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 Sort descending | Product Type | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| MA062 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| MA088 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Strides Pharma Global PTE Limited | Tablet | Prequalification - Full | |
| MA026 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Novartis Pharma AG | Tablet | Prequalification - Abridged | |
| MA164 (Suspended) | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet | Prequalification - Full | |
| MA064 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| MA100 | Artemether/Lumefantrine Tablet 40mg/240mg | Finished Pharmaceutical Product | Malaria | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| MA128 | Artemether/Lumefantrine Tablet 40mg/240mg | Finished Pharmaceutical Product | Malaria | Ajanta Pharma Ltd | Tablet | Prequalification - Full | |
| MA143 | Artemether/Lumefantrine Tablet 40mg/240mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| 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 | |
| MA160 | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| MA138 | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Strides Pharma Global PTE Limited | Tablet | Prequalification - Full | |
| MA130 | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Ajanta Pharma Ltd | Tablet | Prequalification - Full | |
| MA122 | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet | Prequalification - Full | |
| MA142 | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| MA108 | Artemether/Lumefantrine Tablet 80mg/480mg | Finished Pharmaceutical Product | Malaria | Novartis Pharma AG | Tablet | Prequalification - Full | |
| MA092 | Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg | Finished Pharmaceutical Product | Malaria | Ajanta Pharma Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA136 | Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA115 | Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA069 | Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg | Finished Pharmaceutical Product | Malaria | Novartis Pharma AG | Tablet, Dispersible | Prequalification - Abridged | |
| MA110 | Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg | Finished Pharmaceutical Product | Malaria | Strides Pharma Global PTE Limited | Tablet, Dispersible | Prequalification - Full | |
| MA137 | Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals 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 | |
| MA154 (Suspended) | Artemether/Lumefantrine Tablet, Dispersible 40mg/240mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA155 (Suspended) | Artemether/Lumefantrine Tablet, Dispersible 60mg/360mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Tablet, Dispersible | Prequalification - Full | |
| MA123 | Artesunate Capsule, Soft, Rectal 100mg | Finished Pharmaceutical Product | Malaria | Strides Pharma Global PTE Limited | Capsule, Soft, Rectal | Prequalification - Full | |
| MA124 | Artesunate Capsule, Soft, Rectal 100mg | Finished Pharmaceutical Product | Malaria | Cipla Ltd | Capsule, Soft, Rectal | Prequalification - Full | |
| MA186 | Artesunate Powder for solution for injection 120 mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Powder for solution for injection | Prequalification - Full | |
| MA194 | Artesunate Powder for solution for injection 120mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Powder for solution for injection | Prequalification - Full | |
| MA090 | Artesunate Powder for solution for injection 120mg/vial | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Powder for solution for injection | 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 | |
| MA135 | Artesunate Powder for solution for injection 60mg | Finished Pharmaceutical Product | Malaria | Ipca Laboratories Ltd | Powder for solution for injection | Prequalification - Full | |
| MA168 | Artesunate Powder for solution for injection 60mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Powder for solution for injection | Prequalification - Full | |
| MA051 | Artesunate Powder for solution for injection 60mg | Finished Pharmaceutical Product | Malaria | Guilin Pharmaceutical Co. Ltd | Powder for solution for injection | Prequalification - Full | |
| MA152 | Artesunate Powder for solution for injection 60mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Powder for solution for injection | Prequalification - Full | |
| MA079 | Artesunate/Mefloquine (hydrochloride) Tablet, Film-coated 100mg/200mg | Finished Pharmaceutical Product | Malaria | Drugs for Neglected Diseases Initiative (DNDi) | Tablet, Film-coated | Prequalification - Full | |
| MA078 | Artesunate/Mefloquine (hydrochloride) Tablet, Film-coated 25mg/50mg | Finished Pharmaceutical Product | Malaria | Drugs for Neglected Diseases Initiative (DNDi) | Tablet, Film-coated | Prequalification - Full | |
| EMA Art 58 H-W-2319-3 | Artesunate/Pyronaridine (phosphate) Granules for Oral suspension 20mg/60mg | Finished Pharmaceutical Product | Malaria | Shin Poong Pharmaceutical Co Ltd | Granules for Oral suspension | Alternative Listing | |
| EMA Art 58 H-W-2319-2 | Artesunate/Pyronaridine (phosphate) Tablet, Film-coated 60mg/180mg | Finished Pharmaceutical Product | Malaria | Shin Poong Pharmaceutical Co Ltd | Tablet, Film-coated | Alternative Listing | |
| ANDA 078785a USFDA | Atazanavir (sulfate) Capsules, hard 100mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Capsules, hard | Alternative Listing | |
| ANDA 091611a USFDA | Atazanavir (sulfate) Capsules, hard 150mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Capsules, hard | Alternative Listing | |
| ANDA 078785c USFDA | Atazanavir (sulfate) Capsules, hard 150mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Capsules, hard | Alternative Listing | |
| ANDA 212579a USFDA | Atazanavir (sulfate) Capsules, hard 150mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Capsules, hard | Alternative Listing | |
| ANDA 212579b USFDA | Atazanavir (sulfate) Capsules, hard 200mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Capsules, hard | Alternative Listing | |
| ANDA 078785b USFDA | Atazanavir (sulfate) Capsules, hard 200mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Capsules, hard | Alternative Listing | |
| ANDA 212579c USFDA | Atazanavir (sulfate) Capsules, hard 300mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Capsules, hard | Alternative Listing | |
| ANDA 091611b USFDA | Atazanavir (sulfate) Capsules, hard 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Capsules, hard | Alternative Listing | |
| ANDA 200196 USFDA | Atazanavir (sulfate) Capsules, hard 300mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Capsules, hard | Alternative Listing | |
| NDA 205508 USFDA | Atazanavir (sulfate)/Ritonavir Tablet 300mg/100mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Tablet | Alternative Listing | |
| HA720 | Atazanavir (sulfate)/Ritonavir Tablet, Film-coated 300mg/100mg | Finished Pharmaceutical Product | HIV/AIDS | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full |
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