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 Sort descending | INN, Dosage Form and Strength | Product Type | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| NT017 | Miltefosine Capsules, hard 50mg | Finished Pharmaceutical Product | Neglected tropical diseases | Zydus Lifesciences Limited | Capsules, hard | Prequalification - Full | |
| NT019 | Azithromycin Tablet, Film-coated 500mg | Finished Pharmaceutical Product | Neglected tropical diseases | ACI HealthCare Limited | Tablet, Film-coated | Prequalification - Abridged | |
| NT020 | Azithromycin Tablet, Film-coated 500mg | Finished Pharmaceutical Product | Neglected tropical diseases | Rusan Pharma Ltd. | Tablet, Film-coated | Prequalification - Full | |
| NT021 | Albendazole Tablet 400mg | Finished Pharmaceutical Product | Neglected tropical diseases | Ipca Laboratories Ltd | Tablet | Prequalification - Full | |
| NT022 | Praziquantel Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Neglected tropical diseases | Mepro Pharmaceuticals Pvt. Ltd. | Tablet, Film-coated | Prequalification - Full | |
| P-13399 - test | |||||||
| RH002 | Levonorgestrel Tablet, coated 30mcg | Finished Pharmaceutical Product | Reproductive health | Jenapharm GmbH & Co. KG | Tablet, coated | Prequalification - Abridged | |
| RH013 | Ethinylestradiol/Levonorgestrel Tablet, coated 30mcg/150mcg | Finished Pharmaceutical Product | Reproductive health | Senador Laboratories Private Limited | Tablet, coated | Prequalification - Full | |
| RH017 | Levonorgestrel Implant 75mg | Finished Pharmaceutical Product | Reproductive health | Bayer Oy | Implant | Prequalification - Abridged | |
| RH018 | Medroxyprogesterone acetate Powder for suspension for injection 150mg/mL | Finished Pharmaceutical Product | Reproductive health | Pfizer AB | Powder for suspension for injection | Prequalification - Abridged | |
| RH022 | Norethisterone enantate Solution for injection 200mg/ml | Finished Pharmaceutical Product | Reproductive health | Bayer plc | Solution for injection | Prequalification - Abridged | |
| RH025 | Desogestrel/Ethinylestradiol Tablet + Placebo Tablet, coated 0.150mg/0.030mg + 0mg | Finished Pharmaceutical Product | Reproductive health | NV Organon | Tablet + Tablet, coated | Prequalification - Abridged | |
| RH028 | Levonorgestrel Implant 75mg per rod (150mg in total) | Finished Pharmaceutical Product | Reproductive health | Shanghai Dahua Pharmaceutical Co Ltd | Implant | Prequalification - Full | |
| RH031 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | Senador Laboratories Private Limited | Tablet | Prequalification - Full | |
| RH032 | Levonorgestrel Tablet 750mcg | Finished Pharmaceutical Product | Reproductive health | Senador Laboratories Private Limited | Tablet | Prequalification - Full | |
| RH035 | Ethinylestradiol/Levonorgestrel Tablet, Sugar coated+Placebo Tablet, Film-coated 30µg/150µg+0mg | Finished Pharmaceutical Product | Reproductive health | Senador Laboratories Private Limited | Tablet, Film-coated + Tablet, Sugar coated | Prequalification - Full | |
| RH036 | Etonogestrel Implant 68mg | Finished Pharmaceutical Product | Reproductive health | NV Organon | Implant | Prequalification - Abridged | |
| RH038 | Ethinylestradiol/Levonorgestrel Tablet, Sugar coated + Ferrous (Fumarate) Tablet, Sugar coated 30mcg/150mcg + 75mg | Finished Pharmaceutical Product | Reproductive health | Senador Laboratories Private Limited | Tablet, Sugar coated + Tablet, Sugar coated | Prequalification - Full | |
| RH039 | Misoprostol Tablet 200mcg | Finished Pharmaceutical Product | Reproductive health | Cipla Ltd | Tablet | Prequalification - Full | |
| RH041 | Ethinylestradiol/Levonorgestrel Tablet + Placebo Tablet 0.03mg/0.15mg + 0mg | Finished Pharmaceutical Product | Reproductive health | Lupin Ltd | Tablet + Tablet | Prequalification - Abridged | |
| RH042 | Ethinylestradiol/Levonorgestrel Tablet, Film-coated+Placebo Tablet 0.03mg/0.15mg+0mg | Finished Pharmaceutical Product | Reproductive health | Lupin Ltd | Tablet + Tablet, Film-coated | Prequalification - Abridged | |
| RH044 | Desogestrel/Ethinylestradiol Tablet, Film-coated+Placebo Tablet, Film-coated 150mcg/30mcg+0mg | Finished Pharmaceutical Product | Reproductive health | Lupin Ltd | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Abridged | |
| RH046 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | Cipla Ltd | Tablet | Prequalification - Full | |
| RH048 | Misoprostol Tablet 200mcg | Finished Pharmaceutical Product | Reproductive health | China Resources Zizhu Pharmaceutical Co Ltd | Tablet | Prequalification - Full | |
