CHENGDU, China, January 20, 2015 /PRNewswire/ — Tianyin Pharmaceutical Co., Inc. (NYSE MKT: 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 TPI’s Qionglai Tianyin Facility (QLF) has received its Good Manufacturing Practice (GMP) certificate from the China Food & Drug Administration’s (CFDA) with the GMP certification processing number: SC20140067. The latest GMP certification has improved significantly regarding the level of stringency, standardization, quality control and etc and the receipt of the new GMP status is regarded a prominent advantage for the future growth of a pharmaceutical enterprise.
The GMP certification of QLF provides the basis for the growth platform of the strategic Alliance between TPI and Buchang Pharmaceutical Co., Ltd. ("Buchang Pharma", www.buchang.com and its Shanghai main board pre-IPO prospectus: http://www.csrc.gov.cn/pub/zjhpublic/G00306202/201406/t20140620_256436.htm) focusing on TPI’s lead revenue driver Gingko Mihuan Oral Liquid (GMOL).
In preparation for the new GMP standards stipulated by the government of China in early 2011, TPI initiated the process of optimizing the manufacturing facilities in compliance with the new GMP standards. The QLF is approximately 18 miles from the Company’s recently completed Jiangchuan macrolide (JCM) facility. The QLF is estimated to be 80 mu or 53,000 square meters. The designed production capacity of QLF is 30% higher than the TPI’s currently operating Longquan plant. 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. By January 2015, the Company has successfully completed the CFDA site inspection and public notice periods for GMP certification which lead to the final GMP approval of the facility.
About Buchang-Tianyin Alliance
The Buchang-Tianyin Alliance platform will be based upon TPI’s newly completed and GMP-certified QLF with the latest technologies and expanded production capacities in mTCM pre-extraction, purification and formulation manufacturing. The Alliance will be established in the form of a joint venture, with the total registered capital for the Alliance of RMB 200 million (approximately $33 million), which TPI’s wholly owned subsidiary Chengdu Tianyin Pharmaceutical owns 95% and Buchang Pharma owns 5% with the potential of future adjustment of capital investment and ownership percentages. The registered capital forms the basis of valuing TPI’s current portfolio drugs alone at $33 million with possibility of future growth which will lead to further increase of registered capital and ownership percentages. The Alliance will synergize the current TPI’s sales force with the Buchang Pharma’s network resources (>15,000 hospitals nationwide) to achieve significant improvement on the sales expansion of TPI’s product portfolio focusing on TPI’s lead revenue driver Gingko Mihuan Oral Liquid (GMOL). TPI’s JCM, a wholly owned subsidiary of Chengdu Tianyin, currently valued at $18 million, along with various other assets under TPI, are not included in the Alliance.
King & Wood Mallesons participated as an advisor to the establishment of the Alliance.
About Buchang Pharma
Buchang Pharmaceutical Co., Ltd., headquartered in Xi’an, established in 1993, by Prof. Buchang Zhao (founder, http://www.forbes.com/profile/zhao-buchang/ ), is a pre-IPO (Shanghai main board, Citic Securities, 2014) pharmaceutical enterprise focusing on research, development, manufacturing and distribution of medicines in China. Buchang Pharma is one of the leading pharmaceutical companies in China and specializes in cardio-cerebral vascular (CCV) drugs and mTCM research and development. Within its comprehensive portfolio of over 60 nationally reimbursed products, Buchang Pharma’s Naoxintong Capsules, Yinxin Granules and Danhong Injection are three proprietary cardiovascular products that delivered $1.1 billion total annual sales in 2013. Listed in the prospectus of the Company, Buchang’s cardiovascular franchise ranked No.1, making up 8.1% of the total of China’s CCV market in 2012. The three lead cardiovascular drugs mentioned above delivered an accelerated growth curve with 2011, 2012, 2013 sales at $700 million, $900 million and $1.1 billion in total respectively.
With more than 10,000 professional sales representatives covering 15,000 hospitals and 130,000 pharmacies, Buchang Pharma has established a comprehensive network in China’s large healthcare industry. The annual sales of Buchang Pharma were RMB 5.2 billion (approximately $560 million) in 2009, RMB 6.5 billion (approximately $1 billion) in 2010 and RMB 8.6 billion (approximately $1.4 billion) in 2013, more than doubled within 5 years.
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.
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.
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