatible with size 00, 0, 1, 2, 3, 4 and DB capsules

Principle Services

Secondary Packaging

Translations, Kit Design & PrintingApproved technical translatorsSingle and multi-panel/lingual labels and leaflets with over-printing directly on booklet labelOptical Character recognition for printed componentsValidated open-label and randomised printing capabilities within GMP areaElectronic bar-code verification of printed labels

Patient Kit Preparation and CompilationTrakPack® generates assembly instructions and electronic verification of key stepsAutomated label application of vials/syringesTemperature sensitive packaging servicesJust-in-time labelling

Principle Services

Storage and Distribution

Approximately 3,000 dedicated locations-20°C, +2 to +8°C, +15°C to +25°C continuously monitored & alarmedApproved couriers and Cold-Chain vendorsInventory management to the individual kit levelTrakPack® management of IVRS and distribution process

Returns and Destruction Management

3-tier service offeringProcessed within a dedicated areaFull audit trail through TrakPack®

Principle Services

Support Services

QP Declaration and Certification Process

Drug Medication Sourcing – approved wholesalers

GMP Global Depots – Piramal QA audited

Principle Services

SingaporeHong KongTaiwanKoreaThailandMalaysiaPhilippinesIndonesia

FranceAustraliaNew ZealandIndiaFinlandEstoniaIsrael

RussiaUkraineNorth AmericaArgentinaBrazilMexico

Our overriding aim is to offer customers and patients an unsurpassed quality of service and product.

What makes Piramal different?

Piramal take customer feedback very seriously. We want to get better at what we do, so it is important that we spend time talking to clients to find out where we can improve.

We strive to offer continuity of relationships and agility for all customers, irrespective of project scope. Each customer is as important as the next.

Once we understand the scope we work hard to ensure that neither party ‘over commits’ and that we keep project activity focused on the real ‘value-add’ for the client.

Customer service also means regular and rapid communications and a commitment to be transparent with information.

We believe it is important to address issues early and honestly.

Piramal follow a standard documented process which is mapped and procedural.

What does ‘customer service’ mean?

Clinical Trial Service Process

A web based application used to track the status

of manufacturing, distribution and drug returns

Integrates with labelling software and uses barcodes to verify key stages of manufacture and distribution process

Integrates with IVRS using HMTL & CSV formats to permit electronic transfer of data

Provides be-spoke customer and site interface to view status of manufactured and distributed clinical trial kits

How will I know what’s happening?

TrakPack® – Reporting Examples

Report Data Reported

Kit Compilation Status

Quantity of kits completed, expected completion date

Electronic Signatures Full audit trail of status changes to patient kit level

IVRS order receiptsStatus of shipment order (received, processed, packaged, shipped, arrival)

Expiry and re-test monitoring

Returns Management

Site & Deport stock

reports

Alerts on expiring stock based on client defined dates

Patient kits returned, confirmed and full reconciliation

Stock received, despatched and acknowledge to the patient kit level