Drug Approval | June 27, 2024
Shilpa Medicare Bio Analytical unit gets "No Action Indicated" classification from USFDA
This Unit of Shilpa Medicare is engaged in testing biological samples of clinical studies
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
Investment demonstrates confidence in America’s commitment to science and innovation
Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein
The capital raise will also support debt repayment or prepayment, improving the company's debt-to-equity ratio and overall financial resilience
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