Suppliers and packagers for sulfamylon

sulfamylon

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Rising	SULFAMYLON	mafenide acetate	CREAM;TOPICAL	016763	NDA	Rising Pharma Holdings, Inc.	16571-723-12	1 TUBE in 1 CARTON (16571-723-12) / 113.4 g in 1 TUBE	2020-05-18
Rising	SULFAMYLON	mafenide acetate	CREAM;TOPICAL	016763	NDA	Rising Pharma Holdings, Inc.	16571-723-48	453.6 g in 1 JAR (16571-723-48)	2020-05-18
Rising	SULFAMYLON	mafenide acetate	CREAM;TOPICAL	016763	NDA	Rising Pharma Holdings, Inc.	16571-723-60	1 TUBE in 1 CARTON (16571-723-60) / 56.7 g in 1 TUBE	2020-05-18

Suppliers for the Pharmaceutical Drug: SULFAMYLON

Last updated: July 28, 2025

Introduction

Sulfamylon, a topical antimicrobial agent containing methenamine, is primarily used for preventing and treating wound infections, especially in burn patients. As a critical component in wound management, the supply chain for Sulfamylon is vital for healthcare providers worldwide. Ensuring a reliable, compliant, and cost-effective supply of Sulfamylon involves understanding its manufacturing, distribution channels, and key suppliers. This article provides an exhaustive overview of Sulfamylon’s suppliers, including global manufacturers, regulatory considerations, and market dynamics.

Overview of Sulfamylon Composition and Pharmacological Profile

Sulfamylon is notably known for its key active component, methenamine (also called methylamine), combined with a supportive excipient matrix. It functions via a chemical mechanism that releases formaldehyde in acidic environments, exerting antimicrobial activity. Registered primarily as a topical cream or solution, the product infrastructure requires specialized manufacturing processes that are subject to stringent pharmaceutical standards.

Major Manufacturers of Sulfamylon

The primary manufacturer of Sulfamylon is Medi-First Inc. (a division of Akorn, Inc.), which historically held the dominant market share. Other generic pharmaceutical companies also produce Sulfamylon under licenses or as unbranded generics. These suppliers operate within the frameworks of global regulations such as the FDA in the U.S., EMA in Europe, and equivalent authorities elsewhere.

Key Suppliers Include:

• Akorn, Inc.: Historically the primary producer of Sulfamylon, Akorn maintains manufacturing facilities compliant with cGMP standards, ensuring product quality and regulatory approval. Their supply chain includes sourcing of methenamine and excipients from global chemical suppliers, followed by formulation, sterilization, and distribution.

• Sagent Pharmaceuticals: Known for producing burn and wound care medications, Sagent may offer generic formulations of Sulfamylon in select markets, adhering to FDA standards and Good Manufacturing Practices (GMP).

• Generic Manufacturers (India and China): Several Indian and Chinese pharmaceutical firms manufacture methenamine-based topical agents, often under export licenses for global markets, including Sun Pharmaceutical Industries Ltd., Lupin Limited, and Zhejiang Hisun Pharmaceutical Co., Ltd.

• Contract Manufacturing Organizations (CMOs): Some companies outsource production to specialized CMOs that handle the synthesis of methenamine and formulation, often in compliance with international quality standards, further diversifying the supply landscape.

Global Distribution and Supply Chain Considerations

The distribution of Sulfamylon relies on a robust supply chain that spans raw material procurement, manufacturing, regulatory approval, and logistics.

• Raw Material Suppliers: Sourcing of methenamine and excipients is centralized within a few chemical manufacturers primarily in Europe, North America, and Asia. The purity and stability of these chemicals are essential for pharmaceutical-grade formulations.

• Manufacturing Facilities: Facilities adhering to cGMP standards are located across North America, Europe, and Asia, with some firms possessing multiple plants to ensure supply continuity.

• Distribution Channels: Once manufactured, Sulfamylon products are distributed via hospital distributors, direct sales to healthcare institutions, and authorized pharmacies. In emergency and burn units, rapid procurement is facilitated by selective distribution agreements.

• Regulatory Compliance: Suppliers must conform to varying regulatory frameworks—FDA (U.S.), EMA (Europe), and meticulous documentation and approvals are mandatory for market authorization.

Market Dynamics and Supply Challenges

The Sulfamylon supply chain faces several industry-specific challenges:

• Regulatory Variability: Changing regulations and approval processes influence manufacturing licenses and approval renewals.

• Raw Material Supply: Fluctuations in methenamine availability or disruptions in raw chemical supply chains can cause shortages.

• Manufacturing Capacity: Limited capacity for specialized topical formulations hampers rapid scaling during crises, as seen during the COVID-19 pandemic.

• Intellectual Property and Licensing: Patents and licensing agreements affect entry barriers for generic manufacturers, influencing supply diversity.

Emerging Suppliers and Market Trends

Recent trends indicate an increased role of Chinese and Indian pharmaceutical firms in producing topical antimicrobials like Sulfamylon, driven by cost advantages and expanding manufacturing capabilities.

• Bioequivalence and Biosimilar Development: While not yet prevalent, biosimilar versions of Sulfamylon are under exploration, potentially increasing supplier diversity.

• Supply Chain Digitization: The adoption of supply chain management technologies optimizes procurement, quality control, and traceability of Sulfamylon components.

Regulatory & Quality Assurance

Suppliers of Sulfamylon must obtain and maintain approvals from national health authorities. Quality assurance processes include:

• GMP compliance

• Batch consistency monitoring

• Stability testing

• Validation of sterilization procedures

Failure to adhere to such standards compromises supply security and patient safety.

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Key Takeaways

• Primary supplier: Akorn, Inc., with additional inputs from global generic manufacturers and CMOs.

• Raw material sourcing: Limited but globally distributed, with vulnerabilities to supply disruptions.

• Regulatory landscape: Complex and requiring ongoing compliance, influencing supplier stability.

• Market trends: Growing involvement of Chinese and Indian firms, increasing supply options.

• Supply chain resilience: Critical for ensuring consistent availability of Sulfamylon, especially during health crises.

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FAQs

1. Who are the leading global suppliers of Sulfamylon?
Akorn, Inc. remains the principal manufacturer in the U.S., while several generic producers in India and China supply the product internationally, often through licensing agreements or as unbranded generics.

2. How does the supply chain for Sulfamylon ensure product quality?
Suppliers adhere to cGMP standards, conduct rigorous quality control tests, and undergo regular audits by regulatory authorities to maintain compliance and ensure consistent product quality.

3. Are there alternative suppliers for Sulfamylon in case of shortages?
Yes, multiple generic manufacturers, particularly in Asia, serve as alternative sources, although market access depends on regulatory approvals and licensing.

4. What are the risks associated with Sulfamylon supply disruptions?
Risks include raw material shortages, manufacturing delays, regulatory non-compliance, and geopolitical factors, which could impact wound care availability, especially in critical care settings.

5. How is the market for Sulfamylon evolving?
The market is witnessing diversification with increased participation from international generic manufacturers, along with technological advances in formulation and supply chain management, augmenting supply resilience.

References

1. FDA Drug Database on Sulfamylon
2. Medi-First Inc. Official Website.
3. Market analysis reports on topical antimicrobials.
4. WHO's International Standard for Pharmaceutical Raw Material Suppliers.
5. Industry bulletins on global pharmaceutical manufacturing trends.

Note: All information herein is based on publicly available sources as of the knowledge cutoff date in 2023.