Ranbaxy scrambles to make pills for the US

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Sumeet Chatterjee and Ben Hirschler Mumbai and London

Ranbaxy Laboratories was in talks with at least two firms about sourcing ingredients for a generic version of AstraZeneca’s heartburn drug Nexium, to ensure the Indian drug maker could sell the pills in the US, a source said yesterday.

The US banned ingredient shipments from a Ranbaxy plant in India following an inspection that found poor manufacturing practices, effectively barring India’s top pharmaceutical firm by revenue from selling drugs in the US from its Indian plants.

Ranbaxy’s Ohm Laboratories plant in New Jersey is now the company’s only permitted maker of drugs for US sale.

Any delay in the launch of generic Nexium, AstraZeneca’s second-biggest seller, will have a big impact on the British company’s profit.

Retaining exclusivity on Nexium in the all-important US market beyond the end of May would limit a forecast decline in AstraZeneca’s 2014 earnings.

The talks with ingredient makers are part of a scramble to ensure Ranbaxy can still be the first to sell a cheaper copy of Nexium in the US after the drug’s patent term ends on May 27, despite regulatory sanctions for product quality.

The source, who has direct knowledge of the matter, declined to give details yesterday and refused to be named due to the issue’s sensitivity.

A Ranbaxy spokesman said the company had no comment.

Doubts about the ability of Ranbaxy to launch the drug grew after the US Food and Drug Administration in January prohibited it from shipping to the US any pharmaceutical ingredient made at its Toansa plant in northern India.

At the weekend Ranbaxy said it had recalled more than 64 000 bottles of the generic version of cholesterol-lowering Lipitor in the US after a dosage mix-up was detected. – Reuters

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