US health regulator

Lupin gets USFDA nod for cholesterol-lowering drug

Lupin gets USFDA nod for cholesterol-lowering drug

The product is a generic version of iPR Pharmaceuticals Inc's Crestor tablets, it added.

Aug 03, 2017, 16:12 PM IST
Zydus Cadila's anti-diabetic drug gets USFDA marketing nod

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.

 

Jul 04, 2017, 12:04 PM IST
USFDA issues 11 observations for Sun Pharma's Dadra facility

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.

Apr 22, 2017, 18:54 PM IST
USFDA to lift import alert on Sun Pharma's Mohali plant

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.

Mar 14, 2017, 15:02 PM IST
Demonetisation impact: Nifty ends below 8000; Sensex slumps for sixth day, down 385 points

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.

Nov 21, 2016, 16:51 PM IST
Lupin gets USFDA tentative nod for anti-bacterial tablets

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.

Sep 06, 2016, 16:15 PM IST

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.

Apr 01, 2016, 13:50 PM IST

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.

Mar 28, 2016, 16:15 PM IST
Zydus Cadila gets USFDA nod for anti-diabetics tablets

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.

Mar 01, 2016, 13:38 PM IST
Jubilant Life zooms 10% as firm gets USFDA nod for drug

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.

Dec 01, 2015, 15:02 PM IST
Unichem gets USFDA nod for hypertension treatment tablets

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.

Oct 16, 2015, 12:55 PM IST
Sun Pharma withdraws suit filed by Ranbaxy against USFDA

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.

Oct 09, 2015, 14:54 PM IST
Wockhardt surges 3% on USFDA nod to market pain-relieving drug

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.

Jun 22, 2015, 19:34 PM IST

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.

Jun 05, 2015, 19:22 PM IST

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.

Apr 09, 2015, 14:12 PM IST

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.

Mar 24, 2015, 14:20 PM IST

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.

Mar 18, 2015, 20:29 PM IST

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.

Jan 27, 2015, 13:16 PM IST

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.

Jan 06, 2015, 19:47 PM IST

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.

Nov 26, 2014, 19:44 PM IST