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: 251 - 300 of 667
Download list as CSV file
| WHO Reference Number | INN, Dosage Form and Strength | Product Type | Therapeutic Area | Applicant | Dosage Form Sort descending | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| MA130 | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Ajanta Pharma Ltd | Tablet | Prequalification - Full | |
| NDA 22461a USFDA | Efavirenz Tablet 50mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Alternative Listing | |
| MA091 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB386 | Pretomanid Tablet 200mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet | Prequalification - Abridged | |
| MA085 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet | Prequalification - Full | |
| NT005 | Albendazole Tablet 400mg | Finished Pharmaceutical Product | Neglected tropical diseases | Cipla Ltd | Tablet | Prequalification - Full | |
| MA164 (Suspended) | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet | Prequalification - Full | |
| MA103 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| HA600 | Etravirine Tablet 25mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen-Cilag International NV | Tablet | Prequalification - Abridged | |
| ANDA 090309 USFDA | Abacavir (sulfate)/Lamivudine/Zidovudine Tablet 300mg/150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Alternative Listing | |
| MA134 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Micro Labs Limited | Tablet | Prequalification - Full | |
| HA448 | Lamivudine/Tenofovir disoproxil fumarate Tablet 300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Prequalification - Full | |
| MA058 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Sanofi | Tablet | Prequalification - Full | |
| ANDA 203041 USFDA | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| HCnda | Lamivudine/Nevirapine/Zidovudine Tablet 150mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Apotex Pharmachem Inc | Tablet | Alternative Listing | |
| TB243 | Pyrazinamide Tablet 500mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| ANDA 077464b USFDA | Lamivudine Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| MA056 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Sanofi | Tablet | Prequalification - Full | |
| HA599 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| MA062 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| TB383 | Pyridoxine hydrochloride Tablet 50mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| HA569 | Nevirapine Tablet 100mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| ANDA 077267 USFDA | Zidovudine Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| MA057 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Sanofi | Tablet | Prequalification - Full | |
| NDA 22461c USFDA | Efavirenz Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Alternative Listing | |
| RH056 | Misoprostol Tablet 200mcg | Finished Pharmaceutical Product | Reproductive health | Acme Formulation Pvt. Limited | Tablet | Prequalification - Full | |
| ANDA 090471b USFDA | Lopinavir/Ritonavir Tablet 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| ANDA 091677 USFDA | Lopinavir/Ritonavir Tablet 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Alternative Listing | |
| MA083 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet | Prequalification - Full | |
| HA639 | Isoniazid/Pyridoxine hydrochloride/Sulfamethoxazole/Trimethoprim Tablet 300mg/25mg/800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet | Prequalification - Full | |
| HA570 | Nevirapine Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| ANDA 077673 USFDA | Efavirenz Tablet 600mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| MA081 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| MA143 | Artemether/Lumefantrine Tablet 40mg/240mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| HA598 | Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| MA104 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| ANDA 079124 USFDA | Lamivudine/Zidovudine Tablet 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Alternative Listing | |
| RH048 | Misoprostol Tablet 200mcg | Finished Pharmaceutical Product | Reproductive health | China Resources Zizhu Pharmaceutical Co Ltd | Tablet | Prequalification - Full | |
| HA691 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Milan Laboratories (India) Pvt Ltd | Tablet | Prequalification - Full | |
| HA568 | Nevirapine Tablet 50mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| TB196 | Isoniazid Tablet 100mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet | Prequalification - Full | |
| RH068 | Levonorgestrel Tablet 0.75mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet | Prequalification - Full | |
| MA082 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| RH094 | Misoprostol Tablet 200mcg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| MA111 | Artemether/Lumefantrine Tablet 20mg/120mg | 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 | |
| MA165 (Suspended) | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet | Prequalification - Full | |
| MA129 | Artemether/Lumefantrine Tablet 60mg/360mg | Finished Pharmaceutical Product | Malaria | Ajanta Pharma Ltd | Tablet | Prequalification - Full | |
| MA102 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| ANDA 090513 USFDA | Emtricitabine/Tenofovir disoproxil fumarate Tablet 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing |
.