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JCM Begins Operation and Aims for GMP certification in November

2011-10-24 23:08 1323

CHENGDU, China, October 24, 2011 /PRNewswire-Asia-FirstCall/ -- Tianyin Pharmaceutical Co., Inc. (NYSE Amex: TPI, or the "Company"), a pharmaceutical company that specializes in the development and sale of patented biopharmaceutical medicine, modernized traditional Chinese medicine, branded generics and active pharmaceutical ingredients (API) announced that the Jiangchuan Macrolide Facility (JCM) has began its operation manufacturing Azithromycin raw material.

The Company is targeting for Good Manufacturing Practice (GMP) inspection and certification in November.

About GMP

GMP are a set of comprehensive quality management systems 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.

About TPI

Headquartered at Chengdu, China, TPI is a pharmaceutical company that specializes in the development, manufacturing, marketing and sales of patented biopharmaceutical, modernized traditional Chinese medicines, branded generics and active pharmaceutical ingredients (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.tpi.asia

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@tianyinpharma.com

Tel: +86-28-8551-6696 (Chengdu, China)

+86-134-3655-0011 (China)

Address:

Tianyin Pharmaceutical

23rd Floor, Unionsun Yangkuo Plaza

No. 2, Block 3, South Renmin Road

Chengdu, 610041

China



Source: Tianyin Pharmaceutical Co., Inc.
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