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: 101 - 150 of 667
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| WHO Reference Number | INN, Dosage Form and Strength | Product Type | Therapeutic Area | Applicant Sort descending | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| MA081 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| MA135 | Artesunate Powder for solution for injection 60mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Powder for solution for injection | Prequalification - Full | |
| MA080 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| MA136 | Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet, Dispersible | Prequalification - Full | |
| DI011 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | Ipca Laboratories Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA160 | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| NDA 22461c USFDA | Efavirenz Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Alternative Listing | |
| HA466 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA467 | Ritonavir Tablet, Film-coated 100mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| RH094 | Misoprostol Tablet 200mcg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| TB285 | Isoniazid Tablet 300mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| HA687 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| HA433 | Lamivudine/Nevirapine/Zidovudine Tablet, Dispersible 30mg/50mg/60mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Dispersible | Prequalification - Full | |
| TB386 | Pretomanid Tablet 200mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet | Prequalification - Abridged | |
| NDA 22461b USFDA | Efavirenz Tablet, Film-coated 100mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Alternative Listing | |
| IN011 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Mylan Laboratories Limited | Capsules, hard | Prequalification - Full | |
| RH049 | Desogestrel/Ethinylestradiol Tablet + Placebo Tablet 150mcg/30mcg + 0mcg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet + Tablet | Prequalification - Abridged | |
| ANDA 078742 USFDA | Abacavir (sulfate) Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Alternative Listing | |
| HA444 | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| TB365 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| RH013 | Ethinylestradiol/Levonorgestrel Tablet, coated 30mcg/150mcg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet, coated | 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 | |
| HA693 | Flucytosine Tablet 500mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Prequalification - Abridged | |
| CV022 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Mylan Laboratories Limited | Capsules, hard | Prequalification - Full | |
| RH035 | Ethinylestradiol/Levonorgestrel Tablet, Sugar coated+Placebo Tablet, Film-coated 30µg/150µg+0mg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet, Film-coated + Tablet, Sugar coated | Prequalification - Full | |
| MA099 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| HA392 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA678 | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| RH037 | Desogestrel/Ethinylestradiol Tablet 0.150mg/0.030mg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet | Prequalification - Abridged | |
| RH057 | Levonorgestrel Tablet, Film-coated 0.03mg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA417 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA685 | Darunavir (ethanolate) Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA426 | Lamivudine/Nevirapine/Zidovudine Tablet, Film-coated 150mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HP001 | Sofosbuvir Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Hepatitis B and C | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| ANDA 091611a USFDA | Atazanavir (sulfate) Capsules, hard 150mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Capsules, hard | Alternative Listing | |
| HP026 | Sofosbuvir/Velpatasvir Tablet, Film-coated 400mg/100mg | Finished Pharmaceutical Product | Hepatitis B and C | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA721 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Abridged | |
| HA414 | Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| TB304 | Cycloserine Capsules, hard 250mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Capsules, hard | Prequalification - Full | |
| RH031 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| HA686 | Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| RH038 | Ethinylestradiol/Levonorgestrel Tablet, Sugar coated + Ferrous (Fumarate) Tablet, Sugar coated 30mcg/150mcg + 75mg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet, Sugar coated + Tablet, Sugar coated | Prequalification - Full | |
| TB286 | Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| ANDA 090309 USFDA | Abacavir (sulfate)/Lamivudine/Zidovudine Tablet 300mg/150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Alternative Listing | |
| TB388 | Delamanid Tablet, Film-coated 50mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA403 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| NDA 214521 USFDA | Dolutegravir (sodium) Tablet, Dispersible 10mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Dispersible | Alternative Listing | |
| HA410 | Tenofovir disoproxil fumarate Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA688 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full |
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