European regulators give green light to Ranbaxy plant

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European regulators give green light to Ranbaxy plant

Genéricos/General | Posted 13/06/2014 0

In what comes as good news for generics maker Ranbaxy, European Regulators have cleared the company’s Toansa plant.

The European Medicines Agency (EMA) announced on 5 June 2014 that European regulators had finalized their inspection of Ranbaxy’s manufacturing site in Toansa, India. The inspection followed reports of non-compliance with good manufacturing practice (GMP), leading to the suspension of the GMP certificate for the site in the European Union (EU) in January 2014.

European regulators were alerted to problems at the Toansa plant, which manufactures around 70–75% of Ranbaxy’s active pharmaceutical ingredients (APIs), after an inspection by the US Food and Drug Administration (FDA), which revealed areas of non-compliance with GMP at the site [1].

A team of inspectors from Germany, Ireland and the UK were sent to the Toansa plant to undertake an unannounced international inspection of the site. These were subsequently joined by inspectors from Australia and Switzerland.

Although the assessment showed that there were a number of GMP deficiencies at the concerned site, the European regulators considered that the corrective measures put in place by the company were sufficient to ensure GMP-compliant manufacture of products at the site. As a consequence, the EU authorities stated that they will reinstate the GMP certificate.

The inspection team concluded that there was no evidence that any medicines on the EU market that have an API 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.

Assessment of all available information has reassured European regulators that there has been no risk to public health from these deficiencies. Therefore, patients should continue to take medicines produced at the plant.

The Toansa site had been supplying APIs for four centrally authorized medicines – diabetes medicines Enyglid (repaglinide), Repaglinide Krka (repaglinide), and Repaglinide Teva (repaglinide), and HIV infection treatment Nevirapine Teva (nevirapine) – as well as several non-centrally authorized medicines.

The approval does come with the caveat, however, that Europe will keep the site ‘under close supervision’ in collaboration with India and other regulatory authorities around the globe.

Reference

1. GaBI Online - Generics and Biosimilars Initiative. FDA issues Ranbaxy with Form 483 for violations at Toansa plant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 13]. Available from: www.gabionline.net/Generics/News/FDA-issues-Ranbaxy-with-Form-483-for-violations-at-Toansa-plant

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Source: EMA