Botulinum toxin is a protein with strong toxicity, and during production, it must be injected consistently with precise weight to ensure the product's safety.
To ensure the highest quality, Hugel produces botulinum toxin in facilities based on cGMP standards. The culture process involves optimizing the culture conditions and undergoing various purification processes to obtain high-purity toxin. The fill and finish process includes sterile preparation/filling, freeze-drying, capping, inspection, and packaging. All processes meet the criteria to produce high-quality finished products.
Hugel applies strict internal QC (Quality Control) standards to maintain stability and consistent potency for each formulation. Even after dilution, it maintains stable potency under refrigeration conditions for a certain period, making it possible to predict patient treatment results.
Located in Geoduri, Chuncheon, Hugel's botulinum toxin production facility is equipped to manufacture both drug substances (DS) and drug products (DP). Certified with Korea's KGMP in 2016, the facility adheres to the cGMP standards of the U.S. FDA and the EU GMP standards of Europe, demonstrating a manufacturing and quality management system of high standards.
Complying with KGMP, ISO 13485, CE, and NMPA standards, Hugel's fillers undergo stringent quality management to deliver exceptional products. We utilize high-purity sodium hyaluronate meeting EP specifications, along with advanced cross-linking technology and specialized dialysis processes. Particularly, we have successfully developed Unit-Form High Technology (UFHT), an advanced cross-linking method for sodium hyaluronate, ensuring the stabilization and gelation of high-elasticity sodium hyaluronate.
To ensure customer satisfaction and provide reliable products for practitioners, we conduct thorough inspections on all outgoing products, from assessing the quality of raw materials to managing manufacturing environments, in addition to training programs for all associates.
Barbed polydioxanone (PDO) thread is an absorbable suture with barbs formed on its surface. When utilized for tissue repair, these barbed sutures are knotless, thereby reducing excessive incisions on the skin and minimizing scarring. This medical device consists of a bioabsorbable polymer that is inserted into the skin to restore its supporting strength and accelerate skin regeneration. The patented molding technology used to create the barbs features micro-scale protrusions on their surface.
In 2015, three products made of the PDO threads received approvals from the MFDS of Korea, and in 2019, CE certification was obtained for the threads. In 2021, approval for other absorbable sutures using polycaprolactone (PCL) material was completed by the MFDS.
