WHO Prequalification Team: medicines (PQTm) added the below new products to its prequalified list: RH063 - Magnesium sulfate - 500mg/ml (2ml) - Solution for injection - AS KALCEKS - LATVIA RH064 -...

Pyrimethamine ( WHOAPI-278 ) and sulfadoxine (WHOAPI-279) manufactured by Guilin Pharmaceutical Co Ltd have been prequalified by the WHO Prequalification Team: medicines (PQTm) under its active...

WHO Prequalification Team (WHO-PQT) refers to the publication of the response , dated 4 May 2017, to the USFDA warning letter for Mylan Laboratories Limited, Nashik site, dated 3 April 2017. Based on...

The following strength was added : Sulfadoxine/pyrimethamine, tablet 250mg/12.5mg ; The following products were deleted : Artesunate+sulfadoxine/pyrimethamine, tablet 25mg+250mg/12.5mg; tablet 50mg+...

The following products were added : Lamivudine/Abacavir/Dolutegravir, tablet 30mg/60mg/5mg dispersible The following products were deleted : Atazanavir/Ritonavir, tablet (heat stable) 100mg/33mg...

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 middle-...

On 8 th March 2017, Qinhuangdao Zizhu Pharmaceutical was placed on the import alert by the USFDA. The Good Manufacturing Practice (GMP) inspection was carried out by the USFDA at Qinhuangdao Zizhu...

On 31 March 2017, WHO for the first time prequalified a generic active pharmaceutical ingredient (API) for hepatitis C – sofosbuvir. Sofosbuvir is an essential ingredient for new, highly effective...

Sofosbuvir ( WHOAPI-290 ) manufactured by Mylan Laboratories Ltd has been prequalified by the WHO Prequalification Team: medicines under its API prequalification procedure. WHOAPI-290 - Sofosbuvir -...

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 responsibility...