FDAnews Drug Daily Bulletin
Pharmaceuticals / GMPs

Three Chinese Drugmakers Added to Import Alert Lists

April 15, 2016

The FDA is continuing its crackdown on Chinese drugmakers, adding three more companies this week to its import alert lists over faulty GMP practices and a refusal for inspection.

One of the alerts covering GMPs listed several drug products from Xinxiang Pharmaceutical and Xinxiang Tuoxin Biochemical, both based in Henan Province. The companies make active pharmaceutical ingredients, as well as adenosine, choline, uridine, uracil, cytidine and inosine.

The two firms bring the total number of Chinese drugmakers on the alert list imposing “Detention Without Physical Examination” on products failing to comply with GMPs to 44.

Another company — Jiangxi Yuneng Pharmaceutical — was added to a separate list as the sixth Chinese drugmaker for refusing an FDA inspection. Chinese companies dominate this import alert list.