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Tianyin Pharmaceutical Co., Inc. Receives Chinese SFDA Approval for Ofloxacin and Fleroxacin

Products Expand Company's Antibiotic Portfolio and Target New Indications


News provided by

Tianyin Pharmaceutical Co., Inc.

Jan 13, 2010, 08:00 ET

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CHENGDU, China, Jan. 13 /PRNewswire-Asia-FirstCall/ -- Tianyin Pharmaceutical Co., Inc., (NYSE Amex: TPI), a manufacturer and supplier of modernized traditional Chinese medicine ("TCM") and Western Pharmaceuticals based in Chengdu, China, today announced that it has received approvals from the Chinese State Food and Drug Administration (SFDA) to produce both Ofloxacin Tablets (SFDA approval number H20094038) and Fleroxacin Tablets (SFDA approval number H2009S03440).

Ofloxacin is a fluoroquinolone-based antibiotic, which addresses several indications including staph infection, strep throat (Streptococcus), pneumonia, influenza, E. Coli, and several sexually transmitted bacterial diseases such as Chlamydia and gonorrhea. Tianyin will produce these tablets in a 0.1 gram/tablet dosage form at its existing and new production facilities. Typical dosage for adults is 0.3g-0.6g daily which varies according to the level of infection.

Fleroxacin is a quinolone broad-spectrum antibiotic, which addresses several indications including chronic and acute bronchitis and pneumonia, salmonella, multiple gastrointestinal and abdominal infections, and skin/soft tissue infections. Tianyin will produce these tables in a 0.1 gram/tablet dosage form at its existing and new production facilities. Typical dosage for adults is 0.2g-0.4g daily for a period of 7-14 days.

Both drugs are included in China's Essential Drug List (EDL), which is increasing demand. Tianyin will launch both drugs three to four months after official approvals are received from Chinese SFDA. The Company estimates that current annual sales of these two products in the PRC are approximately $256 million with annual growth during the past few years of approximately 20%. The company expects blended gross margins from the sale of these two products to be approximately 38%.

"We are very pleased to receive SFDA approvals for these two generic antibiotics as we further build out our portfolio of infection treating medications. These products address high growth markets in China and create additional revenue opportunities for Tianyin," Dr. Jiang, Chairman and CEO of Tianyin Pharmaceutical Co., Inc., commented. "We expect production at our facility to begin by April 2010 and will leverage our existing distribution channels to sell these products to both hospitals and pharmacies throughout the PRC."

About Tianyin Pharmaceuticals

Tianyin is a manufacturer and supplier of modernized Traditional Chinese Medicine ("TCM") in China. It was established in 1994 and acquired by the current management team in August 2003. It has a comprehensive product portfolio of 39 products, 22 of which are listed in the highly selective National Medicine Catalog of the National Medical Insurance program. Tianyin owns and operates two GMP manufacturing facilities and an R&D platform supported by leading Chinese academic institutions. The Company has a pipeline of 17 pharmaceutical products pending approval. Tianyin has an extensive nationwide distribution network throughout China with a sales force of 720 salespeople. Tianyin is headquartered in Chengdu, Sichuan Province with two manufacturing facilities and a total of 1,365 employees. For more information about Tianyin, please visit http://www.tianyinpharma.com .

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 contact:

    For the Company:
     Allen Tang, Ph.D., MBA, Assistant to the CEO China
     Tel:   +86-158-2122-5642
     Email: [email protected]

    Investors:
     Mr. Matthew Hayden, HC International
     Tel:   +1-561-245-5155
     Email: [email protected]

SOURCE Tianyin Pharmaceutical Co., Inc.

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