USFDA finds issues at Lupin's Pune biotech plant

Business Sep 20, 2025

The US FDA recently found four observations during an inspection at Lupin's Pune biotech facility, which wrapped up on September 19, 2024.
Lupin says it's on it—they'll address the concerns and respond within the required timeline to stay in line with good manufacturing practices.

Despite the hiccups, Lupin continues to thrive globally

Even with these hiccups, Lupin is still a big name worldwide, operating in over 100 markets.
On September 18, 2024, they got FDA approval for their Lenalidomide Capsules (2.5 mg to 25 mg), showing they're keeping momentum despite some bumps along the way.