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 Sort descending | Product Type | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| HA749 | Atazanavir (sulfate)/Ritonavir Tablet, Film-coated 300mg/100mg | Finished Pharmaceutical Product | HIV/AIDS | Shanghai Desano Bio-Pharmaceutical Co., Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HA772 | Atazanavir (sulfate)/Ritonavir Tablet, Film-coated 300mg/100mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| BT-EB001 | Atoltivimab/Maftivimab/Odesivimab Solution for Infusion 16.67 mg/mL/16.67 mg/mL/16.67 mg/mL | Biotherapeutic Product | Ebola | Regeneron Pharmaceuticals Inc. | Solution for Infusion | Prequalification - Abridged | |
| BT-EB002 | Atoltivimab/Maftivimab/Odesivimab Solution for infusion 33.33mg/mL/33.33mg/mL/33.33mg/mL | Biotherapeutic Product | Ebola Virus Disease | Regeneron Pharmaceuticals Inc. | Solution for infusion | Prequalification - Abridged | |
| NT019 | Azithromycin Tablet, Film-coated 500mg | Finished Pharmaceutical Product | Neglected tropical diseases | ACI HealthCare Limited | Tablet, Film-coated | Prequalification - Abridged | |
| TB396 | Bedaquiline fumarate Tablet 100mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet | Prequalification - Full | |
| RH103 | Benzathine benzylpenicillin Powder for suspension for injection + Water for Injection Solvent for parenteral use 1,200,000IU + 4 mL | Finished Pharmaceutical Product | Reproductive health | LABORATORIO REIG JOFRE, S.A. | Powder for suspension for injection + Solvent for parenteral use | Prequalification - Abridged | |
| RH104 | Benzathine benzylpenicillin Powder for suspension for injection + Water for Injection Solvent for parenteral use 2,400,000IU + 6 mL | Finished Pharmaceutical Product | Reproductive health | LABORATORIO REIG JOFRE, S.A. | Powder for suspension for injection + Solvent for parenteral use | Prequalification - Abridged | |
| BT-ON017 | Benzyl alcohol/Water for Injection Solvent for parenteral use+Trastuzumab Powder for concentrate for solution for infusion 1.1%/20mL+440mg | Biotherapeutic Product | Oncology | Biosimilar Collaborations Ireland Limited | Powder for concentrate for solution for infusion + Solvent for parenteral use | Prequalification - Abridged | |
| HA788 | Cabotegravir (sodium) Tablet, Film-coated 30mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare Pty Ltd | Tablet, Film-coated | Prequalification - Abridged | |
| HA789 | Cabotegravir Suspension for injection 600mg/3mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare Pty Ltd | Suspension for injection | Prequalification - Abridged | |
| RH095 | Carbetocin Solution for injection 100 mcg/ml | Finished Pharmaceutical Product | Reproductive health | Ferring International Center SA | Solution for injection | Prequalification - Full | |
| MR001 | Cefiderocol Powder for concentrate for solution for infusion 1g/vial | Finished Pharmaceutical Product | Multi-drug resistant bacterial infections | Shionogi B.V. | Powder for concentrate for solution for infusion | Prequalification - Abridged | |
| 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 | |
| HA692 | Ceftriaxone (sodium) Powder for solution for injection 1g | Finished Pharmaceutical Product | HIV/AIDS | Roche Products Limited | Powder for solution for injection | Prequalification - Abridged | |
| 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 | |
| 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 | |
| HA716 | Ciprofloxacin Tablet, Film-coated 250mg | Finished Pharmaceutical Product | HIV/AIDS | Unique Pharmaceutical Laboratories (Mumbai) | 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 | |
| TB364 | Clofazimine Capsules, soft 100mg | Finished Pharmaceutical Product | Tuberculosis | Dong-A ST Co Ltd | Capsules, soft | Prequalification - Full | |
| TB362 | Clofazimine Tablet, Film-coated 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB361 | Clofazimine Tablet, Film-coated 50mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB330 | Cycloserine Capsules, hard 125mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| TB154 | Cycloserine Capsules, hard 250mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| TB304 | Cycloserine Capsules, hard 250mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Capsules, hard | Prequalification - Full | |
| TB236 | Cycloserine Capsules, hard 250mg | Finished Pharmaceutical Product | Tuberculosis | Dong-A ST Co Ltd | Capsules, hard | Prequalification - Full | |
| TB385 | Cycloserine Capsules, hard 250mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Capsules, hard | Prequalification - Full | |
| HP033 | Daclatasvir (dihydrochloride) Tablet, Film-coated 30 mg | Finished Pharmaceutical Product | Hepatitis B and C | Zydus Lifesciences Limited | 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 | |
| HP021 | Daclatasvir (dihydrochloride) Tablet, Film-coated 30mg | Finished Pharmaceutical Product | Hepatitis B and C | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| HP027 | Daclatasvir (dihydrochloride) Tablet, Film-coated 30mg | Finished Pharmaceutical Product | Hepatitis B and C | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HP034 | Daclatasvir (dihydrochloride) Tablet, Film-coated 60 mg | Finished Pharmaceutical Product | Hepatitis B and C | Zydus Lifesciences 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 | |
| HP022 | Daclatasvir (dihydrochloride) Tablet, Film-coated 60mg | Finished Pharmaceutical Product | Hepatitis B and C | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| HP012 | Daclatasvir (dihydrochloride) Tablet, Film-coated 60mg | Finished Pharmaceutical Product | Hepatitis B and C | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HP028 | Daclatasvir (dihydrochloride) Tablet, Film-coated 60mg | Finished Pharmaceutical Product | Hepatitis B and C | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HP025 | Daclatasvir (dihydrochloride)/Sofosbuvir Tablet, Film-coated 60mg/400mg | Finished Pharmaceutical Product | Hepatitis B and C | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| EMA Art 58 H-W-002168 | Dapivirine Vaginal ring 25mg | Finished Pharmaceutical Product | HIV/AIDS | International Partnership for Microbicides Belgium (IPM Belgium) AISBL | Vaginal ring | Alternative Listing | |
| HA645 | Dapsone Tablet 100mg | Finished Pharmaceutical Product | HIV/AIDS | Everest Life Sciences LLC | Tablet | Prequalification - Abridged | |
| HA530 | Darunavir (ethanolate) Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen Research & Development LLC | Tablet, Film-coated | Prequalification - Abridged | |
| HA685 | Darunavir (ethanolate) Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA780 | Darunavir (ethanolate) Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen-Cilag International NV | Tablet, Film-coated | Prequalification - Abridged | |
| HA529 | Darunavir (ethanolate) Tablet, Film-coated 75mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen Research & Development LLC | 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 | |
| HA719 | Darunavir (ethanolate)/Ritonavir Tablet, Film-coated 400mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA709 | Darunavir Tablet, Film-coated 400mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA723 | Darunavir Tablet, Film-coated 400mg | Finished Pharmaceutical Product | HIV/AIDS | MSN Laboratories Private Limited | Tablet, Film-coated | Prequalification - Full | |
| HA724 | Darunavir Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | MSN Laboratories Private Limited | Tablet, Film-coated | Prequalification - Full | |
| HA710 | Darunavir Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs 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 |
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