The US health regulator has banned the import of products from Ranbaxy’s
plant in Punjab due to
manufacturing violation, a move that will halt
shipment of all products of the pharmaceutical company to the US from
India.
Reacting to the development, the company scrip tumbled 19.54 per cent to
Rs 335.65 from its previous close on the BSE, on Friday.
In its order issued on Thursday, the FDA prohibited Ranbaxy from
producing and distributing drugs from its Toansa facility in Punjab.
“The US Food and Drug Administration (FDA) today notified Ranbaxy
Laboratories, Ltd., 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 in a
statement available on the regulator’s website.
The FDA ban on Ranbaxy's Toansa plant followed an inspection completed
on January 11, which identified “significant CGMP (current good
manufacturing practice) violations”.
The agency said the Toansa facility is now subject to certain terms of a
consent decree of permanent injunction entered against Ranbaxy in
January 2012.
“Under the decree, the FDA has issued an order prohibiting Ranbaxy from
distributing in the US drugs manufactured using API from Toansa,
including drugs made by Ranbaxy’s Ohm Laboratories facility in New
Jersey,” it said.
The US regulator had previously barred products from the company's
facilities in Paonta Sahib, Dewas and Mohali in India as part of a 2012
consent decree.
"We are taking swift action to prevent substandard quality products from
reaching US consumers," said Carol Bennett, acting director of the
Office of Compliance in the FDA's Center for Drug Evaluation and
Research.
Ranbaxy said it was disappointed with the FDA's action and it had
voluntarily suspended shipments of products from the Toansa facility to
the US market when it received the inspection findings.
In a statement, Ranbaxy Chief Executive Officer and Managing Director
Arun Sawhney said, “This development is clearly unacceptable and an
appropriate management action will be taken upon completion of the
internal investigation."
Further, the company said it "would like to apologise to all its
stakeholders for the inconvenience caused by the suspension," adding
that Ranbaxy will cooperate with the USFDA and comply with the consent
decree in both letter and spirit.
