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 | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification Sort descending |
|---|---|---|---|---|---|---|---|
| HA687 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| HA702 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| NT006 | Mebendazole Tablets, Chewable 500mg | Finished Pharmaceutical Product | Neglected tropical diseases | Janssen-Cilag International NV | Tablets, Chewable | Prequalification - Full | |
| HA629 | Lamivudine/Nevirapine/Zidovudine Tablet, Film-coated 150mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| TB338 | Levofloxacin Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | MSN Laboratories Private Limited | Tablet, Film-coated | Prequalification - Full | |
| MA126 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| MA127 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB339 | Levofloxacin Tablet, Film-coated 500mg | Finished Pharmaceutical Product | Tuberculosis | MSN Laboratories Private Limited | Tablet, Film-coated | Prequalification - Full | |
| MA125 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB340 | Levofloxacin Tablet, Film-coated 750mg | Finished Pharmaceutical Product | Tuberculosis | MSN Laboratories Private Limited | Tablet, Film-coated | Prequalification - Full | |
| HP016 | Daclatasvir (dihydrochloride) Tablet, Film-coated 60mg | Finished Pharmaceutical Product | Hepatitis B and C | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA733 | Darunavir Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Krka, d.d., Novo mesto | Tablet, Film-coated | Prequalification - Abridged | |
| HA738 | Ciprofloxacin Tablet, Film-coated 500mg | Finished Pharmaceutical Product | HIV/AIDS | Unique Pharmaceutical Laboratories (Mumbai) | Tablet, Film-coated | Prequalification - Abridged | |
| HA698 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Sun Pharmaceutical Industries Limited | Tablet, Film-coated | Prequalification - Full | |
| HA685 | Darunavir (ethanolate) Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA683 | Darunavir (ethanolate) Tablet, Film-coated 800mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| TB352 | Ethionamide Tablet, Dispersible 125mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| MA142 | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| HA717 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| MA143 | Artemether/Lumefantrine Tablet 40mg/240mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| MA137 | Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| HA714 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| RH079 | Oxytocin Solution for injection 10IU/ml | Finished Pharmaceutical Product | Reproductive health | JSC Grindeks | Solution for injection | Prequalification - Full | |
| HA718 | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| RH083 | Oxytocin Solution for injection 10IU/mL | Finished Pharmaceutical Product | Reproductive health | Steril-Gene Life Sciences (P) Ltd | Solution for injection | Prequalification - Full | |
| TB356 | Levofloxacin Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| MA139 | Dihydroartemisinin/Piperaquine phosphate Tablet, Dispersible 40mg/320mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA140 | Dihydroartemisinin/Piperaquine phosphate Tablet, Film-coated 80mg/640mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Film-coated | Prequalification - Full | |
| RH089 | Mifepristone Tablet + Misoprostol Tablet, vaginal 200mg + 200mcg | Finished Pharmaceutical Product | Reproductive health | China Resources Zizhu Pharmaceutical Co Ltd | Tablet + Tablet, vaginal | Prequalification - Full | |
| MA131 | Dihydroartemisinin/Piperaquine phosphate Tablet, Film-coated 40mg/320mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB355 | Levofloxacin Tablet, Film-coated 750mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| 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 | |
| MA141 | Dihydroartemisinin/Piperaquine phosphate Tablet, Dispersible 20mg/160mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible | Prequalification - Full | |
| HA747 | Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg | Finished Pharmaceutical Product | HIV/AIDS | Eumedica Pharmaceuticals AG | Tablet | Prequalification - Abridged | |
| HP012 | Daclatasvir (dihydrochloride) Tablet, Film-coated 60mg | Finished Pharmaceutical Product | Hepatitis B and C | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HP021 | Daclatasvir (dihydrochloride) Tablet, Film-coated 30mg | Finished Pharmaceutical Product | Hepatitis B and C | Cipla Ltd | Tablet, Film-coated | 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 | |
| HP022 | Daclatasvir (dihydrochloride) Tablet, Film-coated 60mg | Finished Pharmaceutical Product | Hepatitis B and C | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| HP011 | Daclatasvir (dihydrochloride) Tablet, Film-coated 30mg | Finished Pharmaceutical Product | Hepatitis B and C | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA699 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Sun Pharmaceutical Industries Limited | Tablet, Film-coated | Prequalification - Full | |
| 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 | |
| HA703 | Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HA696 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA715 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| RH084 | Medroxyprogesterone acetate Suspension for injection 150mg/ml | Finished Pharmaceutical Product | Reproductive health | Incepta Pharmaceuticals Ltd. | Suspension for injection | Prequalification - Full | |
| TB317 | Kanamycin (sulfate) Solution for injection 500mg | Finished Pharmaceutical Product | Tuberculosis | Shanghai Harvest Pharmaceutical Co., Ltd | Solution for injection | Prequalification - Full | |
| TB384 | Meropenem Powder for solution for injection 1g | Finished Pharmaceutical Product | Tuberculosis | Venus Pharma GmbH | Powder for solution for injection | Prequalification - Abridged | |
| HA701 | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HP009 | Sofosbuvir Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Hepatitis B and C | Strides Pharma Science Limited | Tablet, Film-coated | Prequalification - Full |
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