Suven Life Sciences, the Hyderabad based contract research organisation will set up an independent drug delivery and research centre in the city. The centre would also be engaged in pre-clinical and clinical research.
According Venkat Jasti, vice chairmen and CEO of the company, the centre will be Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) complaint. It will have an animal house. The entire pre-clinical studies like, toxicity, animal model tests, bioequivalence studies, will be conducted at the centre. The centre would be engaged in research in Central Nervous System (CNS), Cardio Vascular (CVS), Parkinson's and Alzheimer diseases.
The investment to set up the drug research facility is around Rs one crore ($ 25 million). The funding would be through loans and internal accruals. To be known as green field centre the facility will be ready by 2009. The proposed area is around 20-25 acres at Patancheru in the city. The land deal is in final stage, he said.
When asked whether the company would go for US FDA approval for the upcoming centre, he said 'as the facility is research oriented there will not be any mandatory approvals from regulatory authority.'
According to Jasti, in accordance with the business vision of the company on Drug Discovery and Development Support Services (DDDSS), the company will file two Investigational New Drug IND applications in therapeutic area of Alzheimer in this month. Another application will be for Obesity by the end of current fiscal, in the US and India.
There is also sign of collaborative research tie-up with some of the US companies. The talks with foreign companies have been successful and positive outcome in next couple of months. The company is also planning to venture into APIs as well as formulations.
To a query on human resource for the upcoming centre, Jasti said, "we are planning to hire 300 personnel for the centre. As reported earlier in Pharmabiz, the IND which it proposes to file in the US has been already granted patent by the European Patent Office (EPO) earlier this year.