Process Development & Transfer
Scale-Up: Seamless transition of processes from laboratory scale to full cGMP manufacturing.
Technology Transfer: Expert management of tech transfer for both drug substances and finished products.
Formulation Optimization: Refinement of drug product formulations to ensure manufacturability and clinical performance.
GMP Production
Clinical Trial Materials (CTM): Manufacture of high-quality materials for Phase I-III clinical trials.
Commercial Manufacturing: Scalable production capabilities for approved pharmaceutical products.
Quality & Release
Release Testing: Comprehensive testing of finished batches against specifications.
Certification: Issuance of detailed Certificates of Analysis (CoA) for every released batch.
Stability Programs: Design and execution of stability studies in strict accordance with ICH guidelines.
US FDA GMP Certified GMP manufacturing facility in Allentown, PA, USA, and in Jiangsu, China ensuring strict adherence to global quality standards.
Proprietary Technology over 30 international patents and intellectual property rights, safeguarding the unique technologies used in production processes.
Advanced Extraction Utilizing cutting-edge extraction methods to retain the full spectrum of raw plant compounds, delivering superior product integrity.
Global Compliance Our operations meet rigorous international production standards, providing regulatory peace of mind for global markets.
Certified Sourcing Raw herbal materials are exclusively sourced from contracted and certified farms to ensure traceability and quality from the ground up.
Pharmacopoeial Compliance All processing adheres strictly to the standards set by the Chinese Pharmacopoeia and established traditional medicine practices.
Toxicity Reduction & Safety Herbs undergo rigorous cleaning and traditional processing to minimize toxicity and enhance safety prior to extraction.
Specialized Preparation Utilize a full range of traditional preparation methods, including steaming, fermenting, germinating, freezing, and stir-frying with liquid adjuvants.
Low-Temperature Filtration Decoctions are filtered between 40-60°C to minimize thermal degradation of heat-sensitive compounds.
Controlled Environment Cryoconcentration processes are conducted within an ISO Class 6 clean area to ensure sterility and prevent contamination.
Quality Assurance An integrated quality monitoring system is implemented to ensure batch-to-batch consistency and product integrity.
Optimized Drying Technology Utilizing brief hot air exposure to rapidly dry materials, minimizing thermal degradation and ensuring the maximum retention of active ingredients.
Standardized Physical Properties Our process maintains strict consistency in critical parameters including freshness, color, texture, and taste.
Moisture Control Precise regulation of water content ensures long-term stability and product uniformity.
Essential Oil Recovery Capture and preservation of volatile essential oils during the water-based extraction process to prevent loss of active components.
Beta-Cyclodextrin Encapsulation Utilization of Beta-Cyclodextrin inclusion technology to stabilize volatile oils and convert them into solid forms.
Matrix Reintroduction Systematic re-integration of solidified essential oils into the final herbal powder to restore the full chemical profile.
Enhanced Efficacy Preservation of volatile components ensures the final product retains the complete therapeutic potency of the original herb.
Precision Extrusion Transformation of crystalline material into uniform thin slices to ensure consistent density.
Controlled Particle Sizing Multi-stage crushing and sizing processes designed to achieve exact, predetermined particle dimensions.
Granule Standardization Strict adherence to particle size specifications to ensure flowability, solubility, and dosing accuracy.
Advanced Instrumentation Our lab is equipped with state-of-the-art technology, including CAMAG REPROSTAR, HPLC, GC, and ICP-AES, to ensure precision in every test.
Safety & Purity Analysis Comprehensive screening for bacterial levels, heavy metals, pesticide residues, and mycotoxins to ensure absolute product safety.
Active Ingredient Quantification High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) are employed to verify the potency and concentration of active ingredients.
Botanical Fingerprinting Advanced thin-layer scanning technology (HPTLC) creates a specific fingerprint profile for each botanical, ensuring accurate identity and authenticity.
Full Regulatory Compliance All products meet US and China FDA requirements, accompanied by a comprehensive Certificate of Analysis (COA) covering authentication, purity, and microbiology.
Precision Automation We utilize advanced automation for the final packaging stage to maximize efficiency and minimize human contact.
The "Human Touch" A final layer of security is added via rigorous visual inspections by trained quality personnel.
Distribution Ready Only products that pass our final physical check move to the warehouse, ensuring you receive exactly what you ordered.
Preserved Integrity We protect your investment by storing all finished goods in a strictly climate-controlled environment to prevent degradation.
Secure Chain of Custody From production line to shipping dock, your products are kept secure and monitored until the moment of distribution.