Celltrion Pharm gets GMP certification from Japan

The PFS facility in Cheongju is certified by regulatory authorities in five countries: S.Korea, EU, US, Brazil, and Japan

The headquarters of Celltrion Pharm
The headquarters of Celltrion Pharm
Ye-Na Kim 1
2023-09-27 17:29:02 yena@hankyung.com
Bio & Pharma

Celltrion Pharm Inc. announced on Wednesday that its pre-filled syringe (PFS) production facility in Cheongju, North Chungcheong Province has obtained good manufacturing practice (GMP) certification from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

According to the company, PMDA investigated conformity on Yuflyma’s PFS production facility and made an approval decision. Yuflyma is a biosimilar of Humira, an autoimmune disease treatment developed by AbbVie, with the active ingredient Adalimumab.

Celltrion Pharm has got GMP certification from regulatory authorities in five countries, including South Korea, the European Union, the US, Brazil, and Japan for its Cheongju plant's PFS production facility.

"We have plans to continue revenue growth by gradually expanding PFS dosage form production, targeting major global markets, including the domestic market," a Celltrion Pharm source said. 

Celltrion Pharm's PFS production facility in Cheongju plant is a three-story building with a total floor area of 2,315 square meters. It is capable of producing pharmaceuticals in three types of PFS: auto-injectors, PFS, and PFS-S (with safety devices).

Write to Ye-Na Kim at yena@hankyung.com
#Celltrion Pharm #pre-filled syringe #Yuflyma #PMDA #Humira #GMP

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