ALEMBIC PHARMA: RECEIVES USFDA FINAL APPROVAL FOR VENETOCLAX

ALEMBIC PHARMA: RECEIVES USFDA FINAL APPROVAL FOR VENETOCLAX TABLETS

• USFDA granted final approval for ANDA for Venetoclax Tablets in 10 mg, 50 mg and 100 mg strengths • Product is therapeutically equivalent to Venclexta Tablets of AbbVie Inc. • Alembic was the first ANDA applicant with Paragraph IV certification and may be eligible for 180 days of generic drug exclusivity • Product is indicated for adult CLL/SLL patients and, in combination, for newly diagnosed AML in adults aged 75 years or older or those with comorbidities • IQVIA estimates the US market size at approximately US$1.58 billion for the 12 months ended June 2026 • Cumulative USFDA approvals for Alembic now stand at 248 ANDAs, comprising 228 final and 20 tentative approvals Impact: Positive — First-to-file Paragraph IV status with potential 180-day exclusivity provides a strong opportunity to capture a meaningful share of a large US generic market. However, the actual revenue benefit will depend on the exclusivity outcome, launch timing, pricing and competitive intensity.