International Feasibility Study with Sri Lanka for Innovative Manufacture Facility of Retinol as a Pharmaceutical Grade API.

Phytoceutical and Regenall have formed a partnership to exploit their IP (Patent and Patent applications) and clinical trial applications (CTA) in the health and medical sectors. Core to both companies IP and CTAs is vitamin A including the form retinol (where molecular size allows skin penetration) used in skin and tissue regenerative medicine. However, retinol is reactive and unstable but Phytoceutical have, including studies with the University of Surrey and NPL, demonstrated their nano-micellar delivery platform successfully stabilises and delivers retinol into skin and tissue.

Retinol is supplied by a small number of reputable global suppliers however nano technology requires a high purity grade only available from laboratory suppliers at high prices or at lower cost and quality. There is no Pharma grade readily available at a cost effective price in the form required as an active pharmaceutical ingredient (API).

Conversations have taken place with the Sri Lankan High Commission with offers to support a compact modern Pharmaceutical manufacturing plant, initially for retinol API synthesis, in a Sri Lanka Free Trade Zone. This project main focus is to build international research and innovation partnerships and networks for the technical, regulatory and commercial feasibility to set up such a facility.

Key objectives include researching freedom to operate i.e. existing IP/patents to guide inventive synthesis approach.

Technical: Research the feasibility with local Universities of novel retinol synthesis from local produce for a new Pharma grade.

Regulatory: Research and conduct due diligence with the Sri Lanka medical regulator NMRA and UK regulator MHRA for facility Pharma GMP approval in Sri Lanka for API to be used in UK Pharma product manufacture for UK and EU markets with future steps to manufacture these for local and Asian markets in Sri Lanka

Commercial: Due diligence to be conducted and meeting with potential local interested parties including State Pharmaceutical Corporation and Board of Investment. Sri Lanka needs new high tech industries and support is willing but requires interaction on the ground.

High-tech compact facility for synthesising retinol as an API for UK manufacture and export is innovative, extending facility in future to produce nano-micellar IP protected products to Pharma GMP for Sri Lankan and Asian markets brings innovative manufacturing to the local country supporting hi value jobs and exports. Benefits accrue back to the UK supporting product manufacture in UK for global EU and USA markets, creating jobs and tax revenue in the UK.