WHO prequalified the first HIV-1 self-test by Urine
IVD
News
Publication of updated Guidance and Application Form for Reportable changes to WHO prequalified and emergency use listed in vitro diagnostics
IVD
WHO is pleased to announce the publication of the revised guidan
Prequalification of IVDs scope expanded to haemoglobin PoC analysers
IVD
WHO is pleased to announce that the Prequalification of in vitro diagnostics programme has been expanded to point-of-care analysers intended for:
Active Pharmaceutical Ingredient (API) Prequalified
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Dolutegravir (sodium) manufactured by Styrax Pharma Pvt Ltd has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
A new HPV assay prequalified by WHO
IVD
On 27 March WHO prequalified one additional in vitro diagnostic, the
Information on the GMP status of Mylan Laboratories Ltd (Viatris, Inc.) manufacturing facility situated at Indore, Pithampur (Madhya Pradesh, India)
IS
WHO Prequalification Inspection Services performed an on-site for-cause inspection on Mylan’s Pithampur manufacturing site from 3 to 7 March 2025.
Active Pharmaceutical Ingredient (API) Prequalified
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Nirmatrelvir manufactured by DongBang Future Tech & Life Co., Ltd.
PQT/MED: Expanded abridged prequalification pathways
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According to WHO’s Procedure for prequalification of pharmaceutical products (TRS 961, Annex 10), “WHO recognizes the evaluation of relevant
38th Invitation of Active Pharmaceutical Ingredients (APIs)
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The following API was added:
Lupin’s ethambutol 100 mg dispersible prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
S Kant’s pyridoxine 10 mg tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
PQT/MED publishes first invitation to manufacturers of medicinal products for treatment of bacterial infections in children to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit
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A first invitation to manufacturers of medicinal products for treatment of bacterial infections in children, to submit an Expression of Interest (EOI) for product evaluation has been published by t
RV Lifesciences’ entecavir products prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
PQT/MED publishes first invitation to manufacturers of Mycobacterium tuberculosis antigen-based skin tests (TBSTs) to submit an Expression of Interest (EOI)
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A first invitation to manufacturers of Mycobacterium tuberculosis antigen-based skin tests (TBSTs), to submit an Expression of Interest (EOI) for product evaluation has been published by the WHO Pr
Active Pharmaceutical Ingredient (API) Prequalified
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Albendazole (WHOAPI-427) manufactured by Sequent Scientific Limited has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Medopharm’s chewable albendazole tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
- NT012 Albendazole Tablets, Chewable 400mg – Medopharm - INDIA
MSN Laboratories’ bedaquiline tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
TB395 Bedaquiline fumarate Tablet 100mg - MSN Lab - INDIA
Mylan’s nirmatrelvir + ritonavir tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Active Pharmaceutical Ingredient (API) Prequalified
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Dihydroartemisinin manufactured by Guilin Pharmaceutical Co., Ltd.
Guilin’s 120 and 180 mg powder for sol for inj prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
2025 Assessment Sessions for In Vitro Diagnostics
IVD
The In Vitro Diagnostics Assessment Team has established a new assessment model combining assessment sessions and between-assessment session work.
First tafenoquine products prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
First dispersible rifapentine tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Cadila’s dispersible ethambutol tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list :
Cadila’s dispersible isoniazid tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Active Pharmaceutical Ingredient (API) Prequalified
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Lamivudine (WHOAPI-428) manufactured by Styrax Life Sciences Pvt Ltd has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Public announcement to TB in vitro diagnostics manufacturers, procurement agencies and national TB programmes: Extension of WHO GTB recommendation-based procurement eligibility for TB NAT assays until 31 December 2025
IVD
The World Health Organization (WHO), through its Prequalification Unit and Global Tuberculosis Programme, would like to announce that the transition period for WHO procurement el
Active Pharmaceutical Ingredient (API) Prequalified
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Rifampicin (WHOAPI-507) manufactured by Macleods Pharmaceuticals Ltd has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Macleods’ bedaquiline tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list: