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 Sort ascending | INN, Dosage Form and Strength | Product Type | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| 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 | |
| DI014 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | Swiss Pharma Nigeria Ltd. | Tablet, Dispersible | Prequalification - Full | |
| DI013 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | The ACME Laboratories Ltd | Tablet, Dispersible | Prequalification - Full | |
| DI011 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | Ipca Laboratories Ltd | Tablet, Dispersible | Prequalification - Full | |
| DI010 | Zinc (sulfate) Syrup 10mg/5ml | Finished Pharmaceutical Product | Diarrhoea | PharmEvo (Pvt) Ltd. | Syrup | Prequalification - Full | |
| DI009 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | PharmEvo (Pvt) Ltd. | Tablet, Dispersible | Prequalification - Full | |
| DI005 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| DI002 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | Laboratoires Pharmaceutiques Rodael | Tablet, Dispersible | Prequalification - Full | |
| CV023 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. | Capsules, hard | Prequalification - Full | |
| CV022 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Mylan Laboratories Limited | Capsules, hard | Prequalification - Full | |
| CV021 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Cipla Ltd | Capsules, hard | Prequalification - Full | |
| CV019 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Shanghai Desano Bio-Pharmaceutical Co., Ltd. | Capsules, hard | Prequalification - Full | |
| CV018 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg | Finished Pharmaceutical Product | Covid-19 | Zhejiang Apeloa Kangyu Pharmaceutical Co Ltd | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| CV017 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg | Finished Pharmaceutical Product | Covid-19 | Celltrion Inc. | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| CV016 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg | Finished Pharmaceutical Product | Covid-19 | Zhejiang Huahai Pharmaceutical Co. Ltd. | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| CV014 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Aurobindo Pharma Ltd | Capsules, hard | Prequalification - Full | |
| CV012 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150 mg + 100 mg | Finished Pharmaceutical Product | Covid-19 | Hetero Labs Ltd | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| CV011 | Remdesivir Powder for concentrate for solution for infusion 100 mg | Finished Pharmaceutical Product | Covid-19 | Gilead Sciences Ireland UC | Powder for concentrate for solution for infusion | Prequalification - Abridged | |
| CV010 | Molnupiravir Capsules, hard 200 mg | Finished Pharmaceutical Product | Covid-19 | Emcure Pharmaceuticals Limited | Capsules, hard | Prequalification - Full | |
| CV009 | Molnupiravir Capsules, hard 200 mg | Finished Pharmaceutical Product | Covid-19 | Dr Reddy's Laboratories Limited | Capsules, hard | Prequalification - Full | |
| CV008 | Molnupiravir Capsules, hard 200 mg | Finished Pharmaceutical Product | Covid-19 | Hetero Labs Ltd | Capsules, hard | Prequalification - Full | |
| 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 | |
| CV006 | Dexamethasone (sodium phosphate) Solution for injection 4mg/ml (2ml) | Finished Pharmaceutical Product | Covid-19 | Demo SA | Solution for injection | Prequalification - Abridged | |
| CV005 | Dexamethasone (sodium phosphate) Solution for injection 4mg/ml (1ml) | Finished Pharmaceutical Product | Covid-19 | Demo SA | Solution for injection | Prequalification - Abridged | |
| CV004 | Dexamethasone (sodium phosphate) Solution for injection 4mg/ml | Finished Pharmaceutical Product | Covid-19 | Farmak JSC | Solution for injection | Prequalification - Full | |
| BT-ON017 | Benzyl alcohol/Water for Injection Solvent for parenteral use+Trastuzumab Powder for concentrate for solution for infusion 1.1%/20mL+440mg | Biotherapeutic Product | Oncology | Biosimilar Collaborations Ireland Limited | Powder for concentrate for solution for infusion + Solvent for parenteral use | Prequalification - Abridged | |
| 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 | |
| BT-ON014 | Water for Injection Solvent for parenteral use + Trastuzumab Powder for concentrate for solution for infusion 20mL + 420mg | Biotherapeutic Product | Oncology | Biocon Biologics Limited | Solvent for parenteral use + Powder for concentrate for solution for infusion | Prequalification - Full | |
| BT-ON013 | Trastuzumab Powder for concentrate for solution for infusion 150mg | Biotherapeutic Product | Oncology | Biocon Biologics Limited | Powder for concentrate for solution for infusion | Prequalification - Full | |
| BT-ON012 | Rituximab Concentrate for solution for infusion 500mg/50mL | Biotherapeutic Product | Oncology | Roche Products Limited | 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 | |
| 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-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-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 | |
| 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 | |
| BT-ON005 | Rituximab Concentrate for solution for infusion 500mg/50mL | Biotherapeutic Product | Oncology | Celltrion Inc. | Concentrate for solution for infusion | Prequalification - Abridged | |
| BT-ON004 | Rituximab Concentrate for solution for infusion 100mg/10mL | Biotherapeutic Product | Oncology | Celltrion Inc. | 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 | |
| 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-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-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 | |
| 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 | |
| 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 | |
| BT-DM004 | Insulin Human Suspension for injection 100IU/ml | Biotherapeutic Product | Diabetes | Novo Nordisk AS | Suspension for injection | Prequalification - Abridged | |
| BT-DM003 | Insulin Human Suspension for injection 100IU/ml | Biotherapeutic Product | Diabetes | Novo Nordisk AS | Suspension 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-DM001 | Insulin Human Solution for injection 100IU/ml | Biotherapeutic Product | Diabetes | Novo Nordisk AS | Solution 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 |
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