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News: USFDA has closed the inspection at Lupin’s Tarapur manufacturing facility with four observations. The inspection was carried out between March 22, 2022 and April 4, 2022
Views: Tarapur facility was placed under USFDA OAI status from January,2020 after it received three observations during USFDA inspection in September,2019. Tarapur is a fermentation and chemical synthesis based multi-product API manufacturing facility, although management indicated at Nagpur facility procuring newer APIs from Vizag facility and older ones from Tarapur and Dabhasa facility, we believe further observations post Lupin's remediation measures reflect poorly and extended USFDA compliance issues at multiple facilities are affecting Lupin's utilisation of assets for the US
Impact: Negative