Medicines/finished pharmaceutical products

Reference Number: 
IN006 (a)

Date of prequalification: 
21 September 2009
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Oseltamivir (phosphate)
Therapeutic area: 
Influenza
Dosage form & strength: 
Capsules, hard 75mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
48
Packaging: 
Blister Alu/PVC/PE/PVdC: 10x1
Applicant: 
Roche Registration GmbH, Emil-Barell-Strasse, 79639 Grenzach-Wyhlen, Germany
FPP Manufacturing Site: 

Delpharm Milano S.r.l, Via Carnevale, 1, 20090 Segrate (Milano), Italy
Patheon Manufacturing Services LLC, 5900 Martin Luther King Jr. Hwy, P.O. Box 1887, Greenville, NC 27834, United States of America
Cenexi SAS, 52 Rue M. et J Gaucher, Fontenay sous Bois, 94120, France
Catalent Germany Schorndorf GmbH, Steinbeisstrasse 1 and 2, Schorndorf, 73614, Germany
F Hoffmann - La Roche Ltd, Wurmisweg, Kaiseraugst, CH-4303, Switzerland

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Oseltamivir (phosphate)) F. Hoffmann - La Roche Ltd, Basel, CH-4070, Switzerland
(Oseltamivir (phosphate)) Patheon API Inc, 6173 E Old Marion Highway, Florence, South Carolina, 29506, United States of America

API WHO Public Inspection Reports: