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.