Lupin Shares Gain Focus After USFDA Clears Pithampur Facility

Lupin Limited’s shares are under scrutiny on January 9, 2025, following the receipt of an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Pithampur Unit-1 manufacturing facility. The EIR, issued with a Voluntary Action Indicated (VAI) classification, comes after a thorough inspection conducted from September 16 to September 27, 2024. The facility, which produces both active pharmaceutical ingredients (APIs) and finished products, is a critical part of Lupin’s operations.

The VAI classification indicates that while the FDA found issues during the inspection, they do not require immediate regulatory action. This outcome is seen as a positive development for Lupin, as it avoids the more severe Official Action Indicated (OAI) classification, which could have led to delays in product approvals or other regulatory hurdles.

In a related development, Lupin recently acquired the Huminsulin brand in India from Eli Lilly on December 30, 2024. The acquisition is aimed at bolstering Lupin’s diabetes portfolio. Huminsulin, used for treating type 1 and type 2 diabetes mellitus, is a significant addition to Lupin’s offerings, catering to both adults and children.

Emkay Global Financial has maintained a ‘buy’ rating on Lupin’s stock, with a target price of Rs 2,750, as stated in its research report dated December 30, 2024. The firm highlighted the strategic importance of the Huminsulin acquisition and the positive implications of the USFDA’s VAI classification for Lupin’s Pithampur facility.

Lupin’s stock performance is expected to remain in focus as investors weigh the implications of these developments. The company’s ability to navigate regulatory challenges and expand its product portfolio will be key factors influencing its market trajectory in the coming months.