Mumbai-based Alkem Laboratories Ltd will be investing about Rs. 50 crore for expansion of its contract research activity during the next three to four years. The company already has CRO, Phoenix Biopharma Research Centre at Taloja with a 24-bed capacity conducting bioavailability and bioequivalence tests for companies in India and abroad.
Under its expansion programme, Alkem is planning enter into clinical trials and other contract research areas also. For its contract research activities, the company is putting up a cGMP lab and a pilot plant at the vicinity of its CRO in Taloja, which is expected to be commissioned in the next six months.
"The funds will be utilised to expand the capability of the CRO to conduct clinical trials and to enter contract research. We are in talks with hospitals for having patients enrolled in our clinical trials programme. In the contract research arena, we would be starting with process research outsourcing. We have started getting enquiries for contract research," said BN Singh, managing director, Alkem Labs Ltd.
After its approval by the DCGI last year, the CRO has conducted five studies in the BE/BA field, of which two have been approved and three are in process of approval. The CRO has 10 permanent staff members with the rest on contract basis.
Phoenix Biopharma is aiming to achieve a turnover of Rs 2 crore for the year ending March 2005. "Our plan is to achieve a turnover of Rs. 8 crore by 2007-08," said Singh.
The non-listed Alkem Labs is ranked among the top 10 pharmaceutical companies in India by way of sales according to latest ORG-Marg study. The company is a leading manufacturer of cephalosporins, quinolones and betalactums.
Alkem, a traditional domestic marketer has started eyeing on regulated export market. The company's manufacturing facility at Daman has already received the MHRA (UK) and MCC (South Africa) certification. Its plant at Baddi is awaiting a US FDA certification. The company currently exports its products to Kenya, Nigeria, South Africa, Vietnam, and Sri Lanka.
According to S Krishnakumar, general manager, business development, Alkem Labs achieved a turnover of about Rs 700 crore for the year ended March 2004. "We are expecting to add another Rs 100 crore for the current year," he said.