CHENGDU, China, September 29, 2014 /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 its Qionglai Facility (QLF) has successfully completed the official site visit by the China Food & Drug Administration’s (CFDA) for its Good Manufacturing Practice (GMP) certification.
In early September 2014, the Company has submitted the GMP dataset for CFDA review, following final rounds of test runs at QLF following months of preparation and production optimization. The site visit is a critical component for GMP certification during which a team of GMP experts and specialists along with CFDA officials conduct a thorough examination of production facility in terms of pre-extraction process, formulation process and various aspects of the pharmaceutical manufacturing procedure. The successful completion of the site visit is required for the final issuance of GMP certificate for QLF. TPI is currently preparing the smooth transition of production capacity from the current Longquan plant to the new QLF in the coming months.
The QLF is a combination of both pre-extraction plant and formulation plant. The pre-extraction facility is designated for processing and purifying raw materials for TCMs using ethanol or distilled water precipitation, filtration, centrifugation, concentration and purification. The TCM extracts will then be processed for the production of mTCM products at the formulation facility where the final biopharmaceutical, TCM and generic products in the forms of oral liquid, granules, tablets, and capsules are produced.
In preparation for the new GMP standards stipulated by the PRC government in early 2011, TPI initiated the process of optimizing the manufacturing facilities in compliance with the new GMP standards. Due to the redesigning of the industrial parks in the suburbs of Chengdu, TPI’s manufacturing facility at the Longquan district, east of Chengdu, is scheduled to be relocated to Qionglai city, south of Chengdu, which is designated for pharmaceutical industry. The QLF is approximately 18 miles from the Company’s recently completed Jiangchuan macrolide (JCM) facility. The proposed relocation project also includes our TCM pre-extraction plant which is located near the center of Chengdu surrounded by rapidly expanding residential area. The QLF is estimated to be 80 mu or 53,000 square meters. The designed production capacity of QLF is 30 percent higher than the TPI’s currently operating Longquan plant.
Headquartered 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, 10 are 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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