Pharmaceutical API Manufacturer & Intermediate Supplier: Global Compliance & Bulk Supply
Since 1997, Exbiol has bridged the gap between complex phytochemical isolation and rigorous pharmaceutical standards. Backed by 29 years of R&D expertise and the ZHONGHONG Group’s industrial scale, we specialize in high-purity Pharmaceutical APIs that solve the industry’s greatest challenge: Batch Consistency vs. Regulatory Compliance. From Bulk Paracetamol (2.7M monthly demand) to precision alkaloids, we ensure every gram is audit-ready for the US, EU, and Asian markets.
Leading 29-year veteran supplier of bulk Pharmaceutical APIs. USP/EP/BP compliant Paracetamol, Berberine HCl & Intermediates. GMP factory with DMF/CEP support.
Strategic API Divisions: Precision-Engineered for Global Therapeutics
Exbiol classifies its Pharmaceutical API portfolio based on therapeutic pathways and industrial processing requirements. Leveraging 29 years of phytochemical synthesis, we provide dedicated technical support for each division—ensuring that whether you are sourcing bulk analgesics or high-purity intermediates, your regulatory and formulation standards are met with molecular precision.
Analgesics & Antipyretics
Global leading supply of Paracetamol (Acetaminophen) API. Engineered for large-scale manufacturing with optimized flowability.
Metabolic & Cardiovascular APIs
Specializing in Berberine HCl (97%+) and metabolic modulators with strict impurity profile control and fingerprint ID.
Advanced Chemical Intermediates
High-purity monomers and building blocks for Drug Discovery and complex chemical synthesis projects.
Flagship API Matrix: Technical Specifications & Capacity
As a leading synthesis base, Exbiol provides high-volume pharmaceutical APIs compliant with global pharmacopeia standards. We ensure 100% traceability and regulatory readiness for every batch.
| Active Molecule | CAS No. | Grade / Standard | Handling (OEB) | Documentation | Annual Capacity |
|---|---|---|---|---|---|
| Paracetamol API | 103-90-2 | USP / EP / BP / IP | OEB 3 | DMF / CEP / WC | 1,200 Tons |
| Berberine HCl | 633-65-8 | 97.0% - 102.0% | OEB 3 | HPLC Fingerprint | 300 Tons |
| Adenine Bulk | 73-24-5 | Pharma Grade | OEB 3 | Technical Dossier | 80 Tons |
| Berberine Sulfate | 633-66-9 | High Purity | OEB 3 | Full Stability Data | 150 Tons |
Comprehensive Portfolio of Pharmaceutical APIs & Intermediates
Reliability in pharmaceutical supply chains is built on molecular integrity and regulatory transparency. Exbiol offers an extensive portfolio of Pharmaceutical APIs and Advanced Intermediates, synthesized under strict GMP protocols. From bulk Paracetamol (Acetaminophen) to high-purity alkaloids, we provide the DMF (Type II/IV) and CEP/COS dossiers required for your global market authorization. Our synthesis facility ensures that large-scale demand never compromises on pharmacopeia compliance.
Beyond Supply: Solving the Critical Challenges of API Sourcing
Elimination of Impurity Profile Risks
Batch rejection due to unknown impurities is a killer for pharma brands. We utilize Waters® HPLC-DAD and Agilent® ICP-MS to monitor not just the marker, but the entire impurity profile, ensuring your formulation passes every time.
29-Year Regulatory Dossier Support
Trust is built on paperwork. Exbiol provides DMF (Type II/IV), CEP/COS, and full Stability Data under ICH Q1A(R2). Our regulatory team has successfully supported audits for global giants like Cargill and BASF-tier partners.
OEB-4 High-Containment Manufacturing
Ensuring zero cross-contamination. Our Xi'an 26,000 sqm base operates specialized suites for APIs, maintaining the molecular integrity required for therapeutic efficacy.
HPAI & API Technical Resource Center
Accelerate your R&D process with our validated technical dossiers and regulatory guides.
2026 Full API Catalog & DMF List
Access our complete technical database of 100+ high-purity molecules for global pharmaceutical sourcing.
🔒Secure Download: TDS/SDS/DMF SummariesSample Technical Dossier (Paracetamol)
Review our documentation depth, including HPLC-DAD impurity studies and detailed batch analysis reports.
View SampleICH Stability Study Methodology
Learn about our validated 24-month stability protocols conducted under global ICH Q1A guidelines.
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Solve Your Formulation Paradox Today
Struggling with ingredient fallout, oxidative instability, or regulatory roadblocks? Don’t let raw material variables stall your innovation. Connect directly with our Senior Engineering Team to discuss your specific purity and stability requirements.
Technical & Commercial Intelligence: API Sourcing FAQ
A: Yes. We understand that an API is only as good as its paperwork. For our flagship molecules like Paracetamol and Berberine HCl, we provide complete technical dossiers including DMF (Type II/IV), CEP/COS support, and manufacturing flowcharts. Our documentation is designed to pass the most stringent FDA and EFSA regulatory audits.
A: Absolutely. Formulation success depends on physical chemistry. Exbiol offers Advanced Particle Engineering, including Micronization (D90 < 10μm) via air-jet milling. We can customize Bulk and Tapped Density to ensure optimal flowability for high-speed tableting or uniform dispersion in liquid tinctures.
A: We support the entire product lifecycle. For R&D and pilot-scale validation, our MOQ starts at 1kg – 5kg. For mass commercial production, we typically supply in 25kg drums, with a manufacturing capacity exceeding 1,200 tons annually for core APIs to ensure supply chain security.
A: Stability is verified under ICH Q1A (R2) guidelines. To prevent degradation during sea or air freight, our APIs are vacuum-sealed in multi-layer OPA/ALU/PE moisture-barrier bags under a nitrogen blanket. Every shipment is accompanied by batch-specific stability statements and HPLC analysis.
A: Yes. Leveraging our 29 years of phytochemical expertise, we provide contract research and manufacturing (CRAMS) for specific isolates. If you require a high-purity marker not found in our standard catalog, our R&D team can develop a custom isolation protocol from pilot to multi-ton scale.
Technical Intelligence & Regulatory Support
Yes. Exbiol provides comprehensive Type II DMFs (US/EU) and CEP/COS documentation for our core APIs, including Paracetamol and Berberine HCl. Our regulatory team ensures that all dossiers strictly follow ICH M4 guidelines (CTD format), facilitating seamless submissions to the FDA, EMA, and other Tier-1 regulatory bodies.
Absolutely. We utilize advanced Jet Milling technology to provide particle size customization (Micronization). We can achieve D90 < 10μm or specific distributions tailored to enhance the bioavailability and dissolution rates of your final dosage forms (Tablets, Capsules, or Suspensions).
Every batch is validated via Waters™ HPLC-DAD and Agilent™ ICP-MS. We conduct rigorous Nitrosamine Risk Assessments and elemental impurity testing (ICH Q3D) to ensure that our botanical isolates reach 99.5%+ purity, with single impurities controlled well below the 0.10% threshold required by global pharmacopeias.
For commercial-scale supply, our standard lead time is 4-6 weeks from our GMP-certified facility. Our MOQ for standard APIs like Paracetamol is 1,200 Tons/Year capacity, while high-value intermediates start from 100kg, supported by full batch-to-batch consistency reports.
