CHENGDU, China, Feb. 17, 2015 /PRNewswire/ -- Tianyin Pharmaceutical Inc. (NYSE Amex: TPI), a pharmaceutical company that specializes in the development and sale of patented biopharmaceutical medicine, modernized traditional Chinese medicine (TCM), branded generics and active pharmaceutical ingredients (API) updated on the business and development at its Jiangchuan Macrolide Facility (JCM) API operation.
In addition to JCM’s certification at India, along with other international clients located at Bangladesh, Philippines and Iran on import status, TPI plans for FDA certification process at its JCM facility in order to service international clients such as Pfizer’s (www.pfizer.com) and their subsidiaries in China. This is expected to translate to further demand for JCM’s macrolide API business in both the domestic and international markets.
About Azithromycin and its intermediates
Azithromycin (Azi) is a macrolide antibiotic related to erythromycin. It is used primarily to treat various bacterial infections caused by respiratory pathogens, such as Aerobic gram-positive microorganisms and Aerobic gram-negative microorganisms. Azi prevents bacterial cells from manufacturing specific proteins necessary for their survival. Azi is rapidly absorbed and is widely distributed to tissues and becomes concentrated in cells. Peak plasma concentrations are achieved within 2 to 3 hours. Azi Amine is a close intermediate of Azi and enjoys competitive pricing trends amongst various derivatives of Azi related products. Comprehensive testing and improvement on quality, purity, stereochemistry, stability in compliance with the international standards of Azithromycin API have been conducted at JCM for the past year to develop sales network with both domestic and international buyers. Previously JCM has been receiving orders to manufacture one of the major intermediates of Azithromycin, Azithromycin amine (Azi Amine) at a competitive international price. And the increasing demand for Azithromycin API necessitates the application for certificate of import.
Drug Master File (DMF) in the United States
Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted to the appropriate regulatory authority at the intended drug market. DMF provides the regulatory authority with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more drugs. The DMF filing allows a company to protect its intellectual property from its partner while complying with regulatory requirements for disclosure of processing details. In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
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, 10 are included in the essential drug list of China. TPI’s pipeline targets various high incidence healthcare indications. For more information about TPI, please visit: http://www.tianyinpharma.com
Following the September 2014 JCM’s application (No. 51268) for the import certificate to India via India’s Central Drugs Standard Control Organization Ministry of Health & Family Welfare, TPI’s JCM has successfully passed the preliminary examination in December 30, 2014, and notified on January 16, 2015 by the Directorate General Of Health Services, Office of Drug Controller General (India) Import and Registration Division for the application to import Azithromycin API products and intermediates to send in samples of Azithromycin API from three different lots for analysis.
In January 2015, TPI and Buchang Pharmaceutical Co., Inc. (with annual sales over $1.4 billion, www.buchang.com) have formed a strategic alliance --- the Buchang-Tianyin Alliance which will be based on TPI’s new Qionglai Tianyin Facility (QLF, 18 miles from the API facility JCM) with the latest technologies and expanded production capacities in mTCM pre-extraction, purification and formulation manufacturing. The Alliance will be established in the form of a joint venture, with the total registered capital for the Alliance of RMB 200 million (approximately $33 million), which TPI’s wholly owned subsidiary Chengdu Tianyin Pharmaceutical owns 95% and Buchang Pharma owns 5% with the potential of future adjustment of capital investment and ownership percentages. The registered capital forms the basis of valuing TPI’s current portfolio drugs alone at $33 million with possibility of future growth which will lead to further increase of registered capital and ownership percentages. The Alliance will synergize the current TPI’s sales force with the Buchang Pharma’s network resources (>15,000 hospitals nationwide) to achieve significant improvement on the sales expansion of TPI’s product portfolio focusing on TPI’s lead revenue driver Gingko Mihuan Oral Liquid (GMOL).
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 Inc.
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/jcm-plans-for-fda-certification-process-for-international-business-development-300037180.html
SOURCE Tianyin Pharmaceutical Co., Inc.
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