Irish Pharma Manufacturer Expands UK Access with Plant-Derived Dronabinol

Dunbar Pharma Brings GMP-Certified API to UK Specials Market

Dunbar Pharmaceuticals, an Ireland-based pharmaceutical manufacturer, has expanded into the UK market with its plant-derived dronabinol active pharmaceutical ingredient (API), WaterClear THC™. The company has entered an agreement with IPS Pharma, a UK pharmaceutical service provider and licensed Specials manufacturer, to make the product available through the country’s regulated supply network.

WaterClear THC™ Enters UK Market

WaterClear THC™ is a GMP-certified dronabinol API manufactured at Dunbar Pharma’s facility in Athlone, Ireland. The company manufactures the API at commercial scale under the oversight of the Health Products Regulatory Authority (HPRA), with validated processes and batch traceability supporting consistent supply.

Dronabinol, the pharmaceutical form of delta-9-THC, has traditionally been produced synthetically. Dunbar Pharma uses plant-derived starting materials for its manufacturing process. The company said this approach supports consistent milligram dosing and minimal compositional variability between batches.

According to Towards Healthcare, the API stability testing services market size was estimated at USD 1.48 billion in 2025 and is predicted to increase from USD 1.55 billion in 2026 to approximately USD 2.35 billion by 2035, expanding at a CAGR of 4.74% from 2026 to 2035. Market growth is fueled by strict global regulatory standards and rising investments in pharmaceutical R&D. Key trends include the widespread adoption of advanced stability testing methodologies and a significant increase in outsourcing by biotechnology firms. These factors collectively streamline drug development pipelines, ensuring that active pharmaceutical ingredients remain safe, effective, and compliant throughout their intended shelf life across global supply chains.

IPS Pharma to Supply UK Medicines

Under the agreement, IPS Pharma will use Dunbar Pharma’s dronabinol API to produce cannabis-based products for medicinal use through the UK’s Specials framework. This pathway allows unlicensed medicines to be manufactured or supplied for individual patients when a suitable licensed alternative is unavailable.

The products will include 5 mg and 10 mg capsules, a 25 mg/mL oral spray, and a 25 mg/mL oily dropper solution. These medicines may be prescribed by clinicians where clinically appropriate under the UK Specials system.

Expanding Access to Pharmaceutical-Grade Cannabinoids

Dunbar Pharma said the UK launch is an important step in its efforts to expand access to pharmaceutical-grade cannabinoid medicines. The company noted that some patients cannot or do not want to use inhaled cannabinoid medicines and may require other treatment options. Through IPS Pharma’s established distribution network, clinicians and pharmacies across the UK can access dronabinol-based medicines while maintaining regulatory and quality requirements throughout the supply chain.

UK Expansion Follows German Market Entry

The UK launch follows Dunbar Pharma’s earlier entry into Germany and forms part of its broader expansion into regulated pharmaceutical markets across Europe. The company received support from Enterprise Ireland as it expands its manufacturing capabilities and commercial reach. The development also highlights Dunbar Pharma’s focus on commercial-scale production of pharmaceutical-grade cannabinoid APIs. The company said its manufacturing model is designed to provide reliable supply, full batch traceability, and consistent quality for regulated pharmaceutical medicines.

A recent report by Towards Healthcare highlights that the API stability testing services market is witnessing growth due to promising opportunities in the development of complex biologics and cell-and-gene therapies, which require highly specialized testing protocols. Furthermore, integrating AI-driven predictive analytics into testing procedures can drastically cut down timeline costs. Expanding specialized testing services into high-growth regional markets across Asia-Pacific and Latin America also offers massive untapped commercial potential for contract research organizations.