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 |
|---|---|---|---|---|---|---|---|
| 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 | |
| ANDA 205412 USFDA | Abacavir (sulfate)/Lamivudine Tablet 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Alternative Listing | |
| ANDA 077558 USFDA | Lamivudine/Zidovudine Tablet 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| HA621 | Ritonavir Tablet, Film-coated 25mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| RH077 | Magnesium sulphate Solution for injection 500mg/mL | Finished Pharmaceutical Product | Reproductive health | Aurum Pharmaceuticals Ltd | Solution for injection | Prequalification - Abridged | |
| HA424 | Lamivudine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA686 | Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| HA736 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB364 | Clofazimine Capsules, soft 100mg | Finished Pharmaceutical Product | Tuberculosis | Dong-A ST Co Ltd | Capsules, soft | Prequalification - Full | |
| RH098 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | Naari BV | Tablet | Prequalification - Abridged | |
| MA145 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 25mg/500mg | Finished Pharmaceutical Product | Malaria | S Kant Healthcare Ltd | Tablet, Dispersible | Prequalification - Full | |
| TB286 | Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA486 | Zidovudine Solution, Oral 10mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Solution, Oral | Prequalification - Full | |
| NT004 | Praziquantel Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Neglected tropical diseases | Macleods Pharmaceuticals Ltd | 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 | |
| HA485 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/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 | |
| HA573 | Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| MA163 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 25mg/500mg | Finished Pharmaceutical Product | Malaria | Universal Corporation Ltd | Tablet, Dispersible | Prequalification - Full | |
| TB302 | Isoniazid/Rifampicin Tablet, Dispersible 50mg/75mg | 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 | |
| CV004 | Dexamethasone (sodium phosphate) Solution for injection 4mg/ml | Finished Pharmaceutical Product | Covid-19 | Farmak JSC | Solution for injection | Prequalification - Full | |
| NT005 | Albendazole Tablet 400mg | Finished Pharmaceutical Product | Neglected tropical diseases | Cipla Ltd | Tablet | Prequalification - Full | |
| MA127 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| MA130 | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Ajanta Pharma Ltd | Tablet | Prequalification - Full | |
| RH072 | Magnesium sulphate Solution for injection 500mg/ml (10ml) | Finished Pharmaceutical Product | Reproductive health | Labesfal, Laboratorios Almiro SA | Solution for injection | Prequalification - Abridged | |
| RH069 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet | 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 | |
| MA093 | Dihydroartemisinin/Piperaquine phosphate Tablet, Film-coated 20mg/160mg | Finished Pharmaceutical Product | Malaria | Alfasigma S.p.A | Tablet, Film-coated | Prequalification - Abridged | |
| 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 | |
| HA702 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| ANDA 078850b USFDA | Lamivudine Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Alternative Listing | |
| HA631 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA572 | Lamivudine/Zidovudine Tablet, Dispersible 30mg/60mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Dispersible | Prequalification - Full | |
| HA740 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| RH089 | Mifepristone Tablet + Misoprostol Tablet, vaginal 200mg + 200mcg | Finished Pharmaceutical Product | Reproductive health | China Resources Zizhu Pharmaceutical Co Ltd | Tablet + Tablet, vaginal | Prequalification - Full | |
| IN018 | Oseltamivir (phosphate) Capsules, hard 30mg | Finished Pharmaceutical Product | Influenza | MSN Laboratories Private Limited | Capsules, hard | Prequalification - Full | |
| RH066 | Desogestrel/Ethinylestradiol Tablet, Film-coated + Placebo Tablet, Film-coated 0.15mg/0.03mg + 0mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| RH044 | Desogestrel/Ethinylestradiol Tablet, Film-coated+Placebo Tablet, Film-coated 150mcg/30mcg+0mg | Finished Pharmaceutical Product | Reproductive health | Lupin Ltd. | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Abridged | |
| 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 | |
| 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 | |
| HA683 | Darunavir (ethanolate) Tablet, Film-coated 800mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full |
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