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.
Displaying: 401 - 450 of 667
Download list as CSV file
| WHO Reference Number | INN, Dosage Form and Strength Sort ascending | Product Type | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| TB367 | Ethambutol hydrochloride Tablet, Dispersible 50mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| TB368 | Ethambutol hydrochloride Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| TB334 | Ethambutol hydrochloride Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| RH087 | Estradiol valerate/Norethisterone enantate Solution for injection 5mg/ml/50mg/ml | Finished Pharmaceutical Product | Reproductive health | Bayer S.A. | Solution for injection | Prequalification - Full | |
| RH054 | Estradiol valerate/Norethisterone enantate Solution for injection 5mg/50mg/mL | Finished Pharmaceutical Product | Reproductive health | Bayer AG | Solution for injection | Prequalification - Full | |
| HP032 | Entecavir Tablet, Film-coated 1 mg | Finished Pharmaceutical Product | Hepatitis B and C | BrightGene Bio-Medical Technology Co., Ltd | Tablet, Film-coated | Prequalification - Abridged | |
| 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 | |
| HA561 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA551 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Sun Pharmaceutical Industries Limited | Tablet, Film-coated | Prequalification - Full | |
| HA631 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA715 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HA726 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals 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 | |
| HA717 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA552 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Science Limited | Tablet, Film-coated | Prequalification - Full | |
| ANDA 203442 USFDA | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| HA439 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA498 | Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | 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 | |
| ANDA 216875 USFDA | Emtricitabine/Tenofovir alafenamide Tablet, Film-coated 200mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet, Film-coated | ||
| ANDA 079188 USFDA | Emtricitabine Capsules, hard 200mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Capsules, hard | Alternative Listing | |
| HA764 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Desano Pharmaceuticals Private Limited | Tablet, Film-coated | Prequalification - Full | |
| HA549 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA466 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA767 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA727 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | 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 | |
| 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 | |
| NDA 210649 USFDA | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| HA770 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA732 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Laurus Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA714 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA766 | Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/300mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Desano Pharmaceuticals Private Limited | Tablet, Film-coated | Prequalification - Full | |
| HA553 | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Strides Pharma Science Limited | Tablet, Film-coated | Prequalification - Full | |
| HA562 | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA538 | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA500 | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA444 | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | 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 | |
| ANDA 203041 USFDA | Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Tablet 600mg/200mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| ANDA 091579 USFDA | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| HA681 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Government Pharmaceutical Organization (GPO) | Tablet, Film-coated | Prequalification - Full | |
| HA337 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Merck Sharp & Dohme BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA306 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Sun Pharmaceutical Industries Limited | Tablet, Film-coated | Prequalification - Full | |
| HA633 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA403 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| HA658 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Shanghai Desano Bio-Pharmaceutical Co., Ltd. | Tablet, Film-coated | Prequalification - Full | |
| HA427 | Efavirenz Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | Merck Sharp & Dohme BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA428 | Efavirenz Tablet, Film-coated 200mg | Finished Pharmaceutical Product | HIV/AIDS | Merck Sharp & Dohme BV | Tablet, Film-coated | Prequalification - Abridged | |
| NDA 22461b USFDA | Efavirenz Tablet, Film-coated 100mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet, Film-coated | Alternative Listing |
.