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Reference Brand: ... Aurobindo adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes. But it is one that brings a history of quality issues when it comes to manufacturing, as exemplified in the latest thrashing by the FDA.

Lilly says it's "extremely well-positioned" to supply Olumiant if granted an emergency use authorization from the FDA in COVID-19.So far in phase 3 testing, Pfizer has seen a "mostly mild to moderate” safety profile, with rare instances of severe or grade 4 side effects.Enclose phrases in quotes. The Food and Drug Administration announced Aurobindo Pharma USA, Inc. is voluntarily recalling 80 lots of Amlodipine Valsartan Tablets, Valsartan HCTZ Tablets, and Valsartan Tablets.The impurity involves a chemical called N-nitrosodiethylamine (NDEA), which the FDA describes as a "substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen. Losartan Potassium 50 mg Film Coated Tablet Bottle 1,000 Tablets Aurobindo Pharma 65862020299 The nationwide voluntary recall of high blood pressure drug in the US by the Indian drug manufacturing companies continues as federal investigations discovered potential cancer-causing impurities in them.The US Food and Drug Administration (FDA) recently said that AurobindoPharma USA, Inc has expanded its voluntary recall of medicines used for treating blood pressure to the consumer level. Register for the ESMO Post Show Virtual RoundtableWhen Aurobindo forked over $1 billion to snap up some of Novartis’ unwanted drugs last year, it set the Indian drugmaker up to be the second-largest generics player in the U.S. "To date, the company says it has not received any reports of patients suffering adverse effects related to the recall.The FDA is advising patients prescribed these medications to continue to take them, as the health risks may be higher if the treatment is stopped immediately without any alternative treatment. Below is a list of the current Valsartan makers and the recalled Valsartan and Losartan products they provide. Aurobindo is recalling lots of valsartan-containing medication that tested positive for NDEA above the interim acceptable daily intake level of 0.083 parts per million. | Technical / White Paper Accelerated development of first-in-human programs. To date, AurobindoPharma USA, Inc has not received any reports of adverse events related to this recall.Amlodipine and Valsartan Tablets USP and Valsartan Tablets USP are indicated to control high blood pressure and for the treatment of heart failure.Recently, Ahmedabad-based Torrent Pharmaceuticals Limited has also initiated a voluntary recall of 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the presence of another probable cancer-causing impurity N-Methylnitrosobutyric acid (NMBA) found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Ltd.Torrent is recalling Losartan-containing products that contain NMBA above the acceptable daily intake levels released by the FDA.Losartan is used to treat hypertension, hypertensive patients with left ventricular hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Hurricane Sally unleashes "catastrophic and life-threatening" floodingTrump says CDC director "made a mistake" on vaccine timeline19-year-old helicopter pilot helps fight California wildfiresChildren of color are dying from COVID-19 at higher ratesSalt Lake City cop charged after ordering K-9 to bite Black manTrump health aide taking leave of absence after targeting CDC scientistsPolice leaders pressed Rochester to keep Prude video secretTrump appears to contradict earlier remarks on killing Syria's leaderPelosi pushes against Dems frustrated over COVID relief negotiationsBattleground Tracker: Latest polls, state of the race and more5 things to know about CBS News' 2020 Battleground TrackerRepublicans see U.S. as better off now than 4 years ago: CBS News pollWith more mail-in ballots, officials urge patience on election nightAmericans and the right to vote: Why it's not easy for everyoneDemocrats are happy with Biden's VP pick: CBS News pollWhy some mail-in ballots are rejected and how to make sure your vote countsWhat happens if the president doesn't accept the election results?Election Day could turn into "Election Week" with rise in mail ballots Since July, recalls involving multiple companies and products have been announced, due to the presence of NDMA in active pharmaceutical ingredient (API) supplied by manufacturer Zhejiang Huahai Pharmaceutical Co Ltd, in Linhai, Taizhou Zhejiang, China.

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