Ranbaxy’s relief after FDA approval

Shares of India’s biggest pharmaceutical company, Ranbaxy Laboratories, opened up 10.4 per cent on Thursday, following news that it had received FDA-approval to market its generic version of Pfizer’s anti-cholesterol drug, Lipitor.

The approvals on Wednesday came at the last moment, just one day before Ranbaxy would be legally allowed to sell the drug, which is expected to generate $500m-$600m in sales for the company in the next six months.

It is one of just two companies worldwide that has exclusive rights to sell the drug in the US, the world’s biggest pharmaceutical market.

As beyondbrics reported Wednesday, analysts were unsure whether Ranbaxy would receive the approvals in time.

Ranbaxy said in a statement on Thursday that it had launched its generic version of the drug, with an undisclosed portion of the profits during the first six months being paid to Teva Pharmaceuticals, “pursuant to an agreement” between the two.

Without the approvals, Ranbaxy risked losing market share to Watson Pharmaceuticals, a partner of Pfizer, on Lipitor, which is the best-selling drug in the history of the pharmaceutical industry.

For its part, Watson was ready to hit the ground running Thursday, having shipped 1.5m bottles of the drug to pharmacies across the country, according to the Wall Street Journal.

Ranbaxy, a unit of Japan’s Daiichi Sankyo that had global sales of nearly $1.9bn last year, was the first to apply for FDA approval in 2002, but was held up over violations at a plant in India.

The stock was trading up 4.76 per cent at 11:25am, compared with the Bombay Stock Exchange’s benchmark Sensex, which was up 2.81 per cent.

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