Irish manufacturer brings EU GMP-certified dronabinol API to UK specials market

Dunbar Pharmaceuticals partners with IPS Pharma to supply plant-derived dronabinol API for UK Specials-pathway cannabis medicines, following its earlier expansion into Germany

Dunbar Pharmaceuticals has launched its plant-derived dronabinol API, WaterClear THC, in the UK through a supply agreement with Specials manufacturer IPS Pharma, extending the Athlone-based company's EU GMP-certified cannabinoid API into a second major European market within a year.


Under the agreement, IPS Pharma will use Dunbar's API to produce cannabis-based products for medicinal use (CBPMs) supplied through the UK's Specials pathway, under which unlicensed medicines are manufactured to meet individual patient needs when no licensed alternative exists.

The CBPMs will comprise oral capsules, an oral spray and an oily dropper solution.


Dunbar Pharma produces WaterClear THC at commercial scale under Health Products Regulatory Authority (HPRA) oversight, with full batch traceability.

Dronabinol (the International Nonproprietary Name for pharmaceutical-grade delta-9-THC) has traditionally been manufactured synthetically.

Dunbar's process instead uses plant-derived starting material, which the company says allows consistent milligram dosing with minimal batch-to-batch variability, addressing a long-standing supply consistency issue in the sector.

“Making WaterClear THC, our GMP-certified dronabinol, available through IPS Pharma marks an important milestone in our efforts to broaden access to pharmaceutical-grade cannabinoid medicines,” said Leah Fletcher, founder and CEO of Dunbar Pharma.

By manufacturing at commercial scale in Ireland to EU GMP standards, we can provide partners such as IPS Pharma with a consistent, reliable supply of dronabinol for oral formulations.

"This is how cannabinoid therapy becomes an accepted part of medicine rather than a category apart."

Ian McFarlane, Director of Strategic Partnerships at IPS Pharma, said the deal gives the company "confidence in the supply of regulated cannabinoid medicines" for clinicians prescribing under the Specials framework.

A regulated niche within a fast-growing market

The UK's medical cannabis sector remains almost entirely privately funded: unlicensed CBPMs can only be prescribed by specialist doctors on the General Medical Council's Specialist Register and NHS prescribing volumes have stayed minimal since the framework was introduced in November 2018.

But, despite this, the private market has grown rapidly, now serving an estimated 50,000-100,000 patients, with prescription volumes rising faster than in mainstream pharmaceuticals.

That growth has created sustained demand for reliably manufactured, pharmacopoeia-standard active ingredients that can support consistent formulation.

It is this gap that Dunbar is positioning itself to fill.

The UK launch follows Dunbar's earlier entry into Germany, where regulatory direction is now moving in the API's favour.

Germany's Statutory Health Insurance Contribution Rate Stabilisation Act, which took effect in July 2026, removed reimbursement for cannabis flower under the country's statutory health insurance (GKV) and instead limited eligible compounded preparations largely to standardised extracts and dronabinol- or nabilone-based medicines.

That shift reinforced the company's account of dronabinol's growing share of the reimbursed German market relative to flower.

For pharma manufacturers, the announcement is notable less for the product itself (dronabinol has been used in regulated medicines for decades) than for the supply model.

Dunbar's pitch rests on offering commercial-scale, traceable API production to Specials manufacturers who have historically relied on smaller-scale or imported supply — an issue that has periodically constrained availability in both the UK and German markets.

You may also like