SILVER SULFADIAZINE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
King Pharms Llc	SILVADENE	silver sulfadiazine	CREAM;TOPICAL	017381	NDA	A-S Medication Solutions	50090-0230-0	1 TUBE in 1 CARTON (50090-0230-0) / 20 g in 1 TUBE	1973-11-26
King Pharms Llc	SILVADENE	silver sulfadiazine	CREAM;TOPICAL	017381	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-0131-0	1 TUBE in 1 CARTON (59762-0131-0) / 20 g in 1 TUBE	2018-01-15
King Pharms Llc	SILVADENE	silver sulfadiazine	CREAM;TOPICAL	017381	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-0131-2	1 TUBE in 1 CARTON (59762-0131-2) / 25 g in 1 TUBE	2018-01-15
King Pharms Llc	SILVADENE	silver sulfadiazine	CREAM;TOPICAL	017381	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-0131-4	400 g in 1 JAR (59762-0131-4)	2018-01-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Silver sulfadiazine (SSD) is a topical antimicrobial agent widely used for preventing and treating burn infections. Its efficacy in inhibiting bacterial growth, particularly in burn wounds, makes it a vital compound in wound management. As demand for advanced wound care products grows globally, the supply chain for silver sulfadiazine becomes increasingly strategic for pharmaceutical companies, healthcare providers, and researchers. This article explores key suppliers, manufacturing landscapes, and market dynamics that underpin the global supply of silver sulfadiazine.

Overview of Silver Sulfadiazine

Silver sulfadiazine is a compound consisting of silver and sulfadiazine, a sulfonamide antibiotic. It is typically formulated as a cream or ointment for topical application. The compound’s antimicrobial properties stem from the release of silver ions, which disrupt bacterial cell walls and inhibit vital enzymatic processes. The synthesis of silver sulfadiazine involves complex chemical procedures requiring high-purity reagents, emphasizing the importance of reliable suppliers capable of meeting strict quality standards, especially those compliant with Good Manufacturing Practices (GMP).

Global Market and Demand Dynamics

The global demand for silver sulfadiazine is primarily driven by the rising incidence of burn injuries and the growing burden of wound infections. The World Health Organization estimates millions of burn cases annually worldwide, with a significant portion requiring antimicrobial interventions like SSD. The outbreaks of antibiotic-resistant bacteria further bolster demand for topical agents with broad-spectrum activity. Moreover, the increase in medical tourism and healthcare infrastructure expansion in emerging markets expand the distribution channels and supplier needs.

From a manufacturing standpoint, key demand centers include North America, Europe, and Asia-Pacific. These regions host prominent healthcare institutions and regulatory bodies increasingly emphasizing supply chain reliability for critical medicines like silver sulfadiazine.

Major Suppliers of Silver Sulfadiazine

1. Chemical and Pharmaceutical Manufacturers

Most silver sulfadiazine supplies originate from specialized chemical manufacturers with robust capabilities for producing high-purity APIs (Active Pharmaceutical Ingredients) and intermediates. These key suppliers are often integrated with large pharmaceutical companies or operate as independent entities.

Pfizer: Historically a major player, Pfizer produces silver sulfadiazine as part of its wound management portfolio, supplying both directly to hospitals and through partnerships globally.
GlaxoSmithKline (GSK): GSK has developed sterile pharmaceutical products, including silver sulfadiazine, focusing on quality assurance and regulatory compliance for global markets.
Hangzhou Huadong Pharmaceutical (China): This Chinese manufacturer supplies bulk silver sulfadiazine intermediates to global formulators. Their products are often used for large-scale manufacturing, with an emphasis on cost-effectiveness.
Dezhou Wecare Chemicals (China): Specializes in sulfonamide derivatives, including high-purity silver sulfadiazine APIs, ensuring supply chain flexibility and cost competitiveness.

2. Contract Manufacturing Organizations (CMOs)

Several organizations provide contract manufacturing services for silver sulfadiazine, enabling pharmaceutical companies to outsource production efficiently.

Zhejiang Hangzhou Pharmaceutical Co.: An established CMO producing topical antimicrobials, including silver sulfadiazine, with certified facilities adhering to international standards.
Yiling Pharmaceutical (China): Offers contract synthesis and formulation services for silver sulfadiazine with reliable regulatory compliance and scalable production capacity.
Ajinomoto Co. (Japan): Known for their expertise in fine chemical synthesis, Ajinomoto supplies intermediates and finished APIs for pharmaceutical partners globally.

3. Raw Material Suppliers and Intermediates

Silver sulfadiazine synthesis requires high-quality silver salts and sulfonamide intermediates. Key providers include:

Sigma-Aldrich (Merck Group): Supplies high-purity silver nitrate, silver ammonium complexes, and sulfonamide intermediates used in synthesis.
TCI Chemicals: Offers raw materials essential for producing silver sulfadiazine, including silver salts and sulfonamide compounds, with global distribution channels.
Alfa Aesar (Thermo Fisher Scientific): Provides reagents, including silver salts and sulfonamide precursors, facilitating custom synthesis needs.

