The Hyderabad-based Sipra Labs is planning to commission its new research facility at Hyderabad by August this year. The centre will carry out bio-equivalence, analytical and clinical studies for international markets.
The research facility forms Phase I of the expansion plan with an investment of about Rs 25 crore. Phase II comprises creating toxicological facilities and other labs with an investment of Rs 15 crore. The entire expansion programme entails an investment of Rs 40 crore, Dr V Satyanarayana, managing director of Sipra Labs told Pharmabiz.
The company would apply for US FDA approval for conducting BE studies at the new facility and expects the approval by the end of 2006. The new facility will cater to the needs of international markets, while the present facility will focus on the domestic markets. Technical dossiers and BE studies will be offered to overseas companies. BE studies can be completed in India in a month compared to 2-3 months taken in the US, he noted.
Sipra is also planning to increase its bed capacity from its current 32 beds to 132 beds soon. The upcoming facility spread over 1,30,000 sq ft will house 100 beds, which will meet international standards. In addition, the company is also planning to set up facilities in the upcoming facility, which may be used by individual pharma companies for specific studies over a period of time.
The company currently generates revenues up to 20 per cent through export markets and is expecting to increase it to 35-40 per cent within one year of starting the new facility, Dr Satyanarayana added.
Sipra's plans are to set up labs, facilities and accreditations in place, besides increasing its work force from the current 140 personnel to 300 in another one year. In order to expand its presence outside India, the company is contemplating to set up an office at New Jersey, following USFDA approval.
Sipra is a government approved and ISO-9002 certified state-of-the-art pharmaceutical / analytical laboratory set up for providing specialised services for bio-availability, bio-equivalence, stability and method development studies in addition to providing services for research and development of drugs, pharmaceuticals and drug intermediates.
Formulation development will be a major area of focus at the company in the coming years. Exclusive strategic business units (SBUs) are created to cater each specialised service. Impurity profile estimation, study of drug release patterns and environmental impact assessment (EIA) studies are the other major thrust areas of Sipra Labs, he said.