Newly prequalified Active Pharmaceutical Ingredients (APIs)
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News
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Notice of Concern (NOC) withdrawn for Svizera Labs Pvt Ltd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:
Strides Shasun's artemether/lumefantrine dispersible tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Laurus' tenofovir tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First entecavir prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First terizidone prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Pfizer’s medroxyprogesterone acetate 104mg/0.65mL suspension for injection (Sayana® Press) prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Hetero's abacavir/lamivudine tablet 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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Atazanavir (sulfate) manufactured by Macleods Pharmaceuticals Ltd has been prequalified by the WHO Prequalification Team: medicines under its API prequalification procedure.
Newly prequalified Active Pharmaceutical Ingredients (APIs)
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Piperaquine (phosphate) (WHOAPI-248) ma
Newly prequalified Active Pharmaceutical Ingredient (API)
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Emtricitabine manufactured by Mangalam Drugs & Organics Ltd has been prequalified by the WHO Prequali
Pre-submission meetings
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Pre-submission meetings provide an opportunity for advice and guidance prior to submission of a medicines dossier, as well as an opportunity for the applicant to meet the PQT medicines (PQTm) asses
First generic dolutegravir prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Bayer AG/Jenapharm’s ethinylestradiol/levonorgestrel prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Micro Labs' efavirenz 600mg tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list: