FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission
If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease
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
The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals
This is the first approval of a prescription transdermal dosage Form in the European markets from this facility
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
The company will respond to the US FDA within the stipulated timelines
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
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