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 Sort ascending | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| HA761 | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA760 | Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| TB389 | Linezolid Tablet, Dispersible 150mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| MA172 | Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 12.5mg/250mg + 75mg | Finished Pharmaceutical Product | Malaria | Universal Corporation Ltd | Tablet, Dispersible + Tablet, Dispersible | Prequalification - Full | |
| MA169 | Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 25mg/500mg + 150mg | Finished Pharmaceutical Product | Malaria | Universal Corporation Ltd | Tablet, Dispersible + Tablet, Dispersible | Prequalification - Full | |
| MA179 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 25mg/500mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA178 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 12.50mg/250mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible | Prequalification - Full | |
| DI010 | Zinc (sulfate) Syrup 10mg/5ml | Finished Pharmaceutical Product | Diarrhoea | PharmEvo (Pvt) Ltd. | Syrup | Prequalification - Full | |
| DI009 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | PharmEvo (Pvt) Ltd. | Tablet, Dispersible | 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 | |
| CV008 | Molnupiravir Capsules, hard 200 mg | Finished Pharmaceutical Product | Covid-19 | Hetero Labs Ltd | Capsules, hard | Prequalification - Full | |
| TB348 | Isoniazid Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | 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 | |
| HA644 | Lamivudine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA692 | Ceftriaxone (sodium) Powder for solution for injection 1g | Finished Pharmaceutical Product | HIV/AIDS | Roche Products Limited | Powder for solution for injection | Prequalification - Abridged | |
| MA137 | Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | 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 | |
| HA629 | Lamivudine/Nevirapine/Zidovudine Tablet, Film-coated 150mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| ANDA 090513 USFDA | Emtricitabine/Tenofovir disoproxil fumarate Tablet 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| TB323 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| MA089 | Artesunate Powder for solution for injection 30mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Powder for solution for injection | Prequalification - Full | |
| MA165 (Suspended) | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet | Prequalification - Full | |
| MA111 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Ajanta Pharma Ltd | Tablet | Prequalification - Full | |
| TB326 | Levofloxacin Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA082 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| HA479 | Ceftriaxone (sodium) Powder for solution for injection 1000mg | Finished Pharmaceutical Product | HIV/AIDS | Egyptian International Pharmaceutical Industries | Powder for solution for injection | Prequalification - Full | |
| TB297 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA620 | Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs 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 | |
| HP027 | Daclatasvir (dihydrochloride) Tablet, Film-coated 30mg | Finished Pharmaceutical Product | Hepatitis B and C | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| ANDA 077673 USFDA | Efavirenz Tablet 600mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| MA088 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Strides Pharma Global PTE Limited | Tablet | Prequalification - Full | |
| MA117 | Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 25mg/500mg + 153mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible + Tablet, Dispersible | Prequalification - Full | |
| HA746 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Desano Pharmaceuticals Private Limited | Tablet, Film-coated | Prequalification - Full | |
| HA567 | Nevirapine Tablet 20mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| TB350 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| ANDA 091144 USFDA | Abacavir (sulfate)/Lamivudine Tablet 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet | Alternative Listing | |
| MA144 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 12.5mg/250mg | Finished Pharmaceutical Product | Malaria | S Kant Healthcare Ltd | Tablet, Dispersible | Prequalification - Full | |
| HA607 | Ondansetron (hydrochloride) Solution for injection 8mg/4mL | Finished Pharmaceutical Product | HIV/AIDS | Demo SA | Solution for injection | Prequalification - Abridged | |
| HA759 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| RH048 | Misoprostol Tablet 200mcg | Finished Pharmaceutical Product | Reproductive health | China Resources Zizhu Pharmaceutical Co Ltd | Tablet | Prequalification - Full | |
| HA568 | Nevirapine Tablet 50mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| HA414 | Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA691 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Milan Laboratories (India) Pvt Ltd | Tablet | Prequalification - Full | |
| ANDA 078128 USFDA | Zidovudine Capsules, hard 100mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Capsules, hard | Alternative Listing | |
| MA081 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| IN002 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Strides Pharma Science Limited | Capsules, hard | Prequalification - Full | |
| ANDA 210963 USFDA | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Alternative Listing | |
| HA480 | Ceftriaxone (sodium) Powder for solution for injection 500mg | Finished Pharmaceutical Product | HIV/AIDS | Egyptian International Pharmaceutical Industries | Powder for solution for injection | Prequalification - Full |
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