Overview of Dr Reddy\’s CPS Extensive Capabilities and Service Offerings

1. Welcome�
to.�.�.�
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2. More�Than�Meets�The�Eye
API�&�Intermediates�
Development
cGMP/FDA�Approved�
Manufacturing�Facilities
PEGs
Chirals
HPAI,�Steroids,
�Prostaglandins�&�Complex�
Carbohydrate�Chemistry
Formulation�Development,�Customised�Solutions
&�Manufacturing
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3. .
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CPS Objective
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The objective of CPS is to be the preferred partner for innovator companies
by providing a complete range of services that are necessary to take their
innovations to the market with more speed, efficiency and cost effective
technological solutions. Innovator companies can now make use of the
technical expertise, capital equipment and flexibility that Dr. Reddy’s CPS
offers in order to bring their products to the market faster and with lower
costs.
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Through smart and flexible Why Partner With CPS?
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partnerships, CPS can deliver a robust
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and tailored development programme
aimed to meet the specific needs of our clients.
CPS operates either as a pure service provider if required or more often
than not, as a truly added value partner, by delivering and putting into
practice consultancy based solutions for our clients.
Our company heritage of more than 25 years pharmaceutical development,
provides us with expert knowledge and understanding of how to address
our innovator partner’s needs. We provide a wide range of services and
technological solutions specifically targeted at the most cost effective and
robust development and manufacture for their API and Drug Product.
Whilst we are an independent business unit within Dr Reddy’s subscribing
to the latest information security standards (IMS ISO27001:2005) we also
have close ties with our parent organisation to capitalise on knowledge
gained in technology areas company-wide through unique “need to know”
information sharing mechanisms.
Excellence in project management systems through dedicated PETs
(Project Execution Teams) and high standards in international customer
communication will ensure meeting aggressive timelines for our partner’s
project.
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4. Foc
CPS Service Offerings
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1 e API and Intermediate
tr Development Services
e, gy C 1
0
en
bri nol d 2
Cam Tech ene
cGMP/FDA Approved
o
op
UK
Manufacturing Facilities
ote cility
dg
Formulation Development
fa
ch
2nd Largest Global
AS
New
PEGs API Producer
ARE
Novel Drug Delivery
Chir
Technologies
Y
NDING TECHNOLOG
FDA Approved
Chirals Manufacture and
Packaging
HPAI, Steroids,
Prostaglandins & Complex
Carbohydrate Chemistry
Customer Focus
EXPA
Formulation /
Tailored Release Dedicated Project
Profile Management
First Class
Quality & Delivery
Stringent IP and
Confidentiality
DNV Certified
ISM ISO 27001:2005
A dedicated account team focuses on partnership building. This
team remains the unique co-ordinator for the customer, deploying the
resource from the designated areas.
Technology managers in 4 key technology areas ensure a tailored
service is delivered to the customer.
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A Brief Introduction
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Custom Pharma Services (CPS) as a strategic business unit of Dr.
Reddy’s draws on Dr. Reddy’s expertise and capabilities in pharmaceutical
development and manufacturing to provide innovators with customized
services and solutions for starting materials, intermediates, active
ingredients and finished dosage forms.
Our CPS business serves many innovators, both Big Pharma and Emerging
Biotech, and a large number of Emerging Pharmaceutical companies.
Within a short span, we have become one of the largest pharmaceutical
outsourcing players from India and a partner-of-choice for innovators,
offering top-end technical expertise, and tailor-made pharmaceutical
solutions. We have a track record of bringing innovations to the market
quickly, efficiently and economically.
We offer both speed and flexibility. We have the capability to supply both
small-scale clinical trial quantities and commercial-scale requirements.
Our end-to-end services make a compelling value proposition to our global
innovator customers.
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Dr. Reddy’s Profile
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Dr. Reddy’s Laboratories is a global, vertically integrated pharmaceutical
company with a presence across the value chain, producing and delivering
safe, innovative, and high quality active pharmaceutical ingredients,
finished dosage forms and biological products, which are marketed to over
100 countries with an emphasis on North America, Europe, Russia, India
and other emerging markets.
