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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: 501 - 550 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
HA736 Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg Finished Pharmaceutical Product HIV/AIDS Macleods Pharmaceuticals Ltd Tablet Prequalification - Full
HA735 Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg Finished Pharmaceutical Product HIV/AIDS Macleods Pharmaceuticals Ltd Tablet Prequalification - Full
RH068 Levonorgestrel Tablet 0.75mg Finished Pharmaceutical Product Reproductive health Laboratorios León Farma SA Tablet Prequalification - Full
RH069 Levonorgestrel Tablet 1.5mg Finished Pharmaceutical Product Reproductive health Laboratorios León Farma SA Tablet Prequalification - Full
HA745 Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg Finished Pharmaceutical Product HIV/AIDS Ipca Laboratories Ltd Tablet Prequalification - Full
HA744 Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg Finished Pharmaceutical Product HIV/AIDS Ipca Laboratories Ltd Tablet Prequalification - Full
HA722 Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg Finished Pharmaceutical Product HIV/AIDS Emcure Pharmaceuticals Ltd Tablet, Film-coated Prequalification - Full
BT-ON014 Water for Injection Solvent for parenteral use + Trastuzumab Powder for concentrate for solution for infusion 20mL + 420mg Biotherapeutic Product Oncology Biocon Biologics Limited Solvent for parenteral use + Powder for concentrate for solution for infusion Prequalification - Full
BT-ON013 Trastuzumab Powder for concentrate for solution for infusion 150mg Biotherapeutic Product Oncology Biocon Biologics Limited Powder for concentrate for solution for infusion Prequalification - Full
TB359 Isoniazid Tablet, Dispersible 100mg Finished Pharmaceutical Product Tuberculosis Macleods Pharmaceuticals Ltd Tablet, Dispersible Prequalification - Full
NT005 Albendazole Tablet 400mg Finished Pharmaceutical Product Neglected tropical diseases Cipla Ltd Tablet Prequalification - Full
MA144 Pyrimethamine/Sulfadoxine Tablet, Dispersible 12.5mg/250mg Finished Pharmaceutical Product Malaria S Kant Healthcare Ltd Tablet, Dispersible Prequalification - Full
MA146 Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 12.5mg/250mg + 75mg Finished Pharmaceutical Product Malaria S Kant Healthcare Ltd Tablet, Dispersible + Tablet, Dispersible Prequalification - Full
MA147 Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 25mg/500mg + 150mg Finished Pharmaceutical Product Malaria S Kant Healthcare Ltd Tablet, Dispersible + Tablet, Dispersible Prequalification - Full
MA145 Pyrimethamine/Sulfadoxine Tablet, Dispersible 25mg/500mg Finished Pharmaceutical Product Malaria S Kant Healthcare Ltd Tablet, Dispersible Prequalification - Full
MA154 (Suspended) Artemether/Lumefantrine Tablet, Dispersible 40mg/240mg Finished Pharmaceutical Product Malaria Guilin Pharmaceutical Co. Ltd Tablet, Dispersible Prequalification - Full
MA153 (Suspended) Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg Finished Pharmaceutical Product Malaria Guilin Pharmaceutical Co., Ltd. Tablet, Dispersible Prequalification - Full
MA152 Artesunate Powder for solution for injection 60mg Finished Pharmaceutical Product Malaria Macleods Pharmaceuticals Ltd Powder for solution for injection Prequalification - Full
MA155 (Suspended) Artemether/Lumefantrine Tablet, Dispersible 60mg/360mg Finished Pharmaceutical Product Malaria Guilin Pharmaceutical Co. Ltd 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
RH098 Levonorgestrel Tablet 1.5mg Finished Pharmaceutical Product Reproductive health Naari BV Tablet Prequalification - Abridged
NT007 Ivermectin Tablet 3mg Finished Pharmaceutical Product Neglected tropical diseases Laboratorios Liconsa SA Tablet Prequalification - Full
RH090 Medroxyprogesterone acetate Suspension for injection 150mg/ml Finished Pharmaceutical Product Reproductive health Tunggal Idaman Abdi (PT) Suspension for injection Prequalification - Full
HA719 Darunavir (ethanolate)/Ritonavir Tablet, Film-coated 400mg/50mg Finished Pharmaceutical Product HIV/AIDS Hetero Labs Ltd Tablet, Film-coated Prequalification - Full
MA158 Pyrimethamine/Sulfadoxine Tablet, Dispersible 12.5mg/250mg Finished Pharmaceutical Product Malaria Macleods Pharmaceuticals Ltd Tablet, Dispersible Prequalification - Full
