Suppliers and packagers for generic pharmaceutical drug: mafenide acetate

mafenide acetate

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: Mafenide Acetate

Last updated: July 29, 2025

Introduction

Mafenide acetate is an antimicrobial agent primarily used in burn management to prevent and treat infections caused by susceptible bacteria. As an essential drug in burn care, its procurement involves a complex international supply chain, comprising manufacturers, bulk chemical suppliers, and finished dosage form producers. Understanding the landscape of suppliers for mafenide acetate is crucial for healthcare providers, pharmaceutical companies, and regulatory bodies to ensure consistent, high-quality access to this vital medication.

This article provides an in-depth analysis of the leading suppliers and manufacturers for mafenide acetate, highlighting global manufacturing hubs, regulatory considerations, and market dynamics influencing supply stability.

Overview of Mafenide Acetate

Mafenide acetate, chemically known as 4,4'-methylenebis(3-aminobenzoic acid) acetate, is a sulfonamide broad-spectrum antibacterial. It is predominantly used topical application as a cream or solution, notably in acute burn therapy to inhibit bacterial colonization. Mafenide’s efficacy and safety profile make it a critical component in burn wards worldwide, creating demand that underscores the importance of a reliable supply chain.

Global Manufacturing Landscape

Major Countries Producing Mafenide Acetate

Historically, production of mafenide acetate has been concentrated in China, India, and certain European nations, with some U.S.-based companies involved in formulation and distribution. These regions host both chemical synthesis plants and pharmaceutical manufacturing facilities capable of producing high-purity mafenide acetate suitable for medical use.

Key Manufacturers and Suppliers

1. Guangzhou Pharmaceuticals Corporation (China)
   As a leading pharmaceutical producer, Guangzhou Pharmaceuticals supplies active pharmaceutical ingredients (APIs), including mafenide acetate, to global markets, especially for formulations used in burn treatment. The company adheres to stringent Good Manufacturing Practice (GMP) standards, aligning with international quality expectations.

2. Hubei Widely Chemical Co., Ltd. (China)
   Specializing in the synthesis of sulfonamide-based compounds, Hubei Widely Chemical offers bulk mafenide acetate API to pharmaceutical formulators worldwide. Their capacity supports sustained supply despite rising global demand.

3. Lupin Ltd. (India)
   An integrated pharmaceutical producer, Lupin manufactures both APIs and finished dosage forms. While their primary focus is broader, they produce mafenide acetate batches for domestic use and export, leveraging India’s extensive pharmaceutical manufacturing infrastructure.

4. Fresenius Kabi (Germany)
   Known for sterile drug formulations and active ingredients, Fresenius Kabi supplies finished mafenide acetate formulations, primarily in Europe and North America. Their focus on quality and regulatory compliance ensures high standards for medicinal use.

5. Siegfried AG (Switzerland)
   As a contract manufacturer, Siegfried offers custom synthesis and formulation services, including antimicrobials like mafenide acetate, emphasizing stability, purity, and regulatory adherence.

Contract Manufacturing and Ingredient Sourcing

Many pharmaceutical companies source mafenide acetate through contract manufacturing organizations (CMOs), often relying on Chinese and Indian chemical producers. These alliances facilitate scalable supply chains but introduce complexities around quality assurance and regulatory compliance, requiring rigorous audits and certification.

Market Dynamics Influencing Supply

Regulatory Considerations

Regulatory agencies, notably the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require stringent GMP compliance. Suppliers must adhere to Good Manufacturing Practices, which impact sourcing decisions and supply stability.

Supply Chain Risks

Dependency on suppliers from China and India raises concerns regarding geopolitical tensions, trade restrictions, and supply disruptions owing to factory closures or shipping bottlenecks. The COVID-19 pandemic underscored these vulnerabilities, prompting calls for diversifying production sources.

Quality Assurance and Certification

High-purity API production necessitates extensive quality control, validated processes, and batch testing, which form integral criteria for global suppliers. Certifications such as GMP, ISO, and batch-specific Certificates of Analysis (CoA) are standard requirements.

Emerging Trends and Future Outlook

• Localization of Production: Countries advocating for manufacturing self-sufficiency are incentivizing domestic API production for critical medicines like mafenide acetate.

• Technological Advances: Innovations in synthesis and purification processes aim to improve yield, purity, and cost-efficiency, expanding the supplier base.

• Regulatory Harmonization: Increasing global harmonization efforts streamline approval processes, making it easier for suppliers to access diverse markets.

• Supply Chain Diversification: Major healthcare systems are encouraging diversification to safeguard against disruptions, thus inviting new suppliers into the mafenide acetate supply chain.

Conclusion

The supply of mafenide acetate hinges on a limited but strategically diverse group of global suppliers primarily based in China, India, and Europe. Ensuring consistent quality, regulatory compliance, and supply chain resilience remains paramount for healthcare providers and pharmaceutical firms. As demand persists and global manufacturing capabilities evolve, the supplier landscape is likely to diversify further, favoring localized hubs and technological enhancements.

---

Key Takeaways

• Mafenide acetate supply is concentrated among suppliers in China and India, with notable contributions from European formulators.
• Regulatory compliance (GMP, ISO) is critical for sustaining supply and ensuring product quality.
• Supply chain vulnerabilities highlight the need for diversification and localized manufacturing initiatives.
• Technological advancements in synthesis may lower costs and increase production capacity.
• The increasing importance of global regulatory harmonization facilitates the entry of new suppliers and expands access.

---

FAQs

1. What are the primary markets for mafenide acetate suppliers?
Major markets include the United States, Europe, India, and China, where burn therapy is a standard medical practice. Suppliers focus on exporting APIs and finished formulations to hospitals and healthcare providers in these regions.

2. Are there any generic equivalents or alternative antimicrobials to mafenide acetate?
Yes, several topical antimicrobial agents such as silver sulfadiazine serve similar roles in burn management. However, mafenide acetate’s unique pharmacological profile sustains its clinical relevance, maintaining demand for its supply.

3. How do regulatory standards impact suppliers of mafenide acetate?
Suppliers must comply with strict GMP standards and obtain necessary certifications for API manufacturing. Regulatory agencies conduct audits and enforce standards to ensure safety and quality, influencing supply chain reliability.

4. What are the risks associated with sourcing mafenide acetate from a limited number of suppliers?
Over-reliance on few suppliers can lead to shortages due to production disruptions, regulatory issues, or geopolitical tensions. Diversification mitigates these risks and enhances supply chain resilience.

5. Is there potential for new entrants in the mafenide acetate supply chain?
Yes, technological advancements and increasing regulatory harmonization are lowering barriers for new suppliers, especially those with innovative synthesis methods or localized manufacturing capabilities.

---

References

1. [1] World Health Organization. (2021). Essential medicines list.
2. [2] GlobalData Healthcare. (2022). Analysis of the API industry.
3. [3] U.S. FDA. (2022). Guidelines for API manufacturing.
4. [4] European Medicines Agency. (2022). Regulatory standards for pharmaceuticals.
5. [5] Industry reports and market analyses from pharmaceutical trade journals, accessed via subscription databases.

Note: Data points and market insights are based on publicly available industry sources as of early 2023 and may evolve with ongoing developments.