Latest news with #Pre-ApprovalInspection


Business Standard
21-07-2025
- Business
- Business Standard
Stock Alert: Reliance Industries, HDFC Bank, ICICI Bank, Yes Bank, Dr Reddys Lab
Securities In F&O Ban: Angel One, Bandhan Bank, Hindustan Copper and RBL Bank shares are banned from F&O trading on 21 July 2025. Upcoming Results: Agi Greenpac, CIE Automotive India, CRISIL, DCM Shriram, Dodla Dairy, Eternal, Ganesh Housing Corporation, Havells India, IDBI Bank, Latent View Analytics, Mahindra Logistics, Oberoi Realty, Parag Milk Foods, PNB Housing Finance, Rajratan Global Wire, Sagar Cements, UCO Bank, UltraTech Cement will announce their result later today. Stocks to Watch: Reliance Industries' (RIL) profit after tax and share of profit/(loss) of associates & JVs increased by 76.5% year-on-year (Y-o-Y) to Rs 30,783 crore in Q1 June 2025. The company's gross revenue increased by 6% Y-o-Y to Rs 273,252 crore in Q1 June 2025. Yes Bank reported 59.43% surge in standalone net profit to Rs 801.07 crore in Q1 FY26 as against Rs 502.43 ecrore posted in Q1 FY25. The banks total income rose 4.82% YoY to Rs 9,348.11 crore in the quarter ended 30 June 2025. ICICI Bank reported a standalone net profit of Rs 12,768.21 crore in Q1 FY26, up 15.45% as against Rs 11,059.11 crore posted in Q1 FY25. Total income increased 11.85% year on year (YoY) to Rs 51,451.81 crore in Q1 FY26. HDFC Bank's profit after tax (PAT) for the quarter ended June 2025 was at Rs 18,155.21 crore, a growth of 12.24% over the quarter ended June 2024. Net interest income (interest earned less interest expended) for the quarter ended June 2025 grew by 5.4% to Rs 31,440 crore from Rs 29,840 crore for the quarter ended June 2024. RBL Banks standalone net profit tumbled 46.07% to Rs 200.33 crore in Q1 FY26 as against Rs 371.52 crore posted in Q1 FY25. However, total income increased 4.85% year on year (YoY) to Rs 4,510.57 crore in the quarter ended 30 June 2025. Firstsource Solutions wholly owned subsidiary, Firstsource Solutions UK has executed a share purchase agreement with Pastdue Credit Solutions (PDC) to acquire 100% stake in PDC for a consideration of GBP 22 million, including upfront payment & earnouts. Dr Reddys Laboratories announced that United States Food & Drug Administration (USFDA) completed a GMP and a Pre-Approval Inspection (PAI) at its formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh, India. USFDA issued a Form 483 with 7 observations.


News18
20-07-2025
- Business
- News18
Dr Reddys gets seven observations from USFDA for Andhra plant
New Delhi, Jul 20 (PTI) Dr Reddy's Laboratories has received a Form 483 with seven observations from the US health regulator for its Srikakulam-based plant in Andhra Pradesh, according to a regulatory filing. The US Food and Drug Administration (USFDA) conducted the GMP and a Pre-Approval Inspection (PAI) at the formulations manufacturing facility from July 10 to 18, 2025, the Hyderabad-based drug major said in the filing. 'We have been issued a Form 483 with seven observations, which we will address within the stipulated timeline," it added. As per the USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food, Drug and Cosmetic (FD&C) Act and related Acts. PTI MSS BAL BAL Disclaimer: Comments reflect users' views, not News18's. Please keep discussions respectful and constructive. Abusive, defamatory, or illegal comments will be removed. News18 may disable any comment at its discretion. By posting, you agree to our Terms of Use and Privacy Policy.


Time of India
20-07-2025
- Business
- Time of India
Dr Reddy's gets seven observations from USFDA for Andhra plant
Dr Reddy's Laboratories has received a Form 483 with seven observations from the US health regulator for its Srikakulam-based plant in Andhra Pradesh , according to a regulatory filing. The US Food and Drug Administration ( USFDA ) conducted the GMP and a Pre-Approval Inspection (PAI) at the formulations manufacturing facility from July 10 to 18, 2025, the Hyderabad-based drug major said in the filing. Explore courses from Top Institutes in Select a Course Category Management healthcare Degree Leadership Project Management Others Data Science Design Thinking CXO Cybersecurity Data Science MCA PGDM MBA Operations Management Data Analytics Digital Marketing Product Management others Public Policy Technology Healthcare Finance Artificial Intelligence Skills you'll gain: Duration: 11 Months IIM Kozhikode CERT-IIMK General Management Programme India Starts on undefined Get Details Skills you'll gain: Duration: 9 Months IIM Calcutta CERT-IIMC APSPM India Starts on undefined Get Details Skills you'll gain: Duration: 10 Months IIM Kozhikode CERT-IIMK GMPBE India Starts on undefined Get Details "We have been issued a Form 483 with seven observations, which we will address within the stipulated timeline," it added. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like 15 Most Beautiful Female Athletes in the World Click Here Undo As per the USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food, Drug and Cosmetic (FD&C) Act and related Acts.