Dr Reddys Cps Presentation Linked In Aug 2011
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Transcript of Dr Reddys Cps Presentation Linked In Aug 2011
Rising to the Pharma Challenge
Introduction to CPS
(Custom Pharmaceutical Services)
For LinkedIn
Christian Jones
European Sales & Business Development Manager
30-Aug-11 1
Corporate Overview
Custom Pharmaceutical Services (CPS) Overview
API – Development Capabilities
API – Commercial Manufacturing
Dosage Form Capabilities
Project Execution
Content
2
Corporate Overview
Purpose: “Providing affordable and innovative medicines for healthier lives” Strategy: Leverage industry-leading science & technology, product offering, and customer service with execution excellence to provide affordable and innovative medicines for healthier lives.
3
$1.7 BN
Size Business Mix
Product Portfolio
Infra structure
Business Mix
•Pharma Services & Active Ingredients contributing 1/3rd of revenues
•Global Generics contributing balance 2/3rd
•Proprietary products business in incubation mode
Size
•FY11 ~ $1.7 Billion in revenues
Product Portfolio
•100+ APIs, 150+ Finished Dosages
•2 biosimilars launched in India
•69 ANDAs pending approval
•200+ DMFs filed globally
•8 biosimilars in development
•Over 200 projects under development
People & Infrastructure
•14,000+ employees; ~ 2,000 in in international workforce
•20 Billion units in finished dosage manufacturing capacities
•16 manufacturing facilities (9 Chemicals, 6 Finished Dosages & 1 Biologics)
Dr. Reddy’s Today
4
Our Businesses
Pharmaceutical Services and Active Ingredients
• Active Pharmaceutical Ingredients
• Custom Pharmaceutical Services (CPS)
Global
Generics
• NA
• EU (Germany, UK)
• India, Russia, Ukraine/CIS & Venezuela
Proprietary Products
• Biologics
• Specialty Pharmaceuticals
5
Built the foundations for a strong business. Moved up the value chain. Strengthened capabilities.
Achieved scale and global presence. Growth aided by acquisitions.
The Last Decade: Achieved Scale and Global Presence
183 234
338 380
463 447
546
1,510
1,250
1,365
1,563
1,700
0
200
400
600
800
1000
1200
1400
1600
1800
FY00 FY01 FY02 FY03 FY04 FY05 FY06 FY07 FY08 FY09 FY10 FY11
FY00 FY02 FY04 FY06 FY08 FY10
37 50
121 94
75
26
68
379
243
285 351 369
EBITDA ($ Mn)
6
Strong Product Development Platform
Strong and Growing Pipeline
Segment Pipeline
Total Filings
Pending ANDAs
126 (including partnered ANDAs)
69 (including partnered ANDAs)
US DMFs
EU DMFs
176
78
European Products
(pending registration)
>60
Dossiers
(Rest Of the World)
150+ pending registration
Specialty (US
Dermatology)
3 ready to market products +
several others in development
Biologics 8 in development
7
Track Record 2010 Agreement for acquisition of GSK’s Penicillin Facility (USA)
2009 Partnership deal with GSK in emerging markets
2008 Acquisition of BASF facility at Shreveport, US
2008 Aquisiton of Dowpharma Small Molecules business associated with Dow’s Mirfield and Cambridge, UK Sites
2007 World’s first biosimilar monoclonal anti-body ,Reditux (rituximab) launched
2007 Fastest Indian Pharma Company to cross $1billion in annual revenue
2006 1st Indian manufacturing company to be Sarbanes-Oxley certified
2006 1st authorized generic deal with multinational pharma
2006 Key acquisition betapharm (Germany)
2005 Key acquisition “Falcon” (Mexico)
2001 1st Indian pharma company to be listed on the New York Stock Exchange
1997 1st Indian company to out-license an NCE to a multinational pharma
1993
1997
2001
2005
2006
2007
2008
8
Care for Environment and Society
• Customer: FDA approved, Product safety (Pharmcovigilance) • Suppliers: Vikreta- B2B portal,GBS • Corporate Governance
Core Purpose
Business Operations
Communities
Society • Dr.Reddy’s Foundation – Livelihoods & Education
