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
New addition to the List of Prequalified Quality Control Laboratories (QCL):
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
WHO Prequalification Team - Medicines (PQT) added the below new products to its prequalified list
DI005: Zinc (as sulfate monohydrate) - 20mg - Dispersible tablets - Macleods Pharmaceuticals Ltd - INDIA
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
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
The following products were added to the EOI:
WHO Prequalification Team - Medicines (PQT) added the below new product to its prequalified list:
Levofloxacin manufactured by Shangyu Jingxin Pharmaceutical Co Ltd has been prequalified by the WHO Prequalification Team: medicines (PQTm) under its API prequalification procedure.
WHO Prequalification Team - Medicines (PQT) added the below new products to its prequalified list
WHO Prequalification Team - Medicines (PQT) added the below new product to its prequalified list: