Lupin's Madhya Pradesh Plant Receives USFDA Observations
The US Food and Drug Administration (USFDA) issued six observations following an inspection of Lupin’s Pithampur Unit-1 in Madhya Pradesh. The inspection, which took place from September 16-27, 2024, highlighted issues in both the API and finished product sections. Lupin is addressing these concerns and will respond within the stipulated timeframe.
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Drug firm Lupin announced that the US health regulator has issued six observations after inspecting its Madhya Pradesh-based manufacturing facility.
The US Food and Drug Administration (USFDA) inspected Lupin's Pithampur Unit-1 API and finished product manufacturing facility from September 16 to September 27, 2024, the company revealed in a regulatory filing.
The investigation concluded with three observations for both the API and finished product sections.
Lupin affirmed, 'We are addressing the observations comprehensively and will respond to the US FDA within the stipulated timeframe.'
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