Celltrion Pharm recently announced on July 27 that it has received U.S. FDA Current Good Manufacturing Practice (cGMP) certification for its Prefilled Syringe (PFS) production line at its Cheongju plant.
Celltrion Pharm recently successfully completed a U.S. Food and Drug Administration (FDA) inspection of its PFS production line with "no findings". The inspection confirms the company's competitiveness as a manufacturing facility that can reliably produce and supply high-quality products that meet global pharmaceutical manufacturing and quality control standards. This paves the way for the company to produce PFS dosage forms for supply to the United States.
The PFS production line is located on the third floor with a gross floor area of 2,315 square meters and is capable of performing the entire process from dispensing drug substance (DS) to filling, foreign object inspection, assembly, and packaging. Based on filling, which is considered the core process, the facility can produce up to 16 million syringes per year.
Three types of PFS dosage forms can be produced: Auto Injector, Prefilled Syringe, and Prefilled Syringe-Safety Device.
In particular, the ability to simultaneously produce Auto Injector and Prefilled Syringe-Safety Device types, which are in high demand due to the recent emphasis on safety and convenience, is also considered an advantage.
"The Cheongju plant has already obtained FDA cGMP and EU GMP certifications for chemical drug production facilities and supplies various products to domestic and overseas markets," said an official from Celltrion Pharm. "Through this certification, Celltrion has proven that its PFS production facility is also equipped with cGMP-level facilities and capabilities, and the company will actively diversify our revenue by contributing to the stable domestic and international supply of PFS-formulated drugs."
Meanwhile, Celltrion's Cheongju plant has previously passed the due diligence of European regulators and the Brazilian Health Regulatory Agency (ANVISA) for its PFS production line and obtained GMP certification. The Cheongju plant has additionally completed due diligence from the Pharmaceuticals and Medical Devices Agency (PMDA) and is expected to receive the results within the year.
