IHS Chemical Week

EnviroTech :: Regulatory :: Regulatory: Legal

European regulatory authorities to reinstate GMP certificate for Ranbaxy’s API plant at Toansa

8:03 AM MDT | June 5, 2014 | Deepti Ramesh

After assessing of Ranbaxy Laboratories' (Gurgaon, India) active pharmaceutical ingredient (API) manufacturing facility at Toansa, India, European regulatory authorities say the company has instituted corrective measures and are satisfied that the measures are sufficient to ensure GMP-compliant manufacture of products at the site, the European Medicines Agency (EMA; London) announced today. As a consequence, EU authorities will reinstate the GMP certificate that was suspended in January, EMA says. The assessment follows a US FDA inspection, which...

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