Brazil approves Celltrion Pharm’s syringe facility

Celltrion Pharm Inc., a South Korean biopharmaceutical company, said on Monday it received certification from Brazil’s health regulator for its pre-filled syringe production facility.

The company said it passed an inspection by Brazil’s National Health Surveillance Agency (ANVISA) at the end of last year at its plant in Cheongju, South Korea. The certification will allow Celltrion to produce and supply syringes to South America.

Celltrion also said it plans to undergo inspections by authorities in Japan and the US this year.

The company's syringe facility received approval from both Korea's Ministry of Food and Drug Safety and the EU in 2021, and started commercial production of autoimmune disease treatments Remsima SC and Yuflyma last year.

A Celltrion official said the company aims to expand its contract manufacturing business for syringes for domestic and foreign companies targeting the global market, and continue to grow through portfolio expansion.

Write to Jae-Young Han at jyhan@hankyung.com