News | September 14, 2023
Zydus receives EIR for injectables manufacturing facility at Zydus Biotech Park, Ahmedabad
The inspection was a cGMP Inspection and had ended with NIL observations
The inspection was a cGMP Inspection and had ended with NIL observations
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Patients Treated with ARIKAYCE plus macrolide-based background regimen had meaningfully larger improvements in QOL-B respiratory score
Amgen will be prohibited from leveraging its drug portfolio to disadvantage rivals and will be required to seek prior approval before acquiring related products
The facility has a potential for capacity expansion up to 2 billion tablets/capsules per year
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The company is committed to address the observations and will submit its response to US FDA within the stipulated time
In Phase I studies, ZYIL1 was found to be safe and well-tolerated in human volunteers
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