New WHO Public Inspection Report (WHOPIR) published
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News
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:
First rectal artesunate prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First dispersible paediatric levofloxacin tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Roche's ceftriaxone powder for injection prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
UPDATE: WHO Position paper on Qinhuangdao Zizhu Pharmaceutical Co Ltd, Active Pharmaceutical Ingredient (API) manufacturing site following the issue of the USFDA import alert
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On 07 April 2017, WHO issued a position paper on the import alert placed on, Qinhuangdao Zizhu Pharmaceutical (QZP) by the United States Food and Drug Administration (USFDA) on 8 March 2017.
Hetero’s sofosbuvir tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Notice of Concern (NOC) withdrawn for Svizera Labs Pvt Ltd
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Following corrective actions taken by Svizera Labs Pvt Ltd and the clarifications provided
Newly prequalified Active Pharmaceutical Ingredient (API)
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Linezolid manufactured by Optimus Drugs Pvt Ltd has been
Temmler Pharma’s ethinylestradiol/levonorgestrel tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Hetero’s aciclovir tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Aurum Pharmaceuticals' magnesium sulfate injection prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Mylan’s cycloserine capsules prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Mylan’s capreomycin injection prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Shanghai Desano’s efavirenz tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Macleods’ linezolid tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Macleods’ paediatric rifampicin/isoniazid/pyrazinamide dispersible tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list: