USFDA raises concerns over Ranbaxy's Toansa plant

Drug major Ranbaxy Laboratories today said the US health regulator has raised concerns over manufacturing practices at its Toansa plant in Punjab.

The US Food and Drug Administration's observations regarding the manufacturing practices in the company's plant in Punjab comes after the recent inspection of the facility by the health regulator.

"On Saturday, January 11, 2014, Ranbaxy received the form 483 with certain observations as a result of the recent US FDA inspection at its active pharmaceutical ingredient (API) plant at Toansa, Punjab, India," the company said in a filing to the BSE.

The US FDA has imposed ban on import of medicines manufactured at Ranbaxy's India-based factories into the US, the world's biggest drug market.

"The company is assessing the observations, and will respond to the US FDA in accordance with the agency's procedure to resolve the concerns at the earliest," Ranbaxy Laboratories said.

The drug maker continues to improve its systems and processes, and remains fully committed to upholding the highest standards that patients, prescribers, regulators and all other stakeholders expect from the company, it added.

Last year in September, the USFDA had issued an import alert on drugs produced by Ranbaxy Laboratories at its Mohali plant in Punjab, for violation of current good manufacturing practices.

In May last year, Ranbaxy had pleaded guilty to 'felony charges' relating to manufacture and distribution of certain 'adulterated' drugs made at two units in India to the US authorities and had agreed to pay USD 500 million as penalty.

The company had admitted to past "shortcomings" but said it has rectified those and insisted that its drugs were safe and efficacious. It had also offered to co-operate fully with any regulator from anywhere in the world wanting to investigate its manufacturing practises.

Shares of Ranbaxy today closed at Rs 438.35 apiece on the BSE, down 5.42 per cent from its previous close.