WHO List of Prequalified Medicinal Products

Please enter the criteria below to display products from the WHO list of prequalified medicinal products. (14-Jun-2013)

INN

Applicant

Manufacturing site

Reference*

Therapeutic area Any Diarrhoea HIV/AIDS Influenza Malaria Reproductive Health Tuberculosis

Formulation Any Single only Combination only

Status Any Active Suspended

WHO Prequalified Any Past two months Past six months Past year Past two years

WHO Prequalified

From:
To:

* WHO reference number or "USFDA"/"HCnda"

Legend:
"+" means combination product, both fixed-dose combination (co-formulated) and co-packaged product (i.e. co-blister)
[A+B] + C means A and B are in a fixed-dose formulation and C is co-packaged
"*" refers to products approved by both WHO Prequalification Programme and US FDA
USFDA¹ approved by US FDA; USFDA² tentatively approved by US FDA; EMEA Art 58 - approved by EMEA according to Article 58
Note: For information about the listing of prequalified products and the alternative approval procedure, please see: General information

Therapeutic area	INN	Formulation and strength	Applicant	Manufacturing site	Packaging	Reference no.	Date of PQ	Status
IN	Oseltamivir (as phosphate)	Powder for oral suspension 12mg/ml	Roche Ltd	Grenzacherstr, Basel, Switzerland (Galenic bulk production); Rottendorf Pharma GmbH, Ennigerloh, Germany (Galenic bulk production); Wurmisweg, Kaiseraugst, Switzerland (packaging); GP Grenzach Produktions GmbH, Wyhlen, Germany (packaging)	Amber glass bottle 30g	IN003	21-Sep-2009
IN	Oseltamivir (as phosphate)	Capsules 75mg	Cipla Ltd	Goa, India	HDPE bottle 30; PVC/PE/PVdC Aluminum blister 10	IN001	13-May-2009
IN	Oseltamivir (as phosphate)	Capsules 75mg	Strides Arcolab Limited	Anekal Taluk, Bangalore, India	PVDC/PVC/Alu blister	IN002	25-Oct-2010
IN	Oseltamivir (as phosphate)	Capsules 75mg	Roche Ltd	Grenzacherstr, Basel, Switzerland (Galenic bulk production); Catalent Germany Schorndorf GmbH, Schorndorf, Germany (Galenic bulk production); CENEXI SAS, Fontenay-sous-Bois, France (Galenic bulk production); Hoffmann-La Roche Inc., New Jersey, USA (Galenic bulk production); Patheon Inc., Cincinnati, OH, USA (Galenic bulk production); DSM Pharmaceuticals Inc, Greenville, USA (Galenic bulk production); Catalent Germany Schorndorf GmbH, Schorndorf, Germany (packaging); GP Grenzach Produktions GmbH, Grenzach-Wyhlen, Germany (packaging); Wurmisweg, Kaiseraugst, Switzerland (packaging)	Blister (PVC/PE/PVDC, sealed with aluminium foil) 10	IN006	21-Sep-2009
IN	Oseltamivir (as phosphate)	Capsules 45mg	Roche Ltd	Grenzacherstr, Basel, Switzerland (Galenic bulk production); Wurmisweg, Kaiseraugst, Switzerland (packaging)	Blister (PVC/PE/PVDC, sealed with aluminium foil) 10	IN005	21-Sep-2009
IN	Oseltamivir (as phosphate)	Capsules 30mg	Roche Ltd	Grenzacherstr, Basel, Switzerland (Galenic bulk production); Wurmisweg, Kaiseraugst, Switzerland (packaging)	Blister (PVC/PE/PVDC, sealed with aluminium foil) 10	IN004	21-Sep-2009
IN	Zanamivir	Inhalation powder 5mg/dose	GlaxoSmithKline	GlaxoSmithKline Australia Pty Ltd, Boronia, Australia; Glaxo Wellcome Production, Evreux, France	Alu/Alu blister, 4 blisters per disk (a pack contains 1 or 5 Alu foil disks)	IN007	22-Sep-2009