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 Sort descending | INN, Dosage Form and Strength | Product Type | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
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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 | |
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 | |
MA151 | Dihydroartemisinin/Piperaquine phosphate Tablet, Film-coated 60mg/480mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Film-coated | Prequalification - Full | |
MA152 | Artesunate Powder for solution for injection + Sodium Chloride Solution for injection + Sodium Bicarbonate Solution for injection 9mg/ml + 50mg/ml+60mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Powder for solution for injection + Solution for injection | Prequalification - Full | |
MA153 (Suspended) | Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co., Ltd. | Tablet, Dispersible | Prequalification - Full | |
MA154 (Suspended) | Artemether/Lumefantrine Tablet, Dispersible 40mg/240mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible | Prequalification - Full | |
MA155 (Suspended) | Artemether/Lumefantrine Tablet, Dispersible 60mg/360mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. 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 | |
MA158 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 12.5mg/250mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
MA159 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 25mg/500mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
MA160 | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
MA163 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 25mg/500mg | Finished Pharmaceutical Product | Malaria | Universal Corporation Ltd | Tablet, Dispersible | Prequalification - Full | |
MA164 (Suspended) | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet | Prequalification - Full | |
MA165 (Suspended) | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet | Prequalification - Full | |
MA166 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 12.50mg/250mg | Finished Pharmaceutical Product | Malaria | Universal Corporation Ltd | Tablet, Dispersible | Prequalification - Full | |
MA167 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Laboratorios Basi - Industria Farmaceutica SA | Tablet | Prequalification - Full | |
MA168 | Arginine Solvent for parenteral use + Artesunate (sterile) Powder for solution for injection 20mg/ml + 60mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Solvent for parenteral use + Powder for solution for injection | 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 | |
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 | |
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 | |
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 | |
MA176 | Primaquine (phosphate) Tablet, Film-coated 15mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | 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 | |
MA178 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 12.50mg/250mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible | Prequalification - Full | |
MA179 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 25mg/500mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible | Prequalification - Full | |
MA186 | Artesunate (sterile) Powder for solution for injection + Sodium Chloride Solution for injection + Sodium Bicarbonate Solution for injection 0.9% w/v + 5% w/v+120 mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Powder for solution for injection + Solution for injection | 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 | |
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 | |
MA191 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 12.50mg/250mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet, Dispersible | Prequalification - Full | |
MA192 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 25mg/500mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet, Dispersible | Prequalification - Full | |
MA193 | Pyrimethamine/Sulfadoxine Tablet 25mg/500mg | Finished Pharmaceutical Product | Malaria | S Kant Healthcare Ltd | Tablet | Prequalification - Full | |
MR001 | Cefiderocol Powder for concentrate for solution for infusion 1g/vial | Finished Pharmaceutical Product | Multi-drug resistant bacterial infections | Shionogi B.V. | Powder for concentrate for solution for infusion | Prequalification - Abridged | |
NDA 202814 USFDA | Lamivudine/Zidovudine Tablet, Dispersible 30mg/60mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Dispersible | Alternative Listing | |
NDA 203076 USFDA | Lamivudine/Nevirapine/Zidovudine Tablet, Dispersible 30mg/50mg/60mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Dispersible | Alternative Listing | |
NDA 205508 USFDA | Atazanavir (sulfate)/Ritonavir Tablet 300mg/100mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Ltd | Tablet | 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 207369 USFDA | Abacavir (sulfate)/Lamivudine Tablet 60mg/30mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Alternative Listing | |
NDA 209618 USFDA | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet, Film-coated | Alternative Listing | |
NDA 210649 USFDA | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
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 | |
NDA 210796 USFDA | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals 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 | |
NDA 211912 USFDA | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Celltrion Inc. | Tablet, Film-coated | Alternative Listing | |
NDA 214521 USFDA | Dolutegravir (sodium) Tablet, Dispersible 10mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Ltd | Tablet, Dispersible | Alternative Listing | |
NDA 214566 USFDA | Dolutegravir (sodium) Tablet, Dispersible 10mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Alternative Listing | |
NDA 217070 USFDA | Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Dispersible 60mg/5mg/30mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet, Dispersible | Alternative Listing | |
NDA 21837 USFDA | Lamivudine/Nevirapine/Stavudine Tablet 150g/200mg/40mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Global PTE Limited | Tablet | Alternative Listing | |
NDA 21854 USFDA | Lamivudine/Stavudine Tablet+Nevirapine Tablet 150mg/40mg+200mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Science Limited | Tablet + Tablet | Alternative Listing | |
NDA 21944 USFDA | Lamivudine/Zidovudine Tablet+Abacavir (sulfate) Tablet 150mg/300mg+300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet + Tablet | Alternative Listing | |
NDA 22096 USFDA | Lamivudine/Zidovudine Tablet+Efavirenz Tablet 150mg/300mg+600mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Science Limited | Tablet + Tablet | Alternative Listing |
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