USFDA completes inspection at Lupin’s Indore facility

19 Oct 2018 Evaluate

The United States Food and Drug Administration (USFDA) has successfully completed inspection at Lupin’s Pithampur Unit-3, Indore facility in the state of Madhya Pradesh. The inspection was a GMP inspection for the facility and also a Pre-Approval Inspection (PAI) for the company's Tiotropium DPI ANDA. The inspection at the site was conducted between October 8, 2018 and October 18, 2018. The inspection closed with five observations. These observations are procedural in nature.

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.

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