USFDA issues observation after inspection at Lupin’s Tarapur facility

NEW DELHI, Sept 4: Drug firm Lupin Tuesday said the US health regulator 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 August 27-31, 2018, by three U S Food and Drug Administration (USFDA) investigators,” Lupin said in a regulatory filing.
The inspection focused on current good manufacturing practices (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, it added.
Lupin said during the inspection, the USFDA concluded that the manufacturing processes of Lupin ‘Sartans’ are safe with no chance of presence of the NDMA impurity in the active pharmaceutical ingredients (APIs).