27 Jul. 2023
OEP’s Cytotoxic Oncology Injection Plant Completed US FDA Inspection
The Cytotoxic Oncology Injection Plant of OP NanoPharma, a subsidiary of OEP Group (4120.TW), completed the inspection of the US Food and Drug Administration (FDA) on July 25, 2023. The FDA onsite inspection of the anticancer drug Decitabine lyophilization injection product manufacture started from July 17, 2023, and there were no serious or major deficiencies founded.
Located at CTSP Huwei Science Park, Yunlin, the Cytotoxic Oncology Injection Plant is a sterile/cytotoxic injection plant dedicated to anticancer drugs manufacturing both lyophilization and solution products. In 2022, it received Taiwan Food and Drug Administration (TFDA) PIC/ S GMP certification. OEP Group also owns an oral dosage plant and R&D centers in Taiwan and the United States. The completion the US FDA inspection will improve the CDMO capability of OEP Group and bring more opportunities for international collaborations.