Sihuan Pharmaceutical Holdings'Roxatidine Acetate Hydrochloride for Injection has passed on-site inspection for drug registration conducted by the Chinese State Food and Drug Administration.
The company anticipates the approval of production in the next three months and plans to introduce the drug in the second half of the 2012.
Sihuan chairman and CEO Che Fengsheng said,"Capitalising on the characteristics and advantages of Roxatidine,along with Sihuan Pharmaceutical's strong sales and marketing capabilities and nationwide sales network,we believe that this drug will bring its clinical therapeutic value into play with wide clinical use."
Roxatidine Acetate Hydrochloride will be manufactured by Beijing Sihuan Pharmaceutical,a wholly-owned manufacturing subsidiary.
Roxatidine is categorized into two formulations,oral and injectable.The oral form is used for gastric and duodenal ulcers,zollinger-ellison syndrome,reflux esophagitis and gastritis.
The injectable form of the drug is used for upper gastrointestinal bleeding and pre-anesthesia application.
