--- title: "Procurement for the Supply of Active Pharmaceutical Ingredient - Physostigmine Free Base" ocid: "ocds-b5fd17-466317a6-4e2b-4af1-98cf-e1408d7b3725" canonical_url: "https://d3tenders.com/contract/?ocid=ocds-b5fd17-466317a6-4e2b-4af1-98cf-e1408d7b3725" markdown_url: "https://d3tenders.com/contract/ocds-b5fd17-466317a6-4e2b-4af1-98cf-e1408d7b3725.md" json_url: "https://d3tenders.com/contract/ocds-b5fd17-466317a6-4e2b-4af1-98cf-e1408d7b3725.json" source: "Contracts Finder" current_stage: "Tender" buyer: "MINISTRY OF DEFENCE, ISTAR, CHEMICAL, BIOLOGICAL, RADIOLOGICAL AND NUCLEAR DELIVERY TEAM (CBRN DT)" published: "2019-11-18" --- # Procurement for the Supply of Active Pharmaceutical Ingredient - Physostigmine Free Base Buyer: MINISTRY OF DEFENCE, ISTAR, CHEMICAL, BIOLOGICAL, RADIOLOGICAL AND NUCLEAR DELIVERY TEAM (CBRN DT) Current stage: Tender OCID: ocds-b5fd17-466317a6-4e2b-4af1-98cf-e1408d7b3725 [View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-b5fd17-466317a6-4e2b-4af1-98cf-e1408d7b3725) [Download OCDS JSON](https://d3tenders.com/contract/ocds-b5fd17-466317a6-4e2b-4af1-98cf-e1408d7b3725.json) ## Summary The Ministry of Defence, specifically the ISTAR, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT), is currently seeking tenders for the "Procurement for the Supply of Active Pharmaceutical Ingredient - Physostigmine Free Base". This contract falls within the specialised chemical products industry category and is located in Bristol, UK. The tender is in the planning stage, with a submission deadline on 17 December 2019. The potential contract value is between £1,000,000 and £10,000,000, and the procurement method used is a selective negotiated procedure. This tender presents a significant opportunity for businesses in the pharmaceutical and chemical sectors, particularly those with capabilities in developing active pharmaceutical ingredients and meeting regulatory standards. Companies experienced in manufacturing, process validation, and quality assurance, especially those that can deliver the specified stability studies and comparability tests, would be well-suited to compete. The contract duration extends from 1 April 2020 to 31 March 2021, providing a window for suppliers to establish a fruitful partnership with the Ministry of Defence. ## Notice The Chemical Biological Radiological and Nuclear Protection Delivery Team is inviting expressions of interest in respect of a proposed contract for the development, process validation, manufacture and supply of Physostigmine free base as an Active Pharmaceutical Ingredient (API) for use in a Ministry of Defence (MOD) final medicinal product currently under development. The Supplier will be required to develop, scale-up and validate the manufacturing method, define a detailed specification and full characterisation of the API, Physostigmine (also known as eserine; chemical name 1,2,3,3ab,8,8ab-hexahydro-1,3a,8-trimethylpyrrolo[2,3-b] indol-5-yl-methylcarbamate; chemical formula C15H21N3O2; molecular weight 275.36 g/mol) The Supplier will be required to supply the Authority with full information on the manufacture and control of the API as described in Annex I to Directive 2001/83/EC as amended (with particular reference to Part I, Section 3) and elaborated in the Notice to Applicants (Eudralex Volume 2: https://ec.europa.eu/health/documents/eudralex/vol-2_en). The specification should meet modern standards and best endeavours should be taken to remove processing impurities. The specification should align with current regulatory requirements for active pharmaceutical ingredients (including Ph.Eur). The Supplier will also be expected to analyse a sample (as much as is required) of the Authority's existing physostigmine API material, to assess the comparability of the two (to permit bridging between studies using old versus new material). The Authority will review the comparability and determine