The inspection focused on cGMP compliance and also on the safety of Lupin's Valsartan, Losartan and Irbesartan APIs (commonly known as 'Sartans') in light of the safety alert issued by Regulatory Authorities on the NDMA (classified as a probable human carcinogen) impurity in Valsartan API supplied by some companies. During the inspection, the US FDA concluded that the manufacturing processes of Lupin 'Sartans' are safe with no chance of presence of the NDMA impurity in the APIs.
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