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

Axxelent Pharma Science (“Axxelent”) has announced the receipt of first  EIR from US FDA for its oral solid dosage facility situated in Sri City SEZ, AP. US FDA inspected  the facility from June 17 to 21, 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.”