Alembic Pharma Receives USFDA Compliance Report for Panelav Facilities

15 Sep 2025 , 11:22 AM

Alembic Pharmaceuticals Ltd. said on Saturday it has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its API–I and API–II plants at Panelav in Gujarat.

The report closes the regulator’s inspection held between May 26 and May 31, 2025. Thereby, confirming that the manufacturing units met compliance standards. The company said the outcome further strengthens its regulatory record. Earlier this year, in June 2025, Alembic received a similar compliance report for its API–III facility at Karakhadi, which was inspected in March.

Alongside its regulatory updates, the drugmaker has been expanding its US generics portfolio. In August 2025, it secured final approval for Macitentan Tablets (10 mg), a generic version of Johnson & Johnson’s Opsumit, used to treat pulmonary arterial hypertension. The approval covers 18 markets across Asia-Pacific and EMEA, with India and Vietnam identified as priority markets.

On the earnings front, Alembic reported a 15% year-on-year rise in net profit to ₹154 crore in the June quarter (Q1FY26). This is up from ₹135 crore in the same period last year. Revenue grew 10% to ₹1,711 crore. EBITDA climbed 19% to ₹282 crore, with operating margins improving to 16.5% from 15.2%.

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