Hebei Guangxiang Pharmaceutical Co., Ltd. is a specialized pharmaceutical manufacturer based in Cangzhou, Hebei Province, China. With over two decades of expertise in active pharmaceutical ingredients (APIs), the company has built a strong reputation for producing high-quality bulk drugs for both domestic and international pharmaceutical companies. Its manufacturing operations are driven by strict quality control systems, robust R&D, and compliance with global regulatory standards.
The company serves as a critical supplier to generic and formulation drug manufacturers across the world and is especially known for its production of purine derivatives and cardiovascular agents.
Core Business
Hebei Guangxiang Pharmaceutical’s product portfolio includes over 20 active pharmaceutical ingredients (APIs), with leading categories as follows:
-
Xanthine Derivatives:
- Caffeine (USP/EP grade)
- Theophylline
- Aminophylline
- Pentoxifylline
-
Nitroimidazole Antimicrobials:
- Metronidazole
- Tinidazole
- Ornidazole
- Levornidazole
-
Cardiovascular Agents:
- Urapidil
- Urapidil Hydrochloride
- Nifedipine
-
Other APIs:
- Adrenaline (Epinephrine)
- Tedizolid Sulfate (Antibiotic)
These products are manufactured in compliance with pharmacopoeial standards such as USP, EP, JP, and CP, depending on client requirements.
Specialization and Unique Selling Proposition (USP)
Hebei Guangxiang stands out in the pharmaceutical supply chain for:
- Specialization in Xanthine and Nitroimidazole APIs with high purity and consistent yield
- Strong control of impurities and adherence to ICH Q7 GMP guidelines
- Extensive experience with custom synthesis and contract manufacturing of rare or niche APIs
- Reliable supply chain with full traceability, validated analytical methods, and DMF support
The company’s large-scale production of metronidazole and theophylline positions it as a competitive supplier in global bulk drug markets.
Financials and Global Presence
Although private, Hebei Guangxiang’s operations indicate strong financial sustainability and growing global footprint:
- Annual API output capacity exceeds 1,200 metric tons
- Export destinations include over 40 countries, such as the United States, Germany, India, Brazil, Mexico, South Korea, and Russia
- Partner to generic pharmaceutical companies and contract manufacturing organizations (CMOs)
The company’s financial resilience is underpinned by repeat international business and expansion into regulated markets.
Shipment and Export Data
Based on insights from ImportYeti and Volza:
- Over 850 export shipments in the last three years
- High-volume API exports include:
- Caffeine and Metronidazole to pharmaceutical intermediaries in the United States and Europe
- Pentoxifylline and Urapidil to formulation manufacturers in Latin America and Eastern Europe
- Tinidazole and Theophylline to South Asia and Africa
Export activity demonstrates a strong compliance record and effective logistics coordination.
Target Market
The company serves a diverse client base across pharmaceutical manufacturing and research sectors:
- Generic drug manufacturers
- Pharmaceutical formulation companies
- API distributors and traders
- CDMOs and R&D organizations
Clients value the company’s consistency in supply, quality certifications, and regulatory support for filings.
Capabilities
- Fully GMP-compliant API production facilities
- Advanced chemical synthesis capabilities with reactor capacity up to 10,000 liters
- Dedicated quality control and analytical labs
- Support for Regulatory Filings, including:
- US DMF (Drug Master File)
- CEP (Certificate of Suitability) for EU markets
- COS and other regional certifications
- Contract manufacturing and custom synthesis services available
Certifications and Compliance
Hebei Guangxiang Pharmaceutical holds multiple certifications ensuring global market readiness:
- Chinese GMP Certification
- ISO 9001:2015 Quality Management System
- DMFs available for major APIs (e.g., caffeine, theophylline, metronidazole)
- Compliant with USP, EP, JP, CP standards
- Strong internal documentation and regulatory audit readiness
The company has passed audits by multiple overseas clients and is considered reliable for long-term supply contracts.
Customer Feedback and Testimonials
Verified buyers on trade and pharmaceutical sourcing platforms note:
- “Very low impurity levels and excellent analytical support”
- “Reliable batch-to-batch consistency with strong documentation”
- “Responsive technical support team, especially for regulatory submissions”
Such endorsements support the company’s standing as a reputable supplier in the international API market.
Major Achievements
- One of the largest caffeine and metronidazole exporters from Northern China
- Successfully supported ANDA and DMF filings in the U.S. and EU
- Received recognition as a High-Tech Enterprise in Hebei Province
- Collaborates with provincial pharmaceutical research institutions for continuous process improvements
Hebei Guangxiang Pharmaceutical Co., Ltd. remains a trusted and globally integrated API manufacturer, offering regulatory-compliant, high-quality active ingredients with a strong focus on client partnerships, quality assurance, and technical innovation.