Oral oncology and specialty pharmaceutical Lotus Pharmaceutical Co., Ltd (“Lotus” or “the Company”, 1795:TT) announced its Nantou manufacturing facility has completed the 5-day inspection by US FDA and received the Establishment Inspection Report today with “zero observations”, or “no action indicated”. This is the fifth inspection by the USFDA since 2010. The FDA investigator reviewed the manufacturing of general drug products and cytotoxic products, warehouse, laboratories, quality systems, utility systems and serialization and found these to be satisfactory.
Lotus Chairman Robert Wessman said, “High quality generic drugs are crucial for patients’ health as generic drugs amount to 90% of all prescriptions filled in the U.S. As more robust inspections have uncovered problems of generic manufacturers, we are glad that we continue to deliver outstanding quality records. Nantou site is expected to be the key supplier of oral oncology and specialty drugs to regulated markets starting this year. In addition to the latest FDA inspection, we are glad to announce that we have passed the audits of many customers and out-licensing partners around the world, including those in the UK, European Union, Brazil, and Japan. We believe that our investment into this R&D and manufacturing hub will create a global leader in the field of oncology and special dosage forms.”