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: 201 - 250 of 667
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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 |
|---|---|---|---|---|---|---|---|
| RH090 | Medroxyprogesterone acetate Suspension for injection 150mg/ml | Finished Pharmaceutical Product | Reproductive health | Tunggal Idaman Abdi (PT) | Suspension 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 | |
| RH074 | Medroxyprogesterone acetate Suspension for injection 150mg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories 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 | |
| RH018 | Medroxyprogesterone acetate Powder for suspension for injection 150mg/mL | Finished Pharmaceutical Product | Reproductive health | Pfizer AB | Powder for suspension for injection | Prequalification - Abridged | |
| NT006 | Mebendazole Tablets, Chewable 500mg | Finished Pharmaceutical Product | Neglected tropical diseases | Janssen-Cilag International NV | Tablets, Chewable | Prequalification - Full | |
| RH063 | Magnesium sulphate Solution for injection 500mg/ml (2ml) | Finished Pharmaceutical Product | Reproductive health | AS KALCEKS | Solution for injection | 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 | |
| RH086 | Magnesium sulphate Solution for injection 500mg/ml (10ml) | Finished Pharmaceutical Product | Reproductive health | Joint-Stock Company Halychpharm | 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 | |
| RH062 | Magnesium sulphate Solution for injection 500mg/mL | Finished Pharmaceutical Product | Reproductive health | Inresa Arzneimittel GmbH | Solution 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 | |
| RH073 | Magnesium sulphate Solution for injection 500mg/mL | Finished Pharmaceutical Product | Reproductive health | Aurum Pharmaceuticals Ltd | Solution for injection | Prequalification - Abridged | |
| RH021 | Lynestrenol Tablet 500mcg | Finished Pharmaceutical Product | Reproductive health | NV Organon | Tablet | Prequalification - Abridged | |
| HA381 | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | AbbVie Deutschland GmbH and Co. KG | Tablet, Film-coated | Prequalification - Abridged | |
| HA761 | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| ANDA 204739b USFDA | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| EMA Art 58 H-W-764-1 | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | AbbVie Deutschland GmbH and Co. KG | Tablet, Film-coated | Alternative Listing | |
| ANDA 90371 USFDA | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Tablet, Film-coated | Alternative Listing | |
| HA492 | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA574 | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA760 | Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| HA573 | Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| ANDA 204739a USFDA | Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Alternative Listing | |
| HA650 | Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| EMA Art 58 H-W-764-2 | Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | AbbVie Deutschland GmbH and Co. KG | Tablet, Film-coated | Alternative Listing | |
| ANDA 090471b USFDA | Lopinavir/Ritonavir Tablet 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| ANDA 090471a USFDA | Lopinavir/Ritonavir Tablet 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| ANDA 091677 USFDA | Lopinavir/Ritonavir Tablet 100mg/25mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Tablet | Alternative Listing | |
| HA098 | Lopinavir/Ritonavir Solution, Oral 80mg/mL/20mg/mL | Finished Pharmaceutical Product | HIV/AIDS | AbbVie Deutschland GmbH and Co. KG | Solution, Oral | Prequalification - Abridged | |
| TB297 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB365 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| TB321 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Cipla Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB299 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB323 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| TB350 | Linezolid Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| TB389 | Linezolid Tablet, Dispersible 150mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| TB391 | Linezolid Tablet, Dispersible 150mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| RH057 | Levonorgestrel Tablet, Film-coated 0.03mg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| RH002 | Levonorgestrel Tablet, coated 30mcg | Finished Pharmaceutical Product | Reproductive health | Jenapharm GmbH & Co. KG | Tablet, coated | Prequalification - Abridged | |
| RH040 | Levonorgestrel Tablet 750mcg | Finished Pharmaceutical Product | Reproductive health | Cipla Ltd | Tablet | Prequalification - Full | |
| RH032 | Levonorgestrel Tablet 750mcg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| RH069 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet | Prequalification - Full | |
| RH065 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | HLL Lifecare Limited | Tablet | Prequalification - Full | |
| RH098 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | Naari BV | Tablet | Prequalification - Abridged | |
| RH046 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | Cipla Ltd | Tablet | Prequalification - Full | |
| RH058 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | Lupin Ltd. | Tablet | Prequalification - Abridged | |
| RH031 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| RH068 | Levonorgestrel Tablet 0.75mg | Finished Pharmaceutical Product | Reproductive health | Laboratorios León Farma SA | Tablet | Prequalification - Full | |
| RH100 | Levonorgestrel Intra-uterine system 52mg | Finished Pharmaceutical Product | Reproductive health | Bayer AG | Intra-uterine system | Prequalification - Abridged |
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