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 Sort descending | INN, Dosage Form and Strength | Product Type | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
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HA772 | Atazanavir (sulfate)/Ritonavir Tablet, Film-coated 300mg/100mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
HA774 | Sulfamethoxazole/Trimethoprim Tablet 400 mg/80 mg | Finished Pharmaceutical Product | HIV/AIDS | Shouguang Fukang Pharmaceutical Co., Ltd. | Tablet | Prequalification - Full | |
HA775 | Sulfamethoxazole/Trimethoprim Tablet 800 mg/160 mg | Finished Pharmaceutical Product | HIV/AIDS | Shouguang Fukang Pharmaceutical Co., Ltd. | Tablet | Prequalification - Full | |
HA778 | Ritonavir Tablet, Film-coated 100 mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Abridged | |
HA779 | Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Dispersible 60 mg/5 mg/30 mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Dispersible | Prequalification - Full | |
HA780 | Darunavir (ethanolate) Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen-Cilag International NV | Tablet, Film-coated | 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 | |
HA791 | Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Dispersible 60mg/5mg/30mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Dispersible | Prequalification - Abridged | |
HCnda | Lamivudine/Nevirapine/Zidovudine Tablet 150mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Apotex Pharmachem Inc | Tablet | Alternative Listing | |
HP001 | Sofosbuvir Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Hepatitis B and C | Mylan Laboratories Ltd | Tablet, Film-coated | Prequalification - Full | |
HP002 | Sofosbuvir Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Hepatitis B and C | Hetero Labs 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 | |
HP009 | Sofosbuvir Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Hepatitis B and C | Strides Pharma Science 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 | |
HP012 | Daclatasvir (dihydrochloride) Tablet, Film-coated 60mg | Finished Pharmaceutical Product | Hepatitis B and C | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
HP016 | Daclatasvir (dihydrochloride) Tablet, Film-coated 60mg | Finished Pharmaceutical Product | Hepatitis B and C | Mylan Laboratories 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 | |
HP022 | Daclatasvir (dihydrochloride) Tablet, Film-coated 60mg | Finished Pharmaceutical Product | Hepatitis B and C | Cipla 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 | |
HP025 | Daclatasvir (dihydrochloride)/Sofosbuvir Tablet, Film-coated 60mg/400mg | Finished Pharmaceutical Product | Hepatitis B and C | Mylan Laboratories Ltd | Tablet, Film-coated | Prequalification - Full | |
HP026 | Sofosbuvir/Velpatasvir Tablet, Film-coated 400mg/100mg | Finished Pharmaceutical Product | Hepatitis B and C | Mylan Laboratories 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 | |
HP028 | Daclatasvir (dihydrochloride) Tablet, Film-coated 60mg | Finished Pharmaceutical Product | Hepatitis B and C | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
HP031 | Entecavir Tablet, Film-coated 0.5 mg | Finished Pharmaceutical Product | Hepatitis B and C | BrightGene Bio-Medical Technology Co., Ltd | Tablet, Film-coated | Prequalification - Abridged | |
HP032 | Entecavir Tablet, Film-coated 1 mg | Finished Pharmaceutical Product | Hepatitis B and C | BrightGene Bio-Medical Technology Co., Ltd | Tablet, Film-coated | Prequalification - Abridged | |
HP033 | Daclatasvir (dihydrochloride) Tablet, Film-coated 30 mg | Finished Pharmaceutical Product | Hepatitis B and C | Zydus Lifesciences 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 | |
IN001 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Cipla Ltd | Capsules, hard | Prequalification - Full | |
IN002 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Strides Pharma Science Limited | Capsules, hard | Prequalification - Full | |
IN004 | Oseltamivir (phosphate) Capsules, hard 30mg | Finished Pharmaceutical Product | Influenza | Roche Registration GmbH | Capsules, hard | Prequalification - Abridged | |
IN005 | Oseltamivir (phosphate) Capsules, hard 45mg | Finished Pharmaceutical Product | Influenza | Roche Registration GmbH | Capsules, hard | Prequalification - Abridged | |
IN006 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Roche Registration GmbH | Capsules, hard | Prequalification - Abridged | |
IN007 | Zanamivir Powder, for Inhalation 5mg | Finished Pharmaceutical Product | Influenza | Glaxo Wellcome UK Ltd | Powder, for Inhalation | Prequalification - Abridged | |
IN011 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Mylan Laboratories Ltd | Capsules, hard | Prequalification - Full | |
IN014 | Oseltamivir (phosphate) Capsules, hard 30mg | Finished Pharmaceutical Product | Influenza | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
IN015 | Oseltamivir (phosphate) Capsules, hard 45mg | Finished Pharmaceutical Product | Influenza | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
IN016 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
IN018 | Oseltamivir (phosphate) Capsules, hard 30mg | Finished Pharmaceutical Product | Influenza | MSN Laboratories Private Limited | Capsules, hard | Prequalification - Full | |
IN019 | Oseltamivir (phosphate) Capsules, hard 45mg | Finished Pharmaceutical Product | Influenza | MSN Laboratories Private Limited | Capsules, hard | Prequalification - Full | |
IN020 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | MSN Laboratories Private Limited | Capsules, hard | Prequalification - Full | |
MA026 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Novartis Pharma AG | Tablet | Prequalification - Abridged | |
MA051 | Artesunate Powder for solution for injection + Sodium Bicarbonate Solvent for parenteral use + Sodium Chloride Solvent for parenteral use 60mg/vial + 50mg/ml + 45mg/5ml | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Powder for solution for injection + Solvent for parenteral use + Solvent for parenteral use | Prequalification - Full | |
MA056 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Sanofi | Tablet | Prequalification - Full | |
MA057 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Sanofi | Tablet | Prequalification - Full | |
MA058 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Sanofi | Tablet | Prequalification - Full | |
MA062 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
MA064 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
MA069 | Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg | Finished Pharmaceutical Product | Malaria | Novartis Pharma AG | Tablet, Dispersible | Prequalification - Abridged | |
MA078 | Artesunate/Mefloquine (hydrochloride) Tablet, Film-coated 25mg/50mg | Finished Pharmaceutical Product | Malaria | Drugs for Neglected Diseases Initiative (DNDi) | Tablet, Film-coated | Prequalification - Full |
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