Lupin receives EIR from USFDA for its Dabhasa facility
The facility is a part of Lupin Manufacturing Solutions
The facility is a part of Lupin Manufacturing Solutions
The Unit has now received Establishment Inspection Report classifying the facility as Voluntary Action Indicated
The facility was inspected from May 7 to May 17, 2024
Renews GMP certifications for India and Malaysia sites
The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time
The USFDA has issued 15 observations pursuant to the completion of audit. JHSGP will submit an action plan on the observations
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
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