Long-acting insulin analogue providing 24-hour basal glycaemic control with a flat pharmacokinetic profile.
Dossier access (CTD/eCTD) and product samples are made available to qualified partners after execution of a confidentiality agreement and country-specific regulatory due diligence. Please use the partner inquiry form above to begin the conversation with our Business Development team.
Manufactured under WHO-GMP and Schedule M; release testing includes identity by LC-MS, purity by RP-HPLC, potency by cell-based bioassay, sterility (USP <71>) and endotoxin (USP <85>).
Validated 2°C–8°C chain per WHO TRS 961 Annex 9 — qualified shippers, temperature mapping and real-time data loggers from manufacture to distributor warehouse.
Complete CTD/eCTD dossier (Modules 1–5) per ICH M4, with stability data (ICH Q1A) and country-specific Module 1 adaptation for licensing partners.