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 Sort descending | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| 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 | |
| CV008 | Molnupiravir Capsules, hard 200 mg | Finished Pharmaceutical Product | Covid-19 | Hetero Labs Ltd | Capsules, hard | Prequalification - Full | |
| RH067 | Desogestrel/Ethinylestradiol Tablet, Film-coated 0.15mg/0.03mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet, Film-coated | Prequalification - Full | |
| RH070 | Ethinylestradiol/Levonorgestrel Tablet, Film-coated 0.03mg/0.15mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet, Film-coated | Prequalification - Full | |
| RH068 | Levonorgestrel Tablet 0.75mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet | 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 | |
| RH069 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet | 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 | |
| EMA Art 58 H-W-002168 | Dapivirine Vaginal ring 25mg | Finished Pharmaceutical Product | HIV/AIDS | International Partnership for Microbicides Belgium (IPM Belgium) AISBL | Vaginal ring | Alternative Listing | |
| MA108 | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Novartis Pharma AG | Tablet | Prequalification - Full | |
| MA069 | Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg | Finished Pharmaceutical Product | Malaria | Novartis Pharma AG | Tablet, Dispersible | Prequalification - Abridged | |
| MA026 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Novartis Pharma AG | Tablet | Prequalification - Abridged | |
| MA122 | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| RH046 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | Cipla Ltd | Tablet | Prequalification - Full | |
| HA666 | Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB321 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| HP021 | Daclatasvir (dihydrochloride) Tablet, Film-coated 30mg | Finished Pharmaceutical Product | Hepatitis B and C | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA662 | Abacavir (sulfate)/Lamivudine Tablet, Dispersible 120mg/60mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA115 | Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet, Dispersible | Prequalification - Full | |
| HP022 | Daclatasvir (dihydrochloride) Tablet, Film-coated 60mg | Finished Pharmaceutical Product | Hepatitis B and C | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA741 | Ritonavir Tablet, Film-coated 25mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA500 | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| MA064 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| RH039 | Misoprostol Tablet 200mcg | Finished Pharmaceutical Product | Reproductive health | Cipla Ltd | Tablet | Prequalification - Full | |
| MA102 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| HA743 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| MA124 | Artesunate Capsule, Soft, Rectal 100mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Capsule, Soft, Rectal | Prequalification - Full | |
| HA770 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| MA104 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| ANDA 90371 USFDA | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Alternative Listing | |
| NDA 203076 USFDA | Lamivudine/Nevirapine/Zidovudine Tablet, Dispersible 30mg/50mg/60mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Dispersible | Alternative Listing | |
| HA439 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB227 | Levofloxacin Tablet, Film-coated 500mg | Finished Pharmaceutical Product | Tuberculosis | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| MA103 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| HA200 | Nevirapine Suspension, Oral 50mg/5mL | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Suspension, Oral | 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 | |
| NT005 | Albendazole Tablet 400mg | Finished Pharmaceutical Product | Neglected tropical diseases | Cipla Ltd | Tablet | Prequalification - Full | |
| IN001 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Cipla Ltd | Capsules, hard | Prequalification - Full | |
| ANDA 091144 USFDA | Abacavir (sulfate)/Lamivudine Tablet 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet | Alternative Listing | |
| TB205 | Levofloxacin Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA639 | Isoniazid/Pyridoxine hydrochloride/Sulfamethoxazole/Trimethoprim Tablet 300mg/25mg/800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet | Prequalification - Full | |
| HA060 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| NDA 202814 USFDA | Lamivudine/Zidovudine Tablet, Dispersible 30mg/60mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Dispersible | Alternative Listing | |
| RH040 | Levonorgestrel Tablet 750mcg | Finished Pharmaceutical Product | Reproductive health | Cipla Ltd | Tablet | Prequalification - Full | |
| HA778 | Ritonavir Tablet, Film-coated 100 mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Abridged | |
| ANDA 203759 USFDA | Ritonavir Tablet 100mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet | Alternative Listing | |
| HA680 | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla 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 | |
| CV021 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Cipla Ltd | Capsules, hard | Prequalification - Full | |
| HA747 | Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg | Finished Pharmaceutical Product | HIV/AIDS | Eumedica Pharmaceuticals AG | Tablet | Prequalification - Abridged |
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