Daewoong Pharmaceutical(174,000 +3.88%)Announced on the 14th that it has obtained a high-tech biopharmaceutical manufacturing license from the Ministry of Food and Drug Safety. Through this, it is explained that it will enter the advanced biopharmaceutical consignment development and production (CDMO) business.
According to the’Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals’ (Symbolism Act), only companies with facilities prescribed by the Presidential Decree and licensed by the Minister of Food and Drug Safety can handle cell therapy products and gene therapy products.
Based on this license, Daewoong Pharmaceutical will start a’all-in-one package’ business that encompasses manufacturing and development of advanced biopharmaceuticals including cell therapy products, quality testing, licensing support, storage and delivery, and sales. Companies that have signed a cooperative contract will be provided with cell therapy production technology that meets global standards and the best sales capabilities in Korea.
It is explained that Daewoong Pharmaceutical possesses leading technology in the field of biopharmaceuticals. For the first time in Korea, it developed the external solution of EasyF, a diabetic foot ulcer treatment using genetic recombination technology. Nabota, a botulinum toxin formulation, has been certified by regulatory agencies in advanced countries, such as the US Food and Drug Administration (FDA) and the Federal Health Canada (Health Canada). Daewoong Pharmaceutical plans to continue its accumulated experience in the development and production of advanced biopharmaceuticals.
“Daewoong Pharmaceutical is a company with the experience and approval of the US Food and Drug Administration (FDA) for biopharmaceuticals,” said Park Jong-won, head of the Daewoong Pharmaceutical’s cell therapy center. As an organization, cooperation with Daewoong Pharmaceutical will be an option without regret.”
Reporter Minsoo Han [email protected]
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