Alembic Pharmaceuticals advanced 1.90% to ₹764 following the announcement of its USFDA approval. According to reports from Business Standard, the company received tentative approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Binimetinib Tablets, 45 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Mektovi Tablets, 15 mg of Array. This follows a previous tentative approval for Binimetinib Tablets, 15 mg, as reported in the latest regulatory filing submitted to the National Stock Exchange of India.
As reported by Business Standard, Binimetinib is a kinase inhibitor indicated in combination with encorafenib for the treatment of patients with unresectable or metastatic melanoma with resistance to specific targeted therapies. The drug is also indicated for adult patients with metastatic non-small cell lung cancer (NSCLC) with resistance to specific targeted therapies. According to IQVIA estimates, the Binimetinib Tablets market is valued at approximately $259 million for the twelve months ending March 2026. The drug is specifically used in combination with encorafenib for treating patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, and for adult patients with metastatic NSCLC with a BRAF V600E mutation.
According to Business Standard, 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. The company had earlier received tentative approval for the 15 mg strength of the drug, as confirmed in the latest regulatory filing.
As reported by Business Standard, Alembic Pharmaceuticals has now accumulated a total of 242 ANDA approvals from the USFDA, including 222 final approvals and 20 tentative approvals. The company is a vertically integrated research and development pharmaceutical company that manufactures and markets generic pharmaceutical products globally. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. Alembic Pharmaceuticals Limited, established in 1907, is recognized as a leader in branded generics within India and is based in India, with facilities approved by regulatory authorities in several developed countries.
According to Business Standard, the company's consolidated net profit jumped 29.19% to ₹202.70 crore in Q4 FY26, compared to ₹156.89 crore posted in Q4 FY25. Revenue from operations grew 4.41% year on year (YoY) to ₹1,847.72 crore in the quarter ended 31 March 2026.
