Source: https://tendernation.io/opportunities/01a13b9c-9ebb-720c-b843-44d54c40ddf2/the-development-validation-and-supply-of-physostigmine-free-base

closed GB restricted procedure

# The Development, Validation and Supply of Physostigmine Free Base

[Ministry of Defence, Defence Science and Technology Laboratory](https://tendernation.io/buyers/ministry-of-defence-defence-science-and-technology-laboratory)

Estimated value

£10,000,000

Published

28 Mar 2023

Deadline

Closed

28 Apr 2023

## About this tender

The Ministry of Defence (MoD) is inviting expressions of interest for a requirement for the provision of Physostigmine Free Base(also known as eserine; chemical name 1,2,3,3aβ,8,8aβ-hexahydro-1,3a,8-trimethylpyrrolo\[2,3-b\] indol-5-yl-methylcarbamate; chemical formula C15H21N3O2; molecular weight 275,36 g/mol). as part of an ongoing product development and anticipated commercialisation.

The initial Physostigmine supplied must be suitable for use in a pivotal Phase I clinical setting and the manufacturing process will produce material which does not add additional non-clinical activities to the overall programme, best endeavours should be taken to remove processing impurities.

The Supplier is to develop, scale-up and validate the manufacturing method for Physostigmine Free Base as an Active Pharmaceutical Ingredient (API) for use in a MoD final medicinal product currently under development.

The API must be developed and manufactured according to Good Manufacturing Practice (GMP) and must conform to European Transmissible Spongiform Encephalopathies (TSE) requirements, developed such that Intellectual property (IP) is vested in the Authority.

The Authority intends to seek a Marketing Authorisation for the final medicinal product from the Medicines and Healthcare products Regulatory Agency (MHRA) and Physostigmine will be required as an active ingredient for a future registered medicinal product.

The Supplier is required to provide information necessary for the Authority to complete the Chemistry, Manufacturing and Control (CMC) documentation to support a Clinical Trial Application (CTA) and Marketing Authorisation Application for the final medicinal product and make this documentation available to the MA applicant in an appropriate format for inclusion within CTD Module 3.

The Authority anticipates a Limited Quality by Design (QBD) approach to the manufacturing process as defined by the International Conference on Harmonisation (ICH).

All procurement documents are accessible via [contracts.mod.uk](https://www.contracts.mod.uk) Quantity or scope: The Contract has an expected duration of 10 years (120 months), plus 5 option years (60 months). Option years may be taken up consecutively or concurrently (to be determined).

Read full description

## CPV classification

Other nervous system medicinal products

Source

Find a Tender (UK) · Notice ocds-h6vhtk-03b6c1-2023-03-28T16:22:22+01:00

[View official notice](https://www.find-tender.service.gov.uk/Notice/ocds-h6vhtk-03b6c1-2023-03-28T16:22:22+01:00)

Never miss a tender like this again

Get AI summaries, deadline alerts and a bid pipeline for tenders matched to your business. Free to start.

[Track tenders free](https://tendernation.io/register)

[Buyer profile Ministry of Defence, Defence Science and Technology Laboratory: past awards and live tenders](https://tendernation.io/buyers/ministry-of-defence-defence-science-and-technology-laboratory) [Sector More Medical equipment & pharmaceuticals tenders](https://tendernation.io/sectors/medical-equipment-pharmaceuticals)

## More tenders like this

[Blood-grouping reagents – ΑΝΤΙΔΡΑΣΤΗΡΙΑ ΑΙΜΟΔΟΣΙΑΣ · ΓΕΝΙΚΟ ΝΟΣΟΚΟΜΕΙΟ ΔΡΑΜΑΣ · 46 days left · 4 Dec 2026](https://tendernation.io/opportunities/01a15183-2813-7182-8d99-b716cf03c730/greece-blood-grouping-reagents-antidrasthria-aimodosias) [Medical consumables – Kärlkateterlås · Region Jönköpings län · 30 days left · 17 Nov 2026](https://tendernation.io/opportunities/01a15183-2a9a-72d4-bb06-f03d9172406e/sweden-medical-consumables-karlkateterlas) [Miscellaneous medical devices and products – DOSTAWA AKCESORIÓW DO SPRZĘTÓW MEDYCZNYCH DLA UNIWERSYTECKIEGO SZPITALA KLINICZNEGO W RADOMSKU. · Uniwersytecki Szpital Kliniczny · 11 days left · 30 Oct 2026](https://tendernation.io/opportunities/01a15183-0b5a-71e9-a08d-e181d06851b0/poland-miscellaneous-medical-devices-and-products-dostawa-akcesoriow-do-sprz) [Medical consumables – Zakup środków ochrony indywidualnej, rękawiczek, pokrowców i sprzętu unieruchamiającego · Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego "Meditrans" Samodzielny Publiczny Zakład Opieki Zdrowotnej w Warszawie · 29 days left · 17 Nov 2026](https://tendernation.io/opportunities/01a15183-1d96-73a3-a8b8-1b3d8556abf8/poland-medical-consumables-zakup-srodkow-ochrony-indywidualnej-rekawiczek) [Devices and instruments for infusion – Infusionspump TPN · Västra Götalandsregionen · 30 days left · 17 Nov 2026](https://tendernation.io/opportunities/01a15183-28be-7144-8e47-d1110f2f2cc8/sweden-devices-and-instruments-for-infusion-infusionspump-tpn) [Medical equipments – Dostawy asortymentu wielorazowego na okres 24 miesięcy - sprawa nr Z/95/PN/26 · Regionalny Szpital Specjalistyczny im. dr Władysława Biegańskiego · 11 days left · 30 Oct 2026](https://tendernation.io/opportunities/01a15183-3711-7240-9b25-1a923d673777/poland-medical-equipments-dostawy-asortymentu-wielorazowego-na-okres-24-mies)