Epsilon Healthcare (ASX: EPN) has achieved a significant regulatory milestone with its subsidiary Epsilon Pharma receiving formal Halal certification from Halal Australia for CBD and THC oil dosage forms manufactured at its Queensland facility. The certification confirms compliance with the internationally recognised GSO/UAE.S 2055-1 standard, covering the complete supply chain from raw material receipt through processing, storage and distribution.
This certification removes a critical regulatory barrier for accessing Muslim-majority markets estimated at 1.9 billion consumers globally, positioning Epsilon Pharma to pursue commercial opportunities across the Middle East and Southeast Asia where Halal compliance is mandatory for pharmaceutical market entry.
What is Halal certification and why it matters for pharmaceutical exports
Halal certification in a pharmaceutical context confirms that products meet Islamic dietary and ethical requirements throughout the entire manufacturing process. For medicinal cannabis products, this extends beyond ingredients to encompass facility operations, handling protocols and supply chain management.
The GSO/UAE.S 2055-1 standard specifically governs the receiving of raw materials, processing methods, storage conditions and distribution practices for pharmaceutical products. Epsilon Pharma’s certification demonstrates that its Queensland-based manufacturing systems, processes and handling protocols meet stringent Halal requirements aligned with the expectations of consumers and regulatory bodies across key international markets.
Without this certification, pharmaceutical companies cannot legally sell into significant portions of global markets regardless of product quality or efficacy. As medicinal cannabis frameworks continue to mature across Middle Eastern and Southeast Asian jurisdictions, Halal certification has become an essential prerequisite for market access rather than a competitive differentiator.
Target markets unlocked
The certification strengthens Epsilon Pharma’s ability to access Halal-regulated international markets where compliance with GSO/UAE.S 2055-1 is essential for commercial operations. This milestone is expected to create new commercial pathways within regions where Halal-compliant products are mandatory, further strengthening the company’s competitive position as a contract development and manufacturing organisation (CDMO).
Strategic benefits include:
- Market access across Middle Eastern jurisdictions with established medicinal cannabis frameworks
- Entry capability into Southeast Asian pharmaceutical markets requiring Halal compliance
- Enhanced appeal to international partners seeking Halal-certified manufacturing capabilities
- Competitive differentiation from non-certified Australian manufacturers in the CDMO sector
Commercial pathway and strategic growth positioning
The Halal certification achievement supports three growth pillars identified by management: establishing new international commercial partnerships, expanding into Halal-compliant markets, and pursuing long-term strategic growth in premium regulated product segments.
Epsilon Pharma operates as a wholly owned contract development and manufacturing subsidiary of Epsilon Healthcare Limited (ASX: EPN), providing CDMO services to clients requiring TGA-licensed manufacturing capabilities. The Halal certification builds on existing regulatory approvals, strengthening the subsidiary’s value proposition for clients seeking manufacturing partners capable of supplying diverse global markets.
CEO Commentary
“Being granted Halal Certification by Halal Australia validates the precision and robustness of our onshore manufacturing systems. It reflects our commitment to maintaining world class standards and supporting market pathways that require the highest levels of compliance. This achievement enhances our competitive position and demonstrates our readiness to supply diverse global markets with confidence and integrity,” said Peter Giannopoulos, Group Chief Executive and Managing Director.
The certification enhances Epsilon’s ability to win CDMO contracts from companies seeking Halal-compliant manufacturing partners for international distribution, particularly as medicinal cannabis regulations continue to evolve in target markets.
Epsilon Healthcare’s vertically integrated model
Epsilon Healthcare operates a diversified portfolio spanning four business segments: healthcare clinics operation, pharmaceutical contract development and manufacture, pharmacy dispensing services, and information services. The Halal certification strengthens the pharmaceutical manufacturing pillar whilst complementing the group’s broader healthcare service offerings.
| Business Segment | Entity | Focus | Status |
|---|---|---|---|
| Pharmaceutical Manufacturing | Epsilon Pharma | CDMO services, CBD/THC oils | Now Halal certified |
| Healthcare Clinics | Epsilon Clinics | Patient services | Operational |
| Pharmacy Services | Epsilon Pharmacy | Dispensing & information | Operational |
This vertically integrated structure positions Epsilon Healthcare to capture value across multiple points in the healthcare delivery chain whilst maintaining operational flexibility across different regulatory environments.
What comes next for Epsilon Healthcare
Management has indicated ongoing investment in quality systems, advanced processing technologies and regulatory compliance frameworks to ensure facilities and operating systems remain aligned with evolving global standards. The company expects the certification to support commercial discussions with potential international partners seeking access to Halal-certified manufacturing capacity for regulated markets.
The Halal certification achievement represents foundational infrastructure that positions the company to capture opportunities as medicinal cannabis regulations mature in target markets across the Middle East and Southeast Asia. Whilst the certification creates no immediate revenue impact, it removes a critical barrier to market entry and enhances the company’s competitive positioning for future contract manufacturing opportunities in high-value pharmaceutical markets.
Epsilon Pharma will continue to pursue commercial partnerships and market access opportunities enabled by this certification, with particular focus on jurisdictions where Halal compliance combines with developing regulatory frameworks for medicinal cannabis products.
Stay Ahead on Healthcare Breakthroughs
Join 20,000+ investors receiving FREE breaking ASX healthcare news within minutes of release, complete with expert analysis. Big News Blast delivers market-moving announcements straight to your inbox before the broader market reacts. Click the “Free Alerts” button to start receiving real-time coverage.