TPI Facility Received GMP Renewal by CFDA
CHENGDU, China, Aug. 15, 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 provided the updates regarding TPI’s manufacturing (pharmaceutical formulation) facility.
TPI manufacturing facility, located at Longquan County of Chengdu, has been awarded the GMP renewal status for the next three years through 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 following criteria: general provisions, quality management (quality assurance, quality control and quality risk management), organization and personnel, premises and facilities, equipment, materials and production, qualification and validation, documentation management, production management, quality control and quality assurance, contract manufacture and analysis, product distribution and recalls, self inspections, and supplementary provisions. After the inspection by the China Food and Drug Administration (CFDA) officials in month of July, the Company received the confirmation that the facility has been awarded GMP renewal status. TPI expects to receive the official certificate at the end of August 2013.
Headquartered in 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: http://www.tianyinpharma.com.
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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.
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SOURCE Tianyin Pharmaceutical Co., Inc.