Lupin gets US FDA report for Pithampur unit; shares jump 2%

Share of Mumbai-based pharmaceutical major Lupin Limited shares surged as much as 1.79% to reach ₹2,292.90 apiece on the BSE after receiving an Establishment Inspection Report (EIR) from the US Food and Drugs Administration (US FDA) for its Pithampur Unit-1 manufacturing facility. The company's Pithampur manufacturing unit produces both APIs (Active Pharmaceutical Ingredients) and finished products.

The company’s shares opened higher at ₹2,284.95 against the previous closing price of ₹2252.40 on the BSE. At the time of reporting, the shares were trading 0.04% higher at ₹2,253.35 apiece on the BSE.

“The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024,” Lupin states.

EIR is a report generated by regulatory authorities after an AI-led inspection of a manufacturing unit, detailing the inspection findings, including compliance issues.

“We are pleased to receive the EIR from the US FDA for our Pithampur Unit-1 facility with a satisfactory VAI classification. This reflects our commitment to the highest standards of quality and compliance," says Nilesh Gupta, managing director, Lupin.

While some issues were identified during the inspection, VAI notes that they’re not significant enough to necessitate immediate regulatory actions like a warning letter.

Recently, Lupin announced the acquisition of Huminsulin in India from Eli Lilly and Company (Lilly) to boost its diabetes portfolio. The company noted that the Huminsulin range of products is indicated for the treatment of type 1 and type 2 diabetes mellitus to improve blood sugar control in both adults and children. Insulin treatment is the cornerstone of type 1 diabetes management and often becomes necessary over time in type 2 diabetes as the disease progresses.

Lupin reported 74% rise in consolidated net profit to ₹853 crore for the July-September quarter of FY25, up from ₹489.67 crore in the same period last year. Revenues increased by 12.6% to ₹5,672.73 crore from ₹5,038.56 crore last year.