Transcript Orchid Presentation

Orchid Chemicals & Pharmaceuticals Ltd.
Creating Sustainable Value
BSE: 524372
NSE: ORCHIDCHEM
Bloomberg: OCP@IN
Reuters: ORCD.BO
April 2011
www.orchidpharma.com
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Disclaimer

This presentation includes forward-looking statements / projections, which are based on current expectations
and forecasts about future events. Such statements involve known / unknown risks, uncertainties and other
factors and may cause and defer the actual results materially. Such factors include, but are not limited to,
changes in local and global economic conditions, Orchid Chemicals & Pharmaceuticals Ltd. (‘Orchid’ or the
‘Company’) ability to successfully implement its strategies, the market acceptance and demand of the
Company’s products and services, the Company’s growth rates, expansion, technological change and the
Company’s exposure to market risks. By this nature, these indications and projections are only estimates and
actual results could differ from these in the future.

These materials are not an offer for sale of securities in the United States or in any other jurisdiction. No
securities of the Company may be offered or sold in the United States absent registration or an exemption from
registration under the U.S. Securities Act of 1933, as amended. The Company does not intend to register any
of its securities for offer or sale in the United States or elsewhere, or to conduct a public offering of securities in
the United States or elsewhere. No money or other consideration is being solicited pursuant to these materials.
www.orchidpharma.com
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Orchid Chemicals & Pharmaceuticals
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Business
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Key Product
Offerings
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Facilities
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Employees
Financials*
Vertically integrated global pharmaceutical company
Established research, manufacturing and marketing capabilities
Multi-therapeutic, multi-product global business
Active Pharmaceutical Ingredients (API), finished dosage forms and drug discovery
Fully integrated API and Finished Dosage Form product offerings
Oral Antibiotics
Diverse (oral) multi-category non-antibiotic product range (Non-Penicillin/Non-Cephalosporin)
2 API manufacturing sites in India and 1 API manufacturing site in China
3 formulations manufacturing sites in India, and 3 research campuses in India
Manufacturing facilities approved by US FDA, UK MHRA, EDQM, DMA, MCC and TGA
R&D facility accredited by National GLP Authority of India (aligned to OECD principles of GLP)
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Human resource base of 4000 plus – includes over 700 scientific & technical manpower in R&D and
manufacturing, and around 1000 field personnel in domestic formulations
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Q3 FY11 Turnover: Rs 4,785 mn (US$ 107.06 mn) / 9-mths FY11 Turnover: Rs 12,455 mn (US$ 279 mn)
FY10 Turnover: Rs 13,435 mn (US$ 298 mn)
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* USD figures based on exchange rate of Rs 44.70= 1$ (YTD FY11) / Rs 45 = 1$ (FY10)
www.orchidpharma.com
Financials are on consolidated basis
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Orchid’s Domain Leadership
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Leader in high technology life-saving antibiotics ; cephalosporins, penicillins /
betalactams and carbapenems
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Complex non-penicillin, non-cephalosporin products
Presence
Amongst the Top-15 Indian pharma companies, a status achieved in just 13 years of operations
Amongst the Top-5 cephalosporin antibiotic producers of the world
Largest manufacturer-exporter of cephalosporin products in India; Amongst the top exporters of all
pharmaceutical products in India
Committed to a culture of high standards in safety, health and environment
Recipient of several awards from Government of India, Confederation of Indian Industry, Madras
Management Association and other national and international agencies
Partner of Choice for ‘Competitive Excellence’ & ‘Contract Research - Collaborative Drug Discovery’
awarded by Frost & Sullivan
www.orchidpharma.com
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Orchid’s Vision is to…
Become an Integrated Pharmaceutical
Corporation of Global Scale and Standing,
with a Comprehensive Coverage from
Discovery to Delivery
Key Differentiators
State-of-the-art
R&D and
Manufacturing
Facilities
• cGMP
• cGLP
• ISO
• OHSHAS
www.orchidpharma.com
Stringent
quality,
regulatory
compliance
End-to-end
connectivity
• API to FDF
• Discovery to Delivery
• Global SCM
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US FDA
UK MHRA
EDQM
SA MCC
TGA
DMA
Global
alliances
and
partnerships
• Joint Ventures
• Collaborations
• License Agreements
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Orchid Group Corporate Structure
Orchid Chemicals &
Pharmaceuticals Ltd.
