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Medical Services Shanghai Starts Production |
September 21, 2004 During the meetings in August 2004, the Company was informed by regulatory authorities that all required testing on the VScan test kit had been completed and that final approvals for the kits would be issued in approximately 60 days. Since these meetings, the Company has not received any additional requests for information or data that would materially affect the approval process. The Company expects that the final regulatory approvals will be received within or close to the time frames indicated. The production facilities in Shanghai are "state of the art" and have an initial production capability of 6 to 8 million kits per year. The facility has received its Quality Assurance Certificate related to ISO 9001:2000/ ISO 13485:2003, IVDD 98/79/E.C. This certificate allows the Company to export as well as sell the VScan test kits in China. In addition to its own facility, the Company has agreed to a joint venture with a government owned pharmaceutical manufacturing Company. This facility is a full GMP certified facility and has an excellent Quality Assurance program. This Company currently supplies 26 distributors, 3000 direct sales outlets and 100 hospitals with medical supplies. This network will give excellent distribution to the VScan products. The Company has already confirmed orders of in excess of 1.5 million VScan kits in China. The Company anticipates that it will generate in excess of $3.4 million US in revenue from kit sales this year with a profit in excess of $800,000.00.
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