Alembic Pharmaceuticals Ltd

Alembic Pharmaceuticals will hold a meeting of the Board of Directors of the Company on 6 May 2025.Powered by Capital Market - Live

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tegretol Tablets, 200 mg, of Novartis Pharmaceuticals Corporation. Carbamazepine Tablets USP, 200 mg, are indicated for use as an anticonvulsant drug. They are also indicated for the treatment of pain associated with true trigeminal neuralgia. Refer to the product label for the complete list of indications. Carbamazepine Tablets USP, 200 mg, have an estimated market size of US$ 32 million for the twelve months ending December 2024, according to IQVIA. With this approval, Alembic now has a cumulative total of 222 ANDA approvals from the USFDA, comprising 196 final approvals and 26 tentative approvals. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company that has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. The company's consolidated net profit tumbled 23.29% to Rs 138.42 crore in Q3 FY25, compared with Rs 180.45 crore posted in Q3 FY24. Revenue from operations was at Rs 1,692.74 crore in the third quarter of FY25, up 3.81% year on year (YoY). Shares of Alembic Pharmaceuticals shed 0.19% to Rs 850.15 on the BSE.Powered by Capital Market - Live

Alembic Pharmaceuticals (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Carbamazepine Tablets USP, 200 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tegretol Tablets, 200 mg, of Novartis Pharmaceuticals Corporation. Carbamazepine Tablets USP, 200 mg are indicated for use as an anticonvulsant drug. It is also indicated in the treatment of the pain associated with true trigeminal neuralgia. Refer label for a detailed indication. Carbamazepine Tablets USP, 200 mg have an estimated market size of US$ 32 million for twelve months ending December 2024 according to IQVIA. Alembic has a cumulative total of 222 ANDA approvals (196 final approvals and 26 tentative approvals) from USFDA.Powered by Capital Market - Live

Alembic Pharmaceuticals has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDAPantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Protonix I.V. for Injection, 40 mg/vial, of Wyeth Pharmaceuticals LLC. Pantoprazole sodium for injection is indicated for treatment of gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. It is also indicated for the treatment of pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults.  Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial) have an estimated market size of US$ 48 million for twelve months ending December 2024 according to IQVIA. Powered by Capital Market - Live

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Protonix I.V. for Injection, of Wyeth Pharmaceuticals LLC. Pantoprazole sodium for injection is indicated for the treatment of gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. It is also indicated for the treatment of pathological hypersecretion conditions, including Zollinger-Ellison (ZE) syndrome in adults. Refer to the label for a detailed indication. According to IQVIA, the estimated market size for pantoprazole sodium for injection was US$ 48 million for the twelve months ending December 2024. With this approval, Alembic has a cumulative total of 221 ANDA approvals from the USFDA, including 195 final approvals and 26 tentative approvals. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. The company's consolidated net profit tumbled 23.29% to Rs 138.42 crore in Q3 FY25, compared with Rs 180.45 crore posted in Q3 FY24. Revenue from operations was at Rs 1,692.74 crore in the third quarter of FY25, up 3.81% year on year (YoY). The counter slipped 2.66% to end at Rs 904.55 on the BSE. Powered by Capital Market - Live

