Cuprina Holdings (CUPR), on April 6, completed construction of, and obtained ISO 13485 certification and a dealer license for, an operational in-vitro fertilization media production facility in Singapore. The ISO 13485 certification, which validates that Cuprina’s quality management system at the facility meets internationally agreed standards for medical device manufacturing, was issued by United Kingdom Accreditation Service, a part of the International Accreditation Forum. The dealer license, which confers legal authorization to businesses operating in specific activities including manufacturing, importing, or wholesaling medical devices, was issued by the Singapore Health Sciences Authority. Built as part of an Agreement with Ferti-Craft, the facility is intended to produce 14 SKUs of the IVF media product containing the nutrients, electrolytes, amino acids, and other materials required to stimulate fertilization of sperm and ovum in-vitro. Cuprina will collaborate with Ferti-Craft to prepare and submit the required regulatory dossiers for registration with Singapore Health Sciences Authority. The goal is to obtain approval for 14 IVF media product SKUs. The project aims to secure HSA approval for commercial sale before the fourth quarter of 2026. Ferti-Craft will be responsible for obtaining all necessary documentation and testing certificates required by HSA, arranging the selection and logistics of all raw materials required for the production of these SKUs, and contributing the intellectual property, subject matter expertise on human assisted reproductive technology, and production know-how on the preparation of these SKUs. Subject to obtaining the necessary regulatory approvals, the facility is expected to commence producing commercialized product by the fourth quarter of 2026. Ferti-Craft expects initial sales to be primarily in Singapore, with an expanded presence to follow in select ASEAN countries, the Middle East and other global markets.
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