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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: 201 - 250 of 667
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WHO Reference Number INN, Dosage Form and Strength Product Type Therapeutic Area Applicant Dosage Form Sort descending Basis of Listing Date of Prequalification
RH094 Misoprostol Tablet 200mcg Finished Pharmaceutical Product Reproductive health Mylan Laboratories Limited Tablet Prequalification - Full
HA567 Nevirapine Tablet 20mg Finished Pharmaceutical Product HIV/AIDS Micro Labs Limited Tablet Prequalification - Full
ANDA 077267 USFDA Zidovudine Tablet 300mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet Alternative Listing
RH052 Mifepristone Tablet 200mg Finished Pharmaceutical Product Reproductive health China Resources Zizhu Pharmaceutical Co Ltd Tablet Prequalification - Full
ANDA 090513 USFDA Emtricitabine/Tenofovir disoproxil fumarate Tablet 200mg/300mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet Alternative Listing
MA102 Amodiaquine (hydrochloride)/Artesunate Tablet 67.5mg/25mg Finished Pharmaceutical Product Malaria Cipla Ltd Tablet Prequalification - Full
ANDA 091144 USFDA Abacavir (sulfate)/Lamivudine Tablet 600mg/300mg Finished Pharmaceutical Product HIV/AIDS Cipla Ltd Tablet Alternative Listing
MA129 Artemether/Lumefantrine Tablet 60mg/360mg Finished Pharmaceutical Product Malaria Ajanta Pharma Ltd Tablet Prequalification - Full
MA165 (Suspended) Artemether/Lumefantrine Tablet 80mg/480mg Finished Pharmaceutical Product Malaria Guilin Pharmaceutical Co. Ltd Tablet Prequalification - Full
ANDA 078644 USFDA Nevirapine Tablet 200mg Finished Pharmaceutical Product HIV/AIDS Zhejiang Huahai Pharmaceutical Co. Ltd. Tablet Alternative Listing
MA111 Artemether/Lumefantrine Tablet 20mg/120mg Finished Pharmaceutical Product Malaria Ajanta Pharma Ltd Tablet Prequalification - Full
ANDA 090471a USFDA Lopinavir/Ritonavir Tablet 100mg/25mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet Alternative Listing
RH069 Levonorgestrel Tablet 1.5mg Finished Pharmaceutical Product Reproductive health Laboratorios León Farma SA 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
MA082 Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg Finished Pharmaceutical Product Malaria Ipca Laboratories Ltd Tablet Prequalification - Full
TB386 Pretomanid Tablet 200mg Finished Pharmaceutical Product Tuberculosis Mylan Laboratories Limited Tablet Prequalification - Abridged
MA081 Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg Finished Pharmaceutical Product Malaria Ipca Laboratories Ltd Tablet Prequalification - Full
MA143 Artemether/Lumefantrine Tablet 40mg/240mg Finished Pharmaceutical Product Malaria Macleods Pharmaceuticals Ltd Tablet Prequalification - Full
HA598 Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg Finished Pharmaceutical Product HIV/AIDS Micro Labs Limited Tablet Prequalification - Full
ANDA 077673 USFDA Efavirenz Tablet 600mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet Alternative Listing
TB196 Isoniazid Tablet 100mg Finished Pharmaceutical Product Tuberculosis Lupin Ltd. Tablet Prequalification - Full
MA104 Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg Finished Pharmaceutical Product Malaria Cipla Ltd Tablet Prequalification - Full
ANDA 079124 USFDA Lamivudine/Zidovudine Tablet 150mg/300mg Finished Pharmaceutical Product HIV/AIDS Hetero Labs Ltd Tablet Alternative Listing
HA568 Nevirapine Tablet 50mg Finished Pharmaceutical Product HIV/AIDS Micro Labs Limited Tablet Prequalification - Full
HA691 Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg Finished Pharmaceutical Product HIV/AIDS Milan Laboratories (India) Pvt Ltd Tablet Prequalification - Full
HA686 Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg 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
HA693 Flucytosine Tablet 500mg Finished Pharmaceutical Product HIV/AIDS Mylan Laboratories Limited Tablet Prequalification - Abridged
RH098 Levonorgestrel Tablet 1.5mg Finished Pharmaceutical Product Reproductive health Naari BV Tablet Prequalification - Abridged
RH048 Misoprostol Tablet 200mcg Finished Pharmaceutical Product Reproductive health China Resources Zizhu Pharmaceutical Co Ltd 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
MA058 Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg Finished Pharmaceutical Product Malaria Sanofi Tablet Prequalification - Full
ANDA 078922 USFDA Zidovudine Tablet 300mg Finished Pharmaceutical Product HIV/AIDS Mylan Laboratories Limited Tablet Alternative Listing
HA736 Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg Finished Pharmaceutical Product HIV/AIDS Macleods Pharmaceuticals Ltd Tablet Prequalification - Full
TB308 Isoniazid Tablet 100mg Finished Pharmaceutical Product Tuberculosis Mylan Laboratories Limited Tablet Prequalification - Full
HA569 Nevirapine Tablet 100mg Finished Pharmaceutical Product HIV/AIDS Micro Labs Limited Tablet Prequalification - Full
MA160 Artemether/Lumefantrine Tablet 80mg/480mg Finished Pharmaceutical Product Malaria Ipca Laboratories Ltd Tablet Prequalification - Full
ANDA 077844 USFDA Abacavir (sulfate) Tablet 300mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet Alternative Listing
MA088 Artemether/Lumefantrine Tablet 20mg/120mg Finished Pharmaceutical Product Malaria Strides Pharma Global PTE Limited Tablet Prequalification - Full
TB383 Pyridoxine hydrochloride Tablet 50mg Finished Pharmaceutical Product Tuberculosis Macleods Pharmaceuticals Ltd Tablet Prequalification - Full
ANDA 078958 USFDA Efavirenz Tablet 600mg Finished Pharmaceutical Product HIV/AIDS Emcure Pharmaceuticals Limited Tablet Alternative Listing
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
MA026 Artemether/Lumefantrine Tablet 20mg/120mg Finished Pharmaceutical Product Malaria Novartis Pharma AG Tablet Prequalification - Abridged
NT009 Ivermectin Tablet 3mg Finished Pharmaceutical Product Neglected tropical diseases Edenbridge Pharmaceuticals LLC Tablet Prequalification - Abridged
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

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