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HindustanTimes Thu,28 Aug 2014

Ranbaxy stops API production at two plants

Reuters  Mumbai, February 25, 2014
First Published: 10:07 IST(25/2/2014) | Last Updated: 17:14 IST(25/2/2014)

Drugmaker Ranbaxy Laboratories Ltd <RANB.NS> on Tuesday said it has suspended all shipments of pharmaceutical ingredients produced at two local factories to review processes and controls.

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The Toansa and Dewas plants are currently banned from shipping products to the United States following quality concerns, so the suspension will hit supplies to other markets including Europe and India, two people with knowledge of the matter said.

The sources declined to be identified due to the sensitivity of the issue, while a statement from Ranbaxy did not give details about the impact of the suspension.

Last month, the US Food and Drug Administration (FDA) prohibited Ranbaxy from shipping to its biggest market any pharmaceutical ingredients made at its facility in Toansa in Punjab.

The sanction was the latest in a series of regulatory rebukes for India's largest drugmaker by revenue since Japan's Daiichi Sankyo Co Ltd <4568.T> took control of the company in 2008.

The Toansa ban, which followed similar action on two plants in 2008 including Dewas and another in September 2013, means Ranbaxy can no longer export to the US from India.

Ranbaxy said in a statement on Tuesday it was "currently examining processes and controls" at all its active pharmaceutical ingredients (API) manufacturing units.

"This voluntary decision was taken as a precautionary measure and out of abundant caution to better allow the company to assess and review the processes and controls," it said in the statement.

Ranbaxy also said it has set up a committee to provide oversight on manufacturing and quality operations, systems, organisation and integrity.

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