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 | Basis of Listing Sort descending | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| TB277 | Levofloxacin Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA569 | Nevirapine Tablet 100mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| TB205 | Levofloxacin Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB377 | Levofloxacin Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Zhejiang Apeloa Kangyu Pharmaceutical Co Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA656 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Anhui Biochem Bio-Pharmaceutical Co Ltd | Tablet, Film-coated | Prequalification - Full | |
| MA083 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet | Prequalification - Full | |
| HA639 | Isoniazid/Pyridoxine hydrochloride/Sulfamethoxazole/Trimethoprim Tablet 300mg/25mg/800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet | Prequalification - Full | |
| MA090 | Artesunate Powder for solution for injection 120mg/vial | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Powder for solution for injection | Prequalification - Full | |
| HA060 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA417 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA570 | Nevirapine Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| MA154 (Suspended) | Artemether/Lumefantrine Tablet, Dispersible 40mg/240mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible | Prequalification - Full | |
| TB206 | Protionamide Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HA657 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| MA159 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 25mg/500mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA084 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet | Prequalification - Full | |
| BT-ON014 | Water for Injection Solvent for parenteral use + Trastuzumab Powder for concentrate for solution for infusion 20mL + 420mg | Biotherapeutic Product | Oncology | Biocon Biologics Limited | Solvent for parenteral use + Powder for concentrate for solution for infusion | Prequalification - Full | |
| RH040 | Levonorgestrel Tablet 750mcg | Finished Pharmaceutical Product | Reproductive health | Cipla Ltd | Tablet | Prequalification - Full | |
| CV009 | Molnupiravir Capsules, hard 200 mg | Finished Pharmaceutical Product | Covid-19 | Dr Reddy's Laboratories Limited | Capsules, hard | Prequalification - Full | |
| CV010 | Molnupiravir Capsules, hard 200 mg | Finished Pharmaceutical Product | Covid-19 | Emcure Pharmaceuticals Limited | Capsules, hard | Prequalification - Full | |
| CV012 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150 mg + 100 mg | Finished Pharmaceutical Product | Covid-19 | Hetero Labs Ltd | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| DI014 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | Swiss Pharma Nigeria Ltd. | Tablet, Dispersible | Prequalification - Full | |
| CV008 | Molnupiravir Capsules, hard 200 mg | Finished Pharmaceutical Product | Covid-19 | Hetero Labs Ltd | Capsules, hard | Prequalification - Full | |
| 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 | |
| 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 | |
| TB389 | Linezolid Tablet, Dispersible 150mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| HA760 | Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA761 | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| TB398 | Rifapentine Tablet, Film-coated 300 mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA772 | Atazanavir (sulfate)/Ritonavir Tablet, Film-coated 300mg/100mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| MA186 | Artesunate Powder for solution for injection 120 mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Powder for solution for injection | 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 | |
| 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 | |
| HA514 | Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | 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 | |
| TB183 | Ethambutol hydrochloride/Isoniazid/Rifampicin Tablet, Film-coated 275mg/75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| MA099 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| HA459 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA680 | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | 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 | |
| TB396 | Bedaquiline fumarate Tablet 100mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet | 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 | |
| TB401 | Pyridoxine hydrochloride Tablet, Film-coated 50mg | Finished Pharmaceutical Product | Tuberculosis | S Kant Healthcare Ltd | Tablet, Film-coated | Prequalification - Full | |
| CV021 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Cipla Ltd | Capsules, hard | Prequalification - Full | |
| HA774 | Sulfamethoxazole/Trimethoprim Tablet 400 mg/80 mg | Finished Pharmaceutical Product | HIV/AIDS | Shouguang Fukang Pharmaceutical Co., Ltd. | Tablet | Prequalification - Full | |
| HA775 | Sulfamethoxazole/Trimethoprim Tablet 800 mg/160 mg | Finished Pharmaceutical Product | HIV/AIDS | Shouguang Fukang Pharmaceutical Co., Ltd. | Tablet | Prequalification - Full |
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