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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 Product Type Therapeutic Area Applicant Dosage Form Basis of Listing Date of Prequalification Sort descending
RH105 Misoprostol Tablet, vaginal 200µg Finished Pharmaceutical Product Reproductive health BIAL-Portela & Ca. SA Tablet, vaginal Prequalification - Abridged
CV009 Molnupiravir Capsules, hard 200 mg Finished Pharmaceutical Product Covid-19 Dr Reddy's Laboratories Limited Capsules, hard Prequalification - Full
DI014 Zinc (sulfate) Tablet, Dispersible 20mg Finished Pharmaceutical Product Diarrhoea Swiss Pharma Nigeria Ltd. Tablet, Dispersible Prequalification - Full
HA770 Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/300mg/300mg Finished Pharmaceutical Product HIV/AIDS Cipla Ltd Tablet, Film-coated Prequalification - Full
BT-DM005 Insulin Glargine Solution for injection 100 U/mL Biotherapeutic Product Diabetes Sanofi-Aventis Deutschland GmbH Solution for injection Prequalification - Abridged
RH102 Desogestrel Tablet, Film-coated 75mcg Finished Pharmaceutical Product Reproductive health NV Organon Tablet, Film-coated Prequalification - Abridged
BT-DM006 Insulin Glargine Solution for injection 100 U/mL Biotherapeutic Product Diabetes Sanofi-Aventis Deutschland GmbH Solution for injection Prequalification - Abridged
HA752 Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg Finished Pharmaceutical Product HIV/AIDS Celltrion Inc. Tablet, Film-coated Prequalification - Full
MA168 Artesunate Powder for solution for injection 60mg Finished Pharmaceutical Product Malaria Guilin Pharmaceutical Co. Ltd Powder for solution for injection Prequalification - Full
DI010 Zinc (sulfate) Syrup 10mg/5ml Finished Pharmaceutical Product Diarrhoea PharmEvo (Pvt) Ltd. Syrup Prequalification - Full
DI009 Zinc (sulfate) Tablet, Dispersible 20mg Finished Pharmaceutical Product Diarrhoea PharmEvo (Pvt) Ltd. Tablet, Dispersible Prequalification - Full
MA172 Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 12.5mg/250mg + 75mg Finished Pharmaceutical Product Malaria Universal Corporation Ltd Tablet, Dispersible + Tablet, Dispersible Prequalification - Full
MA169 Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 25mg/500mg + 150mg Finished Pharmaceutical Product Malaria Universal Corporation Ltd Tablet, Dispersible + Tablet, Dispersible Prequalification - Full
MA179 Pyrimethamine/Sulfadoxine Tablet, Dispersible 25mg/500mg Finished Pharmaceutical Product Malaria Guilin Pharmaceutical Co. Ltd Tablet, Dispersible Prequalification - Full
MA178 Pyrimethamine/Sulfadoxine Tablet, Dispersible 12.50mg/250mg Finished Pharmaceutical Product Malaria Guilin Pharmaceutical Co. Ltd Tablet, Dispersible Prequalification - Full
TB389 Linezolid Tablet, Dispersible 150mg Finished Pharmaceutical Product Tuberculosis Micro Labs Limited Tablet, Dispersible Prequalification - Full
HA760 Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg Finished Pharmaceutical Product HIV/AIDS Micro Labs Limited Tablet, Film-coated Prequalification - Full
HA761 Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg Finished Pharmaceutical Product HIV/AIDS Micro Labs Limited Tablet, Film-coated Prequalification - Full
TB398 Rifapentine Tablet, Film-coated 300 mg Finished Pharmaceutical Product Tuberculosis Macleods Pharmaceuticals 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
MA186 Artesunate Powder for solution for injection 120 mg Finished Pharmaceutical Product Malaria Ipca Laboratories Ltd Powder for solution for injection Prequalification - Full
MA177 Dihydroartemisinin/Piperaquine phosphate Tablet, Film-coated 40mg/320mg Finished Pharmaceutical Product Malaria Beijing Holley-Cotec Pharmaceuticals Co Ltd Tablet, Film-coated Prequalification - Full
CV017 Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg Finished Pharmaceutical Product Covid-19 Celltrion Inc. Tablet, Film-coated + Tablet, Film-coated Prequalification - Full
