The United States Food and Drug Administration (US FDA) has completed a product-specific pre-approval inspection at Lupin’s Chhatrapati Sambhajinagar (Aurangabad) manufacturing facility, issuing two observations.

In a stock exchange filing, the company said the inspection was carried out between September 1 and 5, 2025. Lupin added that it will address the observations and submit its response to the regulator within the stipulated timeframe, reiterating its commitment to maintaining compliance with current Good Manufacturing Practices (cGMP) across all facilities.

The development comes shortly after Lupin received US FDA approval for its Abbreviated New Drug Application (ANDA) for risperidone extended-release injectable suspension (25 mg, 37.5 mg, and 50 mg single-dose vials). This marks Lupin’s first product using proprietary technology from its subsidiary, Nanomi, and carries a 180-day Competitive Generic Therapy (CGT) exclusivity.

Nanomi is focused on the development of innovative long-acting injectable (LAI) medicines to improve health outcomes for patients.

Headquartered in Mumbai, Lupin is a global pharmaceutical company with a presence in more than 100 markets. Its portfolio spans branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company operates 15 manufacturing sites and seven research centres worldwide.