Lupin Gets U.S. Drug Regulator’s Observation For Tarapur API Facility
U.S. FDA has made a procedural deficiency observation after conducting its inspection between Aug. 27 to 31.
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Lupin Ltd. today said the U.S. Food and Drug Administration has issued one observation after completion of inspection at its Tarapur facility in Maharashtra.
“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 said in a regulatory filing.
The inspection focused on current good manufacturing practices compliance 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, it added.
Lupin said during the inspection, the U.S. FDA concluded that the manufacturing processes of Lupin ‘Sartans’ are safe with no chance of presence of the NDMA impurity in the APIs.
Shares of the drug maker were trading down 1.23 percent at Rs 923.30 apiece on the BSE at 12.59 p.m.