Bal Pharma gets Japanese accreditation for 2 drugs

Bangalore, Nov 28 (UNI) Bal Pharma Limited has successfully obtained the coveted foreign manufacturers accreditation from the Japanese Ministry of Health, Labour and Welfare, enabling the leading pharmaceutical company to exploit the market in that country.

Addressing newspersons here today, company Managing Director Shailesh Siroya said his company had been working hard to enter the Japanese market for the last couple of years and with the granting of the Drug Master File (DMF) by the Japan Government, the company would get direct access to all Japanese pharmaceutical manufacturers as an Active Pharma Ingredients (API) supplier. The company was the only non-European source to get this approval in Japan and Spain.

He said the company had been granted the Japanese DMF for its two leading products -- anti-allergic drug Ebestine and anti-diabetes drug Gliclazide. Global sales of Ebestine was around 200 million US Dollars, of which Japan and Spain accounted for 160 million Dollars.

Terming the grant of DMF from the Japan as a milestone for Bal Pharma, he said Bal Pharma had plans to file half a dozen more Japanese DMFs for products developed exclusively for that market in the next two to three years. The company would also be developing formulations for the Japanese market through its new plant based at Rudrapur in Uttaranchal.

Mr Siroya said the company proposed to manufacture and market certain Ayurvedic products. ''To cater to the growing demand, we are setting up one more API plant at Bommasandra and an additional formulations plant at Uttaranchal, both conforming to USFDA standards.'' He said the company, with a turnover of about Rs 76 crore and over 1,000 employees in its four manufacturing centres, targeted to achieve a turnover of Rs 300 crore by the end of 2010. Bal Pharma expected generation of a minimum of 15 per cent of the total revenue from Japanese sales.

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