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Last updated on April 24, 2014 at 5:30 EDT

JCM Passes Internal Quality Assessment for Azithromycin API Production

November 9, 2011

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.

About TPI

Headquartered at Chengdu, China, TPI is a pharmaceutical company that specializes in the development, manufacturing, marketing and sales of patented biopharmaceutical, modernized traditional Chinese medicines, branded generics and active pharmaceutical ingredients (API). TPI currently manufactures a comprehensive portfolio of 58 products, 24 of which are listed in the highly selective national medicine reimbursement list, 7 are included in the essential drug list of China. TPI’s pipeline targets various high incidence healthcare indications. TPI has an extensive nationwide distribution network with a sales force of 730 sales representatives out of totaled 1,365 employees.

For more information about TPI, please visit: http://www.tianyinpharma.com

Safe Harbor Statement

The Statements which are not historical facts contained in this press release are forward-looking statements that involve certain risks and uncertainties including but not limited to risks associated with the uncertainty of future financial results, additional financing requirements, development of new products, government approval processes, the impact of competitive products or pricing, technological changes, the effect of economic conditions and other uncertainties detailed in the Company’s filings with the Securities and Exchange Commission.

For more information, please visit: http://www.tianyinpharma.com, or email: ir@tpi.asia

Tel: +86-28-8551-6696 (Chengdu, China)
+86-134-3655-0011 (China)
Address:
Tianyin Pharmaceutical Inc.
23rd Floor, Unionsun Yangkuo Plaza
No. 2, Block 3, South Renmin Road
Chengdu, 610041
China

SOURCE Tianyin Pharmaceutical Co., Inc.


Source: PR Newswire