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 Sort ascending | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| HA766 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Desano Pharmaceuticals Private Limited | Tablet, Film-coated | Prequalification - Full | |
| ANDA 078850a USFDA | Lamivudine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Alternative Listing | |
| NDA 207315 USFDA | Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 75mg/75mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Alternative Listing | |
| NDA 210880 USFDA | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Alternative Listing | |
| HA486 | Zidovudine Solution, Oral 10mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Solution, Oral | Prequalification - Full | |
| TB133 | Ethionamide Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB134 | Ethambutol hydrochloride Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB332 | Rifampicin Capsules, hard 300mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| HA523 | Lamivudine Solution, Oral 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Solution, Oral | Prequalification - Full | |
| HA526 | Zidovudine Solution, Oral 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Solution, Oral | Prequalification - Full | |
| TB154 | Cycloserine Capsules, hard 250mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| IN015 | Oseltamivir (phosphate) Capsules, hard 45mg | Finished Pharmaceutical Product | Influenza | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| MA142 | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB333 | Ethionamide Tablet, Dispersible 125mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| TB334 | Ethambutol hydrochloride Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| HA516 | Tenofovir disoproxil fumarate Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB303 | Terizidone Capsules, hard 250mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| TB178 | Isoniazid Tablet 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB158 | Isoniazid/Rifampicin Tablet, Film-coated 75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB179 | Isoniazid Tablet 300mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB159 | Pyrazinamide Tablet 400mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| HA713 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| MA125 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| DI005 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| TB279 | Levofloxacin Tablet, Film-coated 750mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB359 | Isoniazid Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | 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 | |
| IN016 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| HA765 | Dolutegravir (sodium) Tablet, Dispersible 10mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA126 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB369 | Isoniazid/Rifapentine Tablet, Film-coated 300mg/300mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB309 | Isoniazid/Pyrazinamide/Rifampicin Tablet, Dispersible 50mg/150mg/75mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| TB330 | Cycloserine Capsules, hard 125mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| ANDA 090688 USFDA | Nevirapine Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet | Alternative Listing | |
| TB362 | Clofazimine Tablet, Film-coated 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB278 | Levofloxacin Tablet, Film-coated 500mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| MA170 | Pyrimethamine/Sulfadoxine Tablet, Dispersible+Amodiaquine (hydrochloride) Tablet, Dispersible 12.50mg/250mg+76.5mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet, Dispersible + Tablet, Dispersible | Prequalification - Full | |
| ANDA 090198b USFDA | Lamivudine Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| TB243 | Pyrazinamide Tablet 500mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB307 | Pyrazinamide Tablet, Dispersible 150mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| ANDA 214397 USFDA | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| MA171 | Pyrimethamine/Sulfadoxine Tablet, Dispersible+Amodiaquine (hydrochloride) Tablet, Dispersible 25mg/500mg+153mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet, Dispersible + Tablet, Dispersible | Prequalification - Full | |
| HA562 | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| IN014 | Oseltamivir (phosphate) Capsules, hard 30mg | Finished Pharmaceutical Product | Influenza | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| HA561 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB391 | Linezolid Tablet, Dispersible 150mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA143 | Artemether/Lumefantrine Tablet 40mg/240mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB226 | Ethambutol hydrochloride Tablet, Film-coated 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA714 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB231 | Isoniazid/Rifampicin Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full |
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