One of the largest Indian
pharmaceutical companies by
revenue
Vertically-integrated
product development
capabilities spanning
APIs, Finished Dosages,
Biologics and Speciality
Pharmaceuticals
Manufacturing
infrastructure includes 8 API
(7 US FDA approved) and 7
Finished Dosage (2 USFDA
approved) facilities
Scientific staff of 1,400+ engaged in R&D across businesses
The second largest API producer globally: over 170 USDMFs
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API and Intermediate
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services
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CPS develops and manufactures APIs for our partners across the entire
lifecycle of pharmaceutical product development. Contract manufacturing
is performed from early Clinical to late stages in Commercial Manufacture
and Lifecycle management options are provided as required. As an example
of this, we have utilised our product portfolio to enable early launch of
combination therapies for our partners. In the later stages of the product
lifecycle, we also provide many added value options in order to rationalise
their API and finished dosage portfolios.
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Development Services
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We draw on our parent company’s expertise in pharmaceutical development
to provide custom development services for APIs, intermediates and RSMs
with an exceptionally wide range of in-house capabilities. We have 4
dedicated R&D facilities - 1 in Cambridge (UK), 2 in Hyderabad (India),
and 1 in Cuernavaca (Mexico), which are supported by Pilot plants – 1 in
Mirfield (UK) and 1 in Hyderabad (India). This enables us to offer a wide
range of reactor capacities.
Quality partnerships, flexible approach and detailed understanding of
our partner’s needs by working closely together
Competence in process research to develop novel, safe and cost-
effective processes
Hazard evaluation expertise that ensures safer scale-up
Significant expertise in handling a wide range of Chemistries
Technology advantages by providing customized solutions
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8. API and Intermediate
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services
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Manufacturing Services
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CPS’ API manufacturing operations are spread across six units in Andhra
Pradesh, India, a state-of-the-art facility in Mexico and a manufacturing
site based in Mirfield, UK.
These facilities have been built and are operated in accordance with the
latest regulatory guidelines to cGMP. All of our facilities have been inspected
by the USFDA and numerous other international regulatory agencies for all
major products.
Health and Safety compliance are of the highest priorities in all aspects of
CPS business, including plant installation, equipment, systems and trained
personnel. A combination of a dedicated team, world class production
facilities and techniques guarantees timely delivery of products to
customers across the globe.
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API and Intermediate
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services
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Lifecycle Management
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A strong portfolio of more than 170 products serving the most
important therapeutic areas and an active pipeline of over 20
development products at any point in time
IP assessment is an integral part of product development to facilitate
launch of line extensions (combinations, new or reformulation) on product
patent expiries
We develop non-infringing synthetic processes or novel polymorphs
Portfolio of ANDAs either filed or in the pipeline that offer ready-
to-use or easily customizable sourcing solutions for prescription to OTC
switches
In combination drug development we combine generic APIs with NCEs
in novel delivery systems
Supporting the Life cycle of your product
Innovative Drug System & Process Market Success Innovation & New IP
Formulation Development
■ Security of supply
■ Quality & GMP compliance
■ Proven technologies ■ Cost competitiveness Re-formulation development to:
■ Scaleable processes ■ Continous improvement ■ increase scope to allow
■ Speed ■ GMP manufacture additional indications
■ Enabling technologies ■ Flexible supply
■ Speed ■ Customer support ■ Improve patient compliance
■ Project management ■ At budgeted costs ■ Obtain patent extension
■ Access to DRL’s IP ■ Develop a supergeneric
■ Activity based costs
NCE Development Clinical trials Market Launch Life Cycle Management
Commercial Manufacturing Generic Defense
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10. API and Intermediate
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Portfolio Management
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125+ dosage filings in the US, 20+ in Europe and 1400+ in the rest of
the world
Products on the market in Dr. Reddy’s key geographies such as US,
Germany, Romania, Bulgaria, India, Russia, Ukraine/CIS, Venezuela
Formulation development team that has significant expertise in
customizing existing products to meet innovator requirements.
Big Pharma looking to rationalize portfolio of finished dosages and
hence outsource manufacture of mature products, has access to a
substantial ready-for-market offerings
Unique non-infringing APIs available for utilisation by our innovator
partner to add value to his portfolio
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PEGylation
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CPS is one of the leading manufacturers and
suppliers of Activated mPEGs for the conjugation
of proteins, antibody fragments and peptides; to
improve the stability and the pharmaco-kinetic
properties of biologic drugs. With outstanding
GMP capabilities and back integration to high
purity mPEG-OH, we can guarantee the quality
and security of supply of our Activated mPEG
products. Our product range, branded under the
PEGtech name, has the following characteristics:
Varied activating groups including: Maleimide,
pNP-carbonate, Propionaldehyde, Amine, NHS ester, iodoacetamide, thiol
etc.
Full range of molecular weights: from 5 to 40 kDa
Narrow polydispersity
Excellent levels of activation
Low diol content
Non-GMP and GMP manufacture from Lab to Commercial scale
Custom activation and branched PEGs
Our customers range from Biotechs to large Pharma organizations, in
the development of biologic drugs. Routinely CPS can provide small scale
samples prepared at our R&D facilities in Cambridge, UK with clinical and
commercial scale manufacture at our GMP production site in Mirfield, UK.
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PEGylation
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Back integration to the key raw material ensures that we are able to control
the quality of the final activated mPEG, throughout the manufacturing
process. Our process to make this high quality pharmaceutical grade
mPEG-OH is patent protected: US 7199193 B2.
The level of control we offer brings an assurance of supply and reliability
that is valued by our customers. We have clients at all stages of the clinical
trials process, including several in late stage phase III trials. Our Activated
mPEGs are also in a launched drug, Dr Reddy’s Peg-grafeel™. Approved
use in a launched drug has been achieved by few other Activated mPEG
suppliers.
Analysis of large polymeric materials such as PEGs can be challenging, but
it is crucial that a high level of accuracy is achieved, to ensure high quality.
For example, the diol impurity must be minimised to prevent the formation
of di-functionally activated molecules, capable of cross reactivity.
We have developed proprietary and unique mPEG analytical methods which
separate diol and the di-functionalised impurities derived from diol, on the
basis of functionality alone.
This technique, “LC under critical conditions” is effective because all weights
are coalesced. Thus the interference associated with different molecular
weights is eliminated. Our analytical methods, which we have patented (US
7824919 B2) ensure that we measure all the di-functionalised content in
our activated mPEGs.
TM
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Chirals
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Dr. Reddy’s Centre of Excellence for chiral
technologies moved into its new Chirotech
Technology Centre in Cambridge, UK in 2011. With
over 20 years of experience utilizing proprietary
and non-proprietary chiral technologies to produce
single enantiomer compounds, this world-class
centre is equipped with the infrastructure and
staff necessary to quickly develop a chiral solution
that meets our partner’s needs.
Chiral Technologies include:
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Asymmetric chemocatalysis
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As a recognized world leader in asymmetric chemocatalysis, our work
is enabled both through technical expertise and access to a diverse
collection of proprietary, third party, and IP-free ligands and catalysts. We
offer experience in all areas of asymmetric chemocatalysis from catalyst
screening to implementation of a process in production reactors.
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Biocatalysis
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As a pillar of our chiral technology offering, our biocatalysis group utilizes
proprietary and non-proprietary enzymes in our partner’s projects. Our
ability to discover an enabling enzyme for a transformation and to produce
the enzyme in-house with an in-licensed proprietary expression system
allows the development of a customized solution to produce the desired
chiral product.
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Chirals
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Diastereomeric Resolution
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This classic approach to producing chiral
compounds provides a 3rd option for our
partners and completes our formidable
chiral technology offering.
Rather than force-fitting a single
technology to our partner’s project, we
strive to offer a chiral solution by utilizing
the most appropriate tool in our many-
faceted chiral toolbox. Furthermore,
we are experts in the marriage of an
enabling chiral step to traditional chemical
development - thus fostering the
establishment of the best overall scale-up route.
We welcome the opportunity to discuss our flexible and collaborative
approach to R&D programs that facilitate the commercial-scale supply of
RSMs, Intermediates and APIs. Take advantage of our broad expertise and
capabilities to develop a secure and cost-effective supply chain.
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HPAI, Steroids, Prostaglandins
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& Complex Carbohydrates
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At CPS we have an exceptional breadth of
capabilities for development and manufacture of
nearly all classes of highly potent compounds.
This breadth of capabilities covers classes of
compounds, scale of operation, unit operations
and geography of facilities.
Within the class of cytotoxic products we have
multiple high potency suites at our facilities in India. These include kilolab
and various scales of commercial manufacturing with vessels up to 2500
liters. Containment is per most modern technologies meeting limits of 0.2
µg/m3 over an 8 hr exposure.
