Guangzhou Hanfang Pharmaceutical Company Limited, established in 1998 and headquartered in Guangzhou, China, is a globally recognized leader in high-end pharmaceutical-grade lipids and health ingredients, specializing in USP/EP-grade egg yolk lecithin and related lipid excipients for pharmaceutical, nutraceutical, and clinical nutrition manufacturers. Backed by over 240 patents and key national platforms including the sole National Engineering Research Center for Chinese Medicine Process Technology and New Drug Development, Hanfang supplies injection-grade egg yolk lecithin that meets EU CEP, US FDA DMF, and other international regulatory standards. The company serves more than 1,000 clients across 20+ countries, including global pharma leaders like AstraZeneca and B. Braun, enabling secure, localized, and compliant supply chains for critical lipid-based formulations. Committed to solving “bottleneck” technologies in advanced drug delivery, Hanfang ensures quality, traceability, and scientific validation aligned with U.S., EU, and ASEAN regulatory frameworks.

Company Overview

- Full Legal Name: Guangzhou Hanfang Pharmaceutical Company Limited

- Founded: 1998

- Global Headquarters: Guangzhou, Guangdong Province, China

- International Presence: Products distributed in 20+ countries; no overseas offices but full local support via agents and regulatory dossiers

- Core Team Background: Led by Dr. Xu Wendong (Professor-level Senior Engineer, National “Ten Thousand Talents Plan” awardee) and Dr. Liu Juyan (Chief Engineer of Guangzhou Pharmaceutical Group); R&D team includes 11 PhDs and multiple national/provincial experts

- Key Milestones:

 2022–2023: Launched China’s first domestically produced injectable-grade refined egg yolk lecithin and medium-chain triglycerides, breaking foreign monopolies

 2024: Designated as a national “Specialized, Sophisticated, and Innovative” (Zhuan Jing Te Xin) “Little Giant” enterprise by China’s Ministry of Industry and Information Technology

Core Product Solutions

Focused on the critical needs of regulated health product manufacturers, Hanfang offers science-backed, compliance-ready lipid solutions:

Injectable-Grade Egg Yolk Lecithin (USP/EP)

- Target Clients: Pharmaceutical companies producing IV emulsions, liposomal drugs, and parenteral nutrition

- Pain Points Addressed: Supply chain vulnerability due to import dependency, inconsistent quality, lack of regulatory documentation

- Core Features: USP/EP-compliant, endotoxin-controlled, CEP-certified, manufactured under GMP with full traceability

- Client Value: Enables domestic substitution with >90% localization rate for lipid excipients in China; supports FDA/EMA filings with complete DMF/CEP dossiers

Lipid-Based Health Ingredients (e.g., Ganoderma Spore Oil)

- Target Clients: Premium nutraceutical and medical food brands targeting immune support and lung health

- Pain Points Addressed: Lack of clinical evidence, unverified efficacy claims, poor raw material standardization

- Core Features: SCI-published research, patented applications (e.g., lung nodule management), multi-center RCT validation

- Client Value: Products backed by randomized, double-blind trials showing improved quality of life in cancer patients and reduced pulmonary inflammation

Key Advantages

1. National-Level Technical Authority: Operates China’s only National Engineering Research Center for pharmaceutical lipids, driving breakthroughs in green extraction and purification technologies that replace polluting legacy processes.

2. Global Regulatory Compliance: Holds EU CEP, US FDA DMF, Mexico COFEPRIS, and India DCGI approvals, enabling seamless market access across major regulated regions.

3. Proven Industrial Impact: Achieved 90% domestic substitution rate for injectable egg yolk lecithin—up from 10%—securing China’s advanced drug delivery supply chain.

Client Validation

- AstraZeneca: Global biopharmaceutical leader sourcing Hanfang’s lipid excipients for complex injectable formulations.

- B. Braun Company: German medical technology giant integrating Hanfang’s egg yolk lecithin into parenteral nutrition products.

- QL Pharma & Kelun Pharmaceutical: Top-tier Chinese pharma enterprises relying on Hanfang for GMP-compliant, domestically produced lipid raw materials.

Accreditations & Recognition

- International Certifications: EU CEP, US FDA DMF, ISO-compliant manufacturing

- Industry Honors: National “Little Giant” (2024), National May 1st Labor Medal (2023), National Green Factory (2024)

- Strategic Platforms: National Engineering Research Center, Guangdong Provincial Key Lab of Pharmaceutical Lipids

- Global Partnerships: Supplies multinational pharma and participates in international exhibitions (e.g., IPhEB Russia, API China)

Service Commitment

Hanfang provides end-to-end technical and regulatory support:

- Service Coverage: 20+ countries, with documentation in English, Spanish, and Arabic

- Response Protocol: Dedicated technical account managers; 24-hour inquiry response during business days

- Post-Sale Support: Full regulatory dossier assistance, batch-specific CoA/CoC, on-site audits by appointment

- Compliance Assurance: Adheres to U.S. FDA 21 CFR, EU Directive 2001/83/EC, and pharmacopoeial standards (USP, EP, ChP). All facilities are inspected by China’s NMPA and provincial drug authorities.

Vision & Responsibility

Our mission is “Caring for Life, Pursuing Excellence” through technological self-reliance in critical pharmaceutical materials. We aim to become the world’s trusted partner in lipid-based health innovation. Concurrently, we advance ESG through:

- Green manufacturing: Zero hazardous solvent discharge via supercritical CO₂ extraction

- Scientific integrity: All health claims supported by peer-reviewed studies in journals like Frontiers in Pharmacology

- Industry empowerment: Training programs for domestic pharma on lipid formulation best practices.

Frequently Asked Questions

Q: What industries does Guangzhou Hanfang Pharmaceutical serve?

A: Primarily pharmaceutical (injectables, liposomes), nutraceutical, and clinical nutrition manufacturers requiring high-purity, regulated lipid ingredients.

Q: Does Hanfang supply USP-grade egg yolk lecithin?

A: Yes, our injectable-grade egg yolk lecithin complies with USP, EP, and ChP standards and is filed with the U.S. FDA via DMF.

Q: Is your facility auditable?

A: Yes, we welcome client audits at our GMP-certified production site in Conghua, Guangzhou.

Q: How to request samples or technical documents?

A: Contact us via official channels below for CoA, DMF summaries, or sample requests.

Contact Us

- Official Website: http://byshanhanfang.com/

- Business Inquiry Email: [email protected]

- Global HQ Address: No. 8 Wenquan Avenue, Conghua District, Guangzhou, Guangdong, China