Italian regulators came down hard recently on Chinese drugmaker Jinan Jida after an inpsection found issues that led the European Directorate for the Quality of Medicines (EDQM) to suspend its certificate of suitability for the antibiotic nitrofurantoin. But the company is responding quickly, having turned to a U.S. company to help it fix its problems and regain its place in the EU API market.
The API maker has hired Connecticut-based ChemWerth to help it get its processes up to EU standards and hopes to reapply for its certificate within a year. ChemWerth is a generic API development and supply specialist that also offers regulatory support. The two already had a business relationship and extended that to include its nitrofurantoin manufacturing.
"We are pleased to announce Jinan Jinda has entered into a 5-year service agreement with ChemWerth with the goal being to correct Jinda's quality system and GMP compliance conditions," Cheng Yushui, general manager of the Shandong-based company, said in a statement. "Our commitment to be a qualified supplier for the EU and U.S. regulatory markets has never changed."
The suspension was recommended to the EDQM by Italian inspectors, who recorded 18 deficiencies at the plant, one which was classified as critical and 6 as major. They were most concerned about raw supplies and finished products they discovered behind a barred door. Inspectors "concluded there was a serious risk of data falsification" related to the ingredients in room, the door of which had been screwed shut by employees. and the possibility that the company was not being forthright about the data for them.
In June the EDQM banned a number of the sterile products made by China's Zhuhai United Laboratories after inspectors from Romania uncovered shortcomings in the company's aseptic manufacturing in a plant in Guangdong, China.
- here's the release