Warm congratulations to LoncomPharma for successfully passing the GMP.
Warm congratulations to LoncomPharma for successfully passing the on-site inspection of desloratadine raw material drug registration and GMP compliance inspection.
From October 16 to October 20, 2020, appointed by the Food and Drug Inspection Center of the State Drug Administration and the Inspection Center of the Osaka Provincial Drug Administration, a six-member inspection team inspected the R&D site of Bainuo Pharmaceuticals and the production site of Lonno Pharmaceuticals A 5-day on-site inspection of drug registration and GMP compliance inspection of desloratadine API was carried out.
During the five-day inspection, the experts of the inspection team, based on the principles of fairness, openness, and transparency, and with a serious and responsible attitude, reviewed the company’s quality management by consulting a large number of documents and records, dynamic inspections of the production process, and personnel exchanges. The system has been thoroughly checked. After intensive and orderly inspections, the inspection team generally commented that the production of “Desloratadine” raw material medicine of our company complied with the requirements of GMP and on-site inspection standards for drug registration, and passed the on-site inspection smoothly.
“Desloratadine” API successfully passed the drug registration on-site inspection and GMP compliance inspection, marking another new product of our company to be launched, and verifying that the software and hardware levels of our production quality system have reached the new standard stipulated by the state , which has won opportunities for the company in the current fierce market competition, and laid a solid foundation for the rapid development of the company.
