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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: 651 - 672 of 672
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WHO Reference Number INN, Dosage Form and Strength Product Type Therapeutic Area Applicant Dosage Form Basis of Listing Date of Prequalification
TB394 Isoniazid/Rifapentine Tablet, Film-coated 300mg/300mg Finished Pharmaceutical Product Tuberculosis Lupin Ltd Tablet, Film-coated Prequalification - Full
TB395 Bedaquiline fumarate Tablet 100mg Finished Pharmaceutical Product Tuberculosis MSN Laboratories Private Limited Tablet Prequalification - Full
TB396 Bedaquiline fumarate Tablet 100mg Finished Pharmaceutical Product Tuberculosis Lupin Ltd Tablet Prequalification - Full
TB397 Pretomanid Tablet 200 mg Finished Pharmaceutical Product Tuberculosis Macleods Pharmaceuticals Ltd Tablet Prequalification - Full
TB398 Rifapentine Tablet, Film-coated 300 mg Finished Pharmaceutical Product Tuberculosis Macleods Pharmaceuticals Ltd Tablet, Film-coated Prequalification - Full
TB400 Isoniazid/Pyrazinamide/Rifampicin Tablet, Dispersible 50mg/150mg/75mg Finished Pharmaceutical Product Tuberculosis Lupin Ltd Tablet, Dispersible Prequalification - Full
TB401 Pyridoxine hydrochloride Tablet, Film-coated 50mg Finished Pharmaceutical Product Tuberculosis S Kant Healthcare Ltd Tablet, Film-coated Prequalification - Full
TB402 Rifapentine Tablet, Dispersible 150mg Finished Pharmaceutical Product Tuberculosis Lupin Ltd Tablet, Dispersible Prequalification - Full
TB403 Pretomanid Tablet 200mg Finished Pharmaceutical Product Tuberculosis Lupin Ltd Tablet Prequalification - Full
TB405 Isoniazid Tablet, Dispersible 100mg Finished Pharmaceutical Product Tuberculosis S Kant Healthcare Ltd Tablet, Dispersible Prequalification - Full
TB406 Ethambutol hydrochloride Tablet, Dispersible 100mg Finished Pharmaceutical Product Tuberculosis Cadila Pharmaceuticals Ltd Tablet, Dispersible Prequalification - Full
TB407 Isoniazid Tablet, Dispersible 100mg Finished Pharmaceutical Product Tuberculosis Cadila Pharmaceuticals Ltd Tablet, Dispersible Prequalification - Full
TB409 Linezolid Tablet, Dispersible 150mg Finished Pharmaceutical Product Tuberculosis Lupin Ltd Tablet, Dispersible Prequalification - Full
TB411 Ethambutol hydrochloride Tablet, Dispersible 100mg Finished Pharmaceutical Product Tuberculosis Lupin Ltd Tablet, Dispersible Prequalification - Full
TB412 Rifapentine Tablet, Dispersible 150mg Finished Pharmaceutical Product Tuberculosis Macleods Pharmaceuticals Ltd Tablet, Dispersible Prequalification - Full
TB413 Pyridoxine hydrochloride Tablet 10mg Finished Pharmaceutical Product Tuberculosis S Kant Healthcare Ltd Tablet Prequalification - Full
TB416 Cycloserine Capsules, hard 250mg Finished Pharmaceutical Product Tuberculosis Strides Pharma Science Limited Capsules, hard Prequalification - Full
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
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
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