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 | Date of Prequalification Sort descending |
|---|---|---|---|---|---|---|---|
| NT019 | Azithromycin Tablet, Film-coated 500mg | Finished Pharmaceutical Product | Neglected tropical diseases | ACI HealthCare Limited | Tablet, Film-coated | Prequalification - Abridged | |
| TB405 | Isoniazid Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | S Kant Healthcare Ltd | Tablet, Dispersible | Prequalification - Full | |
| HA769 | Flucytosine Tablet 500mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| MA192 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 25mg/500mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA191 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 12.50mg/250mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA190 | Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 25mg/500mg + 153mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet, Dispersible + Tablet, Dispersible | Prequalification - Full | |
| MA189 | Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 12.5mg/250mg + 76.5mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet, Dispersible + Tablet, Dispersible | Prequalification - Full | |
| MA193 | Pyrimethamine/Sulfadoxine Tablet 25mg/500mg | Finished Pharmaceutical Product | Malaria | S Kant Healthcare Ltd | Tablet | Prequalification - Full | |
| CV022 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Mylan Laboratories Limited | Capsules, hard | Prequalification - Full | |
| MA194 | Artesunate Powder for solution for injection 120mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Powder for solution for injection | Prequalification - Full | |
| HA787 | Ritonavir Tablet, Film-coated 100mg | Finished Pharmaceutical Product | HIV/AIDS | Shanghai Desano Bio-Pharmaceutical Co., Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HA782 | Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg | Finished Pharmaceutical Product | HIV/AIDS | Reyoung Pharmaceutical Co., Ltd. | Tablet | Prequalification - Full | |
| HA783 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Reyoung Pharmaceutical Co., Ltd. | Tablet | Prequalification - Full | |
| CV023 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. | Capsules, hard | Prequalification - Full | |
| CV019 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Shanghai Desano Bio-Pharmaceutical Co., Ltd. | Capsules, hard | Prequalification - Full | |
| TB393 | Rifapentine Tablet, Film-coated 300mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HA786 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Tablet, Film-coated | Prequalification - Full |
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