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 descending | INN, Dosage Form and Strength | Product Type | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| HA424 | Lamivudine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA433 | Lamivudine/Nevirapine/Zidovudine Tablet, Dispersible 30mg/50mg/60mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Ltd. | Tablet, Dispersible | Prequalification - Full | |
| HA439 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA444 | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HA448 | Lamivudine/Tenofovir disoproxil fumarate Tablet 300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Prequalification - Full | |
| HA459 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA466 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HA467 | Ritonavir Tablet, Film-coated 100mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HA479 | Ceftriaxone (sodium) Powder for solution for injection 1000mg | Finished Pharmaceutical Product | HIV/AIDS | Egyptian International Pharmaceutical Industries | Powder for solution for injection | Prequalification - Full | |
| HA480 | Ceftriaxone (sodium) Powder for solution for injection 500mg | Finished Pharmaceutical Product | HIV/AIDS | Egyptian International Pharmaceutical Industries | Powder for solution for injection | Prequalification - Full | |
| HA485 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA486 | Zidovudine Solution, Oral 10mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Solution, Oral | Prequalification - Full | |
| HA491 | Ritonavir Tablet, Film-coated 100mg | Finished Pharmaceutical Product | HIV/AIDS | AbbVie Deutschland GmbH and Co. KG | Tablet, Film-coated | Prequalification - Abridged | |
| HA492 | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA498 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA500 | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA514 | Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| 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 | |
| HA516 | Tenofovir disoproxil fumarate Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA521 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA523 | Lamivudine Solution, Oral 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Solution, Oral | Prequalification - Full | |
| HA525 | Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Sun Pharmaceutical Industries Limited | Tablet, Film-coated | Prequalification - Full | |
| HA526 | Zidovudine Solution, Oral 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Solution, Oral | Prequalification - Full | |
| HA529 | Darunavir (ethanolate) Tablet, Film-coated 75mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen Research & Development LLC | Tablet, Film-coated | Prequalification - Abridged | |
| HA530 | Darunavir (ethanolate) Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen Research & Development LLC | Tablet, Film-coated | Prequalification - Abridged | |
| HA532 | Etravirine Tablet 100mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen Research & Development LLC | Tablet | Prequalification - Abridged | |
| HA535 | Tenofovir disoproxil fumarate Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Science Limited | Tablet, Film-coated | Prequalification - Full | |
| HA538 | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA549 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA551 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Sun Pharmaceutical Industries Limited | Tablet, Film-coated | Prequalification - Full | |
| HA552 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Science Limited | Tablet, Film-coated | Prequalification - Full | |
| HA553 | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Science Limited | Tablet, Film-coated | Prequalification - Full | |
| HA561 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA562 | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA572 | Lamivudine/Zidovudine Tablet, Dispersible 30mg/60mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Ltd. | Tablet, Dispersible | Prequalification - Full | |
| HA573 | Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA574 | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA595 | Ondansetron (hydrochloride) Tablet, Film-coated 4mg | Finished Pharmaceutical Product | HIV/AIDS | Cadila Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA596 | Ondansetron (hydrochloride) Tablet, Film-coated 8mg | Finished Pharmaceutical Product | HIV/AIDS | Cadila Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA597 | Ondansetron (hydrochloride) Solution for injection 4mg/2mL | Finished Pharmaceutical Product | HIV/AIDS | Demo SA | Solution for injection | Prequalification - Abridged | |
| HA598 | Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| HA599 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| HA600 | Etravirine Tablet 25mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen-Cilag International NV | Tablet | Prequalification - Abridged | |
| HA602 | Aciclovir Powder for solution for injection 250mg/vial | Finished Pharmaceutical Product | HIV/AIDS | Demo SA | Powder for solution for injection | Prequalification - Abridged | |
| HA607 | Ondansetron (hydrochloride) Solution for injection 8mg/4mL | Finished Pharmaceutical Product | HIV/AIDS | Demo SA | Solution for injection | Prequalification - Abridged | |
| HA620 | Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA621 | Ritonavir Tablet, Film-coated 25mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HA622 | Ceftriaxone (sodium) Powder for solution for injection 1g | Finished Pharmaceutical Product | HIV/AIDS | Sinopharm Zhijun (Shenzhen) Pharm Co. Ltd | Powder for solution for injection | Prequalification - Full | |
| HA631 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA634 | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged |
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