Bangalore based Bal Pharma Limited has bagged approval from Therapeutic Goods Administration (TGA), Australia for its active pharmaceutical ingredient (API) plant at Bommasandra in the outskirts of Bangalore.
Bal Pharma is the only non- European source to have this approval beating its competitor China which is still short of an exposure in the said market. Gliclazide contributes 13 percent revenues to its total turnover. The facility manufactures Gliclazide, an anti diabetic API. The Bommasandra API facility had an investment of Rs. 50 lakh for the plant modernization. Bal Pharma clocked a turnover of Rs 78 crore ending March 2007. It targets earnings to the tune of Rs.300 crore by 2010.
The company was also granted the DMF (Drug Master File) approval for Gliclazide. With this approval, the company becomes the first Indian API manufacturer of Gliclazide to gain an entry into Asia Pacific region with clearances to market in Australia and New Zealand.
The TGA approval allows the company to enter the Asia Pacific region only. Six years ago, the company received the Certificate of Suitability for Gliclazide to market in Europe.
The worldwide sale of Gliclazide is estimated at US $600 million, of which Australia would contribute US $30 million. The molecule is registering a growth of around 12 per cent. Bal Pharma has been working closely with Apotex, Canada, the fourth largest global generic major to enter the Australian market for last two years.