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 Sort ascending | Product Type | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| DI005 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| DI009 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | PharmEvo (Pvt) Ltd. | Tablet, Dispersible | Prequalification - Full | |
| DI013 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | The ACME Laboratories Ltd | Tablet, Dispersible | Prequalification - Full | |
| DI014 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | Swiss Pharma Nigeria Ltd. | Tablet, Dispersible | Prequalification - Full | |
| DI002 | Zinc (sulfate) Tablet, Dispersible 20mg | Finished Pharmaceutical Product | Diarrhoea | Laboratoires Pharmaceutiques Rodael | 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 | |
| HA537 | Zidovudine Tablet, Film-coated 60mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA483 | Zidovudine Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| ANDA 077267 USFDA | Zidovudine Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| ANDA 078922 USFDA | Zidovudine Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Alternative Listing | |
| HA115 | Zidovudine Solution, Oral 50mg/5mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Solution, Oral | Prequalification - Abridged | |
| ANDA 077268 USFDA | Zidovudine Solution, Oral 10mg/ml | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Solution, Oral | Alternative Listing | |
| HA526 | Zidovudine Solution, Oral 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Solution, Oral | Prequalification - Full | |
| HA486 | Zidovudine Solution, Oral 10mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Solution, Oral | Prequalification - Full | |
| HA114 | Zidovudine Solution for injection 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Solution for injection | Prequalification - Abridged | |
| HA109 | Zidovudine Capsules, hard 250mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Capsules, hard | Prequalification - Abridged | |
| ANDA 078128 USFDA | Zidovudine Capsules, hard 100mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Capsules, hard | Alternative Listing | |
| HA108 | Zidovudine Capsules, hard 100mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Capsules, hard | Prequalification - Abridged | |
| IN007 | Zanamivir Powder, for Inhalation 5mg | Finished Pharmaceutical Product | Influenza | Glaxo Wellcome UK Ltd | Powder, for Inhalation | 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-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-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-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-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-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-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-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-CV001 | Tocilizumab Concentrate for solution for infusion 20mg/ml (Each vial contains 80 mg of tocilizumab in 4 mL) | Biotherapeutic Product | Covid-19 | Roche Registration GmbH | Concentrate for solution for infusion | 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 | |
| BT-CV002 | Tocilizumab Concentrate for solution for infusion 20mg/ml (Each vial contains 200 mg of tocilizumab in 10 mL) | Biotherapeutic Product | Covid-19 | Roche Registration GmbH | Concentrate for solution for infusion | Prequalification - Abridged | |
| TB303 | Terizidone Capsules, hard 250mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| TB346 | Terizidone Capsules, hard 250mg | Finished Pharmaceutical Product | Tuberculosis | Esteve Pharmaceuticals GmbH | Capsules, hard | Prequalification - Abridged | |
| HA535 | Tenofovir disoproxil fumarate Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Science Limited | Tablet, Film-coated | Prequalification - Full | |
| HA679 | Tenofovir disoproxil fumarate Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA516 | Tenofovir disoproxil fumarate Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| ANDA 203232 USFDA | Tenofovir disoproxil fumarate Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| HA410 | Tenofovir disoproxil fumarate Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| ANDA 090647 USFDA | Tenofovir disoproxil fumarate Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| HA745 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| HA736 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| HA783 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Reyoung Pharmaceutical Co., Ltd. | Tablet | Prequalification - Full | |
| HA687 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| HA599 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| HA691 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Milan Laboratories (India) Pvt Ltd | Tablet | Prequalification - Full | |
| HA748 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Eumedica Pharmaceuticals AG | Tablet | Prequalification - Abridged | |
| HA775 | Sulfamethoxazole/Trimethoprim Tablet 800 mg/160 mg | Finished Pharmaceutical Product | HIV/AIDS | Shouguang Fukang Pharmaceutical Co., Ltd. | Tablet | Prequalification - Full | |
| HA598 | Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| HA747 | Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg | Finished Pharmaceutical Product | HIV/AIDS | Eumedica Pharmaceuticals AG | Tablet | Prequalification - Abridged |
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