Latest news with #ShilpaPharmaLifesciences
Business Standard
15-05-2025
- Business
- Business Standard
Shilpa Medicare gains after arm receives EIR from USFDA for unit-1 facility
Shilpa Medicare rose 4.08% to Rs 722.50 after the company's subsidiary, Shilpa Pharma Lifesciences, has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its Unit-1 manufacturing facility. In an exchange filing, the company stated that the USFDA has classified the inspection outcome as voluntary action indicated (VAI). The inspection was conducted at the Unit-1 facility from 3 March to 7 March 2025. The official announcement was made on 14 May 2025, after market hours. Shilpa Medicare is a manufacturer of API, formulation, and development services. Shilpa Medicare (SML) started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka, India. The company had reported a consolidated net profit of Rs 31.78 crore in Q3 FY25, which is significantly higher as compared with the PAT of Rs 4.58 crore posted in Q3 FY24. Revenue from operations for the third quarter was at Rs 319.32 crore, up 11.35% year on year.
Business Upturn
15-05-2025
- Business
- Business Upturn
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.