| RH050 | Oxytocin Solution for injection 10IU/mL | Finished Pharmaceutical Product | Reproductive health | PT Sanbe Farma | Solution for injection | Prequalification - Full | |
| RH051 | Mifepristone Tablet 200mg | Finished Pharmaceutical Product | Reproductive health | Linepharma International Ltd | Tablet | Prequalification - Abridged | |
| RH052 | Mifepristone Tablet 200mg | Finished Pharmaceutical Product | Reproductive health | China Resources Zizhu Pharmaceutical Co Ltd | Tablet | 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 | |
| RH056 | Misoprostol Tablet 200mcg | Finished Pharmaceutical Product | Reproductive health | Acme Formulation Pvt. Limited | Tablet | Prequalification - Full | |
| RH057 | Levonorgestrel Tablet, Film-coated 0.03mg | Finished Pharmaceutical Product | Reproductive health | Senador Laboratories Private Limited | Tablet, Film-coated | Prequalification - Full | |
| RH058 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | Lupin Ltd | Tablet | Prequalification - Abridged | |
| RH062 | Magnesium sulphate Solution for injection 500mg/mL | Finished Pharmaceutical Product | Reproductive health | Inresa Arzneimittel GmbH | Solution for injection | Prequalification - Abridged | |
| RH063 | Magnesium sulphate Solution for injection 500mg/ml (2ml) | Finished Pharmaceutical Product | Reproductive health | AS KALCEKS | Solution for injection | Prequalification - Full | |
| RH064 | Magnesium sulphate Solution for injection 500mg/ml (10ml) | Finished Pharmaceutical Product | Reproductive health | AS KALCEKS | Solution for injection | Prequalification - Full | |
| RH065 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | HLL Lifecare Limited | Tablet | Prequalification - Full | |
| RH066 | Desogestrel/Ethinylestradiol Tablet, Film-coated + Placebo Tablet, Film-coated 0.15mg/0.03mg + 0mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| RH067 | Desogestrel/Ethinylestradiol Tablet, Film-coated 0.15mg/0.03mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet, Film-coated | Prequalification - Full | |
| RH068 | Levonorgestrel Tablet 0.75mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet | Prequalification - Full | |
| RH069 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet | Prequalification - Full | |
| RH070 | Ethinylestradiol/Levonorgestrel Tablet, Film-coated 0.03mg/0.15mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet, Film-coated | Prequalification - Full | |
| RH071 | Ethinylestradiol/Levonorgestrel Tablet, Film-coated + Placebo Tablet, Film-coated 0.03mg/0.15mg + 0mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| RH072 | Magnesium sulphate Solution for injection 500mg/ml (10ml) | Finished Pharmaceutical Product | Reproductive health | Labesfal, Laboratorios Almiro SA | Solution for injection | Prequalification - Abridged | |
| RH073 | Magnesium sulphate Solution for injection 500mg/mL | Finished Pharmaceutical Product | Reproductive health | Aurum Pharmaceuticals Ltd | Solution for injection | Prequalification - Abridged | |
| RH074 | Medroxyprogesterone acetate Suspension for injection 150mg | Finished Pharmaceutical Product | Reproductive health | Senador Laboratories Private Limited | Suspension for injection | Prequalification - Full | |
| RH075 | Medroxyprogesterone acetate Suspension for injection 104mg/0.65ml | Finished Pharmaceutical Product | Reproductive health | Pfizer Limited | Suspension for injection | Prequalification - Abridged | |
| RH077 | Magnesium sulphate Solution for injection 500mg/mL | Finished Pharmaceutical Product | Reproductive health | Aurum Pharmaceuticals Ltd | Solution for injection | Prequalification - Abridged | |
| RH079 | Oxytocin Solution for injection 10IU/ml | Finished Pharmaceutical Product | Reproductive health | JSC Grindeks | Solution for injection | Prequalification - Full | |
| RH082 | Ethinylestradiol/Levonorgestrel Tablet, Sugar coated + Placebo Tablet, Sugar coated 30mcg/150mcg + 0mcg | Finished Pharmaceutical Product | Reproductive health | Jenapharm GmbH & Co. KG | Tablet, Sugar coated + Tablet, Sugar coated | Prequalification - Abridged | |
| RH083 | Oxytocin Solution for injection 10IU/mL | Finished Pharmaceutical Product | Reproductive health | Steril-Gene Life Sciences (P) Ltd | Solution for injection | Prequalification - Full | |
| RH084 | Medroxyprogesterone acetate Suspension for injection 150mg/ml | Finished Pharmaceutical Product | Reproductive health | Incepta Pharmaceuticals Ltd. | Suspension for injection | Prequalification - Full |
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