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.”
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