Regional Supplier Analysis

North America

The U.S. and Canada are home to multiple GMP-compliant suppliers, including larger pharmaceutical companies and CMOs. Suppliers like Pfizer and smaller biotech firms serve a significant share of the domestic and international markets. Regulatory oversight by the FDA ensures robust quality standards.

Europe

European suppliers, including GSK and smaller biotech firms, benefit from a well-established regulatory environment under the European Medicines Agency (EMA). The continent's emphasis on quality standards makes European API suppliers preferred for high-quality medicinal products.

Asia-Pacific

China and India dominate the production landscape owing to lower manufacturing costs and expanding capacities. Companies such as Zhejiang Hangzhou Pharmaceutical and Dezhou Wecare Chemicals have become key suppliers for global markets, supplying APIs at competitive prices. They often cater to both generic and branded product formulations, emphasizing scalable production and rapid supply.

Regulatory and Supply Chain Considerations

Suppliers for silver sulfadiazine must comply with strict regulatory standards, especially for APIs and finished products. Certification processes, including GMP, ISO certifications, and adherence to WHO prequalification, are critical for supplier approval. Disruptions in supply chains, due to geopolitical issues or raw material shortages (e.g., silver), can impact availability.

The COVID-19 pandemic underscored vulnerabilities in pharmaceutical supply chains, prompting companies to diversify sourcing and establish strategic stockpiles for critical raw materials like silver salts and intermediates.

Emerging Trends and Market Opportunities

Sustainable and Green Manufacturing: Increased focus on environmentally friendly synthesis processes encourages suppliers to adopt green chemistry practices, potentially reshaping supply dynamics.
Vertical Integration: Larger pharmaceutical firms may seek vertical integration by acquiring or partnering with raw material and intermediate suppliers to secure supply stability.
Innovative Formulations: Development of nano-silver formulations or alternative delivery mechanisms can influence raw material demand and supplier priorities.

Conclusion

The supply of silver sulfadiazine hinges on a complex network of chemical manufacturers, CMOs, and raw material providers, primarily based in China, India, North America, and Europe. Ensuring the robustness of this supply requires rigorous quality control, compliance with global regulatory standards, and adaptability to market and geopolitical shifts. As demand escalates driven by healthcare needs and antimicrobial resistance, diversification and strategic partnerships will be vital for stakeholders aiming to secure reliable supply chains.

Key Takeaways

Major suppliers include Pfizer, GSK, and Chinese manufacturers like Hangzhou Huadong Pharmaceutical, offering high-quality APIs and intermediates.
Raw material vendors such as Sigma-Aldrich and TCI supply essential precursors, emphasizing the importance of reliable procurement channels.
Regional disparities influence supply dynamics, with North America and Europe emphasizing regulatory compliance, while Asia offers cost advantages and scale.
Regulatory adherence, including GMP and ISO standards, remains critical for supplier validation and product approval.
Emerging trends in green chemistry and vertical integration may reshape procurement strategies and market competition.

FAQs

1. Who are the leading global suppliers of silver sulfadiazine?
Leading suppliers include pharmaceutical giants like Pfizer and GSK, alongside Chinese chemical manufacturers such as Hangzhou Huadong Pharmaceutical and Dezhou Wecare Chemicals, which provide APIs and intermediates at scale.

2. What regulations must suppliers of silver sulfadiazine comply with?
Suppliers are required to adhere to GMP standards, obtain ISO certifications, and meet the regulatory criteria of agencies like the FDA, EMA, and WHO to ensure product safety and efficacy.

3. How has the COVID-19 pandemic impacted the supply chain for silver sulfadiazine?
Disruptions in raw material availability and logistics highlighted vulnerabilities, prompting companies to diversify sourcing, increase inventories, and foster strategic partnerships for supply resilience.

4. What raw materials are essential in the synthesis of silver sulfadiazine?
High-purity silver salts (e.g., silver nitrate) and sulfonamide intermediates are critical raw materials supplied by vendors like Sigma-Aldrich and TCI Chemicals.

5. Are there regional differences in the quality standards for suppliers of silver sulfadiazine?
Yes, North American and European suppliers generally comply with stricter regulatory standards, while Asian manufacturers provide cost-effective alternatives that still meet global quality requirements.

References

[1] World Health Organization. Global Burn Injury Statistics. (2022).
[2] U.S. Food and Drug Administration. Good Manufacturing Practices (GMP) Guidance.
[3] European Medicines Agency. Regulatory Framework for APIs.
[4] Market Research Future. Global Silver Sulfadiazine Market Analysis. (2023).
[5] Pharmaceutical Technology. Supply Chain Resilience in the Pharmaceutical Industry. (2022).

Suppliers and packagers for generic pharmaceutical drug: SILVER SULFADIAZINE