ExoCoBio obtained 2 GMP Licenses for Exosome Biopharmaceuticals from K…
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작성일 24-07-04
작성일 24-07-04
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ExoCoBio obtained 2 GMP Licenses for Exosome Biopharmaceuticals from Korea MFDS and for Hyaluronic Acid (HA) Dermal Fillers from Brazil ANVISA
ExoGMP™ (Osong, South Korea)
· ExoGMP™ is the world's largest exosome manufacturing facility in Osong, South Korea.
· Cellosome™ HA fillers are expected to be approved in 2023.
· ExoCoBio has all 3 types of GMP clearance for pharmaceuticals, medical devices, & cosmetics.
SEOUL, South Korea, March 2, 2023 /PRNewswire/ -- ExoCoBio Inc. announced that it 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).
This advanced biopharmaceutical manufacturing license was obtained in accordance with Article 23 of the "Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals" and Article 9 Paragraph 3 of the "Rules on Safety and Support for Advanced Biopharmaceuticals". As a result, ExoCoBio earned the title of "Korea's first exosome-based advanced biopharmaceutical manufacturing company."
The Osong ExoGMP™ facility, which ExoCoBio has invested 20 million dollars over the past three years, has 2 key features to be anticipated as a strategic asset in the global exosome industry.
1) It is the world's largest exosome manufacturing facility for stem cells and others, also aiming to provide CDMO services worldwide.
2) It has 220 equipment/instruments and 300 SOPs (Standard Operating Procedures) installed for the most advanced exosome-based drug manufacturing to produce purified exosomes for injectable regenerative medicine.
Moreover, ExoCoBio 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.
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