Find a TenderAwarded without competitionContract award notice
Published 23 Oct 2025, 17:25 BST

Official UK procurement notice

LIONNS-D2 Project - Production of T3S API, IMP and FDF

Official notice

Authority: Cardiff University (Education)·Consortium: 2 public authorities

Direct award
Budget not disclosedValue not published
Award in standstill 22 Oct 2025no call for competition
Award (standstill) to Ardena Holding NV

What is being bought

Published requirement description

Cardiff University's School of Medicine is procuring the manufacture of a novel investigational medicinal product (IMP), Triiodothyronine sulphate (T3S), for use in a Phase 2b clinical trial. The service includes the production of the active pharmaceutical ingredient (API), the IMP, and the finished drug formulation (FDF) in blister packs. This bespoke drug is intended for hypothyroid patients with a specific genetic variation affecting thyroid hormone metabolism. The supplier will manufacture the product to GMP standards, using a validated Route of Synthesis supported by existing preclinical and toxicology data.

The lotProcurement structure

single lot · no lot value published

Procedure terms & legal framework

From the official record
Procedure method
Direct award
Legal basis
UKPGA · 2023/54 Procurement Act 2023
Notice status
Awarded without competition
Procurement threshold
Unspecified in notice
Regulatory regime
Standard
Commercial structure
Stand-alone contract (no framework)
Competition type
Direct award (no call for competition)
GPA / WTO covered
Unspecified in notice
Recurring procurement
Unspecified in notice
First published
23 Oct 2025, 17:25 BST
Last source update
24 Oct 2025, 09:23 BST
Authority reference
CU.1623.RR
FTS notice number
2025/S 000-068032
Latest notice
Contract award notice (UK6)
Delivery area
Wales (UKL)
Official registry OCID
ocds-h6vhtk-05d2df Find a Tender
Why no open competition
Prototypes Development
Published justification

T3S is not commercially available and must be manufactured to GMP standards using a specific Route of Synthesis (RoS) supported by existing preclinical and toxicology data.

Following extensive market engagement, Ardena NV has been identified as the only supplier capable of delivering the full scope of requirements: sourcing raw materials, manufacturing the Active Pharmaceutical Ingredient (API), producing the IMP, and packaging the Finished Drug Formulation (FDF) in blister packs. Other CDMOs approached were unable to meet the technical and regulatory requirements.

The direct award is justified under the following provisions of Schedule 5 of the Procurement Act 2023:

  • The contract concerns the supply of novel goods for research and development purposes.
  • Due to technical reasons and absence of competition, only one supplier can meet the requirement.
  • There are no reasonable alternatives available.

How it was run

Official notice
Submission deadline
—

Timeline

24 Oct 2025 → 4 Nov 2025 · 2 dates
  1. Notice published369 days ago
    24 Oct 2025, 09:23 BST
  2. Standstill ends357 days ago
    4 Nov 2025, 23:59 GMT

Notice history

4 events · 2 releases on Find a Tender · since 23 Oct 2025
  1. Transparency notice published
    23 Oct 2025, 17:25 BST
    UK5
  2. Contract award notice published
    24 Oct 2025, 09:23 BST
    UK6
  3. Buyer details updated
    24 Oct 2025, 09:23 BST
  4. Contract signature expected
    5 Nov 2025, 23:59 GMT
    scheduled

Commercial outcome & contract awards

Published awards, contracts and bid statistics, not a forecast
Awards 1
Awarded toValueDateStatus
Ardena Holding NV6 Nov 2025 – 31 Jan 2027€953,60022 Oct 2025standstill to 4 Nov 2025Standstill

Contracting authority & participating public bodies

2 public bodies on the notice

CARDIFF UNIVERSITY

Contracting authorityPublic authority - sub-central governmentWelsh devolved regulations apply GB-COH: RC000089 · GB-PPON: PHVT-4343-HWYR Park Place, Cardiff, Wales, CF10 3ATContact name, email

Bidders & participating suppliers

1 commercial party on the notice
  • Ardena Holding NVAwarded supplierGB-PPON: PRMH-6467-WRPY Kleimoer 4, Mariakerke, BE, 9030, BEContact email

Official documents & specifications (2)

Official links; attachments are not copied

Notices published for this procedure

  • Contract award notice awardContract award noticeUK6Contract award notice on Find a Tender
  • Transparency notice awardTransparency noticeUK5Transparency notice on Find a Tender