India's pharmaceutical sector has undergone a significant transformation over the past decade, driven by a combination of affordable healthcare initiatives, domestic manufacturing incentives, and innovation-focused policies. According to the Ministry of Chemicals and Fertilizers, the country has expanded access to low-cost medicines while simultaneously strengthening its position as a global pharmaceutical manufacturing hub.

Alembic Pharmaceuticals Limited has announced that it has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Binimetinib Tablets, 45 mg. The company had earlier secured tentative approval for the 15 mg strength of the same drug.

The approved generic product is therapeutically equivalent to Mektovi Tablets, 15 mg, marketed by Array BioPharma. Binimetinib is a kinase inhibitor used in combination with encorafenib for the treatment of patients with specific forms of advanced cancer.