Medicines/finished pharmaceutical products

Reference Number: 
HA645 (a)

Date of prequalification: 
13 January 2015
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Dapsone
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet 100mg
Storage condition: 
Do not store above 25°C, protect from light
Shelf life (months): 
60
Packaging: 
Blister Alu/PVC/TE/PVdC: 15x2
Applicant: 
Jacobus Pharmaceutical Co Inc, PO Box 5290, 37 Cleveland Lane, Princeton, New Jersey, 08540, United States of America
FPP Manufacturing Site: 

Jacobus Pharmaceutical Co Inc, IRL Building, Schalks Crossing Road, Plainsboro, NJ, 08536, United States of America
Future Pak, 28115 Lakeview Drive, Wixom, MI 48393, United States of America

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Dapsone) Jacobus Pharmaceutical Co Inc, IRL Building, Schalks Crossing Road, Plainsboro, NJ, 08536, United States of America

API WHO Public Inspection Reports: