Daewoong Pharmaceutical Received GMP Certification from Brazilian ANVISA

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Nov 27, 2023, 19:00 ET

SEOUL, South Korea, Nov. 27, 2023 /PRNewswire/ -- Daewoong Pharmaceutical is pleased to announce that its Osong factory in Korea achieved Good Manufacturing Practice (GMP) certification from the Regulatory Authority of Brazil, ANVISA.

Daewoong Pharmaceutical, represented by CEO Seng-ho Jeon and Chang-Jae Lee, proudly announced that their Osong factory passed the Brazilian Good Manufacturing Practice (GMP) inspection with a flawless "Zero" Observation in terms of compliance. This success in the rigorous GMP inspection underscores the Osong plant's commitment to the highest quality standards and the excellence of its smart manufacturing practices.

This Successful Inspection paves the way for Daewoong Pharmaceutical to further its entry into the Brazilian pharmaceutical market.

Brazil's GMP review is known to be challenging, involving stringent requirements. ANVISA actively conducts on-site inspections overseas, meticulously examines not only pharmaceutical quality management on-site but also data integrity, manufacturing facilities, and compliance with GMP in production processes. Within the industry, passing Brazil's GMP without any issues is publicly recognized as a difficult task, and achieving a flawless inspection is considered a remarkable accomplishment.

Daewoong Pharmaceutical emphasized the crucial role of the Level 4 smart factory system in the Osong Plant. Level 4 facilitates proactive measures and optimal decision-making, allowing for advanced process operation simulations where data integrity is demonstrable.

Daewoong Pharmaceutical, leveraging its smart process, plans to actively pursue GMP certifications in additional countries, including developed nations. This strategic move aims to establish a smooth global expansion of their innovative drugs.

Forward-Looking Statements

This press release contains forward-looking statements that are based on the current beliefs and expectations of Daewoong Pharmaceutical's management. Factors that could cause or contribute to such differences include, but are not limited to: (1) Regulatory and governmental approvals: The approval process for pharmaceutical products is subject to extensive regulations and may involve uncertainties and delays. Any failure to obtain necessary approvals or the occurrence of delays in the approval process could adversely affect Daewoong Pharmaceutical's business and results of operations; and (2) Clinical trials: The success of Daewoong Pharmaceutical's products depends on the results of clinical trials. The results of early clinical trials may not be indicative of the results of later-stage or larger-scale clinical trials.

SOURCE Daewoong Pharmaceutical Co., Ltd