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Sihuan Roxatidine wins production approval

Sihuan Pharmaceutical Holdings has received a new drug certificate and production approval for Roxatidine Acetate Hydrochloride for injection.

The company anticipates launching the generic drug in or prior to the first quarter of 2013.

Sihuan chairman and CEO Dr. Che Fengsheng said based on the hospital retail price, the market size of the same type of drug has already reached RMB$1bn ($158m).

"Leveraging our strong marketing capabilities and nationwide sales and distribution network, we believe that the official launch and manufacturing of Roxatidine will not only optimize our product mix, but will also strengthen our competitiveness and help us develop the market for therapeutic drugs for the digestive system," Dr. Fengsheng added.

The fourth generation H2 receptor antagonist drug is developed as oral and injectable formulations.

The oral form is used to treat gastric and duodenal ulcers, zollinger-ellison syndrome, reflux esophagitis and gastritis, while injectable form is indicated for gastrointestinal ulcers and bleeding and pre-anesthesia application.