Denosumab biosimilars approved in Canada to expand access for osteoporosis and cancer-related bone conditions
Veteran pharma leader brings 33+ years of experience to drive operational excellence in formulation business
Inspection outcome reinforces company's compliance track record and strengthens its ability to serve regulated markets including the United States
Move comes amid rising regulatory pressures
Targets high-growth eye care expansion push
Manoj has over two decades of experience in healthcare operations and biomedical engineering
Shift from approvals to digital intimation via NSWS portal aims to cut timelines and boost innovation in early-stage drug development
The study was conducted by PwC India in line with ISO 14040 and ISO 14044 protocols
PMDA is regarded among the most stringent regulatory bodies globally
The company stated that it will work closely with the regulator to address the observations within the stipulated timeframe
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