Newly prequalified Active Pharmaceutical Ingredient (API)
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News
WHO list of prequalified in vitro diagnostic products updated
IVD
The WHO list of prequalified in vitro diagnostic products has been updated.
ACME Lab’s dispersible zinc tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
PT Sanbe’s levofloxacin tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Micro Labs’ paediatric ethambutol prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Nitrosamine concerns in rifampicin products - Update
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A nitrosamine impurity, 1-methyl-4-nitrosopiperazine (MeNP), was identified in rifampicin products.
1st Invitation to Manufacturers of therapeutics against Ebola Virus Disease to submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Unit published
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A 1st Invitation to Manufacturers of therapeutics against Ebola Virus Disease to submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Unit is being published by
DEMO’s dexamethasone solution for injection prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First generic flucytosine tablet prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
WHO list of prequalified in vitro diagnostic products updated
IVD
The WHO list of prequalified in vitro diagnostic products has been updated.
Casirivimab and imdevimab combination invited for COVID-19
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Casirivimab and imdevimab combination invited for COVID-19.
Protionamide tablet from Lekhim Joint Stock Company in Ukraine prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Remington’s levofloxacin tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Lupin’s paediatric isoniazid/rifampicin dispersible tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Application of reference-scaled criteria for AUC in bioequivalence studies conducted for submission to PQT/MED
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WHO bioequivalence guidelines (TRS No.
First dolutegravir 5mg dispersible tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First darunavir/ritonavir tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Lab Liconsa’s ivermectin prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Naari’s levonorgestrel tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list: