Manufacturing

The Veloxis proprietary technology platform consists of MeltDose^® and other technologies.

The technologies are applied using conventional equipment without requirement of significant additional investments and are easily scalable to commercial batch sizes. The manufacturing cost of our formulated products is close to the typical manufacturing cost of plain tablets.

Our MeltDose^® technology has been used and validated for the manufacture of clinical trial material for phases 1 to 3 for our Fenoglide^®, AtorFen™, and LCP-Tacro™ projects and has been approved by the FDA for commercial manufacturing of Fenoglide^® for the US market.

Manufacturing of clinical trial material according to Good Manufacturing Practice can be performed either at our site in Hørsholm (DK) or at already implemented Contract Manufacturing Organization (CMO) facilities in both Europe and the US.

Our internal site in Hørsholm can be used for the manufacture of phase 1 and 2 products, and the CMO sites can be used for the manufacture of phase 2 and 3 products, dependent on the required quantity of clinical trial material.

Cooperation with the CMO is facilitated by audits and Quality Agreements. The capabilities of the implemented CMOs cover the manufacture of bulk product, QC, QA, and packaging.

We have established cooperation with a significant number of smaller and larger API, excipient, and packaging material suppliers.

Our Manufacturing team competencies cover Supply Chain Management, Technical Support, Process Implementation, Clinical Trial Manufacturing, and Technology Transfer. With these skills we are able to support any manufacturing aspect of Supply Chain tasks, including technology transfer from Veloxis to partners.