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Ranbaxy's Toansa unit banned by US drug inspectors

New Delhi: The US Food and Drug Administration (FDA) has banned Ranbaxy's Toansa facility in Punjab from making products for the US market. The regulator also extended the ongoing consent decree with Ranbaxy's three formulation
India TV Business Desk January 24, 2014 12:58 IST
India TV Business Desk
New Delhi: The US Food and Drug Administration (FDA) has banned Ranbaxy's Toansa facility in Punjab from making products for the US market. The regulator also extended the ongoing consent decree with Ranbaxy's three formulation facility in India to include Toansa unit.

“The Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012,” the US FDA said in a statement, notifying that the API facility is “prohibited from manufacturing and distributing” for FDA-regulated drug products.

The ban, which follows an FDA inspection of the facility which identified significant violations of sound manufacturing practices, comes as a big blow to the pharma major.  The FDA has earlier banned products from the company's facilities in Paonta Sahib (Himachal Pradesh), Dewas (Madhya Pradesh) and Mohali (Punjab) as part of a consent decree designed to ensure compliance with good manufacturing practices.

The move is seen as a major setback for Ranbaxy which is already distressed with all its India-based formulation manufacturing facilities – at Paonta Sahib (Himachal Pradesh), Dewas (Madhya Pradesh) and Mohali (Punjab) – banned from supplying any products to the US.

Staff at the Toansa facility were found to have re-tested raw materials and other ingredients after the items failed analytical testing "in order to produce acceptable findings," and did not report or investigate the failures, the FDA said.

In a statement, Ranbaxy said it is disappointed with the recent FDA action and would like to apologize to all its stakeholders for the inconvenience caused by the suspension of shipment.

"This development is clearly unacceptable and an appropriate management action will be taken upon completion of the internal investigation," said Arun Sawhney, CEO and Managing Director of Ranbaxy.

Ranbaxy is majority owned by Japan's Daiichi Sankyo. Daiichi Sankyo said in a statement that it was "confirming the situation with Ranbaxy" and would issue a statement when it had more details.