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 Sort descending | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| IN001 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Cipla Ltd | Capsules, hard | Prequalification - Full | |
| MA088 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Strides Pharma Global PTE Limited | Tablet | Prequalification - Full | |
| MA117 | Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 25mg/500mg + 153mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible + Tablet, Dispersible | 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 | |
| HA567 | Nevirapine Tablet 20mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| TB350 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| ANDA 091144 USFDA | Abacavir (sulfate)/Lamivudine Tablet 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet | Alternative Listing | |
| MA144 | Pyrimethamine/Sulfadoxine Tablet, Dispersible 12.5mg/250mg | Finished Pharmaceutical Product | Malaria | S Kant Healthcare Ltd | Tablet, Dispersible | Prequalification - Full | |
| HA607 | Ondansetron (hydrochloride) Solution for injection 8mg/4mL | Finished Pharmaceutical Product | HIV/AIDS | Demo SA | Solution for injection | Prequalification - Abridged | |
| HA759 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| ANDA 077702 USFDA | Nevirapine Suspension, Oral 50mg/5ml | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Suspension, Oral | Alternative Listing | |
| IN002 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Strides Pharma Science Limited | Capsules, hard | Prequalification - Full | |
| ANDA 210963 USFDA | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Alternative Listing | |
| MA081 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| HA598 | Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| RH048 | Misoprostol Tablet 200mcg | Finished Pharmaceutical Product | Reproductive health | China Resources Zizhu Pharmaceutical Co Ltd | Tablet | Prequalification - Full | |
| ANDA 078128 USFDA | Zidovudine Capsules, hard 100mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Capsules, hard | Alternative Listing | |
| HA691 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Milan Laboratories (India) Pvt Ltd | Tablet | Prequalification - Full | |
| HA414 | Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA568 | Nevirapine Tablet 50mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| TB348 | Isoniazid Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| HP027 | Daclatasvir (dihydrochloride) Tablet, Film-coated 30mg | Finished Pharmaceutical Product | Hepatitis B and C | Laurus Labs 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 | |
| TB297 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA479 | Ceftriaxone (sodium) Powder for solution for injection 1000mg | Finished Pharmaceutical Product | HIV/AIDS | Egyptian International Pharmaceutical Industries | Powder for solution for injection | Prequalification - Full | |
| MA082 | Amodiaquine (hydrochloride)/Artesunate Tablet 270mg/100mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| TB326 | Levofloxacin Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA111 | Artemether/Lumefantrine Tablet 20mg/120mg | 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 | |
| MA089 | Artesunate Powder for solution for injection 30mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Powder for solution for injection | Prequalification - Full | |
| TB323 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| ANDA 090513 USFDA | Emtricitabine/Tenofovir disoproxil fumarate Tablet 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| HA629 | Lamivudine/Nevirapine/Zidovudine Tablet, Film-coated 150mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | 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 | |
| MA137 | Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| HA692 | Ceftriaxone (sodium) Powder for solution for injection 1g | Finished Pharmaceutical Product | HIV/AIDS | Roche Products Limited | Powder for solution for injection | Prequalification - Abridged | |
| 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 | |
| IN004 | Oseltamivir (phosphate) Capsules, hard 30mg | Finished Pharmaceutical Product | Influenza | Roche Registration GmbH | Capsules, hard | Prequalification - Abridged | |
| NDA 202814 USFDA | Lamivudine/Zidovudine Tablet, Dispersible 30mg/60mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Dispersible | Alternative Listing | |
| MA084 | Amodiaquine (hydrochloride)/Artesunate Tablet 135mg/50mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet | Prequalification - Full | |
| ANDA 078887 USFDA | Nevirapine Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Tablet | Alternative Listing | |
| RH040 | Levonorgestrel Tablet 750mcg | Finished Pharmaceutical Product | Reproductive health | Cipla Ltd | Tablet | Prequalification - Full | |
| RH103 | Benzathine benzylpenicillin Powder for suspension for injection + Water for Injection Solvent for parenteral use 1,200,000IU + 4 mL | Finished Pharmaceutical Product | Reproductive health | LABORATORIO REIG JOFRE, S.A. | Powder for suspension for injection + Solvent for parenteral use | Prequalification - Abridged | |
| RH100 | Levonorgestrel Intra-uterine system 52mg | Finished Pharmaceutical Product | Reproductive health | Bayer AG | Intra-uterine system | Prequalification - Abridged | |
| RH104 | Benzathine benzylpenicillin Powder for suspension for injection + Water for Injection Solvent for parenteral use 2,400,000IU + 6 mL | Finished Pharmaceutical Product | Reproductive health | LABORATORIO REIG JOFRE, S.A. | Powder for suspension for injection + Solvent for parenteral use | Prequalification - Abridged | |
| RH102 | Desogestrel Tablet, Film-coated 75mcg | Finished Pharmaceutical Product | Reproductive health | NV Organon | Tablet, Film-coated | Prequalification - Abridged | |
| ANDA 212579a USFDA | Atazanavir (sulfate) Capsules, hard 150mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Capsules, hard | Alternative Listing | |
| HA780 | Darunavir (ethanolate) Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen-Cilag International NV | Tablet, Film-coated | Prequalification - Abridged |
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