News
First liposomal amphotericin B powder for injection prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Second rectal artesunate capsule prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Ipca's paediatric artemether/lumefantrine tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Labesfal's Mg injection prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Hisun's kanamycin injection prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
MSN's moxifloxacin tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
ViiV Healthcare's abacavir/lamivudine tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Hetero's paediatric lopinavir/ritonavir tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Questions and answers on DTG use in women of childbearing age
On 18 May 2018, WHO has issued a web statement signalling a potential risk of neural tube defects in infants born to women who were taking dolutegravir (DTG) at the time of conception.
ICHQ3D introduced for APIMF and API prequalification procedures
The ICHQ3D guideline presents a process to assess and control elemental impurities in drug products using the principles of risk assessment.
Report on the international API inspection programme 2011 - 2016
In April 2018, EMA published a report with an overview of the activities of the programme between 2011 and 2016.
First amikacin injection prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Newly prequalified Quality Control Laboratory (QCL)
New addition to the List of Prequalified Quality Control
HLL’s levonorgestrel prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Newly prequalified Quality Control Laboratory (QCL)
New addition to the List of Prequalified Quality Control Laboratories (QCLs):
First flucytosine prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First dispersible paediatric ethambutol prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Riemser Pharma's protionamide prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Riemser Pharma's terizidone prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First rectal artesunate prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First dispersible paediatric levofloxacin tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Roche's ceftriaxone powder for injection prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
UPDATE: WHO Position paper on Qinhuangdao Zizhu Pharmaceutical Co Ltd, Active Pharmaceutical Ingredient (API) manufacturing site following the issue of the USFDA import alert
On 07 April 2017, WHO issued a position paper on the import alert placed on, Qinhuangdao Zizhu Pharmaceutical (QZP) by the United States Food and Drug Administration (USFDA) on 8 March 2017.
Hetero’s sofosbuvir tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list: