CHENGDU, China, Jan. 18, 2012 /PRNewswire-Asia-FirstCall/ -- Tianyin Pharmaceutical Co., Inc. (NYSE Amex: TPI, or the "Company"), a pharmaceutical company that specializes in patented biopharmaceutical medicine, modernized traditional Chinese medicine (mTCM), branded generics and active pharmaceutical ingredients (API) announced the Company has received the Good Manufacturing Practice (GMP) certification for its 250-ton Jiangchuan Macrolide Facility (JCM) designated as "CHUAN M0799" valid through the period of December 31, 2011 until December 31, 2015.
Detailed information of the GMP certification for JCM facility can also be found in the official site of Sichuan Food and Drug Administration (www.scfda.gov.cn/ (Chinese version)).
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, 7 are included in the essential drug list of China. TPI's pipeline targets various high incidence healthcare indications. TPI has an extensive nationwide distribution network with a sales force of 730 sales representatives out of totaled 1,365 employees.
For more information about TPI, please visit: http://www.tianyinpharma.com
Good manufacturing practice (GMP) are a set of comprehensive quality management system required for pharmaceutical manufacturing covering the manufacture and testing of pharmaceuticals including APIs, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production that ensure the quality of a product.
GMP certification is conducted based on several underlying basic principles: 1) Clearly defined manufacturing processes that are controlled with critical processes validated to ensure consistency and compliance with specifications during the production; 2) Good Documentation Practices; 3) Operators are trained to carry out and document procedures; 4) Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were carried out and that ensure the quantity and quality of the drug; 5) Records of manufacture and distribution that trace the complete history of a batch are retained in a comprehensible and accessible form. 6) The distribution of the drugs minimizes any risk to their quality; 7) A system is available for recalling any batch of drug from sale; 8) Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.
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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SOURCE Tianyin Pharmaceutical Co., Inc.