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 Sort descending | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| RH057 | Levonorgestrel Tablet, Film-coated 0.03mg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA523 | Lamivudine Solution, Oral 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Solution, Oral | Prequalification - Full | |
| RH067 | Desogestrel/Ethinylestradiol Tablet, Film-coated 0.15mg/0.03mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet, Film-coated | Prequalification - Full | |
| EMA Art 58 H-W-002168 | Dapivirine Vaginal ring 25mg | Finished Pharmaceutical Product | HIV/AIDS | International Partnership for Microbicides Belgium (IPM Belgium) AISBL | Vaginal ring | Alternative Listing | |
| ANDA 078064c USFDA | Efavirenz Capsules, hard 100mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Capsules, hard | Alternative Listing | |
| HA526 | Zidovudine Solution, Oral 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Solution, Oral | Prequalification - Full | |
| RH037 | Desogestrel/Ethinylestradiol Tablet 0.150mg/0.030mg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Ltd | Tablet | Prequalification - Abridged | |
| TB068 | Isoniazid/Rifampicin Tablet, Film-coated 75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA645 | Dapsone Tablet 100mg | Finished Pharmaceutical Product | HIV/AIDS | Everest Life Sciences LLC | Tablet | Prequalification - Abridged | |
| NDA 21944 USFDA | Lamivudine/Zidovudine Tablet+Abacavir (sulfate) Tablet 150mg/300mg+300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet + Tablet | Alternative Listing | |
| MA108 | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Novartis Pharma AG | Tablet | Prequalification - Full | |
| HA537 | Zidovudine Tablet, Film-coated 60mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| TB154 | Cycloserine Capsules, hard 250mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| TB332 | Rifampicin Capsules, hard 300mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| HA747 | Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg | Finished Pharmaceutical Product | HIV/AIDS | Eumedica Pharmaceuticals AG | Tablet | Prequalification - Abridged | |
| ANDA 077950 USFDA | Abacavir (sulfate) Solution, Oral 20mg/ml | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Solution, Oral | Alternative Listing | |
| MA133 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Micro Labs Limited | Tablet | Prequalification - Full | |
| NT007 | Ivermectin Tablet 3mg | Finished Pharmaceutical Product | Neglected tropical diseases | Laboratorios Liconsa SA | Tablet | Prequalification - Full | |
| HA744 | Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg | Finished Pharmaceutical Product | HIV/AIDS | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| RH070 | Ethinylestradiol/Levonorgestrel Tablet, Film-coated 0.03mg/0.15mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet, Film-coated | Prequalification - Full | |
| IN015 | Oseltamivir (phosphate) Capsules, hard 45mg | Finished Pharmaceutical Product | Influenza | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| HA698 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Sun Pharmaceutical Industries Limited | Tablet, Film-coated | Prequalification - Full | |
| HA532 | Etravirine Tablet 100mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen Research & Development LLC | Tablet | Prequalification - Abridged | |
| TB070 | Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tablet, Film-coated 275mg/75mg/400mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB008 | Ethambutol hydrochloride Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Cadila Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB349 | Moxifloxacin (hydrochloride) Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| HA638 | Morphine hydrochloride Tablets, Prolonged release 60mg | Finished Pharmaceutical Product | HIV/AIDS | GL Pharma GmbH | Tablets, Prolonged release | Prequalification - Abridged | |
| HP032 | Entecavir Tablet, Film-coated 1 mg | Finished Pharmaceutical Product | Hepatitis B and C | BrightGene Bio-Medical Technology Co., Ltd | Tablet, Film-coated | 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 | |
| TB353 | Protionamide Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | LEKHIM Joint Stock Company | Tablet, Film-coated | Prequalification - Full | |
| EMEA/H/W/004252/001 | Arpraziquantel Tablet, Dispersible 150mg | Finished Pharmaceutical Product | Neglected tropical diseases | Merck Europe B.V. | Tablet, Dispersible | ||
| TB009 | Ethambutol hydrochloride/Isoniazid Tablet, Film-coated 400mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Cadila Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| ANDA 212579c USFDA | Atazanavir (sulfate) Capsules, hard 300mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Capsules, hard | Alternative Listing | |
| RH035 | Ethinylestradiol/Levonorgestrel Tablet, Sugar coated+Placebo Tablet, Film-coated 30µg/150µg+0mg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Ltd | Tablet, Film-coated + Tablet, Sugar coated | Prequalification - Full | |
| EMA Art 58 H-W-2319-3 | Artesunate/Pyronaridine (phosphate) Granules for Oral suspension 20mg/60mg | Finished Pharmaceutical Product | Malaria | Shin Poong Pharmaceutical Co Ltd | Granules for Oral suspension | Alternative Listing | |
| HA535 | Tenofovir disoproxil fumarate Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Science Limited | Tablet, Film-coated | Prequalification - Full | |
| TB133 | Ethionamide Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| ANDA 078850a USFDA | Lamivudine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Alternative Listing | |
| HA764 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Desano Pharmaceuticals Private Limited | Tablet, Film-coated | Prequalification - Full | |
| 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 | |
| RH075 | Medroxyprogesterone acetate Suspension for injection 104mg/0.65ml | Finished Pharmaceutical Product | Reproductive health | Pfizer Limited | Suspension for injection | Prequalification - Abridged | |
| TB335 | Pyrazinamide Tablet, Dispersible 150mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| HA337 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Merck Sharp & Dohme BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA525 | Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Sun Pharmaceutical Industries Limited | Tablet, Film-coated | Prequalification - Full | |
| RH036 | Etonogestrel Implant 68mg | Finished Pharmaceutical Product | Reproductive health | NV Organon | Implant | Prequalification - Abridged | |
| MA167 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Laboratorios Basi - Industria Farmaceutica SA | Tablet | Prequalification - Full | |
| HA536 | Lamivudine Tablet, Film-coated 30mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| TB134 | Ethambutol hydrochloride Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB347 | Isoniazid Tablet, Dispersible 50mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| HA678 | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Ltd | Tablet, Film-coated | Prequalification - Full |
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