Daewoong Pharmaceutical Received GMP Certification from Brazilian ANVISA
Daewoong Pharmaceutical Co., Ltd., headquartered in Seoul, South Korea, has achieved a significant milestone by receiving Good Manufacturing Practice (GMP) certification from the Regulatory Authority of Brazil, ANVISA, for its Osong factory in Korea. This achievement was officially announced on November 27, 2023, by Daewoong Pharmaceutical, represented by CEO Seng-ho Jeon and Chang-Jae Lee.
The Osong factory’s success in the GMP inspection is particularly noteworthy as it received a flawless “Zero” Observation in terms of compliance. This accomplishment highlights the Osong plant’s unwavering commitment to maintaining the highest quality standards and the excellence of its smart manufacturing practices. The rigorous GMP inspection by ANVISA is known to be challenging, involving stringent requirements that cover pharmaceutical quality management, data integrity, manufacturing facilities, and compliance with GMP in production processes.
Passing Brazil’s GMP inspection without any issues is widely recognized within the industry as a difficult task, making Daewoong Pharmaceutical’s flawless inspection a remarkable achievement. The successful inspection serves as a crucial stepping stone for the company to expand its presence in the Brazilian pharmaceutical market.
Daewoong Pharmaceutical attributed part of its success to the Level 4 smart factory system implemented at the Osong Plant. This advanced system plays a pivotal role in facilitating proactive measures and optimal decision-making, allowing for advanced process operation simulations where data integrity is demonstrable.
Looking ahead, Daewoong Pharmaceutical plans to leverage its smart manufacturing processes to actively pursue GMP certifications in additional countries, including developed nations. This strategic move aligns with the company’s goal of establishing a smooth global expansion of its innovative drugs.
The press release also includes forward-looking statements cautioning about potential challenges, including regulatory and governmental approvals and the success of clinical trials. These statements provide transparency regarding the uncertainties inherent in the pharmaceutical industry and the potential impact on Daewoong Pharmaceutical’s business and results of operations.
Daewoong Pharmaceutical’s attainment of GMP certification from ANVISA for its Osong factory reflects the company’s dedication to maintaining the highest standards of quality and marks a significant milestone in its global expansion efforts.
