Ranbaxy closes down troubled liquid formulations plant
pharmafile | August 12, 2011 | News story | Manufacturing and Production |Â Â FDA, Ranbaxy, pharma manufacturing news, quality controlÂ
Indian drugmaker Ranbaxy Laboratories has decided to close down a manufacturing facility in the USA which has been under scrutiny by the FDA for quality control problems.
The plant in Gloversville, New York, is operated by Ranbaxy subsidiary Ohm Laboratories, which was acquired by the Indian firm in 2002. The facility specialised in the production of liquid pharmaceutical preparations, but production has been suspended for months while the company attempted to bring it back into compliance.
In a statement, Ranbaxy said it is in the process of decommissioning the Gloversville facility in order to focus resources on two other US facilities. “It is expected that this process will be completed by 1 October, after which the plant will no longer be operational,” it said.
In December 2009, the FDA sent Ranbaxy a warning letter saying it had not taken adequate measures to correct deficiencies at the Gloversville plant, as well as Indian facilities in Dewas and Paonta Sahib, and ordering the drugmaker to undertake a review of its entire manufacturing network.
Problems with the Indian facilities led the FDA to impose an import ban on products made there which remains in force. Earlier this month the company said it was continuing to work with the FDA and the US Department of Justice “for a comprehensive solution to its regulatory issues.”
During the second quarter, 10 regulatory agencies from across the globe inspected Ranbaxy’s API and dosage form facilities in multiple locations across the world, said the company.
The US import ban has contributed to a difficult financial period for Ranbaxy, which posted after tax profits of 2.43 billion rupees ($54 million) in the second quarter of 2011, down 25%, while sales also fell almost 2% to 20.59 billion rupees ($461 million).
Phil Taylor
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