Latest news with #EstablishmentInspectionReport
Business Standard
26-05-2025
- Business
- Business Standard
Cohance Lifesciences' API Unit-IV clears USFDA inspection
Cohance Lifesciences has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for the inspection conducted at its API Unit-IV, located at Plot No. A-21, Road No. 10, IDA Nacharam, Uppal Mandal, Medchal-Malkajgiri, Telangana, India, from 03 March 2025 to 07 March 2025. The inspection was classified as Voluntary Action Indicated (VAI) and indicates the formal closure of the inspection process by the USFDA.
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.
India Today
15-05-2025
- Business
- India Today
Stocks to watch on May 15: Infosys, SBI, Yes Bank, IREDA, Eicher Motors
Stock markets traded in a narrow range on Wednesday, a day after falling sharply. However, they managed to close slightly higher by the end of the session, buoyed by gains in metals, IT, and broader market May 15, several companies will be in focus due to important announcements, including quarterly results, strategic updates, and regulatory are the key stocks to watch:INFOSYSInfosys has completed the sale of its stake in a joint venture in Japan. The joint venture, known as HIPUS, was led by Infosys and operated in partnership with Mitsubishi Heavy Industries. This marks the end of Infosys's direct involvement in the Bank of India (SBI) will be in focus as its board will meet on May 20 to consider raising up to $3 billion through a public offer or other foreign currency instruments in the financial year 2025–26. This move is aimed at supporting its international operations and future BANKYes Bank may see movement after Moody's Ratings called Sumitomo Mitsui Banking Corporation's (SMBC) planned purchase of a 20% stake in the bank a credit positive move. Moody's noted that the partnership would bring in a strong long-term investor with a solid financial base, which could help Yes Bank grow more AND GENSOL ENGINEERINGThe Indian Renewable Energy Development Agency (IREDA) has filed a bankruptcy application against Gensol Engineering over a loan default. Gensol owes IREDA Rs 510 crore (about $59.73 million). The move could lead to further legal proceedings and will be closely watched by MOTORSEicher Motors, the parent company of Royal Enfield, announced that the two-wheeler brand recorded its highest-ever quarterly sales. Royal Enfield sold 2,80,801 units in the fourth quarter of FY25, marking a 23.2% increase over the same period last POWERTata Power is planning to spend Rs 25,000 crore as capital expenditure in FY26. CEO Praveer Sinha also said that the company is interested in bidding for two electricity distribution companies (discoms) in Uttar Pradesh. This signals Tata Power's aim to expand its power distribution FORGEBalu Forge Industries reported a strong 123% year-on-year growth in net profit for the fourth quarter, reaching Rs 63 crore compared to Rs 28 crore in the same period last ENTERPRISESReal estate company Brigade Enterprises reported a 20% growth in net profit for the quarter ending March 31, 2025. The profit came in at Rs 246.8 crore, showing healthy demand in the housing and commercial property MEDICAREShilpa Medicare said its Unit-1, run by its arm Shilpa Pharma Lifesciences, has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA). The site has been classified under Voluntary Action Indicated (VAI), which means there are some issues, but they do not need an immediate fix and will not affect the approval of drug Unilever (HUL) received a 'no adverse observation' letter from both the NSE and BSE regarding its scheme of arrangement with Kwality Wall's India. This clears a regulatory step and allows the company to move forward with its plan.Q4 RESULTS TODAYSeveral companies will report their March quarter results on May 15, including LIC Housing Finance, PB Fintech, Abbott India, Allied, Blenders and Distillers, Balrampur Chini Mills, CESC, Crompton Greaves Consumer Electricals, Endurance Technologies, Gujarat Mineral Development Corporation, Godfrey Phillips India, Godrej Industries, G R Infraprojects, INOX India, ITC Hotels, JSW Energy, Kaynes, Technology India, Medi Assist Healthcare Services, NCC, Patanjali Foods, Tube Investments of India, Websol Energy System, and Welspun Enterprises advertisement
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.
Mint
15-05-2025
- Business
- Mint
Stocks to watch: Tata Power, Eicher Motors, HUL, SBI, Infosys among shares in focus today
Shares of ITC Hotels, JSW Energy, and Cochin Shipyard are expected to be in the spotlight as these companies are set to release their fourth-quarter earnings. The IT services firm has finalized the sale of its stake in HIPUS, a joint venture in Japan led by Infosys, to Mitsubishi Heavy Industries. Tata Power plans to invest ₹ 25,000 crore in capital expenditure for FY26 and is also interested in bidding for two distribution companies in Uttar Pradesh, according to CEO Praveer Sinha. Royal Enfield recorded its highest-ever quarterly sales in Q4 FY25, with 2,80,801 units sold—marking a 23.2% increase compared to the same quarter last year, according to parent company Eicher Motors. The company has received an observation letter from both BSE and NSE stating that there are "no adverse observations" regarding its Scheme of Arrangement with Kwality Wall's India. State Bank of India is set to deliberate on raising up to $3 billion through a public offering or other currency options for the financial year 2025–26 on May 20. IREDA submitted an insolvency petition against Gensol Engineering over a loan default of ₹ 510 crore. Shilpa Medicare announced that Unit-1 of its subsidiary, Shilpa Pharma Lifesciences, has received an Establishment Inspection Report (EIR) from the US FDA. The facility has been classified under the Voluntary Action Indicated (VAI) category. Brigade Enterprises, a real estate company, announced a 20% year-on-year increase in net profit, reaching ₹ 246.8 crore for the quarter ending March 31, 2025. Disclaimer: This story is for educational purposes only. The views and recommendations above are those of individual analysts or broking companies, not Mint. We advise investors to check with certified experts before making any investment decisions.
