Alembic Pharmaceuticals receives USFDA Final Approval

APLLTD Alembic Pharmaceuticals Limited was one of the first ANDA applicants for 15 mg and sole first applicant for 45 mg to submit substantially complete ANDA with a paragraph IV certification for Binimetinib Tablets. Therefore, with this approval, Alembic is eligible for 180 days of generic drug exclusivity for Binimetinib Tablets, 15 mg and 45 mg. Binimetinib tablets have an estimated market size of US$ 282 million for twelve months ending September 2026 according to IQVIA. Alembic has a cumulative total of 248 ANDA approvals (230 final approvals and 18 tentative approvals) from the USFDA. Opinion : This news will have positive impact on the stock price. Disclaimer : I do not hold this stock. This is not a buy,sell or hold recommendation.