Explore our elite portfolio of top-grade biological and chemical compounds, meticulously prepared to exceed pharmaceutical USP, EP, and CP guidelines.
In the contemporary biopharmaceutical arena, the seamless synthesis of advanced Active Pharmaceutical Ingredients (APIs) hinges unconditionally upon the structural integrity and chemical consistency of pharmaceutical intermediates. Global formulation labs and manufacturing companies face escalating pressure to maintain supply security while traversing intensely scrutinized regulatory architectures.
At Shaanxi ShineHerb Biotech Co., Ltd., we identify and optimize process bottlenecks by bridging critical raw material sourcing with strict scientific execution. With a strategic presence in the high-tech development hubs of China, we provide high-throughput, synthetically sound chemical pathways that guarantee seamless scale-up from milligram-scale preclinical verification to multi-ton commercialization.
Addressing global demands requires resolving the complex trade-off between process cost-efficiency and impurity profiling. Our deep synthetic integration limits genotoxic and mutagenic impurities to levels significantly below international thresholds, supporting uninterrupted global pharmaceutical filings.
Established in 2002, Shaanxi ShineHerb Biotech Co., Ltd. is positioned as an industry leader in the R&D, production, and global export of custom enzymes, high-value plant-derived extracts, essential vitamins, pure amino acids, and high-purity pharmaceutical intermediates. Our foundational mission focuses on delivering reliable quality, cost competitiveness, and deep domain regulatory services.
For over twenty years, we have built a fully audited, trace-compliant manufacturing infrastructure. Our products are exported to more than 50 countries and regions across Europe, North America, and Southeast Asia, earning the confidence of international biopharma companies and health supplement brands.
Through strategic integration of advanced process chemistry, high-efficiency biocatalytic platforms, and strict analytical pipelines, we ensure that every chemical lot complies with internationally recognized GMP, FDA, and ISO quality management guidelines.
Discover how our analytical and production standards eliminate raw material risks in high-stakes pharmaceutical synthesis workflows.
We control every step from incoming materials to final release. Our QC utilizes HPLC, GC-MS, ICP-MS, and NMR verification to ensure purity levels and identify traces, heavy metals, and residual solvents.
Supported by seasoned chemists and process development engineers, we provide complete technical documentation, including synthesis path maps, impurity profiling, and COA validation dossiers.
Our facilities adhere strictly to GMP guidelines. Our standard procedures prevent cross-contamination and protect molecule stability through humidity-controlled staging and classified air systems.
How ShineHerb Biotech mitigates process inefficiencies and environmental footprints through next-generation biocatalysis and continuous flow chemical technology.
Chiral synthesis is a core pillar of modern drug design. Our bio-enzymatic platforms integrate engineered transaminases, ketoreductases, and lipases to achieve high stereochemical purity (up to >99% ee).
By replacing toxic heavy metal catalysts with targeted enzymatic systems, we lower waste output, simplify isolation processes, and reduce trace metallic contamination.
By moving beyond traditional batch reactors to micro-reactor systems, we implement continuous flow processes for rapid, highly exothermic reactions. This approach enables precise control over temperature and contact times.
This technology prevents thermal runaway and increases production throughput, while ensuring uniform reaction conditions across multi-ton campaigns.
Highly demanded enzymatic, nutritional, and organic raw materials distributed to major global life science clients.
We deliver integrated solutions across five specialized chemical and biochemical sectors, supporting diverse product applications.
Providing food-grade, feed-grade, pharma-grade, and cosmetic-grade enzyme formulations with stable activity profiles and customizable specifications.
FCC, FDA, HALAL, KOSHER Certified
High-value natural active components designed for weight-management, metabolic support, immune defense, and ocular health formulations.
Direct Factory Sourced • Custom Formula Options
High-purity amino acids, vitamins, mineral complexes, functional probiotics, and high-purity sweeteners supporting clean-label supplement brands.
Full Technical Dossiers • OEM Formulation Support
Functional ingredients targeted for dermatological systems, including anti-aging peptides, antioxidant compounds, natural skin brighteners, and mild surfactants.
Optimized Skin Penetration • Strict Microbiological Control
Rigid organic intermediates and key synthons synthesized to support downstream API production under controlled GMP settings.
Compliance with ICH Guidelines • Detailed DMF Documentation
Our compliance documentation supports worry-free global product registration and quality audits.
Guaranteed Food Safety Management & Risk Controlled production systems.
Good Manufacturing Practice ensuring rigid batch-to-batch consistency.
High-quality products certified to meet dietary audit standards.
International standard recognition for our quality management systems.
US Food & Drug Administration compliance for dietary and pharma materials.
Rigorous quality control verified by the global inspection leader.
Certified suitable for Muslim consumers worldwide.
From custom chemical intermediate parameters to finished nutraceutical formats, ShineHerb Biotech delivers scalable, turnkey solutions. We handle every step—from sourcing raw materials and refining active compounds to final formulation, packaging, and regulatory validation.
Full-Format Formulations: High-purity Powders, Precise Compression Tablets, Hard Shell Gelatin & Veggie Capsules, Softgels, Custom-Flavored Gummies, and Functional Solid Beverages.
Flexible Production Scales: Accommodating both specialized pilot testing runs and high-volume, multi-ton commercial orders.
Integrated Regulatory Support: Fully validated GMP & ISO certified manufacturing, conforming to USA, Europe Union, and APAC regulations.
We optimize delivery timelines and safeguard molecule stability through reliable logistics networks. Our team supports temperature-controlled cold-chain protocols and secure packaging to protect delicate bio-enzymes and active chemical intermediates during transit.
Answers to critical questions asked by pharmaceutical procurement and quality assurance teams regarding production capabilities.
We address impurities at the molecular stage. Utilizing advanced analytical platforms like HPLC and GC-MS, our QA teams identify and control trace contaminants down to ppm levels. In compliance with ICH Q3A/B guidelines, our purification workflows employ specialized recrystallization and chromatography columns, keeping genotoxic and heavy-metal impurities far below global regulatory thresholds.
Yes, we provide comprehensive regulatory documentation. For our key intermediate classes, we support global drug registrations by offering standard COAs, Method of Analysis (MoA) validations, residual solvent data (under ICH Q3C), stability testing dossiers (ICH Q1A-R2), and regulatory documentation to facilitate smooth IND/NDA filing procedures.
Chiral resolution is a core competency. Our R&D team uses biological enzyme systems alongside advanced transition metal catalysts to secure high enantiomeric excess (typically ee > 99%). This minimizes unwanted stereoisomers, simplifies processing stages, and ensures consistency during multi-ton scale-up.
We manage supply risk through strategic backward integration of key building blocks and dual-sourcing options for crucial raw chemicals. Our 20+ years of operation in Xi'an's High-Tech Zone allows us to secure reliable raw chemical access, while our raw storage capacity buffers against unexpected supply chain delays.
Discover our specialized raw materials and bile derivatives, manufactured to meet the high standards of global laboratories.
Whether you are sourcing advanced intermediates, bio-enzymatic preparations, or seeking custom manufacturing for health supplements, our expert chemical engineers are here to support your pipeline requirements.
ShineHerb
