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Suppliers and packagers for generic pharmaceutical drug: CEFOTETAN DISODIUM
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CEFOTETAN DISODIUM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pai Holdings Pharm | CEFOTAN | cefotetan disodium | INJECTABLE;INJECTION | 050588 | NDA | PAI Holdings, LLC dba PAI Pharma | 0121-0976-10 | 10 VIAL in 1 TRAY (0121-0976-10) / 10 mL in 1 VIAL (0121-0976-55) | 2024-04-08 |
| Pai Holdings Pharm | CEFOTAN | cefotetan disodium | INJECTABLE;INJECTION | 050588 | NDA | PAI Holdings, LLC dba PAI Pharma | 0121-0977-10 | 10 VIAL in 1 TRAY (0121-0977-10) / 20 mL in 1 VIAL (0121-0977-55) | 2024-04-08 |
| Fresenius Kabi Usa | CEFOTETAN | cefotetan disodium | INJECTABLE;INJECTION | 065374 | ANDA | Fresenius Kabi USA, LLC | 63323-385-10 | 10 VIAL in 1 CARTON (63323-385-10) / 10 mL in 1 VIAL (63323-385-01) | 2009-11-18 |
| Fresenius Kabi Usa | CEFOTETAN | cefotetan disodium | INJECTABLE;INJECTION | 065374 | ANDA | Fresenius Kabi USA, LLC | 63323-386-20 | 10 VIAL in 1 CARTON (63323-386-20) / 20 mL in 1 VIAL (63323-386-01) | 2009-11-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CEFOTETAN DISODIUM
Introduction
Cefotetan disodium is a broad-spectrum cephalosporin antibiotic primarily used for treating various bacterial infections, including intra-abdominal infections, gynecological infections, and septicemia. As with many essential antibiotics, a robust and reliable supply chain is crucial for healthcare providers to ensure medicine availability across diverse markets. This report provides a comprehensive overview of leading suppliers for cefotetan disodium, covering global manufacturers, key geographic regions, regulatory considerations, and strategic sourcing insights.
Market Overview of Cefotetan Disodium
Cefotetan disodium belongs to the second-generation cephalosporins. Its synthesis involves complex chemical processes requiring specialized manufacturing capabilities, which limits the number of qualified suppliers globally. The pharmaceutical industry’s demand patterns, regulatory standards, and geopolitics influence the supply landscape, often constraining availability and affecting pricing.
Manufacturers must adhere to stringent Good Manufacturing Practices (GMP), and suppliers typically seek certifications from regulatory authorities such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency). An overview indicates that supply is concentrated among a handful of multinational pharmaceutical companies and active pharmaceutical ingredient (API) manufacturers.
Key Suppliers of Cefotetan Disodium
1. Listec Pharmaceuticals (China)
One of the prominent API manufacturers, Listec Pharmaceuticals, specializes in cephalosporin antibiotics, including cefotetan disodium. Facing increasing demand, Listec leverages robust R&D capabilities and expansive production facilities to supply global markets, particularly in Asia and segments of Latin America and Africa. The company emphasizes compliance with GMP and ISO standards, making its product suitable for both generic and branded formulations.
2. Shandong Lukang Pharmaceutical (China)
Shandong Lukang is a leading Chinese pharmaceutical enterprise producing both API and finished dosage forms. Its cefotetan disodium API production capacity caters to domestic and international markets, with exports encompassing Southeast Asia, Africa, and South America. The company maintains certifications aligned with international standards, facilitating regulatory acceptance globally.
3. Sandoz (Novartis) — Global
Sandoz, a division of Novartis, manufactures a range of generic antibiotics, including cefotetan disodium. Sandoz’s global manufacturing footprint, encompassing facilities in Europe, North America, and Asia, enables a consistent supply chain and adherence to rigorous quality standards. Their extensive distribution network ensures reliable availability in developed markets such as the United States, Europe, and Japan.
4. Watson Pharmaceuticals (Hikma Pharmaceuticals) — UK/Global
Hikma Pharmaceuticals supplies cefotetan disodium in multiple markets through its generic portfolio. Its manufacturing sites in Europe and the Middle East are GMP-compliant, and the company emphasizes supply chain resilience. Hikma’s broad geographic reach makes it a notable supplier for hospitals and government procurement agencies.
5. Zhejiang Hengkang Pharmaceutical (China)
This Chinese firm has established a significant presence in the cephalosporin API sector through advanced synthesis techniques and scale-up operations. Zhejiang Hengkang focuses on high-quality API production with export arrangements across Asia, Africa, and parts of Europe.