We have six modules of varying size, each located within FDA approved
manufacturing facilities and supplying products to all major markets
worldwide.
We also have the required laboratory experience and facility to develop
processes for developmental APIs. Our FTO-7 site at Vizag in India is a
state-of-the-art high potents USFDA approved manufacturing facility.
Steroid development and manufacturing capabilities are located in our
facility in Cuernavaca, Mexico. This site has a long history of developing
and manufacturing steroids and currently manufactures a number of APIs
and Intermediates.
Facilities include a large volume steroid bay with cryogenic capability and
a smaller volume steroid bay with 3 trains of different sizes, which was
completely modernized in 2005. The plant is FDA inspected and has supplied
products to regulated markets for decades. The process development group
here has the benefit of this long experience in this specialized chemistry.
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16. HPAI, Steroids, Prostaglandins
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& Complex Carbohydrates
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Our development capability in prostaglandins is located at our Chirotech
Technology Centre in Cambridge, UK whilst our manufacturing facility
is located in Mirfield, UK. We have a long history of developing and
manufacturing prostaglandins and considerable expertise in this
challenging chemistry.
CPS has extensive experience in process development and scale up of
carbohydrate building blocks and polysaccharides. The expertise includes
synthesis of azasugars, oligo building blocks and differentially protected
carbohydrates. CPS has experience in synthesis of a complex API involving
over 55 chemical steps that uses thioglycosides, trichloroimidates and
glycosides. The five monosaccharide building blocks involve extensive
protection/deprotection and thioglycosylation chemistry. The glycosylation
chemistry to form di-, tri- and penta saccharides was performed at 25-
50kg scale using a variety of activating triflates. The purification of the API
was accomplished using unconventional ion exchange and gel filtration
chromatographies. These techniques were studied and detailed at
laboratory scale and then successfully reproduced in pilot and commercial
scale. CPS also has in depth experience in analytical method development
and characterization of complex carbohydrates and polysaccharides. A
variety of analytical detectors UV, RI, ELSD and MS as well as capillary
electrophoresis capabilities are available within CPS.
In each of the four product families
mentioned we have the resources
and interest in working with our
customers on development projects
for new APIs, transfer of processes
for mature APIs, or development of
new processes for older APIs.
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Formulation Services
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CPS offers a full range of dosage development capabilities from
preformulation, formulation development, cGMP clinical batch
manufacturing, scale up, registration batch manufacturing to commercial
manufacturing. These activities are conducted in our FDA / MHRA / EU
approved facilities and are supported by state-of-the-art analytical
capabilities for development and method validation. In addition, CPS has
dedicated labs and manufacturing facilities for highly potent and cytotoxic
compounds which can accommodate an OEL of 0.2µg/m3 over 8hrs
exposure.
Additional services such as the following are also offered:
Full API Solid State Characterization
CMC Documentation
Stability Studies
Process Validations
Trouble Shooting
Packaging Development
In-house Quality Control
Qualified Person (QP) Services
Application of QbD techniques such as DoE for formulation and process
optimization
Registration in eCDT format
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Formulation Services
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The Formulation TechOps 3 (FTO-3) site is Dr. Reddy’s Flagship site for
oral solids manufacturing and is FDA and MHRA, ISO 9001, ISO 14001
approved and is the first plant in India to be OHSAS 18001 approved.
The development labs and pilot plant are designed to be directly scalable
to commercial facilities as they have similar equipment to our commercial
manufacturing units. The latest FDA inspection was successfully concluded
in Nov 2009.
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Formulation Services
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Enabling Technologies
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CPS has a wide range of novel technology expertise and capability that
can add significant value to our partner’s development and manufacturing
projects.
These technologies provide a wide range of benefits from enabling a unique
IP position to increasing speed of manufacture whilst delivering quality,
safety and cost improvements.
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Specialty Formulations
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With a substantial track record
spanning the entire lifecycle from pre-
clinical development to commercial
product launch and beyond to
Lifecycle management, CPS are the
partner of choice from Biotechs to
Major Pharma clients for specialty
formulation needs.
Further to conventional oral solids,
including bi and trilayer tablets, we have developed key expertise in the
area of modified release tablets and capsules (Delayed, Sustained and
Tailored release) and Topical formulations using a wide range of different
technologies including our own microspheres, Dermastick™ and EVAP™
(Evaporation technologies).
