CHENGDU, China, December 17, 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 it expects to receive the formal Good Manufacturing Practice (GMP) certificate for its Qionglai Facility’s (QLF) from the China Food & Drug Administration’s (CFDA) by the end of December 2014. Prior to the official issuance of the GMP certificate, there is a public notice period which is likely to take place within this week. The public notice period is an important step of GMP certificate 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 is to 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.
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.
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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