WHO药品预认证项目发布第44次API预认证意向书邀请，新增五种原料药

News

29 October, 2026 - 12:12 (CET)

Announcement

A 44th invitation to manufacturers of Active Pharmaceutical Ingredients (API) to submit an Expression of Interest (EOI) for API evaluation to the WHO Prequalification of Medicines Programme has been published.

This 44th invitation has been expanded to include:

•    Acoziborole 
•    Alpha Methyl dopa
•    Hydralazine
•    Labetalol
•    Nifedipine
 

API prequalification is intended to support national and global efforts to increase access to and the affordability of care and treatment of priority diseases, by identifying suppliers of high quality API for prospective FPP manufacturers and National Medicine Regulatory Agencies.

Further information on the API Prequalification can be found at this link: http://www.who.int/prequal/info_applicants/API_info_applicants.htm.

Manufacturers of APIs, particularly, those already involved in the FPP prequalification programme through the APIMF procedure are encouraged to consider the benefits that recognition as a prequalified API might offer to them.