Enforcing A Belated Chemistry Lesson – The Nitrosamines In Sartans Saga

How authorities plan to root out the carcinogenic impurities and what it means for other classes of medicines.

Lantech
Solvent recovery operations are a major point of concern • Source: Lantech Pharmaceuticals

When Swissmedic and US Food and Drug Administration investigators converged in March on Lantech Pharmaceuticals Ltd.’s solvent recovery facility near National Highway 16 along India’s east coast, they were on a mission to drive probable human carcinogens out of some of the world’s most popular blood pressure medications.

By tanker truck, the solvent recycler is just a few minutes across Surampeta Road from Aurobindo Pharma Ltd.’s Unit XI active pharmaceutical ingredient manufacturing plant, which the FDA had visited the month before. That’s when Aurobindo pointed to the undisclosed contract solvent recovery facility as the likely source of nitrosamines in its API

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