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US FDA Warning Letter Draws Indian Solvent Recycler Into Valsartan Crisis

 
• By Joanne S. Eglovitch

Lantech’s solvent recovery operations expected to meet US drug GMP requirements due to risk of carcinogens in blood pressure medications.

Blood pressure
FDA Going After Solvent Suppliers In Addressing Tainted Blood Pressure Medicines • Source: Shutterstock

The US Food and Drug Administration has issued a warning letter to Lantech Pharmaceuticals Ltd. for failing to adequately evaluate the presence of nitrosamine impurities in solvents it recovered for use in manufacturing angiotensin II receptor blockers (ARBs) such as valsartan, and failing to control and monitor procedures to recover solvents to ensure that they meet appropriate standards before they are reused.

By targeting the solvent recycler, the agency is demonstrating a willingness to extend its enforcement of US drug good manufacturing practices requirements beyond the active pharmaceutical ingredient and drug product firms involved, at least in the high profile matter of the

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