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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
Note:
  • 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: 101 - 150 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
MA147 Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 25mg/500mg + 150mg Finished Pharmaceutical Product Malaria S Kant Healthcare Ltd Tablet, Dispersible + Tablet, Dispersible Prequalification - Full
MA189 Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 12.5mg/250mg + 76.5mg Finished Pharmaceutical Product Malaria Ipca Laboratories Ltd Tablet, Dispersible + Tablet, Dispersible Prequalification - Full
MA116 Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 12.5mg/250mg + 76.5mg Finished Pharmaceutical Product Malaria Guilin Pharmaceutical Co. Ltd Tablet, Dispersible + Tablet, Dispersible Prequalification - Full
MA172 Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 12.5mg/250mg + 75mg Finished Pharmaceutical Product Malaria Universal Corporation Ltd Tablet, Dispersible + Tablet, Dispersible Prequalification - Full
MA146 Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 12.5mg/250mg + 75mg Finished Pharmaceutical Product Malaria S Kant Healthcare Ltd Tablet, Dispersible + Tablet, Dispersible Prequalification - Full
MA193 Pyrimethamine/Sulfadoxine Tablet 25mg/500mg Finished Pharmaceutical Product Malaria S Kant Healthcare Ltd Tablet Prequalification - Full
MA113 Pyrimethamine/Sulfadoxine Tablet 25mg/500mg Finished Pharmaceutical Product Malaria Guilin Pharmaceutical Co. Ltd Tablet Prequalification - Full
TB401 Pyridoxine hydrochloride Tablet, Film-coated 50mg Finished Pharmaceutical Product Tuberculosis S Kant Healthcare Ltd Tablet, Film-coated Prequalification - Full
TB383 Pyridoxine hydrochloride Tablet 50mg Finished Pharmaceutical Product Tuberculosis Macleods Pharmaceuticals Ltd Tablet Prequalification - Full
TB382 Pyridoxine hydrochloride Tablet 10mg Finished Pharmaceutical Product Tuberculosis Macleods Pharmaceuticals Ltd Tablet Prequalification - Full
TB335 Pyrazinamide Tablet, Dispersible 150mg Finished Pharmaceutical Product Tuberculosis Micro Labs Limited Tablet, Dispersible Prequalification - Full
TB307 Pyrazinamide Tablet, Dispersible 150mg Finished Pharmaceutical Product Tuberculosis Macleods Pharmaceuticals Ltd Tablet, Dispersible Prequalification - Full
TB172 Pyrazinamide Tablet 500mg Finished Pharmaceutical Product Tuberculosis Micro Labs Limited Tablet Prequalification - Full
TB267 Pyrazinamide Tablet 500mg Finished Pharmaceutical Product Tuberculosis Antibiotice SA Tablet Prequalification - Abridged
TB243 Pyrazinamide Tablet 500mg Finished Pharmaceutical Product Tuberculosis Macleods Pharmaceuticals Ltd Tablet Prequalification - Full
TB171 Pyrazinamide Tablet 400mg Finished Pharmaceutical Product Tuberculosis Micro Labs Limited Tablet Prequalification - Full
TB015 Pyrazinamide Tablet 400mg Finished Pharmaceutical Product Tuberculosis Cadila Pharmaceuticals Ltd Tablet Prequalification - Full
TB159 Pyrazinamide Tablet 400mg Finished Pharmaceutical Product Tuberculosis Macleods Pharmaceuticals Ltd Tablet Prequalification - Full
TB239 Protionamide Tablet, Film-coated 250mg Finished Pharmaceutical Product Tuberculosis Micro Labs Limited Tablet, Film-coated Prequalification - Full
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
TB345 Protionamide Tablet, Film-coated 250mg Finished Pharmaceutical Product Tuberculosis Esteve Pharmaceuticals GmbH Tablet, Film-coated Prequalification - Abridged
MA176 Primaquine (phosphate) Tablet, Film-coated 15mg Finished Pharmaceutical Product Malaria Macleods Pharmaceuticals Ltd Tablet, Film-coated Prequalification - Full
TB386 Pretomanid Tablet 200mg Finished Pharmaceutical Product Tuberculosis Mylan Laboratories Limited Tablet Prequalification - Abridged
NT011 Praziquantel Tablet, Film-coated 600mg Finished Pharmaceutical Product Neglected tropical diseases Hetero Labs 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
NT004 Praziquantel Tablet, Film-coated 600mg Finished Pharmaceutical Product Neglected tropical diseases Macleods Pharmaceuticals Ltd Tablet, Film-coated Prequalification - Full
TB229 Para-aminosalicylate (sodium) Powder for Oral solution 4g Finished Pharmaceutical Product Tuberculosis OlainFarm JSC Powder for Oral solution Prequalification - Abridged
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
RH083 Oxytocin Solution for injection 10IU/mL Finished Pharmaceutical Product Reproductive health Steril-Gene Life Sciences (P) Ltd Solution for injection 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
IN001 Oseltamivir (phosphate) Capsules, hard 75mg Finished Pharmaceutical Product Influenza Cipla Ltd 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
IN016 Oseltamivir (phosphate) Capsules, hard 75mg 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
IN014 Oseltamivir (phosphate) Capsules, hard 30mg Finished Pharmaceutical Product Influenza Macleods Pharmaceuticals Ltd Capsules, hard 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
HA596 Ondansetron (hydrochloride) Tablet, Film-coated 8mg Finished Pharmaceutical Product HIV/AIDS Cadila Pharmaceuticals Ltd Tablet, Film-coated Prequalification - Full
HA595 Ondansetron (hydrochloride) Tablet, Film-coated 4mg Finished Pharmaceutical Product HIV/AIDS Cadila Pharmaceuticals Ltd Tablet, Film-coated Prequalification - Full
HA607 Ondansetron (hydrochloride) Solution for injection 8mg/4mL Finished Pharmaceutical Product HIV/AIDS Demo SA 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
RH022 Norethisterone enantate Solution for injection 200mg/ml Finished Pharmaceutical Product Reproductive health Bayer plc Solution for injection Prequalification - Abridged
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
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

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