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 |
|---|---|---|---|---|---|---|---|
| HA107 | Abacavir (sulfate) Solution, Oral 20mg/mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Solution, Oral | Prequalification - Abridged | |
| ANDA 077950 USFDA | Abacavir (sulfate) Solution, Oral 20mg/ml | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Solution, Oral | Alternative Listing | |
| ANDA 077844 USFDA | Abacavir (sulfate) Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| ANDA 078742 USFDA | Abacavir (sulfate) Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Ltd | Tablet | Alternative Listing | |
| HA674 | Abacavir (sulfate) Tablet, Dispersible 60mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| HA106 | Abacavir (sulfate) Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | 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 | |
| NDA 217070 USFDA | Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Dispersible 60mg/5mg/30mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet, Dispersible | Alternative Listing | |
| HA791 | Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Dispersible 60mg/5mg/30mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Dispersible | Prequalification - Abridged | |
| ANDA 205412 USFDA | Abacavir (sulfate)/Lamivudine Tablet 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Alternative Listing | |
| ANDA 091144 USFDA | Abacavir (sulfate)/Lamivudine Tablet 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet | Alternative Listing | |
| NDA 207369 USFDA | Abacavir (sulfate)/Lamivudine Tablet 60mg/30mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Alternative Listing | |
| HA662 | Abacavir (sulfate)/Lamivudine Tablet, Dispersible 120mg/60mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Dispersible | Prequalification - Full | |
| HA763 | Abacavir (sulfate)/Lamivudine Tablet, Dispersible 120mg/60mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| HA740 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA706 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA743 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | 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 | |
| HA657 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA635 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Ltd | Tablet, Film-coated | Prequalification - Full | |
| ANDA 90159 USFDA | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet, Film-coated | Alternative Listing | |
| ANDA 090309 USFDA | Abacavir (sulfate)/Lamivudine/Zidovudine Tablet 300mg/150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Ltd | Tablet | Alternative Listing | |
| HA602 | Aciclovir Powder for solution for injection 250mg/vial | Finished Pharmaceutical Product | HIV/AIDS | Demo SA | Powder for solution for injection | Prequalification - Abridged | |
| NT005 | Albendazole Tablet 400mg | Finished Pharmaceutical Product | Neglected tropical diseases | Cipla Ltd | Tablet | Prequalification - Full | |
| TB319 | Amikacin (sulfate) Solution for injection 500mg | Finished Pharmaceutical Product | Tuberculosis | Qilu Pharmaceutical Co.,Ltd | Solution for injection | Prequalification - Full | |
| MA081 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| MA084 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet | Prequalification - Full | |
| MA133 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Micro Labs Limited | Tablet | Prequalification - Full | |
| MA126 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| MA057 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Sanofi | Tablet | Prequalification - Full | |
| MA103 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| MA127 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| MA134 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Micro Labs Limited | Tablet | Prequalification - Full | |
| MA082 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| MA058 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Sanofi | Tablet | Prequalification - Full | |
| MA104 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| MA085 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet | Prequalification - Full | |
| MA132 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Micro Labs Limited | Tablet | Prequalification - Full | |
| MA125 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| MA080 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| MA102 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| MA083 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet | Prequalification - Full | |
| MA056 | Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg | Finished Pharmaceutical Product | Malaria | Sanofi | Tablet | Prequalification - Full | |
| 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 | |
| MA168 | Arginine Solvent for parenteral use + Artesunate (sterile) Powder for solution for injection 20mg/ml + 60mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Solvent for parenteral use + Powder for solution for injection | Prequalification - Full | |
| EMEA/H/W/004252/001 | Arpraziquantel Tablet, Dispersible 150mg | Finished Pharmaceutical Product | Neglected tropical diseases | Merck Europe B.V. | Tablet, Dispersible | ||
| MA088 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Strides Pharma Global PTE Limited | Tablet | Prequalification - Full | |
| MA064 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| MA062 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| MA091 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full |
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