EMA to inspect Ranbaxy's India unit
Europe's drug regulator, the European Medicines Agency (EMA) has indicated that it is planning to inspect the Indian plants of generic drug maker Ranbaxy Laboratories.
The regulator is likely to conduction inspection at company's Dewas plant in India in June following concerns over manufacturing processes followed at the plant due to a host of sanctions. The company had to suspend production at the Dewas plant in February to examine processes. The company voluntarily decided to suspend production at Dewas and another plant in Toansa in the northern Punjab in February after sanctions against it by the U. S. Food and Drug Administration (FDA) due to poor manufacturing processes.
Ranbaxy had communicated to the European Union at an internal investigation has revealed that Dewas plant did not comply with good manufacturing practices, according to a statement released by EMA. FDA had announced a ban on export of medicines from the plant in 2008 as well as other plants due to violations of drug manufacturing standards.
Meanwhile, India's largest drug maker by market value, Sun Pharmaceutical Industries has indicated that it is planning to buy Ranbaxy Laboratories in a deal valued at $3.2 billion in stock.