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MARKET INTEL by PharmaCompass
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By PharmaCompass
2019-03-07
Impressions: 116 Article
Nitrosamine impurities continue to worry the US drug supply chain — last week, the FDA found a third cancer-causing substance in losartan potassium tablets made by India’s Hetero Labs and distributed by New Jersey-based Camber Pharmaceuticals.
Known as N-Nitroso N-Methyl 4-amino butyric acid (NMBA), trace amounts of this new impurity were detected in the active pharmaceutical ingredient (API) manufactured by Hetero Labs’ Unit-1 situated in Telangana (India).
Hetero Labs issued a fresh recall of 87 lots of losartan potassium tablets up to the consumer level due to the detection of this third nitrosamine impurity.
The FDA said this recall is “the first ARB (angiotensin II receptor blocker) recall resulting from the presence of NMBA”.
The FDA’s evaluation suggests that the nitrosamines found in ARBs may be generated when specific chemicals and reaction conditions are present in the manufacturing process of the drug’s API, and may also result from the reuse of materials, such as solvents.
Meanwhile, Torrent Pharmaceuticals Limited has expanded its recall to include 114 additional lots of losartan potassium and losartan potassium/hydrochlorothiazide tablets due to the presence of NMBA in the losartan API manufactured by Hetero Labs.
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