Washington / New Delhi: The US drug regulator is reviewing a corrective action plan from Ranbaxy Laboratories Ltd after some medicines from its plants in the nation were barred from being exported to the US.
The Food and Drug Administration (FDA) is working very closely with the firm to ensure that all the Ranbaxy products currently in the US market are safe and effective, FDA spokesman Christopher Kelly said in an email on Wednesday. The next steps will be dependent on the actions identified in the plan, he said.
Tough role: Ranbaxy chief operating officer Atul Sobti. Pankaj Nangia / Bloomberg
US sales of Ranbaxy, the country’s biggest drug maker, fell for two straight quarters after the US FDA on 16 September blocked the import of 30 medicines produced at two of its factories. The FDA decision to block the products in the US, the world’s largest drug market, led Ranbaxy’s stock to plunge 45% until chief executive officer Atul Sobti said earlier this week that the company had submitted the plan.
The regulator in February barred Ranbaxy from introducing new generic medicines from one of the two plants. The FDA said Ranbaxy falsified data from the factory in Paonta Sahib. Drugs from that plant were approved for sale in the UK and Australia after a joint audit by regulators, Ranbaxy said 23 March.
Ranbaxy, controlled by Tokyo-based Daiichi Sankyo Co. Ltd, rose 4.24% to Rs272.95 at close in Mumbai trading, while benchmark sensitive index gained 1.3%.
Sobti, who replaced Malvinder Singh as CEO under a plan by its parent to turn around the unprofitable company, said Ranbaxy expects the full approval process by the FDA to take months. The FDA said it received Ranbaxy’s corrective action plan on 18 May.