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US health regulator
US health regulator News
Drug firm Lupin
03 Aug 2017
Lupin gets USFDA nod for cholesterol-lowering drug
The product is a generic version of iPR Pharmaceuticals Inc's Crestor tablets, it added.
New Delhi
04 Jul 2017
Zydus Cadila's anti-diabetic drug gets USFDA marketing nod
The group now has nearly 120 approvals from the USFDA and so far filed 300 abbreviated new drug applications (ANDAs), Cadila Healthcare said.
Sun Pharmaceutical Industries
22 Apr 2017
USFDA issues 11 observations for Sun Pharma's Dadra facility
Drug major Sun Pharmaceutical Industries has received 11 observations from the US health regulator after inspection of its Dadra facility.
US health regulator
14 Mar 2017
USFDA to lift import alert on Sun Pharma's Mohali plant
The US health regulator has proposed to lift the import alert on Sun Pharma's Mohali (Punjab) based manufacturing plant.
Sensex
21 Nov 2016
Demonetisation impact: Nifty ends below 8000; Sensex slumps for sixth day, down 385 points
The market on Monday remained under pressure as the Sensex was down 385.10 points or 1.47 percent at 25765.14 and the Nifty down 145 points or 1.80 percent at 7929.10, erasing all 2016 gains.
Lupin
06 Sep 2016
Lupin gets USFDA tentative nod for anti-bacterial tablets
Drug firm Lupin has received tentative approval from the US health regulator to market its generic anti-bacterial moxifloxacin hydrochloride tablets in the American market.
Aurobindo Phrama
01 Apr 2016
Aurobindo Pharma gets final USFDA nod for anti-viral drug
Aurobindo Pharma has received final approval from the US health regulator to manufacture and market anti-viral Valganciclovir tablets in the American market.
Glenmark Pharmaceuticals
28 Mar 2016
Glenmark gets two ANDA approvals from USFDA
Glenmark Pharmaceuticals has received final approval from the US health regulator USFDA for oral contraceptives and leukemia treatment injection.
Zydus Cadila
01 Mar 2016
Zydus Cadila gets USFDA nod for anti-diabetics tablets
Drug firm Zydus Cadila has received final nod from the US health regulator to sell anti-diabetics Glyburide and Metformin Hcl tablets in the American market.
Jubilant Life Sciences
01 Dec 2015
Jubilant Life zooms 10% as firm gets USFDA nod for drug
Jubilant Life Sciences shares soared almost 10 per cent, to touch its 52-week high level today, as the company received final approval from the US health regulator for its generic version of anti-depressant Paxil tablets.
Drug firm Unichem Laboratories
16 Oct 2015
Unichem gets USFDA nod for hypertension treatment tablets
Pharmaceutical firm Unichem Laboratories has received US FDA approval for the Losartan Potassium tablets used in treatment of hypertension.
Sun Pharmaceutical
09 Oct 2015
Sun Pharma withdraws suit filed by Ranbaxy against USFDA
The lawsuit challenged FDA's revocation of Ranbaxy's tentative approvals for its generic versions of Nexium and Valcyte in the US.
Wockhardt
22 Jun 2015
Wockhardt surges 3% on USFDA nod to market pain-relieving drug
Shares of drug firm Wockhardt rose by nearly 3 percent on Monday as the company received approval from the US health regulator to market its Oxycodone HCl liquid, used for treating chronic pain, in the American market.
drug firms
05 Jun 2015
Two drugs manufactured by Wockhardt recalled in the US
According to information on the US Food and Drug Administration (USFDA) website, 166 bottles of Captopril tablets of 50 mg strength are being recalled in the US.
Aurobindo Pharma
09 Apr 2015
Aurobindo gets USFDA nod for Atracurium Besylate injections
Drug major Aurobindo Pharma has received final approval from the US health regulator to manufacture and market Atracurium Besylate injections in the American market.
Aarti Drugs
24 Mar 2015
USFDA issues import alert on two plants of Aarti Drugs
Aarti Drugs on Tuesday said its two manufacturing facilities have received import alert from the US health regulator, a development which could impact the company's exports to the American market.
USFDA
18 Mar 2015
Indian companies not singled out for inspections, says USFDA
The US health regulator said it is looking to increase training and joint inspections in various areas, including manufacturing while also discussing possibility of information sharing with Indian officials.
Ranbaxy
27 Jan 2015
Ranbaxy forfeits 180 days exclusivity for stomach drugs
Drug major Ranbaxy on Tuesday said that the US health regulator has "determined" that the Indian drug manufacturer has forfeited its 180 days exclusivity for stomach and esophagus problems treatment tablets.
Hypertension drug
06 Jan 2015
Aurobindo, Lupin & Jubilant get USFDA nod for hypertension drug
Three domestic firms, Aurobindo Pharma, Lupin and Jubilant Life Sciences, have received final approval from US health regulator to sell generic copies of Valsartan tablets used for treatment of hypertension.
Dr Reddy's
26 Nov 2014
Dr Reddy's plant gets USFDA fiat on suspected lapses
The company is in the process of responding to the FDA's observations, a Dr Reddy's spokesperson said.
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