USFDA clears Alembic Pharma’s Panelav manufacturing units after inspection

Alembic Pharmaceuticals Limited on Saturday said it has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its API–I and API–II facilities at Panelav, Gujarat.The EIR marks the closure of the inspection carried out between May 26-31, 2025, signalling regulatory compliance at the manufacturing sites.

The development reinforces Alembic’s regulatory track record. Earlier this year, in June 2025, the company also received an EIR for its API–III facility at Karakhadi, following a March inspection by the USFDA.

Alembic has been actively expanding its US portfolio. On August 19, 2025, it secured final approval from the USFDA for its abbreviated new drug application (ANDA) for Macitentan Tablets, 10 mg — a generic equivalent of Opsumit Tablets, used in the treatment of pulmonary arterial hypertension in adults.The company has also been delivering steady financial performance. In its June quarter (Q1FY26) results, Alembic reported a 15% rise in net profit to ₹154 crore, up from ₹135 crore in the same quarter last year. Revenue grew 10% to ₹1,711 crore, while EBITDA rose 19% to ₹282 crore, with margins improving to 16.5% from 15.2% year-on-year.

On Friday, shares of Alembic Pharmaceuticals closed at ₹945.40 on the NSE, down 0.18%.