Drug Approval | June 27, 2025
SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services
The inspection concluded with zero Form 483 observations
The inspection concluded with zero Form 483 observations
This Unit of Shilpa Medicare is engaged in testing biological samples of clinical studies
This newly set up Centre for bio-analytical testing has already received European Regulatory Authority clearance recently
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 facility is designed with advanced analytical equipment to provide testing services such as In-vitro Permeation testing
More than 2,500 submissions are currently under review in the Food and Drug Administration's (FDA) cell and gene therapy pipeline
This partnership is in line with the strategic focus of DKSH Business Unit Technology to solidify its position as a leading integrated solutions provider for the scientific Instrumentation market
The transaction, approved by both companies' boards of directors, is expected to close by the end of the first quarter of 2026
The company’s largest center for medical device applications, serving the entire Asian market
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