Terming the USFDA ban on medicines manufactured at its Toansa plant in Punjab as 'disappointing', Ranbaxy Laboaratories here on Friday said it will take 'appropriate management action' for the lapses at the manufacturing facility after the conclusion of an internal investigation.
"The company is disappointed with the recent US Food and Drug Administration (USFDA) action and would like to apologise to all its stakeholders for the inconvenience caused by the suspension of shipment," Ranbaxy Laboratories said in a statement. "This is unacceptable and appropriate management action will be taken upon completion of the internal investigation," Ranbaxy CEO and managing director Arun Sawhney said. USFDA has notified the company that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products, it said.
The US health regulator had earlier this month issued the Form 483 to the company for its Toansa plant in Punjab for violations of the current good manufacturing practice (CGMP). "Subsequent to the Form 483 issued in early January 2014, Ranbaxy voluntarily and proactively suspended shipments of API from this facility to the US market when it received the inspection findings," the company said.
Ranbaxy's other key facilities at Ponta Sahib (Himachal Pradesh) and Dewas (Madhya Pradesh) are already under an US import alert since 2008. Last year, its other key facility at Mohali also came under USFDA import alert.