New Delhi: The Paonta Sahib factory of Ranbaxy Laboratories Ltd, barred by the US from introducing new products, was approved to sell medicines in the UK and Australia after a joint audit by regulators, the drug maker said on Monday.
Renewed trust: Ranbaxy headquarters in Gurgaon. Its Paonta Sahib unit has been certified to follow good manufacturing practices. Adrian Fisk / Bloomberg
Regulators in the UK and Australia—Medicines and Healthcare Products Regulatory Agency (MHRA) and Therapeutic Goods Administration (TGA) of the department of health and ageing, respectively—have certified that the Paonta Sahib plant follows good manufacturing practices after conducting a joint audit in October, Ranbaxy said in a statement.
“The MHRA approval will not only cover product filings for the UK but will also apply to product filings for the entire European Union,” it said.
The certificates, which expired in 2006, have now been renewed for three years by MHRA and two years by TGA, it said.
This follows an action by the US Food and Drugs Administration (FDA), which on 25 February suspended review of all approval applications from the plant on charges of falsifying data and test results.
‘Mint’ had reported on 28 February that Ranbaxy, a unit of Japanese company Daiichi Sankyo Co. Ltd, was safe in the UK. MHRA had said: “Paonta Sahib site was inspected as recently as October 2008 by MHRA inspectors in collaboration with inspectors from a number of other EU member states and MHRA partners.”
“In view of the MHRA findings at Paonta Sahib and at other Ranbaxy sites, we have no evidence to suggest that there are any data verification concerns, and hence, products will continue to be imported and marketed,” MHRA press officer Florence Palmer said by email.
Ranbaxy has agreed to quarantine all drugs it sells in Canada from its Paonta Sahib factory, following a request by the Canadian regulator, Health Canada, on the basis of the FDA action.
Shares of the pharmaceuticals company rose 11%, or Rs15.70, to close at Rs161.05 on Monday on the Bombay Stock Exchange.
(Bloomberg contributed to this story.)