Indoco Remedies Limited has received the Establishment Inspection Report (EIR) from the U.S. FDA for the Pre-Approval Inspection (PAI) conducted for the oral dosage form at the manufacturing facility located at Goa Plant-I, L-14 Verna Industrial Area Verna, Goa, 403722, India, in October 2023.

Indoco had addressed the observations comprehensively and within the stipulated time. The receipt of the Establishment Inspection Report (EIR) indicates a successful closure of the inspection.

The PAI was conducted for two drug product applications (ANDAs) filed from this facility, for which approvals are expected soon.

Commenting on this development, Aditi Panandikar, Managing Director, Indoco Remedies said, "We stay committed to enabling affordable access to our high-quality products for patients in the US and around the world. This is a testament to our commitment to global standards of Quality and Compliance."