whether the specification of the new API is acceptable. The Supplier will be required to conduct appropriate stability studies as often as required as per the International Conference on Harmonisation (standard and accelerated), forced degradation and provide data in the form of a written report (including protocol(s)) to support the shelf life to be applied. A shelf life of at least 3 years under storage conditions 2-8degC is required. The Supplier will prepare a primary reference standard no later than the day of commencement of performance validation batches. This standard will be tested throughout its shelf life to maintain its usability and where necessary replaced with a new standard. This standard must be sufficient for all testing required throughout the life of the contract and the Authority reserves the right to request quantities on an ad-hoc basis. Additional information: To view this notice, register as a supplier here: http://www.contracts.mod.uk/delta/signup.html?userType=supplier and search for the notice with reference 'UK-Bristol: Pharmaceutical products.'. ## Key Details | Field | Value | | --- | --- | | Publication source | Contracts Finder | | Latest notice | https://www.contractsfinder.service.gov.uk/Notice/c782dd1f-6c71-41b1-b417-df50cd9816b6 | | Notice type | Tender Notice | | Procurement type | Standard | | Procurement category | Goods | | Procurement method | Selective | | Procurement method details | Negotiated procedure | | Tender suitability | SME | | Awardee scale | Not specified | | All stages | Tender | ## Dates | Field | Value | | --- | --- | | Publication date | 18 Nov 2019 | | Submission deadline | 17 Dec 2019 | | Future notice date | Not specified | | Award date | Not specified | | Contract period | 31 Mar 2020 - 31 Mar 2021 | | Recurrence | Not specified | ## Values | Field | Value | | --- | --- | | Tender value | £10,000,000 | | Lots value | Not specified | | Awards value | Not specified | | Contracts value | Not specified | ## Status | Field | Value | | --- | --- | | Tender status | Active | | Lots status | Not specified | | Awards status | Not specified | | Contracts status | Not specified | ## Buyer | Field | Value | | --- | --- | | Main buyer | MINISTRY OF DEFENCE, ISTAR, CHEMICAL, BIOLOGICAL, RADIOLOGICAL AND NUCLEAR DELIVERY TEAM (CBRN DT) | | Locality | BRISTOL | | Post town | Bristol | | Postcode | BS34 8JH | | Country | England | | ITL 1 | TLK South West (England) | | ITL 2 | TLK5 West of England | | ITL 3 | TLK52 Bath & North East Somerset and South Gloucestershire | | Local authority | South Gloucestershire | | Electoral ward | Stoke Park & Cheswick | | Westminster constituency | Filton and Bradley Stoke | | Delivery location | Not specified | ## CPV Codes ### Divisions - 24 - Chemical products - 33 - Medical equipments, pharmaceuticals and personal care products - 35 - Security, fire-fighting, police and defence equipment ### Codes - 24000000 - Chemical products - 24950000 - Specialised chemical products - 33000000 - Medical equipments, pharmaceuticals and personal care products - 33140000 - Medical consumables - 33600000 - Pharmaceutical products - 33680000 - Pharmaceutical articles - 35113200 - Nuclear, biological, chemical and radiological protection equipment ## Release History - 18 Nov 2019 at 15:31 - Tender - Tender Notice - https://www.contractsfinder.service.gov.uk/Notice/c782dd1f-6c71-41b1-b417-df50cd9816b6 ## Documents - https://www.contractsfinder.service.gov.uk/Notice/c782dd1f-6c71-41b1-b417-df50cd9816b6 18th November 2019 - Opportunity notice on Contracts Finder ## Notice URLs - http://www.contracts.mod.uk/delta/signup.html?userType=supplier - https://ec.europa.eu/health/documents/eudralex/vol-2_en ## 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-b5fd17-466317a6-4e2b-4af1-98cf-e1408d7b3725. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-b5fd17-466317a6-4e2b-4af1-98cf-e1408d7b3725.json.