This US drug regulator conducted an inspection from 8 April to 12 April 2024. Now, the inspection is classified as 'No Action Indicated' (NAI), indicating compliance with current Good Manufacturing Practices (cGMP) standards and confirming that no further regulatory action is required. 'This outcome reflects the facility's high standards in the production of Active Pharmaceutical Ingredients (APIs) and Finished Dosages (FDs) for both oncology and non-oncology therapeutic areas,' said the drug regulator. During the inspection, the FDA conducted a comprehensive pre-approval inspection (PAI) and cGMP audit, which concluded with zero Form 483 observations. Krishna Prasad Chigurupati, chairman & managing director of Granules India said, The successful completion of this US FDA inspection with zero observations and the subsequent receipt of the EIR with NAI status reflects our unwavering commitment to maintaining the highest quality standards in our manufacturing operations. Granules India is primarily involved in the manufacturing and selling of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation intermediates (PFIs) and Finished Dosages (FDs). Granules India consolidated net profit fell 4.79% to Rs 97.23 crore on 18.74% declined in total revenue from operations to Rs 966.62 crore in Q2 FY25 over Q2 FY24. Powered by Capital Market - Live

Net profit of Granules India declined 4.79% to Rs 97.23 crore in the quarter ended September 2024 as against Rs 102.12 crore during the previous quarter ended September 2023. Sales declined 19.48% to Rs 956.52 crore in the quarter ended September 2024 as against Rs 1188.00 crore during the previous quarter ended September 2023. ParticularsQuarter EndedSep. 2024Sep. 2023% Var. Sales956.521188.00 -19 OPM %21.2617.93 - PBDT180.91188.54 -4 PBT128.38136.02 -6 NP97.23102.12 -5 Powered by Capital Market - Live

Bupropion hydrochloride extended-release tablets USP (SR) is bioequivalent and therapeutically equivalent to wellbutrin SR sustained-release tablets, 100 mg, 150 mg, and 200 mg, by GlaxoSmithKline LLC. The approved ANDA is a widely prescribed medication for the treatment of major depressive disorder and for the prevention of seasonal affective disorder. The group now has a total of 67 ANDA approvals from the US FDA. Dr. Krishna Prasad Chigurupati, chairman and managing director, Granules India, said, This ANDA approval marks a significant milestone in our journey to expand Granules' presence in the U.S. market. Our continued focus on expanding our product portfolio in regulated markets like the U.S. ensures that we are meeting the growing healthcare needs of patients globally, while maintaining the highest standards of safety and efficacy.' Granules India is primarily involved in the manufacturing and selling of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation intermediates (PFIs) and Finished Dosages (FDs). The pharma company reported a consolidated net profit of Rs 134.65 crore in Q1 FY25, steeply higher than Rs 47.89 crore posted in Q1 FY24. Revenue from operations in first quarter of FY25 was at Rs 1,179.87 crore, up 19.72% from Rs 985.52 crore reported in the same period a year ago. Shares of Granules India shed 0.19% to Rs 592.15 on the BSE.Powered by Capital Market - Live

Granules India announced today that the U.S. Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets USP (SR) 100 mg, 150 mg, and 200 mg filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the Company. Bupropion Hydrochloride Extended-Release Tablets USP (SR) are bioequivalent and therapeutically equivalent to Wellbutrin SR Sustained-Release Tablets, 100 mg, 150 mg, and 200 mg, by GlaxoSmithKline LLC. This is a widely prescribed medication for the treatment of major depressive disorder and for the prevention of seasonal affective disorder. Granules now has a total of 67 ANDA approvals from the US FDA.Powered by Capital Market - Live

Granules India will hold a meeting of the Board of Directors of the Company on 6 November 2024.Powered by Capital Market - Live