The key equity benchmarks traded with major gains in early trade. The Nifty traded above 23,500 level. Realty, oil &gas and PSU bank advanced while IT and Auto shares declined. At 09:26 IST, the barometer index, the S&P BSE Sensex, added 524.12 points or 0.68% to 77,429.63. The Nifty 50 index advanced 153.30 points or 0.66% to 23,503.70. The broader market broader market outperformed the frontline indices. The S&P BSE Mid-Cap index rose 0.80% and the S&P BSE Small-Cap index added 0.99%. The market breadth was strong. On the BSE, 2,612 shares rose and 590 shares fell. A total of 151 shares were unchanged. Foreign portfolio investors (FPIs) bought shares worth Rs 7,470.36 crore, while domestic institutional investors (DIIs) were net sellers to the tune of Rs 3,202.26 crore in the Indian equity market on 21 March 2025, provisional data showed. Stocks in Spotlight: Alembic Pharmaceuticals declined 2.10%. The company said that its API'III facility located at Karakhadi, Gujarat, has successfully cleared the US Food and Drug Administration (USFDA) inspection with zero observations. Larsen & Toubro (L&T) added 2.44% after the company announced that Subramanian Sarma will be elevated from whole-time director & president, Energy to deputy managing director (MD) & president of the company with effect from 2nd April 2025. Meanwhile, the company's board approved long term borrowings of upto Rs 12,000 crore, including through external commercial borrowings, term loans, non-convertible debentures or any other instrument as may be appropriate. Reliance Industries advanced 1.02% after the company said that its step-down wholly owned subsidiary Nauyaan Tradings has completed the acquisition of 74% equity stake in Nauyaan Shipyard (NSPL), from Welspun Corp, for an aggregate consideration of Rs 382.73 crore. Numbers to Track: The yield on India's 10-year benchmark federal paper advanced 1.66% to 6.737 as compared with the previous close of 6.620. In the foreign exchange market, the rupee edged higher against the dollar. The partially convertible rupee was hovering at 85.8975, compared with its close of 85.9800 during the previous trading session. MCX Gold futures for the 4 April 2025 settlement shed 0.06% to Rs 87,737. The US Dollar index (DXY), which tracks the greenback's value against a basket of currencies, was up 0.04% to 104.13. The United States 10-year bond yield rose 0.47% to 4.272. In the commodities market, Brent crude for May 2025 settlement advanced 17 cents or 0.24% to $72.17 a barrel. Global Markets: US Dow Jones index futures rose 217 points, signaling a strong opening for US stocks today. Media reports suggest that President Donald Trump's April 2 tariffs will be narrower and less stringent than initially feared, easing concerns about their economic impact. Asian stocks traded mixed on Monday as investors braced for Trump's looming April 2 tariff deadline. In Japan, business activity shrank for the first time in five months. The au Jibun Bank Manufacturing PMI fell to 48.3 in March, down from 49.0 in February, marking its ninth consecutive month of contraction. Meanwhile, the Services PMI dropped to 49.5 from 53.7, the first decline since mid-2024. A PMI reading below 50 indicates contraction. Meanwhile, Chinese Premier Li Qiang warned of 'rising instability' and urged nations to open up their markets. On Friday, US market closed higher as Trump hinted at flexibility on tariffs, although he reaffirmed the April 2 deadline for reciprocal duties. The S&P 500 rose 0.08% to 5,667.56 points, while the NASDAQ Composite rose 0.52% to 17,784.05 points. The Dow Jones Industrial Average rose 0.08% to 41,985.35 points. Nike stock slipped over 5% after fiscal fourth-quarter revenue estimate came in below analysts' expectations. While stocks have rebounded from oversold levels, investors remain cautious. Until there is clarity on the tariff situation'expected by April 2'the market's upside potential will likely remain limited.Powered by Capital Market - Live

