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Suppliers and packagers for sulfadiazine
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sulfadiazine
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Chartwell Molecular | SULFADIAZINE | sulfadiazine | TABLET;ORAL | 080084 | ANDA | Chartwell RX, LLC | 62135-842-60 | 60 TABLET in 1 BOTTLE (62135-842-60) | 2024-09-23 |
| Epic Pharma Llc | SULFADIAZINE | sulfadiazine | TABLET;ORAL | 040091 | ANDA | EPIC PHARMA, LLC | 42806-757-60 | 60 TABLET in 1 BOTTLE (42806-757-60) | 2021-12-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Sulfadiazine
Introduction
Sulfadiazine remains a critical antibiotic within the sulfonamide class, renowned for its efficacy in combating bacterial infections, including toxoplasmosis and urinary tract infections. Its continued relevance in clinical settings hinges on the reliable supply chain secured from a network of reputable manufacturers and distributors. This article provides a detailed overview of major suppliers of sulfadiazine, analyzing their global footprint, regulatory compliance, and market positioning to inform stakeholders in procurement, healthcare, and investment sectors.
Overview of Sulfadiazine Production and Supply Chain
Sulfadiazine was first introduced in the 1940s and has since been integrated into various pharmaceutical formulations. Its synthesis involves intricate chemical processes requiring specialized facilities adhering to stringent Good Manufacturing Practice (GMP) standards. The supply chain spans raw material providers, chemical manufacturers, formulation plants, and distribution networks.
The global demand is primarily driven by hospitals, clinics, and pharmaceutical companies developing combination therapies. As generic production dominates the market, many suppliers compete on price, quality, and regulatory adherence.
Key Suppliers of Sulfadiazine
1. GlaxoSmithKline (GSK)
Although GSK's involvement with sulfadiazine has diminished with the rise of generics, historically, the company played a prominent role. Presently, GSK's manufacturing facilities in Europe and Asia comply with international GMP standards, ensuring high-quality supply channels. They primarily focus on research-based formulations and strategic partnerships for supply continuity.
2. Pfizer Inc.
Pfizer, a global pharmaceutical giant, holds licenses to produce sulfadiazine in certain regions. Their manufacturing facilities located across North America and Europe have capabilities for large-scale production, adhering strictly to regulatory standards (FDA, EMA). Pfizer’s vast distribution network facilitates the broad availability of sulfadiazine in hospital settings and retail pharmacies.
3. Trailing Generics Manufacturers
The majority of sulfadiazine supply comes from generic pharmaceutical manufacturers operating in Asia, India, and South America. These manufacturers produce cost-effective versions of sulfadiazine and comply with local GMP certifications. Notable among them are:
- Sun Pharmaceutical Industries Ltd. (India): A leading manufacturer with over 600 molecules in their portfolio, Sun Pharma supplies sulfadiazine to numerous markets worldwide.
- Dr. Reddy’s Laboratories (India): Known for its extensive generic portfolio, Dr. Reddy’s ensures quality through rigorous testing and global GMP adherence.
- Macleods Pharmaceuticals (India): Offers sulfadiazine as part of their antibacterial range, with export licenses covering Asia, Africa, and Latin America.
4. Chinese Manufacturers
The Chinese pharmaceutical industry has emerged as a significant supplier of sulfadiazine, driven by large-scale manufacturing capacities and competitive pricing. Notable suppliers include:
- North China Pharmaceutical Group Corporation (NCPC)
- Hubei Jade Pharmaceutical Co., Ltd.
These companies often export under various brand or generic labels, subject to compliance with importing country regulations.
5. Official and Government Procurement Agencies
In some countries, government agencies and procurement consortia negotiate bulk contracts with local state-owned enterprises or approved private manufacturers, ensuring a steady minimal supply of sulfadiazine for public health needs, especially in resource-limited regions.
