Prequalified Active Pharmaceutical Ingredients
This list contains sources of active pharmaceutical ingredients (APIs) that have been assessed by WHO and found to be acceptable, in principle, for use in manufacture of finished pharmaceutical products to be procured by UN agencies.
Prequalification of APIs generally involves evaluation of data relating to their quality, as well as inspection of the relevant manufacturing site(s).
The APIs listed are those for which the submitted data and information were found to meet — at the time of assessment — WHO norms and standards, and for which the relevant manufacturing sites were found to comply — at the time of inspection — with Good Manufacturing Practices.
Some of the APIs listed have been listed on the basis of assessment and inspection carried out by stringent regulatory authorities who are willing to share information with WHO.
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WHO Product ID Sort descending | INN | Grade | Therapeutic area | Applicant | Date of prequalification | Confirmation of Prequalification Document Date |
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WHOAPI-005a | Isoniazid | Standard | Tuberculosis | Amsal Chem Pvt Ltd | ||
WHOAPI-005b | Isoniazid | Standard | Tuberculosis | Amsal Chem Pvt Ltd | ||
WHOAPI-010 | Abacavir (sulfate) | Standard | HIV/AIDS | Mylan Laboratories Ltd | ||
WHOAPI-028 | Rifampicin | Standard | Tuberculosis | Lupin Ltd | ||
WHOAPI-030 | Amodiaquine (hydrochloride) | Standard | Malaria | Ipca Laboratories Ltd | ||
WHOAPI-035 | Lumefantrine | Standard | Malaria | Shanghai Desano Chemical Pharmaceutical Co Ltd | ||
WHOAPI-038 | Tenofovir disoproxil fumarate | Standard | HIV/AIDS | Mylan Laboratories Ltd | ||
WHOAPI-039 | Emtricitabine | Standard | HIV/AIDS | Mylan Laboratories Ltd | ||
WHOAPI-040 | Pyrazinamide | Standard | Tuberculosis | Lupin Ltd | ||
WHOAPI-042 | Lumefantrine | Standard | Malaria | Ipca Laboratories Ltd | ||
WHOAPI-046 | Lamivudine | Standard | HIV/AIDS | Shanghai Desano Chemical Pharmaceutical Co Ltd | ||
WHOAPI-047 | Nevirapine | Standard | HIV/AIDS | Shanghai Desano Chemical Pharmaceutical Co Ltd | ||
WHOAPI-049a | Zidovudine | Standard | HIV/AIDS | Shanghai Desano Chemical Pharmaceutical Co Ltd | ||
WHOAPI-049b | Zidovudine | Standard | HIV/AIDS | Shanghai Desano Chemical Pharmaceutical Co Ltd | ||
WHOAPI-050 | Lopinavir | Standard | HIV/AIDS | Mylan Laboratories Ltd | ||
WHOAPI-065 | Ritonavir | Standard | HIV/AIDS | Mylan Laboratories Ltd | ||
WHOAPI-069 | Lamivudine | Standard | HIV/AIDS | Mylan Laboratories Ltd | ||
WHOAPI-071 | Efavirenz | Standard | HIV/AIDS | Mylan Laboratories Ltd | ||
WHOAPI-072 | Zidovudine | Standard | HIV/AIDS | Mylan Laboratories Ltd | ||
WHOAPI-078 | Pyrazinamide | Standard | Tuberculosis | Calyx Chemicals & Pharmaceuticals Ltd | ||
WHOAPI-080 | Artemether | Standard | Malaria | Shanghai Desano Chemical Pharmaceutical Co Ltd | ||
WHOAPI-081 | Artesunate | Standard | Malaria | Ipca Laboratories Ltd | ||
WHOAPI-083 | Rifampicin | Standard | Tuberculosis | Shenyang Antibiotic Manufacturer | ||
WHOAPI-084 | Artesunate | Standard | Malaria | Huvepharma Italia S.r.l | ||
WHOAPI-086 | Isoniazid | Standard | Tuberculosis | Calyx Chemicals & Pharmaceuticals Ltd | ||
WHOAPI-090 | Efavirenz | Standard | HIV/AIDS | Laurus Labs Limited | ||
WHOAPI-093 | Ethambutol hydrochloride | Standard | Tuberculosis | Lupin Ltd | ||
WHOAPI-097a | Artesunate | Standard | Malaria | Solara Active Pharma Sciences Limited | ||
WHOAPI-097b | Artesunate | Micronised | Malaria | Solara Active Pharma Sciences Limited | ||
WHOAPI-100 | Lumefantrine | Standard | Malaria | Mangalam Drugs & Organics Ltd | ||
WHOAPI-105 | Ethionamide | Standard | Tuberculosis | Pen Tsao Chemical Industry Ltd | ||
WHOAPI-106 | Protionamide | Standard | Tuberculosis | Pen Tsao Chemical Industry Ltd | ||
WHOAPI-108 | Efavirenz | Standard | HIV/AIDS | Shanghai Desano Chemical Pharmaceutical Co Ltd | ||
WHOAPI-112 | Lamivudine | Standard | HIV/AIDS | Shijiazhuang Lonzeal Pharmaceuticals Co Ltd | ||
WHOAPI-113a | Rifampicin | Non-compacted | Tuberculosis | Olon S.p.A. | ||
WHOAPI-113b | Rifampicin | Compacted | Tuberculosis | Olon S.p.A. | ||
WHOAPI-118 | Cycloserine | Standard | Tuberculosis | Dong-A ST Co Ltd | ||
WHOAPI-120a | Artemether | Standard | Malaria | Calyx Chemicals & Pharmaceuticals Ltd | ||
WHOAPI-120b | Artemether | Standard (<25°C) | Malaria | Calyx Chemicals & Pharmaceuticals Ltd | ||
WHOAPI-121 | Lumefantrine | Standard | Malaria | Calyx Chemicals & Pharmaceuticals Ltd | ||
WHOAPI-125 | Artemether | Standard | Malaria | KPC Pharmaceuticals Inc | ||
WHOAPI-134 | Amodiaquine (hydrochloride) | Standard | Malaria | Mangalam Drugs & Organics Ltd | ||
WHOAPI-135 | Artesunate | Standard | Malaria | Mangalam Drugs & Organics Ltd | ||
WHOAPI-137 | Lumefantrine | Standard | Malaria | Solara Active Pharma Sciences Ltd | ||
WHOAPI-138 | Artemether | Standard | Malaria | Mangalam Drugs & Organics Ltd | ||
WHOAPI-139 | Emtricitabine | Standard | HIV/AIDS | Laurus Labs Limited | ||
WHOAPI-146 | Zinc (sulfate) | Standard | Diarrhoea | Canton Laboratories Pvt Ltd | ||
WHOAPI-149a | Piperaquine phosphate | Standard | Malaria | Mangalam Drugs & Organics Ltd | ||
WHOAPI-149b | Piperaquine phosphate | Micronised | Malaria | Mangalam Drugs & Organics Ltd | ||
WHOAPI-151 | Dihydroartemisinin | Standard | Malaria | Mangalam Drugs & Organics Ltd |
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