CHENGDU, China, August 18, 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 provided further updates for the GMP certification regarding the Company’s Qionglai Facility (QLF).
Through a series of testing runs using various traditional Chinese medicine (TCM) raw materials at individual production lines, QLF has been preparing for the final GMP examination by the provincial China Food and Drug Administration (CFDA). Further optimization of the production process according to the latest GMP standards were also conducted along with equipment installation and production tests. The manufacturing specialists at TPI’s currently operating Longquan plant have also contributed tremendously to the GMP preparation process. TPI has also consulted a designated GMP advisory team for the documentation and compliance for the final GMP examination.
The Company is now scheduling September for the official inspection for both QLF’s pre-extraction and formulation facility.
The QLF facility is a combination of both pre-extraction plant for TCM and formulation plant. The pre-extraction facility is designed to process and purify raw materials for TCMs using ethanol or distilled water precipitation, filtration, centrifugation, concentration and purification, which will be further 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% 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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