Securities in F&O Ban: Hindustan Copper, IndusInd Bank and Polycab India shares are banned from F&O trading on 24th March 2025 Stocks to Watch: Alembic Pharmaceuticals said that its API'III facility located at Karakhadi, Gujarat, has successfully cleared the US Food and Drug Administration (USFDA) inspection with zero observations. Larsen & Toubro (L&T) announced that Subramanian Sarma will be elevated from whole-time director & president, Energy to deputy managing director (MD) & president of the company with effect from 2nd April 2025. Meanwhile, the company's board approved long term borrowings of upto Rs 12,000 crore, including through external commercial borrowings, term loans, non-convertible debentures or any other instrument as may be appropriate. Reliance Industries said that its step-down wholly owned subsidiary Nauyaan Tradings has completed the acquisition of 74% equity stake in Nauyaan Shipyard (NSPL), from Welspun Corp, for an aggregate consideration of Rs 382.73 crore. Mahindra & Mahindra (M&M) announced an increase in prices of up to 3% for its SUV and CV range, effective April 2025. This price increase is attributed to rising input cost and increased commodity prices, among other reasons. Godrej Properties (GPL) announced the acquisition of approximately 10 acres of land in Yelahanka, Bengaluru, for a new development project with an estimated revenue potential of Rs 2,500 crore. SMS Pharmaceuticals announced that it has successfully completed a US Food and Drug Administration (USFDA) inspection at its Active Pharmaceutical Ingredient (API) manufacturing facility located in Bachupally, Hyderabad, Telangana. The inspection was conducted from 17 March to 21 March 2025 and concluded with one observation in Form 483. Powered by Capital Market - Live

The inspection was conducted from 17th March to 21st March, 2025. This was a scheduled GMP inspection and was successfully completed without any Form 483 observation. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. The company's consolidated net profit tumbled 23.29% to Rs 138.42 crore in Q3 FY25, compared with Rs 180.45 crore posted in Q3 FY24. Revenue from operations was at Rs 1,692.74 crore in the third quarter of FY25, up 3.81% year on year (YoY). The counter surged 13.62% to end at Rs 947.75 on the BSE on Friday.Powered by Capital Market - Live

Nuvoco Vistas Corporation Ltd, Jupiter Wagons Ltd, New India Assurance Company Ltd, Manappuram Finance Ltd are among the other stocks to see a surge in volumes on NSE today, 21 March 2025.Alembic Pharmaceuticals Ltd notched up volume of 19.75 lakh shares by 14:14 IST on NSE, a 19.76 fold spurt over two-week average daily volume of 99960 shares. The stock rose 13.57% to Rs.947.95. Volumes stood at 1.11 lakh shares in the last session.Nuvoco Vistas Corporation Ltd recorded volume of 22.68 lakh shares by 14:14 IST on NSE, a 18.92 times surge over two-week average daily volume of 1.20 lakh shares. The stock gained 8.53% to Rs.330.80. Volumes stood at 1.11 lakh shares in the last session.Jupiter Wagons Ltd clocked volume of 288.2 lakh shares by 14:14 IST on NSE, a 12.82 times surge over two-week average daily volume of 22.48 lakh shares. The stock gained 12.34% to Rs.352.20. Volumes stood at 24.24 lakh shares in the last session.New India Assurance Company Ltd clocked volume of 58.56 lakh shares by 14:14 IST on NSE, a 10.19 times surge over two-week average daily volume of 5.75 lakh shares. The stock gained 7.45% to Rs.164.80. Volumes stood at 6.61 lakh shares in the last session.Manappuram Finance Ltd witnessed volume of 1303.7 lakh shares by 14:14 IST on NSE, a 10.03 times surge over two-week average daily volume of 130.00 lakh shares. The stock increased 8.97% to Rs.237.02. Volumes stood at 361.59 lakh shares in the last session.Powered by Capital Market - Live

Post the conclusion of this scheduled inspection, the US FDA issued a Form 483 with one procedural observation the company's aforementioned unit. 'The company will provide comprehensive response to US FDA for the observations within the stipulated period,' Alembic Pharmaceuticals said in a statement. The announcement was made after market hours on Friday. Alembic Pharmaceuticals is in the business of the development, manufacturing, and marketing of pharmaceutical products, i.e., formulations and active pharmaceutical ingredients. The company's consolidated net profit tumbled 23.29% to Rs 138.42 crore in Q3 FY25, compared with Rs 180.45 crore posted in Q3 FY24. Revenue from operations was at Rs 1,692.74 crore in the third quarter of FY25, up 3.81% year on year (YoY). The scrip had jumped 4.26% to end at Rs 845.65 on the BSE on Friday. Powered by Capital Market - Live