UBI Pharma Inc. Passes Ukrainian Inspection, Joining Lumosa Therapeutics to Enter European Market

UBI Pharma Inc. Passes Ukrainian Inspection, Joining Lumosa Therapeutics to Enter European Market

On the 23rd, UBI Pharma Inc. (Stock Code: 6562) announced that it has received the Good Manufacturing Practices (GMP) inspection report from the State Service of Ukraine on Medicine of Drug Control (SMDC), making it the only injectable drug manufacturer in Taiwan to pass the SMDC inspection in Ukraine. In the future, UBI Pharma Inc. will join forces with Lumosa Therapeutics (Stock Code: 6535) to enter the European market.

UBI Pharma Inc., entrusted by Lumosa Therapeutics, has obtained drug licenses in Taiwan, Singapore, Thailand, and Malaysia for its long-acting analgesic injection LT1001. With the recent acquisition of the Ukrainian drug license, UBI Pharma Inc. will also assist Lumosa Therapeutics in accelerating the drug license application process in countries like Jordan and South Korea. UBI Pharma Inc. has already delivered a batch of products to Lumosa Therapeutics in mid-July and will continue to collaborate with them in developing the European market.

Having already passed five inspections by the U.S. Food and Drug Administration (FDA) and two inspections by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), UBI Pharma Inc.has now successfully integrated into the pharmaceutical supply chains of Europe, the United States, and Japan. In 2021, UBI Pharma Inc. initiated a project to expand its sterile injectable production line, increasing production capacity by fourfold. This move is aimed at continuously expanding its presence in the international pharmaceutical market and providing comprehensive CDMO services to more customers, aspiring to become the best partner for clinical and commercial production of new drugs for pharmaceutical companies.

UBI Pharma Inc. stated that besides continuing to develop its CDMO business, its proprietary product, the new compound drug NDF01, has completed data analysis. After finalizing the analysis report and drug manufacturing documents, it will promptly apply for registration and inspection with the Taiwan Food and Drug Administration (TFDA) for the new compound drug’s marketing authorization.