USFDA completes inspection of Lupin\'s Pithampur facility

USFDA completes inspection of Lupin's Pithampur facility

Lupin, on Friday, informed the exchanges of the completion of a US FDA inspection carried out at its Pithampur Unit-3 (Indore) facility.

The inspection was related to Good Manufacturing Practice (GMP) for the facility as well as a Pre-Approval Inspection (PAI) for the company’s Tiotropium DPI ANDA. The inspection at the site was conducted between October 8 and October 18.

The inspection closed with five observations. These observations are procedural in nature, it said. Shares of Lupin slipped 2 per cent at ₹877.60 on the BSE.

Published on October 19, 2018

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