LEO Pharma and VIANEX of the Giannakopoulos Group are joining forces for the production by the Greek company of non-fractionated heparin and low molecular weight heparin.

The agreement includes the transfer of the production of injectable products from LEO Pharma's facility in Ballerup, Denmark, to the facilities of the Greek company.

VIANEX will manage the raw material, vial filling, laboratory analyses, and packaging, while LEO Pharma, as the Marketing Authorization Holder, will distribute the final product.

The 5 product codes that will be produced at VIANEX are estimated to reach a quantity of several million vials annually, distributed in more than 23 countries across Europe, Asia, North Africa, and the Middle East, including Greece.

The new production line is unique in Greece for filling sterile liquid products using Isolator technology, with the capability to fill approximately 18,000 vials per hour.

The process of transferring production of the products and exploring potential partners began in mid-2021, with negotiations and agreement recently concluded. Critical stages of knowledge transfer, testing, and implementation of processes in compliance with Good Manufacturing Practices (GMP) have been completed to date. Approvals from regulatory authorities are expected to commence from 2024.