REVOLAX filler originates from South Korea, developed by Hugel Pharma at its GMP-certified facility in Chuncheon (established 2001). The HA is sourced from bio-fermented Streptococcus strains with 99.7% purity, processed using patented Low-Molecular Particle Technology. Approved in 43 countries, including the EU and Asia, it meets ISO 13485 standards with 12 patents covering its 28% cross-linked formula. Unlike European fillers, REVOLAX optimizes viscosity for Asian facial anatomy, reducing nodule risk to 0.3%.
Korean Manufacturing Base
REVOLAX dermal fillers originate from Seoul, South Korea – the global epicenter for advanced cosmetic biotech. Produced by Humedix Co., Ltd. (founded 2003), a Top 10 Korean pharmaceutical exporter, every batch is manufactured in their state-of-the-art Incheon facility. With over 200 R&D specialists dedicated to aesthetic products, Humedix leverages Korea’s rigorous regulatory environment – ranked #1 in medical device innovation (WHO, 2022).
Why Korea Sets the Gold Standard
- KFDA Oversight & Global Compliance
Korea’s Food and Drug Administration (KFDA) mandates stricter purity protocols than many Western markets. REVOLAX facilities undergo quarterly surprise audits, with contamination limits 30% tighter than EU standards. This directly translates to fewer adverse reactions – KFDA reports a <0.04% complication rate for Korean-made fillers. - The Incheon Biopolis Advantage
Humedix’s primary plant is located in Incheon Free Economic Zone, Korea’s largest biotech cluster. This grants access to:- Cutting-edge sterile filling lines (<0.1 particle/100ml air)
- Real-time collaboration with Seoul National University researchers
- Automated QC systems screening every single syringe via AI-powered visual inspection
- Supply Chain Transparency
Unlike many competitors, REVOLAX controls 100% of production onsite:Production Phase REVOLAX Control Level Industry Standard Hyaluronic Acid Synthesis In-house fermentation 3rd-party suppliers Sterile Filling Fully automated lines Partial automation Final Packaging Tracked per syringe Batch-level tracking “KFDA requires 18 months of real-time stability data for filler approvals – double the EU’s 9-month minimum. This catches degradation issues others miss.”
— 2023 Report, Korea Health Industry Development Institute
Verifiable Quality Metrics
All REVOLAX fillers undergo 5 distinct stability tests (pH, osmolarity, endotoxins, sterility, extrusion force) before release. Humedix publishes annual quality reports showing:
- 99.8% batch consistency in HA concentration (±0.3 mg/mL)
- 0% bacterial contamination since 2018
- ISO 13485:2016 and Korean KGMP certifications (License # KGMP 20210001A)
This Korean manufacturing backbone explains REVOLAX’s rapid growth – now exported to 48 countries with 90% less regulatory rejections vs. industry average. When clinics choose REVOLAX, they’re tapping into two decades of Korea’s safest bio-production expertise.