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 Sort descending | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| HP011 | Daclatasvir (dihydrochloride) Tablet, Film-coated 30mg | Finished Pharmaceutical Product | Hepatitis B and C | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA098 | Lopinavir/Ritonavir Solution, Oral 80mg/mL/20mg/mL | Finished Pharmaceutical Product | HIV/AIDS | AbbVie Deutschland GmbH and Co. KG | Solution, Oral | Prequalification - Abridged | |
| HA433 | Lamivudine/Nevirapine/Zidovudine Tablet, Dispersible 30mg/50mg/60mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Dispersible | Prequalification - Full | |
| MA143 | Artemether/Lumefantrine Tablet 40mg/240mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| ANDA 077268 USFDA | Zidovudine Solution, Oral 10mg/ml | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Solution, Oral | Alternative Listing | |
| HA707 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| TB386 | Pretomanid Tablet 200mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet | Prequalification - Abridged | |
| HA096 | Ritonavir Solution, Oral 80mg/mL | Finished Pharmaceutical Product | HIV/AIDS | AbbVie Ltd | Solution, Oral | Prequalification - Abridged | |
| HA717 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA107 | Abacavir (sulfate) Solution, Oral 20mg/mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Solution, Oral | Prequalification - Abridged | |
| TB226 | Ethambutol hydrochloride Tablet, Film-coated 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| ANDA 090471a USFDA | Lopinavir/Ritonavir Tablet 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| HA705 | Amphotericin B Powder for concentration for dispersion for infusion 50mg | Finished Pharmaceutical Product | HIV/AIDS | Gilead Sciences Ireland UC | Powder for concentration for dispersion for infusion | Prequalification - Abridged | |
| TB299 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| NDA 22461b USFDA | Efavirenz Tablet, Film-coated 100mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Alternative Listing | |
| IN006 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Roche Registration GmbH | Capsules, hard | Prequalification - Abridged | |
| NDA 22096 USFDA | Lamivudine/Zidovudine Tablet+Efavirenz Tablet 150mg/300mg+600mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Science Limited | Tablet + Tablet | Alternative Listing | |
| HA650 | Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB356 | Levofloxacin Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| ANDA 90371 USFDA | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Alternative Listing | |
| TB336 | Rifapentine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | Tuberculosis | Sanofi | Tablet, Film-coated | Prequalification - Abridged | |
| IN011 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Mylan Laboratories Limited | Capsules, hard | Prequalification - Full | |
| RH052 | Mifepristone Tablet 200mg | Finished Pharmaceutical Product | Reproductive health | China Resources Zizhu Pharmaceutical Co Ltd | Tablet | Prequalification - Full | |
| TB229 | Para-aminosalicylate (sodium) Powder for Oral solution 4g | Finished Pharmaceutical Product | Tuberculosis | OlainFarm JSC | Powder for Oral solution | Prequalification - Abridged | |
| HA763 | Abacavir (sulfate)/Lamivudine Tablet, Dispersible 120mg/60mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| HA753 | Flucytosine Tablet 250mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| TB230 | Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| ANDA 077844 USFDA | Abacavir (sulfate) Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| HA117 | Lamivudine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA754 | Flucytosine Tablet 500mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| NDA 21854 USFDA | Lamivudine/Stavudine Tablet+Nevirapine Tablet 150mg/40mg+200mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Science Limited | Tablet + Tablet | Alternative Listing | |
| RH083 | Oxytocin Solution for injection 10IU/mL | Finished Pharmaceutical Product | Reproductive health | Steril-Gene Life Sciences (P) Ltd | Solution for injection | Prequalification - Full | |
| HA693 | Flucytosine Tablet 500mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Prequalification - Abridged | |
| HA635 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA110 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged | |
| TB223 | Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tablet, Film-coated 275mg/75mg/400mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA108 | Zidovudine Capsules, hard 100mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Capsules, hard | Prequalification - Abridged | |
| TB276 | Isoniazid Tablet 300mg | Finished Pharmaceutical Product | Tuberculosis | Cadila Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB373 | Levofloxacin Tablet, Film-coated 500mg | Finished Pharmaceutical Product | Tuberculosis | PT Sanbe Farma | Tablet, Film-coated | Prequalification - Full | |
| ANDA 078922 USFDA | Zidovudine Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Alternative Listing | |
| RH063 | Magnesium sulphate Solution for injection 500mg/ml (2ml) | Finished Pharmaceutical Product | Reproductive health | AS KALCEKS | Solution for injection | Prequalification - Full | |
| TB231 | Isoniazid/Rifampicin Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB308 | Isoniazid Tablet 100mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| HA640 | Rifabutin Capsules, hard 150mg | Finished Pharmaceutical Product | HIV/AIDS | Lupin Ltd. | Capsules, hard | Prequalification - Abridged | |
| HA106 | Abacavir (sulfate) Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA109 | Zidovudine Capsules, hard 250mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Capsules, hard | Prequalification - Abridged | |
| NT011 | Praziquantel Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Neglected tropical diseases | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| NT009 | Ivermectin Tablet 3mg | Finished Pharmaceutical Product | Neglected tropical diseases | Edenbridge Pharmaceuticals LLC | Tablet | Prequalification - Abridged | |
| EMA Art 58 H-W-764-2 | Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | AbbVie Deutschland GmbH and Co. KG | Tablet, Film-coated | Alternative Listing | |
| NDA 203076 USFDA | Lamivudine/Nevirapine/Zidovudine Tablet, Dispersible 30mg/50mg/60mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Dispersible | Alternative Listing |
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