Chinese API producer refuses entry of EU inspectors
The European Medicine Agency (EMA)’s EudraGMDP database revealed that inspectors had been turned away from carrying out their work at the Yixing City-based API facility of Jiangsu Yew Pharmaceutical.
As a result, EudraGMDP made a statement that the company was non-compliant with the European Union’s manufacturing standards and had suspended its marketing authorisation.
The active pharmaceutical ingredient (API) produced at the plant is temozolomide. The API is used in oral chemotherapy drugs and is a treatment for some brain cancers, astrocytoma and is a first-line therapy for glioblastoma multiforme.
The EMA has advised a recall of the ingredient, based upon National Competent Authority’s risk assessment of the situation.
The European Directorate for the Quality of Medicines is now poised to refuse approval of the company’s Certification of Suitability (CEP).
JYP produces 25 other products, including commonly used chemotherapy treatment cisplatin and docetaxel.
The company did not immediately respond to a request for comment prior to publication.
China’s manufacturing draws spotlight
This latest case of problems within the API manufacturing industry in China adds to a series of stories that have broken over the last few months regarding the safe production of medicine in the country.
The largest of which is the case of valsartan medication, with this ongoing investigation drawing in several companies over impurities and led to a global recall of medicines containing the contaminated API.
At the same time as this case arose, a public scandal over improperly produced vaccines culminated in the dismissal of several officials linked to the case.
