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JCM Passes Internal Quality Assessment For Azithromycin API Production

CHENGDU, China, Nov. 9, 2011 /PRNewswire-Asia-FirstCall/ -- Tianyin Pharmaceutical Inc. (NYSE Amex: TPI), a pharmaceutical company that specializes in the development and sale of patented biopharmaceutical medicine, modernized traditional Chinese medicine (TCM), branded generics and active pharmaceutical ingredients (API) announced that following the initial phase of operation, the Jiangchuan Macrolide Facility (JCM) has passed the internal quality assessment for its first batch of production of Azithromycin API.

A series of data points have been collected in terms of the purity, intermediates contents, stereochemistry, stability and the quality in comparison with the national standard of Azithromycin API that were issued in the latest version (2010) of Pharmacopoeia of China. Various parameters for quality control purposes were also measured during the production process. The results showed that Azithromycin API made at JCM has met the quality standards stipulated by China's State Food and Drug Administration (SFDA).

TPI reaffirms the November time line for its Good Manufacturing Practice (GMP) inspection.

About Azithromycin quality control

Azithromycin is a macrolide antibiotic related to erythromycin. It is used primarily to treat various bacterial infections caused by respiratory pathogens, such as Aerobic gram-positive microorganisms and Aerobic gram-negative microorganisms. Azithromycin prevents bacterial cells from manufacturing specific proteins necessary for their survival. Azithromycin is rapidly absorbed and is widely distributed to tissues and becomes concentrated in cells. Peak plasma concentrations are achieved within 2 to 3 hours. Since Azithromycin is synthesized from Erythromycin, impurities will undergo the same modifications and the Azithromycin analogues of these impurities can be found in Azithromycin bulk samples. In addition, degradation products of Azithromycin as well as intermediate compounds of the semi-synthesis may be present as well. The detection and assessment of the purity of the Azithromycin sample become the key element for quality control.

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