NCA30963 GMP Mangafodipir

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    "date": "2021-08-10T08:55:04+01:00",
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        "title": "NCA30963 GMP Mangafodipir",
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            "id": "33696000",
            "description": "Reagents and contrast media"
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        "mainProcurementCategory": "goods",
        "description": "Formulation and Good Manufacturing Practice preparation of mangafodipir for clinical use in healthy volunteers and patients.",
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                "hasOptions": true,
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                    "description": "If the initially feasibility study is successful, the production and stability testing of mangafodipir is included in the procurement at the cost of 244,105 USD excluding VAT."
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                "deliveryLocation": {
                    "description": "CENTRE FOR CARDIOVASCULAR RESEARCH THE UNIVERSITY OF EDINBURGH CHANCELLOR'S BUILDING 49 LITTLE FRANCE CRESCENT EDINBURGH EH16 4SB"
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        ],
        "procurementMethodRationale": "For the last 2 years, we have been trying to source further preparations of the mangafodipir. This has included a global search for suppliers which has been unsuccessful. We are working with a Norwegian company to provide the product but has proved unsuccessful although future supplies may be possible in 1-2 years' time. However, we have ongoing clinical trials and need a supply as soon as possible. We have now engaged with Avomeen (Element) who have previous experience with working with the product: this is quite unique with no other supplier having this experience. The product is rather complex to manufacture and formulate and given that they are the only current provider to generate the product and have the expertise, we have gone back to them. They seem to be the only company able to deal with the complexity of manufacture. The other issue is availability. The world's supply and capacity for sterile fill products is severely stretched due to the massive global demand for SARS-CoV2 vaccines. We have worked with Element to try alternative sterile fill premises but there is no capacity in other facilities for the immediate future."
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