Orchid Research Laboratories Ltd.,
Chennai
NCPC Orchid Pharmaceuticals
Company Ltd. China
Wholly owned subsidiary for drug discovery and
development
50:50 joint venture for manufacture of sterile
cephalosporin APIs in China
Orchid Pharma Japan K K, Tokyo
Wholly owned subsidiary for business development (generics
and CRAMS) in Japan
Orchid Europe Ltd. London, UK
Wholly owned subsidiary for generics foray in
Europe
Orchid Pharmaceuticals, Inc.,
Delaware, USA
Wholly owned subsidiary
Orgenus Pharma Inc., Princeton, NJ,
USA
www.orchidpharma.com
Wholly owned subsidiary for rendering select
services in US
Orchid Pharmaceuticals SA (Pty) Ltd.
South Africa
Wholly owned subsidiary for undertaking South
African generics foray
Bexel Pharmaceuticals Inc., Union
City, CA, USA
Wholly owned subsidiary for drug discovery and
development in US
Diakron Pharmaceuticals Inc. San
Diego, USA
Affiliate (planned to be a subsidiary) for discovery and
development of new cardiovascular drugs
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API facilities (Alathur, Chennai)
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Largest cephalosporin API manufacturing
complex
Approved by US FDA, UK MHRA and
other international regulatory agencies
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Variety of non-sterile and sterile
(crystalline & lyophilised) APIs
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High levels of throughput and
manufacturing integration (980 MT of
capacity per annum)
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State-of-the-art infrastructure designed
for highest levels of process efficiencies
and environmental friendliness
www.orchidpharma.com
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GMP - Approved (WHO)
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US-FDA – Approved (Nov’02, Sep’03 & Dec’06)
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EDQM – Approved (Sep’03)
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MHRA – Approved (Jan’06)
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Hamburg Health Authority – Approved (Jan’06)
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Australian-TGA - Approved (Feb’03)
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ISO 9001:2000-certified Quality Management System (Re-certified in
May’08)
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ISO 14001-certified Environment Management System (Re-certified
in May’08)
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Danish Medicines Agency (EU-GMP) – Approval (Jan’09)
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Pharmaceuticals & Medical Devices Agency (PMDA, Japan) – Oct’09)
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API facilities (Aurangabad)
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Multi-site API complex with dedicated facilities for
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Penicillins
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Sterile Carbapenems
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Non-penicillin, Non-cephalosporins (NPNC)
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Facilities designed for automated production
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Manufacturing capacities : 48 MT for Penicillins, 12 MT for
Sterile Carbapenems and 120 MT for NPNC
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Approvals:
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UK MHRA (Approved - Jan ’07)
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US FDA (Approved - Feb ’07)
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OHSAS 18001:1999
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Danish Medicines Agency [EU-GMP] (Approved - Jan ’09)
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WHO GMP Audit (Approved - Apr ‘10)
www.orchidpharma.com
Sterile Carbapenem Facility
ISPE, INTERPHEX and
Pharmaceutical Processing
Facility Awards 2009
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Formulation Facilities – Advanced Markets (Irungattukottai, Chennai)
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Large state-of-the-art oral dosage form complex with multi-therapeutic facilities
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World-class facilities with US FDA & UK MHRA and other international regulatory approvals
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High throughput Oral cephalosporin formulations facility
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Pilot and commercial scale NPNC (non-antibiotic) dosage forms plant
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Global scale capacities
www.orchidpharma.com
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Highlights of Orchid’s Generics Contracts – US, EU model
 Orchid has long term partnerships with leading global generic players in US and
Europe to distribute its products in the respective markets.
 Orchid licenses the generic products in return for development cum licensing fees
received from the partners.
 Orchid manufactures and supplies the products from its US FDA, UK MHRA
approved facilities based on pre-agreed costs of goods and also receives share of
revenues or net profits as per agreements.
 The arrangements incorporate mutual performance parameters in terms of market
and supply performance.
 The typical initial term ranges upwards of five years from product launch, with the
agreements providing for renewal.
 The partnerships have been expanded in terms of product range and extended in
terms of geographic coverage reflecting Orchid’s performance and partnership
equity
Orchid is currently working on creating front-end marketing
organisations of its own in the advanced markets
www.orchidpharma.com
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Novel Drug Delivery Systems (NDDS)
 A new initiative to support product life cycle management of established drugs
 Undertakes development of new dosage forms and strengths to enhance the efficacy and
safety of existing drugs
 Develops novel combinations of existing drugs for better compliance and / or synergistic
effect
 Platform technologies deployed to undertake NDDS developments
 Strategy focuses on developing NDDS on bench scale and establishing limited proof-of-
concept
 Business strategy envisages collaborative approaches with MNCs and specialist delivery
companies for further studies and eventual commercialization
 Also provides support to development of conventional and novel formulations for New
Chemical Entities
www.orchidpharma.com
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Orchid Research Laboratories Limited (ORLL)
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Business
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Objectives
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Facilities
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Employees
Recognition
www.orchidpharma.com
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A wholly owned subsidiary of Orchid Chemicals & Pharmaceuticals for undertaking drug
discovery and development
An integrated research company with end-to-end capabilities in drug discovery and
development
Among the top ranked pharmaceutical discovery entities in India, with global standing
Discovery and development of New Chemical Entities (NCEs)
Custom Research and Manufacturing Services (CRAMS)
Drug Discovery Centre, Biology Centre, Animal House cum Pre-clinical Facility, CMC Facility,
Analytical Centre, Formulation Facility in Chennai, India
R&D Facilities GLP accredited by National GLP Authority of India, aligned with OECD Principles
Scientific base of 130 plus with several doctoral and post-doctoral scientists
Access to 200 plus scientists in other R&D and technical domains of the Parent organization
Partner of choice in ‘Contract Research – Collaborative Drug Discovery’ awarded by Frost &
Sullivan
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Orchid Research Laboratories Ltd (ORLL)
High quality
infrastructure
Special
competencies
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Molecular modeling
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Animal House facility
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IPM
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Microbiology Facility
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Medicinal Chemistry
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Microbiology Capabilities: MRO
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Analytical Chemistry
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Process Research & Development
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Assay Development
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Microbiology in vivo capabilities
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Microbiology in vitro functional
capabilities
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Pre-Form/Formulation and DMPK
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Toxicology Capabilities
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Access to Parent’s Process Research
and Pharma Research infrastructure
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Microbiology in vitro hit profiling
capabilities
 130 plus scientists exclusively for drug discovery and drug biology. Supported by access to the
parent’s process research and pharmaceutical capabilities, as needed
 Has the capability to link up with clinical research organizations for human clinicals
Orchid’s integrated drug discovery and development infrastructure helps simultaneous, fast-track pursuit
of multiple therapeutic programs
www.orchidpharma.com
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ORLL’s product and services strategy
Proprietary Drug Discovery
Collaborative Drug Discovery
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MNC oriented
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Therapeutic area based
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Risk-reward shared models
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Multiple TAs
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PCC in animals
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POC in humans
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Out-licensing
Project based services
www.orchidpharma.com
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Pfizer
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Biovitrum
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Dermact etc.
