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Suppliers and packagers for SILVADENE
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SILVADENE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: SILVADENE
Introduction
Silvadene, commercially known as Silver Sulfadiazine, is a critical antimicrobial agent primarily used in burn care to prevent and treat microbial infections in burn wounds. Ensuring a reliable supply chain for Silvadene is vital for hospitals, clinics, and pharmaceutical distributors. This article analyzes the key suppliers of Silver Sulfadiazine globally, their manufacturing capabilities, quality assurance protocols, regulatory compliance, and market dynamics shaping supply stability.
Overview of Silver Sulfadiazine (Silvadene)
Silver Sulfadiazine is a topical antibacterial agent that combines the broad-spectrum antimicrobial properties of silver with sulfadiazine. Its effectiveness against bacteria such as Pseudomonas aeruginosa makes it indispensable in burn wound management. The global demand for Silvadene has persisted due to the high incidence of burn injuries worldwide, especially in regions with limited access to advanced wound care technologies.
Manufacturers vary from large pharmaceutical conglomerates with integrated production lines to specialized chemical suppliers focusing solely on active pharmaceutical ingredients (APIs). Ensuring supply security involves understanding the geographic spread, manufacturing quality, and regulatory landscape of these suppliers.
Major Suppliers of Silver Sulfadiazine
1. Sandoz (Novartis Group)
Overview:
Sandoz, a division of Novartis, has historically been one of the largest suppliers of Silver Sulfadiazine. Their extensive global manufacturing footprint ensures high-capacity production aligned with international quality standards.
Manufacturing Capabilities:
Sandoz operates multiple manufacturing sites in Europe and North America, equipped with state-of-the-art facilities for API synthesis and finished dosage form production. Their rigorous quality assurance processes comply with Good Manufacturing Practice (GMP) certifications.
Supply Chain & Distribution:
Sandoz supplies Silvadene primarily to hospital systems and pharmaceutical distributors across North America and Europe. Their robust logistics network enables timely delivery, crucial during supply surges caused by burn injury outbreaks or pandemic-related disruptions.
Regulatory Compliance:
Sandoz’s manufacturing adheres to the US FDA’s cGMP standards, European Medicines Agency (EMA) regulations, and other regional standards, ensuring product consistency and safety.
2. Mylan (Now part of Viatris)
Overview:
Mylan, acquired by Viatris in 2020, is a significant producer of topical antimicrobials, including Silver Sulfadiazine. Their global footprint enhances their capacity to meet regional demands.
Manufacturing Capabilities:
Viatris operates multiple manufacturing facilities in the US, India, and Europe, with dedicated units for complex chemical synthesis, including APIs like Silver Sulfadiazine. The company emphasizes scalable production to meet fluctuating global demands.
Supply Chain & Market Reach:
Viatris supplies Silvadene globally, with a focus in emerging markets where burn management resources are limited. Their diverse supply chain minimizes regional shortages.
Regulatory Standards:
Viatris maintains compliance with rigorous regulatory standards, facilitating swift approval processes and continuous product quality oversight.
3. Maruho Co., Ltd.
Overview:
Maruho is a Japanese pharmaceutical manufacturer with a growing footprint in topical antimicrobials. Their focus on Asian markets positions them as a key regional supplier.
Manufacturing Capabilities:
Maruho produces Silver Sulfadiazine through licensed manufacturing partnerships and in-house facilities, ensuring high quality standards tailored for local regulatory requirements.
Market Focus:
Their main markets include Japan and Southeast Asia, where they supply hospitals and burn centers with domestically manufactured Silvadene equivalents.
Regulatory & Quality Assurance:
Maruho complies with Japan’s Pharmaceuticals and Medical Devices Act and international GMP standards, ensuring reliable product quality.
4. Zhitomir Chemical Plant (Ukraine)
Overview:
Zhitomir Chemical Plant is a regional API producer specializing in sulfonamide antibiotics, including Silver Sulfadiazine.
Manufacturing Capabilities:
With a focus on cost-effective production, they cater mainly to Eastern European markets and some Asian regions.
Supply Chain Considerations:
Regional geopolitical issues and regulatory uncertainties can influence supply stability; however, their strategic positioning allows for competitive pricing.
5. Other Suppliers and Emerging Players
Several smaller manufacturers and chemical brokers supply Silver Sulfadiazine globally, often serving niche markets or providing API intermediates. Their role is crucial in supplementing primary supplier volumes, especially during shortages.
- Chemical Brokers and Distributors: Facilitate global trading, ensuring regional access.
