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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
Note:
  • 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.
Displaying: 601 - 650 of 667
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WHO Reference Number INN, Dosage Form and Strength Sort ascending Product Type Therapeutic Area Applicant Dosage Form Basis of Listing Date of Prequalification
MA137 Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg Finished Pharmaceutical Product Malaria Macleods Pharmaceuticals Ltd Tablet, Dispersible Prequalification - Full
MA160 Artemether/Lumefantrine Tablet 80mg/480mg Finished Pharmaceutical Product Malaria Ipca Laboratories Ltd Tablet Prequalification - Full
MA165 (Suspended) Artemether/Lumefantrine Tablet 80mg/480mg Finished Pharmaceutical Product Malaria Guilin Pharmaceutical Co. Ltd Tablet Prequalification - Full
MA122 Artemether/Lumefantrine Tablet 80mg/480mg Finished Pharmaceutical Product Malaria Cipla Ltd Tablet Prequalification - Full
MA108 Artemether/Lumefantrine Tablet 80mg/480mg Finished Pharmaceutical Product Malaria Novartis Pharma AG Tablet Prequalification - Full
MA130 Artemether/Lumefantrine Tablet 80mg/480mg Finished Pharmaceutical Product Malaria Ajanta Pharma Ltd Tablet Prequalification - Full
MA142 Artemether/Lumefantrine Tablet 80mg/480mg Finished Pharmaceutical Product Malaria Macleods Pharmaceuticals Ltd Tablet Prequalification - Full
MA138 Artemether/Lumefantrine Tablet 80mg/480mg Finished Pharmaceutical Product Malaria Strides Pharma Global PTE Limited Tablet Prequalification - Full
MA129 Artemether/Lumefantrine Tablet 60mg/360mg Finished Pharmaceutical Product Malaria Ajanta Pharma Ltd Tablet Prequalification - Full
MA128 Artemether/Lumefantrine Tablet 40mg/240mg Finished Pharmaceutical Product Malaria Ajanta Pharma Ltd Tablet Prequalification - Full
MA143 Artemether/Lumefantrine Tablet 40mg/240mg Finished Pharmaceutical Product Malaria Macleods Pharmaceuticals Ltd Tablet Prequalification - Full
MA100 Artemether/Lumefantrine Tablet 40mg/240mg Finished Pharmaceutical Product Malaria Mylan Laboratories Limited Tablet Prequalification - Full
MA064 Artemether/Lumefantrine Tablet 20mg/120mg Finished Pharmaceutical Product Malaria Cipla Ltd Tablet Prequalification - Full
MA164 (Suspended) Artemether/Lumefantrine Tablet 20mg/120mg Finished Pharmaceutical Product Malaria Guilin Pharmaceutical Co. Ltd Tablet Prequalification - Full
MA091 Artemether/Lumefantrine Tablet 20mg/120mg Finished Pharmaceutical Product Malaria Macleods Pharmaceuticals Ltd Tablet Prequalification - Full
MA099 Artemether/Lumefantrine Tablet 20mg/120mg Finished Pharmaceutical Product Malaria Mylan Laboratories Limited Tablet Prequalification - Full
MA167 Artemether/Lumefantrine Tablet 20mg/120mg Finished Pharmaceutical Product Malaria Laboratorios Basi - Industria Farmaceutica SA Tablet Prequalification - Full
MA062 Artemether/Lumefantrine Tablet 20mg/120mg Finished Pharmaceutical Product Malaria Ipca Laboratories Ltd Tablet Prequalification - Full
MA088 Artemether/Lumefantrine Tablet 20mg/120mg Finished Pharmaceutical Product Malaria Strides Pharma Global PTE Limited Tablet Prequalification - Full
MA111 Artemether/Lumefantrine Tablet 20mg/120mg Finished Pharmaceutical Product Malaria Ajanta Pharma Ltd Tablet Prequalification - Full
MA026 Artemether/Lumefantrine Tablet 20mg/120mg Finished Pharmaceutical Product Malaria Novartis Pharma AG Tablet Prequalification - Abridged
EMEA/H/W/004252/001 Arpraziquantel Tablet, Dispersible 150mg Finished Pharmaceutical Product Neglected tropical diseases Merck Europe B.V. Tablet, Dispersible
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
MA102 Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg Finished Pharmaceutical Product Malaria Cipla Ltd Tablet Prequalification - Full
MA056 Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg Finished Pharmaceutical Product Malaria Sanofi Tablet Prequalification - Full
MA132 Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg Finished Pharmaceutical Product Malaria Micro Labs Limited Tablet Prequalification - Full
MA083 Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg Finished Pharmaceutical Product Malaria Guilin Pharmaceutical Co. Ltd Tablet Prequalification - Full
MA080 Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg Finished Pharmaceutical Product Malaria Ipca Laboratories Ltd Tablet Prequalification - Full
MA125 Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg Finished Pharmaceutical Product Malaria Macleods Pharmaceuticals Ltd Tablet Prequalification - Full
MA127 Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg Finished Pharmaceutical Product Malaria Macleods Pharmaceuticals Ltd 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
MA134 Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg Finished Pharmaceutical Product Malaria Micro Labs Limited 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
MA133 Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg Finished Pharmaceutical Product Malaria Micro Labs Limited Tablet Prequalification - Full
MA103 Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg Finished Pharmaceutical Product Malaria Cipla Ltd 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
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
TB319 Amikacin (sulfate) Solution for injection 500mg Finished Pharmaceutical Product Tuberculosis Qilu Pharmaceutical Co.,Ltd Solution for injection Prequalification - Full
NT005 Albendazole Tablet 400mg Finished Pharmaceutical Product Neglected tropical diseases Cipla Ltd Tablet Prequalification - Full
HA602 Aciclovir Powder for solution for injection 250mg/vial Finished Pharmaceutical Product HIV/AIDS Demo SA Powder for solution for injection Prequalification - Abridged
ANDA 090309 USFDA Abacavir (sulfate)/Lamivudine/Zidovudine Tablet 300mg/150mg/300mg Finished Pharmaceutical Product HIV/AIDS Mylan Laboratories Limited Tablet Alternative Listing
HA657 Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg Finished Pharmaceutical Product HIV/AIDS Hetero Labs Ltd Tablet, Film-coated Prequalification - Full
HA740 Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg Finished Pharmaceutical Product HIV/AIDS Macleods Pharmaceuticals Ltd Tablet, Film-coated Prequalification - Full
HA635 Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg Finished Pharmaceutical Product HIV/AIDS Mylan Laboratories Limited 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
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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