Bulk Pharmaceutical API Sources for cefadroxil/cefadroxil hemihydrate

Bulk Pharmaceutical API Sources for cefadroxil/cefadroxil hemihydrate

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C7020_SIGMA
Vitas-M Laboratory		STK801939
MolPort		MolPort-002-507-346
ABI Chem		AC1L2J3O
AKos Consulting & Solutions		AKOS005622555

Bulk Active Pharmaceutical Ingredient (API) Sources for Cefadroxil and Cefadroxil Hemihydrate

Last updated: August 5, 2025

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Introduction

Cefadroxil, a first-generation cephalosporin antibiotic, is predominantly marketed as cefadroxil hemihydrate, an oral broad-spectrum agent effective against various bacterial infections. Its bulk active pharmaceutical ingredient (API) sourcing is critical for pharmaceutical manufacturers aiming to ensure quality, consistency, and regulatory compliance. This report explores the principal sources of cefadroxil and cefadroxil hemihydrate API, market landscapes, quality considerations, and key supplier evaluations.

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Market Overview of Cefadroxil API

The demand for cefadroxil remains steady due to its use in respiratory, skin, and soft tissue infections. Both innovator and generic manufacturers rely on global API suppliers, primarily in Asia, to meet production needs. The manufacturing process of cefadroxil involves complex chemical synthesis, necessitating high standards for raw materials and process controls, as per pharmacopoeial requirements.

Principal API Suppliers for Cefadroxil and Cefadroxil Hemihydrate

1. Chinese API Manufacturers

China remains a dominant player in cefadroxil API production, leveraging its cost advantages and established chemical manufacturing infrastructure. Several key firms supply both cefadroxil and cefadroxil hemihydrate:

• Shenzhen Weike Biotechnology Co., Ltd.
  Offers cefadroxil API compliant with international standards, with GMP certification. Known for reliable quality and competitive pricing.

• Hubei Hanhua Pharmaceutical Co., Ltd.
  Provides cefadroxil hemihydrate API with a focus on purity and consistent batch-to-batch quality.

• Lunan Pharmaceutical Group Co., Ltd.
  Specializes in cephalosporin APIs, including cefadroxil, with extensive regulatory documentation.

2. Indian API Manufacturers

India is prominent for its robust pharmaceutical sector, offering high-quality cefadroxil API:

• Gland Pharma
  Supplies cefadroxil API, adhering to strict regulatory standards like US FDA, EU GMP, and WHO GMP.

• Jubilant Life Sciences
  Offers cefadroxil API with proven quality, supported by extensive analytical and stability data.

• Hetero Labs Ltd.
  Provides cefadroxil API with a focus on chemical purity and cost-effectiveness.

3. Other Notable Suppliers

• Korea United Pharm Inc. (South Korea)
  Known for high-quality cephalosporin APIs, including cefadroxil, with advanced manufacturing facilities aligning with global standards.

• F. Hoffmann-La Roche Ltd. (Europe)
  Historically supplied cefadroxil as part of its portfolio, though production has shifted towards licensed generics.

Quality and Regulatory Considerations

Manufacturers must ensure that cefadroxil API procured from suppliers adheres to pharmacopoeial monographs (USP, EP, JP) and regulatory frameworks such as FDA, EMA, or WHO standards. Key quality attributes include:

• Chemical purity (> 99% preferred)
• Residual solvents within permissible limits
• Impurity profiles compliant with ICH guidelines
• Certificate of Analysis (CoA) and regulatory documentation

Supply chain integrity, manufacturing site inspections, and quality audits are critical decision factors for sourcing.

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Emerging Trends and Challenges

• Regulatory Harmonization: Increasing global standards push suppliers towards better documentation and process validation.
• Supply Chain Disruptions: The COVID-19 pandemic underscored vulnerabilities; diversified sourcing strategies are essential.
• Raw Material Sourcing: Steady supply of raw materials such as cephalosporin core intermediates influences API quality.
• Environmental Standards: Green chemistry practices are gaining importance, affecting supplier evaluation.

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Global API Sourcing Strategies

To mitigate risks, pharmaceutical companies adopt diversified sourcing, combining Asian suppliers’ cost advantages with a few high-quality Western or regional providers. Strategic stockpiling, rigorous qualification processes, and ongoing quality assessments are best practices.

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Procurement Due Diligence

Key steps in API sourcing for cefadroxil include:

• Verifying GMP and ISO certifications
• Reviewing third-party audits and site inspections
• Confirming regulatory approvals or filings in target markets
• Assessing supply chain stability and capacity
• Analyzing pricing trends and contractual terms

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Conclusion

The global cefadroxil API market is characterized by robust suppliers primarily rooted in China and India, offering high-quality, cost-effective options suitable for generic and branded formulations. Ensuring compliance with stringent quality standards and regulatory requirements remains paramount. Diversifying sources and maintaining rigorous supplier qualification procedures can enhance supply security and product integrity.

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Key Takeaways

• The leading sources of cefadroxil and cefadroxil hemihydrate API are predominantly in China and India, offering a mix of cost-effective and high-quality options.
• Regulatory compliance (GMP, ICH standards) is essential for sustained market access and product quality.
• Supply chain resilience depends on diversification, thorough qualification, and ongoing quality audits.
• Emerging trends favor green chemistry and environmental sustainability, influencing supplier selection.
• Strategic procurement involves balancing cost, quality, regulatory compliance, and supply chain stability.

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FAQs

1. What are the main raw materials used in cefadroxil manufacturing?
Cefadroxil synthesis involves cephalosporin intermediates derived from cefalothin or other cephalosporin nuclei, with key raw materials including D-phenylglycine and other amino acids.

2. How does the quality of cefadroxil API impact pharmaceutical formulations?
High API purity and consistent impurity profiles are critical to ensure drug efficacy, safety, and regulatory compliance, preventing adverse reactions and ensuring therapeutic consistency.

3. Are there regulatory differences between Chinese and Indian cefadroxil API suppliers?
Both regions are capable of supplying GMP-certified APIs aligned with international standards. Verification of specific certifications (FDA, EMA, WHO) is necessary during qualification.

4. What role does environmental compliance play in sourcing cefadroxil API?
Suppliers adhering to green practices and environmental regulations are increasingly preferred, impacting manufacturer reputation and regulatory approval.

5. How can a pharmaceutical company mitigate risks associated with API sourcing?
By diversifying suppliers, conducting thorough audits, maintaining strategic inventory, and establishing long-term quality agreements, companies can minimize supply disruptions and ensure product quality.

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References

1. U.S. Pharmacopeia (USP). Cephalosporins Monographs.
2. European Pharmacopoeia (EP). Cephalosporin API standards.
3. WHO Good Manufacturing Practices (GMP) guidelines.
4. Industry reports on global cephalosporin API markets (2022).
5. Supplier websites and certification documentation.

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This comprehensive analysis facilitates informed decision-making for pharmaceutical manufacturers, procurement officers, and regulatory teams engaged in sourcing cefadroxil API globally.