Gujarat based Cadila Pharmaceuticals is venturing into biotech research in a big way by setting up a new R&D facility at Ahmedabad. The civil work for the new state-of-the-art R&D facility, at its 180-acre premises of Dholka plant, is expected to commence within next five months. The company has assigned a major consulting agency to prepare a feasibility report on the project, which will be submitted soon, according to Indravatan A Modi, chairman, Cadila Pharmaceuticals Ltd.

"With this we will have a nice facility to handle R&D to manufacturing of Biotech products. The new project is planned to be the strongest facility we have in the sector. We should have the facility ready in the end of 2008 or by the beginning of 2009," Modi told Pharmabiz. He added that the initial investment for the facility would be around Rs 75 crore.

The company is also planning to file its first Abbreviated New Drug Application (ANDA) in July 2007 and will line up for filing eight to ten Drug Master Files (DMFs) in every year, in an effort to strengthen its presence in the regulated market.

Cadila, which has already received eight DMFs is waiting for approval of another 12 DMFs, and works are accelerated to go for eight to ten filings per annum in future. The company is expected to initiate its clinical trial at US on its molecule on Bladder cancer within next two months. The US based Bladder Cancer Foundation has shown interest to carry the clinical trials and the company is currently engaged in talks with the foundation for finalizing the project.

The company has five Investigational New Drug (IND) filings with US, on therapeutic areas namely Tuberculosis, Cancer and Leprosy. The IND on cancer is on Melanoma, Bladder cancer and prostrate cancer, while the filings on TB is for category one and two. The clinical trial for Melanoma has already initiated in US. The protocol for leprosy drug has been completely approved by the US regulatory authority, which also agreed to accept the Indian clinical data as basic data.

"I doubt that any other Indian pharmceutical company currently have this number of IND filing in their list. We are planning to pursue the aggressive regulatory filing mode in future. Currently, our R&D efforts are on therapeutic areas including Tuberculosis, Cancer, Malaria and Lipids," said Modi.

With its current strength in contract manufacturing and research activities, the company is actively talking with three global pharmaceutical players to offer outsourcing capabilities. The company has also shown its interest in the hospital sector by investing Rs 50 crore in the Ahmedabad unit of Apollo Hospitals Group. Though there is no immediate plans into involve much into the sector, the company is planning to assist Apollo's ventures in Gujarat in future. The company is expecting a revenue of Rs 100 crore per annum with these operations being active.