SMS Pharmaceuticals receives EIR from USFDA for Central Laboratory Analytical Services
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
The inspection concluded with zero Form 483 observations
This is the second US FDA GMP inspection of this facility within one year
The company will be submitting the responses to US FDA observations within stipulated timeline
The Union Minister reviewed DST-supported SATHI-BHU facility
The new LEED Gold-certified building will serve as CordenPharma Colorado’s sole tenant
TED?A9 is part of S.Biomedics’ expanding pipeline of stem-cell-based therapies, developed using the company’s proprietary targeted embryonic stem cell differentiation platform
The Eugene facility, with more than 20 years of history, houses a 16,000-square-foot R&D lab and a newly constructed 30,000-square-foot manufacturing facility
The inspection concluded with one minor observation in Form 483
Vivo Bio Tech will have end-to-end responsibility for conducting the full spectrum of pre-clinical safety and regulatory studies
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