Tianyin Pharmaceutical Co., Inc. Receives Chinese SFDA Approval for Ofloxacin and Fleroxacin
January 13 2010 - 7:00AM
PR Newswire (US)
Products Expand Company's Antibiotic Portfolio and Target New
Indications 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: Investors: Mr. Matthew Hayden, HC
International Tel: +1-561-245-5155 Email: DATASOURCE: Tianyin
Pharmaceutical Co., Inc. CONTACT: Allen Tang, Ph.D., MBA, Assistant
to the CEO China of Tianyin Pharmaceutical Co., Inc.,
+86-158-2122-5642, ; or Investors, Matthew Hayden of HC
International, +1-561-245-5155, Web site:
http://www.tianyinpharma.com/
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