Drug Approval | June 14, 2024
There was no observation related to data integrity reported
The state-of-the-art facility is equipped with best-in-class equipment and control systems
Facility in The Woodlands, Texas to produce critical starting material for cell and gene therapy, DNA/RNA-based, and recombinant protein therapeutics in Q1/2025
Operationally ready by 2029, it will be the Company’s first-ever facility to cover the full manufacturing process for ADCs
The company is committed to address this observation comprehensively within stipulated time
With this, for all our USFDA facilities, EIRs are in place
The USFDA has issued 5 observations pursuant to the completion of audit
The company will closely work with the USFDA to address and respond to the observations in an expeditious manner
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