Dr Reddy's Laboratories (DRL), the third largest pharmaceutical company in India after Ranbaxy Laboratories and Cipla, is set to achieve 20 per cent revenue for new product launches over next three year.

The company's pipeline today comprises 65 DMFs and 45 ANDAs pending approval with the US FDA. The ANDA pipeline addresses an innovator sales opportunity of US $ 25 billion. Of these, 45 are Para IVs and 12 are potential first-to-file opportunities. DRL has filed 306 international dossiers in branded finished dosage segment and has also submitted product license applications for six products to UK MHRA.

Dr Reddy's investment in research and development has translated into significant discovery capabilities. The company has also started building capabilities in clinical development both in India and abroad. It is currently managing the clinical development of two of its own NCEs outside India and one within the country. Its molecules DRF 2593, DRF 10945, RUS 3108, DRF 1042, DRF 11605, DRF 13792 are in various stages of development.

DRL has completed Phase II of development of DRF 2593 (Balaglitazone), a PPAR gamma agonist. It has confirmed activity in patients for Type II diabetes. As of now, two-year carcinogenicity studies are in progress.

The Phase I of development of DRF 10945 (a non-fibrate PPAR alpha agonist) has been completed. This drug candidate for the treatment of dyslipidemia has completed its Phase I trials in Canada and the company is preparing to progress the compound into Phase II trials. RUS 3108 (perlecan inducer), a drug candidate for the treatment of atherosclerosis is undergoing Phase I trials in Europe.

Whereas DRF 1042 (oral topoisomerase inhibitor), a drug candidate for the treatment of specific cancer tumours is also being developed. Phase II trials are progressing in India with respect to diastereomeric mixture and Phase I trials are in progress in India for the single isomer.

GLP toxicity studies are in progress in the case of DRF 11605 (pan PPAR alpha agonist), a candidate for the treatment of obesity and Type II diabetes and DRF 13792 (oxazolidinone analogue)-a drug candidate for the treatment of metacillin resistance, vancomycin resistance and gram positive bacteria.

DRL has stepped up product filings in several international markets over the last three years and supplementing its internal pipeline with in-licensing efforts, targeting to generate 20 per cent of revenues from new product launches over the next three years.