Bulk Pharmaceutical API Sources for CLAFORAN

Bulk Pharmaceutical API Sources for CLAFORAN

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemShuttle		104549
Clearsynth		CS-O-06208
001Chemical		DY111392
Matrix Scientific		145093
Smolecule		S619042

Bulk Active Pharmaceutical Ingredient (API) Sources for Claforan (Cefotaxime)

Last updated: July 29, 2025

Introduction

Claforan, marketed under the generic name Cefotaxime, is a third-generation cephalosporin antibiotic used extensively worldwide to treat serious bacterial infections. As an injectable broad-spectrum antibiotic, Cefotaxime’s efficacy hinges on the quality and reliability of its active pharmaceutical ingredient (API) supply. For pharmaceutical manufacturers, procurement of high-quality Cefotaxime API from reputable bulk suppliers is critical to maintaining product quality, regulatory compliance, and cost-effectiveness.

This comprehensive analysis explores global sources of Cefotaxime API, delving into leading API producers, regional suppliers, manufacturing capabilities, regulatory standing, and emerging trends. The goal: to serve as an authoritative resource enabling procurement professionals and manufacturers to make informed sourcing decisions.

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Overview of Cefotaxime API Manufacturing

Cefotaxime API synthesis involves complex chemical processes requiring advanced R&D capacity, stringent quality controls, and compliance with internationally recognized standards (e.g., GMP). Major API producers often also supply related cephalosporin APIs, leveraging shared manufacturing platforms and expertise.

Key considerations in selecting IDEA sources include:

• GMP compliance: Ensures API meets global quality standards, critical for regulatory approval.
• Manufacturing capacity & consistency: Ability to meet demand and provide reliable supply.
• Regulatory acceptance: Approved by major health authorities like FDA, EMA, etc.
• Cost & lead times: Competitive pricing and efficient lead times.

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Leading Global API Suppliers for Cefotaxime

1. Chinese API Manufacturers

China remains the dominant producer of Cephalosporin APIs, including Cefotaxime, owing to established manufacturing infrastructure and cost advantages.

• Hepeng Pharmaceutical Co., Ltd.
  Hepeng specializes in cephalosporin APIs and intermediates, with GMP-approved facilities. They export API to global markets, including North America, Europe, and Asia. Their Cefotaxime API meets international pharmacopeial standards.

• Zhejiang Hongene Biotech Co., Ltd.
  Known for high-volume cephalosporin APIs, Hongene has built a solid reputation for GMP quality and consistent supply. Their Cefotaxime API is utilized in various pharmaceutical formulations worldwide.

• Qingdao Yuting Pharmaceutical Co., Ltd.
  Yuting produces Cefotaxime API compliant with Chinese and international standards, targeting high-volume clients. They invest in R&D to improve process efficiency.

2. Indian API Manufacturers

India’s pharmaceutical sector is renowned for its API manufacturing expertise and global compliance, with several established suppliers producing Cefotaxime:

• Lupin Ltd.
  A leading Indian pharmaceutical firm with extensive API manufacturing capabilities, including cephalosporins. Lupin’s APIs are approved by global regulators and supplied to multinational generic firms.

• Aurobindo Pharma Ltd.
  A robust API producer with a comprehensive portfolio of cephalosporin APIs, including Cefotaxime. Their facilities operate under stringent GMP conditions with USFDA and EMA approvals.

• Sun Pharmaceutical Industries Ltd.
  Known for high-quality APIs, Sun’s Cefotaxime API is produced in GMP-compliant plants and distributed globally.

3. European & U.S. API Suppliers

While fewer in number, the European and U.S. API markets host reputable manufacturers with advanced regulatory status:

• Celltrion Pharmaceutical Co., Ltd. (South Korea)
  An emerging player in biopharma and advanced APIs, Celltrion’s manufacturing facilities comply with stringent GMP standards aligned with global regulators. They offer Cefotaxime API suitable for high-end markets.

• Grande Biotech (India)
  Part of the Eurofarma Group, Grande Biotech operates GMP-certified facilities capable of supplying high-quality Cefotaxime API primarily for North American and European clients.

4. Contract Manufacturing & ODM/OEM Suppliers

For companies seeking OEM services or custom contracts:

• CordenPharma (GSK, Merck, and other partnerships)
  Specializes in custom API synthesis, including cephalosporins, providing tailored manufacturing with high regulatory compliance.