- Regional Manufacturers: Provide localized alternatives to global suppliers, primarily in Asia and Eastern Europe.
Market Dynamics Influencing Supplier Selection
Regulatory Landscape
Manufacturers must navigate complex regulatory environments, including FDA approvals, EMA certifications, and regional registration processes. Suppliers with proven regulatory compliance provide confidence to buyers regarding safety and efficacy.
Supply Chain Resilience
Recent geopolitical tensions, COVID-19 disruptions, and raw material shortages have underscored the importance of diversified sourcing. Leading suppliers with multiple manufacturing sites and regional offices mitigate risks.
Quality Assurance and Certification
WHO Good Manufacturing Practices, ISO certifications, and batch validation studies are critical criteria. Suppliers with validated quality management systems significantly reduce the risk of substandard products entering the supply chain.
Pricing and Market Competition
Price competitiveness varies based on manufacturing scale, raw material costs, and regional regulations. Procurement strategies often balance cost with quality assurance to maintain supply security.
Regulatory and Quality Considerations in Supplier Selection
Effective procurement of Silver Sulfadiazine mandates strict adherence to quality standards. Manufacturers should possess valid GMP certification, FDA approval (for U.S. markets), and ISO accreditation. Traceability, validation, and robust pharmacovigilance frameworks ensure ongoing product safety. Buyers should verify suppliers’ documentation, conduct audits when feasible, and incorporate due diligence protocols into their sourcing strategies.
Key Challenges in the Silver Sulfadiazine Supply Chain
- Global Supply Disruptions: Political instability, pandemics, and trade restrictions can interrupt raw material availability and manufacturing.
- Raw Material Scarcity: High-quality silver compounds and sulfadiazine intermediates are sourced globally, with fluctuations affecting output.
- Regulatory Barriers: Different regional approval processes can delay product registration and procurement.
- Pricing Pressures: Competitive markets may pressure manufacturers to compromise on quality, necessitating vigilant supplier evaluation.
Conclusion
The supply landscape for Silver Sulfadiazine encompasses a mix of established global pharmaceutical manufacturers, regional producers, and chemical intermediates suppliers. Leading suppliers such as Sandoz and Viatris maintain dominant positions due to their extensive manufacturing, regulatory compliance, and distribution networks. Regional firms like Maruho cater to local markets, emphasizing the importance of regional supply resilience.
Healthcare providers and distributors should prioritize suppliers with proven quality standards, regulatory approval, and adaptable supply chains to mitigate risks during emergencies or global disruptions.
Key Takeaways
- Diverse supplier base: Relying on multiple suppliers across regions reduces the risk of shortages.
- Regulatory compliance: Ensure suppliers adhere to GMP, ISO, and regional certifications for safety and efficacy.
- Supply chain resilience: Diversify sourcing strategies, including regional manufacturers, to mitigate geopolitical and logistical risks.
- Quality assurance: Verify documentation, batch validation, and pharmacovigilance processes before procurement.
- Market monitoring: Stay informed of geopolitical and regulatory developments impacting supplier capabilities and availability.
FAQs
1. Who are the top global suppliers of Silver Sulfadiazine?
Leading global suppliers include Sandoz (Novartis), Viatris (formerly Mylan), and regional manufacturers like Maruho in Japan. Other regional and niche suppliers also contribute to the global supply chain.
2. How does regulatory compliance impact Silver Sulfadiazine sourcing?
Regulatory compliance ensures product safety, efficacy, and legal market access. Suppliers with GMP certification and approvals from agencies like FDA and EMA provide greater assurance of quality.
3. What are the common challenges faced in sourcing Silver Sulfadiazine?
Challenges include supply chain disruptions due to geopolitical issues, raw material shortages, regulatory delays, and price fluctuations.
4. How can healthcare providers mitigate risks related to Silver Sulfadiazine shortages?
Diversify supplier sources, establish relationships with regional manufacturers, maintain safety stock, and continuously monitor supply chain developments.
5. Are there regional differences in Silver Sulfadiazine quality and availability?
Yes, regional regulatory standards and manufacturing capacity influence product quality and availability. Buyers should assess regional suppliers’ certifications and quality systems carefully.
References
[1] Novartis Sandoz Official Website. "Silver Sulfadiazine," 2023.
[2] Viatris Official Website. "Topical Antimicrobials," 2023.
[3] Japanese Pharmaceutical Database. "Maruho Product Line," 2023.
[4] WHO Guidelines on Good Manufacturing Practice. World Health Organization, 2021.
[5] Market Analysis Reports on Topical Antimicrobials, 2022.
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