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 Sort ascending | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| ANDA 090688 USFDA | Nevirapine Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet | Alternative Listing | |
| RH058 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | Lupin Ltd. | Tablet | Prequalification - Abridged | |
| TB171 | Pyrazinamide Tablet 400mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet | Prequalification - Full | |
| MA126 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB265 | Isoniazid Tablet 100mg | Finished Pharmaceutical Product | Tuberculosis | Antibiotice SA | Tablet | Prequalification - Abridged | |
| TB285 | Isoniazid Tablet 300mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| TB382 | Pyridoxine hydrochloride Tablet 10mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| MA100 | Artemether/Lumefantrine Tablet 40mg/240mg | Finished Pharmaceutical Product | Malaria | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| TB266 | Isoniazid Tablet 300mg | Finished Pharmaceutical Product | Tuberculosis | Antibiotice SA | Tablet | Prequalification - Abridged | |
| MA064 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| HA687 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| MA084 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet | Prequalification - Full | |
| RH052 | Mifepristone Tablet 200mg | Finished Pharmaceutical Product | Reproductive health | China Resources Zizhu Pharmaceutical Co Ltd | Tablet | Prequalification - Full | |
| MA128 | Artemether/Lumefantrine Tablet 40mg/240mg | Finished Pharmaceutical Product | Malaria | Ajanta Pharma Ltd | Tablet | Prequalification - Full | |
| NT009 | Ivermectin Tablet 3mg | Finished Pharmaceutical Product | Neglected tropical diseases | Edenbridge Pharmaceuticals LLC | Tablet | Prequalification - Abridged | |
| RH046 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | Cipla Ltd | Tablet | Prequalification - Full | |
| HA532 | Etravirine Tablet 100mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen Research & Development LLC | Tablet | Prequalification - Abridged | |
| MA026 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Novartis Pharma AG | Tablet | Prequalification - Abridged | |
| ANDA 078958 USFDA | Efavirenz Tablet 600mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Tablet | Alternative Listing | |
| ANDA 203759 USFDA | Ritonavir Tablet 100mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet | Alternative Listing | |
| RH040 | Levonorgestrel Tablet 750mcg | Finished Pharmaceutical Product | Reproductive health | Cipla Ltd | Tablet | Prequalification - Full | |
| MA160 | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| ANDA 078887 USFDA | Nevirapine Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Tablet | Alternative Listing | |
| TB178 | Isoniazid Tablet 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB308 | Isoniazid Tablet 100mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| ANDA 078922 USFDA | Zidovudine Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Alternative Listing | |
| TB276 | Isoniazid Tablet 300mg | Finished Pharmaceutical Product | Tuberculosis | Cadila Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| HA570 | Nevirapine Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| HA693 | Flucytosine Tablet 500mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Prequalification - Abridged | |
| NT007 | Ivermectin Tablet 3mg | Finished Pharmaceutical Product | Neglected tropical diseases | Laboratorios Liconsa SA | Tablet | Prequalification - Full | |
| HA754 | Flucytosine Tablet 500mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| ANDA 077844 USFDA | Abacavir (sulfate) Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| HA753 | Flucytosine Tablet 250mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| ANDA 090457 USFDA | Lamivudine Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Science Limited | Tablet | Alternative Listing | |
| HA448 | Lamivudine/Tenofovir disoproxil fumarate Tablet 300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Prequalification - Full | |
| NDA 21837 USFDA | Lamivudine/Nevirapine/Stavudine Tablet 150g/200mg/40mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Global PTE Limited | Tablet | Alternative Listing | |
| ANDA 077267 USFDA | Zidovudine Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| MA102 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| MA129 | Artemether/Lumefantrine Tablet 60mg/360mg | Finished Pharmaceutical Product | Malaria | Ajanta Pharma Ltd | Tablet | Prequalification - Full | |
| ANDA 078644 USFDA | Nevirapine Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Zhejiang Huahai Pharmaceutical Co. Ltd. | Tablet | Alternative Listing | |
| HA645 | Dapsone Tablet 100mg | Finished Pharmaceutical Product | HIV/AIDS | Everest Life Sciences LLC | Tablet | Prequalification - Abridged | |
| RH094 | Misoprostol Tablet 200mcg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| MA108 | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Novartis Pharma AG | Tablet | Prequalification - Full | |
| TB174 | Isoniazid Tablet 300mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet | Prequalification - Full | |
| HA747 | Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg | Finished Pharmaceutical Product | HIV/AIDS | Eumedica Pharmaceuticals AG | Tablet | Prequalification - Abridged | |
| TB173 | Isoniazid Tablet 100mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet | Prequalification - Full | |
| ANDA 077673 USFDA | Efavirenz Tablet 600mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| TB196 | Isoniazid Tablet 100mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet | Prequalification - Full | |
| ANDA 078929 USFDA | Lamivudine/Zidovudine Tablet 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Tablet | Alternative Listing | |
| ANDA 078742 USFDA | Abacavir (sulfate) Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Alternative Listing |
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