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Sept. 12, 2013 /PRNewswire/ -- Tianyin Pharmaceutical Co., Inc. (NYSE Amex: TPI), a pharmaceutical company that specializes in patented biopharmaceutical, modernized traditional Chinese medicine (mTCM), branded generics and active pharmaceutical ingredients (API) today announced that the Company has received the Official Certificate of GMP for both of its pre-extraction plant and formulate facilities.
TPI manufacturing facilities including its pre-extraction plant and formulation facility have been awarded the GMP renewal status for the next three years till the end of 2015. The new GMP standards, issued in 2011 (Guidelines in English:
http://eng.sfda.gov.cn/WS03/CL0768/65113.html), which provide the specification for pharmaceutical manufacturing facility in the criteria such as quality assurance, quality control and quality risk management, organization and personnel regulations, premises and facilities guidelines, equipment, materials and production criteria, qualification and validation procedure, documentation management, contract manufacture and analysis, product distribution and recalls, self inspections, along with general and supplementary provisions. After the inspection by the China Food and Drug Administration (CFDA) officials, the Company was awarded GMP renewal status. Both Chinese and English versions of the official certificate will be available via the Company's link at:
Chengdu, China, TPI is a pharmaceutical company that specializes in the development, manufacturing, marketing and sales of patented biopharmaceutical, mTCM, branded generics and API. TPI currently manufactures a comprehensive portfolio of 58 products, 24 of which are listed in the highly selective national medicine reimbursement list, and 10 included in the essential drug list of
China. For more information about TPI, please visit:
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.