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 |
|---|---|---|---|---|---|---|---|
| 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 | |
| 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 | |
| ANDA 90371 USFDA | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Alternative Listing | |
| ANDA 90159 USFDA | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet, Film-coated | Alternative Listing | |
| ANDA 21988 USFDA | Lamivudine/Zidovudine Tablet + Nevirapine Tablet 150mg/300mg + 200mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Science Limited | Tablet + Tablet | Alternative Listing | |
| ANDA 216875 USFDA | Emtricitabine/Tenofovir alafenamide Tablet, Film-coated 200mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet, Film-coated | ||
| ANDA 214397 USFDA | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| ANDA 213541 USFDA | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Alternative Listing | |
| ANDA 212579c USFDA | Atazanavir (sulfate) Capsules, hard 300mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Capsules, hard | Alternative Listing | |
| ANDA 212579b USFDA | Atazanavir (sulfate) Capsules, hard 200mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Capsules, hard | Alternative Listing | |
| ANDA 212579a USFDA | Atazanavir (sulfate) Capsules, hard 150mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Capsules, hard | Alternative Listing | |
| ANDA 210963 USFDA | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Alternative Listing | |
| ANDA 210642 USFDA | Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Film-coated 600mg/50mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet, Film-coated | ||
| ANDA 208355 USFDA | Dolutegravir (sodium) Tablet 50mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| ANDA 205412 USFDA | Abacavir (sulfate)/Lamivudine Tablet 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Alternative Listing | |
| ANDA 204739b USFDA | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| ANDA 204739a USFDA | Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| ANDA 203759 USFDA | Ritonavir Tablet 100mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet | Alternative Listing | |
| ANDA 203442 USFDA | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| ANDA 203232 USFDA | Tenofovir disoproxil fumarate Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| ANDA 203041 USFDA | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| ANDA 200196 USFDA | Atazanavir (sulfate) Capsules, hard 300mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Capsules, hard | Alternative Listing | |
| ANDA 091677 USFDA | Lopinavir/Ritonavir Tablet 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Alternative Listing | |
| ANDA 091611b USFDA | Atazanavir (sulfate) Capsules, hard 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Capsules, hard | Alternative Listing | |
| ANDA 091611a USFDA | Atazanavir (sulfate) Capsules, hard 150mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Capsules, hard | Alternative Listing | |
| ANDA 091579 USFDA | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| ANDA 091475 USFDA | Lamivudine Solution, Oral 10mg/ml | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Solution, Oral | Alternative Listing | |
| ANDA 091144 USFDA | Abacavir (sulfate)/Lamivudine Tablet 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet | Alternative Listing | |
| ANDA 090688 USFDA | Nevirapine Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet | Alternative Listing | |
| ANDA 090679 USFDA | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| ANDA 090647 USFDA | Tenofovir disoproxil fumarate Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| ANDA 090513 USFDA | Emtricitabine/Tenofovir disoproxil fumarate Tablet 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| ANDA 090471b USFDA | Lopinavir/Ritonavir Tablet 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| ANDA 090471a USFDA | Lopinavir/Ritonavir Tablet 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| ANDA 090457 USFDA | Lamivudine Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Science Limited | Tablet | Alternative Listing | |
| ANDA 090309 USFDA | Abacavir (sulfate)/Lamivudine/Zidovudine Tablet 300mg/150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Alternative Listing | |
| ANDA 090198b USFDA | Lamivudine Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| ANDA 090198 USFDA | Lamivudine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| ANDA 079188 USFDA | Emtricitabine Capsules, hard 200mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Capsules, hard | Alternative Listing | |
| ANDA 079124 USFDA | Lamivudine/Zidovudine Tablet 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Alternative Listing | |
| ANDA 078958 USFDA | Efavirenz Tablet 600mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Tablet | Alternative Listing | |
| ANDA 078929 USFDA | Lamivudine/Zidovudine Tablet 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Tablet | Alternative Listing | |
| ANDA 078922 USFDA | Zidovudine Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Alternative Listing | |
| ANDA 078887 USFDA | Nevirapine Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Tablet | Alternative Listing | |
| ANDA 078850b USFDA | Lamivudine Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Alternative Listing | |
| ANDA 078850a USFDA | Lamivudine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Alternative Listing | |
| ANDA 078785c USFDA | Atazanavir (sulfate) Capsules, hard 150mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Capsules, hard | Alternative Listing | |
| ANDA 078785b USFDA | Atazanavir (sulfate) Capsules, hard 200mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Capsules, hard | Alternative Listing | |
| ANDA 078785a USFDA | Atazanavir (sulfate) Capsules, hard 100mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Capsules, hard | Alternative Listing | |
| ANDA 078742 USFDA | Abacavir (sulfate) Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Alternative Listing |
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