Nona aims to help global biopharmaceutical companies fast-track clinical trial initiation without compromising scientific rigor or quality standards
These observations are procedural in nature and the company does not anticipate any impact on supply of its commercial products
Additional investments planned to expand the site’s capacity and capabilities to support growing manufacturing programs
USFDA determines Sun Pharma's Baska facility inspection classification as OAI
If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease
The plant can reach an annual capacity of 300 crore tablets and 90 crore capsules
The inspection concluded with one minor observation in Form 483
India has deep strengths in reverse engineering and API development, while Russia has strong capabilities in certain vaccines, biologicals, and niche therapeutic segments. Collaboration can significantly shorten R&D timelines
Granules Consumer Health serves as Granules’ front-end division for OTC products in the US
This inspection was conducted following the warning letter issued by the USFDA
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