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 Sort descending | INN, Dosage Form and Strength | Product Type | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| CV005 | Dexamethasone (sodium phosphate) Solution for injection 4mg/ml (1ml) | Finished Pharmaceutical Product | Covid-19 | Demo SA | Solution for injection | Prequalification - Abridged | |
| CV006 | Dexamethasone (sodium phosphate) Solution for injection 4mg/ml (2ml) | Finished Pharmaceutical Product | Covid-19 | Demo SA | Solution for injection | Prequalification - Abridged | |
| CV007 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg | Finished Pharmaceutical Product | Covid-19 | Pfizer Limited | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Abridged | |
| CV008 | Molnupiravir Capsules, hard 200 mg | Finished Pharmaceutical Product | Covid-19 | Hetero Labs Ltd | Capsules, hard | 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 | |
| CV011 | Remdesivir Powder for concentrate for solution for infusion 100 mg | Finished Pharmaceutical Product | Covid-19 | Gilead Sciences Ireland UC | Powder for concentrate for solution for infusion | Prequalification - Abridged | |
| CV016 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg | Finished Pharmaceutical Product | Covid-19 | Zhejiang Huahai Pharmaceutical Co. Ltd. | Tablet, Film-coated + 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 | |
| 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 | |
| CV019 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Shanghai Desano Bio-Pharmaceutical Co., Ltd. | Capsules, hard | Prequalification - Full | |
| CV020 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg | Finished Pharmaceutical Product | Covid-19 | Yaopharma Co., Ltd. | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| CV021 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Cipla Ltd | Capsules, hard | Prequalification - Full | |
| CV022 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Mylan Laboratories Ltd. | Capsules, hard | Prequalification - Full | |
| CV023 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Guilin Pharmaceutical Co Ltd | Capsules, hard | Prequalification - Full | |
| CV024 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg | Finished Pharmaceutical Product | Covid-19 | Mylan Laboratories Ltd. | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| CV026 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg | Finished Pharmaceutical Product | Covid-19 | Shanghai Desano Bio-Pharmaceutical Co., Ltd. | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| DI005 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | 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 | |
| DI011 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | Ipca Laboratories Ltd | Tablet, Dispersible | Prequalification - Full | |
| DI013 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | The ACME Laboratories Ltd | Tablet, Dispersible | Prequalification - Full | |
| DI014 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | Swiss Pharma Nigeria Ltd. | Tablet, Dispersible | 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 | |
| EMA Art 58 H-W-002320 | Fexinidazole Tablet 600mg | Finished Pharmaceutical Product | Neglected tropical diseases | Sanofi-aventis groupe | Tablet | Alternative Listing | |
| 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 | |
| EMA Art 58 H-W-2319-3 | Artesunate/Pyronaridine (phosphate) Granules for Oral suspension 20mg/60mg | Finished Pharmaceutical Product | Malaria | Shin Poong Pharmaceutical Co Ltd | Granules for Oral suspension | Alternative Listing | |
| EMA Art 58 H-W-4252-1 | Arpraziquantel Tablet, Dispersible 150mg | Finished Pharmaceutical Product | Neglected tropical diseases | Merck Europe B.V. | Tablet, Dispersible | Alternative Listing | |
| EMA Art 58 H-W-764-1 | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | AbbVie Deutschland GmbH and Co. KG | Tablet, Film-coated | Alternative Listing | |
| EMA Art 58 H-W-764-2 | Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | AbbVie Deutschland GmbH and Co. KG | Tablet, Film-coated | Alternative Listing | |
| HA060 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA098 | Lopinavir/Ritonavir Solution, Oral 80mg/mL/20mg/mL | Finished Pharmaceutical Product | HIV/AIDS | AbbVie Deutschland GmbH and Co. KG | Solution, Oral | Prequalification - Abridged | |
| HA106 | Abacavir (sulfate) Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA107 | Abacavir (sulfate) Solution, Oral 20mg/mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Solution, Oral | Prequalification - Abridged | |
| HA108 | Zidovudine Capsules, hard 100mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Capsules, hard | Prequalification - Abridged | |
| HA109 | Zidovudine Capsules, hard 250mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Capsules, hard | Prequalification - Abridged | |
| HA110 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA114 | Zidovudine Solution for injection 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Solution for injection | Prequalification - Abridged | |
| HA115 | Zidovudine Solution, Oral 50mg/5mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Solution, Oral | Prequalification - Abridged | |
| HA117 | Lamivudine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA128 | Lamivudine Solution, Oral 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Solution, Oral | Prequalification - Abridged | |
| HA200 | Nevirapine Suspension, Oral 50mg/5mL | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Suspension, Oral | Prequalification - Full | |
| HA286 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Sun Pharmaceutical Industries Limited | Tablet, Film-coated | Prequalification - Full | |
| HA306 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Sun Pharmaceutical Industries Limited | Tablet, Film-coated | Prequalification - Full | |
| HA381 | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | AbbVie Deutschland GmbH and Co. KG | Tablet, Film-coated | Prequalification - Abridged | |
| HA392 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HA403 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HA410 | Tenofovir disoproxil fumarate Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HA414 | Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HA417 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Ltd. | Tablet, Film-coated | Prequalification - Full |
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