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Novartis unit Sandoz under WHO scrutiny -paper

Mon Sep 22, 2008 1:34pm IST
 
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ZURICH, Sept 22 (Reuters) - Sandoz, the generic drugs unit of Novartis (NOVN.VX: Quote, Profile, Research), could lose World Health Organisation authorisation to sell some of its antibiotics due to problems at a South African plant, the Financial Times reported on Monday.

A Novartis spokesman said Sandoz was working hard to solve the problems at the plant.

"We are doing everything to complete changes as quickly as possible and to reschedule a visit of the WHO by the first quarter of 2009," the spokesman said.

The newspaper said the WHO was poised to tell customers to stop buying products made at a plant in South Africa due to manufacturing lapses including failure to prevent contamination. A WHO spokeswoman had no immediate comment.

After Sandoz told the WHO its inspectors would not be able to make a follow-up visit this year, the newspaper said the WHO was gearing up to suspend the plant's products from its list of prequalified medicines and refuse applications for other drugs. The Financial Times said the WHO threat highlighted the difficulty even big drugs firms had meeting international safety standards.

Last week, U.S. health officials banned dozens of drugs made by India's Ranbaxy Laboratories Ltd (RANB.BO: Quote, Profile, Research) after the generic drugmaker failed to fix numerous record-keeping and other operational problems, although the drugs are considered safe. (Reporting by Emma Thomasson; Editing by Quentin Bryar)

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