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A video on Investment Pitch Media describes the completed production of a test batch of Voyageur Pharmaceuticals’ SmoothX™ Barium Sulfate CT Contrast Oral Suspension for the Canadian CT Imaging Market.

VANCOUVER, British Columbia, November 29, 2022 (GLOBE NEWSWIRE) — Voyageur Pharmaceuticals (TSXV:VM) (OTCPink:VYYRF) announces a test batch of SmoothX™ Barium Sulfate CT Contrast Oral Suspension for the CT Imaging Market has completed production. in Canada. This production represents a significant transition in Voyageur’s transition from development to production, as the company now scales to commercially viable quantities of his SmoothX to supply the Canadian imaging market. I am focused on improving.

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Management hopes these two milestones will facilitate the initial commercial launch in Canada and filing for FDA approval in the United States. Voyageur has developed nine of his barium contrast media products for the Canadian radiopharmaceutical market and is developing and testing the remaining four of his products, while five of his imaging products, including SmoothX, have been approved by Health Canada. Licensed from.

CEO Brent Willis said:The completion of SmoothX production trials and scaling up to commercial quantities to begin sales in Canada are important milestones for the company. This is also a key point in our effort to build a fully integrated Canadian supply he chain of barium contrast agents. It also supports Canada’s national strategy to separate itself from China for critical mineral supplies and critical pharmaceutical production. Manufacturing testing under FDA protocols will prepare him to submit a generic drug to the FDA for approval of his SmoothX for gastrointestinal imaging. We have been working with the FDA toward approval of his SmoothX since earlier this year and are now in formal communication with the FDA’s Office of Generic Drugs regarding the specific requirements for approval of SmoothX.

In preparation for a generic drug submission to the US FDA, Voyageur manufactured a recent batch in a manner that complies with the company’s FDA- and Health Canada-compliant quality management system. Voyageur’s customer base. The product batches produced will be scaled up and, after completing 180 days of stability testing, will be submitted to the FDA in the second quarter of 2023 as part of SmoothX’s Marketing Authorization Application process. in the US market.

The contract manufacturer (CMO) of the company’s barium contrast media product line recently obtained FDA site registration. This is an important step in the company’s plans to expand into the US market. Subject to funding, Voyageur continues to move forward with the construction of its own certified pharmaceutical manufacturing facility, has completed the feasibility study and facility design phase, and is currently finalizing its capital plans.

The sterile, carbon-neutral, GMP manufacturing facility is designed to generate revenue streams from pharmaceutical barium and iodine contrast media products, generate additional revenue from the sale of industrial barite, and produce carbon fullerene allotropes for new drug development programs. is expected to produce In the meantime, we will continue our relationship with the CMO to manufacture and test imaging products for sale to the Canadian and US markets.

Voyageur is focused on developing both barium and iodine drug substances and high-performance, cost-effective imaging contrast agents for the medical imaging market.

These contrast agents, which can be taken orally or rectally, are used to improve images inside the body, help distinguish or “contrast” selected areas of the body from surrounding tissue, and are used by radiologists. Allows physicians to perform imaging functions such as fluoroscopy, CT scans, and more. , and MRI to distinguish between normal and abnormal conditions.

Currently, a large amount of iodine contrast media is being supplied from Shanghai, China, where operations have been suspended due to the impact of the new coronavirus infection. doing. every year.

The company owns a 100% interest in three barium sulfate (barite) projects, including the Francis Creek property, including grades suitable for the pharmaceutical barite market, and a Utah property. We are also interested in certain high grade iodine, lithium and bromine brine projects. The company is unique because it sources its main ingredients from its own deposits.

With the motto “From the Earth to the Bottle”, Voyageur pursues a business plan to become the only fully integrated company in the radiology field by controlling all primary input costs.

The stock is currently trading at $0.075. For more information, see: www.VoyageurPharmaceuticals.caemail Brent Willis, President and CEO. [email protected]or Al Deslauriers, CFO, [email protected].

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A video on Investment Pitch Media describes the completed production of a test batch of Voyageur Pharmaceuticals’ SmoothX™ Barium Sulfate CT Contrast Oral Suspension for the Canadian CT Imaging Market.

Source link A video on Investment Pitch Media describes the completed production of a test batch of Voyageur Pharmaceuticals’ SmoothX™ Barium Sulfate CT Contrast Oral Suspension for the Canadian CT Imaging Market.

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