Europe's regulator to inspect Ranbaxy's India plant in June
MUMBAI (Reuters) - Europe's drug regulator said on Wednesday an inspection of Indian generic drugmaker Ranbaxy Laboratories Ltd's(RANB.NS) 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 (4568.T) agreed to sell it to Sun Pharmaceutical Industries Ltd (SUN.NS) 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)
- Tweet this
- Share this
- Digg this
- Tendulkar factor adds to pressure on Sindhu
- Taiwan says weather not seen as cause of plane crash that killed 48
- With sales sputtering, Apple's iPad looks to IBM alliance
- Exclusive - Ukraine rebel commander acknowledges fighters had BUK missile
- TransAsia Airways stocks plunge after plane crashes in landing
India is set to offer Nepal a landmark pact to help develop its huge hydro-electric power potential as the South Asian giant takes another step to re-assert influence among smaller neighbours where China has been forging closer ties. Full Article