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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: 651 - 667 of 667
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WHO Reference Number INN, Dosage Form and Strength Product Type Therapeutic Area Applicant Dosage Form Basis of Listing Date of Prequalification
MA192 Pyrimethamine/Sulfadoxine Tablet, Dispersible 25mg/500mg Finished Pharmaceutical Product Malaria Ipca Laboratories Ltd Tablet, Dispersible Prequalification - Full
HA769 Flucytosine Tablet 500mg Finished Pharmaceutical Product HIV/AIDS Macleods Pharmaceuticals Ltd Tablet Prequalification - Full
MA193 Pyrimethamine/Sulfadoxine Tablet 25mg/500mg Finished Pharmaceutical Product Malaria S Kant Healthcare Ltd Tablet Prequalification - Full
EMEA/H/W/004252/001 Arpraziquantel Tablet, Dispersible 150mg Finished Pharmaceutical Product Neglected tropical diseases Merck Europe B.V. Tablet, Dispersible
CV022 Molnupiravir Capsules, hard 200mg Finished Pharmaceutical Product Covid-19 Mylan Laboratories Limited Capsules, hard Prequalification - Full
MA194 Artesunate Powder for solution for injection 120mg Finished Pharmaceutical Product Malaria Macleods Pharmaceuticals Ltd Powder for solution for injection Prequalification - Full
NDA 215448 USFDA Dolutegravir (sodium)/Emtricitabine/Tenofovir alafenamide Tablet, Film-coated 50mg/200mg/25mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet, Film-coated
ANDA 216875 USFDA Emtricitabine/Tenofovir alafenamide Tablet, Film-coated 200mg/25mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet, Film-coated
ANDA 210642 USFDA Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Film-coated 600mg/50mg/300mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet, Film-coated
HA791 Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Dispersible 60mg/5mg/30mg Finished Pharmaceutical Product HIV/AIDS ViiV Healthcare BV Tablet, Dispersible Prequalification - Abridged
HA787 Ritonavir Tablet, Film-coated 100mg Finished Pharmaceutical Product HIV/AIDS Shanghai Desano Bio-Pharmaceutical Co., Ltd. Tablet, Film-coated Prequalification - Full
HA782 Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg Finished Pharmaceutical Product HIV/AIDS Reyoung Pharmaceutical Co., Ltd. Tablet Prequalification - Full
HA783 Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg Finished Pharmaceutical Product HIV/AIDS Reyoung Pharmaceutical Co., Ltd. Tablet Prequalification - Full
CV023 Molnupiravir Capsules, hard 200mg Finished Pharmaceutical Product Covid-19 Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. Capsules, hard Prequalification - Full
CV019 Molnupiravir Capsules, hard 200mg Finished Pharmaceutical Product Covid-19 Shanghai Desano Bio-Pharmaceutical Co., Ltd. Capsules, hard Prequalification - Full
TB393 Rifapentine Tablet, Film-coated 300mg Finished Pharmaceutical Product Tuberculosis Lupin Ltd. Tablet, Film-coated Prequalification - Full
HA786 Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg Finished Pharmaceutical Product HIV/AIDS Emcure Pharmaceuticals Limited Tablet, Film-coated Prequalification - Full
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