CHENGDU, China, December 2, 2014 /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 updates that its Qionglai Facility's (QLF) Good Manufacturing Practice (GMP) certification to be issued by the China Food & Drug Administration's (CFDA) is expected to receive the status of public notice period within the month of December. The public notice period is a required procedure of GMP certification during which the pharmaceutical manufacturing facility's GMP application will be disclosed on the CFDA website. The public notice time will last for approximately 10 business days which could be followed by immediate issuance of the GMP certificate. TPI is currently preparing for the smooth transition of production capacity from the current Longquan facilities to the new QLF immediately following the official issuance of GMP certificate.
With the expanded manufacturing facility and high throughput TCM ingredients extraction technologies, TPI is seeking various growth opportunities that include 1) further in-depth research and development of Gingko Mihuan series product and other proprietary products; 2) seeking strategic collaboration and alliance with entities that are endowed with significant market platform in cardiovascular diseases and other high incidence conditions in China. And the imminent GMP certification of the QLF is to serve the basis of growth in revenue and earnings with these strategies.
About QLF
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. 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% 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. In September 2014, the Company has successfully completed the site visit 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.
About TPI
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.
For more information, please visit: http://www.tianyinpharma.com, or email: ir@tpi.asia
Tel: +86-28-8551-6696 (Chengdu, China)
Address:
Tianyin Pharmaceutical
23rd Floor, Unionsun Yangkuo Plaza
No. 2, Block 3, South Renmin Road
Chengdu, 610041
China
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/tpi-updates-on-its-new-facility-gmp-certification-progress-and-growth-strategies-300003165.html
