Biostar Pharma Provides Update Regarding Gel Capsule Safety Issues

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5/30/2012 5:47 PM ET

Biostar Pharmaceuticals Inc. (BSPM) announced that, following an onsite inspection by Xianyang's State Food and Drug Administration or SFDA, samples from a batch of its Xin Aoxing capsules were found to contain chromium content higher than edible gelatin, which capsules, in the Company's estimation, were sold in the PRC market in mid-2011.

As previously announced, on April 27, 2012, SFDA launched an investigation of several capsule manufacturers based in Zhejiang, Hebei and Jiangxi provinces into their use of industrial gelatin, which contains impermissibly high chromium content.

Biostar Pharmaceuticals said that On May 25, 2012, following a nationwide inspection, SFDA authorities reported that 669 batches of gel capsules from 254 drug manufacturers in 28 provinces were found to have high chromium levels.

"our Quality Control staff is in process of completing a self-administered inspection of all drugs utilizing capsules as delivery method and capsule samples acquired during the period from June 2009 to April 2012. We anticipate completing this process by May 31, 2012. We intend to announce the results of this self-administered inspection in middle of June, when Xianyang SFDA, in turn, reviews and approves the conclusions of our inspection, " Ronghua Wang, Biostar's Chief Executive Officer and Chairman said.

As reported by SFDA and published in a major local newspaper, Huashang News on May 26, 2012, the results of the SFDA investigation indicate that gel capsules containing drugs of all of China's pharmaceutical companies distributed after May 1, 2012 are made with edible gelatin, do not have high chromium levels and are safe to use.

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