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The Indian Pharmaceutical leader, Lupin Limited today said in the BSE filing, that the U.S. Food and Drug Administration (FDA) has issued one observation after completing the inspection at its Tarapur facility in Maharashtra.
Lupin released a statement in the regulatory filing, “The inspection closed with one observation, a procedural deficiency. The inspection at the site was conducted between Aug. 27 and Aug. 31 by three investigators.”
Lupin also added that the inspection was focused on the compliance in the current good manufacturing practices and also on the safety of Lupin’s Valsartan, Losartan and Irbesartan active pharmaceutical ingredients (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 (active pharmaceutical ingredient) supplied by some companies.
Lupin said after the inspection, the U.S. Food and Drug Administration reached the conclusion that the manufacturing processes of Lupin ‘Sartans’ are safe with no chance of the presence of the NDMA impurity in the APIs.
