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.
Displaying: 101 - 150 of 174
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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-289 | Atazanavir (sulfate) | Standard | HIV/AIDS | Shanghai Desano Chemical Pharmaceutical Co Ltd | ||
WHOAPI-290 | Sofosbuvir | Standard | Hepatitis B and C | Tianish Laboratories Private Limited | ||
WHOAPI-301 | Praziquantel | Standard | Neglected tropical diseases | Hisun Pharmaceutical (Nantong) Co Ltd | ||
WHOAPI-302 | Dolutegravir (sodium) | Standard | HIV/AIDS | Shanghai Desano Chemical Pharmaceutical Co Ltd | ||
WHOAPI-303 | Atazanavir (sulfate) | Standard | HIV/AIDS | Macleods Pharmaceuticals Ltd | ||
WHOAPI-307 | Para-aminosalicylate (sodium) | Standard | Tuberculosis | Liaoyuan Silver Eagle Pharmaceutical Co Ltd | ||
WHOAPI-309 | Praziquantel | Standard | Neglected tropical diseases | Shanghai Desano Chemical Pharmaceutical Co Ltd | ||
WHOAPI-311 | Sofosbuvir | Standard | Hepatitis B and C | Solara Active Pharma Sciences Limited | ||
WHOAPI-314 | Emtricitabine | Standard | HIV/AIDS | Mangalam Drugs & Organics Ltd | ||
WHOAPI-318a | Efavirenz | Standard | HIV/AIDS | Mangalam Drugs & Organics Ltd | ||
WHOAPI-318b | Efavirenz | micronized | HIV/AIDS | Mangalam Drugs & Organics Ltd | ||
WHOAPI-319 | Sofosbuvir | Standard | Hepatitis B and C | Laurus Labs Limited | ||
WHOAPI-324 | Clofazimine | Standard | Tuberculosis | Pen Tsao Chemical Industry Ltd | ||
WHOAPI-325 | Dolutegravir (sodium) | Standard | HIV/AIDS | Laurus Labs Limited | ||
WHOAPI-327 | Daclatasvir (dihydrochloride) | Standard | Hepatitis B and C | Tianish Laboratories Private Limited | ||
WHOAPI-329 | Dolutegravir (sodium) | Micronised | HIV/AIDS | Micro Labs Limited | ||
WHOAPI-331 | Clofazimine | Standard | Tuberculosis | Dong-A ST Co Ltd | ||
WHOAPI-332 | Linezolid | Standard | Tuberculosis | Symed Labs Ltd | ||
WHOAPI-335 | Daclatasvir (dihydrochloride) | Standard | Hepatitis B and C | Laurus Labs Limited | ||
WHOAPI-338a | Praziquantel | Standard | Neglected tropical diseases | Jiangsu Chengxin Pharmaceutical Co Ltd | ||
WHOAPI-338b | Praziquantel | Micronised | Neglected tropical diseases | Jiangsu Chengxin Pharmaceutical Co Ltd | ||
WHOAPI-341 | Praziquantel | Standard | Neglected tropical diseases | Alivira Animal Health Limited | ||
WHOAPI-346a | Lamivudine | Standard | HIV/AIDS | Laurus Labs Limited | ||
WHOAPI-346b | Lamivudine | Micronised | HIV/AIDS | Laurus Labs Limited | ||
WHOAPI-350 | Darunavir (ethanolate) | Standard | HIV/AIDS | Zhejiang Jiangbei Pharmaceutical Co Ltd | ||
WHOAPI-353 | Velpatasvir | Standard | Hepatitis B and C | Tianish Laboratories Private Limited | ||
WHOAPI-354 | Dolutegravir (sodium) | Standard | HIV/AIDS | Sun Pharmaceutical Industries Limited | ||
WHOAPI-355 | Artesunate | Standard | Malaria | Guilin Pharmaceutical Co Ltd | ||
WHOAPI-356 | Sulfadoxine | Standard | Malaria | Mangalam Drugs & Organics Ltd | ||
WHOAPI-357 | Darunavir | Standard | HIV/AIDS | Laurus Labs Limited | ||
WHOAPI-360 | Pyrimethamine | Standard | Malaria | Mangalam Drugs & Organics Ltd | ||
WHOAPI-361 | Oxytocin | Standard | Reproductive health | Piramal Pharma Limited | ||
WHOAPI-362 | Dolutegravir (sodium) | Standard | HIV/AIDS | Tianish Laboratories Private Limited | ||
WHOAPI-363 | Lopinavir | Standard | HIV/AIDS | Shanghai Desano Chemical Pharmaceutical Co Ltd | ||
WHOAPI-364a | Pyrimethamine | Standard | Malaria | Anuh Pharma Ltd | ||
WHOAPI-364b | Pyrimethamine | Micronised | Malaria | Anuh Pharma Ltd | ||
WHOAPI-375 | Rifapentine | Standard | Tuberculosis | Macleods Pharmaceuticals Ltd | ||
WHOAPI-377 | Abacavir (sulfate) | Standard | HIV/AIDS | Jiangsu Weiqida Pharmaceutical Co Ltd | ||
WHOAPI-378 | Darunavir (ethanolate) | Standard | HIV/AIDS | Porton Pharma Solutions Ltd | ||
WHOAPI-379 | Oseltamivir (phosphate) | Standard | Influenza | Laurus Labs Limited | ||
WHOAPI-386a | Dolutegravir (sodium) | Standard | HIV/AIDS | Mangalam Drugs & Organics Ltd | ||
WHOAPI-386b | Dolutegravir (sodium) | Micronised | HIV/AIDS | Mangalam Drugs & Organics Ltd | ||
WHOAPI-387 | Dolutegravir (sodium) | Standard | HIV/AIDS | Laurus Labs Limited | ||
WHOAPI-389 | Atazanavir (sulfate) | Standard | HIV/AIDS | Sun Pharmaceutical Industries Limited | ||
WHOAPI-392 | Efavirenz | Standard | HIV/AIDS | Arene Lifesciences | ||
WHOAPI-393 | Lopinavir | Standard | HIV/AIDS | Laurus Labs Limited | ||
WHOAPI-398 | Ritonavir | Standard | HIV/AIDS | Laurus Labs Limited | ||
WHOAPI-401 | Miltefosine | Standard | Neglected tropical diseases | Zydus Lifesciences Limited | ||
WHOAPI-405a | Pyronaridine (phosphate) | Standard | Malaria | Mangalam Drugs & Organics Ltd | ||
WHOAPI-405b | Pyronaridine (phosphate) | Micronised | Malaria | Mangalam Drugs & Organics Ltd |
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