EMA: Assessment of Ranbaxy’s India Site Shows No Risk to Public Health
European regulators said they will reinstate a good manufacturing practice certification for Ranbaxy’s manufacturing facility in Toansa, India, following an inspection that found the generic drugmaker had addressed reported GMP violations.
The European Medicines Agency said an assessment of the plant that produces active pharmaceutical ingredients (API) found “a number of GMP deficiencies,” but that the deficiencies do not pose a risk to public health.
The agency had suspended Ranbaxy’s GMP certificate in January following an FDA inspection that found significant GMP violations, such as retesting of raw materials, intermediate drug products and APIs that failed analytical testing to produce passing results.
A team of investigators from Germany, Ireland, the UK, Switzerland and Australia subsequently inspected the site. The investigators concluded that the manufacturer had put in place “corrective and preventative measures” and that there was no evidence that drugs made with APIs from Toansa were of unacceptable quality in the EU market, according to the EMA.
“This conclusion was supported by tests of samples of these medicines, all of which met the correct quality specifications,” the EMA said.
In January, the FDA prohibited the plant from manufacturing and distributing APIs for U.S. products. In March, Indian authorities suspended the Toansa facility’s certification to export APIs to Europe. Ranbaxy voluntarily stopped exports to Europe from the plant in January.
The EMA said it would continue to closely supervise the Toansa site, in collaboration with India and other regulatory authorities around the world.
The company declined to comment on the EMA’s announcement.
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