Alembic has received USFDA approval for ANDA for Binimetinib

APLLTD a final USFDA ANDA approval removes a key regulatory barrier to sell in the US market for this product. 180-day exclusivity can meaningfully raise early launch prices and volumes versus immediate generic competition, improving near-term revenue potential for the product. Addressable market cited at US$282m (12 months to Sep 2026) — material for a single molecule in generics terms but company share is uncertain. Alembic’s cumulative 248 ANDA approvals indicate regulatory and filing scale, supporting realistic commercial launch capability. Balance-sheet context: Market cap Rs 20,249 Cr; Cash & Bank Rs 262 Cr; Borrowings Rs 1,547 Cr — cash is small relative to market cap and debt is moderate, limiting large one-off investments but sufficient for routine launch activity.