CV018 Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg Finished Pharmaceutical Product Covid-19 Zhejiang Apeloa Kangyu Pharmaceutical Co Ltd Tablet, Film-coated + Tablet, Film-coated Prequalification - Full
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
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
TB396 Bedaquiline fumarate Tablet 100mg Finished Pharmaceutical Product Tuberculosis Lupin Ltd. Tablet 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
TB401 Pyridoxine hydrochloride Tablet, Film-coated 50mg Finished Pharmaceutical Product Tuberculosis S Kant Healthcare Ltd 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
CV021 Molnupiravir Capsules, hard 200mg Finished Pharmaceutical Product Covid-19 Cipla Ltd Capsules, hard Prequalification - Full
HA775 Sulfamethoxazole/Trimethoprim Tablet 800 mg/160 mg Finished Pharmaceutical Product HIV/AIDS Shouguang Fukang Pharmaceutical Co., Ltd. Tablet Prequalification - Full
CV014 Molnupiravir Capsules, hard 200mg Finished Pharmaceutical Product Covid-19 Aurobindo Pharma Ltd Capsules, hard Prequalification - Full
CV016 Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg Finished Pharmaceutical Product Covid-19 Zhejiang Huahai Pharmaceutical Co. Ltd. Tablet, Film-coated + Tablet, Film-coated 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
HA789 Cabotegravir Suspension for injection 600mg/3mL Finished Pharmaceutical Product HIV/AIDS ViiV Healthcare Pty Ltd Suspension for injection Prequalification - Abridged
HP034 Daclatasvir (dihydrochloride) Tablet, Film-coated 60 mg Finished Pharmaceutical Product Hepatitis B and C Zydus Lifesciences Limited Tablet, Film-coated Prequalification - Full
HA788 Cabotegravir (sodium) Tablet, Film-coated 30mg Finished Pharmaceutical Product HIV/AIDS ViiV Healthcare Pty Ltd Tablet, Film-coated Prequalification - Abridged
MA176 Primaquine (phosphate) Tablet, Film-coated 15mg Finished Pharmaceutical Product Malaria Macleods Pharmaceuticals Ltd Tablet, Film-coated Prequalification - Full
TB392 Isoniazid Tablet 300mg Finished Pharmaceutical Product Tuberculosis Svizera Labs Pvt. Ltd. Tablet 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
NT017 Miltefosine Capsules, hard 50mg Finished Pharmaceutical Product Neglected tropical diseases Zydus Lifesciences Limited Capsules, hard Prequalification - Full
NT013 Praziquantel Tablet, Film-coated 600mg Finished Pharmaceutical Product Neglected tropical diseases Merck Healthcare KGaA Tablet, Film-coated Prequalification - Full
RH093 Ethinylestradiol/Levonorgestrel Tablet, Sugar coated + Placebo Tablet, Film-coated 30mcg/150mcg + 0mg Finished Pharmaceutical Product Reproductive health Renata Ltd Tablet, Sugar coated + Tablet, Film-coated Prequalification - Full
HA791 Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Dispersible 60mg/5mg/30mg Finished Pharmaceutical Product HIV/AIDS ViiV Healthcare BV Tablet, Dispersible Prequalification - Abridged
TD002 Nicotine resinate (polacrilex) 20% Medicated chewing gum 4mg Finished Pharmaceutical Product Disorders caused by tobacco use McNeil Sweden AB Medicated chewing gum Prequalification - Abridged
TD005 Nicotine Patch 25mg/16 hours Finished Pharmaceutical Product Disorders caused by tobacco use McNeil Sweden AB Patch Prequalification - Abridged
TD004 Nicotine Patch 15mg/16 hours Finished Pharmaceutical Product Disorders caused by tobacco use McNeil Sweden AB Patch Prequalification - Abridged
TD003 Nicotine Patch 10mg/16 hours Finished Pharmaceutical Product Disorders caused by tobacco use McNeil Sweden AB Patch Prequalification - Abridged
TD001 Nicotine resinate (polacrilex) 20% Medicated chewing gum 2mg Finished Pharmaceutical Product Disorders caused by tobacco use McNeil Sweden AB Medicated chewing gum Prequalification - Abridged

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