Pharmabiz
 

Tianyin Pharma gets Chinese SFDA nod for Ofloxacin & Fleroxacin

Chengdu, ChinaFriday, January 15, 2010, 08:00 Hrs  [IST]

Tianyin Pharmaceutical Co., Inc., (TPI), a manufacturer and supplier of modernized traditional Chinese medicine (TCM) and Western Pharmaceuticals based in Chengdu, China, 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 gonorrhoea. 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 per cent. The company expects blended gross margins from the sale of these two products to be approximately 38 per cent. "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." 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.

 
[Close]