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 | Therapeutic Area | Applicant | Dosage Form | Basis of Listing Sort descending | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| HA645 | Dapsone Tablet 100mg | Finished Pharmaceutical Product | HIV/AIDS | Everest Life Sciences LLC | Tablet | Prequalification - Abridged | |
| TB090 | Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tablet, Film-coated 275mg/75mg/400mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Sandoz Pvt Ltd | Tablet, Film-coated | Prequalification - Abridged | |
| BT-ON001 | Trastuzumab Powder for concentrate for solution for infusion 150 mg | Biotherapeutic Product | Oncology | Samsung Bioepis NL B.V. | Powder for concentrate for solution for infusion | Prequalification - Abridged | |
| BT-EB001 | Atoltivimab/Maftivimab/Odesivimab Solution for Infusion 16.67 mg/mL/16.67 mg/mL/16.67 mg/mL | Biotherapeutic Product | Ebola | Regeneron Pharmaceuticals Inc. | Solution for Infusion | Prequalification - Abridged | |
| TB085 | Isoniazid/Rifampicin Tablet, coated 75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Sandoz Pvt Ltd | Tablet, coated | Prequalification - Abridged | |
| BT-ON009 | Trastuzumab Powder for concentrate for solution for infusion 150mg | Biotherapeutic Product | Oncology | Roche Products Limited | Powder for concentrate for solution for infusion | Prequalification - Abridged | |
| HA530 | Darunavir (ethanolate) Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen Research & Development LLC | Tablet, Film-coated | Prequalification - Abridged | |
| BT-ON003 | Trastuzumab Powder for concentrate for solution for infusion 420mg | Biotherapeutic Product | Oncology | Celltrion Inc. | Powder for concentrate for solution for infusion | Prequalification - Abridged | |
| RH037 | Desogestrel/Ethinylestradiol Tablet 0.150mg/0.030mg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet | Prequalification - Abridged | |
| RH036 | Etonogestrel Implant 68mg | Finished Pharmaceutical Product | Reproductive health | NV Organon | Implant | Prequalification - Abridged | |
| BT-ON008 | Trastuzumab Powder for concentrate for solution for infusion 150mg | Biotherapeutic Product | Oncology | Biosimilar Collaborations Ireland Limited | Powder for concentrate for solution for infusion | Prequalification - Abridged | |
| HA532 | Etravirine Tablet 100mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen Research & Development LLC | Tablet | Prequalification - Abridged | |
| HA337 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Merck Sharp & Dohme BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA791 | Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Dispersible 60mg/5mg/30mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Dispersible | Prequalification - Abridged | |
| MR001 | Cefiderocol Powder for concentrate for solution for infusion 1g/vial | Finished Pharmaceutical Product | Multi-drug resistant bacterial infections | Shionogi B.V. | Powder for concentrate for solution for infusion | Prequalification - Abridged | |
| RH075 | Medroxyprogesterone acetate Suspension for injection 104mg/0.65ml | Finished Pharmaceutical Product | Reproductive health | Pfizer Limited | Suspension for injection | Prequalification - Abridged | |
| HA638 | Morphine hydrochloride Tablets, Prolonged release 60mg | Finished Pharmaceutical Product | HIV/AIDS | GL Pharma GmbH | Tablets, Prolonged release | Prequalification - Abridged | |
| BT-EB002 | Atoltivimab/Maftivimab/Odesivimab Solution for infusion 33.33mg/mL/33.33mg/mL/33.33mg/mL | Biotherapeutic Product | Ebola Virus Disease | Regeneron Pharmaceuticals Inc. | Solution for infusion | Prequalification - Abridged | |
| HA788 | Cabotegravir (sodium) Tablet, Film-coated 30mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare Pty Ltd | Tablet, Film-coated | Prequalification - Abridged | |
| TD001 | Nicotine resinate (polacrilex) 20% Medicated chewing gum 2mg | Finished Pharmaceutical Product | Disorders caused by tobacco use | McNeil Sweden AB | Medicated chewing gum | Prequalification - Abridged | |
| RH051 | Mifepristone Tablet 200mg | Finished Pharmaceutical Product | Reproductive health | Linepharma International Ltd | Tablet | Prequalification - Abridged | |
| NT019 | Azithromycin Tablet, Film-coated 500mg | Finished Pharmaceutical Product | Neglected tropical diseases | ACI HealthCare Limited | Tablet, Film-coated | Prequalification - Abridged | |
| HA789 | Cabotegravir Suspension for injection 600mg/3mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare Pty Ltd | Suspension for injection | Prequalification - Abridged | |
