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: 151 - 200 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 |
|---|---|---|---|---|---|---|---|
| CV017 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg | Finished Pharmaceutical Product | Covid-19 | Celltrion Inc. | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| CV016 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg | Finished Pharmaceutical Product | Covid-19 | Zhejiang Huahai Pharmaceutical Co. Ltd. | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| CV012 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150 mg + 100 mg | Finished Pharmaceutical Product | Covid-19 | Hetero Labs Ltd | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Full | |
| TD002 | Nicotine resinate (polacrilex) 20% Medicated chewing gum 4mg | Finished Pharmaceutical Product | Disorders caused by tobacco use | McNeil Sweden AB | Medicated chewing gum | Prequalification - Abridged | |
| TD001 | Nicotine resinate (polacrilex) 20% Medicated chewing gum 2mg | Finished Pharmaceutical Product | Disorders caused by tobacco use | McNeil Sweden AB | Medicated chewing gum | Prequalification - Abridged | |
| TD005 | Nicotine Patch 25mg/16 hours | Finished Pharmaceutical Product | Disorders caused by tobacco use | McNeil Sweden AB | Patch | Prequalification - Abridged | |
| TD004 | Nicotine Patch 15mg/16 hours | Finished Pharmaceutical Product | Disorders caused by tobacco use | McNeil Sweden AB | Patch | Prequalification - Abridged | |
| TD003 | Nicotine Patch 10mg/16 hours | Finished Pharmaceutical Product | Disorders caused by tobacco use | McNeil Sweden AB | Patch | Prequalification - Abridged | |
| HA568 | Nevirapine Tablet 50mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| HA567 | Nevirapine Tablet 20mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| ANDA 077521 USFDA | Nevirapine Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Tablet | Alternative Listing | |
| ANDA 078644 USFDA | Nevirapine Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Zhejiang Huahai Pharmaceutical Co. Ltd. | Tablet | Alternative Listing | |
| ANDA 090688 USFDA | Nevirapine Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Tablet | Alternative Listing | |
| HA570 | Nevirapine Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| ANDA 078887 USFDA | Nevirapine Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Tablet | Alternative Listing | |
| HA569 | Nevirapine Tablet 100mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| HA200 | Nevirapine Suspension, Oral 50mg/5mL | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Suspension, Oral | Prequalification - Full | |
| ANDA 077702 USFDA | Nevirapine Suspension, Oral 50mg/5ml | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Suspension, Oral | Alternative Listing | |
| TB315 | Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB263 | Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| TB286 | Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet, Film-coated | Prequalification - Full | |
| TB376 | Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| TB341 | Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | MSN Laboratories Private Limited | Tablet, Film-coated | Prequalification - Full | |
| TB230 | Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB311 | Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Getz Pharma Pvt Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB349 | Moxifloxacin (hydrochloride) Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| TB342 | Moxifloxacin (hydrochloride) Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| HA638 | Morphine hydrochloride Tablets, Prolonged release 60mg | Finished Pharmaceutical Product | HIV/AIDS | GL Pharma GmbH | Tablets, Prolonged release | Prequalification - Abridged | |
| HA637 | Morphine hydrochloride Tablets, Prolonged release 30mg | Finished Pharmaceutical Product | HIV/AIDS | GL Pharma GmbH | Tablets, Prolonged release | Prequalification - Abridged | |
| HA636 | Morphine hydrochloride Tablets, Prolonged release 10mg | Finished Pharmaceutical Product | HIV/AIDS | GL Pharma GmbH | Tablets, Prolonged release | Prequalification - Abridged | |
| CV019 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Shanghai Desano Bio-Pharmaceutical Co., Ltd. | Capsules, hard | Prequalification - Full | |
| CV021 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Cipla Ltd | Capsules, hard | Prequalification - Full | |
| CV014 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Aurobindo Pharma Ltd | Capsules, hard | Prequalification - Full | |
| CV023 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. | Capsules, hard | Prequalification - Full | |
| CV022 | Molnupiravir Capsules, hard 200mg | Finished Pharmaceutical Product | Covid-19 | Mylan Laboratories Limited | Capsules, hard | Prequalification - Full | |
| CV010 | Molnupiravir Capsules, hard 200 mg | Finished Pharmaceutical Product | Covid-19 | Emcure Pharmaceuticals Limited | Capsules, hard | Prequalification - Full | |
| CV009 | Molnupiravir Capsules, hard 200 mg | Finished Pharmaceutical Product | Covid-19 | Dr Reddy's Laboratories Limited | Capsules, hard | Prequalification - Full | |
| CV008 | Molnupiravir Capsules, hard 200 mg | Finished Pharmaceutical Product | Covid-19 | Hetero Labs Ltd | Capsules, hard | Prequalification - Full | |
| RH099 | Misoprostol Tablet, vaginal 25μg | Finished Pharmaceutical Product | Reproductive health | BIAL-Portela & Ca. SA | Tablet, vaginal | Prequalification - Abridged | |
| RH105 | Misoprostol Tablet, vaginal 200µg | Finished Pharmaceutical Product | Reproductive health | BIAL-Portela & Ca. SA | Tablet, vaginal | Prequalification - Abridged | |
| RH056 | Misoprostol Tablet 200mcg | Finished Pharmaceutical Product | Reproductive health | Acme Formulation Pvt. Limited | Tablet | Prequalification - Full | |
| RH048 | Misoprostol Tablet 200mcg | Finished Pharmaceutical Product | Reproductive health | China Resources Zizhu Pharmaceutical Co Ltd | Tablet | Prequalification - Full | |
| RH039 | Misoprostol Tablet 200mcg | Finished Pharmaceutical Product | Reproductive health | Cipla Ltd | Tablet | Prequalification - Full | |
| RH094 | Misoprostol Tablet 200mcg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet | Prequalification - Full | |
| NT017 | Miltefosine Capsules, hard 50mg | Finished Pharmaceutical Product | Neglected tropical diseases | Zydus Lifesciences Limited | Capsules, hard | Prequalification - Full | |
| RH052 | Mifepristone Tablet 200mg | Finished Pharmaceutical Product | Reproductive health | China Resources Zizhu Pharmaceutical Co Ltd | Tablet | Prequalification - Full | |
| RH051 | Mifepristone Tablet 200mg | Finished Pharmaceutical Product | Reproductive health | Linepharma International Ltd | Tablet | Prequalification - Abridged | |
| RH061 | Mifepristone Tablet 200mg | Finished Pharmaceutical Product | Reproductive health | Exelgyn | Tablet | Prequalification - Abridged | |
| RH089 | Mifepristone Tablet + Misoprostol Tablet, vaginal 200mg + 200mcg | Finished Pharmaceutical Product | Reproductive health | China Resources Zizhu Pharmaceutical Co Ltd | Tablet + Tablet, vaginal | Prequalification - Full | |
| TB384 | Meropenem Powder for solution for injection 1g | Finished Pharmaceutical Product | Tuberculosis | Venus Pharma GmbH | Powder for solution for injection | Prequalification - Abridged |
.