Dr. Reddy's Laboratories

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 finished dosage forms, active pharmaceutical ingredients and biological products, which are marketed to over 100 countries with an emphasis on North America, Europe, Russia, India and other emerging markets. Through its Custom Pharmaceutical Services business unit, the company provides APIs, RSMs, Intermediates, a range of dosage forms and related development and R&D services to pharma innovators.

• Headquartered in India
• One of the Largest Indian pharmaceutical company by revenue[1]
• Diversified and vertically-integrated product development capabilities spanning APIs, Finished Dosages, Biologics and Specialty Pharmaceuticals
• Manufacturing infrastructure of 13 facilities (10 USFDA inspected)
• Scientific staff of 1,400+ engaged in R&D across businesses
• Among the largest API players globally with a portfolio of over 100 USDMFs
• Amongst the Best Employers in India 2007[2]

Custom Pharmaceutical Services

A strategic business of Dr. Reddy's, draws on the company's expertise in pharmaceutical development and manufacturing to provide custom manufacturing & development services for both intermediate, bulk and formulation needs with an exceptionally wide range of capabilities.

CPS' competitive advantage lies in its unique and novel business model which combines an innovator service expertise with our generic experience to offer a compelling value proposition tailor to the challenging times facing the pharma industry.

Dosage Form Contract Manufacturing OSD capabilities

The Formulations 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.

Total capacity is well over 10 billion units and has integrated R&D labs and GMP pilot plant facilities with 4 independent production suites for scale up and GMP manufacturing of batches for clinical trials and has capabilities to handle a full range of oral solid product technologies up to 900L scale. The development labs and pilot plant are designed to be directly scalable to commercial facilities as they have similar equipment as our commercial manufacturing units. The latest FDA inspection was successfully concluded in May 2007.

Dr. Reddy's Shreveport facility in Louisiana, USA has a long history in contract development- and manufacturing services and is specializing in OSD products for prescription as well as OTC markets. In addition, this site also offers pilot to commercial manufacturing of non-sterile liquids, cream and ointments.

All dosage plants are equipped with packaging capabilities (blisters, bottles, pouches, tubes, jars, and vials in cartons), to offer innovative packaging solutions for your products.  Senior friendly, child resistant options are available as well as ePedigree and tamper evident solutions and blister 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 blister, strip and cartons.

Dosage Development, Life Cycle Management and Drug Delivery

CPS offers a full range of dosage development capabilities from pre-formulation, formulation development, cGMP clinical batch manufacturing, scale up, registration batch manufacturing to commercial manufacturing. These activities are conducted in our FDA / MHRA approved facilities, and are supported by state-of-the art analytical capabilities for development and method validation. In addition, Dr. Reddy's has dedicated labs and manufacturing facilities for high potency and Cytotoxic compounds.

Additional services such as full Solid State Characterization, Stability studies, DOE, PAT and IVIVC and registration in eCDT format are also offered.

Further to conventional oral solids, including bi and trilayer tablets, we have developed key expertise in the area of modified release tablets or capsules (Delayed, Sustained, Immediate and Pulse release), and Topical formulations for liquids, foams, creams or ointments using our microsphere, Dermastick^TM and ES-Gel/EVAP^TM (extra strength Gel / Evaporation technologies.

Use of advanced technologies and Dr. Reddy's IP offers 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-precipitate or premix. 

We also offer novel drug delivery approaches for life cycle management (LCM) to enhance therapeutic outcome and improve patient compliance.

Excellence in project management will ensure meeting aggressive timelines for early market launch.

High containment and Cytotoxic Capabilities

CPS is one of the few service providers to offer a complete solution for high containment and Cytotoxic compounds, from API development and manufacturing to development and commercial manufacturing of the finished product.

For API development and commercial manufacturing of highly potent and Cytotoxic compounds, Dr. Reddy's has 2 facilities, one in Hyderabad and one in Vizag, India to handle products up to category V, with Occupational Exposure Limits (OEL) of 0.2µg/m3 for 8 hrs. Capacity for Cyto and High Potency oral solids is 80 mio. units  and 6mio for sterile vials (both SVP and Lyophilized powder in vials (OEL of 0.1ug/m3 (class 5) which can be readily expanded. Production capacity ranges from 25 kg up to 2500 kg API per year in each of the suites.

For subsequent Dosage Development, dedicated laboratories are available at FTO-2. In combination with Dr. Reddy's Cytotoxic API manufacturing capabilities, we offer a unique and integrated development and manufacturing solution for cytotoxic oral solids and parenterals (liquid and lyo).

A recent addition to our dosage capability is a high precision Xcelodose capsule filling machine, contained in an isolator. Very small quantities of cytotoxic powder (as low as 100Ìg and greater than 100mg) can be filled with extreme precision into capsules suitable for cGMP clinical supplies. This technology can improve product quality and significantly reduces cost and time in the pharmaceutical development process. In addition, the quantity of API required is minimal.  Another building on the same campus offers high potentcy (non-cytotoxic) oral solid  products (OEL of 0.1ug/m3 (class 5) with a capacity of ca. 40 mio. units.

