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

Net profit of Alembic Pharmaceuticals rose 12.34% to Rs 153.41 crore in the quarter ended September 2024 as against Rs 136.56 crore during the previous quarter ended September 2023. Sales rose 3.33% to Rs 1647.98 crore in the quarter ended September 2024 as against Rs 1594.93 crore during the previous quarter ended September 2023. ParticularsQuarter EndedSep. 2024Sep. 2023% Var. Sales1647.981594.93 3 OPM %14.5213.03 - PBDT238.06202.20 18 PBT167.55134.64 24 NP153.41136.56 12 Powered by Capital Market - Live

The headline equity benchmarks traded with limited losses in early-afternoon trade. The Nifty traded below the 24,750 mark. Metal shares decline after rising for the past trading session. At 11:25 IST, the barometer index, the S&P BSE Sensex, was down 197.25 points or 0.24% to 81,026.95. The Nifty 50 index fell 105.15 points or 0.42% to 24,748.90. In the broader market, the S&P BSE Mid-Cap index fell 0.46% and the S&P BSE Small-Cap index shed 0.99%. The market breadth was weak. On the BSE, 1,254 shares rose and 2,637 shares fell. A total of 154 shares were unchanged. Waree Energies IPO received strong interest from investors. The IPO received bids for 3,16,95,741 shares as against 2,10,79,384 shares on offer. The IPO was subscribed 1.50 times. Economy: India's net direct tax collections jumped by 182.02% over last decade to Rs 19.60 lakh crore in FY24, from 6.95 lakh crore in FY15, following strong growth in personal income tax, the latest time series data from the Income Tax Department showed. Personal income tax collections zoomed up nearly 300% to Rs 10.45 lakh crore, from 2.65 lakh crore in FY15, outpacing corporate tax collections, which rose by 112.85% to Rs 9.11 lakh crore from Rs 4.28 lakh crore in FY15. Derivative: The NSE's India VIX, a gauge of the market's expectation of volatility over the near term, advanced 7.09% to 13.96. The Nifty 31 October 2024 futures were trading at 24,760.60, at a premium of 95.70 points as compared with the spot at __ . The Nifty option chain for the 31 October 2024 expiry showed maximum Call OI of 92.8 lakh contracts at the 25,000 strike price. Maximum Put OI of 44.2lakh contracts were seen at 24,000 strike price. Buzzing Index: The Nifty Metal index fell 1.40% to 9,617.75. The index advanced 1.57% in the past trading session. Jindal Stainless Ltd (down 5.84%), APL Apollo Tubes Ltd (down 2.42%), NMDC Ltd (down 2.14%), Adani Enterprises Ltd (down 2.1%) and Hindustan Copper Ltd (down 2.04%), Steel Authority of India Ltd (down 1.77%), Hindalco Industries Ltd (down 1.55%), National Aluminium Company Ltd (down 1.49%), Vedanta Ltd (down 0.93%) and JSW Steel Ltd (down 0.9%) declined. Stock in Spotlight: Alembic Pharmaceuticals rose 0.21%. The company has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg.Powered by Capital Market - Live

Alembic Pharmaceuticals will hold a meeting of the Board of Directors of the Company on 7 November 2024.Powered by Capital Market - Live

The US FDA had conducted an inspection at the company's oncology (injectable and oral solid) formulation facility from 7 October 2024 to 8 October 2024. The inspection was successfully completed without any Form 483 observation, the company said in a statement. Alembic Pharmaceuticals is in the business of development, manufacturing, and marketing of pharmaceutical 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. Powered by Capital Market - Live

Alembic Pharmaceuticals has successfully completed the United States Food and Drug Administration (USFDA) inspection for its Oncology (Injectable and Oral Solid) Formulation Facility (F-2) located at Panelav. The inspection was successfully completed without any Form 483 observation. The inspection was conducted from 7 October 2024 to 8 October 2024. Powered by Capital Market - Live

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lastacaft Solution of AbbVie Inc. Alcaftadine Ophthalmic Solution is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander. Alembic has a cumulative total of 216 ANDA approvals (189 final approvals and 27 tentative approvals) from USFDA. Alembic Pharmaceuticals is in the business of development, manufacturing, and marketing of pharmaceutical 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 1.03% to currently trade at Rs 1229.35 on the BSE. Powered by Capital Market - Live

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lamictal XR Extended-Release Tablets, 200 mg, 250 mg, and 300 mg, of GlaxoSmithKline LLC (GSK). Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. Also indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg have an estimated market size of US$ 163 million for twelve months ending June 2024 according to IQVIA. Alembic has a cumulative total of 216 ANDA approvals (188 final approvals and 28 tentative approvals) from USFDA.Powered by Capital Market - Live