China Sky One Makes Progress on CE Mark

China Sky One Medical (CSKI) reported it has successfully completed the first phase of examinations for the Conformité Européenne [CE] certification, or CE mark. If granted, the CE mark will give the company the ability to sell its OTC medical products in the European Union. China Sky One submitted its application for CE certification in May, 2008.

In the first phase of the examination, representatives of the European Union spent three months reviewing and examining manufacturing materials, on-site facilities, and product samples. China Sky One thinks the second phase could be completed soon, allowing the company to begin exporting products to the EU before the end of 2008.

China Sky One’s portfolio of OTC drugs, which emphasizes topically applied products, is growing rapidly. About ten days ago, the company reported that it has 26 products currently awaiting approval from the SFDA. Its revenues are estimated to grow 67% this year and an additional 60% in 2009.

Disclosure: none.