Celltrion Pharm Cheongju Plant Obtains FDA cGMP Certification

Celltrion Pharm announced on the 27th that it recently obtained the U.S. Food and Drug Administration (FDA) certification for current Good Manufacturing Practice (cGMP) for the prefilled syringe (PFS) production line at its Cheongju plant in Chungbuk.

Exterior view of Celltrion Pharm factory in Cheongju, Chungbuk [Photo by Celltrion Pharm]

This certification follows the recent successful inspection of the PFS production line, which was completed with "no observations." Through this, the manufacturing facility has been recognized for its competitiveness as a high-quality production site that meets global GMP standards and can stably produce and supply products. It also establishes a foundation for producing PFS formulation pharmaceuticals supplied to the United States.

The PFS production line is a three-story building with a total floor area of 2,315㎡ (approximately 700 pyeong), designed to handle the entire process from formulation to filling, foreign matter inspection, assembly, and packaging by receiving active pharmaceutical ingredients (DS). Based on the core filling process, it can produce up to 16 million syringes annually.

It is capable of producing three types of PFS formulation pharmaceuticals: pen (auto-injector), PFS, and PFS-S (Safety Device). In particular, the ability to simultaneously produce the pen and PFS-S types, which have recently seen increased demand due to their emphasis on safety and convenience, is considered an advantage.

A Celltrion Pharm official stated, “The Cheongju plant has already obtained FDA cGMP and European Union (EU) GMP certifications for chemical pharmaceutical production facilities and supplies various products to domestic and international markets. By acquiring this certification, we have proven that the PFS production facility also possesses cGMP-level equipment and capabilities. Moving forward, we will contribute to the stable supply of PFS formulation pharmaceuticals both domestically and internationally and actively pursue diversification of profits.”

Meanwhile, in addition to this FDA cGMP certification, Celltrion Pharm has also obtained EU GMP and Brazilian Health Regulatory Agency (ANVISA) GMP certifications. The company has completed the inspection for the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) GMP and expects to receive the results within this year.

This content was produced with the assistance of AI translation services.