• Patient Assistance Programs & DRHFE
• Employee Engagement- Volunteer Program & Power of Ten
• Employees: Policies / Talent Mgmt Board / Leadership dev/ BPE
To help people lead healthier lives through Access & Affordability
• Environment: ISO 14001 & OHSAS 18001certified facilities;
Zero Liquid Discharge & SHE technologies
• Community Development– Health/Education/Livelihoods/Employability
Triple Bottom Line Approach…
9
Achievements
Dun & Bradstreet American Express Corporate Awards 2007
Best Corporate Social Responsibility Initiative 2007 BSE - India
Pharma Excellence Awards 2006-07 for sustained Growth The Indian Express
Asia-Pacific HRM Congress 2007 Global HR Excellence Award for Innovative HR Practices
Aon-Hewitt 25 best Employers in India 2011 Business Leader in the Pharmaceutical Sector
Forbes 2010 Asia Fab 50 companies 2011 First time featured on the list
10
Overview – Custom Pharmaceutical Services
11
Background
39%
One of the largest Custom Pharma businesses from India
End-to-end capabilities
Discovery
Chemistry
Clinical
Development
Commercial
Launch
Process
Development
Process
Development
Kilolab quantities
Intermediates
APIs &
Dosage Supplies for clinical trials
Intermediates
APIs &
Commercial drug product
3 dedicated R&D facilities (2 in Hyderabad
and 1 in Cambridge)
Broad Client Base:
Large Pharma – 10+
Mid Sized Pharma – 5+
Emerging Pharma and Biotech – 30+
12
13
Custom Pharmaceutical Services
To be the preferred supplier of APIs, Intermediates and
Formulations to ‘Innovators’ worldwide
Delivering cost-effective and cGMP compliant products and services
Managing intellectual property consistent with Global standards
Emphasizing safety, health and environment
Speed
Competitive Pricing
cGMP
Innovation
13
Technology Development Centre commissioned
Acquired Roche’s Facility in Mexico.
70 110
800
Focus on API Development and scale up
Integrated offer of services with Dosage Form Development and Supplies
Offer contract Development & Manufacture of Niche API’s (High Potent - Cytotoxic, Hormonal etc)
Manpower
Services
Initiated contracts with Big Pharma Business
Expanded customer base to about 30 with several repeat business
History
Acquired Dow Pharma’s technology platforms and facility in the UK, BASF Dosage site in the US.
950
Offer niche technology solutions in complex Chiral molecules, PEG’s, Peptides, prostaglandins, carbohydrates
2003 2004 2005 2006-7 2008-10
14
Custom Pharmaceutical Services
North America
Europe
Sales & Marketing
Manufacturing
Technology Dev. Centers
Asia Pacific
Pilot Plant
R&D
Chemical Plants
Hyderabad, India
Cambridge, UK
Hyderabad, India
Mirfield, UK
Hyderabad, India
Cuernavaca, Mexico
Mirfield, UK
Formulation Plants
Hyderabad, India
Custom Pharmaceutical Services A Global Organization
Louisiana, USA
15
16
CPS Value Proposition
Technology: ► Chiral Capabilities – Chemo and Bio Catalysis ► PEGylation Technology ► Continuous Processing ► Steroid and HPAI capabilities ► Carbohydrate Chemistry (Ex.Fondaparinux) ► Traditional Chemistry ► Peptide, Prostaglandins & Oligo building blocks
Manufacturing & Security of Supply: ► Extensive, flexible capacity ► Geographical versatility -India/UK/Mexico ► Large portfolio of DMF’s available off the shelf ► More than 100 tech transfers of Innovator projects ► Competent technical staff ► Dedicated project management teams through
product life cycle
Cost-effective: ► Geographic advantage ► Fit-to-purpose scale of production ► Global supply chain
Track Record & Quality: ► Large base of customers with several repeat business ► High quality products and services ► Corporate philosophy supports global markets ► cGMP compliant, USFDA inspected facilities ► ISO 27001 certification (IP and Documentation standard)
16
API – Product Development Capabilities
17
18
Technology Development Center (Hyderabad, IN)
Dedicated R&D facility for CPS with ~300 chemists and engineers
Kilo Lab / Pilot Plant with about 10,000 sq ft
Class 100,000 clean room
Discovery Chemistry & Process R&D
21 Chemistry Labs
5 Analytical Labs
Class 100, 000 Cytotoxic suite
18
19
Analytical Capabilities
Method development and validation
Impurity profile: Established expertise in isolation, identification and
characterization
Certified, qualified and validated equipment: DSC/TG, GC/LC-MS, LC-MS-
MS, powder XRD, single crystal XRD, NMR, LC-NMR, FT-IR, CHN analyzer
19
20
Chemocatalysis • Technologies with utility in large scale manufacturing • World leader in asymmetric hydrogenation • Other capabilities for fine chemical applications such as
• Achiral • Asymmetric hydro-formylation
Biocatalysis • Discovery and development of Industrial biocatalysts and their application in bio-catalytic manufacture of fine chemical intermediates • In-house culture collection of more than 2000 microorganisms in 96 well plate format
Complex Synthesis • Have experience of more than 120 customer projects over the last 12 years • Capability to develop efficient processes to manufacture complex target molecules including
• Sugars • Prostoglandin analogues • Oxa-prostoglandins
Technology Development Center (Cambridge, UK)
Mirfield
Cambridge
20
21
Activated PEG Offering
► mPEG-X
–Linear architecture
–Molecular Weights: 5, 10, 20, 30, 40, 60 kDa
–Narrow polydispersity
–Low levels of difunctional PEG: < 1-5% depending on MW
► Functional Groups
–p-nitrophenyl carbonate
–propionaldehyde
–Maleimide
–Amine
► Custom PEGs
21
API – Commercial Manufacturing Capabilities
22
23
API Production Facilities - India
Six commercial production units – All inspected by USFDA
Six Pilot Plants, Two Kilo Labs
Over 2 million liters of reaction volume
Over 500 GL and SS reactors that can handle temperature range
of –75 to 300 oC
Operations fully integrated through SAP
and global supply chain practices
23
24
Highly Potent API Production Blocks - India
Contained Blocks 1&2:
► Fully contained cGMP compliant facility
► Range of reactor capacity – 63 L to 630 L, 250 L to 2000 L
► Occupational Exposure Limits (OEL) 0.2µg/m3 for 8 h TWA
► Containment practiced through Air Handling, Pressure Zoning, Isolators
and Personal Protective Equipment
24
API Manufacturing Network: India
Miryalguda
Hyderabad
Vizag
CTO I – 1985
CTO II – 1986
CTO III – 1995
CTO IV – 1984 CTO V – 1987
CTO VI – 1990
25
Regulatory Experience
Type Number
USDMF 176
EDMF 78
CEP 22
Canada 51
Japan 18
Korea 23
China 14
Turkey 12
Singapore 5
26
27
USFDA Inspections
Unit Date
Unit IV November 1987
Unit IV March 1996
Unit V March 1997
Unit I & IV June 1999
Unit II, III & VI February 2000
Unit V November 2000
Unit IV November 2002
Unit Date
Unit II & III March 2003
Unit VI May 2004
Unit V March 2005
Unit I & II
Nov 2005
Unit III & IV March 2007
Unit VI April 2008
Unit I & Unit 5 Feb 2009
Unit III September 2010
27
API Production Facilities – Cuernavaca, Mexico
Mexico City
Cuernavaca
USA
Guatemala
Belize
Toluca
28
Quality Centre
Production
Utilities
Warehouses
Tank Farm Incinerator
Main Offices
29
30
API Production Facilities – Cuernavaca, Mexico
Installed production capacity : 3350 MT
7 Reactor Bays with reactor volume ranging from 100L to 20KL
1000L and 3000L Cryogenic reactors capable of -110 oC
20 Steroidal API’s and several Steroid Intermediates currently produced
Unit audited by FDA
125 Multi-disciplinary professionals
• 25 post-graduates (Ph.D. and Masters)
• 100 graduates (chemists, engineers, accountants)
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Product Lines - Mexico Facility
Naproxen:
• 32 Years of experience in producing Naproxen
• Installed capacities: Naproxen & Naproxen Sodium – 1000+ TPA History of
Supplying of Naproxen globally including USA, EU and Japan
• Inspected & approved by USFDA
Steroids:
• Expertise in development of NCE steroids
• Dedicated, refurbished bay at a cost of ~ $29 M
• 3 Flexible manufacturing trains
• Containment for Offloading & Milling
• Class 100,000
• More than 20 DMF’s,
80% on exclusive basis on behalf of customers 31
Dosage Form Capabilities
32
• Preformulation
• Analytical and Bioanalytical Development
• Formulation Development
• Pilot Scale-up
• Clinical Trial (CT) Supplies Manufacturing
• Commercial Scale Contract Manufacturing
Analytical Development
Preformulation Development
Formulation Development
CT Manufacturing
Commercial Manufacturing
Preclinical Clinical Supply Market Launch
Seamless Formulation Services Covering the Entire Product Development Chain
33
NCE Product Development - Capabilities
Preformulation Studies: Solution stability studies
Chemical Physical properties
Solid-state characterization
Solubility and reactivity and forced degradation studies
Formulation Development; Formulation development for safety assessment studies
Prototype formulations for clinical evaluation
Process development
Formulations for comparator studies
Commercial formulation development
34
NCE Product Development - Capabilities
Clinical Trials Supplies Manufacturing and Packaging: Process optimisation, scale-up and technology transfer
Clinical trials supplies manufacturing and release testing
NDA stability and registration batches
CMC documentation for IND submission
Analytical Development: Method development and validation
Cleaning method development and validation
Dissolution and drug release profiling
Forced degradation studies
Specification development
Stability studies per ICH guidelines
35
Clinical Trial (CT) Supplies Manufacturing
cGMP Manufacturing of CT supplies for Phase I, II and III.
Scales of 1/100, 1/10 and 1 in similar equipment.
Seamless scale-up and technology transfer to commercial site.
Drug product supplies for comparator trials (DB encapsulation).
Packaging for clinical studies, comparator trials and commercial supplies.
IND and NDA support documentation.
Experienced Product Development teams
36
Product Registration Support
Support Includes:
Manufacturing, packaging and release testing of registration
batches
Stability studies per ICH guidelines and monitoring
Process validation plan, protocol and validation reports
Documentation:
• CMC for IND and NDA
• Technical reports
Experienced PAI teams
37
NCE Product Development - Experience
Rapid prototyping for “quick” first time in human (FTIH) studies
Clinical product development integrating formula, process and analytical development minimizing costly reformulation
o Solubilization Technology;
Nanoparticulate Formulations
Cyclodextrin-based Formulations
o Injectables:
Small volume parenterals
Lyophilization
o Cytotoxic Product Development;
IV
Oral
o CMC for Regulatory Submission
38
Product Development Capabilities
New Drug Delivery Systems
39
40 40
Apart from standard oral solid dose formulations, specialized
technology platforms and IP have been developed to target:
Delivery of drugs with tailored release profile
Combination product with multiple incompatible DS
Combination product with sequential release
Solubility, dissolution and bioavailability
enhancement
Taste masking and stabilization
Drug Delivery Technologies
40
Novel Drug Delivery Systems (NDDS) - Capabilities
• Explore drug delivery approaches for life cycle management
(LCM) to enhance therapeutic outcome and improve patient
compliance.
• Delivery System Based:
• Gastro-Retentive Systems
• Colon Specific Drug Delivery systems
• Small Drug particles
• Solid-Lipid particles
• Orally Disintegrating Tablets
41
42 42
Technologies practiced at Dr Reddy’s…..
Pellets/ beads
Gastro-retentive
Zein Coating
Muco-adhesive
Combination product
Liquid API in solid dosage form
Nanotechnology
Cyclodextrin Complexes
ODT
Ion exchange resins
Ultra sound particle sizing
42
Dosage Forms Commercial Manufacturing Sites
Hyderabad Vyzag
Yanam
• FTO 1 - Bollaram, Hyderabad
• FTO 2 - Bachupalli, Hyderabad
• FTO 3 - Bachupalli, Hyderabad including R/D and pilot plant
• FTO 4 - Yanam
• FTO 5 - Recently divested
• FTO 6 - Baddi (started up April 1 2006)
• FTO 7 - Vishakapatanam ~800km from
Hyderabad (Vyzag)
Baddi
43
Main site for the development and manufacturing of standard oral dosage forms and specialized dosage forms
Modular concept - All batches follow linear
flow movement and one product at a time
Total of 11 modular manufacturing suites: •9 Modules for Tablet Manufacturing ~ 4’750 mn units/year
•2 Modules for Hard Gelatin Capsules Manufacturing ~ 650 mn units/year
•3 Pilot Plants (10 suites + 2 pkg)
Integrated development services
FTO-3 Capabilities
44
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Processes and Equipments: Fully aligned from Laboratory to Pilot Scale
100 mL – 5 Ltr / hrBuchi / HemrajSpray DryerSpray Drying
200 – 2000 vialsVertisLyophilizerLyophilization
5 K/hr – 40 K/hrPAMTamp Filling MachineCapsule Filling
1 Ltr – 125 LtrGlattFluid Bed (Wurster)
Coater
500 g – 30 kg / lotGansonsSide Vented PansCoatings (Tablets
and Pellets)
150 g – 35 kgGlattDrug Layering
1 kg – 2.5 kgFuji PaudelSpheroidizer
1 kg/hr – 20 kg/hrFuji PaudelExtruderPelletization
8 – 20 StationCadmachRotary Compression
PressCompression
1 Ltr – 425 LtrAdamsDouble Cone and
OctagonalBlending
1 Ltr – 125 LtrGlattFluid Bed
100 mL – 250 LtrKevinHigh ShearGranulation
100 mL – 2 LtrNetzsch
Labstar
Bead MillSolubilization
CapacityMakeEquipmentProcess
100 mL – 5 Ltr / hrBuchi / HemrajSpray DryerSpray Drying
200 – 2000 vialsVertisLyophilizerLyophilization
5 K/hr – 40 K/hrPAMTamp Filling MachineCapsule Filling
1 Ltr – 125 LtrGlattFluid Bed (Wurster)
Coater
500 g – 30 kg / lotGansonsSide Vented PansCoatings (Tablets
and Pellets)
150 g – 35 kgGlattDrug Layering
1 kg – 2.5 kgFuji PaudelSpheroidizer
1 kg/hr – 20 kg/hrFuji PaudelExtruderPelletization
8 – 20 StationCadmachRotary Compression
PressCompression
1 Ltr – 425 LtrAdamsDouble Cone and
OctagonalBlending
1 Ltr – 125 LtrGlattFluid Bed
100 mL – 250 LtrKevinHigh ShearGranulation
100 mL – 2 LtrNetzsch
Labstar
Bead MillSolubilization
CapacityMakeEquipmentProcess
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Different batch sizes (20 kg – 1800 kg)
Granulation (low and high shear, FBP)
Aqueous-based
Solvent-based (x-proof)
Blending (60 L to 5000 L)
Compression: Sejong, Cadmach, Manesty (8 – 75
stations), bi-layer- tablets
Coating: Accela-cota equivalent (24’’ up to 66” from
15 kg – 450 kg)
Fluidized Bed Coating (125 to 500 Liters)
Aqueous coating (Functional and non-functional
coating)
Organic solvent-based coatings
Granulation, Blending and Tablet Manufacturing Capabilities
46
• Different Batch Size
• Bead Manufacturing (Pelletization or non
pareil seeds, dry powder loading).
• Fluid Bed Drying (15 kg – 300 kg)
• Blending (60 L – 5000 L)
• Coating (24’’ up to 66” from 15 kg – 450 kg)
• Encapsulation tamping and dosator - from
40 K/hour up to 120 K/hour
Capsule Manufacturing
47
Conversion of dosage forms to finished packs of
HDPE Bottles, Blisters (PVC/Alu, PVC-PVdC/Alu,
Alu-Alu, including cold form, PVC/ACLAR or
Aluminium Pouches
Total of 10 Lines
4 Bottle Lines
6 Blister-cartonators
Dosage Forms Primary Packaging
48
Automated equipment designed and constructed as
per cGMP requirements
BossPack (Aus), Swiftpack(UK), Countec (Korea)
BQS, BP-602, Cartonator (IMA)
Dosage Form Secondary Packaging Capabilities
49
Highly Potent Formulation Facility
• Will comply with USFDA and MHRA requirements
• Containment practiced through Air Handling, Pressure Zoning,
Isolators and Personal Protective Equipment
• Three modules for
• Hormonal Tablets – 40 mn units/yr
• Cyto Capsules – 15 mn units/yr
• Cyto Injectable (Liquid/Lyophilized) – 3 mn units/yr
• Being commissioned
50
Project Execution
51
Well Knit Support Structure
Process & Formulation R&D
Production
QA QC
Supply Chain Management
Regulatory Affairs
Planning Project Management
Capacity & Infrastructure
52
Confidentiality
• Global Standards practiced for Confidential Disclosure Agreements
• IP ownership and rights clearly defined at project initiation
• Complete data protection for customers. Firewalls within various Project Teams
• Non disclosure and confidentiality agreement executed by all employees
• ISO 27001:2005 certified for information security management
©
53
R&D Support for R&D Work
350 Chemists and Engineers across 3
centers
Access to Kilo-Labs for piloting
Multiple Analytical Labs for process
research support
DSC/TG, GC/LC-MS, LC-MS-MS,
powder XRD, single crystal XRD, NMR,
LC-NMR, FT-IR, CHN analyzer, ICP-MS
CHEMISTRY
Preformulation
Analytical & Bioanalytical
development
Formulation development
Pilot scale-up
LC-MS/MS, Prep-HPLC, Capillary-HPLC,
GC, FTIR, NIR, p-XRD, Photo Stability
Chamber , Dissolution Apparatus (Type
I, II, III & IV)
FORMULATION
54
Project Path – Functional Involvement
R&D
Feasibility Optimization Hazop Studies Lab Validation Piloting Trial Production Comm. Production
AR&D
PE
QC
QA
MFG
55
Communication Process
Project manager is single point of contact
Communication between functional departments of CPS & clients
Regular e-mail updates & periodic progress reports
Use of web-based communication channels like Groove
Weekly / Fortnightly teleconferences & videoconferences
Face to face meetings
Proactive communication of deviations for joint problem solving
Campaign reports
Reduces re-work leading to better control on cost, quality and time
Establishes strong customer orientation
56
Service Orientation
Niche Capabilities
Assets (Dossiers, DMFs, IP,
Manufacturing)
Life Cycle Mgmt
Portfolio Mgmt
Tech-Transfer
Niche Offerings
Uniquely Positioned to meet pharma challenges…
57
CPS uniquely poised to meet pharma challenges…
58
…By leveraging organizational strengths
59
CPS Group in Dr. Reddy’s – A Summary
• Wide experience and use of several Technology solutions
• Breadth of experience in process R&D, scale-up and commercial contract
manufacturing
• Intellectual property managed as per global standards
• Well-trained man power, quality systems and excellent infrastructure
• Well-versed with API & Formulation development, scale up, technology transfer,
Regulatory requirements and CMC Documentation needs
Our Value Proposition: Excellent speed and cost advantage without compromising quality
60
For more information or to discuss your specific interest please contact: Christian Jones European Sales and Business Development Manager Dr Reddy’s CPS ChiroTech Technology Limited, 410 Cambridge Science Park, Cambridge, UK CB4 0PE T:+44(0)1223 728 030 M:+44(0)7827 157 247 E: [email protected]
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