New WHO Public Inspection Reports (WHOPIRs) published
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Past News
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:
Request for Proposals: Prequalification Team Quality Systems Consultancy
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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
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
NCPC's capreomycin injection prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Mylan's isoniazid 100mg and 300mg tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Mylan's protionamide 250mg tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Minimum stability data required at the time of filing a generic product application
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The previous exception to allow 3 months stability data (at time of submission) for RH and 2nd line TB products was made, as an interim measure, to encourage the submission of poorly-represented pr
Newly prequalified Active Pharmaceutical Ingredients (APIs)
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Lamivudine (WHOAPI-265) manufactured by Anhui Biochem United Pharmaceutical Co Ltd and Praziquantel (WHOAPI-301) manufactured by Hisun Pharmaceutical (Nantong) Co Ltd have been pr