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 |
|---|---|---|---|---|---|---|---|
| TB362 | Clofazimine Tablet, Film-coated 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB278 | Levofloxacin Tablet, Film-coated 500mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA688 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA286 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Sun Pharmaceutical Industries Limited | Tablet, Film-coated | Prequalification - Full | |
| TB382 | Pyridoxine hydrochloride Tablet 10mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| HA500 | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| MA100 | Artemether/Lumefantrine Tablet 40mg/240mg | Finished Pharmaceutical Product | Malaria | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| RH013 | Ethinylestradiol/Levonorgestrel Tablet, coated 30mcg/150mcg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet, coated | Prequalification - Full | |
| MA064 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| TB238 | Levofloxacin Tablet, Film-coated 500mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| TB327 | Kanamycin (sulfate) Solution for injection 500mg/2ml | Finished Pharmaceutical Product | Tuberculosis | Livzon (Group) Pharmaceutical Factory | Solution for injection | Prequalification - Full | |
| MA116 | Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 12.5mg/250mg + 76.5mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible + Tablet, Dispersible | Prequalification - Full | |
| HA687 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| MA051 | Artesunate Powder for solution for injection 60mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Powder for solution for injection | Prequalification - Full | |
| HP028 | Daclatasvir (dihydrochloride) Tablet, Film-coated 60mg | Finished Pharmaceutical Product | Hepatitis B and C | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| RH039 | Misoprostol Tablet 200mcg | Finished Pharmaceutical Product | Reproductive health | Cipla Ltd | Tablet | Prequalification - Full | |
| MA079 | Artesunate/Mefloquine (hydrochloride) Tablet, Film-coated 100mg/200mg | Finished Pharmaceutical Product | Malaria | Drugs for Neglected Diseases Initiative (DNDi) | Tablet, Film-coated | Prequalification - Full | |
| RH068 | Levonorgestrel Tablet 0.75mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet | Prequalification - Full | |
| HA668 | Lamivudine Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Beximco Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB239 | Protionamide Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA694 | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Shanghai Desano Bio-Pharmaceutical Co., Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HP012 | Daclatasvir (dihydrochloride) Tablet, Film-coated 60mg | Finished Pharmaceutical Product | Hepatitis B and C | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| MA140 | Dihydroartemisinin/Piperaquine phosphate Tablet, Film-coated 80mg/640mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB319 | Amikacin (sulfate) Solution for injection 500mg | Finished Pharmaceutical Product | Tuberculosis | Qilu Pharmaceutical Co.,Ltd | Solution for injection | Prequalification - Full | |
| HA595 | Ondansetron (hydrochloride) Tablet, Film-coated 4mg | Finished Pharmaceutical Product | HIV/AIDS | Cadila Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA681 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Government Pharmaceutical Organization (GPO) | Tablet, Film-coated | Prequalification - Full | |
| RH056 | Misoprostol Tablet 200mcg | Finished Pharmaceutical Product | Reproductive health | Acme Formulation Pvt. Limited | Tablet | Prequalification - Full | |
| RH050 | Oxytocin Solution for injection 10IU/mL | Finished Pharmaceutical Product | Reproductive health | PT Sanbe Farma | Solution for injection | Prequalification - Full | |
| MA057 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Sanofi | Tablet | Prequalification - Full | |
| NT006 | Mebendazole Tablets, Chewable 500mg | Finished Pharmaceutical Product | Neglected tropical diseases | Janssen-Cilag International NV | Tablets, Chewable | Prequalification - Full | |
| MA058 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Sanofi | Tablet | Prequalification - Full | |
| HA466 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| TB242 | Ethionamide Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| TB236 | Cycloserine Capsules, hard 250mg | Finished Pharmaceutical Product | Tuberculosis | Dong-A ST Co Ltd | Capsules, hard | Prequalification - Full | |
| MA170 | Pyrimethamine/Sulfadoxine Tablet, Dispersible+Amodiaquine (hydrochloride) Tablet, Dispersible 12.50mg/250mg+76.5mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet, Dispersible + Tablet, Dispersible | Prequalification - Full | |
| RH084 | Medroxyprogesterone acetate Suspension for injection 150mg/ml | Finished Pharmaceutical Product | Reproductive health | Incepta Pharmaceuticals Ltd. | Suspension for injection | Prequalification - Full | |
| HA596 | Ondansetron (hydrochloride) Tablet, Film-coated 8mg | Finished Pharmaceutical Product | HIV/AIDS | Cadila Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| MA062 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| HA755 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA599 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| MA056 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Sanofi | Tablet | Prequalification - Full | |
| TB237 | Levofloxacin Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA467 | Ritonavir Tablet, Film-coated 100mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| TB243 | Pyrazinamide Tablet 500mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| MA131 | Dihydroartemisinin/Piperaquine phosphate Tablet, Film-coated 40mg/320mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Film-coated | Prequalification - Full | |
| MA078 | Artesunate/Mefloquine (hydrochloride) Tablet, Film-coated 25mg/50mg | Finished Pharmaceutical Product | Malaria | Drugs for Neglected Diseases Initiative (DNDi) | Tablet, Film-coated | Prequalification - Full | |
| MA102 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| TB307 | Pyrazinamide Tablet, Dispersible 150mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA129 | Artemether/Lumefantrine Tablet 60mg/360mg | Finished Pharmaceutical Product | Malaria | Ajanta Pharma Ltd | Tablet | Prequalification - Full | |
| TB189 | Isoniazid/Rifampicin Tablet, Film-coated 75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Svizera Europe BV | Tablet, Film-coated | Prequalification - Full |
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