Biopharmaceuticals are poised to grow in double digits worldwide. What are the companys new initiatives on this front
Biopharmaceuticals constitute about 70% of revenues of RLS. We currently operate the largest mammalian cell culture biopharmaceutical facility in Navi Mumbai. This facility is also equipped with microbial production suite and fill-finish capabilities, and has been approved by European Medicines Agency (EMEA) and by ANVISA (Brazilian Regulatory Authority). RLS is coming up with a second biopharmaceutical manufacturing facility for only mammalian cell culture.
Branded biologics worth $55billion are estimated to face patent expiry between 2011 and 2015. What is your strategy for the launch of biosimilars in India and also abroad
We plan to launch our products in the Indian market, then enter semi-regulated market and later target developed markets. The approvals received for the manufacturing facilities from ANVISA and other European authorities would open up the markets for the products in Brazil, Latin America and other countries. A key challenge in enhancing the geographical footprint is in developing numerous product registration dossiers according to the regulatory requirements of each country and understanding its marketing nuances. RLS has launched five biosimilars in the market.
What is the progress on the pharmaceuticals front, where you had trimmed your earlier plans for a full-fledged entry
The focus of RLS is on the speciality range of pharmaceutical products in the categories of oncology products, steroids, hormones and peptides. RLS has a manufacturing facility for pharmaceutical API (active pharma ingredient). It has commenced a new facility for oral solid dosages in oncology and is in the process of coming up with a facility for injectable oncology. We have launched four formulations temozolomide, capecitabine, pemetrexed and imatinib in India. We plan to export these formulations to semi-regulated markets as well as enter regulated markets at an appropriate time.
What is the percentage of contribution from exports What are the future growth opportunities
Last year, the proportion of exports was to the tune of around 50% and this is now increasing. Contract manufacturing, in both pharmaceuticals and biopharmaceuticals, is another growth avenue. The product pipeline of the company continues to grow with several products entering the clinical development phase.