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US health regulator
US HEALTH REGULATOR NEWS
Glenmark Pharma gets tentative nod from USFDA for acne treatment drug
June 20, 2019 11:18 am
Glenmark Pharmaceuticals, USA, has been granted tentative approval by the United States Food and Drug Administration (USFDA) for Clindamycin Phosphate Foam, 1 per cent, the company said in a BSE filing.
Flies in Ranbaxy’s Toansa plant’s sample storage room: USFDA
January 27, 2014 3:02 am
Other alleged lapses included usage of un-calibrated and unqualified instruments in lab.
USFDA raises concerns over Ranbaxy’s Toansa plant
January 14, 2014 4:38 am
The USFDA has imposed ban on import of medicines manufactured at Ranbaxy’s India-based factories into the US, the world’s biggest drug market.
Wockhardts Chikalthana plant hit by US import curbs
November 28, 2013 1:33 am
The company had said it would take an annual hit of $100 million due to the import alert.
Ranbaxy posts loss in Q3 on forex woes
October 30, 2013 2:09 am
The company had pleaded guilty in May to US felony charges related to drug safety and agreed to a record $500 million in fines.
US to hike fees for generic drugmakers; Indian firms to be hit
August 12, 2013 1:12 am
Many Indian drugmakers will soon have to bear higher costs for sale of products in American markets
Lupin,DRL,Sun get nod for generic drug
March 29, 2012 12:43 am
Three Indian drug majors,Lupin,Dr Reddys,Sun Pharma have got approvals from the US health regulator to sell generic quetiapine fumarate tablets,used in treating mental disorders,in the US
Lupin recalls blood pressure drug from the US market
August 08, 2011 11:22 pm
Drug firm Lupin is recalling one batch of Losartan Potassium Tablets,used in treating high blood pressure.
Aurobindo Pharma stock plunges 9%
May 23, 2011 7:01 pm
Aurobindo Pharma stock tumbled after it received a warning letter from the US health regulator.
US warns Aurobindo Pharma for violations
May 23, 2011 3:10 pm
Drug-maker Aurobindo Pharma today said it has received a warning letter from the US health regulator with regard to its antibiotics manufacturing unit in Hyderabad.
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