New Delhi Drug firm Lupin on Saturday said the US health regulator has issued six observations after inspecting its Madhya Pradesh-based manufacturing facility.
The US Food and Drug Administration (USFDA) inspected the company’s Pithampur Unit-1 API and finished product manufacturing facility from September 16 to September 27, 2024, Lupin said in a regulatory filing.
The inspection closed with three observations each on the API and finished product side, it added.
“We are addressing the observations comprehensively and will respond to the US FDA within the stipulated timeframe,” the Mumbai-based drug maker said.
