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Ranbaxy gets FDA approval for Novartis' Diovan generic

Last Updated: Friday, June 27, 2014, 09:39

Ranbaxy will be the first rival drugmaker to launch a copy of Diovan in the United States and will be entitled to six months of exclusivity to sell it.

Dr Reddy's launches generic Paricalcitol capsules in US market

Last Updated: Wednesday, June 25, 2014, 13:32

Drug firm Dr Reddy's Laboratories has launched generic Paricalcitol capsules used for treating secondary hyperparathyroidism associated with chronic kidney disease in the American market, following approval by the US health regulator.

USFDA cites Apotex's Bangalore drug facility for fraudulent data

Last Updated: Wednesday, June 18, 2014, 09:38

The inspection found that the company routinely completed sample analyses and recorded the data only if the results were acceptable.

USFDA finds procedural lapses at Wockhardt's US facility

Last Updated: Tuesday, June 03, 2014, 17:57

The US Food and Drug Administration has found as many as 12 procedural lapses in drug maker Wockhardt's US facility in Illinois.

Andhra HC order not to impact merger with Ranbaxy: Sun Pharma

Last Updated: Tuesday, May 27, 2014, 19:23

Last week, the court had vacated the status quo order it had issued earlier on the merger process between Sun Pharma and Ranbaxy.

Wockhardt Q4 Net plunges 78% to Rs 74.45 cr

Last Updated: Monday, May 26, 2014, 18:33

Drug firm Wockhardt on Monday reported nearly 78 percent drop in consolidated net profit at Rs 74.45 crore for the quarter ended March 2014 mainly due to regulatory issues with US and UK health regulators.

Sun Pharma response to import ban inadequate: USFDA

Last Updated: Tuesday, May 20, 2014, 22:28

The FDA banned imports from Sun Pharma`s Karkhadi plant in Gujarat in March, but the reason for the ban was not clear at that time.

Sun Pharma settles litigation with Novartis over cancer drug

Last Updated: Thursday, May 15, 2014, 09:40

Sun Pharma`s subsidiary holds a tentative approval from the U.S Food and Drug Administration for a generic version of Gleevec.

'Indian pharma cos face problems in US due to documentation'

Last Updated: Tuesday, May 06, 2014, 19:32

Problems faced by Indian drug makers in the US are not related with quality but more due to documentation and data maintenance, a senior government official said Tuesday.

Ranbaxy's recalls 29,790 packs of anti-allergy drug in US

Last Updated: Friday, May 02, 2014, 17:03

Ranbaxy started recalling 29,790 packs of an allergy-relief medicine in the United States after finding defects in the packaging.

Glenmark recalls 2,904 bottles of Rantidine tablets in US market

Last Updated: Thursday, April 17, 2014, 17:54

Glenmark Pharmaceuticals is voluntarily recalling 2,904 bottles of Rantidine Tablets, used to treat ulcers of the stomach and intestines, in the US market, according to the US Food and Drug Administration.

Sun Pharma chief hopes the worst is over for Ranbaxy

Last Updated: Wednesday, April 09, 2014, 22:12

Sun Pharma would have to do a lot of work to get USFDA to revoke the ban on Ranbaxy facilities but it has not put any time-frame for this, company Chairman Israel Makov said Wednesday.