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 | Date of Prequalification Sort descending |
|---|---|---|---|---|---|---|---|
| TB348 | Isoniazid Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| TB365 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| RH086 | Magnesium sulphate Solution for injection 500mg/ml (10ml) | Finished Pharmaceutical Product | Reproductive health | Joint-Stock Company Halychpharm | Solution for injection | Prequalification - Full | |
| TB347 | Isoniazid Tablet, Dispersible 50mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| HA732 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | 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 | |
| HA726 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Ltd | 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 | |
| HA713 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| BT-ON004 | Rituximab Concentrate for solution for infusion 100mg/10mL | Biotherapeutic Product | Oncology | Celltrion Inc. | Concentrate for solution for infusion | Prequalification - Abridged | |
| BT-ON005 | Rituximab Concentrate for solution for infusion 500mg/50mL | Biotherapeutic Product | Oncology | Celltrion Inc. | Concentrate for solution for infusion | Prequalification - Abridged | |
| DI011 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | Ipca Laboratories Ltd | Tablet, Dispersible | Prequalification - Full | |
| 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 | |
| HA709 | Darunavir Tablet, Film-coated 400mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA711 | Darunavir Tablet, Film-coated 800mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA727 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA710 | Darunavir Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA729 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Science Limited | Tablet, Film-coated | Prequalification - Full | |
| IN020 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | MSN Laboratories Private Limited | Capsules, hard | Prequalification - Full | |
| IN018 | Oseltamivir (phosphate) Capsules, hard 30mg | Finished Pharmaceutical Product | Influenza | MSN Laboratories Private Limited | Capsules, hard | Prequalification - Full | |
| IN019 | Oseltamivir (phosphate) Capsules, hard 45mg | Finished Pharmaceutical Product | Influenza | MSN Laboratories Private Limited | Capsules, hard | Prequalification - Full | |
| BT-ON002 | Trastuzumab Powder for concentrate for solution for infusion 150mg | Biotherapeutic Product | Oncology | Celltrion Inc. | Powder for concentrate for solution for infusion | 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 | |
| RH054 | Estradiol valerate/Norethisterone enantate Solution for injection 5mg/50mg/mL | Finished Pharmaceutical Product | Reproductive health | Bayer AG | Solution for injection | Prequalification - Full | |
| 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 | |
| BT-ON012 | Rituximab Concentrate for solution for infusion 500mg/50mL | Biotherapeutic Product | Oncology | Roche Products Limited | Concentrate for solution for infusion | Prequalification - Abridged | |
| BT-ON010 | Water for Injection Solvent for parenteral use + Trastuzumab Powder for concentrate for solution for infusion 1.1% benzyl alcohol + 440mg | Biotherapeutic Product | Oncology | Roche Products Limited | Solvent for parenteral use + Powder for concentrate for solution for infusion | Prequalification - Abridged | |
| BT-ON011 | Rituximab Concentrate for solution for infusion 100mg/10ml | Biotherapeutic Product | Oncology | Roche Products Limited | Concentrate for solution for infusion | Prequalification - Abridged | |
| HA708 | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Sun Pharmaceutical Industries Limited | Tablet, Film-coated | Prequalification - Full | |
| RH087 | Estradiol valerate/Norethisterone enantate Solution for injection 5mg/ml/50mg/ml | Finished Pharmaceutical Product | Reproductive health | Bayer S.A. | Solution for injection | Prequalification - Full | |
| TB361 | Clofazimine Tablet, Film-coated 50mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| NT009 | Ivermectin Tablet 3mg | Finished Pharmaceutical Product | Neglected tropical diseases | Edenbridge Pharmaceuticals LLC | Tablet | Prequalification - Abridged | |
| TB362 | Clofazimine Tablet, Film-coated 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| MA151 | Dihydroartemisinin/Piperaquine phosphate Tablet, Film-coated 60mg/480mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Film-coated | Prequalification - Full | |
| BT-ON007 | Rituximab Concentrate for solution for infusion 500mg/50mL | Biotherapeutic Product | Oncology | Sandoz GmbH | Concentrate for solution for infusion | Prequalification - Abridged | |
| BT-ON006 | Rituximab Concentrate for solution for infusion 100mg/10mL | Biotherapeutic Product | Oncology | Sandoz GmbH | Concentrate for solution for infusion | Prequalification - Abridged | |
| HP025 | Daclatasvir (dihydrochloride)/Sofosbuvir Tablet, Film-coated 60mg/400mg | Finished Pharmaceutical Product | Hepatitis B and C | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| RH066 | Desogestrel/Ethinylestradiol Tablet, Film-coated + Placebo Tablet, Film-coated 0.15mg/0.03mg + 0mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| HP026 | Sofosbuvir/Velpatasvir Tablet, Film-coated 400mg/100mg | Finished Pharmaceutical Product | Hepatitis B and C | Mylan Laboratories Limited | Tablet, Film-coated | 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 | |
| HA694 | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Shanghai Desano Bio-Pharmaceutical Co., Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HA734 | Dexamethasone (sodium phosphate) Solution for injection 4mg/ml | Finished Pharmaceutical Product | HIV/AIDS | Farmak JSC | Solution for injection | Prequalification - Full | |
| CV004 | Dexamethasone (sodium phosphate) Solution for injection 4mg/ml | Finished Pharmaceutical Product | Covid-19 | Farmak JSC | Solution for injection | Prequalification - Full | |
| MA157 | Dihydroartemisinin/Piperaquine phosphate Tablet, Dispersible 30mg/240mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible | Prequalification - Full | |
| TB386 | Pretomanid Tablet 200mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet | Prequalification - Abridged | |
| HP027 | Daclatasvir (dihydrochloride) Tablet, Film-coated 30mg | Finished Pharmaceutical Product | Hepatitis B and C | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HP028 | Daclatasvir (dihydrochloride) Tablet, Film-coated 60mg | Finished Pharmaceutical Product | Hepatitis B and C | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| BT-ON016 | Trastuzumab Powder for concentrate for solution for infusion 420mg | Biotherapeutic Product | Oncology | Biosimilar Collaborations Ireland Limited | Powder for concentrate for solution for infusion | Prequalification - Abridged | |
| HA751 | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| TB364 | Clofazimine Capsules, soft 100mg | Finished Pharmaceutical Product | Tuberculosis | Dong-A ST Co Ltd | Capsules, soft | Prequalification - Full |
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