PHC Obtains GMP Certification for Rapid Antigen Test Kit

[Asia Economy Reporter Hyungsoo Park] PHC announced on the 16th that its affiliate, Philosis, has obtained GMP (Good Manufacturing Practice for medical devices) certification from the Ministry of Food and Drug Safety for its COVID-19 rapid antigen test kit.

Philosis received conditional domestic manufacturing approval for the rapid antigen test kit in January. They have fulfilled the conditions and acquired GMP certification.

PHC has recently expanded sales channels by obtaining rapid test kit approvals in multiple countries including Australia, Thailand, Germany, and Russia. With domestic MFDS approval and GMP certification completed, they have demonstrated excellent COVID-19 diagnostic technology.

PHC recently signed a memorandum of understanding (MOU) with Hanmi Pharmaceutical for overseas COVID-19 diagnostic business cooperation. In February, they signed a supply contract for rapid antigen test kits with SoluM Healthcare, a subsidiary of SoluM, establishing a foothold for sales in Europe.

A PHC official stated, "From the 14th, positive results from professional rapid antigen tests are also confirmed as cases," adding, "We will continue efforts to expand stable supply volumes of the verified rapid antigen test kits amid the COVID-19 situation."

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