Chinese API Manufacturer Refuses EU Officials’ Inspection
China-based active pharmaceutical ingredient (API) and intermediate manufacturer Jiangsu Yew Pharmaceutical Co. has refused an inspection by Hungarian officials and has been found to not comply with Good Manufacturing Practice requirements, according to a European database of pharmaceutical inspections updated Wednesday.The refusal of the inspection on 20 June means the company, which manufactures intermediates for the active substance temozolomide, will not win approval for a Certificate of suitability (CEP). However, recalls and suspension of marketing authorization shall be assessed by national competent authorities, according to the database.
This is just one in a series of Asia-based companies refusing inspections.
Last month, the US Food and Drug Administration added four Chinese, one Indian and one South Korea-based drug manufacturers to its import alert list for refusing inspections.