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.
Displaying: 351 - 400 of 667
Download list as CSV file
| WHO Reference Number | INN, Dosage Form and Strength Sort ascending | Product Type | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| TB179 | Isoniazid Tablet 300mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB285 | Isoniazid Tablet 300mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| TB308 | Isoniazid Tablet 100mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| TB265 | Isoniazid Tablet 100mg | Finished Pharmaceutical Product | Tuberculosis | Antibiotice SA | Tablet | Prequalification - Abridged | |
| TB196 | Isoniazid Tablet 100mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet | Prequalification - Full | |
| TB178 | Isoniazid Tablet 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB173 | Isoniazid Tablet 100mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet | Prequalification - Full | |
| BT-DM003 | Insulin Human Suspension for injection 100IU/ml | Biotherapeutic Product | Diabetes | Novo Nordisk AS | Suspension for injection | Prequalification - Abridged | |
| BT-DM004 | Insulin Human Suspension for injection 100IU/ml | Biotherapeutic Product | Diabetes | Novo Nordisk AS | Suspension for injection | Prequalification - Abridged | |
| BT-DM001 | Insulin Human Solution for injection 100IU/ml | Biotherapeutic Product | Diabetes | Novo Nordisk AS | Solution for injection | Prequalification - Abridged | |
| BT-DM002 | Insulin Human Solution for injection 100IU/ml | Biotherapeutic Product | Diabetes | Novo Nordisk AS | Solution for injection | 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 | |
| HA515 | Ganciclovir (sodium) Powder for solution for injection 500mg | Finished Pharmaceutical Product | HIV/AIDS | Hainan Poly Pharma Co Ltd | Powder for solution for injection | Prequalification - Full | |
| HA693 | Flucytosine Tablet 500mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Prequalification - Abridged | |
| HA769 | Flucytosine Tablet 500mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| HA754 | Flucytosine Tablet 500mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| HA753 | Flucytosine Tablet 250mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| EMA Art 58 H-W-002320 | Fexinidazole Tablet 600mg | Finished Pharmaceutical Product | Neglected tropical diseases | Sanofi-aventis groupe | Tablet | Alternative Listing | |
| HA600 | Etravirine Tablet 25mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen-Cilag International NV | Tablet | Prequalification - Abridged | |
| HA532 | Etravirine Tablet 100mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen Research & Development LLC | Tablet | Prequalification - Abridged | |
| RH036 | Etonogestrel Implant 68mg | Finished Pharmaceutical Product | Reproductive health | NV Organon | Implant | Prequalification - Abridged | |
| TB242 | Ethionamide Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| TB133 | Ethionamide Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB352 | Ethionamide Tablet, Dispersible 125mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| TB333 | Ethionamide Tablet, Dispersible 125mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| RH035 | Ethinylestradiol/Levonorgestrel Tablet, Sugar coated+Placebo Tablet, Film-coated 30µg/150µg+0mg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet, Film-coated + Tablet, Sugar coated | Prequalification - Full | |
| RH082 | Ethinylestradiol/Levonorgestrel Tablet, Sugar coated + Placebo Tablet, Sugar coated 30mcg/150mcg + 0mcg | Finished Pharmaceutical Product | Reproductive health | Jenapharm GmbH & Co. KG | Tablet, Sugar coated + Tablet, Sugar coated | Prequalification - Abridged | |
| RH093 | Ethinylestradiol/Levonorgestrel Tablet, Sugar coated + Placebo Tablet, Film-coated 30mcg/150mcg + 0mg | Finished Pharmaceutical Product | Reproductive health | Renata Ltd | Tablet, Sugar coated + Tablet, Film-coated | Prequalification - Full | |
| RH038 | Ethinylestradiol/Levonorgestrel Tablet, Sugar coated + Ferrous (Fumarate) Tablet, Sugar coated 30mcg/150mcg + 75mg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet, Sugar coated + Tablet, Sugar coated | Prequalification - Full | |
| RH042 | Ethinylestradiol/Levonorgestrel Tablet, Film-coated+Placebo Tablet 0.03mg/0.15mg+0mg | Finished Pharmaceutical Product | Reproductive health | Lupin Ltd. | Tablet + Tablet, Film-coated | Prequalification - Abridged | |
| RH096 | Ethinylestradiol/Levonorgestrel Tablet, Film-coated 30mcg/150mcg | Finished Pharmaceutical Product | Reproductive health | HLL Lifecare Limited | Tablet, Film-coated | 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 | |
| RH071 | Ethinylestradiol/Levonorgestrel Tablet, Film-coated + Placebo Tablet, Film-coated 0.03mg/0.15mg + 0mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| RH013 | Ethinylestradiol/Levonorgestrel Tablet, coated 30mcg/150mcg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet, coated | Prequalification - Full | |
| RH041 | Ethinylestradiol/Levonorgestrel Tablet + Placebo Tablet 0.03mg/0.15mg + 0mg | Finished Pharmaceutical Product | Reproductive health | Lupin Ltd. | Tablet + Tablet | Prequalification - Abridged | |
| TB199 | Ethambutol hydrochloride/Isoniazid/Rifampicin Tablet, Film-coated 275mg/75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| TB192 | Ethambutol hydrochloride/Isoniazid/Rifampicin Tablet, Film-coated 275mg/75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Svizera Europe BV | Tablet, Film-coated | Prequalification - Full | |
| TB183 | Ethambutol hydrochloride/Isoniazid/Rifampicin Tablet, Film-coated 275mg/75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| 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 | |
| TB070 | Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tablet, Film-coated 275mg/75mg/400mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| TB168 | Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tablet, Film-coated 275mg/75mg/400mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB193 | Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tablet, Film-coated 275mg/75mg/400mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Svizera Europe BV | Tablet, Film-coated | Prequalification - Full | |
| TB223 | Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tablet, Film-coated 275mg/75mg/400mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| TB009 | Ethambutol hydrochloride/Isoniazid Tablet, Film-coated 400mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Cadila Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB177 | Ethambutol hydrochloride Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| TB264 | Ethambutol hydrochloride Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Antibiotice SA | Tablet, Film-coated | Prequalification - Abridged | |
| TB134 | Ethambutol hydrochloride Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals 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 | |
| TB226 | Ethambutol hydrochloride Tablet, Film-coated 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full |
.