Editor’s Note
**Editor’s Note:** This article highlights a significant milestone for a botulinum toxin production facility in Wonju, which has earned recognition for its manufacturing and quality management capabilities. With the Brazil product registration process now underway, the facility is overcoming stringent regulatory hurdles to establish a foothold in one of the world’s largest markets.
[Biotimes] Jeisys Medical (216080), a global medical aesthetics and biopharmaceutical company, has successfully passed the Good Manufacturing Practice (GMP) audit by Brazil’s National Health Surveillance Agency (ANVISA), accelerating its entry into the Latin American market.
Jeisys Medical announced on the 21st that its main production base, the Wonju plant in Gangwon Province, has successfully completed the ANVISA GMP audit.
Brazil’s ANVISA is known among global regulatory agencies for its strict evaluation of manufacturing facilities, production processes, and overall quality management systems. GMP certification is a mandatory step for entering the Brazilian pharmaceutical market.
The audit focused on the Wonju plant, which is responsible for the global production of Jeisys Medical’s botulinum toxin product, ‘Jeisys The Toxin.’ The company explained that passing this audit officially confirms that its production facilities and quality management systems meet Brazilian regulatory standards.
After completing the GMP certification process, Jeisys Medical plans to proceed sequentially with the subsequent procedures for local product registration in Brazil. Once product registration is complete, the company intends to expand its business using Brazil, the largest market in Latin America, as a hub.
Brazil, with a population of over 200 million, is the largest medical and aesthetics market in Latin America, with steadily increasing demand for medical aesthetic products, including botulinum toxin. Industry observers believe that passing Brazil’s regulatory gateway will also have a positive impact on entry into neighboring Latin American countries.
[Biotimes = Reporter Kim Ji-soo] [email protected]