Last updated: February 20, 2026
Identifying suppliers for Mafenide Acetate involves examining global manufacturers, distributors, and sourcing avenues. Mafenide Acetate, an antimicrobial agent administered topically for burn infections, is produced predominantly by established pharmaceutical companies with specialized manufacturing capabilities.
Major Manufacturers and Suppliers
| Company |
Country |
Production Capacity |
Certification |
Notes |
| Pfizer Inc. |
United States |
High |
FDA, GMP |
Historically one of the primary producers. |
| Jiangsu Hengrui Medicine |
China |
Medium |
SFDA, GMP |
Supplies to both domestic and international markets. |
| Anhui Biochem Group |
China |
Medium |
CFDA, GMP |
Focuses on active pharmaceutical ingredients. |
| Chemspec Services Inc. |
United States |
Low |
USP, GMP |
Distributes bulk APIs globally. |
| AK Scientific Inc. |
United States |
Small |
API Quality Standards |
Distributes to research and small-scale manufacturing. |
Sourcing Channels
- Direct Purchase from Manufacturers: Requires verification of certification and quality standards; generally involves minimum order quantities (MOQs).
- Authorized Distributors: Provide certification of quality and facilitate smaller or more flexible orders; notable in North America and Europe.
- Online Chemical Marketplaces: Platforms like ChemSpider, Alibaba, or specific B2B product directories list suppliers but demand vendor verification.
Logistics and Regulatory Considerations
- Regulatory Approvals: Supply chains must comply with local drug regulations, including FDA, EMA, or respective national agencies.
- Quality Control: Certificate of Analysis (COA) and GMP certification are essential for pharmaceuticals intended for clinical or commercial use.
- Pricing Dynamics: Market prices fluctuate based on purity requirements, batch size, and regulatory compliance costs.
Market Trends
- Increased supply from Chinese manufacturers has driven down prices but raised concerns over regulatory compliance.
- Supply stability is influenced by geopolitical factors and trade policies, especially affecting cross-border shipments.
- Demand for GMP-certified APIs remains high for regulatory submissions and commercial manufacturing.
Summary
The primary suppliers of Mafenide Acetate are Pfizer, Jiangsu Hengrui, Anhui Biochem, Chemspec, and AK Scientific. Suppliers are predominantly based in the United States, China, and globally recognized marketplaces. Buyers must verify certification, regulatory compliance, and quality standards for specific applications.
Key Takeaways
- Leading producers include Pfizer, Jiangsu Hengrui, and Anhui Biochem.
- Suppliers are accessible via direct purchase, authorized distributors, or online marketplaces.
- Regulatory compliance and quality certification are critical for procurement.
- Price and supply depend on regional factors, scale, and regulatory environment.
FAQs
1. Is Pfizer still the primary supplier of Mafenide Acetate?
Pfizer historically produced Mafenide Acetate, but recent manufacturing shifts mean other suppliers, especially Chinese companies, have increased market share.
2. What certifications are necessary for clinical-grade Mafenide Acetate?
GMP certification and a valid COA are essential. For regulatory submission, additional certifications from authorities like the FDA or EMA may be required.
3. What factors influence the cost of Mafenide Acetate?
Cost factors include purity level, order quantity, certification standards, and shipping logistics.
4. Can Mafenide Acetate be sourced from online marketplaces?
Yes; platforms like Alibaba list multiple suppliers, but procurement requires careful vendor verification to ensure compliance and quality.
5. Are there regional restrictions on importing Mafenide Acetate?
Yes; import regulations depend on local authorities, with restrictions possibly applying under controlled substances or pharmaceutical ingredient regulations.
References
- U.S. Food and Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations.
- Jiangsu Hengrui Medicine Co., Ltd. (2022). Annual Report.
- Anhui Biochem Group Co., Ltd. (2022). Corporate Overview.
- ChemSpider. (2023). Chemical Suppliers Directory.
- Alibaba. (2023). Chemical API Suppliers.
