Voyageur Pharmaceuticals Ltd. announced completion of the production test batch of its SmoothX barium sulfate CT contrast media oral suspension for the CT imaging market in Canada. This development represents a significant transition for Voyageur from the development phase to the production phase, where the focus will change to scaling up to commercially viable volumes of SmoothX to supply the Canadian imaging market. Management estimates that these two milestones will likely speed up first commercial sales in Canada and the FDA filing for approval in the US.

Voyageur continues to advance the development and testing of four additional Health Canada approved imaging products for sales in the Canadian radiology market. Voyageur currently holds Health Canada approval licenses for five barium contrast media products. In preparation for a generic drug submission to the U.S. FDA, Voyageur has produced the recent batch in a manner that adheres to the Company's FDA and Health Canada compliant quality management system.

This system has been implemented to ensure that a consistent and high-quality product is delivered to Voyageur's customer base. The product batch that has been produced will be scaled up and, after completion of 180 days stability tests, will be submitted to the FDA as part of the application process for approval of SmoothX for sale in the United States market. This submission is expected to occur in the second quarter of 2023.

The Company contract manufacturer (CMO) of it's barium contrast media product line recently received their FDA site registration, an important step for the Company's plan to penetrate the U.S. market. Subject to financing, the Company continues to advance towards the construction of its own certified pharmaceutical manufacturing facility. The Company has completed the feasibility study and facility design phase and is currently finalizing the capital plan.

In the interim, the Company will continue its relationship with its CMO for production and testing of its imaging products for sale into the Canadian and U.S. markets.