13 Sep 2025 | 5 Mins Read
US FDA clears Alembic Pharma's Panelav plants after inspection
Flipitmoney
Alembic Pharma obtained an EIR from the USFDA for its API-I and API-II facilities, marking closure of May 26-31 inspection, signaling regulatory compliance. This reinforces Alembic's regulatory track record. The company received EIR for API-III facility in June 2025, secured USFDA approval for Macitentan Tablets in August 2025, and reported 15% net profit growth in Q1FY26.