NEW DELHI, Oct 19: 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.
(PTI)
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