FDA bans Ranbaxy’s fourth plant in India

January 24, 2014 09:26 am | Updated December 04, 2021 11:19 pm IST - New Delhi

The U.S. Food and Drug Administration (FDA) has banned the import of products from Ranbaxy’s plant in Punjab [the company’s fourth unit] due to manufacturing violation, a move that will halt shipment of all products of the pharmaceutical company to the U.S.

Reacting to the development, the company’s scrip tumbled 19.33 per cent to Rs.336.50 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 U.S. Food and Drug Administration (FDA) today [Friday] 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 questions about Ranbaxy’s Toansa facilities come in the wake of the firm pleading guilty to seven criminal charges relating to fraud last May, and coughing up $500 million in fines. To date the FDA has restricted imports from three other Ranbaxy facilities in India, including Paonta Sahib, Dewas and Mohali.’’

The agency said the Toansa facility was 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 U.S. drugs manufactured using API from Toansa, including drugs made by Ranbaxy’s Ohm Laboratories facility in New Jersey,” it said.

The U.S. 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 U.S. 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 U.S. 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 would co-operate with the USFDA and comply with the consent decree in both letter and spirit.

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