․ Proprietary fermentation process to produce high quality Antrodia cinnamomea mycelia(ACM) with high content of Hepasim®(Antrodin A~E)
․ The safety of the pure compound Hepasim® is indirectly proven by clinical studies using dietary supplement ACM which contained high percentage (~15%) of Hepasim
․ Hepasim®-rich ACM passed animal safety tests:
90-days Oral toxicity, Acute Oral, Sub-acute (28 day) Oral, Ames Test, Chromosome Aberration Assay, and Micronucleus Assay
ISO22000:2018
HACCP
【Ingredients】: Fermented Antrodia cinnamomea mycelium (liquid culture)
【Capsule ingredients】: Hydroxypropyl methylcellulose, purified water, carrageenan, potassium chloride.
Each capsule: 0.4g ± 0.02g
Simpson Biotech Co., Ltd.
Incoming Material Inspection: Raw materials are sampled and inspected according to Standard Operating Procedures (SOPs) upon arrival. Certificates of Analysis (COA) are verified, along with physicochemical and microbiological testing.
Process Control: Manufacturing quality inspections are conducted in accordance with production control standards, including environmental monitoring and in-process stability testing.
Finished Product Inspection: After packaging, products undergo appearance, specification, and labeling inspections. Batch records are reviewed and approved before storage, while OOS (Out-of-Specification) procedures are implemented to ensure consistent product quality.
The product undergoes strict quality and safety inspections. Key third-party and internal testing includes:
Heavy metal(As、Cd、Hg、Pb)
Microbiological testing(Total Plate Count (TPC)、Escherichia coli (E. coli)、Coliform)
Self-Inspection and Monitoring: An independent Quality Assurance and Inspection Department is established to manage the food safety control system.
Nonconformance Management: Risk assessments and root cause investigations are conducted for production and incoming material abnormalities, with preventive actions implemented accordingly.
Customer Complaints and Post-Market Surveillance: A customer complaint management system and customer surveys are established to track feedback and implement continuous improvements.
Crisis Management System: Production processes are regularly audited by external organizations to ensure compliance with ISO 22000 and HACCP standards.
․ Nakamura et al., J NaturaProduct.2004, 67,46-48.
․ Phuong et al., Phytother. Res.2009, 23,582-584.
․ Han et al., Chem. Pharm. Bull. 2006, 54(4)496-500.
USA : US7109232/US7763723/US864813/US8703968
TW : I318877/I372049/I377064/I418538/I426916/I430990
JP : JP5199370/JP5403844
EU : EP1634877