• CIPLA Ltd.
  While primarily a manufacturer of formulations, CIPLA also produces APIs through its GMP-certified plants, with potential OEM offerings.

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Emerging Trends & Considerations in API Sourcing

Regulatory & Quality Assurance

Supply chain security hinges on compliance with internationally accepted GMP standards and inspections by agencies such as the FDA, EMA, and WHO. Suppliers with active regulatory approvals limit potential compliance risks.

Supply Chain Diversification

Dependence on a single source exposes manufacturers to procurement risks. Sourcing from multiple GMP-certified suppliers across geographies, primarily from India, China, and South Korea, mitigates supply disruptions.

Technological Innovations

Advancements in synthetic pathways and process intensification improve API yield and purity. Suppliers investing in R&D often offer more consistent quality and lower impurity profiles, essential for injectable APIs like Cefotaxime.

Environmental & Ethical Standards

Global regulators scrutinize environmental impacts and sustainable manufacturing practices. Leading suppliers adhere to responsible environmental, health, and safety policies.

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Regulatory & Certification Landscape

Most reputable API suppliers maintain certifications such as:

• GMP (Good Manufacturing Practice)
• ISO 9001/ISO 14001
• U.S. FDA, EDQM, or EMA approvals if applicable

Regulatory dossiers and validation reports are vital in confirming supplier compliance and facilitating registration of finished pharmaceutical products.

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Supply Chain and Procurement Considerations

• Lead times typically range from 3 to 6 months, depending on supplier location and regulatory clearance.
• Pricing varies based on regional manufacturing costs, quality certifications, and order volume. Chinese suppliers often provide the most competitive prices, but buyers must verify quality credentials.
• Logistics & Customs: Maritime shipping remains prevalent, with considerations for importing tariffs, customs clearance, and storage conditions, especially for temperature-sensitive APIs.

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Conclusion

Cefotaxime API sourcing requires meticulous assessment of supplier quality, regulatory compliance, and supply stability. Tiered sourcing strategies incorporating established Chinese and Indian producers, along with select Asian and European manufacturers, optimize risk management. As global standards tighten, continuous validation of supplier GMP credentials and adherence to environmental and ethical practices remains essential.

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Key Takeaways

• Robust Quality & Regulatory Standards: Prioritize suppliers with GMP approval and proven regulatory track records for Cefotaxime API.
• Geographic Diversification: Reduce supply risk by sourcing from multiple regions—China, India, Korea, and Europe.
• Cost vs. Quality Balance: Chinese suppliers offer competitive pricing; however, Indian and European suppliers provide added assurance of compliance.
• Innovative Manufacturing: Seek suppliers investing in process improvements to ensure consistent API purity and yield.
• Supply Chain Preparedness: Plan ahead for lead times and logistic considerations, especially for temperature-sensitive injectable APIs.

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FAQs

1. What are the main factors influencing the selection of Cefotaxime API suppliers?

Key factors include GMP compliance, regulatory approvals (FDA, EMA, WHO), manufacturing capacity, product quality, supply reliability, cost competitiveness, and environmental practices.

2. Which countries are leading producers of Cefotaxime API?

China and India dominate as primary producers, with additional significant suppliers in South Korea and compliance-focused European manufacturers.

3. How can buyers verify the quality of Cefotaxime API suppliers?

Perform supplier audits, review GMP certifications, request batch records and analytical data, and validate regulatory approvals via official dossiers and inspection reports.

4. What are the typical lead times for Cefotaxime API procurement?

Lead times generally range from 3 to 6 months, influenced by supplier location, production schedule, and regulatory clearance processes.

5. Are there any emerging suppliers or trends in Cefotaxime API sourcing?

Emerging suppliers from South Korea and Southeast Asia, along with technology-driven process innovations, are shaping future sourcing dynamics focused on quality, sustainability, and supply security.

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References

[1] World Health Organization. "WHO Model List of Essential Medicines," 2023.
[2] U.S. Food and Drug Administration. API Inspection Reports, 2023.
[3] European Directorate for the Quality of Medicines & HealthCare (EDQM). "CEP Certificates," 2023.
[4] Global API Market Reports, 2022.
[5] Company websites and industry publications.

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This article aims to serve as an authoritative guide on Cefotaxime API sourcing, supporting strategic procurement and regulatory compliance. For tailored supplier recommendations, consult with industry-specific sourcing agents or regulatory experts.