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 ascending | Product Type | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| NDA 203076 USFDA | Lamivudine/Nevirapine/Zidovudine Tablet, Dispersible 30mg/50mg/60mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Dispersible | Alternative Listing | |
| HA433 | Lamivudine/Nevirapine/Zidovudine Tablet, Dispersible 30mg/50mg/60mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Dispersible | Prequalification - Full | |
| HCnda | Lamivudine/Nevirapine/Zidovudine Tablet 150mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Apotex Pharmachem Inc | Tablet | Alternative Listing | |
| NDA 22177 USFDA | Lamivudine/Nevirapine/Stavudine Tablet 150mg/200mg/30mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Science Limited | Tablet | Alternative Listing | |
| NDA 21837 USFDA | Lamivudine/Nevirapine/Stavudine Tablet 150g/200mg/40mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Global PTE Limited | Tablet | Alternative Listing | |
| HA536 | Lamivudine Tablet, Film-coated 30mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| ANDA 090198b USFDA | Lamivudine Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| HA668 | Lamivudine Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | Beximco Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA644 | Lamivudine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA117 | Lamivudine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA424 | Lamivudine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | 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 | |
| ANDA 078850a USFDA | Lamivudine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Alternative Listing | |
| ANDA 077464b USFDA | Lamivudine Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| ANDA 090457 USFDA | Lamivudine Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Science Limited | Tablet | Alternative Listing | |
| ANDA 078850b USFDA | Lamivudine Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Alternative Listing | |
| ANDA 078545 USFDA | Lamivudine Tablet 300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Alternative Listing | |
| ANDA 077464a USFDA | Lamivudine Tablet 150mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| ANDA 077695 USFDA | Lamivudine Solution, Oral 10mg/ml | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Solution, Oral | Alternative Listing | |
| HA128 | Lamivudine Solution, Oral 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Solution, Oral | Prequalification - Abridged | |
| ANDA 091475 USFDA | Lamivudine Solution, Oral 10mg/ml | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Solution, Oral | Alternative Listing | |
| HA523 | Lamivudine Solution, Oral 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Solution, Oral | Prequalification - Full | |
| TB327 | Kanamycin (sulfate) Solution for injection 500mg/2ml | Finished Pharmaceutical Product | Tuberculosis | Livzon (Group) Pharmaceutical Factory | Solution for injection | Prequalification - Full | |
| TB317 | Kanamycin (sulfate) Solution for injection 500mg | Finished Pharmaceutical Product | Tuberculosis | Shanghai Harvest Pharmaceutical Co., Ltd | Solution for injection | Prequalification - Full | |
| TB328 | Kanamycin (sulfate) - non sterile Solution for injection 1000mg/3ml | Finished Pharmaceutical Product | Tuberculosis | Livzon (Group) Pharmaceutical Factory | Solution for injection | Prequalification - Full | |
| NT009 | Ivermectin Tablet 3mg | Finished Pharmaceutical Product | Neglected tropical diseases | Edenbridge Pharmaceuticals LLC | Tablet | Prequalification - Abridged | |
| NT007 | Ivermectin Tablet 3mg | Finished Pharmaceutical Product | Neglected tropical diseases | Laboratorios Liconsa SA | Tablet | Prequalification - Full | |
| HA704 | Itraconazole Capsules, hard 100mg | Finished Pharmaceutical Product | HIV/AIDS | Laboratorios Liconsa S.A. | Capsules, hard | Prequalification - Abridged | |
| TB369 | Isoniazid/Rifapentine Tablet, Film-coated 300mg/300mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB189 | Isoniazid/Rifampicin Tablet, Film-coated 75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Svizera Europe BV | Tablet, Film-coated | Prequalification - Full | |
| TB158 | Isoniazid/Rifampicin Tablet, Film-coated 75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB068 | Isoniazid/Rifampicin Tablet, Film-coated 75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| TB231 | Isoniazid/Rifampicin Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB195 | Isoniazid/Rifampicin Tablet, Film-coated 150mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| TB302 | Isoniazid/Rifampicin Tablet, Dispersible 50mg/75mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| TB360 | Isoniazid/Rifampicin Tablet, Dispersible 50mg/75mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Dispersible | Prequalification - Full | |
| TB085 | Isoniazid/Rifampicin Tablet, coated 75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Sandoz Pvt Ltd | Tablet, coated | Prequalification - Abridged | |
| TB270 | Isoniazid/Rifampicin Capsules, hard 150mg/300mg | Finished Pharmaceutical Product | Tuberculosis | Antibiotice SA | Capsules, hard | Prequalification - Abridged | |
| HA762 | Isoniazid/Pyridoxine hydrochloride/Sulfamethoxazole/Trimethoprim Tablet, Film-coated 300mg/25mg/800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA639 | Isoniazid/Pyridoxine hydrochloride/Sulfamethoxazole/Trimethoprim Tablet 300mg/25mg/800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet | Prequalification - Full | |
| TB309 | Isoniazid/Pyrazinamide/Rifampicin Tablet, Dispersible 50mg/150mg/75mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| TB347 | Isoniazid Tablet, Dispersible 50mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| TB359 | Isoniazid Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| TB405 | Isoniazid Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | S Kant Healthcare Ltd | Tablet, Dispersible | Prequalification - Full | |
| TB348 | Isoniazid Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| TB174 | Isoniazid Tablet 300mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet | Prequalification - Full | |
| TB392 | Isoniazid Tablet 300mg | Finished Pharmaceutical Product | Tuberculosis | Svizera Labs Pvt. Ltd. | Tablet | Prequalification - Full | |
| TB276 | Isoniazid Tablet 300mg | Finished Pharmaceutical Product | Tuberculosis | Cadila Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB375 | Isoniazid Tablet 300mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet | Prequalification - Full | |
| TB266 | Isoniazid Tablet 300mg | Finished Pharmaceutical Product | Tuberculosis | Antibiotice SA | Tablet | Prequalification - Abridged |
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