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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: 401 - 450 of 667
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WHO Reference Number INN, Dosage Form and Strength Product Type Therapeutic Area Applicant Dosage Form Sort ascending Basis of Listing Date of Prequalification
RH065 Levonorgestrel Tablet 1.5mg Finished Pharmaceutical Product Reproductive health HLL Lifecare Limited Tablet Prequalification - Full
ANDA 205412 USFDA Abacavir (sulfate)/Lamivudine Tablet 600mg/300mg Finished Pharmaceutical Product HIV/AIDS Hetero Labs Ltd Tablet Alternative Listing
TB015 Pyrazinamide Tablet 400mg Finished Pharmaceutical Product Tuberculosis Cadila Pharmaceuticals Ltd Tablet Prequalification - Full
HA569 Nevirapine Tablet 100mg Finished Pharmaceutical Product HIV/AIDS Micro Labs Limited Tablet Prequalification - Full
NDA 207369 USFDA Abacavir (sulfate)/Lamivudine Tablet 60mg/30mg Finished Pharmaceutical Product HIV/AIDS Hetero Labs Ltd Tablet Alternative Listing
MA080 Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg Finished Pharmaceutical Product Malaria Ipca Laboratories Ltd Tablet Prequalification - Full
ANDA 203041 USFDA Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet 600mg/200mg/300mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet Alternative Listing
ANDA 090513 USFDA Emtricitabine/Tenofovir disoproxil fumarate Tablet 200mg/300mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet Alternative Listing
RH021 Lynestrenol Tablet 500mcg Finished Pharmaceutical Product Reproductive health NV Organon Tablet Prequalification - Abridged
RH069 Levonorgestrel Tablet 1.5mg Finished Pharmaceutical Product Reproductive health Laboratorios León Farma SA Tablet Prequalification - Full
RH032 Levonorgestrel Tablet 750mcg Finished Pharmaceutical Product Reproductive health Mylan Laboratories Limited Tablet Prequalification - Full
MA132 Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg Finished Pharmaceutical Product Malaria Micro Labs Limited Tablet Prequalification - Full
MA058 Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg Finished Pharmaceutical Product Malaria Sanofi Tablet Prequalification - Full
RH039 Misoprostol Tablet 200mcg Finished Pharmaceutical Product Reproductive health Cipla Ltd Tablet Prequalification - Full
HA748 Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg Finished Pharmaceutical Product HIV/AIDS Eumedica Pharmaceuticals AG Tablet Prequalification - Abridged
RH068 Levonorgestrel Tablet 0.75mg Finished Pharmaceutical Product Reproductive health Laboratorios León Farma SA Tablet Prequalification - Full
HA775 Sulfamethoxazole/Trimethoprim Tablet 800 mg/160 mg Finished Pharmaceutical Product HIV/AIDS Shouguang Fukang Pharmaceutical Co., Ltd. Tablet Prequalification - Full
HA774 Sulfamethoxazole/Trimethoprim Tablet 400 mg/80 mg Finished Pharmaceutical Product HIV/AIDS Shouguang Fukang Pharmaceutical Co., Ltd. Tablet Prequalification - Full
TB396 Bedaquiline fumarate Tablet 100mg Finished Pharmaceutical Product Tuberculosis Lupin Ltd. Tablet Prequalification - Full
ANDA 090471b USFDA Lopinavir/Ritonavir Tablet 200mg/50mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet Alternative Listing
RH056 Misoprostol Tablet 200mcg Finished Pharmaceutical Product Reproductive health Acme Formulation Pvt. Limited Tablet Prequalification - Full
MA167 Artemether/Lumefantrine Tablet 20mg/120mg Finished Pharmaceutical Product Malaria Laboratorios Basi - Industria Farmaceutica SA Tablet Prequalification - Full
NDA 22461c USFDA Efavirenz Tablet 200mg Finished Pharmaceutical Product HIV/AIDS Mylan Laboratories Limited Tablet Alternative Listing
