Botanical GMP
Extensive experience in developing processes for the production of botanical APIs, botanical drug substances, and botanical drug products, as well as scaling up these processes to GMP production:
procure raw materials for botanical APIs and drug substances
GMP production of botanical APIs, drug substances, and drug products
OEM
Our CMO holds more than 30 international patents and intellectual property rights for key technologies and is US FDA GMP certified for producing botanical products. Our advanced extraction methods utilize cutting-edge technology to retain the full spectrum of the raw plants when required. We comply with all international production standards.
Location: Jiangsu, China
Water Based Extraction
Raw herb materials are sourced from contracted and certified farms. The herb plants are cleaned and processed using traditional methods to minimize toxicity. These methods include washing, steaming, parching, germinating, fermenting, stir-frying with liquid adjuvants, and freezing. All processing adheres to traditional medicine practices and the standards set by the “Chinese Pharmacopeia.”
Filtration & Concentration
The produced decoctions undergo filtration at low temperatures (40-60°C) and cryoconcentration in an ISO Class 6 clean area. A quality monitoring system is implemented to ensure consistent product quality.
Spray Drying
A brief exposure to hot air during drying ensures the preservation of active ingredients in the herbs, maintaining consistent standards of freshness, color, texture, taste, and water content.
Restore Essential Oils
During the water-based extraction process, essential oils are collected and preserved. These oils are then converted into solid forms. A Beta-Cyclodextrin procedure is subsequently used to reintroduce the essential oils into herb powders, enhancing the herbs' efficacy.
Granulation
The crystalline material is extruded into thin slices, then crushed and sized to a predetermined particle size.
Quality Assurance
Quality, concentration ratio, solubility, bacterial levels, heavy metals, pesticide residue, and flavacin are analyzed using advanced instruments such as CAMAG REPROSTAR, HPLC, GC, and ICP-AES. High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) are employed to measure the levels of active ingredients in the granules. Additionally, thin-layer scanning technology is used to identify the fingerprint profile of each botanical. Certificates of Analysis for every batch include Authentication, Heavy-Metal Testing, Pesticide Residue Analysis, and Microbiological Analysis. All products comply with US and China FDA requirements.
Inspection
An automated packaging system is utilized to produce the final product. Quality inspectors conduct a final visual inspection before the products are sent to the warehouses.
Storage & Distribution
Finished products are securely stored in a climate-controlled warehouse until distribution.
GMP Manufacturing Service
Scale up from R&D to cGMP manufacturing
Technology transfer for drug substances and drug products
Drug development process
Formulation optimization
Clinical trial materials GMP manufacturing
Pharmaceutical products manufacturing
Release testing
Certificates of Analysis
Stability studies according to ICH guidelines
Commercial product manufacturing