Alembic Pharmaceuticals Ltd

The approved ANDA is therapeutically equivalent to Aczone Gel, 5%, of Almirall, LLC, and is indicated for the topical treatment of acne vulgaris. With this approval, Alembic Pharmaceuticals now has a cumulative total of 244 ANDA approvals from the USFDA, comprising 224 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. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. The company's consolidated net profit jumped 29.19% to Rs 202.70 crore in Q4 FY26, compared to Rs 156.89 crore posted in Q4 FY25. Revenue from operations grew 4.41% year on year (YoY) to Rs 1,847.72 crore in the quarter ended 31 March 2026.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) Dapsone Gel, 5%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Aczone Gel, 5%, of Almirall, LLC. Dapsone Gel is indicated for the topical treatment of acne vulgaris. Refer label for a detailed indication. Alembic has a cumulative total of 244 ANDA approvals (224 final approvals and 20 tentative approvals) from USFDA.

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) Oseltamivir Phosphate for Oral Suspension, 6 mg/mL. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tamiflu Oral Suspension, 6 mg/mL, of Hoffmann-La Roche, Inc. Oseltamivir Phosphate is an influenza neuraminidase inhibitor (NAI) indicated for: i) treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours, and ii) Prophylaxis of influenza A and B in patients 1 year and older. Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, have an estimated market size of US$ 27 million for twelve months ending March 2026 according to IQVIA.

Alembic Pharmaceuticals (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Binimetinib Tablets, 45 mg. Alembic had previously received tentative approval for Binimetinib Tablets, 15mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Mektovi Tablets, 15 mg of Array.  Binimetinib is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. It is also indicated, in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Mektovi Tablets, 15 mg of Array. Binimetinib is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. It is also indicated, in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. The company had earlier received tentative approval for the 15 mg strength of the drug. Alembic stated that it is the sole first applicant for the 45 mg strength under a Paragraph IV certification filed under the Hatch-Waxman Act. Upon final approval, the company may be eligible for 180 days of generic marketing exclusivity in the US market. According to IQVIA estimates, the Binimetinib Tablets market is valued at approximately $ 259 million for the twelve months ending March 2026. Alembic Pharmaceuticals has now accumulated a total of 242 ANDA approvals from the USFDA, including 222 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. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. The company's consolidated net profit jumped 29.19% to Rs 202.70 crore in Q4 FY26, compared to Rs 156.89 crore posted in Q4 FY25. Revenue from operations grew 4.41% year on year (YoY) to Rs 1,847.72 crore in the quarter ended 31 March 2026. 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) Tretinoin Cream USP, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.05%, of Bausch Health US, LLC. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. Tretinoin Cream USP, 0.05%, has an estimated market size of US$ 76 million for twelve months ending March 2026 according to IQVIA.

The approved product is therapeutically equivalent to the reference listed drug, Retin-A Cream, 0.05%, marketed by Bausch Health US, LLC. Tretinoin Cream is used for the topical treatment of acne vulgaris. According to IQVIA data, the approved product has an estimated market size of approximately $76 million for the 12 months ended March 2026. With this approval, Alembic Pharmaceuticals has received a cumulative total of 242 ANDA approvals from the USFDA, comprising 222 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. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. The company's consolidated net profit jumped 29.19% to Rs 202.70 crore in Q4 FY26, compared to Rs 156.89 crore posted in Q4 FY25. Revenue from operations grew 4.41% year on year (YoY) to Rs 1,847.72 crore in the quarter ended 31 March 2026. Powered by Capital Market - Live

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Vitrakvi Capsules, 25 mg and 100 mg, of Bayer Healthcare Pharmaceuticals Inc. (Bayer). Larotrectinib is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that harbor a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation. The therapy is intended for patients with metastatic disease or those for whom surgical resection is likely to result in severe morbidity, and who have either no satisfactory alternative treatment options or whose disease has progressed following prior treatment. 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 29.19% to Rs 202.70 crore in Q4 FY26, compared to Rs 156.89 crore posted in Q4 FY25. Revenue from operations grew 4.41% year on year (YoY) to Rs 1,847.72 crore in the quarter ended 31 March 2026.Powered by Capital Market - Live

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Larotrectinib Capsules, 25 mg and 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Vitrakvi Capsules, 25 mg and 100 mg, of Bayer Healthcare Pharmaceuticals Inc. (Bayer). Larotrectinib is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: a) have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, b) are metastatic or where surgical resection is likely to result in severe morbidity, and c) have no satisfactory alternative treatments or that have progressed following treatment. Larotrectinib Capsules, 25 mg and 100 mg, have an estimated market size of US$ 91 million for twelve months ending March 2026 according to IQVIA.

The approved product is therapeutically equivalent to the reference listed drug, Haldol Tablets, of Ortho McNeil Pharmaceutical. According to IQVIA data, the product had an estimated market size of approximately $27 million in the United States for the 12 months ended March 2026. Following the approval, Alembic Pharmaceuticals has a cumulative total of 240 ANDA approvals from the USFDA, comprising 221 final approvals and 19 tentative approvals. 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 29.19% to Rs 202.70 crore in Q4 FY26, compared to Rs 156.89 crore posted in Q4 FY25. Revenue from operations grew 4.41% year on year (YoY) to Rs 1,847.72 crore in the quarter ended 31 March 2026. Shares of Alembic Pharmaceuticals rose 0.92% to Rs 742.50 on the BSE.Powered by Capital Market - Live