Humasis Obtains Certification for Compliance with Manufacturing and Quality Control Standards at Uiwang Plant

[Asia Economy Reporter Lee Gwan-joo] Humasis announced on the 10th that it has obtained the domestic in vitro diagnostic medical device manufacturing and quality management standards compliance certification (GMP) from the Ministry of Food and Drug Safety for its new manufacturing facility in Uiwang-si, Gyeonggi-do.

Following the increase in overseas orders for diagnostic kits after the COVID-19 outbreak, Humasis secured a production plant in Uiwang-si, Gyeonggi-do, starting from November last year, producing about 100,000 units per day for export.

Subsequently, as domestic confirmed cases increased and self-test kits were used at screening clinics, domestic demand surged sharply. To respond to this, the company applied for KGMP certification and obtained approval for the in vitro diagnostic medical device immunoassay device product group.

The Humasis Uiwang plant can produce up to 300,000 tests per day with additional automated equipment. Combined with the production capacity of the existing Anyang and Gunpo plants, it can produce up to 50 million tests per month.

In addition, Humasis obtained export approval on the 8th for a molecular diagnostic kit for detecting the Omicron variant. This product can detect the Omicron variant and 'Stealth Omicron' in COVID-19 infected patients.

A Humasis official stated, “We are focusing our research capabilities on expanding our product lineup for rapid entry into the molecular diagnostics market. In particular, we are planning products for infectious diseases such as influenza and dengue fever, as well as genetic diseases. The product that received approval this time is expected to obtain the European Conformity (CE) certification related to safety in Europe soon.”

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