Medicines (Finished Pharmaceutical Products/Biotherapeutic products) - Prequalification
- "+" means co-packaged product while “/” means fixed dose combination
- [A/B] + C means A and B are in a fixed-dose formulation and C is co-packaged
- For information about the listing of prequalified products and the alternative listing procedure, please see: General Information
- Some products prequalified via abridged assessment may have different storage conditions and shelf life from those accepted by the reference authority. For more information, see WHOPAR part 1.
- In product details page, the FPP sites that are used only for primary packaging are listed under “FPP Packaging only” section.
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| WHO Reference Number | INN, Dosage Form and Strength | Product Type | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification Sort descending |
|---|---|---|---|---|---|---|---|
| HA096 | Ritonavir Solution, Oral 80mg/mL | Finished Pharmaceutical Product | HIV/AIDS | AbbVie Ltd | Solution, Oral | Prequalification - Abridged | |
| HA110 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA114 | Zidovudine Solution for injection 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Solution for injection | Prequalification - Abridged | |
| HA106 | Abacavir (sulfate) Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA128 | Lamivudine Solution, Oral 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Solution, Oral | Prequalification - Abridged | |
| HA108 | Zidovudine Capsules, hard 100mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Capsules, hard | Prequalification - Abridged | |
| HA109 | Zidovudine Capsules, hard 250mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Capsules, hard | Prequalification - Abridged | |
| TB008 | Ethambutol hydrochloride Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Cadila Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB070 | Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tablet, Film-coated 275mg/75mg/400mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| TB015 | Pyrazinamide Tablet 400mg | Finished Pharmaceutical Product | Tuberculosis | Cadila Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB068 | Isoniazid/Rifampicin Tablet, Film-coated 75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| MA026 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Novartis Pharma AG | Tablet | Prequalification - Abridged | |
| TB085 | Isoniazid/Rifampicin Tablet, coated 75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Sandoz Pvt Ltd | Tablet, coated | Prequalification - Abridged | |
| TB090 | Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tablet, Film-coated 275mg/75mg/400mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Sandoz Pvt Ltd | Tablet, Film-coated | Prequalification - Abridged | |
| HA060 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA286 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Sun Pharmaceutical Industries Limited | Tablet, Film-coated | Prequalification - Full | |
| HA337 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Merck Sharp & Dohme BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA306 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Sun Pharmaceutical Industries Limited | Tablet, Film-coated | Prequalification - Full | |
| HA381 | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | AbbVie Deutschland GmbH and Co. KG | Tablet, Film-coated | Prequalification - Abridged | |
| TB159 | Pyrazinamide Tablet 400mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB134 | Ethambutol hydrochloride Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB154 | Cycloserine Capsules, hard 250mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| TB133 | Ethionamide Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB158 | Isoniazid/Rifampicin Tablet, Film-coated 75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB168 | Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tablet, Film-coated 275mg/75mg/400mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA392 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| TB179 | Isoniazid Tablet 300mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB178 | Isoniazid Tablet 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| HA428 | Efavirenz Tablet, Film-coated 200mg | Finished Pharmaceutical Product | HIV/AIDS | Merck Sharp & Dohme BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA427 | Efavirenz Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Merck Sharp & Dohme BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA403 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| MA056 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Sanofi | Tablet | Prequalification - Full | |
| MA058 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Sanofi | Tablet | Prequalification - Full | |
| MA057 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Sanofi | Tablet | Prequalification - Full | |
| TB183 | Ethambutol hydrochloride/Isoniazid/Rifampicin Tablet, Film-coated 275mg/75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA426 | Lamivudine/Nevirapine/Zidovudine Tablet, Film-coated 150mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| MA069 | Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg | Finished Pharmaceutical Product | Malaria | Novartis Pharma AG | Tablet, Dispersible | Prequalification - Abridged | |
| IN001 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Cipla Ltd | Capsules, hard | Prequalification - Full | |
| MA064 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| HA200 | Nevirapine Suspension, Oral 50mg/5mL | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Suspension, Oral | Prequalification - Full | |
| RH002 | Levonorgestrel Tablet, coated 30mcg | Finished Pharmaceutical Product | Reproductive health | Jenapharm GmbH & Co. KG | Tablet, coated | Prequalification - Abridged | |
| TB172 | Pyrazinamide Tablet 500mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet | Prequalification - Full | |
| TB171 | Pyrazinamide Tablet 400mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet | Prequalification - Full | |
| IN005 | Oseltamivir (phosphate) Capsules, hard 45mg | Finished Pharmaceutical Product | Influenza | Roche Registration GmbH | Capsules, hard | Prequalification - Abridged | |
| IN006 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Roche Registration GmbH | Capsules, hard | Prequalification - Abridged | |
| IN004 | Oseltamivir (phosphate) Capsules, hard 30mg | Finished Pharmaceutical Product | Influenza | Roche Registration GmbH | Capsules, hard | Prequalification - Abridged | |
| IN007 | Zanamivir Powder, for Inhalation 5mg | Finished Pharmaceutical Product | Influenza | Glaxo Wellcome UK Ltd | Powder, for Inhalation | Prequalification - Abridged | |
| RH017 | Levonorgestrel Implant 75mg | Finished Pharmaceutical Product | Reproductive health | Bayer Oy | Implant | Prequalification - Abridged | |
| HA433 | Lamivudine/Nevirapine/Zidovudine Tablet, Dispersible 30mg/50mg/60mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Dispersible | Prequalification - Full | |
| HA410 | Tenofovir disoproxil fumarate Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full |
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