Axxelent receives its first US FDA EIR

Sri City : Axxelent Pharma Science Private Limited (Axxelent) has received the 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 June 17-21.

Co-founder and Chairman of Axxelent Jitesh Devendra said that they are very glad about the outcome of the first US FDA inspection for the oral solid dosage facility. The next step is to trigger the sterile facility with the qualification expected to complete by Q3 in the FY25. He said that they have a pipeline of around 45 projects in various phases across multiple geographies and dosage forms.

Axxelent, headquartered in Chennai is a speciality Pharma company offering various development and manufacturing capabilities in immediate and modified release oral dosage forms, oral liquids, semi-solids, injectables and ophthalmic.