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FTE or Fee for Service models
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IPM
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Draft, file and prosecute high quality patent
applications
Patent Applications Filed : Total - 644
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644 patent applications filed in various national and
international patent offices
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Includes 187 patent applications for NCEs, 28 for
NDDS and 14 for biotech
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Several patent and search data bases
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Prepare novelty / infringement reports
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Monitor competitors’ patent portfolio
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Coordinate with foreign patent attorneys
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Prepare patent evaluation reports
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Support Business Development & clarify portfolio
related queries
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187
399
NCE
Process
Biotech
Generics
Patents Published : 226
136
86
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NDDS
Robust IPM systems to protect inventions, secure
intellectual property and assure client confidentiality
www.orchidpharma.com
NCE
Process
1
Biotech
NDDS
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ORLL’s multi-therapeutic, multi-lead discovery program
NCE Development Status
Therapeutic
Segment
Diabetes
NCE
Discovery
Early
Pre-clinical
1
Tyrosine-TZD, Non-PPAR molecule
2
DPP IV Inhibitor
3
Novel
1
Th1 / Th2 Cytokine Synthase Inhibitor
2
PDE IV Inhibitor
3
TNF  Inhibitor
1
STAT 3 / IL-6 Inhibitor
2
HDAC Inhibitor
1
Oxazolidinone
2
Cephalosporin
3
Betalactamase Inhibitor
Clotting Disorders
1
Oral Direct Thrombin Inhibitor
Obesity
1
Novel
CNS
1
Inflammation
Oncology
(Non-Cytotoxic)
Anti-Infectives
www.orchidpharma.com
Late
Pre-Clinical
Regulatory
Toxicology
Phase 1
Clinical
Phase II
Clinical
Novel
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Orchid’s multi-horizon strategy would focus on a larger basket
of oral products and new value adding niche opportunities
Horizon 3 – Innovation
Horizon 2 - Formulations
Horizon 1 - API
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for in-house generics
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for regulated markets
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for emerging markets
www.orchidpharma.com
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Generics for regulated markets
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Branded for emerging markets
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Branded for India
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New Drug Discovery
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Novel Drug Delivery
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CRAMS
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Growth strategy
Orchid
Existing Business
API / Oral FDF /
CRAMS / NDDS
Inorganic
Strategies
(Front-end Mktg /
in-licensing
of products)
New niche
Initiatives
(New product
segments)
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Target to grow topline by 15-20% y-o-y
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Strong operational cash flow going forward based on niche product opportunities
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Orchid recently acquired US-based marketing company Karalex Pharma, LLC.
www.orchidpharma.com
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Orchid’s Value Proposition
API
GLOBAL
APIs
Formulations
DOMESTIC
FORMULATIONS
GLOBAL
GENERICS
(ORAL)
Innovation
CRAMS
NDDS
NCEs
 State-of-the-art manufacturing infrastructure; two API sites, one oral generic formulations facility
for advanced markets, two formulations facilities for certain emerging markets and R&D and drug
discovery facilities
 Global regulatory compliance, including US FDA, UK MHRA and DMA
 Multi-therapeutic product portfolio, with an increased focus on oral cephalosporin and non-
penicillin, non-cephalosporin (NPNC) products
 Long term contracts with Hospira / other innovators for supply of APIs with assured capacity
utilization
 Integrated drug discovery capabilities with proprietary NCE pipeline as well as custom research
and collaborative drug discovery
 Financial flexibility to identify growth opportunities across the value chain
www.orchidpharma.com
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THANK YOU
For any information or clarifications, please visit www.orchidpharma.com
or call
Ch Ram, Head - Communications & Investor Relations
on +91 98400 11626 / [email protected]
© 2011 Orchid Chemicals & Pharmaceuticals Ltd., All Rights Reserved.
This material was used during an oral presentation; it is not a complete record of the discussion. This work may not be used, sold, transferred, adapted, abridged, copied or
reproduced in whole on or in part in any manner or form or in any media without the prior written consent. All product names and company names and logos mentioned
herein are the trademarks or registered trademarks of their respective owners.
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