ST PHARM Passes Regular cGMP Inspection by US FDA of Oligo Manufacturing Plant

ST PHARM, a subsidiary of South Korea's Dong-A Socio Group, announced on October 25 that its oligonucleotide production plant, Banwol Campus, has successfully passed regular inspections by the U.S. Food and Drug Administration (FDA) Current Good Manufacturing Practices (cGMP) inspection and received an Enterprise Inspection Report (EIR).

With FDA inspection approval, ST PHARM is now recognized as a manufacturing facility capable of consistently producing and supplying high-quality oligonucleotides in compliance with global pharmaceutical manufacturing and quality management standards. This further drives the company's competitive advantage globally.

ST PHARM Banwol Campus has reached cGMP standards and continues to enhance its oligonucleotide production capabilities through continuous investment. Following the construction of its first Oligo Building in 2018, the company added a third and fourth floor expansion in 2020. Recently, they have begun construction on a second oligonucleotide building. Upon completion of the expansion of the second oligonucleotide building, the company's oligonucleotide production capacity is expected to increase from the current 6.4 mol per year to a maximum of 14 mol by 2026, making the company the world's top oligonucleotide production capacity enterprise.

Importantly, as some new drug commercialization plans for blood cancer and cardiovascular diseases are carried out, ST PHARM, as a raw material supplier, will undergo multiple FDA reviews in the future, and the recent manufacturing facility inspection approval is regarded as a positive indicator.