The inspection of the plant in February came just weeks after Aurobindo recalled 80 lots of valsartan because of the detection of N-nitrosodiethylamine (NDEA) one of the impurities. Aurobindo blames the problem on ingredients it bought from a contractor and poor cleaning procedures, but the FDA says the company did not do enough to get to the root cause. Site provides product details, company profile and information to the six manufacturing facilities in India. A recall of common blood pressure medication losartan has been expanded for a fifth time after manufacturer Torrent Pharmaceuticals found a possibly carcinogenic impurity in more batches of the drug, federal health officials said.Three additional lots of losartan potassium tablets and two additional lots of losartan potassium/hydrochlorothiazide tablets were The lots contained levels of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the acceptable daily intake levels determined by the FDA. "The risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment," federal health officials wrote in a statement.The FDA has said the contaminants likely resulted from a manufacturing change adopted by factories in China and India that make the drug ingredients. The discovery has led to a global recall of hundreds of lots and millions of bottles of the commonly prescribed blood pressure meds valsartan, losartan and Irbesartan. Aurobindo gets warning letter over valsartan recall messNovartis, stressing Beovu safety, matches Eylea in head-to-head diabetic macular edema trialMDLive raises $50M to build out telehealth platform5 Home Health startups to watch at INVEST Digital Health virtual Sept 21-25Pharma scores modest boost in annual image poll, hands last place back to the fedsMerck, Seattle Genetics form partnerships worth $4.5B focused on two cancer drugs Now the FDA has savaged it in a warning letter for missteps that paved the pathway to the mess. In April, Teva and Torrent recalled more than 350 lots of tainted Losartan. Biopharma is a fast-growing world where big ideas come along daily. India’s Aurobindo Pharma has been one of the culprits found manufacturing the high blood pressure medicine valsartan with high levels of impurities that carry a risk of cancer. When 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. © Copyright 2017 Winway.me. 2019-01-01 20:38:00. Aurobindo Recalls 80 Lots of Valsartan Tablets. Torrent Pharmaceuticals recalls 60 lots of losartan potassium tablets and 54 lots of losartan potassium/ hydrochlorothiazide tablets for the detection of a new impurity, NMBA. Manufacturers and exporters of bulk drugs, formulations, and oral suspensions. All Right Reserved In April, Teva and Torrent recalled more than 350 lots of tainted Losartan.
It says the risk from heart problems is greater than the risk of getting cancer from the impurities. © 2020 USA TODAY, a division of Gannett Satellite Information Network, LLC. The manufacturing change may generate the contaminants "when specific chemicals and reaction conditions are present" and can result of reusing materials such as solvents.In January, the agency admitted that some versions of the drug valsartan contained However, FDA officials said the cancer risk for any person who took valsartan that had the carcinogen N-nitrosodimethylamine, or NDMA, is small. You updated the information in your Drug Master File (DMF) only after FDA investigators communicated during the inspection that you should be reporting all observed impurities above the reporting threshold.”The FDA ordered the company to do a risk assessment for all the API and intermediates manufactured at the facility to check for the potential presence of the impurities.Aurobindo is one of a number of companies whose products have been found tainted. Torrent Pharmaceuticals Ltd. has expanded its recall of losartan potassium and losartan potassium/hydrochlorothiazide tablets. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. National authorities in the EU are currently considering whether to recall medicines containing Aurobindo Pharma’s irbesartan from pharmacies as a precaution.
Sign up today to get pharma news and updates delivered to your inbox and read on the go.The FDA last year determined that the suspected carcinogens NDMA, NDEA and NMBA, can form through specific and commonly used manufacturing processes that involve using certain solvents.
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