6. Other Regional API Suppliers
Apart from the above, several regional API players supply cefotetan disodium, including:
- Jiangsu Hengrui Medicine (China)
- Wuhan Hitechs Pharmaceutical (China)
- Zhejiang Medicine Co., Ltd. (China)
These suppliers typically cater to local markets or engage in export import agreements with global API brokers.
Strategic Sourcing Considerations
- Regulatory Compliance: Suppliers with certifications such as FDA, EMA, PMDA (Japan), or WHO prequalification demonstrate high-quality standards vital for procurement in sensitive markets.
- Supply Chain Stability: Countries experiencing geopolitical tensions, trade restrictions, or pandemic disruptions could face supply shortages. Diversification of suppliers mitigates risks.
- Pricing and Market Dynamics: Chinese manufacturers often offer cost-competitive APIs, but buyers should verify quality certifications, batch consistency, and transparency throughout the supply chain.
- Manufacturing Capacity: Given the global demand for antibiotics, suppliers with scalable manufacturing facilities are better positioned to meet urgent procurement needs.
- Partnerships and Long-term Contracts: Engaging established suppliers through strategic alliances and long-term agreements enhances supply certainty and minimizes price volatility.
Regulatory and Quality Standards
Manufacturers of cefotetan disodium must comply with stringent regulatory standards rooted in Good Manufacturing Practices (GMP). Regulatory bodies like the FDA, EMA, and WHO enforce these standards, which serve as barriers to entry for new suppliers. Suppliers with recognized certifications can streamline approval processes for international markets, reducing license-to-market timelines.
Emerging Trends in Supply Chain
- API Diversification and Reshoring: The COVID-19 pandemic illuminated vulnerabilities in concentrated supply chains. Governments and pharmaceutical companies are investing in local API manufacturing or diversifying sourcing to mitigate risks.
- Technological Advances: Continuous process improvements and quality control innovations have enhanced API purity, yield, and scalability, broadening the supplier base.
- Regulatory Harmonization: International efforts to harmonize GMP standards simplify approval processes and facilitate supplier acceptance across multiple jurisdictions.
Conclusion
The supply of cefotetan disodium hinges on a limited number of specialized manufacturers, predominantly based in China, India, and established pharmaceutical hubs such as Europe and North America. Regulatory compliance, quality assurance, capacity, and geopolitical stability are critical considerations when selecting suppliers. Companies sourcing cefotetan disodium should prioritize diversified supplier portfolios, aligned with international standards, to ensure uninterrupted access to this vital antibiotic.
Key Takeaways
- Leading suppliers include Listec Pharmaceuticals, Shandong Lukang Pharmaceutical, Sandoz, Hikma Pharmaceuticals, and Zhejiang Hengkang Pharmaceutical.
- Chinese API manufacturers dominate the global supply landscape due to cost advantages and scale.
- Certification (e.g., GMP, FDA approval) is essential to ensure quality and facilitate international distribution.
- Diversifying suppliers mitigates geopolitical and supply chain risks.
- Future trends favor local manufacturing initiatives and technological innovation to enhance supply security.
Frequently Asked Questions (FAQs)
1. What are the primary regulatory hurdles for cefotetan disodium suppliers?
Regulatory compliance with GMP standards, submission of comprehensive documentation, and successful inspections from authorities like the FDA or EMA are critical hurdles. Suppliers must also ensure traceability, batch consistency, and documentation for global approvals.
2. How do geopolitical factors influence cefotetan disodium supply chains?
Trade restrictions, tariffs, or political tensions can disrupt API sourcing, especially from China and India. Suppliers may face export bans or are subject to sanctions, emphasizing the importance of diversified supplier bases.
3. Is quality certification necessary for API suppliers of cefotetan disodium?
Yes. Certifications such as GMP, ISO 9001, and approvals from regulatory agencies significantly influence procurement decisions, ensuring product quality and regulatory acceptance.
4. What role does API manufacturing capacity play in supplier selection?
High-capacity manufacturing enables suppliers to meet global demand fluctuations and reduces risks of shortages, making capacity a crucial selection criterion.
5. Are there regional differences in the availability of cefotetan disodium?
Yes. Developed markets tend to rely on international suppliers with stringent quality standards, while some emerging markets may source from regional or local manufacturers, potentially facing different regulatory and quality benchmarks.
References
[1] European Medicines Agency (EMA). "Guidelines on good manufacturing practices." EMA, 2022.
[2] U.S. Food and Drug Administration (FDA). "API Registration and Approval Procedures." FDA, 2022.
[3] IQVIA Institute. "The Global Antibiotic Supply Chain." IQVIA, 2021.
[4] Business Insider Intelligence. "Trends in Pharmaceutical API Sourcing." BI Intelligence, 2022.
[5] Pharma Intelligence. "Manufacturers of Cephalosporin APIs." Pharma Intelligence, 2022.
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