The oncology active pharmaceutical ingredients major, Shilpa Medicare, is investing Rs 50 crore to set up a oncology formulation manufacturing facility at Raichur in north Karnataka.
The company has acquired 21 acres in the proximity of the existing facilities. It has already invested Rs 100 crore for establishing a new oncology API manufacturing facility and research and development centre at Raichur in Karnataka. The new manufacturing facility is expected to be commissioned by mid 2008. The company has sourced its funds from both internal accruals and from banks.
"We have a total of 13 API in oncology drugs and therefore we will do well in formulations. Not only that we are one of the few dedicated oncology drug manufacturers in the country along with Intas, Venus Remedies and Biocon. But these companies are addressing other therapy areas too. There is a constant demand for oncology APIs from leading formulation producers. We have the largest facility in API and therefore formulation is only an extension of this expertise", Vishnukanth Bhutada , managing director, told Pharmabiz.
The new API facility is a dedicated oncology unit also for Contract Research and Manufacturing Services (CRAMS) facility. It is also designed for international regulatory compliance and is customized for emerging market volume and price requirement. The production plant will conform to US FDA, UK MHRA and Australia TGA Standards.
The company will have a strong oncology presence offering highest global quality products at lean cost structure. There will be backward integration into key intermediates. Our focus is on the economies of scale and manufacturing process improvements. By 2010, estimated turnover target is around Rs 430 crore (US$ 100 million), stated Bhutada.
"We have chalked out strategies to build a robust pipeline, consolidate our offerings to the regulated markets. Going forward, we will be into finished dosage forms. Our blueprint for next five years is to become a dependable company with non-infringing processes in place to bring innovative product to market and create value for stakeholders through innovation and quality", stated Bhutada.
The company has a range of APIs for various disease segments, but is well known for its oncology bulk drug range. It is also engaged in the production of nutraceuticals. The leading oncology APIs manufcured by Shilpa include Gemcitabine HCL, Irinotecan HCl, Trihydrate, Oxaliplatin, Bicalutamide ,Carboplatin, Anastrozole, Cisplatin, Temozolomide, Capecitabine, Docetaxel, Letrozole, Thalidomide and Topotecan HCl. Among the fastest growing oncology drugs are Gemcitabine HCl which has been filed in 27 countries in the European Union. Oxaliplatin, Irinotecan and Gemcitabine will be off patent in 2009 in the US. Irinotecan will also be off patent in the European Union around the same time.