Ranbaxy Laboratories' API plant in Toansa, which both the U.S. and the EU had banned from shipping products, has gotten an all-clear from Europe. A regulatory authority will reinstate the permit to ship to the countries there.
The European Medicines Agency (EMA) said today that inspectors, which responded after the FDA had banned the facility, did find problems with GMP compliance. The agency sent a team of inspectors from Germany, Ireland and the U.K., who were joined by inspectors from Switzerland and Australia. But with changes Ranbaxy has made and after testing, the EMA has decided the four drugs coming out of the facility post "no risk to public health from these deficiencies." It is reinstating its permit the the U.S.
The EMA announcement did not address its earlier disclosure that had been informed by regulators in India that they had suspended the export license for the Toansa plant. In April the agency said that "On 26 March 2014, Indian authorities withdrew the site's 'Written Confirmation,' effectively making the suspension of the exports official for the time being. The Written Confirmation is a document that accompanies all APIs exported to the EU (and elsewhere) to certify that relevant manufacturing standards have been met." It also didn't say anything about the status of shipments from Ranbaxy's plant in Dewas.
In January, Ranbaxy voluntarily halted shipments to Europe from the Toansa and Dewas plants after bans and warning letters from the FDA raised serious questions about their operations. The FDA had long ago banned the Dewas plant but in September also put a Ranbaxy plant in Mohali on import alert. It then banned the Toansa plant in January after a follow-up inspection there. The warning letters said the Toansa and Mohali facilities had faked analytical data and then covered it up by deleting audit trails from computer systems. Serious sanitation issues were also identified.
Problems with the FDA have plagued Ranbaxy for years, finally convincing Japan's Daiichi Sankyo, which owns a majority stake in Ranbaxy, to sell it off to India's Sun Pharmaceutical. A stock swap valued at about $3.2 billion is expected to be completed by the end of the year.
- here's the announcement