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American Shipper

FDA bans drug products from Indian maker

FDA bans drug products from Indian maker

The U.S. Food and Drug Administration issued an import ban Sept. 16 on more than 30 different generic drugs manufactured by Indian firm Ranbaxy Laboratories, citing serious deficiencies in the company's manufacturing processes.

   FDA investigators documented the deficiencies during inspections conducted at Ranbaxy's plants at Dewas and Paonta Sahib earlier this year.

   The FDA said its actions are 'proactive measures' to ensure that drugs entering the United States are manufactured in accordance with U.S. standards.

   'While this action does not involve removing products from the market, FDA has no evidence to date that Ranbaxy has shipped defective products,' the agency said in a statement. 'We will continue to monitor the situation.'

      Since Ranbaxy is the sole supplier to the United States of Ganciclovirm oral capsules, an antiviral drug, the FDA said it would not detain these shipments in order to avoid creating a shortage of the drug.

   FDA officials called their actions against the Indian pharmaceutical company's two plants 'clearly warranted.'

   This isn't the first time that Ranbaxy has failed to pass FDA inspections. In 2006, the FDA cited the company for violations of U.S. manufacturing processes at its Paonta Sahib plant.

   'Until the company addresses these deficiencies, APIs (active pharmaceutical ingredients) and finished drug products from these plants will remain on the (FDA) Import Alert, and we will not approve any abbreviated new drug applications or new drug applications that list either of the two facilities as the manufacturer of APLs or finished drug products,' said Deborah M. Autor, director of FDA's Center for Drug Evaluation and Research Office of Compliance, in a statement.

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