US regulator tightens drug approval norms

Companies asked to give data for three batches instead of one; move may lead to significant rise in development cost of genericsPharmaceutical companies operating in the US might be in for a......

Indian drug makers face heat of US regulator's crackdown

Data also show that several other leading domestic pharma companies have recalled their products from the US Frequent drug recalls, warning letters and import alerts from the US in the recent past......

Ranbaxy's Lipitor generic may miss Dec deadline for return to US market

Ranbaxy's generic version of Lipitor, which faced recall from the US market last month, could remain missing at the beginning of 2013, if the company fails to resume supplies of the drug by the end......

Wait for Indian generic launches gets longer

Indian generic drug makers, such as Ranbaxy, Lupin, Dr Reddy's and Aurobindo, which often opt to challenge patents in the US, might have to wait longer to launch their generic versions there. For......