Notice Information
Notice Title
Procurement for the Supply of Active Pharmaceutical Ingredient - Physostigmine Free Base
Notice Description
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.'.
Notice Details
Publication & Lifecycle
- Open Contracting ID
- ocds-b5fd17-466317a6-4e2b-4af1-98cf-e1408d7b3725
- Publication Source
- Contracts Finder
- Latest Notice
- https://www.contractsfinder.service.gov.uk/Notice/c782dd1f-6c71-41b1-b417-df50cd9816b6
- Current Stage
- Tender
- All Stages
- Tender
Procurement Classification
- 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
Common Procurement Vocabulary (CPV)
- CPV Divisions
24 - Chemical products
33 - Medical equipments, pharmaceuticals and personal care products
35 - Security, fire-fighting, police and defence equipment
-
- CPV 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
Notice Value(s)
- Tender Value
- £10,000,000 £10M-£100M
- Lots Value
- Not specified
- Awards Value
- Not specified
- Contracts Value
- Not specified
Notice Dates
- Publication Date
- 18 Nov 20196 years ago
- Submission Deadline
- 17 Dec 2019Expired
- Future Notice Date
- Not specified
- Award Date
- Not specified
- Contract Period
- 31 Mar 2020 - 31 Mar 2021 6-12 months
- Recurrence
- Not specified
Notice Status
- Tender Status
- Active
- Lots Status
- Not Specified
- Awards Status
- Not Specified
- Contracts Status
- Not Specified
Buyer & Supplier
Contracting Authority (Buyer)
- Main Buyer
- MINISTRY OF DEFENCE, ISTAR, CHEMICAL, BIOLOGICAL, RADIOLOGICAL AND NUCLEAR DELIVERY TEAM (CBRN DT)
- Contact Name
- Not specified
- Contact Email
- karen.wilson371@mod.gov.uk
- Contact Phone
- +4403067933663
Buyer Location
- Locality
- BRISTOL
- Postcode
- BS34 8JH
- Post Town
- Bristol
- Country
- England
-
- Major Region (ITL 1)
- TLK South West (England)
- Basic Region (ITL 2)
- TLK5 West of England
- Small Region (ITL 3)
- TLK52 Bath & North East Somerset and South Gloucestershire
- Delivery Location
- Not specified
-
- Local Authority
- South Gloucestershire
- Electoral Ward
- Stoke Park & Cheswick
- Westminster Constituency
- Filton and Bradley Stoke
Further Information
Notice Documents
-
https://www.contractsfinder.service.gov.uk/Notice/c782dd1f-6c71-41b1-b417-df50cd9816b6
18th November 2019 - Opportunity notice on Contracts Finder
Open Contracting Data Standard (OCDS)
View full OCDS Record for this contracting process
The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts.
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