2025/11/26
Genovior Biotech (“Genovior”) announced today the expansion of its sterile injectable manufacturing capacity, enabling large-scale commercial production of fully synthetic peptide medicines and specialty sterile dosage forms for global markets.
The expanded capacity focuses on complex injectables, fully synthetic peptide-based therapeutics, and integrated API-to-FDF manufacturing, supported by two core production lines:
- Cartridge line for pre-filled and pen-injector systems
- Vial line for sterile liquid and lyophilized products
Both production lines are now aligned with international partners for commercial ramp-up and are preparing for U.S. FDA and European EMA regulatory inspections.
Dr. Steve Hsu, Chairman of Polaris Group and Genovior Biotech Corporation, stated:
“Genovior uniquely integrates fully synthetic peptide capability with aseptic injectable manufacturing and multi-country GMP experience. This expansion further positions Genovior as a reliable global supplier of high-quality peptide and injectable therapeutics.”
Initial contract manufacturing orders are anticipated to generate up-front signing payments, with additional growth expected as capacity and customer programs scale.
Furthermore, multiple specialty injectable generic products are expected to file the official submission for regulatory approvals beginning of Q3 next year (2026), supporting margin expansion and long-term revenue growth.