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Formulation Services
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Use of advanced technologies and CPS IP offers our partner solutions
for enhancement of bioavailability and improved drug loading, targeting
the site of absorption with pH dependent release coatings, drug layering
for combination products with incompatibility barriers, and Ion Exchange
Resins for taste masking.
For poorly soluble compounds, we enhance bioavailability by using our
expertise in Nanotechnology, Cyclodextrin complexing, liquid fill capsule
technology and amorphous co-precipitates or premixes. We also offer
novel drug delivery approaches for life cycle management (LCM) to enhance
therapeutic outcome and improve patient compliance.
All dosage plants are equipped with packaging capabilities (blisters, bottles,
pouches and vials in cartons), to offer innovative packaging solutions for
your products. Senior friendly or child resistant options are available as
well as ePedigree and tamper evident solutions and blisters with Braille
script.
Also, Dr. Reddy’s is
implementing innovative
anti-counterfeiting
packaging solutions,
containing Holographic
base foils, including bar
coding, variable data
coding on blisters, strips
and cartons.
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Dedicated Project
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Management
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A team of dedicated and experienced project managers ensures smooth
progress from initiation to completion of our partners’ projects, with a
focus on minimizing development timelines and maximizing on quality.
World-class software, hardware and communication channels support
each functional team so that projects move along efficiently to completion,
meeting our partner’s expectations.
Our experienced chemists and engineers have significant knowledge in
cGMP manufacturing and regulatory requirements for chemical synthesis
and formulation of NCEs from pre-clinical stages to commercialization.
They operate as the dedicated project team at CPS, collaborating as an
effective extension of our partner’s own internal project management.
The advantages of Partner interface through single point of contact.
Strong and consistent
customer orientation
Regulatory
throughout the lifetime of the Affairs
project by the appointment of a
dedicated project manager
QA
Supply Chain
Coordinated end-to-end Management
Planning QC
project ownership by every Project Management
Capacity & Infrastructure
member of the assigned PET
(Project Execution Team)
Process &
Production Formulation R&D
Reduced re-work resulting
in better efficiency throughout
the project
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22. Strict IP and
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Confidentiality Security
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Prior to initiation of a project a CDA is signed which enables a
thorough discussion and IP evaluation to be conducted
An in-depth survey is then completed, which identifies the partner’s
needs and scope for the project before a proposal is submitted
On agreement of the proposal the project is implemented in an
environment of complete confidence and trust between both parties
We guarantee full data protection for our partners by enforcing
stringent firewalls within the various Project Teams
Non disclosure and confidentiality agreements are executed by all
employees
We are DNV ISO 27001:2005 certified for Information Security
Management
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23. Contacts
Europe India
Dr.Reddy's�Laboratories�(SA)�Ltd Dr.�Reddy's�Laboratories�Ltd.
Hauptstrasse�62, CPS,�Bollaram�Road,�Miyapur,
Binningen,�CH-4102, Hyderabad-�500049,�Andhra
Switzerland Pradesh,�India,
Tel:�+41�61�271�4754 Tel:�+91�40�4465�8888
Fax:�+41�61�271�4755 Fax:�+91�40�4465�8654
andyevans@drreddys.com mkale@drreddys.com
Chirotech�Technology�Ltd Japan
Unit�410,�Cambridge�Science�Park, Dr.�Reddy's�Laboratories�Ltd
Milton�Road,�Cambridge�CB4�0PE,�UK AIG�Kabutocho�Building�3rd�floor
Tel:�+44�1223�728010 5-1�Nihonbashi�Kabutocho
Fax:�+44�1223�506701 Chuo-ku�Tokyo�113-0026
chirotechenquiries@drreddys.com Tel:�+81-3-5847�7928
Mob:�+81-90-2638�5051
USA Fax:�+81-3-5847�7906
Business�Development�(North�America) durgeshs@drreddys.com
Custom�Pharmaceutical�Services
Dr.�Reddy's�Laboratories�Inc.
200,�Somerset�Corporate�Blvd,
Bridgewater,�NJ�08807
Tel:�+1�908�203�4925
Fax:�+1�908�203�4914
gaurabs@drreddys.com
www.drreddys-cps.com