USFDA ban on Toansa plant disappointing: Ranbaxy
Jan 24 2014 , New Delhi
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 development is clearly unacceptable and an 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.
"With this import alert, the operations of the company in US business which contributes around 40 per cent could come under impact, unless it can compensate for the same at the earliest and mange a smooth supply of key raw material," Angel Broking VP - Reasearch Pharma Sarabjit Kour Nangra said.
Shares of Ranbaxy were trading at Rs 351.50 apiece on the BSE, down 15.74 per cent from its previous close.