HA768 Dolutegravir (sodium) Tablet, Dispersible 5mg Finished Pharmaceutical Product HIV/AIDS ViiV Healthcare BV Tablet, Dispersible Prequalification - Abridged
MA159 Pyrimethamine/Sulfadoxine Tablet, Dispersible 25mg/500mg Finished Pharmaceutical Product Malaria Macleods Pharmaceuticals Ltd Tablet, Dispersible Prequalification - Full
TB360 Isoniazid/Rifampicin Tablet, Dispersible 50mg/75mg Finished Pharmaceutical Product Tuberculosis Lupin Ltd. Tablet, Dispersible Prequalification - Full
TB381 Levofloxacin Tablet, Film-coated 250mg Finished Pharmaceutical Product Tuberculosis Remington Pharmaceutical Industries (Pvt) Ltd Tablet, Film-coated Prequalification - Full
TB353 Protionamide Tablet, Film-coated 250mg Finished Pharmaceutical Product Tuberculosis LEKHIM Joint Stock Company Tablet, Film-coated Prequalification - Full
CV006 Dexamethasone (sodium phosphate) Solution for injection 4mg/ml (2ml) Finished Pharmaceutical Product Covid-19 Demo SA Solution for injection Prequalification - Abridged
HA753 Flucytosine Tablet 250mg Finished Pharmaceutical Product HIV/AIDS Mylan Laboratories Limited Tablet Prequalification - Full
HA754 Flucytosine Tablet 500mg Finished Pharmaceutical Product HIV/AIDS Mylan Laboratories Limited Tablet Prequalification - Full
TB367 Ethambutol hydrochloride Tablet, Dispersible 50mg Finished Pharmaceutical Product Tuberculosis Micro Labs Limited Tablet, Dispersible Prequalification - Full
TB368 Ethambutol hydrochloride Tablet, Dispersible 100mg Finished Pharmaceutical Product Tuberculosis Micro Labs Limited Tablet, Dispersible Prequalification - Full
TB373 Levofloxacin Tablet, Film-coated 500mg Finished Pharmaceutical Product Tuberculosis PT Sanbe Farma Tablet, Film-coated Prequalification - Full
DI013 Zinc (sulfate) Tablet, Dispersible 20mg Finished Pharmaceutical Product Diarrhoea The ACME Laboratories Ltd Tablet, Dispersible Prequalification - Full
TB376 Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg Finished Pharmaceutical Product Tuberculosis Lupin Ltd. Tablet, Film-coated Prequalification - Full
HA741 Ritonavir Tablet, Film-coated 25mg Finished Pharmaceutical Product HIV/AIDS Cipla Ltd Tablet, Film-coated Prequalification - Full
HA765 Dolutegravir (sodium) Tablet, Dispersible 10mg Finished Pharmaceutical Product HIV/AIDS Macleods Pharmaceuticals Ltd Tablet, Dispersible Prequalification - Full
RH099 Misoprostol Tablet, vaginal 25μg Finished Pharmaceutical Product Reproductive health BIAL-Portela & Ca. SA Tablet, vaginal Prequalification - Abridged
CV005 Dexamethasone (sodium phosphate) Solution for injection 4mg/ml (1ml) Finished Pharmaceutical Product Covid-19 Demo SA Solution for injection Prequalification - Abridged
MA165 (Suspended) Artemether/Lumefantrine Tablet 80mg/480mg Finished Pharmaceutical Product Malaria Guilin Pharmaceutical Co. Ltd Tablet Prequalification - Full
MA164 (Suspended) Artemether/Lumefantrine Tablet 20mg/120mg Finished Pharmaceutical Product Malaria Guilin Pharmaceutical Co. Ltd Tablet Prequalification - Full
MA160 Artemether/Lumefantrine Tablet 80mg/480mg Finished Pharmaceutical Product Malaria Ipca Laboratories Ltd Tablet Prequalification - Full
MA167 Artemether/Lumefantrine Tablet 20mg/120mg Finished Pharmaceutical Product Malaria Laboratorios Basi - Industria Farmaceutica SA Tablet Prequalification - Full
BT-CV003 Tocilizumab Concentrate for solution for infusion 20mg/ml (Each vial contains 400 mg of tocilizumab in 20 mL) Biotherapeutic Product Covid-19 Roche Registration GmbH Concentrate for solution for infusion Prequalification - Abridged
BT-CV002 Tocilizumab Concentrate for solution for infusion 20mg/ml (Each vial contains 200 mg of tocilizumab in 10 mL) Biotherapeutic Product Covid-19 Roche Registration GmbH Concentrate for solution for infusion Prequalification - Abridged
BT-CV001 Tocilizumab Concentrate for solution for infusion 20mg/ml (Each vial contains 80 mg of tocilizumab in 4 mL) Biotherapeutic Product Covid-19 Roche Registration GmbH Concentrate for solution for infusion Prequalification - Abridged
HA725 Darunavir Tablet, Film-coated 800mg Finished Pharmaceutical Product HIV/AIDS MSN Laboratories Private Limited Tablet, Film-coated Prequalification - Full

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