Bulk Pharmaceutical API Sources for CEFTIN

Bulk Pharmaceutical API Sources for CEFTIN

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		5361467
NovoSeek		6321416
ISpharm		I06-1564
MolPort		MolPort-005-935-571

Bulk Active Pharmaceutical Ingredient (API) Sources for: CEFTIN (Cefuroxime Axetil)

Last updated: July 28, 2025

Introduction

Ceftin, the brand name for Cefuroxime Axetil, is an oral second-generation cephalosporin antibiotic used predominantly to treat respiratory tract infections, urinary tract infections, skin infections, and gonorrhea. The efficacy of Ceftin hinges on the consistent quality and supply of its active pharmaceutical ingredient (API), Cefuroxime Axetil. As global demand rises, identifying reliable bulk API sources becomes critical for pharmaceutical manufacturers to ensure supply chain stability, regulatory compliance, and cost-effectiveness.

This analysis provides a detailed overview of the primary and emerging sources of Cefuroxime Axetil API, examining manufacturing countries, key producers, quality standards, and supply considerations.

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Global Manufacturing Landscape for Cefuroxime Axetil API

1. Major API Production Countries

The bulk API for Cefuroxime Axetil is predominantly produced in several strategic locations worldwide. Leading manufacturing hubs include:

• China: The dominant supplier, leveraging extensive API manufacturing infrastructure, competitive pricing, and comprehensive regulatory frameworks compliant with International Council for Harmonisation (ICH) standards. Major Chinese API producers invest heavily in quality systems and validation processes to meet global demand.

• India: A rapidly growing API manufacturing hub, India offers a robust supply of Cefuroxime Axetil API. Indian pharmaceutical companies adhere to strict Good Manufacturing Practices (GMP), ensuring product quality. Several India-based companies export to North America, Europe, and other regions.

• Eastern Europe and Eastern Asia: Countries such as Russia and South Korea have smaller but reliable API manufacturing capacities, often catering to regional markets or specializing in contract manufacturing.

• European Union / United States: Limited direct production; instead, these regions predominantly import APIs from China and India, emphasizing rigorous quality control and regulatory validation upon importation.

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2. Key API Manufacturers

Numerous manufacturers supply Cefuroxime Axetil API globally, with select companies recognized for their quality standards and regulatory compliance:

• Jiangxi Junyou Pharmaceutical Co., Ltd. (China): An established manufacturer with a comprehensive GMP certification, exporting bulk Cefuroxime Axetil API globally.

• Hetero Labs Ltd. (India): A prominent API manufacturer with WHO prequalification, offering high-quality Cefuroxime Axetil API.

• Sichuan Kelun Pharmaceutical Co., Ltd. (China): Known for extensive cephalosporin API production, including Cefuroxime Axetil, with strong regulatory track records.

• Aurobindo Pharma Ltd. (India): API manufacturing capabilities include Cefuroxime Axetil, with approvals from major regulatory agencies.

• Cipla Limited (India): Offers a reliable supply chain and quality-controlled Cefuroxime Axetil API, leveraging established GMP practices.

Note: The selection of API suppliers should prioritize compliance with current Good Manufacturing Practices (cGMP), regulatory accreditation, and product stability data.

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3. Quality Standards and Certification

Ensuring API quality is crucial for pharmaceutical companies. Leading manufacturers typically adhere to:

• ISO Certifications
• WHO Prequalification
• FDA and EMA approvals
• GMP certification

These certifications confirm products meet international quality, purity, potency, and safety standards, essential for regulatory approval of finished formulations.

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4. Supply Chain Considerations

Dependence on a limited number of API sources can create supply risks. Diversification strategies are advisable, involving multiple reputable suppliers. Major considerations include:

• Regulatory Compliance: Suppliers must meet regional regulatory standards, particularly for markets like the US, EU, and Japan.

• Pricing and Lead Times: Competitive pricing often correlates with Chinese and Indian suppliers, though logistics and lead times vary.

• Traceability and Documentation: Robust documentation ensures traceability, essential for audits and regulatory filings.

• Raw Material Security: Reliable supply chains for starting materials impact overall API production stability.

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5. Emerging Trends and Opportunities

• Contract Manufacturing: Increased outsourcing to specialized CMOs offers flexibility, quality assurance, and scalability.

• Localization of API Production: Some pharmaceutical companies are establishing regional API manufacturing facilities to reduce import dependency and enhance supply security.

• Technological Advancements: Advances in fermentation and synthesis processes enable higher yields and cleaner APIs, encouraging newer manufacturers to enter the market.

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Conclusion

The landscape for Cefuroxime Axetil API sourcing remains dynamic, dominated by manufacturers in China and India, offering high-quality, cost-effective supply options. The choice of supplier should align with regulatory requirements, product quality, supply stability, and cost considerations. As markets evolve, diversification and adherence to stringent quality standards are vital for sustained success.

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Key Takeaways

• China and India are the primary sources of Cefuroxime Axetil API, providing the majority of global supply.
• Rigorous evaluation of supplier certifications (GMP, ISO, WHO prequalification) is essential.
• Diversification across reputable suppliers mitigates supply chain risks.
• Ongoing technological and geopolitical developments influence API sourcing strategies.
• Emphasis on regulatory compliance ensures smooth approval processes for finished pharmaceutical products.

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FAQs

1. What are the top factors to consider when sourcing Cefuroxime Axetil API?
Quality certifications (GMP, ISO), regulatory approvals, production capacity, compliance history, pricing, and supply reliability.

2. Are Chinese API manufacturers compliant with international standards?
Yes. Leading Chinese API producers adhere to GMP, ISO, and often attain WHO prequalification, ensuring international compliance.

3. How does Indian API manufacturing compare to Chinese sources?
Indian manufacturers generally maintain high GMP standards, are more regulated domestically, and offer competitive pricing with increasing global presence.

4. What risks are associated with sole-source API supply chains?
Risks include supply disruptions, quality issues, regulatory non-compliance, and geopolitical factors influencing import/export policies.

5. How can pharmaceutical companies ensure the quality of Cefuroxime Axetil API?
Through stringent supplier qualification, audit processes, verifying certifications, and conducting batch testing aligned with pharmacopoeial standards.

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Sources
[1] U.S. Food and Drug Administration (FDA). Database of approved drug ingredients.
[2] World Health Organization (WHO). Prequalification of medicines programme.
[3] Global Pharmaceuticals Market Data. IQVIA Report, 2022.
[4] Chinese National Medical Products Administration (NMPA). API manufacturer compliance details.
[5] Indian Drug Controller General Office (DCGI). API manufacturing approvals.