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 Sort ascending | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| 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 | |
| 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 | |
| HA691 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Milan Laboratories (India) Pvt Ltd | Tablet | Prequalification - Full | |
| HA746 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Desano Pharmaceuticals Private Limited | Tablet, Film-coated | Prequalification - Full | |
| RH098 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | Naari BV | Tablet | Prequalification - Abridged | |
| RH072 | Magnesium sulphate Solution for injection 500mg/ml (10ml) | Finished Pharmaceutical Product | Reproductive health | Labesfal, Laboratorios Almiro SA | Solution for injection | Prequalification - Abridged | |
| TB317 | Kanamycin (sulfate) Solution for injection 500mg | Finished Pharmaceutical Product | Tuberculosis | Shanghai Harvest Pharmaceutical Co., Ltd | Solution for injection | Prequalification - Full | |
| RH087 | Estradiol valerate/Norethisterone enantate Solution for injection 5mg/ml/50mg/ml | Finished Pharmaceutical Product | Reproductive health | Bayer S.A. | Solution for injection | Prequalification - Full | |
| BT-ON006 | Rituximab Concentrate for solution for infusion 100mg/10mL | Biotherapeutic Product | Oncology | Sandoz GmbH | Concentrate for solution for infusion | Prequalification - Abridged | |
| BT-ON007 | Rituximab Concentrate for solution for infusion 500mg/50mL | Biotherapeutic Product | Oncology | Sandoz GmbH | Concentrate for solution for infusion | Prequalification - Abridged | |
| CV018 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg | Finished Pharmaceutical Product | Covid-19 | Zhejiang Apeloa Kangyu Pharmaceutical Co Ltd | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| TB377 | Levofloxacin Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Zhejiang Apeloa Kangyu Pharmaceutical Co Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB378 | Levofloxacin Tablet, Film-coated 500mg | Finished Pharmaceutical Product | Tuberculosis | Zhejiang Apeloa Kangyu Pharmaceutical Co Ltd | 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 | |
| RH063 | Magnesium sulphate Solution for injection 500mg/ml (2ml) | Finished Pharmaceutical Product | Reproductive health | AS KALCEKS | Solution for injection | Prequalification - Full | |
| RH064 | Magnesium sulphate Solution for injection 500mg/ml (10ml) | Finished Pharmaceutical Product | Reproductive health | AS KALCEKS | Solution for injection | Prequalification - Full | |
| TB229 | Para-aminosalicylate (sodium) Powder for Oral solution 4g | Finished Pharmaceutical Product | Tuberculosis | OlainFarm JSC | Powder for Oral solution | Prequalification - Abridged | |
| HA108 | Zidovudine Capsules, hard 100mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Capsules, hard | Prequalification - Abridged | |
| HA114 | Zidovudine Solution for injection 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Solution for injection | Prequalification - Abridged | |
| HA115 | Zidovudine Solution, Oral 50mg/5mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Solution, Oral | 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 | |
| HA448 | Lamivudine/Tenofovir disoproxil fumarate Tablet 300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Prequalification - Full | |
| NT009 | Ivermectin Tablet 3mg | Finished Pharmaceutical Product | Neglected tropical diseases | Edenbridge Pharmaceuticals LLC | Tablet | Prequalification - Abridged | |
| IN007 | Zanamivir Powder, for Inhalation 5mg | Finished Pharmaceutical Product | Influenza | Glaxo Wellcome UK Ltd | Powder, for Inhalation | Prequalification - Abridged | |
| RH052 | Mifepristone Tablet 200mg | Finished Pharmaceutical Product | Reproductive health | China Resources Zizhu Pharmaceutical Co Ltd | Tablet | Prequalification - Full | |
| RH048 | Misoprostol Tablet 200mcg | Finished Pharmaceutical Product | Reproductive health | China Resources Zizhu Pharmaceutical Co Ltd | Tablet | 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 | |
| CV011 | Remdesivir Powder for concentrate for solution for infusion 100 mg | Finished Pharmaceutical Product | Covid-19 | Gilead Sciences Ireland UC | Powder for concentrate for solution for infusion | Prequalification - Abridged | |
| 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 | |
| ANDA 078850b USFDA | Lamivudine Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Alternative Listing | |
| ANDA 079124 USFDA | Lamivudine/Zidovudine Tablet 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Alternative Listing | |
| RH079 | Oxytocin Solution for injection 10IU/ml | Finished Pharmaceutical Product | Reproductive health | JSC Grindeks | Solution for injection | Prequalification - Full | |
| RH074 | Medroxyprogesterone acetate Suspension for injection 150mg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Suspension for injection | Prequalification - Full | |
| ANDA 078644 USFDA | Nevirapine Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Zhejiang Huahai Pharmaceutical Co. Ltd. | Tablet | Alternative Listing | |
| CV016 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg | Finished Pharmaceutical Product | Covid-19 | Zhejiang Huahai Pharmaceutical Co. Ltd. | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| TB193 | Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tablet, Film-coated 275mg/75mg/400mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Svizera Europe BV | Tablet, Film-coated | Prequalification - Full | |
| TB192 | Ethambutol hydrochloride/Isoniazid/Rifampicin Tablet, Film-coated 275mg/75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Svizera Europe BV | Tablet, Film-coated | Prequalification - Full | |
| TB189 | Isoniazid/Rifampicin Tablet, Film-coated 75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Svizera Europe BV | Tablet, Film-coated | Prequalification - Full | |
| HA704 | Itraconazole Capsules, hard 100mg | Finished Pharmaceutical Product | HIV/AIDS | Laboratorios Liconsa S.A. | Capsules, hard | Prequalification - Abridged | |
| HCnda | Lamivudine/Nevirapine/Zidovudine Tablet 150mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Apotex Pharmachem Inc | Tablet | Alternative Listing | |
| MA062 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| RH084 | Medroxyprogesterone acetate Suspension for injection 150mg/ml | Finished Pharmaceutical Product | Reproductive health | Incepta Pharmaceuticals Ltd. | Suspension for injection | Prequalification - Full | |
| NT006 | Mebendazole Tablets, Chewable 500mg | Finished Pharmaceutical Product | Neglected tropical diseases | Janssen-Cilag International NV | Tablets, Chewable | Prequalification - Full | |
| HA780 | Darunavir (ethanolate) Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen-Cilag International NV | Tablet, Film-coated | Prequalification - Abridged | |
| HA600 | Etravirine Tablet 25mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen-Cilag International NV | Tablet | Prequalification - Abridged | |
| RH050 | Oxytocin Solution for injection 10IU/mL | Finished Pharmaceutical Product | Reproductive health | PT Sanbe Farma | Solution for injection | Prequalification - Full | |
| TB373 | Levofloxacin Tablet, Film-coated 500mg | Finished Pharmaceutical Product | Tuberculosis | PT Sanbe Farma | Tablet, Film-coated | Prequalification - Full | |
| RH056 | Misoprostol Tablet 200mcg | Finished Pharmaceutical Product | Reproductive health | Acme Formulation Pvt. Limited | Tablet | Prequalification - Full | |
| HA681 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Government Pharmaceutical Organization (GPO) | Tablet, Film-coated | Prequalification - Full |
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