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.
Displaying: 151 - 200 of 667
Download list as CSV file
| WHO Reference Number | INN, Dosage Form and Strength | Product Type Sort descending | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| NT005 | Albendazole Tablet 400mg | Finished Pharmaceutical Product | Neglected tropical diseases | Cipla Ltd | Tablet | Prequalification - Full | |
| CV004 | Dexamethasone (sodium phosphate) Solution for injection 4mg/ml | Finished Pharmaceutical Product | Covid-19 | Farmak JSC | Solution for injection | Prequalification - Full | |
| MA158 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 12.5mg/250mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| TB302 | Isoniazid/Rifampicin Tablet, Dispersible 50mg/75mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA163 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 25mg/500mg | Finished Pharmaceutical Product | Malaria | Universal Corporation Ltd | Tablet, Dispersible | Prequalification - Full | |
| HA573 | Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | 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 | |
| HA485 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA574 | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| NT004 | Praziquantel Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Neglected tropical diseases | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA486 | Zidovudine Solution, Oral 10mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Solution, Oral | Prequalification - Full | |
| TB286 | Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| MA145 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 25mg/500mg | Finished Pharmaceutical Product | Malaria | S Kant Healthcare Ltd | Tablet, Dispersible | Prequalification - Full | |
| RH098 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | Naari BV | Tablet | Prequalification - Abridged | |
| ANDA 091579 USFDA | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| CV021 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Cipla Ltd | Capsules, hard | Prequalification - Full | |
| TB401 | Pyridoxine hydrochloride Tablet, Film-coated 50mg | Finished Pharmaceutical Product | Tuberculosis | S Kant Healthcare Ltd | Tablet, Film-coated | 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 | |
| TB396 | Bedaquiline fumarate Tablet 100mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet | Prequalification - Full | |
| CV018 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg | Finished Pharmaceutical Product | Covid-19 | Zhejiang Apeloa Kangyu Pharmaceutical Co Ltd | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| HA680 | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA459 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| MA099 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Mylan Laboratories Limited | 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 | |
| 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 | |
| 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 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 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 | |
| ANDA 204739b USFDA | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| ANDA 204739a USFDA | Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| NDA 214566 USFDA | Dolutegravir (sodium) Tablet, Dispersible 10mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Alternative Listing | |
| ANDA 203442 USFDA | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| 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 | |
| RH105 | Misoprostol Tablet, vaginal 200µg | Finished Pharmaceutical Product | Reproductive health | BIAL-Portela & Ca. SA | Tablet, vaginal | Prequalification - Abridged | |
| ANDA 213541 USFDA | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Alternative Listing | |
| CV008 | Molnupiravir Capsules, hard 200 mg | Finished Pharmaceutical Product | Covid-19 | Hetero Labs Ltd | Capsules, hard | Prequalification - Full | |
| NDA 21837 USFDA | Lamivudine/Nevirapine/Stavudine Tablet 150g/200mg/40mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Global PTE Limited | Tablet | Alternative Listing | |
| DI009 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | PharmEvo (Pvt) Ltd. | Tablet, Dispersible | Prequalification - Full | |
| DI010 | Zinc (sulfate) Syrup 10mg/5ml | Finished Pharmaceutical Product | Diarrhoea | PharmEvo (Pvt) Ltd. | Syrup | 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 | |
| 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 | |
| ANDA 090679 USFDA | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| MA186 | Artesunate Powder for solution for injection 120 mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Powder for solution for injection | Prequalification - Full | |
| ANDA 090198 USFDA | Lamivudine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| HA772 | Atazanavir (sulfate)/Ritonavir Tablet, Film-coated 300mg/100mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| ANDA 203232 USFDA | Tenofovir disoproxil fumarate Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing |
.