LTR Pharma has announced that SPONTAN® has achieved an 18-month shelf life under International Council for Harmonisation (ICH) stability conditions – a significant milestone that strengthens its commercial position in the global ED market.
Achieving an 18-month shelf life under ICH standards demonstrates that SPONTAN is ready for large-scale distribution. Specifically, this milestone:
- Confirms the robustness of SPONTAN’s formulation, device and packaging, exceeding distribution requirements for our expanding Australian pharmacy network.
- Strengthens the Chemistry, Manufacturing & Controls (CMC) package for global regulatory submissions, including the US, Europe and Asia.
- Validates commercial-scale manufacturing capability and supports ongoing partnership discussions with leading pharmaceutical companies.
This result materially strengthens SPONTAN’s global market potential. The extended shelf life provides the stability foundation essential for international expansion and large-scale distribution, while also increasing the product’s attractiveness to potential partners. LTR Pharma’s stability studies are ongoing, and will continue to 24 months and beyond, offering additional commercial flexibility as data becomes available.
Click to read the ASX release.