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The Lupin’s Tarapur API facility received one observation on account of cGMP deficiency

Lupin is India’s third largest drug manufacturing company. The Tarapur API manufacturing facility of Lupin has received one observation by USFDA. The Tarapur facility produces fermentation based APIs. USFDA conducted the inspection of the site from 27th August to 31ST August. The inspection was carried out by three USFDA inspectors. One observation related to procedural deficiency was cited by the investigators. The investigators during the inspection were focused on cGMP compliance and also on the safety of Lupin’s Valsartaan, Losartan and Irbesartan APIs, commonly known as Sartans ;). This was due to safety alert issued by Regulatory Authorities on the NDMA (N-Nitrosodimethylamine, a potent human carcinogen) impurity in Valsartan API supplied by some companies. After the inspection, USFDA investigators found that the manufacturing processes of Lupin’s Sartans are safe with no chance of presence of the NDMA impurity in the APIs.