Bertozzi currently serves as the Baker Family Director of Sarafan ChEM-H, Anne T. and Robert M. Bass Professor at Stanford University, and Investigator of the Howard Hughes Medical Institute
The EIR was issued following an inspection of the facility from September 8 to September 16, 2025
If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease
Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility
The inspection concluded with one minor observation in Form 483
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
This is the first approval of a prescription transdermal dosage Form in the European markets from this facility
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
VitiPure serves as essential solubilizers, emulsifiers, and bioavailability enhancers in drug formulations
Ipca Laboratories receives three observations from USFDA for API facility at Tarapur
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