Regulatory Considerations and Market Access
Most suppliers tailored for international markets must obtain approval from relevant health authorities, such as the FDA (United States), EMA (European Union), PMDA (Japan), or country's national drug authorities. Manufacturing facilities need current GMP certifications, and products require registration before entry into regulated markets.
Suppliers often navigate regional nuances—for example, complying with Indian drug regulations (DCGI), Chinese SFDA standards, and African medicine registration requirements—to extend their market reach.
Emerging Trends: Impact on Supply Dynamics
- Generic Market Growth: The proliferation of generic sulfadiazine manufacturers has increased supply options but also led to variability in product quality and regulatory challenges.
- Supply Chain Disruptions: External factors such as the COVID-19 pandemic have caused delays, prompting stakeholders to diversify suppliers and enhance inventory management.
- Regulatory Stringency: Increasing quality standards are steering suppliers toward more rigorous compliance, impacting capacity and pricing.
Risk Factors and Mitigation Strategies for Supply
- Dependency on geographic regions with unstable political or economic environments increases supply risk.
- Limited differentiation between suppliers necessitates diligent qualification and quality audits.
- Regulatory non-compliance can lead to market withdrawals and shortages.
Manufacturers and buyers should implement risk mitigation strategies such as multi-sourcing, strategic stockpiling, and adhering to supplier qualification protocols.
Conclusion
The global sulfadiazine supply chain comprises a blend of longstanding pharmaceutical giants and aggressive generic manufacturers primarily based in Asia. Ensuring consistent supply hinges on selecting suppliers with robust regulatory compliance, scalable manufacturing capabilities, and proven quality standards. With the evolving landscape driven by regulatory shifts and market demand, maintaining supply stability requires strategic sourcing, ongoing supplier evaluation, and a keen understanding of regional manufacturing strengths.
Key Takeaways
- Major suppliers include global pharmaceutical companies like Pfizer and a significant portion of generics from Indian manufacturers such as Sun Pharma, Dr. Reddy’s, and Macleods.
- Asian manufacturers dominate sulfadiazine production, providing cost-effective options while facing regulatory and quality oversight.
- Regulatory compliance (GMP), quality control, and regional registration are critical for market access.
- Supply chain resilience can be enhanced through diversification, strategic inventory management, and ongoing supplier qualification.
- Emerging market trends and disruptions necessitate adaptive procurement strategies for healthcare providers and stakeholders.
FAQs
1. Is sulfadiazine still widely produced globally?
Yes. While newer antibiotics have emerged, sulfadiazine remains in production, mainly through generic manufacturers, to meet ongoing clinical demands, especially in resource-constrained settings.
2. How does regional regulation impact sulfadiazine suppliers?
Suppliers must comply with regional regulatory agencies like the FDA, EMA, or local health authorities. Regulatory approvals influence market access, product registration, and overall supply stability.
3. Can I source sulfadiazine directly from Chinese manufacturers?
Yes. Several Chinese companies manufacture sulfadiazine for export markets. Procurement should verify quality certifications and regulatory compliance to ensure product integrity.
4. What are the risks associated with sourcing sulfadiazine from generic manufacturers?
Risks include variability in product quality, regulatory non-compliance, and supply disruptions. Thorough qualification and supplier audits mitigate these concerns.
5. Are there any notable alternative suppliers for sulfadiazine?
While most suppliers are concentrated in India and China, some regional manufacturers in Africa and the Middle East also produce sulfadiazine, often for local distribution under strict regulatory oversight.
Sources
- World Health Organization. International Pharmacopoeia. 2021 Edition.
- U.S. Food and Drug Administration (FDA). Approved Drug Products; Data Files.
- Indian Drug Controller General of India (DCGI). List of approved formulations.
- Industry reports from IQVIA and GlobalData on generic pharmaceutical markets.
- Company websites and annual reports of Pfizer, Sun Pharma, Dr. Reddy’s, Macleods, and Chinese suppliers.
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