Updated on 6 June 2014
The GMP inspection concluded that appropriate corrective and preventive measures have been put in place by the manufacturer. 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. This conclusion was supported by tests of samples of these medicines, all of which met the correct quality specifications.
European regulatory authorities have identified the need to keep the Toansa site under close supervision and this will be done in collaboration with India and other regulatory authorities around the globe, Ranbaxy stated.
The Toansa site had been supplying APIs for four centrally authorized medicines - Enyglid (repaglinide), Repaglinide Krka (repaglinide), Repaglinide Teva (repaglinide) and Nevirapine Teva (nevirapine) - and several non-centrally authorized medicines.