Newly prequalified Active Pharmaceutical Ingredient (API)
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Past News
First sofosbuvir/velpatasvir prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Strides' artemether/lumefantrine tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Livzon’s kanamycin solution for injection prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Celltrion’s linezolid tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
16th Invitation to manufacturers and suppliers of medicinal products for HIV infections and related diseases to submit and Expression of Interest (EOI) for product evaluation to the WHO Prequalification Team: medicines
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The following products were deleted:
Mylan’s kanamycin prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Beximco’s lamivudine tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
First FDC with dolutegravir prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Anhui's lamivudine/zidovudine tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Unique's ciprofloxacin prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
EEPI's sofosbuvir prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Guilin's artesunate + SP tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Lupin's linezolid prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Macleods' paediatric moxifloxacin dispersible tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Ipca's artesunate injection prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Emergency Use Listing Procedure - Deadline extended to 15 December 2018
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DEADLINE EXTENDED TO 15 DECEMBER 2018
First generic medroxyprogesterone injection prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
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.
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
New appendix added to Bioequivalence Trial Information (BTIF)
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An appendix has been added to the Bioequivalence Trial Information Form (BTIF).
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) fo