WHO Public Assessment Reports (WHOPARs) published
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News
Information on the GMP status of Mylan Laboratories Ltd (Viatris, Inc.) manufacturing facility situated at Indore, Pithampur (Madhya Pradesh, India)
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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
Active Pharmaceutical Ingredient (API) Prequalified
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Dihydroartemisinin manufactured by Guilin Pharmaceutical Co., Ltd.
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:
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:
Cadila’s dispersible ethambutol tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product 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 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:
22nd Invitation to Manufacturers and Suppliers of Medicinal Products for HIV Infections and Related Diseases to Submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Unit
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The Invitation to Manufacturers for HIV Infections and Related Diseases to submit an Expression of Interest for Product E
Macleods’ pretomanid tabl prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Revised NTD EOI published
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On 29 October 2024, the revised 9th NTD EOI, now including Moxidectin, was published.
WHO grants approval for use of Bavarian Nordic’s mpox vaccine in adolescents
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On 8 October 2024, WHO granted prequalification for the age-extension of the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine for use in adolescents aged 12 to 17 years, expanding its indi
Lupin’s isoniazid/rifapentine tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Recent Highlights
IVD
On 14 October 2024 WHO listed the second mpox IVD under the WHO Emergency Use Listing (EUL) procedure.
Public consultation on proposed revisions to the WHO Prequalification of in vitro diagnostics assessment process
IVD