US FDA inspects Axxelent Pharma unit in Sri City

Hyderabad: Chennai-based Axxelent Pharma Science Pvt Ltd on Wednesday announced the receipt of first Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its oral solid dosage facility in Sri City SEZ, Andhra Pradesh.

The pharma company said that US FDA officials had inspected the facility in June 2024. The manufacturing facility has two blocks – non-sterile facility with oral solid, oral liquids, and semi-solids dosage forms, and a sterile facility for injectables and ophthalmic (that is currently under qualification).

On the outcome of the inspection, Jitesh Devendra, Co-founder and Chairman, Axxelent, said, “We are pleased about the result of US FDA inspection of our oral solid dosage facility. We expect further inspections for other dosage forms in the coming 12 months from US FDA, as well as other regulatory agencies. Our next step is to trigger our sterile facility with the qualification likely to complete by the third quarter of FY25. We have a pipeline of around 45 projects in various phases across multiple geographies and dosage forms.” Axxelent is a specialty pharma company offering various development and manufacturing capabilities in immediate and modified release oral dosage forms, oral liquids, semi-solids, injectables, and ophthalmic.