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Lupin gets 5 observations from USFDA for Pithampur plant

twitter-logo PTI        Last Updated: October 19, 2018  | 15:42 IST

New Delhi, Oct 19 (PTI) Drug maker Lupin said Friday the US Food and Drug Administration has issued five observations after inspecting its Pithampur based manufacturing unit, sending its shares down by close to 2 per cent. The inspection at Pithampur Unit-3 (Indore) was a GMP inspection for the facility and also a Pre-Approval Inspection (PAI) for the company’s Tiotropium DPI ANDA (abbreviated new drug application), Lupin said in a statement. The inspection at the site was conducted between October 8 and October 18, 2018, it added. "The inspection closed with five observations. These observations are procedural in nature," Lupin said. Shares of the company dropped 1.89 per cent to Rs 878.65 in preclose session on BSE. PTI MSS MR MR

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