MA057 Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg Finished Pharmaceutical Product Malaria Sanofi Tablet Prequalification - Full
MA125 Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg Finished Pharmaceutical Product Malaria Macleods Pharmaceuticals Ltd Tablet Prequalification - Full
TB392 Isoniazid Tablet 300mg Finished Pharmaceutical Product Tuberculosis Svizera Labs Pvt. Ltd. Tablet Prequalification - Full
MA099 Artemether/Lumefantrine Tablet 20mg/120mg Finished Pharmaceutical Product Malaria Mylan Laboratories Limited Tablet Prequalification - Full
TB159 Pyrazinamide Tablet 400mg Finished Pharmaceutical Product Tuberculosis Macleods Pharmaceuticals Ltd Tablet Prequalification - Full
MA062 Artemether/Lumefantrine Tablet 20mg/120mg Finished Pharmaceutical Product Malaria Ipca Laboratories Ltd Tablet Prequalification - Full
HA599 Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg Finished Pharmaceutical Product HIV/AIDS Micro Labs Limited Tablet Prequalification - Full
MA056 Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg Finished Pharmaceutical Product Malaria Sanofi Tablet Prequalification - Full
TB179 Isoniazid Tablet 300mg Finished Pharmaceutical Product Tuberculosis Macleods Pharmaceuticals Ltd Tablet Prequalification - Full
ANDA 077464b USFDA Lamivudine Tablet 300mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet Alternative Listing
TB243 Pyrazinamide Tablet 500mg Finished Pharmaceutical Product Tuberculosis Macleods Pharmaceuticals Ltd Tablet Prequalification - Full
HCnda Lamivudine/Nevirapine/Zidovudine Tablet 150mg/200mg/300mg Finished Pharmaceutical Product HIV/AIDS Apotex Pharmachem Inc Tablet Alternative Listing
RH037 Desogestrel/Ethinylestradiol Tablet 0.150mg/0.030mg Finished Pharmaceutical Product Reproductive health Mylan Laboratories Limited Tablet Prequalification - Abridged
MA113 Pyrimethamine/Sulfadoxine Tablet 25mg/500mg Finished Pharmaceutical Product Malaria Guilin Pharmaceutical Co. Ltd Tablet Prequalification - Full
HA745 Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg Finished Pharmaceutical Product HIV/AIDS Ipca Laboratories Ltd Tablet Prequalification - Full
HA783 Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg Finished Pharmaceutical Product HIV/AIDS Reyoung Pharmaceutical Co., Ltd. Tablet Prequalification - Full
HA782 Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg Finished Pharmaceutical Product HIV/AIDS Reyoung Pharmaceutical Co., Ltd. Tablet Prequalification - Full
TB375 Isoniazid Tablet 300mg Finished Pharmaceutical Product Tuberculosis Lupin Ltd. Tablet Prequalification - Full
NT002 Diethylcarbamazine (citrate) Tablet 100mg Finished Pharmaceutical Product Neglected tropical diseases Eisai Co Ltd Tablet Prequalification - Full
MA193 Pyrimethamine/Sulfadoxine Tablet 25mg/500mg Finished Pharmaceutical Product Malaria S Kant Healthcare Ltd Tablet Prequalification - Full
RH061 Mifepristone Tablet 200mg Finished Pharmaceutical Product Reproductive health Exelgyn Tablet Prequalification - Abridged
ANDA 090647 USFDA Tenofovir disoproxil fumarate Tablet 300mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet Alternative Listing
ANDA 077464a USFDA Lamivudine Tablet 150mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet Alternative Listing
HA769 Flucytosine Tablet 500mg 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
TB267 Pyrazinamide Tablet 500mg Finished Pharmaceutical Product Tuberculosis Antibiotice SA Tablet Prequalification - Abridged
MA133 Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg Finished Pharmaceutical Product Malaria Micro Labs Limited Tablet Prequalification - Full

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