Alembic Pharmaceuticals Ltd

Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Travoprost Ophthalmic Solution USP, 0.004% (Ionic Buffered Solution). The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Travatan Z Ophthalmic Solution, 0.004%, of Sandoz Inc. (Sandoz). Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Travoprost Ophthalmic Solution USP, 0.004%, has an estimated market size of US$ 61 million for twelve months ending September 2025 according to IQVIA. Alembic has a cumulative total of 232 ANDA approvals (212 final approvals and 20 tentative approvals) from USFDA.Powered by Capital Market - Live

The key equity benchmarks traded with minor gains in afternoon trade. The Nifty traded above the 25,850 level. Investor sentiment improved as buying interest emerged following profit booking over past few sessions. Market participants also remained focused on ongoing IPO activity. IT, realty and consumer durables shares advanced while media, auto and pharma shares declined. At 13:25 ST, the barometer index, the S&P BSE Sensex, climbed 90.46 points or 0.11% to 84,695.19. The Nifty 50 index added 57.05 points or 0.22% to 25,877.25. In the broader market, the S&P BSE Mid-Cap index jumped 0.16% and the S&P BSE Small-Cap index fell 0.21%. The market breadth was weak. On the BSE, 1,623 shares rose and 2,401 shares fell. A total of 188 shares were unchanged. Gainers & Losers: Interglobe Aviation (Indigo) (up 3.04%), Max Healthcare Institute (up 3.04%), Tata Consultancy Services (up 1.77%), Infosys (up 1.48%) and Hindalco Industries (up 1.26%) were the major Nifty50 gainers. Sun Pharmaceuticals Industries (down 2.88%), Powergrid Corporation of India (down 1.72%), NTPC (down 1.04%), Mahindra% Mahindra (down 0.87%) and Bajaj-Auto (down 0.84%) were the major Nifty50 losers. Max Healthcare Institute jumped 3.04% after the company announced that its board has approved the acquisition of of 100% equity stake in Yerawada Properties Private (YPPL), Pune, Maharashtra. Sun Pharmaceutical Industries declined 2.88% after the company announced that the US FDA, post an audit, has determined the Baska facility inspection classification as Official Action Indicated (OAI). IPO Update: KSH International received bids for 53,72,991 shares as against 1,36,16,438 shares on offer, according to stock exchange data at 13:15 IST on Thursday (18 December 2025). The issue was subscribed 0.39 times. The issue opened for bidding on 16 December 2025 and it will close on 18 December 2025. The price band of the IPO is fixed between Rs 365 and 384 per share. Stocks in Spotlight: Shares of asset management companies jumped on Wednesday after SEBI on Wednesday (17 December 2025) decided to lower mutual fund expense ratio limits, now termed the Base Expense Ratio or BER. The BER will exclude all statutory levies such as GST, stamp duty, SEBI fees and exchange charges. Nippon Life India Asset Management surged 4.64%. HDFC Asset Management Company surged 6.68%. UTI Asset Management Company gained 2.24%. Nuvama Wealth Management rose 1.96%. Aditya Birla Sun Life AMC advanced 1.36%, while Motilal Oswal Financial Services rallied 4.18%. Alembic Pharmaceuticals declined 1.07%. The company announced that it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Travoprost Ophthalmic Solution USP, 0.004% (ionic buffered solution). Bajaj Electricals added 0.20%. The company announced that its management has decided to enter into the solar solutions business as a new and additional line under its Lighting Solutions segment. Aurobindo Pharma advanced 1.57%. The company said that the US Food and Drug Administration (US FDA) has completed the inspection of APL Healthcare's Unit-IV, wholly owned subsidiary, located at Palchur village, Andhra Pradesh (AP). At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature. Antony Waste Handling Cell zoomed 14.88% after its subsidiary, AG Enviro Infra Projects, has bagged two contracts for collection & transportation of municipal solid waste (MSW) in Mumbai by the Brihanmumbai Municipal Corporation (BMC). The total value of the contracts is around Rs 1,330 crore. GMR Power and Urban Infra shed 0.31%. The company said that its board has approved raising up to Rs 1,200 crore through the issuance of equity shares and convertible warrants to select investors on a preferential basis. Global Markets: Most of European market advanced as traders prepare for central bank decisions today. Most Asian stocks fell on Thursday, led by renewed weakness in technology stocks as lingering concerns over stretched artificial intelligence valuations resurfaced. Investor sentiment was further dampened by expectations of a hawkish stance from the Bank of Japan, adding to regional market pressure. Artificial intelligence-related stocks dragged indexes after a media report stated that Oracle's primary investor, Blue Owl Capital, has pulled out from funding one of its data center projects. Over in Asia, the Bank of Japan will kick off its two-day meeting, with the central bank expected to raise rates to 0.75% Friday, its highest level in 30 years. Overnight in the U.S., all three major indexes fell, with the S&P 500 down 1.16%, and the Nasdaq Composite seeing the largest loss of 1.81%. The Dow Jones Industrial Average slipped 0.47%. Traders are awaiting the release of the U.S. consumer price index reading for November, due Thursday morning. It will mark the first consumer inflation report issued to the public since the government shutdown ended last month. Media reports stated that the headline inflation is expected to have grown at a pace of 3.1% on a year-over-year basis.Powered by Capital Market - Live

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Travatan Z Ophthalmic Solution, 0.004%, marketed by Sandoz Inc. Travoprost ophthalmic solution is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. According to IQVIA, Dasatinib tablets have an estimated market size of US$ 61 million for the 12 months ending September 2025. With this approval, Alembic has a cumulative total of 232 ANDA approvals from the USFDA, including 212 final approvals and 20 tentative approvals. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. The company's consolidated net profit jumped 20.40% to Rs 184.71 crore in Q2 FY26, compared to Rs 153.41 crore posted in Q2 FY25. Revenue from operations grew 15.90% year on year (YoY) to Rs 1,910.15 crore in Q2 September 2025. Shares of Alembic Pharmaceuticals shed 0.34% to Rs 844 on the BSE.Powered by Capital Market - Live

Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, 0.5%/0.3% (5 mL and 10 mL). The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb Incorporated. Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3%, is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Alembic was granted a Competitive Generic Therapy (CGT) designation for this application. With this approval, Alembic is eligible for 180 days of CGT exclusivity upon commercialization. Powered by Capital Market - Live

Alembic Pharmaceuticals announced that Prashant Khandelwal, Head-International Business Formulations, has resigned from the said position and relieved w.e.f. 1 December 2025 after closure of business hours.Powered by Capital Market - Live

The approval covers strengths of 30 mg, 60 mg, 90 mg and 120 mg. The product is the generic version of Cardizem, sold by Bausch Health. The medicine is used to manage chronic stable angina and angina caused by coronary artery spasm. Alembic said this approval adds to its strong US portfolio. The company now has 230 ANDA approvals. These include 210 final and 20 tentative approvals. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. The company's consolidated net profit jumped 20.40% to Rs 184.71 crore in Q2 FY26, compared to Rs 153.41 crore posted in Q2 FY25. Revenue from operations grew 15.90% year on year (YoY) to Rs 1,910.15 crore in Q2 September 2025. Powered by Capital Market - Live

Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Cardizem Tablets, 30 mg, 60 mg, 90 mg, and 120 mg, of Bausch Health US, LLC. Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm. Alembic has a cumulative total of 230 ANDA approvals (210 final approvals and 20 tentative approvals) from USFDA. Powered by Capital Market - Live

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Cardizem Tablets of Bausch Health US, LLC. Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm. Alembic has a cumulative total of 230 ANDA approvals (210 final approvals and 20 tentative approvals) from USFDA. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. The company's consolidated net profit jumped 20.40% to Rs 184.71 crore in Q2 FY26, compared to Rs 153.41 crore posted in Q2 FY25. Revenue from operations grew 15.90% year on year (YoY) to Rs 1,910.15 crore in the quarter ended 30 September 2025. The scrip had fallen 1.58% to end at Rs 902.80 on the BSE yesterday. Powered by Capital Market - Live

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Dexilant Delayed-Release Capsules, 30 mg and 60 mg, of Takeda Pharmaceuticals USA, Inc. (Takeda). Dexlansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for use in patients 12 years of age and older for the healing of all grades of erosive esophagitis (EE), the maintenance of healed EE and relief of heartburn, as well as the treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). Dexlansoprazole Delayed-Release Capsules (30 mg and 60 mg) have an estimated market size of $285 million for the twelve months ending September 2025, according to IQVIA. With this approval, Alembic now holds a cumulative total of 229 ANDA approvals (including 209 final approvals and 20 tentative approvals) from the USFDA. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. The company's consolidated net profit jumped 20.40% to Rs 184.71 crore in Q2 FY26, compared to Rs 153.41 crore posted in Q2 FY25. Revenue from operations grew 15.90% year on year (YoY) to Rs 1,910.15 crore in the quarter ended 30 September 2025. The counter rose 0.53% to currently trade at Rs 922 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) Sumatriptan Injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, Single-Dose Autoinjector System. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Imitrex STATdose System, 4 mg/0.5 mL and 6 mg/0.5 mL, of GlaxoSmithKline Intellectual Property Ltd. England. Sumatriptan injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Refer label for a detailed indication. This is Alembic's first drug device combination product. Sumatriptan Injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, Single-Dose Autoinjector System, have an estimated market size of US$ 73 million for twelve months ending September 2025 according to IQVIA.Powered by Capital Market - Live