Lupin's Indore Plant Gets 6 Observations After USFDA Inspection
Mumbai: Pharma major Lupin has announced the completion of a United States Food and Drug Administration (USFDA) inspection at its Pithampur Unit-2 manufacturing facility in Indore.
The inspection was conducted between January 14 and January 25, 2019. The company stated that the inspection concluded with six observations.
Lupin said it is confident of addressing the observations satisfactorily within the stipulated timeline.
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The Pithampur Unit-2 facility is part of Lupin’s manufacturing network catering to global markets, including the United States. Regulatory inspections by the USFDA are critical for pharmaceutical companies exporting products to the US market, as they assess compliance with current Good Manufacturing Practices (cGMP).
Lupin is a transnational pharmaceutical company engaged in developing and delivering a broad range of branded and generic formulations, biotechnology products, and active pharmaceutical ingredients (APIs) globally. The company has a significant presence in the cardiovascular, diabetology, asthma, pediatric, central nervous system (CNS), gastrointestinal (GI), anti-infective, and NSAID segments, and holds a global leadership position in the anti-TB space.
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