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US FDA tightens regulatory noose on Indian drug firms

Import alert on Ranbaxy’s Mohali unit; Strides’ injectible arm gets warning letter Indian drug makers have again come under the scrutiny of the US Food and Drug Administration (US FDA),......

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......
  Web results for Praful Bohra
US approvals key to Glenmark's prospects

Operations here and in other countries continue to fare well; earnings growth to pick up in FY15 as new US product launches gain momentum Ujjval... ...
Natco Pharma up 5%, US PTO rejects Teva's application

Shares of Natco Pharma ended 5 percent higher after US patent office rejected Teva's patent reissue application on Copaxone. This, however, does... ...
Praful Bohra, Nirmal Bang

You take Wockhardt, Ranbaxy, Strides Arcolab, all these companies, all these names have sort of a problem with the FDA. In an interview with ET... ...
Nirmal Bang

W However, there is a likelihood of Natco Phrama going in for an at risk launch around May after all the necessary approvals are received, he... ...
Sensex, Nifty end at record high

03.40 p.m. Markets end at record high. Sensex closes at 22,214, up 119 points, Nifty ends at 6,642 after rising 40 points. State-run lenders... ...

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