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 Sort descending | INN, Dosage Form and Strength | Product Type | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| TB383 | Pyridoxine hydrochloride Tablet 50mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB384 | Meropenem Powder for solution for injection 1g | Finished Pharmaceutical Product | Tuberculosis | Venus Pharma GmbH | Powder for solution for injection | Prequalification - Abridged | |
| TB385 | Cycloserine Capsules, hard 250mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Capsules, hard | Prequalification - Full | |
| TB386 | Pretomanid Tablet 200mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Ltd. | Tablet | Prequalification - Abridged | |
| TB388 | Delamanid Tablet, Film-coated 50mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Ltd. | Tablet, Film-coated | Prequalification - Full | |
| TB389 | Linezolid Tablet, Dispersible 150mg | Finished Pharmaceutical Product | Tuberculosis | Micro Labs Limited | Tablet, Dispersible | Prequalification - Full | |
| TB390 | Bedaquiline fumarate Tablet 100mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet | Prequalification - Full | |
| TB391 | Linezolid Tablet, Dispersible 150mg | Finished Pharmaceutical Product | Tuberculosis | Macleods Pharmaceuticals Ltd | Tablet, Dispersible | Prequalification - Full | |
| TB392 | Isoniazid Tablet 300mg | Finished Pharmaceutical Product | Tuberculosis | Svizera Labs Pvt. Ltd. | Tablet | Prequalification - Full | |
| TB393 | Rifapentine Tablet, Film-coated 300mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Film-coated | Prequalification - Full | |
| 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 | |
| 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 | |
| TB411 | Ethambutol hydrochloride Tablet, Dispersible 100mg | Finished Pharmaceutical Product | Tuberculosis | Lupin Ltd. | Tablet, Dispersible | Prequalification - Full | |
| TB413 | Pyridoxine hydrochloride Tablet 10mg | Finished Pharmaceutical Product | Tuberculosis | S Kant Healthcare Ltd. | Tablet | 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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