News
Notice of Concern (NOC) withdrawn for Svizera Labs Pvt Ltd
Following corrective actions taken by Svizera Labs Pvt Ltd and the clarifications provided
Newly prequalified Active Pharmaceutical Ingredient (API)
Linezolid manufactured by Optimus Drugs Pvt Ltd has been
Temmler Pharma’s ethinylestradiol/levonorgestrel tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Hetero’s aciclovir tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Aurum Pharmaceuticals' magnesium sulfate injection prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Mylan’s cycloserine capsules prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Mylan’s capreomycin injection prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Shanghai Desano’s efavirenz tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Macleods’ linezolid tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Macleods’ paediatric rifampicin/isoniazid/pyrazinamide dispersible tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Strides Shasun's artemether/lumefantrine dispersible tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Laurus' tenofovir tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First entecavir prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First terizidone prequalified
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
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Hetero's abacavir/lamivudine tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Newly prequalified Active Pharmaceutical Ingredient (API)
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)
Piperaquine (phosphate) (WHOAPI-248) ma
Newly prequalified Active Pharmaceutical Ingredient (API)
Emtricitabine manufactured by Mangalam Drugs & Organics Ltd has been prequalified by the WHO Prequali
Pre-submission meetings
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
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Bayer AG/Jenapharm’s ethinylestradiol/levonorgestrel prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Micro Labs' efavirenz 600mg tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Request for Proposals: Prequalification Team Quality Systems Consultancy
The Prequalification Team is publishing a request for proposals for consultancy services relating to - developing and maintaining the Quality Management Systems (QMS) and assuming the responsibilit
Micro Labs' pyrazinamide dispersible tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
NCPC's capreomycin injection prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Mylan's isoniazid 100mg and 300mg tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Mylan's protionamide 250mg tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list: