| Technical / White Paper Accelerated development of first-in-human programs. The presented program is laid out as integrated Drug Substance, Particle Engineering and Drug Product services, enabling drug substance and drug product... | Product Presentation Lonza | 25-Aug-2020 FDA scientists concluded there would be one more cancer case above average rates for every 8,000 people on the highest dose of valsartan for four years. Lonza’s SimpliFiH® Solutions NMBA is a "potential human carcinogen," the The recall comes amid a larger string of recalls of blood pressure medications valsartan, losartan and irbesartan that contain trace levels of carcinogens NMBA, N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), the FDA says.Hundreds of lots of the medication have been recalled since last July.The drugs, angiotensin II receptor blockers (ARBs), work by widening or relaxing blood vessels, thus lowering blood pressure. "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. 4 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. Stress has been called the ‘health epidemic of the 21st century’ by the World Health Organization. Lupin Pharmaceuticals, the third largest Indian pharma company, issued a regulatory filing announcing that it had been inspected by the US Food and Drug Administration (FDA) between August 27 and August 31, 2018.The inspection looked into Lupin’s current good manufacturing practices (cGMP), but also had another focus; the agency examined Lupin’s ‘sartan’ active pharmaceuticals ingredients (APIs), including valsartan, losartan, and irbesartan.The decision to observe the manufacturing procedure of the sartan products occurred as issues have been found in the production of valsartan among The FDA did not find any issues at Lupin’s facility in Tarapur, Indian.
© 2020 USA TODAY, a division of Gannett Satellite Information Network, LLC. The US FDA’s inspection of Lupin gave its manufacturing process for its ‘sartan’ products the all clear but managed to find one “procedural deficiency”. The company stated in a release : “the US FDA concluded that the manufacturing processes of Lupin ‘sartans’ are safe with no chance of presence of the NDMA [N-Nitrosodimethylamine] impurity in the APIs.”
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. | Sponsored Link Indena | 10-Mar-2020 Tests found trace amounts of … However, not all ARBs have been affected, and patients should continue to use their medication, the FDA says. Since July 2018, multiple companies have voluntarily recalled products containing valsartan, irbesartan, and losartan, stemming from concerns about levels of impurities, including NDEA and NMBA. Ingredia | 27-Aug-2020 The recall comes amid a larger string of recalls of blood pressure medications valsartan, losartan and irbesartan that contain trace levels of carcinogens NMBA, N-Nitrosodimethylamine (NDMA…
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