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Daewoong Pharmaceutical Received GMP Certification from Brazilian ANVISA
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.
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.
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