Dr Reddy's CPS - More Than Meets The Eye

Welcome�to.�.�.�

MORE�THAN�MEETS�THE�EYE

More�Than�Meets�The�Eye

HPAI,�Steroids,�Prostaglandins�&�Complex�Carbohydrate�Chemistry

API�&�Intermediates�Development

cGMP/FDA�Approved�Manufacturing�Facilities

Chirals

PEGs

Formulation�Development,�Customised�Solutions&�Manufacturing

MORE�THAN�MEETS�THE�EYE

CPS Objective

MORE THAN MEETS THE EYE

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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.

Through smart and flexiblepartnerships, CPS can deliver a robust 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.

Why Partner With CPS?

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Customer Focus

API and Intermediate Development Services

cGMP/FDA Approved Manufacturing Facilities

2nd Largest Global API Producer

Formulation Development

Novel Drug Delivery Technologies

FDA Approved Manufacture and

Packaging

Dedicated Project Management

Stringent IP and Confidentiality

DNV Certified ISM ISO 27001:2005

First Class Quality & Delivery

Formulation /Tailored Release

Profile

EXP

ANDING TE

CHNOL

OGY AR

EAS

HPAI, Steroids, Prostaglandins & Complex Carbohydrate Chemistry

PEGs

Chirals

New

facility opened 2

01

1

Chirotech Technolo

gy Centr

e

Cam

bridg

e, UK


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CPS Service Offerings

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.

A Brief Introduction

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 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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Dr. Reddy’s Profile


API and Intermediate 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.

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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Development Services


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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Manufacturing Services



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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

NCE Development Market LaunchCommercial Manufacturing

■ Speed■ Enabling technologies■ Project management■ Access to DRL’s IP■ Activity based costs

■ Security of supply■ Quality & GMP compliance■ Cost competitiveness■ Continous improvement■ Flexible supply■ Customer support

■ Proven technologies■ Scaleable processes■ GMP manufacture■ Speed■ At budgeted costs

Clinical trials

Innovative DrugFormulation

System & ProcessDevelopment

Market Success

Re-formulation development to:■ increase scope to allow

additional indications■ Improve patient compliance■ Obtain patent extension■ Develop a supergeneric

Life Cycle ManagementGeneric Defense

Innovation & New IP

Supporting the Life cycle of your product

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Lifecycle Management


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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Portfolio Management

PEGylation

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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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.


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PEGylation

TM

Chirals

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:

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.

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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Asymmetric chemocatalysisFocus on. . .

Biocatalysis

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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Chirals

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Diastereomeric Resolution

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.


HPAI, Steroids, Prostaglandins & 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 ofcarbohydrate building blocks and polysaccharides. The expertise includessynthesis of azasugars, oligo building blocks and differentially protectedcarbohydrates. CPS has experience in synthesis of a complex API involvingover 55 chemical steps that uses thioglycosides, trichloroimidates andglycosides. The five monosaccharide building blocks involve extensiveprotection/deprotection and thioglycosylation chemistry. The glycosylationchemistry to form di-, tri- and penta saccharides was performed at 25-50kg scale using a variety of activating triflates. The purification of the APIwas accomplished using unconventional ion exchange and gel filtrationchromatographies. 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 capillaryelectrophoresis 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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HPAI, Steroids, Prostaglandins & Complex Carbohydrates


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

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.


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.

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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Enabling Technologies

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Specialty Formulations


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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.


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 throughout the lifetime of the project by the appointment of a dedicated project manager

Coordinated end-to-end project ownership by every member of the assigned PET (Project Execution Team) Reduced re-work resulting in better efficiency throughout the project

Dedicated Project Management

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PlanningProject Management

Capacity & Infrastructure

Regulatory Affairs

QA

QC

Process & Formulation R&DProduction

Supply ChainManagement


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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Strict IP and Confidentiality Security

ContactsEuropeDr.Reddy's�Laboratories�(SA)�LtdHauptstrasse�62,Binningen,�CH-4102,SwitzerlandTel:�+41�61�271�4754Fax:�+41�61�271�[email protected]

Chirotech�Technology�LtdUnit�410,�Cambridge�Science�Park,Milton�Road,�Cambridge�CB4�0PE,�UKTel:�+44�1223�728010Fax:�+44�1223�[email protected]

USABusiness�Development�(North�America)Custom�Pharmaceutical�ServicesDr.�Reddy's�Laboratories�Inc.200,�Somerset�Corporate�Blvd,Bridgewater,�NJ�08807Tel:�+1�908�203�4925Fax:�+1�908�203�[email protected]

IndiaDr.�Reddy's�Laboratories�Ltd.CPS,�Bollaram�Road,�Miyapur,Hyderabad-�500049,�AndhraPradesh,�India,Tel:�+91�40�4465�8888Fax:�+91�40�4465�[email protected]

JapanDr.�Reddy's�Laboratories�LtdAIG�Kabutocho�Building�3rd�floor5-1�Nihonbashi�KabutochoChuo-ku�Tokyo�113-0026Tel:�+81-3-5847�7928Mob:�+81-90-2638�5051Fax:�+81-3-5847�[email protected]

www.drreddys-cps.com

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Dr Reddy's CPS - More Than Meets The Eye