MMV Request for Proposal: Development of low dose primaquine tablets in a child-friendly formulation
Medicine for Malaria Venture (MMV) is seeking proposals from eligible manufacturers to develop and deliver dispersible, taste-masked paediatric formulations of primaquine (PQ). MMV is interested to hear from a wide range of manufacturing companies including, but not limited to the following:
- Companies who may already be planning the development, manufacture and seek WHO pre-qualification of a child-friendly formulation of PQ
- Companies manufacturing PQ drug substance or drug product now or in the past but who have not, to date, considered the WHO pre-qualification process
- Companies with experience of taking other products through the WHO pre-qualification process, for example, HIV medicines, and who are therefore familiar with the process.
All interested parties should have experience of developing and manufacturing quality pharmaceutical products and have experience of product introduction in malaria-endemic countries (even if not specifically malaria products). Responding parties (“Responders”) may be invited for further discussions regarding a possible collaboration.
Summary of Project Scope:
- Development of taste-masked, dispersible tablet formulations of PQ tablets with a focus on the three lowest strengths (2.5mg, 3.75mg and 5 mg) for submission to WHO Prequalification for evaluation
- Support to ensure GMP audit-readiness of manufacturing facility (if required)
- Packaging: Blister pack containing 14 tablets
- Stability: Climatic Zone IVb in order to safeguard product quality throughout its entire intended shelf-life, stability studies under the conditions defined for Climatic Zones IVb should be performed and the data submitted, i.e. the shelf-life should be established based on complete long-term data at 30ºC ±2ºC/75% RH ±5% RH.
* Development and manufacturing must comply with International Conference on Harmonization (ICH) standards.
Read more here.
Applications deadline February 10, 2020 (15:00 CET).