| BT-CV003 | Tocilizumab Concentrate for solution for infusion 20mg/ml (Each vial contains 400 mg of tocilizumab in 20 mL) | Biotherapeutic Product | Covid-19 | Roche Registration GmbH | Concentrate for solution for infusion | Prequalification - Abridged | |
| TD003 | Nicotine Patch 10mg/16 hours | Finished Pharmaceutical Product | Disorders caused by tobacco use | McNeil Sweden AB | Patch | Prequalification - Abridged | |
| TB345 | Protionamide Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Esteve Pharmaceuticals GmbH | Tablet, Film-coated | Prequalification - Abridged | |
| RH105 | Misoprostol Tablet, vaginal 200µg | Finished Pharmaceutical Product | Reproductive health | BIAL-Portela & Ca. SA | Tablet, vaginal | Prequalification - Abridged | |
| BT-DM006 | Insulin Glargine Solution for injection 100 U/mL | Biotherapeutic Product | Diabetes | Sanofi-Aventis Deutschland GmbH | Solution for injection | Prequalification - Abridged | |
| BT-DM005 | Insulin Glargine Solution for injection 100 U/mL | Biotherapeutic Product | Diabetes | Sanofi-Aventis Deutschland GmbH | Solution for injection | Prequalification - Abridged | |
| TD002 | Nicotine resinate (polacrilex) 20% Medicated chewing gum 4mg | Finished Pharmaceutical Product | Disorders caused by tobacco use | McNeil Sweden AB | Medicated chewing gum | Prequalification - Abridged | |
| HA747 | Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg | Finished Pharmaceutical Product | HIV/AIDS | Eumedica Pharmaceuticals AG | Tablet | Prequalification - Abridged | |
| RH022 | Norethisterone enantate Solution for injection 200mg/ml | Finished Pharmaceutical Product | Reproductive health | Bayer plc | Solution for injection | Prequalification - Abridged | |
| CV007 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg | Finished Pharmaceutical Product | Covid-19 | Pfizer Limited | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Abridged | |
| BT-CV001 | Tocilizumab Concentrate for solution for infusion 20mg/ml (Each vial contains 80 mg of tocilizumab in 4 mL) | Biotherapeutic Product | Covid-19 | Roche Registration GmbH | Concentrate for solution for infusion | Prequalification - Abridged | |
| BT-CV002 | Tocilizumab Concentrate for solution for infusion 20mg/ml (Each vial contains 200 mg of tocilizumab in 10 mL) | Biotherapeutic Product | Covid-19 | Roche Registration GmbH | Concentrate for solution for infusion | Prequalification - Abridged | |
| TD004 | Nicotine Patch 15mg/16 hours | Finished Pharmaceutical Product | Disorders caused by tobacco use | McNeil Sweden AB | Patch | Prequalification - Abridged | |
| HA529 | Darunavir (ethanolate) Tablet, Film-coated 75mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen Research & Development LLC | Tablet, Film-coated | Prequalification - Abridged | |
| HP031 | Entecavir Tablet, Film-coated 0.5 mg | Finished Pharmaceutical Product | Hepatitis B and C | BrightGene Bio-Medical Technology Co., Ltd | Tablet, Film-coated | Prequalification - Abridged | |
| RH099 | Misoprostol Tablet, vaginal 25μg | Finished Pharmaceutical Product | Reproductive health | BIAL-Portela & Ca. SA | Tablet, vaginal | Prequalification - Abridged | |
| RH021 | Lynestrenol Tablet 500mcg | Finished Pharmaceutical Product | Reproductive health | NV Organon | Tablet | Prequalification - Abridged | |
| TD005 | Nicotine Patch 25mg/16 hours | Finished Pharmaceutical Product | Disorders caused by tobacco use | McNeil Sweden AB | Patch | Prequalification - Abridged | |
| HA737 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| MA164 (Suspended) | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet | Prequalification - Full | |
| NT017 | Miltefosine Capsules, hard 50mg | Finished Pharmaceutical Product | Neglected tropical diseases | Zydus Lifesciences Limited | Capsules, hard | Prequalification - Full | |
| HA483 | Zidovudine Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| TB342 | Moxifloxacin (hydrochloride) Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA103 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| MA139 | Dihydroartemisinin/Piperaquine phosphate Tablet, Dispersible 40mg/320mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible | Prequalification - Full | |
| HA410 | Tenofovir disoproxil fumarate Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA200 | Nevirapine Suspension, Oral 50mg/5mL | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Suspension, Oral | Prequalification - Full |
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