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 Sort ascending | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| HA466 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| TB242 | Ethionamide Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| TB236 | Cycloserine Capsules, hard 250mg | Finished Pharmaceutical Product | Tuberculosis | Dong-A ST Co Ltd | Capsules, hard | 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 | |
| RH084 | Medroxyprogesterone acetate Suspension for injection 150mg/ml | Finished Pharmaceutical Product | Reproductive health | Incepta Pharmaceuticals Ltd. | Suspension for injection | Prequalification - Full | |
| HA596 | Ondansetron (hydrochloride) Tablet, Film-coated 8mg | Finished Pharmaceutical Product | HIV/AIDS | Cadila Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA636 | Morphine hydrochloride Tablets, Prolonged release 10mg | Finished Pharmaceutical Product | HIV/AIDS | GL Pharma GmbH | Tablets, Prolonged release | Prequalification - Abridged | |
| MA062 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| HA755 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA599 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| MA056 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Sanofi | Tablet | Prequalification - Full | |
| 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 | |
| TB237 | Levofloxacin Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| ANDA 090198b USFDA | Lamivudine Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| ANDA 077464b USFDA | Lamivudine Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| HA467 | Ritonavir Tablet, Film-coated 100mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| MA069 | Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg | Finished Pharmaceutical Product | Malaria | Novartis Pharma AG | Tablet, Dispersible | Prequalification - Abridged | |
| TB243 | Pyrazinamide Tablet 500mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| HCnda | Lamivudine/Nevirapine/Zidovudine Tablet 150mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Apotex Pharmachem Inc | 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 | |
| HA704 | Itraconazole Capsules, hard 100mg | Finished Pharmaceutical Product | HIV/AIDS | Laboratorios Liconsa S.A. | Capsules, hard | Prequalification - Abridged | |
| MA131 | Dihydroartemisinin/Piperaquine phosphate Tablet, Film-coated 40mg/320mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Film-coated | Prequalification - Full | |
| ANDA 077267 USFDA | Zidovudine Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| CV006 | Dexamethasone (sodium phosphate) Solution for injection 4mg/ml (2ml) | Finished Pharmaceutical Product | Covid-19 | Demo SA | Solution for injection | Prequalification - Abridged | |
| MA078 | Artesunate/Mefloquine (hydrochloride) Tablet, Film-coated 25mg/50mg | Finished Pharmaceutical Product | Malaria | Drugs for Neglected Diseases Initiative (DNDi) | Tablet, Film-coated | Prequalification - Full | |
| EMA Art 58 H-W-2319-2 | Artesunate/Pyronaridine (phosphate) Tablet, Film-coated 60mg/180mg | Finished Pharmaceutical Product | Malaria | Shin Poong Pharmaceutical Co Ltd | Tablet, Film-coated | Alternative Listing | |
| MA102 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| TB307 | Pyrazinamide Tablet, Dispersible 150mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| HA634 | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged | |
| MA129 | Artemether/Lumefantrine Tablet 60mg/360mg | Finished Pharmaceutical Product | Malaria | Ajanta Pharma Ltd | Tablet | Prequalification - Full | |
| TB189 | Isoniazid/Rifampicin Tablet, Film-coated 75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Svizera Europe BV | Tablet, Film-coated | Prequalification - Full | |
| ANDA 078644 USFDA | Nevirapine Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Zhejiang Huahai Pharmaceutical Co. Ltd. | Tablet | Alternative Listing | |
| 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 | |
| RH094 | Misoprostol Tablet 200mcg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| HA743 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| RH074 | Medroxyprogesterone acetate Suspension for injection 150mg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Suspension for injection | 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 | |
| TB195 | Isoniazid/Rifampicin Tablet, Film-coated 150mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| MA124 | Artesunate Capsule, Soft, Rectal 100mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Capsule, Soft, Rectal | Prequalification - Full | |
| HA715 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| IN014 | Oseltamivir (phosphate) Capsules, hard 30mg | Finished Pharmaceutical Product | Influenza | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| TB192 | Ethambutol hydrochloride/Isoniazid/Rifampicin Tablet, Film-coated 275mg/75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Svizera Europe BV | Tablet, Film-coated | Prequalification - Full | |
| HA706 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged | |
| RH079 | Oxytocin Solution for injection 10IU/ml | Finished Pharmaceutical Product | Reproductive health | JSC Grindeks | Solution for injection | 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 | |
| TB193 | Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tablet, Film-coated 275mg/75mg/400mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Svizera Europe BV | Tablet, Film-coated | Prequalification - Full | |
| ANDA 077673 USFDA | Efavirenz Tablet 600mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| TB196 | Isoniazid Tablet 100mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet | Prequalification - Full | |
| HA565 | Ritonavir Tablet, Film-coated 100mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full |
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