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 ascending |
|---|---|---|---|---|---|---|---|
| TB352 | Ethionamide Tablet, Dispersible 125mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | 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 | |
| HA683 | Darunavir (ethanolate) Tablet, Film-coated 800mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| 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 | |
| MA126 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| MA125 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | 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 | |
| HP016 | Daclatasvir (dihydrochloride) Tablet, Film-coated 60mg | Finished Pharmaceutical Product | Hepatitis B and C | Mylan Laboratories 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 | |
| TB340 | Levofloxacin Tablet, Film-coated 750mg | Finished Pharmaceutical Product | Tuberculosis | MSN Laboratories Private Limited | Tablet, Film-coated | Prequalification - Full | |
| MA127 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | 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 | |
| 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 | |
| HA687 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| HA686 | Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| NT006 | Mebendazole Tablets, Chewable 500mg | Finished Pharmaceutical Product | Neglected tropical diseases | Janssen-Cilag International NV | Tablets, Chewable | Prequalification - Full | |
| TB354 | Levofloxacin Tablet, Film-coated 500mg | Finished Pharmaceutical Product | Tuberculosis | PT. Dankos Farma | Tablet, Film-coated | Prequalification - Full | |
| TB311 | Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Getz Pharma Pvt Ltd | Tablet, Film-coated | Prequalification - Full | |
| HP024 | Sofosbuvir/Velpatasvir Tablet, Film-coated 400mg/100mg | Finished Pharmaceutical Product | Hepatitis B and C | Gilead Sciences Ireland UC | Tablet, Film-coated | Prequalification - Abridged | |
| TB327 | Kanamycin (sulfate) Solution for injection 500mg/2ml | Finished Pharmaceutical Product | Tuberculosis | Livzon (Group) Pharmaceutical Factory | Solution for injection | Prequalification - Full | |
| MA138 | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Strides Pharma Global PTE Limited | Tablet | Prequalification - Full | |
| TB328 | Kanamycin (sulfate) - non sterile Solution for injection 1000mg/3ml | Finished Pharmaceutical Product | Tuberculosis | Livzon (Group) Pharmaceutical Factory | Solution for injection | Prequalification - Full | |
| HA668 | Lamivudine Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Beximco Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA716 | Ciprofloxacin Tablet, Film-coated 250mg | Finished Pharmaceutical Product | HIV/AIDS | Unique Pharmaceutical Laboratories (Mumbai) | Tablet, Film-coated | Prequalification - Abridged | |
| HA656 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Anhui Biochem Bio-Pharmaceutical Co Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA688 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| TB350 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HP003 | Sofosbuvir Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Hepatitis B and C | European Egyptian Pharmaceuticals Industries Co | Tablet, Film-coated | Prequalification - Full | |
| MA135 | Artesunate Powder for solution for injection 60mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Powder for solution for injection | Prequalification - Full | |
| TB342 | Moxifloxacin (hydrochloride) Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA132 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Micro Labs Limited | Tablet | Prequalification - Full | |
| TB323 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA678 | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| MA134 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Micro Labs Limited | Tablet | Prequalification - Full | |
| MA133 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Micro Labs Limited | Tablet | Prequalification - Full | |
| TB349 | Moxifloxacin (hydrochloride) Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| HA721 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Abridged | |
| MA113 | Pyrimethamine/Sulfadoxine Tablet 25mg/500mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet | Prequalification - Full | |
| RH074 | Medroxyprogesterone acetate Suspension for injection 150mg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Suspension for injection | Prequalification - Full | |
| MA117 | Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 25mg/500mg + 153mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible + Tablet, Dispersible | Prequalification - Full | |
| MA116 | Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 12.5mg/250mg + 76.5mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible + Tablet, Dispersible | Prequalification - Full | |
| HA681 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Government Pharmaceutical Organization (GPO) | Tablet, Film-coated | Prequalification - Full | |
| HA704 | Itraconazole Capsules, hard 100mg | Finished Pharmaceutical Product | HIV/AIDS | Laboratorios Liconsa S.A. | Capsules, hard | Prequalification - Abridged | |
| HA682 | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB330 | Cycloserine Capsules, hard 125mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| TB332 | Rifampicin Capsules, hard 300mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| MA123 | Artesunate Capsule, Soft, Rectal 100mg | Finished Pharmaceutical Product | Malaria | Strides Pharma Global PTE Limited | Capsule, Soft, Rectal | Prequalification - Full | |
| HA706 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged |
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