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 Sort ascending | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| HA683 | Darunavir (ethanolate) Tablet, Film-coated 800mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA621 | Ritonavir Tablet, Film-coated 25mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA492 | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| ANDA 90159 USFDA | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet, Film-coated | Alternative Listing | |
| HA740 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA428 | Efavirenz Tablet, Film-coated 200mg | Finished Pharmaceutical Product | HIV/AIDS | Merck Sharp & Dohme BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA719 | Darunavir (ethanolate)/Ritonavir Tablet, Film-coated 400mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | 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 | |
| HA410 | Tenofovir disoproxil fumarate Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| TB223 | Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tablet, Film-coated 275mg/75mg/400mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA110 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA635 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA117 | Lamivudine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged | |
| TB230 | Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA703 | Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| TB378 | Levofloxacin Tablet, Film-coated 500mg | Finished Pharmaceutical Product | Tuberculosis | Zhejiang Apeloa Kangyu Pharmaceutical Co Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA403 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA483 | Zidovudine Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HP025 | Daclatasvir (dihydrochloride)/Sofosbuvir Tablet, Film-coated 60mg/400mg | Finished Pharmaceutical Product | Hepatitis B and C | Mylan Laboratories Limited | Tablet, Film-coated | 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 | |
| HP024 | Sofosbuvir/Velpatasvir Tablet, Film-coated 400mg/100mg | Finished Pharmaceutical Product | Hepatitis B and C | Gilead Sciences Ireland UC | Tablet, Film-coated | Prequalification - Abridged | |
| NDA 210787 USFDA | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Alternative Listing | |
| TB361 | Clofazimine Tablet, Film-coated 50mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA631 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | 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 | |
| MA190 | Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 25mg/500mg + 153mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet, Dispersible + Tablet, Dispersible | Prequalification - Full | |
| 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 | |
| MA147 | Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 25mg/500mg + 150mg | Finished Pharmaceutical Product | Malaria | S Kant Healthcare Ltd | Tablet, Dispersible + 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 | |
| MA117 | Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 25mg/500mg + 153mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. 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 | |
| MA146 | Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 12.5mg/250mg + 75mg | Finished Pharmaceutical Product | Malaria | S Kant Healthcare Ltd | Tablet, Dispersible + Tablet, Dispersible | Prequalification - Full | |
| MA116 | Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 12.5mg/250mg + 76.5mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible + Tablet, Dispersible | Prequalification - Full | |
| MA189 | Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 12.5mg/250mg + 76.5mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet, Dispersible + Tablet, Dispersible | Prequalification - Full | |
| MA153 (Suspended) | Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co., Ltd. | Tablet, Dispersible | Prequalification - Full | |
| HA765 | Dolutegravir (sodium) Tablet, Dispersible 10mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA192 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 25mg/500mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet, Dispersible | Prequalification - Full | |
| HA779 | Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Dispersible 60 mg/5 mg/30 mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA191 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 12.50mg/250mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet, Dispersible | Prequalification - Full | |
| TB389 | Linezolid Tablet, Dispersible 150mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| TB359 | Isoniazid Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA158 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 12.5mg/250mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA092 | Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg | Finished Pharmaceutical Product | Malaria | Ajanta Pharma Ltd | Tablet, Dispersible | Prequalification - Full | |
| HA662 | Abacavir (sulfate)/Lamivudine Tablet, Dispersible 120mg/60mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Dispersible | Prequalification - Full | |
| TB391 | Linezolid Tablet, Dispersible 150mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| HA768 | Dolutegravir (sodium) Tablet, Dispersible 5mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Dispersible | Prequalification - Abridged | |
| TB309 | Isoniazid/Pyrazinamide/Rifampicin Tablet, Dispersible 50mg/150mg/75mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA157 | Dihydroartemisinin/Piperaquine phosphate Tablet, Dispersible 30mg/240mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible | Prequalification - Full | |
| HA674 | Abacavir (sulfate) Tablet, Dispersible 60mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| MA145 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 25mg/500mg | Finished Pharmaceutical Product | Malaria | S Kant Healthcare Ltd | Tablet, Dispersible | Prequalification - Full |
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