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
- 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.
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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 |
|---|---|---|---|---|---|---|---|
| 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 | ||
| HA573 | Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HP031 | Entecavir Tablet, Film-coated 0.5 mg | Finished Pharmaceutical Product | Hepatitis B and C | BrightGene Bio-Medical Technology Co., Ltd | Tablet, Film-coated | Prequalification - Abridged | |
| HA631 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA683 | Darunavir (ethanolate) Tablet, Film-coated 800mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA740 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA787 | Ritonavir Tablet, Film-coated 100mg | Finished Pharmaceutical Product | HIV/AIDS | Shanghai Desano Bio-Pharmaceutical Co., Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HP025 | Daclatasvir (dihydrochloride)/Sofosbuvir Tablet, Film-coated 60mg/400mg | Finished Pharmaceutical Product | Hepatitis B and C | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| NDA 210880 USFDA | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Alternative Listing | |
| HA426 | Lamivudine/Nevirapine/Zidovudine Tablet, Film-coated 150mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA721 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Abridged | |
| HA620 | Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| ANDA 090679 USFDA | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| TB297 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| ANDA 090198 USFDA | Lamivudine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| HA772 | Atazanavir (sulfate)/Ritonavir Tablet, Film-coated 300mg/100mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus 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 | |
| HA761 | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA760 | Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| TB323 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA629 | Lamivudine/Nevirapine/Zidovudine Tablet, Film-coated 150mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA644 | Lamivudine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HP001 | Sofosbuvir Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Hepatitis B and C | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HP027 | Daclatasvir (dihydrochloride) Tablet, Film-coated 30mg | Finished Pharmaceutical Product | Hepatitis B and C | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| TB277 | Levofloxacin Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| ANDA 213541 USFDA | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Alternative Listing | |
| TB205 | Levofloxacin Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB377 | Levofloxacin Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Zhejiang Apeloa Kangyu Pharmaceutical Co Ltd | Tablet, Film-coated | Prequalification - Full | |
| RH102 | Desogestrel Tablet, Film-coated 75mcg | Finished Pharmaceutical Product | Reproductive health | NV Organon | Tablet, Film-coated | Prequalification - Abridged | |
| HA656 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Anhui Biochem Bio-Pharmaceutical Co Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA780 | Darunavir (ethanolate) Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen-Cilag International NV | Tablet, Film-coated | Prequalification - Abridged | |
| HA060 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA417 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| TB206 | Protionamide Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HA657 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA778 | Ritonavir Tablet, Film-coated 100 mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Abridged | |
| HA427 | Efavirenz Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Merck Sharp & Dohme BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA392 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| NT004 | Praziquantel Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Neglected tropical diseases | Macleods Pharmaceuticals Ltd | 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 | |
| HP034 | Daclatasvir (dihydrochloride) Tablet, Film-coated 60 mg | Finished Pharmaceutical Product | Hepatitis B and C | Zydus Lifesciences Limited | 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 | |
| MA176 | Primaquine (phosphate) Tablet, Film-coated 15mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB286 | Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| TB401 | Pyridoxine hydrochloride Tablet, Film-coated 50mg | Finished Pharmaceutical Product | Tuberculosis | S Kant Healthcare Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA424 | Lamivudine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA746 | Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Desano Pharmaceuticals Private Limited | Tablet, Film-coated | Prequalification - Full | |
| TB350 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HA680 | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA459 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full |
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