Alembic Pharma Secures USFDA Clearance for Panelav Units, Strengthens US Portfolio

has received the Establishment Inspection Report (EIR) from the USFDA for its API–I and API–II facilities at Panelav, Gujarat, marking the closure of the May 2025 inspection with no compliance issues. This adds to the regulatory clearance earned for its API–III facility at Karakhadi earlier this year and highlights Alembic’s consistent compliance track record. The company continues to expand its presence in the US market, recently securing final approval for Macitentan Tablets (10 mg), a generic of Opsumit used for pulmonary arterial hypertension. On the financial front, Q1FY26 results showed steady growth with net profit up 15% YoY to ₹154 crore, revenue rising 10% to ₹1,711 crore, and EBITDA improving 19% to ₹282 crore, with margins strengthening to 16.5% from 15.2%. Regulatory stability and product approvals reinforce Alembic’s strong positioning in both compliance and growth. Disclaimer: This post is for informational purposes only and not a recommendation to buy or sell any securities. I, or my family, associates, or relatives, may have a financial interest in the securities mentioned.