Bulk Pharmaceutical API Sources for ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C5020_SIGMA
Ambinter		STOCK1N-08270
Ambinter		ST024775
NovoSeek		4214199
NovoSeek		23675322

Bulk Active Pharmaceutical Ingredient (API) Sources for: ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER

Last updated: August 12, 2025

Overview of ANCEF (Cefazolin) API

Cefazolin, marketed under the trade name ANCEF, is a first-generation cephalosporin antibiotic widely used for prophylaxis and treatment of bacterial infections. It functions by inhibiting bacterial cell wall synthesis, exhibiting potent activity against gram-positive bacteria and some gram-negative organisms. The API, cefazolin, is complex chemically and must adhere to strict pharmaceutical manufacturing standards, including Good Manufacturing Practices (GMP).

Global API Manufacturing Landscape

The sourcing of cefazolin API involves identifying reputable chemical manufacturers capable of producing high-quality, GMP-compliant APIs. The supply chain spans multiple regions—primarily China, India, Europe, and North America—each with distinct advantages.

Key API Manufacturers for Cefazolin (ANCEF)

1. India-Based API Manufacturers

India hosts numerous well-established pharmaceutical API producers known for large-scale manufacturing, competitive pricing, and compliance with international standards.

• Sipra Labs (Gujarat, India): A proven supplier offering cefazolin API with verified GMP certification. They produce bulk APIs adhering to international pharmacopeial standards, including USP and EP.

• Hikma Pharmaceuticals: While primarily a formulation company, Hikma's partnership and licensing agreements facilitate access to high-quality cefazolin APIs suitable for bulk procurement.

• Sandoz (Novartis): Offers cefazolin API primarily for their formulations but also supplies bulk API to authorized partners in compliance with global regulatory norms.

2. China-Based API Manufacturers

China remains a dominant player in bulk API manufacturing, with numerous facilities specializing in cephalosporin antibiotics, including cefazolin.

• North China Pharmaceutical Group Corporation (NCPC): Known for large-scale cephalosporin API production, including cefazolin, with compliance certificates and extensive export history.

• Qingdao¨Lupin Healthcare: Offers cefazolin API compliant with international standards, with verifiable GMP certifications.

• Shandong Weifang Pharmaceutical Co., Ltd.: Supplies GMP-certified cefazolin API, with a focus on large-volume exports.

3. European API Suppliers

European manufacturers, although fewer, are distinguished by stringent regulatory standards, reliable quality, and regulatory acceptance:

• Basilea Pharmaceutica AG (Switzerland): Produces high-purity cefazolin API, compliant with EMA standards, mainly for integration into European formulations.

• Bachem AG (Switzerland): Specializes in complex peptide synthesis but also supplies active pharmaceutical ingredients, including cefazolin, under strict GMP conditions.

4. North American API Manufacturers

North American API sources emphasize regulatory compliance, quality control, and reliable supply:

• Piramal Pharma Solutions (USA): Offers cefazolin API manufacturing with cGMP certification, suitable for pharmaceutical use in North America and beyond.

• Sicor Biotech (USA): Provides GMP-compliant cefazolin API, with proven export credentials to global markets.

Considerations in API Sourcing for ANCEF

Regulatory Compliance

Selecting a supplier requires verifying that their manufacturing facilities hold current GMP certification aligned with FDA, EMA, or respective national standards. Conducting audits and review of Certificate of Suitability (CoS) and Drug Master Files (DMF) is essential.

Quality Certifications

Ensure API suppliers provide batch certificates, API purity (generally >99%), residual solvent profiles, and microbial limits complying with pharmacopeial standards (USP, Ph.Eur., JP).

Supply Chain Reliability

Prioritize suppliers with stable production capacity and consistent GMP compliance, especially given global supply chain disruptions. Establish long-term agreements with suppliers capable of scaling with demand.

Cost and Lead Time

Competitive pricing is crucial; however, it must balance with quality and regulatory assurances. Lead times depend on the manufacturing complexity and logistical considerations, especially when sourcing from Asia or Europe.

Procurement Channels for API

• Direct Manufacturer Engagement: Establish direct contracts with verified API producers, preferably with audited facilities.

• Authorized Distributors: Leverage distribution networks with proven credentials – particularly useful for easier quality verification and logistical support.

• API Brokers/Trading Companies: Use only with high due diligence; ensure they provide validated documentation and traceability.

Market Trends and Future Outlook

The demand for cefazolin API remains steady due to its vital role in hospital infection control and surgical prophylaxis. The ongoing emphasis on manufacturing quality and supply chain resilience is prompting companies to diversify sources and increase inventory buffers.

Emerging players in China and India are investing in advanced GMP-compliant facilities to meet international standards, offering competitive options for global buyers.

Critical Challenges in API Sourcing

• Regulatory Divergence: Variations in GMP standards across regions may impact registration processes.

• Quality Assurance: Ensuring batch-to-batch consistency and conformity with pharmacopeial specifications.

• Supply Chain Disruptions: Ongoing geopolitical and pandemic-related disruptions can impact lead times and availability.

Conclusion

Sourcing cefazolin API (ANCEF) demands a rigorous approach that balances quality, regulatory acceptance, supply reliability, and cost. Top-tier suppliers across India, China, Europe, and North America provide GMP-compliant APIs suitable for manufacturing injectable formulations in plastic containers. Establishing partnerships with verified manufacturers and ensuring compliance with pertinent regulatory standards ensure the consistent supply of high-quality API essential for the production of ANCEF in dextrose 5% solutions.

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Key Takeaways

• Identify reputable GMP-certified API manufacturers across India, China, Europe, and North America with proven track records.
• Ensure supplier certifications, including CoS and DMFs, are up-to-date and verifiable.
• Prioritize suppliers capable of supporting regulatory submissions in target markets, especially for injectable antibiotics.
• Diversify sources to mitigate risks based on geopolitical or logistical factors.
• Maintain rigorous quality assurance protocols, including batch testing and documentation review, before procurement.

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Frequently Asked Questions (FAQs)

1. What are the main quality parameters for cefazolin API?
The API should have a purity greater than 99%, low residual solvents, minimal impurities, verified microbial limits, and compliance with pharmacopeial standards (USP, EP, JP).

2. How do I verify a manufacturer's GMP compliance?
Review their current GMP certification, conduct supplier audits if feasible, and verify documentation such as CoS, DMF filings, and third-party audit reports.

3. Are Chinese cefazolin APIs suitable for US and European markets?
Yes, if certified GMP and compliant with local regulatory standards are in place. It's vital to review their certifications and conduct thorough quality assessments.

4. What are the considerations for long-term supply stability?
Evaluate supplier production capacity, compliance history, logistical capabilities, and their ability to meet growing demand without quality compromise.

5. How does the sourcing of cefazolin API impact the cost of the final ANCEF formulation?
API costs represent a significant component; sourcing from competitive, high-quality suppliers can optimize overall formulation costs, provided logistical and regulatory compliance are maintained.

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References

1. United States Pharmacopeia (USP) - Cefazolin Monograph: Ensures quality parameters for APIs used in injectable formulations.
2. European Pharmacopoeia (EP) - Cefazolin Standards: Provides specifications for European markets.
3. GMP Certification Reports: Verified manufacturing compliance of selected suppliers.
4. Industry Market Reports: Trends in cephalosporin API production and supply chain analyses.
5. WHO – International Pharmacopoeia Guidelines: Standards applicable across multiple regions for injectable APIs.

Note: Actual supplier details, certifications, and supply chain specifics should be verified through direct communication and documentation review before procurement decisions.