First generic medroxyprogesterone injection prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
News
First 800mg darunavir tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
First efavirenz/lamivudine/tenofovir 400/300/300mg tablets prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
First moxifloxacin 100mg dispersible tablets prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Zheijiang Hisun’s moxifloxacin tablets prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Micro Labs’ linezolid tablets prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Micro Labs’ amodiaquine/artesunate tablets prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Guilin’s pyrimethamine/sulfadoxine prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Mylan’s dolutegravir tablets prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Oxytocin injection - Clarification of stability data and storage statement requirements
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This notice is issued to clarify the required stability data and storage statement for prequalification of oxytocin injection products.
Revised sample zinc acceptability study protocol available
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WHO Prequalification provides new advice on zinc.
Updated bioequivalence and biowaiver application documents
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Updated versions of the Bioequivalence Trial Information Form (BTIF) and the Application for a biowaiver: Biopharmaceutics Classification System (BCS) form have be
New appendix added to Bioequivalence Trial Information (BTIF)
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An appendix has been added to the Bioequivalence Trial Information Form (BTIF).
Additional bioequivalence information now required in Module 2.7
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In order to improve the PQTm’s depth of knowledge regarding products submitted for prequalification and to better understand their performance as it potentially relates to safety and efficacy, PQTm
Shanghai Desano’s lamivudine/nevirapine/zidovudine tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
First dispersible sulfadoxine/pyrimethamine + amodiaquine in co-blister prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
First valganciclovir prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
GPO’s efavirenz tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Capreomycin 500mg injection prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Newly prequalified Active Pharmaceutical Ingredient (API)
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Tenofovir disoproxil fumarate (
Newly prequalified Quality Control Laboratories (QCLs)
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New addition to the List of Prequalified Quality Control Laboratories (QCLs):
Note on paediatric products in PQT Medicines
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The development of paediatric formulations for essential medicines has been recognized as a critical step for successful healthcare delivery.
First Itraconazole prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First paediatric cycloserine prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First generic rifampicin 300mg capsule
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Dolutegravir 50mg prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Newly prequalified Active Pharmaceutical Ingredient (API)
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Praziquantel (WHOAPI-309) manufactured by Shanghai Desano Chemical Pharmaceutical Co Ltd has been prequalified by the WHO Prequalification Team: medicines under its AP
WHO kick-starts pilot prequalification of biotherapeutics for cancer treatment
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WHO today launches a pilot project for prequalifying biotherapeutic medicines, a step towards making some of the most expensive treatments for cancer more widely available in low- and middle-income
Newly prequalified Active Pharmaceutical Ingredients (APIs)
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Linezolid (WHOAPI-252) and