Biological E gets nod for hepatitis-B vaccine 'Bevac'

Company to launch product in next 3 months

City-based Biological E Limited has received the permission of Genetic Engineering Approval Committee (GEAC) for commercial manufacture of recombinant hepatitis-B vaccine 'Bevac'. The company expects to launch the product in the next three months.

N Eswara Reddy, vice-president of Biological E, told Business Standard that the company would be launching new products in the antibiotics segment in the next couple of months.

Reddy said that the company had approached GEAC in September 2003 after completing all the clinical trials on the vaccine. GEAC accorded its permission for the vaccine on June 10.

The 51-year-old company is the first private sector pharmaceutical and vaccines manufacturing company in south India. The company's product range covers bulk drugs, sera and vaccines, oncology, biological and formulations (branded and generic).

On the new vaccines facility coming up at the second phase of Shapoorji Pallonji Biotech Park at Shamirpet, he said that the facility would manufacture combination vaccines like DPT and Hepatitis B. A two lakh sqft building for the manufacture of vaccines would be ready by December 2004.

Reddy said that the plant would be made to comply with the standards of regulatory bodies like WHO-GMP, USFDA, UK-MHRA, Australia - TGA etc, besides the Indian Schedule M-GMP.

This would help the company enter the foreign markets and also supply its vaccines to international institutional purchasers such as Unicef.

The company is targeting specialty and high-tech products for oncology, anti-TB, cardiology sera and vaccines etc. It also plans to make inroads into gynaecology and paediatric segments with more novel formulations.