ALEMBIC PHARMACEUTICALS LTD.

Alembic Pharmaceuticals Limited announced that its partner, NATCO Pharma Limited, has received tentative approval from the US Food & Drug Administration (USFDA) for Olaparib Tablets, 100 mg and 150 mg. This approval is for an Abbreviated New Drug Application (ANDA) that is therapeutically equivalent to AstraZeneca's Lynparza Tablets. Alembic will handle distribution in the U.S., while NATCO will manufacture the product. The U.S. market for Olaparib Tablets is estimated at USD 1.4 billion. This marks Alembic's 20th tentative approval from the USFDA, adding to its total of 244 ANDA approvals.

Alembic Pharmaceuticals Ltd has been informed that the USFDA has issued a Warning Letter dated July 10, 2026, to a Clinical Investigator associated with a bioequivalence study conducted at its Vadodara facility. The inspection occurred from March 3-7, 2025. The letter pertains to observations regarding the Informed Consent Form (ICF) and does not relate to data integrity. Alembic Pharma's preliminary assessment indicates no restriction on its facility's operations. The company is cooperating with the Clinical Investigator to submit a timely response. No material financial impact is identified at this stage.

Alembic Pharmaceuticals Limited has announced its 16th Annual General Meeting (AGM) will be held on Wednesday, August 5, 2026, at 4:00 p.m. IST via Video Conference/Other Audio Visual Means. The company is also providing access to the Annual Report for FY 2025-26 and the Notice convening the AGM through email to shareholders with registered email addresses and via weblinks on the company's website and stock exchanges for others. Key dates for TDS exemption, record date for final dividend, and e-voting have been set for July 29, 2026, and August 2-4, 2026, respectively. Dividend payment is scheduled on or from August 6, 2026. Shareholders are also reminded to update KYC details if not already registered.

Alembic Pharmaceuticals Ltd has announced July 29, 2026, as the record date for determining shareholder entitlement to dividends for the financial year ended March 31, 2026. The dividend payment is scheduled to commence on or after August 6, 2026, subject to approval at the Annual General Meeting (AGM) on August 5, 2026. This intimation is in compliance with SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Alembic Pharmaceuticals Ltd. has submitted its Business Responsibility and Sustainability Report (BRSR) for the financial year ended March 31, 2026. The report, which includes a Reasonable Assurance Report from Bureau Veritas (India) Private Ltd., details the company's performance across environmental, social, and governance (ESG) parameters. Key disclosures cover corporate identity, business activities contributing 100% to turnover in pharmaceutical manufacturing, operational locations (12 national plants, 3 international offices), and market reach across 19 national states and 74 countries. The report also highlights employee demographics, with 16,324 permanent employees and 3,825 workers, and notes a significant export contribution of 57% to total turnover.

Alembic Pharmaceuticals Ltd has filed its Annual Report for the financial year ended March 31, 2026, as per SEBI regulations. The report includes the notice of the Annual General Meeting. The integrated annual report, themed 'Catalysing opportunities Strengthening growth', covers various aspects of the company's performance and strategy, including highlights of FY26, Chairman's and Managing Directors' statements, sectoral and business performance, business strategy, risk management, sustainability goals, stakeholder engagement, materiality assessment, value creation model, and financial capital.

Alembic Pharmaceuticals Ltd has announced its 16th Annual General Meeting (AGM) will be held on Wednesday, August 5, 2026, at 4:00 p.m. IST. The meeting will be conducted through Video Conferencing (VC) / Other Audio Visual Means (OAVM). Key agenda items include the adoption of audited standalone and consolidated financial statements for the financial year ended March 31, 2026, declaration of dividend for FY 2025-26, re-appointment of a director, appointment of Mr. Sujit Jaysukh Bhayani as an Independent Director, and ratification of remuneration for Cost Auditors for FY 2026-27.

Alembic Pharmaceuticals Limited has announced receiving final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dapsone Gel, 5%. This gel is indicated for the topical treatment of acne vulgaris and is therapeutically equivalent to Almirall, LLC's Aczone Gel, 5%. This approval adds to Alembic's portfolio, bringing their total USFDA ANDA approvals to 244, comprising 224 final and 20 tentative approvals. The company, a vertically integrated pharmaceutical entity, has a history dating back to 1907 and operates globally with manufacturing facilities approved by major regulatory bodies.

Alembic Pharmaceuticals Ltd has announced the closure of its trading window for designated persons and their immediate relatives. This closure is in accordance with SEBI (Prohibition of Insider Trading) Regulations, 2015, and the company's internal code of conduct. The trading window will be shut from July 1, 2026, until 48 hours after the declaration of the unaudited financial results for the quarter ended June 30, 2026. The specific date for the board meeting to approve these results will be communicated separately.

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL. This generic drug is therapeutically equivalent to Hoffmann-La Roche's Tamiflu Oral Suspension, 6 mg/mL. Oseltamivir Phosphate is used for the treatment and prophylaxis of influenza A and B. The estimated market size for this product is US$ 27 million for the twelve months ending March 2026. This approval adds to Alembic's portfolio of 243 USFDA ANDA approvals.