Europe's regulator to inspect Ranbaxy's India plant in June

MUMBAI Wed Apr 9, 2014 11:30am EDT

MUMBAI (Reuters) - Europe's drug regulator said on Wednesday an inspection of Indian generic drugmaker Ranbaxy Laboratories Ltd's Dewas plant in India is planned for June, amid concerns about its production processes after a spate of regulatory sanctions.

Ranbaxy, which owner Japan's Daiichi Sankyo Ltd agreed to sell it to India's Sun Pharmaceutical Industries Ltd for $3.2 billion on Monday, suspended production at the Dewas plant in February to examine processes.

The company's voluntary suspension at Dewas and another plant in Toansa in the northern Punjab state in February, came after a spate of sanctions against it by the U.S. Food and Drug Administration (FDA) due to poor manufacturing processes.

Ranbaxy informed authorities in the European Union that its internal investigation revealed the Dewas site failed some so-called good manufacturing practices, the European Medicines Agency (EMA) said in a statement issued to Reuters.

A Ranbaxy spokesman did not immediately respond to requests for comment on the EMA statement.

Imports from Dewas had already been banned by the FDA back in 2008 after the agency found violations of drug manufacturing standards there. The FDA has also banned shipments from the three other Ranbaxy plants in India.

(Reporting by Zeba Siddiqui; Editing by Sumeet Chatterjee and Elaine Hardcastle)

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