Every batch manufactured at Golden Hour undergoes >500 quality checkpoints. Our three FDA‑inspected facilities maintain strict cGMP standards, and we hold ISO 9001:2024 certification.
We publish annual quality reports and maintain full traceability via blockchain from API source to administration.
Our continuous monitoring program exceeds Pharmacopeia standards (USP, EP, JP).
ICH Q1A compliant — real‑time and accelerated studies for all formulations.
ISO 14644 cleanrooms, Grade A/B barriers, continuous particle counting.
2‑8°C / -20°C stability with real‑time GPS temperature logging.
Boston aseptic processing hub recognized for innovation.
Third consecutive FDA inspection with no Form 483.
Goldcef and G‑TRAUMA added to WHO essential medicines list.