The source is out

As outsourcing evolves once again to accommodate the shift in industry perspective, Dr. Reddys continues to place itself on its leading edge.

What is your outlook for the global pharma outsourcing industry and how is CPS - the pharma outsourcing business unit of Dr Reddy's, positioned?

There is an imminent need to enhancing innovation and R&D productivity. In addition, there is the diminishing Blockbuster product model and ever more complicated lifecycle management programmes - these are just some of the new and ever-changing issues that form the broader challenge faced by innovative pharmaceutical companies in today's environment. This is amplified by increasing cost pressures from healthcare payers whether they are governments or institutional healthcare providers. In view of these changes, pharma outsourcing is no longer an option but has become a strategic imperative for global pharma companies.

Our Custom Pharmaceutical Services (CPS) business offers speed, flexibility and cost efficiency. We have the capability to develop and supply both small-scale clinical quantities  as well as commercial-scale requirements. Our end-to-end services from clinical stage intermediates/APIs to formulation development and manufacturing services including some niche technology offerings, competitive pricing and global presence makes a compelling value proposition to our global 'innovator' customers. CPS is thus uniquely positioned to become the preferred partner for innovators.

Can you give us an overview of CPS and its operations?

CPS has emerged as one of the largest pharma outsourcing businesses from India. Our dedicated R&D facilities - one in Cambridge, UK and three in Hyderabad, India; one in Cuarnevaca, Mexico is supported by pilot plants in UK and India. For high volume manufacturing, we have plants in the UK, Mexico and India. We have sales and marketing offices in Europe (UK, France and Switzerland), North America (USA), and Asia Pacific (India and Japan). This network provides an ideal platform to serve global pharma outsourcing demand.

We are a select few pharma outsourcing companies that can offer end-to-end capabilities. On the API side, services offered by CPS include process development, scale-up and commercial manufacture including highly potent APIs. On the formulation side, there is formulation development, clinical trial manufacturing and commercial scale manufacturing of finished dosages including oral solids and fill-finish for highly potent compounds. In addition we provide CMC support for IND, NDA and DMF filings. Compliance with global quality standards of cGMP, USFDA and European regulatory authorities reiterates our emphasis on quality as a key Dr. Reddy's value.

Does the acquisition of Chirotech bring something new to the table for your customers?

Chirotech has more than 20 years of experience in Chemo catalysis as well as Biocatalysis and has a vast library of enzymes. This gives us an edge to provide cost effective solutions for chiral intermediates and commercialise a number of projects. We have an extremely efficient enzyme production system based on pseudomonas expression technology.

 We have expertise in asymmetric hydrogenation with a portfolio of proprietary catalysts and experience in producing commercial quantities of pharmaceutical intermediates. The catalysts can selectively reduce a broad range of substrates very selectively and are complementary to biocatalysis.

Another interesting addition to our toolbox is hydroformylation in both achiral and asymmetric variance. This technology has proven to be readily scalable in a cost efficient way giving access to some unique intermediates. Other catalytic technology used by the team includes the asymmetric alkylation technology developed by Prof Trost for which we have an exclusive license. Since the last six years, Chirotech has offered activated mPEG material for the conjugation of proteins, antibody fragments and peptides to enhance stability and pharmaco-kinetic properties of biologic drugs. We can readily tailor this product to meet our customer's requirements.

All of these technologies have enabled us to differentiate our offerings to innovator companies and provide technology enabled manufacturing services.

Are there another technology service offerings you would like to talk about?

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. Dr Reddy's has developed a large number of high potency APIs that are available for sale to pharma companies. We have the right skills and infrastructure to manufacture these APIs.

We offer a full range of reactor capacities. We have a strong quality and safety culture. For example, we practice containment through air handling, pressure zoning, and isolation. There are a large number of oncology products in various stages of development and we are very well positioned to offer development services to innovators.

In addition, we have a strong value proposition in Steroid, female hormonal products, Prostaglandin chemistry, and carbohydrate chemistry apart from chiral capabilities. We also offer a differentiated product services offering integrating our APIs to finished dosage forms.

About

Dr. R Ananthanarayanan has over 20 years of experience in the pharmaceutical industry with specialisation in research & development, manufacturing operations, regulatory affairs, quality assurance, business development, global strategic sourcing, mergers & acquisitions.

Ananthanarayanan was a key leadership member on the Executive Management Committee at Piramal Healthcare Ltd and was the President & Head of Pharma Solutions business. He worked with Piramal Healthcare for over seven years and was involved since the inception of Pharma Solutions business. Prior to joining Piramal Healthcare, Ananthanarayanan was Managing Director - Asia & Head of Global Sourcing for Galpharm International Ltd, a UK based manufacturer/distributor of specialty pharmaceuticals and baby products. He led strategic outsourcing of product development, launch product manufacturing, and management of late lifecycle products.

Ananthanarayanan has also been involved in various other positions of increasing responsibility in both Indian and multinational Pharmaceutical companies like Zydus Cadila, Wockhardt and Rhone-Poulenc Rorer.

Ananthanarayanan has a PhD in Pharmaceutical Technology from University of Mumbai, India.