ExoCoBio Obtains GMP Licenses for Exosome Biopharmaceuticals in Korea and Hyaluronic Acid (HA) Dermal Fillers in Brazil

03/02/2023

ExoCoBio announced that it has obtained the "Certificate of Advanced Biopharmaceutical Manufacturing" from the Ministry of Food and Drug Safety in Korea, and the "HA Filler GMP Certification" from the Brazilian Food and Drug Health Monitoring Agency (ANVISA).

According to ExoCoBio, the Osong ExoGMP facility in South Korea, which ExoCoBio has invested $20 million over the past 3 years, has 2 features to be anticipated as a strategic asset in the global exosome industry.

  • It is the world's largest exosome manufacturing facility for stem cells and others, also aiming to provide CDMO services worldwide.
  • It has 220 equipment/instruments and 300 SOPs (Standard Operating Procedures) installed for advanced exosome-based drug manufacturing to produce purified exosomes for injectable regenerative medicine.

ExoCoBio also recently achieved another GMP certification for hyaluronic acid (HA) fillers from ANVISA in Brazil. HA fillers are grade 4 medical devices. After this ANVISA GMP certification, ExoCoBio is expecting to export them to South America after product registration/approval in 2023, which will accelerate its growth of 50% per annum for next 3 years, according to a company news release.

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