Granules India announced today that its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc. (GPI), has received approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lisdexamfetamine Dimesylate Chewable Tablets. The approved drug is available in multiple strengths: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg. This generic drug product has been determined to be bioequivalent (AB Rating) to the reference listed drug, Vyvanse' Chewable Tablets by Takeda Pharmaceuticals USA Inc. Lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients aged six years and older, as well as Moderate to Severe Binge Eating Disorder (BED) in adults. Granules has received approval in the first review cycle, reflecting the company's consistent focus on regulatory excellence and expedited product delivery. Lisdexamfetamine Dimesylate Chewable Tablets are currently published on the FDA Drug Shortages List, emphasizing their critical role in patient care. Powered by Capital Market - Live

The approved drug is available in multiple strengths: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg. This generic drug product has been determined to be bioequivalent (AB Rating) to the reference listed drug, Vyvanse chewable tablets by Takeda Pharmaceuticals USA Inc. Lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged six years and older, as well as moderate to severe binge eating disorder (BED) in adults. The approved drug is currently published on the FDA drug shortages list, emphasizing their critical role in patient care. Dr Krishna Prasad Chigurupati, chairman & managing director of Granules, said, This milestone reflects our unwavering commitment to addressing unmet patient needs by delivering high-quality, affordable medications. With this approval, GPI reinforces its dedication to alleviating critical drug shortages in the U.S. healthcare market. Granules India now holds 68 ANDA approvals, including 30 ANDAs from GPI. 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% decline in total revenue from operations to Rs 966.62 crore in Q2 FY25 over Q2 FY24. The scrip rose 0.13% to currently trade at Rs 585.10 on the BSE. Powered by Capital Market - Live

Granules India Ltd is up for a fifth straight session in a row. The stock is quoting at Rs 580.3, up 0.03% on the day as on 12:44 IST on the NSE. The benchmark NIFTY is down around 0.26% on the day, quoting at 24554.85. The Sensex is at 81341.22, down 0.21%. Granules India Ltd has added around 1.4% in last one month. Meanwhile, Nifty Pharma index of which Granules India Ltd is a constituent, has added around 0.49% in last one month and is currently quoting at 22309.1, down 0.33% on the day. The volume in the stock stood at 6.31 lakh shares today, compared to the daily average of 37.56 lakh shares in last one month. The benchmark December futures contract for the stock is quoting at Rs 580.65, down 0.07% on the day. Granules India Ltd is up 50.59% in last one year as compared to a 16.94% gain in NIFTY and a 38.62% gain in the Nifty Pharma index.The PE of the stock is 37.46 based on TTM earnings ending September 24.Powered by Capital Market - Live

The United States Food and Drug Administration (USFDA) has further classified the inspection as 'Official Action Indicated' (OAI). The drug maker has responded to all the observations issued by the USFDA. Additionally, it has voluntarily undertaken a comprehensive evaluation of the facility for further enhancements that lead to improvement of the facility. 'The company will work with the US FDA on this activity and is confident that it will result in the US FDA approving the company's facility at Gagillapur in compliance with its expectations within a short time,' Granules stated in a regulatory filing. 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% decline in total revenue from operations to Rs 966.62 crore in Q2 FY25 over Q2 FY24. Powered by Capital Market - Live

C.E. Info Systems Ltd, Zen Technologies Ltd, Deepak Nitrite Ltd and Avalon Technologies Ltd are among the other losers in the BSE's 'A' group today, 03 December 2024.Granules India Ltd tumbled 9.44% to Rs 538.5 at 14:47 IST.The stock was the biggest loser in the BSE's 'A' group.On the BSE, 2.31 lakh shares were traded on the counter so far as against the average daily volumes of 83078 shares in the past one month.C.E. Info Systems Ltd crashed 8.22% to Rs 1550.5. The stock was the second biggest loser in 'A' group.On the BSE, 58968 shares were traded on the counter so far as against the average daily volumes of 8389 shares in the past one month.Zen Technologies Ltd lost 5.17% to Rs 1813.3. The stock was the third biggest loser in 'A' group.On the BSE, 27.18 lakh shares were traded on the counter so far as against the average daily volumes of 30586 shares in the past one month.Deepak Nitrite Ltd plummeted 5.05% to Rs 2617.75. The stock was the fourth biggest loser in 'A' group.On the BSE, 23267 shares were traded on the counter so far as against the average daily volumes of 28729 shares in the past one month.Avalon Technologies Ltd fell 4.67% to Rs 912. The stock was the fifth biggest loser in 'A' group.On the BSE, 32407 shares were traded on the counter so far as against the average daily volumes of 99736 shares in the past one month.Powered by Capital Market - Live

Granules India Ltd gained for a third straight session today. The stock is quoting at Rs 591.25, up 1.19% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is up around 0.22% on the day, quoting at 24184. The Sensex is at 79872.83, up 0.09%. Granules India Ltd has gained around 7.51% in last one month. Meanwhile, Nifty Pharma index of which Granules India Ltd is a constituent, has gained around 0.69% in last one month and is currently quoting at 22240.2, up 1.08% on the day. The volume in the stock stood at 9.38 lakh shares today, compared to the daily average of 26.4 lakh shares in last one month. The benchmark December futures contract for the stock is quoting at Rs 595.1, up 1.48% on the day. Granules India Ltd is up 51.02% in last one year as compared to a 16.91% jump in NIFTY and a 38.53% jump in the Nifty Pharma index.The PE of the stock is 37.91 based on TTM earnings ending September 24.Powered by Capital Market - Live

Granules India has received validation and approval from the Science Based Targets initiative (SBTi) for its near-term, long-term, and net-zero goals. These targets, aligned with the 1.5'C pathway, set Granules apart as one of the select Indian pharmaceutical companies with SBTi-validated targets under the initiative's new guidelines. Granules' goals are notable for their comprehensive scope and ambition. Granules India has committed to achieving net-zero greenhouse gas (GHG) emissions across its value chain, including all subsidiaries, by FY2050. In the near term, the company targets a 42% reduction in absolute Scope 1 and 2 emissions and Scope 3 emissions by FY2030, using FY2023 as the baseline, alongside transitioning to 100% renewable electricity. These near-term and long-term targets are aligned with the 1.5'C pathway, emphasizing Granules' dedication to ambitious climate action and achieving net-zero well before FY2050. Powered by Capital Market - Live

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