Daewoong Pharmaceutical Builds 'Aseptic Micro-Needle Manufacturing Facility'… Pushing for GMP Approval Next Year

Yim Kwangsoo Correspondent

pydonga@gmail.com | 2026-10-14 16:57:23

Daewoong Pharmaceutical announced on the 14th that it is building a manufacturing infrastructure for micro-needles, a next-generation drug delivery technology, at the Daewoong Bio Plant 3 in Hyangnam, Hwaseong-si, Gyeonggi-do.

Daewoong Pharmaceutical plans to complete the Good Manufacturing Practice (GMP) approval for a dedicated aseptic clinical drug manufacturing facility for micro-needles within Plant 3 by the first half of next year, thereby establishing a stable supply of clinical drugs and a foundation for commercialization.

Daewoong Pharmaceutical explained that the core of this infrastructure construction is establishing an aseptic manufacturing process and an automated production system that reflect the characteristics of micro-needle patch-type pharmaceuticals.

Based on Daewoong Therapeutics' micro-needle technology "CLOPAM®," the company plans to expand infrastructure optimized for the production of next-generation patch-type pharmaceuticals, such as the obesity and diabetes treatment candidate substance (DWRX5003) containing semaglutide.

Micro-needle pharmaceuticals are drawing attention as a superior treatment alternative that reduces the burden of patient administration associated with injectables and significantly enhances convenience.

Lee Seung-ha, Head of Production at Daewoong Pharmaceutical, stated, "For innovative formulations like micro-needles, beyond simple technology development, proving the highest level of aseptic and quality perfection under strict GMP standards is the top priority." He added, "We will seamlessly build the aseptic automated manufacturing infrastructure to lay the foundation for the global commercialization of our next-generation pipeline."

[ⓒ Global Economic Times. 무단전재-재배포 금지]

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