Shares of Lupin Ltd surged over 2% on February 24 after the company announced that it has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its Somerset, New Jersey manufacturing facility. The stock climbed to ₹1,944, gaining ₹38.65 in intraday trade, reflecting positive investor sentiment following the regulatory development.
The US FDA conducted an inspection at Lupin’s Somerset facility from January 27 to January 31, 2025, as part of its routine compliance check to assess adherence to current Good Manufacturing Practices (cGMP). Following the successful completion of the inspection, the EIR was issued, confirming that the facility meets the regulatory standards required for manufacturing and distributing pharmaceutical products in the US market.
An EIR is a critical approval document in the pharmaceutical industry, indicating that the facility has cleared regulatory scrutiny. This strengthens Lupin’s standing in the US market, ensuring uninterrupted production and supply of its drugs. The Somerset plant is a key unit for Lupin, manufacturing both branded and generic formulations targeted at the US healthcare sector.
Lupin’s Managing Director, Nilesh Gupta, expressed satisfaction with the development, stating, “We are very pleased to have received the EIR for our Somerset facility. This milestone underscores our commitment to upholding the highest standards of quality and compliance, solidifying our position as a leading pharmaceutical manufacturer.”
Lupin has a strong global footprint, operating in over 100 markets with a focus on complex generics, biotechnology products, and active pharmaceutical ingredients (APIs). The company runs 15 manufacturing facilities and seven research centers worldwide, maintaining regulatory compliance across multiple geographies.
In the latest session, Lupin’s stock traded in the range of ₹1,880 – ₹1,945.80, with a market capitalization of ₹887.38 billion. The stock has been gaining traction in recent months, benefiting from positive regulatory approvals, expansion plans, and growing demand in international markets.
Stock Details:
- Previous Close: ₹1,905.35
- Day Range: ₹1,880.00 – ₹1,945.80
- 52-Week Range: ₹1,493.30 – ₹2,402.90
- Market Cap: ₹887.38 billion
- P/E Ratio: 31.02
- Dividend Yield: 0.41%
The regulatory clearance is expected to further bolster investor confidence, as Lupin continues to strengthen its presence in the US pharmaceutical market, which remains a key revenue driver for the company.
