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Bal Pharma’s gliclazide set for Oz market

More drug master files lined up for Asia-Pacific

Our Bureau

Bangalore, March 14 Bal Pharma says it is all set to enter the lucrative Australia-New Zealand market with its anti-diabetic active pharma ingredient, gliclazide, during the first quarter of 2008-09.

The Bommasandra plant for active pharma ingredients (API) has been approved by the Australian drug regulator TGA (Therapeutic Goods Administration).

Bal’s DMF (drug master file) for the drug has also been approved, Mr Shailesh Siroya, Managing Director of the Bangalore-based drug maker, said in a release.

According to the Bangalore-based Bal Pharma, it would be the first Indian company to gain entry into one of the richest pharmaceutical markets in the Asia-Pacific region. It has been the lone non-European source so far to be granted the DMF approval for gliclazide, its leading product.

Over the next 6-9 months, more DMFs are lined up for a basket of products that are needed in the Asia-Pacific market, it said. With this approval, the company gets direct access to supply the API to pharma manufacturers in Australia and New Zealand — which have only 7-8 international players in a growing market.

Sale flow

Gliclazide has a worldwide sale of around $600 million (around Rs 2,400 crore), of which Australia accounts for $30 million (around Rs 120 crore). The molecule is growing annually at the rate of 10-12 per cent.

Mr Siroya said: “It is definitely a milestone to enter the 13th largest market in the world. The company sees itself among the leading Indian pharma players in the international market.” Bal Pharma has been working closely with Canadian company Apotex, the world’s fourth largest generics company, to enter the Australian market for the last two years and got the approval within 14 months of filing the papers.

The company posted a turnover of Rs 78 crore during 2006-07 and is targeting a four-fold growth to touch a turnover of Rs 300 crore by the end of 2010.

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Bal Pharma’s gliclazide set for Oz market

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