Banyu Pharmaceutical Co. Ltd. / Merck & Co. Inc. / Ono Pharmaceutical Co. Ltd. / Sitagliptin Phosphate Hydrate [Applicant] Banyu Pharmaceutical Co. Ltd. / Merck / Dohme (Italia) S.p.A. / /
Continent
Europe / /
Country
Japan / United States / /
Currency
pence / /
Event
FDA Phase / /
Facility
Whitehouse Station / /
IndustryTerm
pharmaceutical product / channel site / drug product / biological product / manufacturing process development / control / manufacturing process etc / manufacturing process / specified biological product / mg/kg groups / integrated near ultraviolet energy / manufacturing process affecting bioavailability / vehicle control / physical and chemical stability / Diabetes Care / /
First Committee on New Drugs / Pharmaceutical Affairs Department of the Pharmaceutical Affairs / Pharmaceutical Affairs and Food Sanitation Council / Evaluation and Licensing Division / None Office / Pharmaceuticals and Medical Devices Agency / US Federal Reserve / Food Safety / Ministry of Health / /
Product
Each tablet / glucagon / Glactiv Tablets / Glactiv Tablet / I This English / Januvia / P054 / Sitagliptin / /
Report on the Deliberation Results August 25, 2009 Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare