Athenex suspends Chinese API production after safety concerns
The company suspended production activities at its active pharmaceutical ingredient (API) plant in Chongqing, China, last month.
The action was taken following industry-wide inspections and evaluations by the Department of Emergency Management of Chongqing, after two separate explosions at chemical factories in March and April that resulted in fatalities.
The incident in April, related to Qilu Tianhe Huishi Pharmaceuticals, left 10 workers dead at the API producer’s facility. While the prior explosion at a pesticide plant in eastern China killed 78 people and injured 617.
As a result, industry-wide inspections focused on production safety took place and Athenex voluntarily ceased production, though it will be able to supply API through existing inventories until, at least, the third quarter of this year, the company stated.
Regarding its decision, Athenex said that "this self-imposed action demonstrates the company’s good faith in working with the Department of Emergency Management of Chongqing and that the company takes work safety very seriously."
Athenex noted that its clinical trials will not suffer from suspended API production, it currently has two pivotal Phase III clinical candidates and six additional candidate in Phase I and II studies.
The company will soon possess another API plant in the city, with a new plant expected to be completed in the first half of 2020.
Despite the suspension of activity, Athenex stated that it projects product sales to increase by 25% to 30% during 2019.
Athenex further stated, “The company believes the API plant has been in compliance from a safety and regulatory perspective. The company will continue to work closely with the department and aims to conclude the inspection as soon as practicable.”
