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WHO List of Prequalified Medicinal Products
 Printed from WHO prequalification web site (http://www.who.int/prequal/) on 2009-Oct-18 00:56 GMT.

 For information about the listing of prequalified products and the alternative approval procedure, please see "General information" at http://www.who.int/prequal/info_general/notes_registry.htm.
 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 USFDA; USFDA2 - tentatively approved by USFDA

Therapeutic                          INN                               Formulation and strength                 Applicant                 Manufacturing site                   Packaging              Reference   Date of PQ
   area
                                                                                                                                                                        HDPE bottle 30;
    IN     Oseltamivir (as phosphate)                                Capsules 75mg                      Cipla Ltd                   Goa, India                          PVC/PE/PVdC                    IN001      2009-May-13
                                                                                                                                                                        Aluminum blister 10
                                                                                                                                    Grenzacherstr, Basel,
                                                                                                                                    Switzerland (Galenic bulk
                                                                                                                                    production);
                                                                     Powder for oral suspension         Roche Ltd,                  Wurmisweg, Kaiseraugst,             Amber glass bottle
    IN     Oseltamivir (as phosphate)                                                                                                                                                                  IN003      2009-Sep-21
                                                                     12mg/ml                            Switzerland                 Switzwerland (packaging);           30g
                                                                                                                                    GP Grenzach Produktions
                                                                                                                                    GmbH, Wyhlen, Germany
                                                                                                                                    (packaging)
                                                                                                                                    Grenzacherstr, Basel,               Blister
                                                                                                                                    Switzerland (Galenic bulk
                                                                                                        Roche Ltd,                                                      (PVC/PE/PVDC,
    IN     Oseltamivir (as phosphate)                                Capsules 30mg                                                  production);                                                       IN004      2009-Sep-21
                                                                                                        Switzerland                                                     sealed with
                                                                                                                                    Wurmisweg, Kaiseraugst,             aluminium foil) 10
                                                                                                                                    Switzerland (packaging)
                                                                                                                                    Grenzacherstr, Basel,               Blister
                                                                                                                                    Switzerland (Galenic bulk
                                                                                                        Roche Ltd,                                                      (PVC/PE/PVDC,
    IN     Oseltamivir (as phosphate)                                Capsules 45mg                                                  production);                                                       IN005      2009-Sep-21
                                                                                                        Switzerland                                                     sealed with
                                                                                                                                    Wurmisweg, Kaiseraugst,             aluminium foil) 10
                                                                                                                                    Switzerland (packaging)
Therapeutic                    INN      Formulation and strength         Applicant            Manufacturing site              Packaging         Reference   Date of PQ
   area
                                                                                         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.,         Blister
                                                                                         New Jersey, USA (Galenic
                                                                   Roche Ltd,                                            (PVC/PE/PVDC,
    IN    Oseltamivir (as phosphate)   Capsules 75mg                                     bulk production);                                       IN006      2009-Sep-21
                                                                   Switzerland                                           sealed with
                                                                                         Patheon Inc., Cincinnati, OH,   aluminium foil) 10
                                                                                         USA (Galenic bulk
                                                                                         production);
                                                                                         Catalent Germany Schorndorf
                                                                                         GmbH, Schorndorf, Germany
                                                                                         (packaging);
                                                                                         GP Grenzach Produktions
                                                                                         GmbH, Grenzach-Wyhlen,
                                                                                         Germany (packaging);
                                                                                         Wurmisweg, Kaiseraugst,
                                                                                         Switzerland (packaging)
                                                                                         GlaxoSmithKline Australia Pty   Alu/Alu blister, 4
                                       Inhalation powder 5mg/dose GlaxoSmithKline Ltd,   Ltd, Boronia, Australia;        blisters per disk (a
    IN    Zanamivir                                                                                                                              IN007      2009-Sep-22
                                                                  United Kingdom         Glaxo Wellcome Production,      pack contains 1 or 5
                                                                                         Evreux, France                  Alu foil disks)

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OMS Sustenta La Aprobacion Nuestro Generico Oseltamivir

  • 1. WHO List of Prequalified Medicinal Products Printed from WHO prequalification web site (http://www.who.int/prequal/) on 2009-Oct-18 00:56 GMT. For information about the listing of prequalified products and the alternative approval procedure, please see "General information" at http://www.who.int/prequal/info_general/notes_registry.htm. 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 USFDA; USFDA2 - tentatively approved by USFDA Therapeutic INN Formulation and strength Applicant Manufacturing site Packaging Reference Date of PQ area HDPE bottle 30; IN Oseltamivir (as phosphate) Capsules 75mg Cipla Ltd Goa, India PVC/PE/PVdC IN001 2009-May-13 Aluminum blister 10 Grenzacherstr, Basel, Switzerland (Galenic bulk production); Powder for oral suspension Roche Ltd, Wurmisweg, Kaiseraugst, Amber glass bottle IN Oseltamivir (as phosphate) IN003 2009-Sep-21 12mg/ml Switzerland Switzwerland (packaging); 30g GP Grenzach Produktions GmbH, Wyhlen, Germany (packaging) Grenzacherstr, Basel, Blister Switzerland (Galenic bulk Roche Ltd, (PVC/PE/PVDC, IN Oseltamivir (as phosphate) Capsules 30mg production); IN004 2009-Sep-21 Switzerland sealed with Wurmisweg, Kaiseraugst, aluminium foil) 10 Switzerland (packaging) Grenzacherstr, Basel, Blister Switzerland (Galenic bulk Roche Ltd, (PVC/PE/PVDC, IN Oseltamivir (as phosphate) Capsules 45mg production); IN005 2009-Sep-21 Switzerland sealed with Wurmisweg, Kaiseraugst, aluminium foil) 10 Switzerland (packaging)
  • 2. Therapeutic INN Formulation and strength Applicant Manufacturing site Packaging Reference Date of PQ area 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., Blister New Jersey, USA (Galenic Roche Ltd, (PVC/PE/PVDC, IN Oseltamivir (as phosphate) Capsules 75mg bulk production); IN006 2009-Sep-21 Switzerland sealed with Patheon Inc., Cincinnati, OH, aluminium foil) 10 USA (Galenic bulk production); Catalent Germany Schorndorf GmbH, Schorndorf, Germany (packaging); GP Grenzach Produktions GmbH, Grenzach-Wyhlen, Germany (packaging); Wurmisweg, Kaiseraugst, Switzerland (packaging) GlaxoSmithKline Australia Pty Alu/Alu blister, 4 Inhalation powder 5mg/dose GlaxoSmithKline Ltd, Ltd, Boronia, Australia; blisters per disk (a IN Zanamivir IN007 2009-Sep-22 United Kingdom Glaxo Wellcome Production, pack contains 1 or 5 Evreux, France Alu foil disks)