ALEMBIC PHARMACEUTICALS LTD.

Alembic Pharmaceuticals Ltd has announced that its Board of Directors will convene on November 4, 2026. The primary agenda item is to consider and approve the unaudited financial results for the quarter and half-year ended September 30, 2026. Additionally, the company will address the re-opening of the trading window for its securities, which will resume 48 hours after the declaration of these financial results. The trading window had been closed since October 1, 2026, in accordance with the company's code of conduct for designated persons.

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Valganciclovir for Oral Solution, 50 mg/mL. This generic drug is therapeutically equivalent to CHEPLAPHARM Arzneimittel GmbH's Valcyte for Oral Solution 50 mg/mL. The oral solution is indicated for the treatment of CMV retinitis in AIDS patients and for the prevention of CMV disease in transplant patients. This approval marks Alembic's 227th final ANDA approval from the USFDA, contributing to its cumulative total of 247 ANDA approvals.

Alembic Pharmaceuticals Ltd announced the incorporation of its wholly-owned subsidiary, Alvesta Pharmaceuticals FZCO, in Dubai, United Arab Emirates, on September 1, 2026. This new entity, a step-down subsidiary of Alembic Pharmaceuticals, was established with a cash consideration of AED 100,000. Alvesta Pharmaceuticals FZCO will focus on exploring new business opportunities and promoting, selling, and distributing pharmaceutical products of the parent company. The incorporation signifies Alembic's strategic move to expand its international presence and business operations within the pharmaceutical sector.

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%. This generic drug is therapeutically equivalent to Sandoz Inc.'s Ciprodex Otic Suspension. The suspension is indicated for treating specific ear infections in pediatric, adult, and elderly patients. The estimated market size for this product was US$110 million for the twelve months ending June 2026. This approval adds to Alembic's portfolio, bringing their total USFDA ANDA approvals to 246.

DSP Trustee Private Limited, on behalf of schemes of DSP Mutual Fund and DSP Global Funds ICAV, has sold 1,36,574 shares of Alembic Pharmaceuticals Ltd. The transaction, executed via the open market on September 24, 2026, resulted in a decrease in their shareholding from approximately 4.47% (calculated from 59,68,340 shares before the sale, assuming a total capital of 19,65,63,124 shares) to 2.97% (58,31,766 shares). This sale represents a 1.50% reduction in their stake in the company. The total equity share capital of Alembic Pharmaceuticals remains unchanged at 19,65,63,124 shares.

Alembic Pharmaceuticals Ltd has announced the closure of its trading window for designated persons and their immediate relatives. This closure is in compliance with SEBI (Prohibition of Insider Trading) Regulations, 2015. The trading window will be shut from October 1, 2026, until 48 hours after the declaration of the company's unaudited financial results for the quarter and half-year ending September 30, 2026. This measure is standard practice to prevent potential insider trading ahead of financial result announcements.

Alembic Pharmaceuticals Ltd has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA), confirming the closure of the inspection conducted at its Bioequivalence Facility in Vadodara, Gujarat. The inspection took place from March 3rd to March 7th, 2025. This closure signifies regulatory compliance and is a positive development for the company's operations and product approvals in the US market.

Alembic Pharmaceuticals Limited announced the successful completion of an unannounced onsite Bioequivalence inspection by the United States Food and Drug Administration (USFDA) at its facility in Vadodara, Gujarat. The inspection, conducted from August 31st to September 10th, 2026, concluded with no Form 483 observations, indicating compliance with regulatory standards. This successful inspection is crucial for the company's ability to export pharmaceutical products to the US market.

Alembic Pharmaceuticals Ltd has announced the incorporation of its wholly owned subsidiary, Alembic Pharmaceuticals Global FZCO, in Dubai, United Arab Emirates. The subsidiary was incorporated on August 24, 2026, with an initial investment of AED 100,000. Its primary objective is to explore new business opportunities and promote, sell, and distribute the company's pharmaceutical products in the region. This move signifies Alembic Pharma's strategic expansion into international markets to enhance its global presence and sales network.

Alembic Pharmaceuticals reported a resilient Q1 FY27 performance with a 26% year-on-year increase in revenue from operations, reaching ₹2150 Cr. Profit After Tax (PAT) grew by 12% YoY to ₹173 Cr. EBITDA pre-R&D stood at ₹523 Cr, with a margin of 24%. The company saw strong growth in its US Formulation business, up 49% to ₹778 Cr, and a 33% rise in its API business to ₹346 Cr. The India Branded Business grew 7% YoY to ₹642 Cr. Management highlighted broad-based growth driven by volume, new product launches, and execution across key markets. The company also received 10 ANDA approvals and launched 7 new products in the US market during the quarter.