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: 51 - 100 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-153 | Artemether | Standard | Malaria | Tianish Laboratories Private Limited | ||
WHOAPI-155 | Lumefantrine | Standard | Malaria | Tianish Laboratories Private Limited | ||
WHOAPI-158 | Pyrazinamide | Standard | Tuberculosis | Anuh Pharma Ltd | ||
WHOAPI-163 | Artemether | Standard | Malaria | Ipca Laboratories Ltd | ||
WHOAPI-167 | Zidovudine | Standard | HIV/AIDS | Zhejiang Langhua Pharmaceutical Co Ltd | ||
WHOAPI-168 | Isoniazid | Standard | Tuberculosis | Second Pharma Co Ltd | ||
WHOAPI-170a | Mifepristone | Standard | Reproductive health | Qinhuangdao Zizhu Pharmaceutical Co Ltd | ||
WHOAPI-170b | Mifepristone | Micronised | Reproductive health | Qinhuangdao Zizhu Pharmaceutical Co Ltd | ||
WHOAPI-171 | Ethinylestradiol | Standard | Reproductive health | Qinhuangdao Zizhu Pharmaceutical Co Ltd | ||
WHOAPI-172 | Levonorgestrel | Standard | Reproductive health | Qinhuangdao Zizhu Pharmaceutical Co Ltd | ||
WHOAPI-176 | Piperaquine phosphate | Standard | Malaria | Zhuhai Rundu Pharmaceutical Co Ltd | ||
WHOAPI-177 | Cycloserine | Standard | Tuberculosis | Solara Active Pharma Sciences Limited | ||
WHOAPI-181 | Artemether | Standard | Malaria | Guilin Pharmaceutical Co Ltd | ||
WHOAPI-191 | Ritonavir | Standard | HIV/AIDS | Shanghai Desano Chemical Pharmaceutical Co Ltd | ||
WHOAPI-193 | Abacavir (sulfate) | Standard | HIV/AIDS | Laurus Labs Limited | ||
WHOAPI-195a | Tenofovir disoproxil fumarate | Standard | HIV/AIDS | Laurus Labs Limited | ||
WHOAPI-195b | Tenofovir disoproxil fumarate | Compacted | HIV/AIDS | Laurus Labs Limited | ||
WHOAPI-197 | Ethambutol hydrochloride | Standard | Tuberculosis | Lupin Ltd. | ||
WHOAPI-202 | Emtricitabine | Standard | HIV/AIDS | Shanghai Desano Chemical Pharmaceutical Co Ltd | ||
WHOAPI-203 | Levofloxacin | Standard | Tuberculosis | Zhejiang Langhua Pharmaceutical Co Ltd | ||
WHOAPI-204 | Tenofovir disoproxil fumarate | Standard | HIV/AIDS | Mangalam Drugs & Organics Ltd | ||
WHOAPI-208a | Tenofovir disoproxil fumarate | Standard | HIV/AIDS | Shanghai Desano Chemical Pharmaceutical Co Ltd | ||
WHOAPI-208b | Tenofovir disoproxil fumarate | Standard | HIV/AIDS | Shanghai Desano Chemical Pharmaceutical Co Ltd | ||
WHOAPI-210 | Medroxyprogesterone acetate | Sterile-Micronized | Reproductive health | Farmabios S.p.A | ||
WHOAPI-211 | Oseltamivir (phosphate) | Standard | Influenza | Tianish Laboratories Private Limited | ||
WHOAPI-214 | Darunavir (ethanolate) | Standard | HIV/AIDS | Tianish Laboratories Private Limited | ||
WHOAPI-220 | Mebendazole | Standard | Neglected tropical diseases | Changzhou Yabang-QH Pharmachem Co Ltd | ||
WHOAPI-226 | Misoprostol Dispersion (1:100 in HPMC) | Standard | Reproductive health | Piramal Healthcare UK Ltd | ||
WHOAPI-227 | Piperaquine phosphate | Standard | Malaria | Ipca Laboratories Ltd | ||
WHOAPI-232 | Zinc (sulfate) | Standard | Diarrhoea | Dr Paul Lohmann GmbH & Co KGaA | ||
WHOAPI-233 | Dihydroartemisinin | Standard | Malaria | Ipca Laboratories Ltd | ||
WHOAPI-234 | Sulfadoxine | Standard | Malaria | Anuh Pharma Ltd | ||
WHOAPI-235 | Artemether | Standard | Malaria | Huvepharma Italia S.r.l | ||
WHOAPI-239a | Dihydroartemisinin | Standard | Malaria | KPC Chongqing Wuling Mountain Pharmaceutical Co., Ltd | ||
WHOAPI-239b | Dihydroartemisinin | Micronised | Malaria | KPC Chongqing Wuling Mountain Pharmaceutical Co., Ltd | ||
WHOAPI-240 | Artesunate (sterile) | Sterile | Malaria | Ipca Laboratories Ltd | ||
WHOAPI-243 | Praziquantel | Standard | Neglected tropical diseases | Solara Active Pharma Sciences Limited | ||
WHOAPI-245 | Levofloxacin | Standard | Tuberculosis | Shaoxing Jingxin Pharmaceutical Co Ltd | ||
WHOAPI-246 | Kanamycin (sulfate) - non sterile | Standard | Tuberculosis | Livzon Group Fuzhou Fuxing Pharmaceutical Co. Ltd | ||
WHOAPI-248 | Piperaquine phosphate | Standard | Malaria | Chongqing Kangle Pharmaceutical Co Ltd | ||
WHOAPI-261 | Praziquantel | Standard | Neglected tropical diseases | Minsheng Group Shaoxing Pharmaceutical Co Ltd | ||
WHOAPI-264 | Zidovudine | Standard | HIV/AIDS | Anhui Biochem Bio-Pharmaceutical Co Ltd | ||
WHOAPI-265 | Lamivudine | Standard | HIV/AIDS | Anhui Biochem Bio-Pharmaceutical Co Ltd | ||
WHOAPI-267 | Zidovudine | Standard | HIV/AIDS | Shanghai Shyndec Pharmaceutical (Haimen) Co Ltd | ||
WHOAPI-271 | Medroxyprogesterone acetate | Standard | Reproductive health | Jiangsu Grand Xianle Pharmaceutical Co Ltd | ||
WHOAPI-273 | Ethambutol hydrochloride | Standard | Tuberculosis | Micro Labs Limited | ||
WHOAPI-278 | Pyrimethamine | Standard | Malaria | Guilin Pharmaceutical Co Ltd | ||
WHOAPI-279 | Sulfadoxine | Standard | Malaria | Guilin Pharmaceutical Co Ltd | ||
WHOAPI-286 | Linezolid | Standard | Tuberculosis | Optimus Drugs Pvt Ltd | ||
WHOAPI-287 | Tenofovir disoproxil fumarate | Standard | HIV/AIDS | Shijiazhuang Lonzeal Pharmaceuticals Co Ltd |
Pagination
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