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news.Tianyin Pharmaceutical (Tianyin) and Western Pharmaceuticals have received approvals from the Chinese State Food and Drug Administration (SFDA) to produce both Ofloxacin and Fleroxacin tablets. Tianyin is expected to launch both drugs three to four months after official approvals are received from Chinese SFDA.
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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 0.1g/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 0.1g/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.
Jiang, chairman and CEO of Tianyin, said: “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. 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.”