Ranbaxy has voluntarily suspended all API shipments from its Toansa and Dewas. This follows suspension of API shipments from its Toansa plant by the US FDA
Pharma company Ranbaxy Laboratories Ltd said it is examining the 'processes and controls' at all its active pharmaceutical ingredients (API) manufacturing and quality units, which has led to temporarily putting on hold shipments from its API facilities of Toansa and Dewas plants.
The announcement comes a month after Ranbaxy had said that the US Food and Drug Administration (US FDA) had notified the company prohibiting it from manufacturing and distributing APIs from its facility in Toansa for FDA-regulated drug products.
In a regulatory filing, Ranbaxy said its decision to examine the processes and controls at all its API manufacturing and quality units was taken as a precautionary measure and out of abundant caution to better allow it to assess and review the processes and controls. The company said it would resume shipments after reassuring them about the processes and controls at these facilities.
A committee of the board has been formed this month as Quality & Integrity Committee to help ensure good governance to all Ranbaxy stakeholders. The principal role of this committee was to offer oversight on its manufacturing and quality operations, systems, organisation and integrity, the pharma company said.
In late January, the company said that the FDA barred Ranbaxy from manufacturing and distributing APIs from its facility in Toansa for FDA-regulated drug products. The Toansa facility was subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012.
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