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 descending | Product Type | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| HA200 | Nevirapine Suspension, Oral 50mg/5mL | Finished Pharmaceutical Product | HIV/AIDS | Cipla Ltd | Suspension, Oral | Prequalification - Full | |
| HA569 | Nevirapine Tablet 100mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| 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 | |
| ANDA 078887 USFDA | Nevirapine Tablet 200mg | Finished Pharmaceutical Product | HIV/AIDS | Emcure Pharmaceuticals Limited | Tablet | Alternative Listing | |
| HA570 | Nevirapine Tablet 200mg | 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 | |
| HA567 | Nevirapine Tablet 20mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| HA568 | Nevirapine Tablet 50mg | Finished Pharmaceutical Product | HIV/AIDS | Micro Labs Limited | Tablet | Prequalification - Full | |
| TD003 | Nicotine Patch 10mg/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 | |
| TD005 | Nicotine Patch 25mg/16 hours | Finished Pharmaceutical Product | Disorders caused by tobacco use | McNeil Sweden AB | Patch | 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 | |
| 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 | |
| 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 | |
| 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 | |
| CV007 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg | Finished Pharmaceutical Product | Covid-19 | Pfizer Limited | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Abridged | |
| CV018 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg | Finished Pharmaceutical Product | Covid-19 | Zhejiang Apeloa Kangyu Pharmaceutical Co Ltd | 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 | |
| RH022 | Norethisterone enantate Solution for injection 200mg/ml | Finished Pharmaceutical Product | Reproductive health | Bayer plc | Solution for injection | Prequalification - Abridged | |
| HA597 | Ondansetron (hydrochloride) Solution for injection 4mg/2mL | Finished Pharmaceutical Product | HIV/AIDS | Demo SA | Solution for injection | Prequalification - Abridged | |
| HA607 | Ondansetron (hydrochloride) Solution for injection 8mg/4mL | Finished Pharmaceutical Product | HIV/AIDS | Demo SA | Solution for injection | Prequalification - Abridged | |
| HA595 | Ondansetron (hydrochloride) Tablet, Film-coated 4mg | Finished Pharmaceutical Product | HIV/AIDS | Cadila Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| HA596 | Ondansetron (hydrochloride) Tablet, Film-coated 8mg | Finished Pharmaceutical Product | HIV/AIDS | Cadila Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| IN018 | Oseltamivir (phosphate) Capsules, hard 30mg | Finished Pharmaceutical Product | Influenza | MSN Laboratories Private Limited | Capsules, hard | Prequalification - Full | |
| IN004 | Oseltamivir (phosphate) Capsules, hard 30mg | Finished Pharmaceutical Product | Influenza | Roche Registration GmbH | Capsules, hard | Prequalification - Abridged | |
| IN014 | Oseltamivir (phosphate) Capsules, hard 30mg | Finished Pharmaceutical Product | Influenza | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| IN019 | Oseltamivir (phosphate) Capsules, hard 45mg | Finished Pharmaceutical Product | Influenza | MSN Laboratories Private Limited | Capsules, hard | Prequalification - Full | |
| IN015 | Oseltamivir (phosphate) Capsules, hard 45mg | Finished Pharmaceutical Product | Influenza | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| IN005 | Oseltamivir (phosphate) Capsules, hard 45mg | Finished Pharmaceutical Product | Influenza | Roche Registration GmbH | Capsules, hard | Prequalification - Abridged | |
| IN001 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Cipla Ltd | Capsules, hard | Prequalification - Full | |
| IN016 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Macleods Pharmaceuticals Ltd | Capsules, hard | Prequalification - Full | |
| IN006 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Roche Registration GmbH | Capsules, hard | Prequalification - Abridged | |
| IN011 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Mylan Laboratories Limited | Capsules, hard | Prequalification - Full | |
| IN002 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Strides Pharma Science Limited | Capsules, hard | Prequalification - Full | |
| IN020 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | MSN Laboratories Private Limited | Capsules, hard | Prequalification - Full | |
| RH083 | Oxytocin Solution for injection 10IU/mL | Finished Pharmaceutical Product | Reproductive health | Steril-Gene Life Sciences (P) Ltd | Solution for injection | Prequalification - Full | |
| RH079 | Oxytocin Solution for injection 10IU/ml | Finished Pharmaceutical Product | Reproductive health | JSC Grindeks | Solution for injection | Prequalification - Full | |
| RH050 | Oxytocin Solution for injection 10IU/mL | Finished Pharmaceutical Product | Reproductive health | PT Sanbe Farma | Solution for injection | Prequalification - Full | |
| TB229 | Para-aminosalicylate (sodium) Powder for Oral solution 4g | Finished Pharmaceutical Product | Tuberculosis | OlainFarm JSC | Powder for Oral solution | Prequalification - Abridged | |
| NT004 | Praziquantel Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Neglected tropical diseases | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| NT013 | Praziquantel Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Neglected tropical diseases | Merck Healthcare KGaA | Tablet, Film-coated | Prequalification - Full | |
| NT011 | Praziquantel Tablet, Film-coated 600mg | Finished Pharmaceutical Product | Neglected tropical diseases | Hetero Labs Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB386 | Pretomanid Tablet 200mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet | Prequalification - Abridged | |
| MA176 | Primaquine (phosphate) Tablet, Film-coated 15mg | Finished Pharmaceutical Product | Malaria | Macleods Pharmaceuticals Ltd | Tablet, Film-coated | Prequalification - Full | |
| TB345 | Protionamide Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Esteve Pharmaceuticals GmbH | Tablet, Film-coated | Prequalification - Abridged | |
| TB353 | Protionamide Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | LEKHIM Joint Stock Company | Tablet, Film-coated | Prequalification - Full | |
| TB206 | Protionamide Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| TB239 | Protionamide Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Film-coated | Prequalification - Full | |
| TB015 | Pyrazinamide Tablet 400mg | Finished Pharmaceutical Product | Tuberculosis | Cadila Pharmaceuticals Ltd | Tablet | Prequalification - Full |
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