---
title: "Provision of Fasudil Hydrochloride Capsules"
ocid: "ocds-h6vhtk-02c838"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-h6vhtk-02c838"
markdown_url: "https://d3tenders.com/contract/ocds-h6vhtk-02c838.md"
json_url: "https://d3tenders.com/contract/ocds-h6vhtk-02c838.json"
source: "Find A Tender Service"
current_stage: "Award"
buyer: "UNIVERSITY OF EXETER"
published: "2021-11-23"
---

# Provision of Fasudil Hydrochloride Capsules

Buyer: UNIVERSITY OF EXETER  
Current stage: Award  
OCID: ocds-h6vhtk-02c838

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## Summary

The University of Exeter is conducting a procurement process for the "Provision of Fasudil Hydrochloride Capsules," categorised under medical equipment and pharmaceuticals. The procurement is currently in the award stage, with the value of the contract signed at £815,555. The contract was awarded on 8 November 2021 and pertains to supplying products necessary for a Phase IIa clinical trial likely to be held in the United States and Europe (specifically the UK and Norway). Key compliance standards include Good Manufacturing Practice (GMP) and regulatory requirements of the USP/EP/BP, necessitating that suppliers ensure clinical supplies are released by a certified Quality Person. 

These procurement opportunities can significantly benefit businesses in the pharmaceutical and healthcare industries, particularly those experienced in drug development, manufacturing, and regulatory compliance. Companies with capabilities in sourcing and supplying medical ingredients, conducting clinical trials, and adhering to stringent quality assurance protocols would be well-positioned to compete for this contract. The tender also represents an opportunity for growth within the clinical supply chain in the UK and Norway, appealing to both large-scale suppliers and specialised service providers in pharmaceuticals.

## Notice

The University of Exeter requires an end-to-end solution for Fasudil Hydrochloride Capsules. The product will be used as clinical supply for a Phase IIa study. The clinical trial will likely be conducted in the USA and/or Europe (United Kingdom and Norway), therefore all formulation components and finished product must meet the regulatory requirements of USP/EP/BP and any required Norwegian pharmacopeia standards. The supplier must also comply with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) and ensure that all supplies are released for clinical use by a duly certified Quality Person (QP).

### Lot Information

Lot 1

The University of Exeter requires an end-to-end solution for Fasudil Hydrochloride Capsules. The product will be used as clinical supply for a Phase IIa study. The clinical trial will likely be conducted in the USA and/or Europe (United Kingdom and Norway), therefore all formulation components and finished product must meet the regulatory requirements of USP/EP/BP and any required Norwegian pharmacopeia standards. The supplier must also comply with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) and ensure that all supplies are released for clinical use by a duly certified Quality Person (QP). The supplier will undertake an evaluation of 3rd party suppliers for the procurement of the Drug Substance (DS) Fasudil Hydrochloride. It is anticipated that approximately 8.5kg of DS will be required for use in Drug Product development and manufacturing activities. This includes approximately 1kg DS for non-GMP activities and 7.5kg DS for GMP activities related to the project. The supplier will perform development activities in order to establish suitable capsule formulations for 20mg and 40mg active dose strengths and matching placebo. These development activities will include the manufacture of up to six development batches at a batch size of approximately 750g -1.5kg. The lead and back-up formulations will be subjected to a short-term stability evaluation. The purpose of this effort is to manufacture sufficient supplies of prototypes to illustrate the likely process for clinical supply, and to prepare samples for accelerated stability testing so that suitable formulations of active and placebo tablets can be identified. To fulfil clinical supply, the CTM active and placebo batches will be manufactured in three separate campaigns. First Campaign: one CTM Placebo batch at approximately 43,000 units one CTM Active 20mg dose strength batch at 6,000 units one CTM Active 40mg strength batch at approximately 40,000 units Second campaign: one CTM Placebo batch at approximately 43,000 units one CTM Active batch at approximately 40,000 units Third campaign: one CTM Placebo batch at approximately 43,000 units one CTM Active batch at approximately 40,000 units Each CTM batch will be bulk packaged, labelled (in English and Norwegian) and shipped to enable delivery of the final QP released batches to the locations requested by Client (anticipated to be in the UK and Norway, 3 or 4 sites in total). The supplier will be responsible for any customs clearance required. The supplier will be required to provide all necessary supporting services including, but not limited to, sourcing materials and the active pharmaceutical ingredient/drug substance, production, storage, labelling, packaging, quality control, qualified person release, packing, transport, loading/unloading, import/export, delivery and waste disposal.

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Find A Tender Service |
| Latest notice | https://www.find-tender.service.gov.uk/Notice/029136-2021 |
| Notice type | Tender Notice |
| Procurement type | Standard |
| Procurement category | Goods |
| Procurement method | Open |
| Procurement method details | Open procedure |
| Tender suitability | Not specified |
| Awardee scale | Large |
| All stages | Tender, Award |

## Dates

| Field | Value |
| --- | --- |
| Publication date | 23 Nov 2021 |
| Submission deadline | 16 Aug 2021 |
| Future notice date | Not specified |
| Award date | 8 Nov 2021 |
| Contract period | Not specified |
| Recurrence | Not specified |

## Values

| Field | Value |
| --- | --- |
| Tender value | £500,000 |
| Lots value | £500,000 |
| Awards value | Not specified |
| Contracts value | £815,555 |

## Status

| Field | Value |
| --- | --- |
| Tender status | Complete |
| Lots status | Cancelled |
| Awards status | Active |
| Contracts status | Active |

## Buyer

| Field | Value |
| --- | --- |
| Main buyer | UNIVERSITY OF EXETER |
| Locality | EXETER |
| Post town | Exeter |
| Postcode | EX4 4QH |
| Country | England |
| ITL 1 | TLK South West (England) |
| ITL 2 | TLK4 Devon |
| ITL 3 | TLK43 Devon CC |
| Local authority | Exeter |
| Electoral ward | Duryard and St James |
| Westminster constituency | Exeter |
| Delivery location | TLK4 Devon |

## Supplier

| Field | Value |
| --- | --- |
| Number of suppliers | 1 |
| Supplier names | PATHEON |

## CPV Codes

### Divisions

- 33 - Medical equipments, pharmaceuticals and personal care products

### Codes

- 33000000 - Medical equipments, pharmaceuticals and personal care products

## Release History

- 23 Nov 2021 at 12:10 - Award - Award Notice - https://www.find-tender.service.gov.uk/Notice/029136-2021
- 15 Jul 2021 at 10:08 - Tender - Tender Notice - https://www.find-tender.service.gov.uk/Notice/016582-2021

## Notice URLs

- http://www.exeter.ac.uk
- https://uk.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=38809&B=EXETER
- https://uk.eu-supply.com/ctm/Company/CompanyInformation/Index/53042

## Provenance

This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-h6vhtk-02c838. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-h6vhtk-02c838.json.