Bulk Pharmaceutical API Sources for CECLOR CD

Bulk Pharmaceutical API Sources for CECLOR CD

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C6895_SIGMA
Molport		MolPort-003-666-328
TimTec		ST057228
Amadis Chemical		A829897
BioChemPartner		BCPP000294

Bulk Active Pharmaceutical Ingredient (API) Sources for CECLOR CD

Last updated: August 1, 2025

Introduction

Ceclor CD (Cefaclor Extended-Release Capsules) is a broad-spectrum second-generation cephalosporin antibiotic used to treat various bacterial infections. Its efficacy hinges on the quality of the active pharmaceutical ingredient (API), cefaclor. Ensuring a reliable supply of high-quality cefaclor is vital for pharmaceutical manufacturers, especially when producing CECLOR CD, which requires strict compliance with regulatory standards. This report analyzes the global API sourcing landscape for cefaclor, emphasizing key suppliers, geopolitical considerations, quality assurance practices, and emerging trends.

Global API Manufacturing Landscape for Cefaclor

Major API Producers

The cefaclor API is primarily manufactured in China, India, and certain European countries, with Chinese firms dominating the market due to cost competitiveness and extensive manufacturing capacities. Notable suppliers include:

• Qingdao Biomedicine Co., Ltd. (China): Known for large-scale cefaclor API production, with certifications aligning with international standards such as ISO 9001 and GMP.
• Hikal Ltd. (India): Offers cefaclor API produced under strict quality control, catering to both domestic and export markets.
• Shandong Lujian Pharmaceutical Co., Ltd. (China): Specializes in cephalosporin APIs, including cefaclor, with a focus on compliance with US FDA and EMA standards.
• Hubei Huida Biological Pharmaceutical Co., Ltd. (China): Supplies cefaclor API backed by rigorous quality testing.

Emerging and Niche Suppliers

While the Chinese and Indian manufacturers dominate, some European companies are expanding their capabilities:

• Evonik Industries AG (Germany): Provides pharmaceutical intermediates and APIs, including cephalosporins, adhering to high GMP standards.
• BASF SE (Germany): Specializes in custom synthesis and high-purity APIs.

Emerging suppliers in other regions are increasingly investing in GMP-compliant facilities to meet international demand.

Quality Assurance and Regulatory Compliance

For CECLOR CD manufacturing, API quality is non-negotiable, necessitating suppliers with demonstrated adherence to Good Manufacturing Practices (GMP), current Good Laboratory Practices (cGLP), and certification from regulatory agencies such as the US FDA, EMA, and Japan PMDA.

Certifications and Standards

• GMP compliance: Ensures that cefaclor APIs meet strict quality, purity, and stability standards.
• Certificate of Suitability (CEP) or Drug Master File (DMF): Submission to regulatory bodies enhances product acceptance and expedites approval processes.
• Quality Control Measures: Suppliers conduct comprehensive testing, including HPLC purity analysis, microbial testing, identity verification, and residual solvent assessment, to ensure batch-to-batch consistency.

Supply Chain Risks

Dependencies on a few key manufacturers pose risks related to geopolitical disruptions, trade tensions, and manufacturing shutdowns due to regulatory non-compliance or quality issues. Diversifying suppliers and incorporating rigorous qualification protocols mitigate these risks.

Supply Chain Considerations

Geopolitical Factors

• The US-China trade dynamics influence procurement options, emphasizing the need for due diligence regarding compliance and geopolitical stability.
• Indian suppliers face evolving regulatory standards, requiring continuous audits and certifications.
• European suppliers, while often more expensive, tend to provide more reliable compliance pathways for Western markets.

Pricing and Lead Time

Cost competitiveness is central, with Chinese manufacturers typically offering lower prices. However, long lead times and international shipping complexities necessitate strategic planning for procurement cycles.

Regulatory Acceptance

Most regulatory agencies prioritize API suppliers with validated manufacturing processes, comprehensive dossiers, and proven compliance histories. Partnership with suppliers holding validated CEPs or DMFs facilitates smoother approval processes for CECLOR CD.

Emerging Trends in API Sourcing

Shift toward Smarter, Diversified Supply Chains

Companies increasingly adopt dual sourcing strategies to mitigate risks. Digital platforms and supplier qualification tools enhance transparency and streamline vendor evaluation.

Technological Advances in API Manufacturing

Innovations such as continuous manufacturing and advanced process analytical technology (PAT) improve API quality control and reduce batch variability.

Regulatory Harmonization and Global Standards

International efforts, including ICH guidelines, promote consistent quality benchmarks, providing confidence in API quality regardless of the manufacturing source.

Conclusion

The sourcing of cefaclor API for CECLOR CD remains concentrated primarily in China and India, with European manufacturers playing an ancillary role. Ensuring API quality requires meticulous supplier qualification, adherence to GMP, and regulatory validation. As supply chain resilience becomes increasingly critical, pharmaceutical companies are diversifying sources and integrating advanced quality assurance practices. The evolving landscape underscores the importance of strategic partnerships with compliant, certified API producers to sustain high standards for CECLOR CD production.

Key Takeaways

• The primary API sources for cefaclor are Chinese and Indian manufacturers, with European suppliers expanding their share.
• Procurement strategies should incorporate robust supplier qualification, quality audits, and validation of GMP compliance.
• Regulatory recognition (CEP, DMF) significantly impacts the ease of API acceptance in international markets.
• Diversifying API supply sources mitigates geopolitical and supply chain risks, ensuring consistent manufacturing capabilities.
• Technological innovations and harmonized standards are enhancing API quality and manufacturing efficiency globally.

FAQs

1. What are the most reputable API manufacturers for cefaclor?
Reputable manufacturers include Qingdao Biomedicine Co., Ltd. (China), Hikal Ltd. (India), and suppliers certified by major regulatory agencies such as US FDA and EMA, with proven track records in GMP compliance.

2. How does regulatory certification influence API sourcing decisions?
Regulatory certifications like CEP and DMFs facilitate compliance verification, reduce approval timelines, and mitigate regulatory risks when sourcing APIs internationally.

3. What are the primary risks associated with cefaclor API supply chains?
Risks include geopolitical disruptions, quality non-compliance, manufacturing capacity limitations, and regulatory changes that may impede supply continuity.

4. How are emerging manufacturing technologies impacting cefaclor API quality?
Technologies such as continuous manufacturing and real-time quality control improve process efficiency, batch consistency, and compliance, leading to higher quality APIs.

5. Why is diversification of API suppliers vital for CECLOR CD production?
Diversification reduces dependency on a single source, diminishes supply disruption risks, maintains competitive pricing, and ensures regulatory compliance across different markets.

---

Sources
[1] U.S. Food and Drug Administration (FDA). "API Suppliers Listing" and approval dossiers.
[2] European Medicines Agency (EMA). "CEP and API Quality Standards."
[3] Market intelligence reports: "Global Cephalosporin API Market," 2022.
[4] Industry publications and supplier websites.