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 low- and midd
Artemether (WHOAPI-268) manufactured by Chongqing Holley Wuling Mountain Pharmaceutical Co Ltd and Darunavir (ethanolate) (WHOAPI-214) ma
The lack of prequalified reproductive health medicines is of great concern to WHO and to partner organizations working to improve reproductive health.
Agreement seeks to improve health options for hepatitis C patients in low- and middle-income countries.
WHO Prequalification Team - Medicines (PQT) added the below new products to its prequalified list
WHO Prequalification Team - Medicines (PQT) added the below new products to its prequalified list
WHO Prequalification Team - Medicines (PQT) added the below new products to its prequalified list
The following products were added:
On 31 March 2017, WHO for the first time prequalified a generic active pharmaceutical ingredient (API) for hepatitis C – sofosbuvir.
Sofosbuvir (WHOAPI-290) manufactured by
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
Applicants and Contract Research Organizations (CROs) performing bioequivalence studies are reminded that all studies with human subjects must be conducted in compliance with Good Clinical Practice
TB336: Rifapentine - 150mg - Film-coated tablets - Sanofi-Aventis U.S. LLC - USA
Miltefosine 10mg and 50mg capsule
The revisions to the BTIF (Bioequivalence Trial Information Form) include the following changes to facilitate study assessment:
The Medicines Patent Pool today announced that it has signed a licence w
Medroxyprogesterone manufactured by Taizhou Taifa Pharmaceutical Co Ltd has been prequalified by the WHO Prequalification Team: medicines (PQTm) under its API prequalification procedure.
Treatment of maternal syphilis and prevention of congenital syphilis
Adult formulations
New addition to the List of Prequalified Quality Control Laboratories (QCL):
WHO Prequalification Team - Medicines (PQT) added the below new products to its prequalified list
Cycloserine manufactured by Zhejiang Hisun Pharmaceutical Co Ltd and Zinc (sulfate) manufactured by Canton Laboratories Pvt Ltd have been prequalified by the WHO Prequalification Team: medicines (P
DI005: Zinc (as sulfate monohydrate) - 20mg - Dispersible tablets - Macleods Pharmaceuticals Ltd - INDIA
Dihydroartemisinin manufactured by Ipca Laboratories Ltd has been prequalified by the WHO Prequalification Team: medicines (PQTm) under its API prequalification procedure.
WHO Prequalification Team - Medicines (PQT) adds the below new products to its prequalified list
WHO Prequalification Team - Medicines (PQT) adds the below new products to its prequalified list
The 11th invitation to manufacturers of active pharmaceutical ingredients (APIs) to submit an expression of interest (EOI) for API prequalification to the WHO Prequalification Team: medicines (PQTm