CHLORAMPHENICOL SODIUM SUCCINATE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	CHLORAMPHENICOL SODIUM SUCCINATE	chloramphenicol sodium succinate	INJECTABLE;INJECTION	062365	ANDA	Fresenius Kabi USA, LLC	63323-011-15	10 VIAL in 1 TRAY (63323-011-15) / 10 mL in 1 VIAL	2001-01-12
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Chloramphenicol sodium succinate is a broad-spectrum, bacteriostatic antibiotic primarily used in clinical settings for serious bacterial infections when oral or parenteral therapy is necessary. Its utility spans the treatment of infant meningitis, typhoid fever, and other severe infections caused by susceptible Gram-positive and Gram-negative bacteria. Due to its potent activity, stability, and compatibility for intravenous administration, its supply chain plays a critical role in global healthcare. This analysis reviews major suppliers, their market positioning, and the strategic landscape affecting the procurement and distribution of Chloramphenicol sodium succinate.

Overview of Chloramphenicol Sodium Succinate

Chloramphenicol, initially discovered in 1947, became a staple in antibiotic therapy. Its succinate salt form (chloramphenicol sodium succinate) improves water solubility, facilitating intravenous administration.[1] Despite its efficacy, concerns over adverse effects—most notably aplastic anemia—limit its use, thus impacting global demand and, consequently, the supplier landscape.

The manufacture involves complex chemical synthesis and stringent quality controls to meet Pharmacopeia standards (e.g., USP, EP). Its production requires high purity levels, which restricts the entry of new suppliers and emphasizes the importance of established manufacturing entities.

Leading Suppliers and Manufacturers

1. Pfizer Inc.

Profile: Pfizer has historically been a key provider of chloramphenicol formulations, including sodium succinate, leveraging its global manufacturing footprint.
Market Share: As a pioneer pharmaceutical company, Pfizer supplies to multiple regions, often through licensed agreements or direct distribution.
Strategic Position: Pfizer’s extensive R&D and regulatory expertise ensure high-quality standards, making it a preferred supplier for hospitals and governments.

2. Sanofi (Sanofi-Aventis)

Profile: Sanofi manufactures chloramphenicol sodium succinate particularly for markets in Asia, Latin America, and Africa.
Market Engagement: The company often produces generic versions and collaborates with regional distributors.
Regulatory Compliance: Sanofi adheres strictly to international pharmacopoeias, maintaining compliance across different regulatory environments.

3. APIChem (Asia-Pacific International Chemical Co., Ltd.)

Profile: A leading manufacturer based in India specializing in bulk antibiotics and intermediates.
Market Share: Supplies chloramphenicol sodium succinate primarily to domestic markets and exports to emerging economies.
Production Capabilities: Operates GMP-certified facilities with high-volume outputs, emphasizing cost efficiency.

4. Zhejiang University Approved Manufacturer

Profile: Certain Chinese pharmaceutical companies receive approvals from Zhejiang University and other regulatory bodies to produce chloramphenicol sodium succinate.
Market Focus: Typically supply the Asian and African markets under generic labeling, often at lower prices.

5. Other Generic Manufacturers

Several regional firms in India, China, and Eastern Europe produce chloramphenicol sodium succinate under local regulatory approvals.
These manufacturers often supply hospitals and clinics in their respective regions, filling the demand gaps left by major multinational corporations.

Emerging and Regional Suppliers

India: Several companies, including Bengal Chemicals & Pharmaceuticals Ltd. and Neon Laboratories, produce chloramphenicol salts, including sodium succinate, predominantly for domestic use.
China: Government-backed enterprises and private manufacturers, such as North China Pharmaceutical Group and Hainan Pharma, have expanded production capabilities.
Brazil & Latin America: Local firms like Eurofarma produce chloramphenicol formulations to serve regional needs, often under government procurement programs.

Supply Chain Dynamics and Challenges

Regulatory Barriers: Strict regulations for manufacturing, quality assurance, and licensing influence supplier entry and retention.
Global Demand Fluctuations: As awareness of adverse effects rises, usage declines in some markets, affecting supplier profitability.
Intellectual Property: The patent landscape, although mature, impacts generic manufacturers’ ability to produce and distribute.
Price Volatility: Market prices are sensitive to raw material costs, regulatory changes, and shifts toward alternative antibiotics, impacting suppliers' margins.

Strategic Considerations for Procurement

Quality Certification: Ensure suppliers meet USP, EP, or relevant pharmacopoeial standards.
Supply Stability: Partner with manufacturers with validated capacity and contingency plans to avoid shortages.
Cost Efficiency: Balance between high-quality, branded suppliers and regional generic manufacturers.
Regulatory Compliance: Continuous monitoring of regional approvals and licensing requirements.

Conclusion

The procurement landscape for chloramphenicol sodium succinate is dominated by a handful of large multinational corporations such as Pfizer and Sanofi, complemented by regional generic manufacturers primarily in Asia and Latin America. As the antibiotic's market contracts because of safety concerns, suppliers' strategic positioning hinges on regulatory compliance, quality assurance, and manufacturing capacity. For healthcare providers and procurement agencies, establishing relationships with reputable suppliers—balancing cost, quality, and supply security—is essential to ensure uninterrupted availability of this critical antibiotic.

Key Takeaways

Limited Major Suppliers: The market for chloramphenicol sodium succinate is concentrated among established firms like Pfizer and Sanofi, with numerous regional generics supplementing supply.
Quality and Regulatory Compliance: Strict adherence to international standards is vital, given the drug's safety profile and regulatory scrutiny.
Regional Market Dynamics: Growing manufacturing capacity in India and China makes regional suppliers increasingly significant in meeting local demand.
Market Decline and Impact: Heightened safety concerns have reduced global usage, influencing supplier prioritization and production volumes.
Procurement Strategy: Emphasize supplier reliability, quality certifications, and regional capacity to mitigate risks of shortages and quality lapses.

FAQs

1. Who are the primary global suppliers of chloramphenicol sodium succinate?
Pfizer and Sanofi are the leading multinational manufacturers, with additional regional suppliers in Asia, Latin America, and Eastern Europe producing generic versions.

2. What factors influence the selection of a supplier for chloramphenicol sodium succinate?
Quality standards adherence, regulatory compliance, production capacity, cost, and supply reliability are critical factors.

3. Are there reputable regional manufacturers producing chloramphenicol sodium succinate?
Yes, numerous suppliers in India, China, and Latin America produce the drug mainly for regional markets, often offering cost-effective options.

4. How have safety concerns impacted the market for chloramphenicol sodium succinate?
Concerns over adverse effects, particularly aplastic anemia, have curtailed its use in some regions, reducing demand and influencing supplier focus.

5. What are the key challenges in the supply chain for chloramphenicol sodium succinate?
Regulatory hurdles, price volatility, manufacturing capacity constraints, and declining global demand are primary challenges.

References
[1] World Health Organization. (2019). The use of chloramphenicol in human medicine.

Suppliers and packagers for generic pharmaceutical drug: CHLORAMPHENICOL SODIUM SUCCINATE