Diabytes
US health regulator News
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The product is a generic version of iPR Pharmaceuticals Inc's Crestor tablets, it added.
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The group now has nearly 120 approvals from the USFDA and so far filed 300 abbreviated new drug applications (ANDAs), Cadila Healthcare said.
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Drug major Sun Pharmaceutical Industries has received 11 observations from the US health regulator after inspection of its Dadra facility.
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The US health regulator has proposed to lift the import alert on Sun Pharma's Mohali (Punjab) based manufacturing plant.
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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.
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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.
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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 has received final approval from the US health regulator USFDA for oral contraceptives and leukemia treatment injection.
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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.
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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.
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Pharmaceutical firm Unichem Laboratories has received US FDA approval for the Losartan Potassium tablets used in treatment of hypertension.
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The lawsuit challenged FDA's revocation of Ranbaxy's tentative approvals for its generic versions of Nexium and Valcyte in the US.
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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.
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.
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 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.
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.
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.
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.
The company is in the process of responding to the FDA's observations, a Dr Reddy's spokesperson said.
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