Newly prequalified Quality Control Laboratories (QCLs)
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New addition to the List of Prequalified Quality Control Laboratories (QCLs):
News
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 Kanamycin (acid
First liposomal amphotericin B powder for injection prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Second rectal artesunate capsule prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Ipca's paediatric artemether/lumefantrine tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Labesfal's Mg injection prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Hisun's kanamycin injection prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
MSN's moxifloxacin tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
ViiV Healthcare's abacavir/lamivudine tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Hetero's paediatric lopinavir/ritonavir tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Questions and answers on DTG use in women of childbearing age
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On 18 May 2018, WHO has issued a web statement signalling a potential risk of neural tube defects in infants born to women who were taking dolutegravir (DTG) at the time of conception.
ICHQ3D introduced for APIMF and API prequalification procedures
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The ICHQ3D guideline presents a process to assess and control elemental impurities in drug products using the principles of risk assessment.
Report on the international API inspection programme 2011 - 2016
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In April 2018, EMA published a report with an overview of the activities of the programme between 2011 and 2016.
First amikacin injection prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Newly prequalified Quality Control Laboratory (QCL)
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New addition to the List of Prequalified Quality Control
HLL’s levonorgestrel prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Newly prequalified Quality Control Laboratory (QCL)
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New addition to the List of Prequalified Quality Control Laboratories (QCLs):
First flucytosine prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First dispersible paediatric ethambutol prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Riemser Pharma's protionamide prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Riemser Pharma's terizidone prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list: