Shilpa Medicare shares climb nearly 4% after USFDA EIR for subsidiary, gains European GMP nod for biologics unit
By Aditya Bhagchandani Published on May 15, 2025, 09:20 IST
Shares of Shilpa Medicare rose 3.86% to ₹721.75 on the NSE in early trade on Wednesday after the company announced multiple regulatory approvals across its units. The stock opened at ₹701.20 and touched an intraday high of ₹729.45, driven by investor optimism around recent global clearances.
The company disclosed that its subsidiary, Shilpa Pharma Lifesciences (Unit-1), received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) following an inspection conducted from March 3–7, 2025. The site was classified as Voluntary Action Indicated (VAI), indicating compliance with the agency's expectations.
Additionally, Shilpa Biologics' manufacturing site in Dharwad, Karnataka, secured a European GMP certification earlier this month. The certification came after an inspection by the Austrian competent authority between February 18–20, 2025, which concluded with zero observations.
In another strategic development, Shilpa Biologicals signed a binding term sheet with Switzerland-based mAbTree Biologics AG in March 2025 for the development, production, and commercialisation of a new biological entity (NBE).
The stock currently trades near ₹721.75 with a market capitalization of ₹70,510 crore. It has seen a 52-week high of ₹959.50 and a low of ₹417.60, reflecting continued investor interest in the company's growing global footprint in both generics and biologics.
Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
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