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

By Pharmaceutical Processing | January 13, 2010

TianyinPharmaceutical Co., Inc., a manufacturer and supplier ofmodernized traditional Chinese medicine and Western Pharmaceuticalsbased in Chengdu, China, today announced that it has received approvals fromthe Chinese State Food and Drug Administration (SFDA) to produce bothOfloxacin Tablets (SFDA approval number H20094038) and Fleroxacin Tablets(SFDA approval number H2009S03440). Ofloxacin is a fluoroquinolone-based antibiotic, which addresses severalindications including staph infection, strep throat (Streptococcus), pneumonia,influenza, E. Coli, and several sexually transmitted bacterial diseases suchas Chlamydia and gonorrhea. Tianyin will produce these tablets in a 0.1gram/tablet dosage form at its existing and new production facilities. Typicaldosage for adults is 0.3g-0.6g daily which varies according to the level ofinfection. Fleroxacin is a quinolone broad-spectrum antibiotic, which addressesseveral indications including chronic and acute bronchitis and pneumonia,salmonella, multiple gastrointestinal and abdominal infections, and skin/softtissue infections. Tianyin will produce these tables in a 0.1 gram/tabletdosage form at its existing and new production facilities. Typical dosage foradults 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 isincreasing demand. Tianyin will launch both drugs three to four months afterofficial approvals are received from Chinese SFDA. The Company estimates thatcurrent annual sales of these two products in the PRC are approximately $256million with annual growth during the past few years of approximately 20%. Thecompany expects blended gross margins from the sale of these two products tobe approximately 38%. “We are very pleased to receive SFDA approvals for these two genericantibiotics as we further build out our portfolio of infection treatingmedications. These products address high growth markets in China and createadditional revenue opportunities for Tianyin,” Dr. Jiang, Chairman and CEO ofTianyin Pharmaceutical Co., Inc., commented. “We expect production at ourfacility to begin by April 2010 and will leverage our existing distributionchannels to sell these products to both hospitals and pharmacies throughoutthe PRC.”

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