Ranbaxy's Paonta plant gets nod from UK, Australia regulators

Ranbaxy Laboratories’ Paonta Sahib factory today won good manufacturing certification from British and Australian drug regulators. This comes almost a month after the US Food and Drug Administration (USFDA) charged the company with falsifying data from the factory. The company’s stock rose the most in more than four months.

The Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK and the Therapeutic Goods Administration (TGA) of Australia renewed the good manufacturing practice (GMP) certificates they had earlier issued to the Paonta Sahib facility, Ranbaxy said today.

This means Ranbaxy will be able to supply medicines from the facility to the entire European Union and Australia. Europe is Ranbaxy’s second-biggest market after the US. Nearly $300 million of the company’s sales in 2008 came from 23 EU member countries.

Following the USFDA action, doubts had arisen whether other regulators would also review their approvals to the facility. The British and Australian regulators’ decisions have enabled Ranbaxy to allay such fears partially, analysts say.

“It’s a relief to the company as other regulators have decided not to follow the USFDA”, said Sarabjit Kaur Nagra, vice-president, research, Angel Broking.

Ranbaxy was among the top gainers at Indian stock exchanges today, rising 10.8 per cent to close at Rs 161.05 on the Bombay Stock Exchange.

“Both these authorities had inspected this facility in 2006 and found it to be compliant with the respective principles and guidelines of GMP. GMP certificates valid for up to two years were issued. Subsequent to the routine re-audit in November 2008 conducted by these authorities, the certification has been extended for a further three years by the MHRA and for two years by the TGA,” Ranbaxy said.

The USFDA had put an import alert on the Paonta Sahib facility in September 2008, preventing Ranbaxy from selling 30 medicines manufactured in this facility in the country. A month earlier, the agency had charged Ranbaxy with falsifying data and test results to get approvals for medicines manufactured in this plant.