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EMA inspectors give Ranbaxy plant all-clear

A safety inspection by the European Medicines Agency at the Ranbaxy Laboratories plant in Toansa, India, found drugs manufactured at the facility pose no risk to public health.

The EMA had suspended the plant’s Good Manufacturing Practice (GMP) certificate in January 2014 after the US Food and Drug Administration found there was “non-compliance” with GMP standards during an inspection.

EMA inspectors said tests of samples of active pharmaceutical ingredients manufactured at the site met all quality standards. It announced last week that “appropriate corrective and preventative measures” had been implemented and that the certificate was being reinstated.

A statement from the agency said: “The inspection team concluded that there was no evidence that any medicines on the EU market that have an active pharmaceutical ingredient manufactured in Toansa were of unacceptable quality or presented a risk to the health of patients taking them.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11139037

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