Alembic Pharmaceuticals has received tentative approval from the US Food and Drug Administration (USFDA) for Binimetinib Tablets, 45 mg. This approval positions the company as the sole first applicant for the product, potentially granting it 180 days of generic marketing exclusivity in the US market upon final approval. The drug addresses a significant market need, with an estimated market size of $259 million for the twelve months ending March 2026, according to IQVIA.

Approval Details and Therapeutic Indication

The tentative approval was granted for the company's Abbreviated New Drug Application (ANDA) for Binimetinib Tablets, 45 mg. This product is therapeutically equivalent to the reference listed drug Mektovi Tablets, 15 mg, marketed by Array. Binimetinib is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with encorafenib. It is also indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation.

Market Position and Exclusivity

Based on the FDA's Paragraph IV Certifications List, Alembic is the first applicant to have filed its ANDA containing a Paragraph IV certification for this dosage. Consequently, upon final approval, the company may be eligible for 180 days of marketing exclusivity. Alembic had previously received tentative approval for Binimetinib Tablets, 15 mg.

Key Metrics

Alembic Pharmaceuticals has appointed Sujit Jaysukh Bhayani as a Non-Executive Independent Director, effective June 18, 2026, for a period of five years. The Board of Directors approved the appointment through a circular resolution based on the recommendation of the Nomination and Remuneration Committee. This governance enhancement adds an experienced professional to the company's leadership structure.

The appointment is subject to the approval of shareholders at the ensuing Annual General Meeting. Upon approval, Bhayani will not be liable to retire by rotation. The company confirmed that the appointee is not debarred from holding the office of Director by any SEBI order or other authority.

Profile of the Appointee

Sujit Jaysukh Bhayani is the Founder and Managing Director of the Sudeep Group. He holds a Bachelor's degree in Chemistry from the University of Tulsa and possesses more than 35 years of experience in the pharmaceuticals industry. Previously, he served as a Director of Dinesh Remedies Limited.

Key Details of Appointment

The company has disclosed that Bhayani is not related to any of the Directors or Key Managerial Personnel of Alembic Pharmaceuticals.