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: 301 - 350 of 667
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| WHO Reference Number | INN, Dosage Form and Strength | Product Type | Therapeutic Area | Applicant Sort ascending | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| HA538 | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| ANDA 091475 USFDA | Lamivudine Solution, Oral 10mg/ml | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Solution, Oral | Alternative Listing | |
| NDA 207369 USFDA | Abacavir (sulfate)/Lamivudine Tablet 60mg/30mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Alternative Listing | |
| HA521 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA696 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HP002 | Sofosbuvir Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Hepatitis B and C | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA549 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA682 | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA498 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HP012 | Daclatasvir (dihydrochloride) Tablet, Film-coated 60mg | Finished Pharmaceutical Product | Hepatitis B and C | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA565 | Ritonavir Tablet, Film-coated 100mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HP011 | Daclatasvir (dihydrochloride) Tablet, Film-coated 30mg | Finished Pharmaceutical Product | Hepatitis B and C | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB299 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA650 | Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB315 | Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA719 | Darunavir (ethanolate)/Ritonavir Tablet, Film-coated 400mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA492 | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| ANDA 205412 USFDA | Abacavir (sulfate)/Lamivudine Tablet 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Alternative Listing | |
| HA759 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| ANDA 091677 USFDA | Lopinavir/Ritonavir Tablet 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Alternative Listing | |
| HA657 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | 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 | |
| CV008 | Molnupiravir Capsules, hard 200 mg | Finished Pharmaceutical Product | Covid-19 | Hetero Labs Ltd | Capsules, hard | Prequalification - Full | |
| MA167 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Laboratorios Basi - Industria Farmaceutica SA | Tablet | Prequalification - Full | |
| RH036 | Etonogestrel Implant 68mg | Finished Pharmaceutical Product | Reproductive health | NV Organon | Implant | Prequalification - Abridged | |
| RH021 | Lynestrenol Tablet 500mcg | Finished Pharmaceutical Product | Reproductive health | NV Organon | Tablet | Prequalification - Abridged | |
| RH025 | Desogestrel/Ethinylestradiol Tablet + Placebo Tablet, coated 0.150mg/0.030mg + 0mg | Finished Pharmaceutical Product | Reproductive health | NV Organon | Tablet + Tablet, coated | Prequalification - Abridged | |
| RH102 | Desogestrel Tablet, Film-coated 75mcg | Finished Pharmaceutical Product | Reproductive health | NV Organon | Tablet, Film-coated | Prequalification - Abridged | |
| HA337 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Merck Sharp & Dohme BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA428 | Efavirenz Tablet, Film-coated 200mg | Finished Pharmaceutical Product | HIV/AIDS | Merck Sharp & Dohme BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA427 | Efavirenz Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Merck Sharp & Dohme BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA638 | Morphine hydrochloride Tablets, Prolonged release 60mg | Finished Pharmaceutical Product | HIV/AIDS | GL Pharma GmbH | Tablets, Prolonged release | Prequalification - Abridged | |
| HA637 | Morphine hydrochloride Tablets, Prolonged release 30mg | Finished Pharmaceutical Product | HIV/AIDS | GL Pharma GmbH | Tablets, Prolonged release | Prequalification - Abridged | |
| HA636 | Morphine hydrochloride Tablets, Prolonged release 10mg | Finished Pharmaceutical Product | HIV/AIDS | GL Pharma GmbH | Tablets, Prolonged release | Prequalification - Abridged | |
| HA764 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Desano Pharmaceuticals Private Limited | Tablet, Film-coated | Prequalification - Full |
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