Axxelent Receives its first US FDA Establishment Inspection Report (EIR)

Axxelent Pharma Science Private Limited (Axxelent) is pleased to announce receipt of first Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its oral solid dosage facility situated in Sri City SEZ, AP. US FDA officials inspected the facility during 17th-21st June 2024.

Commenting on the outcome of the inspection, Jitesh Devendra, Co-Founder and Chairman, said "We are very glad about the outcome of our first US FDA inspection for our oral solid dosage facility. We expect further inspections for our 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 expected to complete by Q3 FY25. We have a pipeline of around 45 projects in various phases across multiple geographies and dosage forms."