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: 151 - 177 of 177
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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-411 | Dexametasone | Standard | Covid-19 | Tianjin Tianyao Pharmaceuticals Co., Ltd | ||
WHOAPI-412 | Dexamethasone (sodium phosphate) | Standard | Covid-19 | Tianjin Tianyao Pharmaceuticals Co., Ltd | ||
WHOAPI-413 | Levofloxacin | Standard | Tuberculosis | Zhejiang East-Asia Pharmaceutical Co Ltd | ||
WHOAPI-418 | Isoniazid | Standard | Tuberculosis | Anuh Pharma Ltd | ||
WHOAPI-419 | Medroxyprogesterone acetate - Sterile | micronised | Reproductive health | Zhejiang Xianju Pharmaceutical Co., Ltd. | ||
WHOAPI-422 | Ethionamide | Standard | Tuberculosis | Micro Labs Limited | ||
WHOAPI-423 | Carbetocin | Standard | Reproductive health | Piramal Pharma Limited | ||
WHOAPI-424 | Protionamide | Standard | Tuberculosis | Micro Labs Limited | ||
WHOAPI-430 | Dolutegravir (sodium) | Standard | HIV/AIDS | Emcure Pharmaceuticals Limited | ||
WHOAPI-436 | Dolutegravir (sodium) | Standard | HIV/AIDS | Sun Pharmaceutical Industries Limited | ||
WHOAPI-438 | Molnupiravir | Standard | Covid-19 | Optimus Drugs Pvt Ltd | ||
WHOAPI-439 | Molnupiravir | Standard | Covid-19 | Emcure Pharmaceuticals Limited | ||
WHOAPI-442 | Bedaquiline fumarate | Standard | Tuberculosis | Lupin Manufacturing Solutions Limited | ||
WHOAPI-444 | Delamanid | Standard | Tuberculosis | Tianish Laboratories Private Limited | ||
WHOAPI-447 | Rifapentine | Standard | Tuberculosis | Lupin Ltd. | ||
WHOAPI-449 | Molnupiravir | Standard | Covid-19 | Shanghai Desano Chemical Pharmaceutical Co Ltd | ||
WHOAPI-451 | Molnupiravir | Standard | Covid-19 | Divi’s Laboratories Limited | ||
WHOAPI-457 | Molnupiravir | Standard | Covid-19 | Aurobindo Pharma Ltd | ||
WHOAPI-458 | Nirmatrelvir | Standard | Covid-19 | Zhejiang Jiuzhou Pharmaceutical Co, Ltd | ||
WHOAPI-464a | Nirmatrelvir | Standard | Covid-19 | Zhejiang Huahai Pharmaceutical Co. Ltd. | ||
WHOAPI-464b | Nirmatrelvir | Micronized | Covid-19 | Zhejiang Huahai Pharmaceutical Co. Ltd. | ||
WHOAPI-467 | Nirmatrelvir | Standard | Covid-19 | Zhejiang Apeloa Kangyu Pharmaceutical Co Ltd | ||
WHOAPI-469 | Nirmatrelvir | Standard | Covid-19 | Shanghai Desano Chemical Pharmaceutical Co Ltd | ||
WHOAPI-471 | Nirmatrelvir | Standard | Covid-19 | Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. | ||
WHOAPI-477 | Molnupiravir | standard | Covid-19 | Tianish Laboratories Private Limited | ||
WHOAPI-481a | Nirmatrelvir | Non-micronized | Covid-19 | Tianish Laboratories Private Limited | ||
WHOAPI-481b | Nirmatrelvir | Micronized | Covid-19 | Tianish Laboratories Private Limited |
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