Alembic Pharmaceuticals (Alembic) announced that it has received Final Approval from the US Food adjunctive therapy in patients with multiple seizure types that include absence seizures. Refer label for a detailed indication. Divalproex Sodium Delayed-Release Capsules USP, 125 mg have an estimated market size of US$ 61.1 million for twelve months ending September 2024 according to IQVIA. Powered by Capital Market - Live

The key equity indices tumbled with substantial losses in the mid-afternoon trade. The Nifty dropped below the 23,750 mark. Realty shares extended losses for the fourth consecutive trading session. At 14:25 IST, the barometer index, the S&P BSE Sensex, tumbled 782.23 points or 0.99% to 78,436.88. The Nifty 50 index dropped 229.80 points or 0.96% to 23,721.90. In the broader market, the S&P BSE Mid-Cap index slipped 1.52% and the S&P BSE Small-Cap index fell 1.47%. The market breadth was weak. On the BSE, 1,166 shares rose and 2,775 shares fell. A total of 108 shares were unchanged. Buzzing Index: The Nifty Realty index slipped 2.59% to 1,074.65. The index fell 3.93% for the four consecutive trading sessions. Sobha (down 3.66%), Brigade Enterprises (down 3.35%), Macrotech Developers (down 3.13%), Prestige Estates Projects (down 2.95%) and Raymond (down 2.42%) were the top losers. Among the other losers were Phoenix Mills (down 2.27%), DLF (down 1.91%), Godrej Properties (down 1.66%), Oberoi Realty (down 0.63%) declined Numbers to Track: The yield on India's 10-year benchmark federal paper rose 1.74% to 6.905 as compared with the previous close of 6.899. In the foreign exchange market, the rupee edged lower against the dollar. The partially convertible rupee was hovering at 85.0775, compared with its close of 84.9450 during the previous trading session. MCX Gold futures for the 5 February 2025 settlement rose 0.13% to Rs 75,770. The US Dollar index (DXY), which tracks the greenback's value against a basket of currencies, was down 0.25% to 108.13. The United States 10-year bond yield fell 0.24% to 4.559. In the commodities market, Brent crude for February 2024 settlement lost 32 cents, or 0.44% to $72.56 a barrel. Stocks in Spotlight: Alembic Pharmaceuticals rose 0.64%. The company announced that it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Divalproex Sodium Delayed-Release Capsules. Hindustan Construction Company declined 3.49%. The company said that its board has approved the closure of the issue for the qualified institutions placement of equity shares of the company on Thursday, 19 December 2024. Kothari Products hit an upper circuit of 20% after the company's board scheduled to meet on 27 December 2024 to consider bonus issue of equity shares.Powered by Capital Market - Live

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Depakote Sprinkle Capsules. Divalproex Sodium is an anti-epileptic drug indicated for monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures. Refer label for a detailed indication. Divalproex Sodium Delayed-Release Capsules USP, 125 mg have an estimated market size of $ 61.1 million for twelve months ending September 2024 according to IQVIA. Alembic has a cumulative total of 220 ANDA approvals (193 final approvals and 27 tentative approvals) from USFDA. Alembic Pharmaceuticals is in the business of the development, manufacturing, and marketing of pharmaceutical products, i.e., formulations and active pharmaceutical ingredients. The pharmaceutical company's consolidated net profit increased 12.3% to Rs 153.41 crore in Q2 FY25 as compared to Rs 136.56 crore posted in Q2 FY24. Revenue from operations grew 3.3% year on year (YoY) to Rs 1,647.98 crore in the quarter ended 30 September 2024. The scrip slipped 1.34% to currently trade at Rs 1,088.95 on the BSE. Powered by Capital Market - Live

Alembic Pharmaceuticals has successfully completed the Brazilian Health Regulatory Agency (ANVISA) GMP audit at active pharmaceutical ingredient (API)-II Facilty at Panelav for its 8 APIs. The inspection was conducted from 16 to 20 September 2024. Alembic Pharmaceuticals is in the business of the development, manufacturing, and marketing of pharmaceutical products, i.e., formulations and active pharmaceutical ingredients. The pharmaceutical company's consolidated net profit increased 12.3% to Rs 153.41 crore in Q2 FY25 as compared to Rs 136.56 crore posted in Q2 FY24. Revenue from operations grew 3.3% year on year (YoY) to Rs 1,647.98 crore in the quarter ended 30 September 2024. The scrip slipped 1.34% to currently trade at Rs 1,088.95 on the BSE.Powered by Capital Market - Live

Alembic Pharmaceuticals announced that it has received Tentative Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pataday Once Daily Relief Ophthalmic Solution, 0.7%, of Alcon Laboratories, Inc. (Alcon) NDA - 206276. Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander. Powered by Capital Market - Live

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pataday Once Daily Relief Ophthalmic Solution, of Alcon Laboratories, Inc. Olopatadine Hydrochloride Ophthalmic Solution USP is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander. According to IQVIA, Olopatadine Hydrochloride Ophthalmic Solution USP has an estimated market size of $22 million for twelve months ending September 2024. Alembic has a cumulative total of 219 ANDA approvals (192 final approvals and 27 tentative approvals) from USFDA. Alembic Pharmaceuticals is in the business of the development, manufacturing, and marketing of pharmaceutical products, i.e., formulations and active pharmaceutical ingredients. The pharmaceutical company's consolidated net profit increased 12.3% to Rs 153.41 crore in Q2 FY25 as compared to Rs 136.56 crore posted in Q2 FY24. Revenue from operations grew 3.3% year on year (YoY) to Rs 1,647.98 crore in the quarter ended 30 September 2024. The scrip rose 0.06% to currently trade at Rs 1,101.05 on the BSE. Powered by Capital Market - Live

The GMP inspection was conducted from 14 November 2024 to 22 November 2024. The USFDA issued Form-483 with 5 observations. The company stated that it would provide a comprehensive response to the USFDA for the observations within the stipulated period. It also committed to maintaining the highest quality standards and compliance at all times. Alembic Pharmaceuticals is in the business of development, manufacturing and marketing of Pharmaceuticals products i.e. Formulations and Active Pharmaceutical Ingredients. The pharmaceutical company's consolidated net profit increased 12.3% to Rs 153.41 crore in Q2 FY25 as compared to Rs 136.56 crore posted in Q2 FY24. Revenue from operations grew 3.3% year on year (YoY) to Rs 1,647.98 crore in the quarter ended 30 September 2024. The scrip rallied 3.44% to currently trade at Rs 1,077.60 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) Ivabradine Tablets, 5 mg and 7.5 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Corlanor Tablets, 5 mg and 7.5 mg, of Amgen Inc. (Amgen). Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US$ 145.3 million for twelve months ending September 2024 according to IQVIA. Alembic has a cumulative total of 218 ANDA approvals (192 final approvals and 26 tentative approvals) from USFDA.Powered by Capital Market - Live

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cardizem CD extended-release capsules of Bausch Health US, LLC. The approved strengths for the said drug are 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg. Diltiazem Hydrochloride Extended-Release (ER) capsules are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications. It is also indicated for the management of chronic stable angina and angina due to coronary artery spasm. Diltiazem Hydrochloride extended-release capsules have an estimated market size of $105.3 million for twelve months ending June 2024 according to IQVIA. Alembic has a cumulative total of 218 ANDA approvals (191 final approvals and 27 tentative approvals) from USFDA. Alembic Pharmaceuticals is in the business of development, manufacturing, and marketing of Pharmaceuticals products i.e. Formulations and Active Pharmaceutical Ingredients. The pharmaceutical company's consolidated net profit increased 11.69% to Rs 134.71 crore in Q1 FY25 as compared to Rs 120.60 crore posted in Q1 FY24. Revenue from operations grew 5.09% year on year (YoY) to Rs 1,561.73 crore in the quarter ended 30 June 2024. The scrip fell 1.89% to currently trade at Rs 1019.35 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) for Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cardizem CD Extended-Release Capsules, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, of Bausch Health US, LLC. Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications. It is also indicated for the management of chronic stable angina and angina due to coronary artery spasm. Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg have an estimated market size of US$105.3 million for twelve months ending June 2024 according to IQVIA. Alembic has a cumulative total of 218 ANDA approvals (191 final approvals and 27 tentative approvals) from USFDA. Powered by Capital Market - Live