CPS-Chirotech: Chiral Technologies and Services

CPS has assembled an industry-leading portfolio of technologies with specific strengths in chiral chemistry. Our main focus is also on catalysis as this provides long-term advantages and sustainability for chemical processing. Technologies include: asymmetric hydrogenation, hydro-formylation and biocatalysis - working together with customers we have proven ability to select and combine technologies to deliver optimal solutions to even the most challenging of projects.

Our expertise in biocatalysis spans more than 20 years and offers all aspects of biocatalysis development: rapid screening for enzymes; molecular biology to clone enzymes; process development of enzyme manufacture; biotransformation optimization.

We are a recognized world leader in chemocatalysis, with most extensive capabilities in asymmetric hydrogenation enabled through a diverse collection of proprietary ligands and catalysts. In addition, we have an exclusive license to the Trost asymmetric allylic alkylation technology. Furthermore we have recently broadened our expertise to the highly versatile area of hydroformylation.

In addition to our core platforms, we have expertise in crystallization-based resolutions and use of chiral pool starting material, coupled with long history of complex multi-step synthesis, particularly in the area of high potency molecules, such as prostaglandins.

We offer a flexible approach to access these powerful technologies, through collaborative research and development programs, commercial-scale supply of RSM's, intermediates and API's at the scale that you require. Take advantage of our broad expertise and capabilities to develop a secure and cost-effective supply chain.

CPS-Chirotech: Activated mPEGs

Over the last 5 years, CPS has manufactured and supplied 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 and characteristics include:

• Varied activating groups: Maleimide; pNP-carbonate;
• Propionaldehyde; Amine
• Full range of molecular weights: from 5 to 60 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 flexible and progressive business model has engaged customers broadly across the industry, from Biotechs to large Pharma organizations, in the development of biologic drugs. Routinely CPS-Chirotech can provide small scale samples from stock prepared at our R&D facilities in Cambridge, UK, with clinical and commercial scale manufacture at our GMP production site in Mirfield, UK.

As one of the leaders in the provision of Activated mPEGs to the pharmaceutical industry, CPS-Chirotech is quickly becoming a preferred supplier of these complex and enabling materials. With a comprehensive product range and tailored services, we are the ideal partner for the development and commercial success of your biologic pharmaceuticals.

Contract Manufacture of API and Intermediates at CPS-Cuernavaca, Mexico

This large facility, US FDA and EU approved, has a variety of special capabilities and characteristics that make it an excellent choice for manufacture of various APIs and intermediates.

It consists of 7 large production bays, dedicated to various kinds of products and operations. Of these bays, 3 are dedicated to naproxen, 2 are used for steroids, and the other 2 bays are used for various intermediates and APIs. Process development resources are available as well for introduction of new products.

Naproxen
This plant has the world's largest capacity of both naproxen and naproxen sodium of nearly 2000 mt/yr. Highly automated and has an extraordinary record of consistent and high product quality, making it an excellent source, particularly when consistent formulation performance is important.

Cryogenic Manufacturing
One of the unique capabilities of the facility is the large volume cryogenic reactors that are capable of running reactions at -110 deg C. Vessels include 3200 and 9600 liter sizes, in Stainless Steel and Hastelloy. 

General API and Intermediates
In addition to the specialized capabilities described above, a number of other APIs and intermediates are made in the plant. Additional capacity is available for either tech transfer of existing products, or development of new products.

Steroid Process Development and Manufacture at Dr Reddy's Laboratories CPS

One of the many specialized capabilities at CPS is process development and manufacture of steroids. This expertise is associated with our large API facility located in Cuernavaca Mexico. This location has a long history in steroids dating through its years as a Syntex, and later Roche manufacturing facility. CPS acquired this facility late 2005, and has placed a renewed focus on new product development for steroids. The plant has a large number of DMFs, and has been FDA inspected as recently as 2006, with no observations.

The plant operates two dedicated production bays to steroids. One of these bays is used for larger volume steroids, and includes cryogenic capabilities. The other bay is used for small and medium volume manufacture. This plant is one of the finest high containment steroid facilities in the world. The bay consists of 3 completely separated trains at 3 different scales.

In addition to the physical assets, the plant has an experienced R & D staff with special expertise in steroids. This group takes responsibilities for the necessary development and tech transfer for new products into the plant.

Currently our plant produces 12 different commercial steroid APIs for various customers, and a larger number of intermediates. Products include androgens, estrogens, anti-inflammatories, and others. We have capacity available for new products. Options for new products range from new process development to tech transfer of existing products. We can also prepare and submit DMFs as required for new products. If you have further interest, please review the enclosed powerpoint file on steroids and contact our CPS representative.