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 Sort ascending | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| HA403 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| RH064 | Magnesium sulphate Solution for injection 500mg/ml (10ml) | Finished Pharmaceutical Product | Reproductive health | AS KALCEKS | Solution for injection | Prequalification - Full | |
| MA152 | Artesunate Powder for solution for injection 60mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Powder for solution for injection | Prequalification - Full | |
| TB342 | Moxifloxacin (hydrochloride) Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA103 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| HA410 | Tenofovir disoproxil fumarate Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| MA164 (Suspended) | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet | Prequalification - Full | |
| MA139 | Dihydroartemisinin/Piperaquine phosphate Tablet, Dispersible 40mg/320mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible | Prequalification - Full | |
| HA737 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| TB361 | Clofazimine Tablet, Film-coated 50mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA200 | Nevirapine Suspension, Oral 50mg/5mL | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Suspension, Oral | Prequalification - Full | |
| HA483 | Zidovudine Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| MA085 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet | Prequalification - Full | |
| MA091 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB368 | Ethambutol hydrochloride Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| HA722 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| MA138 | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Strides Pharma Global PTE Limited | Tablet | Prequalification - Full | |
| HA719 | Darunavir (ethanolate)/Ritonavir Tablet, Film-coated 400mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| MA141 | Dihydroartemisinin/Piperaquine phosphate Tablet, Dispersible 20mg/160mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible | Prequalification - Full | |
| HA492 | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| MA092 | Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg | Finished Pharmaceutical Product | Malaria | Ajanta Pharma Ltd | Tablet, Dispersible | Prequalification - Full | |
| RH065 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | HLL Lifecare Limited | Tablet | Prequalification - Full | |
| HA621 | Ritonavir Tablet, Film-coated 25mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| RH087 | Estradiol valerate/Norethisterone enantate Solution for injection 5mg/ml/50mg/ml | Finished Pharmaceutical Product | Reproductive health | Bayer S.A. | Solution for injection | Prequalification - Full | |
| MA080 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| MA123 | Artesunate Capsule, Soft, Rectal 100mg | Finished Pharmaceutical Product | Malaria | Strides Pharma Global PTE Limited | Capsule, Soft, Rectal | Prequalification - Full | |
| 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 | |
| RH071 | Ethinylestradiol/Levonorgestrel Tablet, Film-coated + Placebo Tablet, Film-coated 0.03mg/0.15mg + 0mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| TB317 | Kanamycin (sulfate) Solution for injection 500mg | Finished Pharmaceutical Product | Tuberculosis | Shanghai Harvest Pharmaceutical Co., Ltd | Solution for injection | Prequalification - Full | |
| TB259 | Rifampicin Capsules, hard 150mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| HA762 | Isoniazid/Pyridoxine hydrochloride/Sulfamethoxazole/Trimethoprim Tablet, Film-coated 300mg/25mg/800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA749 | Atazanavir (sulfate)/Ritonavir Tablet, Film-coated 300mg/100mg | Finished Pharmaceutical Product | HIV/AIDS | Shanghai Desano Bio-Pharmaceutical Co., Ltd. | Tablet, Film-coated | Prequalification - Full | |
| DI009 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | PharmEvo (Pvt) Ltd. | Tablet, Dispersible | 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 | |
| HA392 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA514 | Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| CV017 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg | Finished Pharmaceutical Product | Covid-19 | Celltrion Inc. | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| MA177 | Dihydroartemisinin/Piperaquine phosphate Tablet, Film-coated 40mg/320mg | Finished Pharmaceutical Product | Malaria | Beijing Holley-Cotec Pharmaceuticals Co Ltd | Tablet, Film-coated | Prequalification - Full | |
| MA186 | Artesunate Powder for solution for injection 120 mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Powder for solution for injection | Prequalification - Full | |
| HA772 | Atazanavir (sulfate)/Ritonavir Tablet, Film-coated 300mg/100mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| TB398 | Rifapentine Tablet, Film-coated 300 mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA761 | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA760 | Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| TB389 | Linezolid Tablet, Dispersible 150mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| MA172 | Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 12.5mg/250mg + 75mg | Finished Pharmaceutical Product | Malaria | Universal Corporation Ltd | Tablet, Dispersible + Tablet, Dispersible | Prequalification - Full | |
| MA169 | Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 25mg/500mg + 150mg | Finished Pharmaceutical Product | Malaria | Universal Corporation Ltd | Tablet, Dispersible + Tablet, Dispersible | Prequalification - Full | |
| MA179 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 25mg/500mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA178 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 12.50mg/250mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible | Prequalification - Full | |
| DI010 | Zinc (sulfate) Syrup 10mg/5ml | Finished Pharmaceutical Product | Diarrhoea | PharmEvo (Pvt) Ltd. | Syrup | Prequalification - Full | |
| HA657 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full |
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