Granules India Ltd is up for a fifth straight session today. The stock is quoting at Rs 605.5, up 0.27% on the day as on 12:44 IST on the NSE. The benchmark NIFTY is up around 0.69% on the day, quoting at 25137.7. The Sensex is at 82005.67, up 0.77%. Granules India Ltd has gained around 10.11% in last one month. Meanwhile, Nifty Pharma index of which Granules India Ltd is a constituent, has gained around 0.37% in last one month and is currently quoting at 23582.25, down 0.2% on the day. The volume in the stock stood at 25.12 lakh shares today, compared to the daily average of 46.32 lakh shares in last one month. The benchmark October futures contract for the stock is quoting at Rs 608.35, up 0.5% on the day. Granules India Ltd is up 71.77% in last one year as compared to a 27.4% jump in NIFTY and a 55.19% jump in the Nifty Pharma index.The PE of the stock is 32.51 based on TTM earnings ending June 24.Powered by Capital Market - Live

Granules India Ltd is up for a third straight session today. The stock is quoting at Rs 572.65, up 2.52% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is down around 0.13% on the day, quoting at 25777.65. The Sensex is at 84211.69, down 0.1%. Granules India Ltd has slipped around 16.26% in last one month. Meanwhile, Nifty Pharma index of which Granules India Ltd is a constituent, has slipped around 0.65% in last one month and is currently quoting at 23281.2, down 0.62% on the day. The volume in the stock stood at 40.39 lakh shares today, compared to the daily average of 63.92 lakh shares in last one month. The benchmark October futures contract for the stock is quoting at Rs 580.55, up 3.06% on the day. Granules India Ltd is up 60.7% in last one year as compared to a 32% jump in NIFTY and a 51.41% jump in the Nifty Pharma index.The PE of the stock is 30.08 based on TTM earnings ending June 24.Powered by Capital Market - Live

Granules India unveiled its Mobile Cancer Screening Unit at AIG Hospitals. This initiative, spearheaded by the Granules Trust in partnership with Asian Medical Foundation, UC Breast Foundation and AIG Hospitals aims to enhance cancer detection and treatment in underserved communities. The state-of-the-art mobile unit Breast Health Express, brings advanced medical technology directly to communities in need. Equipped with cutting-edge mammography and ultrasound capabilities, as well as facilities for essential health checks such as haemoglobin, blood pressure, and glucose levels, this mobile clinic marks a major advancement in equitable and accessible healthcare. By offering these critical services and free medicine distribution, the initiative seeks to revolutionize cancer screening, with a particular emphasis on early breast cancer detection. Timed to coincide with Breast Cancer Awareness Month in October, the Breast Health Express aligns seamlessly with the global focus on breast cancer prevention and early detection. The mobile unit is set to commence operations in and around Hyderabad, with plans to expand to additional districts of Telangana in the coming monthsPowered by Capital Market - Live

Granules India Ltd fell for a fifth straight session today. The stock is quoting at Rs 549.15, down 0.14% on the day as on 13:19 IST on the NSE. The benchmark NIFTY is up around 0.13% on the day, quoting at 25417.95. The Sensex is at 83067.63, up 0.1%.Granules India Ltd has lost around 17.25% in last one month.Meanwhile, Nifty Pharma index of which Granules India Ltd is a constituent, has increased around 5.37% in last one month and is currently quoting at 23448.75, down 0.07% on the day. The volume in the stock stood at 21.73 lakh shares today, compared to the daily average of 53.17 lakh shares in last one month. The benchmark September futures contract for the stock is quoting at Rs 550.05, down 0.05% on the day. Granules India Ltd jumped 67.99% in last one year as compared to a 26.25% rally in NIFTY and a 51.14% spurt in the Nifty Pharma index.The PE of the stock is 29.64 based on TTM earnings ending June 24.Powered by Capital Market - Live

Granules India announced the completion of USFDA inspection of its Gagillapur FD facility with six observations. The inspection was conducted from 26 August 2024 to 06 September 2024. Powered by Capital Market - Live