Alembic Pharmaceuticals Limited has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Binimetinib Tablets, 45 mg, further strengthening the company’s oncology portfolio and expanding its pipeline of complex generic products for the US market.The latest regulatory milestone follows the company’s earlier tentative approval for Binimetinib Tablets, 15 mg. The newly approved application is therapeutically equivalent to the reference listed drug Mektovi® (Binimetinib) Tablets, 15 mg, marketed by Array BioPharma.
Binimetinib is a kinase inhibitor used in combination with encorafenib for the treatment of patients with unresectable or metastatic melanoma carrying BRAF V600E or V600K mutations. The therapy is also indicated, when administered with encorafenib, for adult patients with metastatic non-small cell lung cancer (NSCLC) associated with a BRAF V600E mutation. These targeted therapies play an important role in the treatment of specific forms of cancer by addressing genetic mutations that drive disease progression.
The tentative approval represents a significant achievement for Alembic. According to the US FDA’s Paragraph IV Certification List, the company is currently the sole first applicant to have filed an ANDA for the 45 mg strength of Binimetinib Tablets containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Subject to receiving final approval from the USFDA, Alembic may qualify for 180 days of generic marketing exclusivity in the United States, providing a valuable commercial opportunity in a highly specialized therapeutic segment. Market data indicates that Binimetinib products generated estimated annual sales of approximately US$259 million in the United States for the twelve-month period ending March 2026, highlighting the commercial significance of the product category.
The approval further reinforces Alembic’s growing presence in regulated global markets and reflects its continued investment in research, development and regulatory excellence. The company has steadily expanded its portfolio of complex generic products across multiple therapeutic areas, including oncology, cardiovascular care, anti-infectives and specialty medicines.
With this development, Alembic’s cumulative USFDA approval count has reached 242 ANDAs, comprising 222 final approvals and 20 tentative approvals. The milestone underscores the company’s strong track record in navigating complex regulatory pathways and bringing high-quality generic medicines to patients worldwide.
Established in 1907, Alembic Pharmaceuticals is one of India’s longstanding pharmaceutical companies with integrated research, development and manufacturing capabilities. The company operates globally and maintains manufacturing facilities approved by several international regulatory authorities. Its broad portfolio of branded and generic medicines continues to support healthcare needs across domestic and international markets, serving millions of patients through a commitment to quality, innovation and accessibility.
