New WHO Public Assessment Reports (WHOPARs) published
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News
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
Second generic sofosbuvir prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Second generic praziquantel prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Global public consultation on WHO prequalification of similar biotherapeutic products
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In October this year WHO will launch a pilot project for prequalifying biosimilar medicines, a step towards making some of the most expensive treatments for cancer more widely available in lo
Newly prequalified Active Pharmaceutical Ingredient (API)
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Isoniazid (WHOAPI-005) manufactured by Amsal Chem Pvt Ltd has been prequalified by the WHO Prequalification Team: medicines under its active pharmaceutical ingredient (API) prequalification procedu
First paediatric isoniazid/rifampicin 50/75 dispersible tablet prequalified
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On 31 August 2017, WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
WHO Prequalifies key treatment for children with TB
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WHO has just prequalified a two-pills-in-one paediatric medicine that is critical for the continuation phase of the six-month treatment required to cure tuberculosis (TB).
Key performance indicators for WHO prequalification
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In the interest of monitoring performance and increasing its capacity to report on that performance to its many stakeholders, the WHO Prequalification Team has developed new key performance indicat
First generic sofosbuvir prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Shanghai Desano’s lamivudine/zidovudine tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Hetero's moxifloxacin 400mg tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Hetero's ritonavir 100mg tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list: