News about "PMDA"

GlycoNex Submits Denosumab Biosimilar SPD8 for Regulatory Approval in Japan

GlycoNex Submits Denosumab Biosimilar SPD8 for Regulatory Approval in Japan

Subject to regulatory review and approval, SPD8 could receive marketing approval in Japan by the end of 2027, paving the way for its commercial launch.

PMDA | 09/11/2026 | By Abha Rustagi

Shilpa Biologicals Launches PartnerPower Platform for Real-time Visibility on Process Development and GMP Manufacturing

Shilpa Biologicals Launches PartnerPower Platform for Real-time Visibility on Process Development and GMP Manufacturing

Shilpa Biologicals has launched PartnerPower, a proprietary platform offering real-time visibility into process development and Good Manufacturing Practice (GMP) manufacturing, setting a new benchmark for transparency in CDMO operations.

PMDA | 24/06/2026 | By News Bureau |  186


 

 

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