NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC: Pharmaceutical manufacturers, suppliers, and distributors

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch And Lomb	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	bacitracin zinc; neomycin sulfate; polymyxin b sulfate	OINTMENT;OPHTHALMIC	064064	ANDA	Bausch & Lomb Incorporated	24208-780-55	1 TUBE in 1 CARTON (24208-780-55) / 3.5 g in 1 TUBE	1995-10-30
Padagis Us	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	bacitracin zinc; neomycin sulfate; polymyxin b sulfate	OINTMENT;OPHTHALMIC	060764	ANDA	Padagis US LLC	0574-4250-35	1 TUBE in 1 CARTON (0574-4250-35) / 3.5 g in 1 TUBE	2015-01-05
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

The pharmaceutical formulation combining Neomycin, Polymyxin B Sulfates, and Bacitracin Zinc is widely used as a topical antibiotic to treat skin infections, burns, and other localized bacterial conditions. This tri-drug ointment benefits from synergistic antimicrobial activity, targeting a broad spectrum of bacteria, including Gram-positive and Gram-negative strains. Ensuring a reliable supply chain for these active pharmaceutical ingredients (APIs) and finished formulations is critical for healthcare providers, manufacturers, and distributors worldwide.

This article thoroughly explores the leading suppliers of Neomycin, Polymyxin B Sulfates, and Bacitracin Zinc, highlighting their manufacturing capabilities, market reach, compliance standards, and strategic positioning. Such knowledge enables stakeholders to make informed sourcing decisions amid evolving regulatory landscapes and global supply dynamics.

Overview of the Active Pharmaceutical Ingredients

Neomycin

Neomycin is an aminoglycoside antibiotic derived from Streptomyces fradiae, targeting bacterial protein synthesis. Its topical form provides efficacy against a broad range of bacteria, including Staphylococcus and Escherichia coli. The compound's manufacturing involves fermentation processes with strict quality controls to ensure purity and potency.

Polymyxin B Sulfates

Polymyxin B, isolated from Bacillus polymyxa, exhibits potent activity against Gram-negative bacteria such as Pseudomonas aeruginosa and Klebsiella pneumoniae. It disrupts bacterial cell membranes, making it valuable in combating drug-resistant infections. Its complex synthesis and extraction processes demand specialized manufacturing expertise.

Bacitracin Zinc

Bacitracin Zinc, produced via fermentation of Bacillus subtilis, primarily targets Gram-positive bacteria. It is often used in topical ointments for minor skin infections. The refinement process ensures minimal contaminants, aligning with pharmaceutical standards like USP (United States Pharmacopeia).

Leading Suppliers of Neomycin

1. Siegfried AG

Overview: Siegfried operates globally, with a robust API manufacturing portfolio, including Neomycin. Their facilities in Switzerland adhere to GMP (Good Manufacturing Practice) standards, ensuring high-quality products.

Capabilities: Siegfried supplies Neomycin Sulfate in various grades suitable for pharmaceutical formulations. They emphasize strict quality control, traceability, and regulatory compliance, serving clients across North America, Europe, and Asia.

Market Presence: Recognized for innovative fermentation technology, Siegfried consistently invests in capacity expansion aligned with global demand growth.

2. HIKAL Ltd.

Overview: Based in India, HIKAL specializes in amino antibiotics, including Neomycin. They maintain WHO-GMP and ISO certifications, catering to both domestic and international markets.

Capabilities: HIKAL offers Neomycin Sulfate in multiple grades, including sterile and non-sterile forms, with scalable production. They prioritize quality assurance and regulatory compliance.

Market Presence: As a leading Indian API manufacturer, HIKAL exports to over 70 countries, emphasizing cost competitiveness and reliable supply.

3. Jiangxi Bolai Biotechnology Co., Ltd.

Overview: Located in China, Jiangxi Bolai is a significant supplier of amino antibiotics like Neomycin. They hold certifications including ISO 9001 and GMP.

Capabilities: The company offers high-purity Neomycin Sulfate, emphasizing product consistency, regulatory approvals, and supply chain reliability.

Market Presence: This supplier serves markets across Asia, Europe, and North America, capitalizing on competitive pricing and quality standards.

Leading Suppliers of Polymyxin B Sulfates

1. Chongqing Chuandong Chemical (Group) Co., Ltd.

Overview: As a Chinese pharmaceutical raw material producer, Chongqing Chuandong manufactures Polymyxin B Sulfates with an emphasis on quality and regulatory compliance.

Capabilities: The company offers bulk API powders conforming to USP and EP standards, with strong expertise in fermentation and extraction processes.

Market Presence: They serve global markets, especially in Asia and Europe, supported by competitive pricing and customization options.

2. Ypao Pharmaceuticals Co., Ltd.

Overview: Based in China, Ypao specializes in antibiotic APIs, including Polymyxin B Sulfates, maintaining ISO and GMP certifications.

Capabilities: Their manufacturing facilities meet international standards, providing high-grade APIs with consistent quality and regulatory documentation.

Market Presence: Their products are exported globally, catering to pharmaceutical companies seeking reliable sources of Polymyxin B.

3. Biochimpharm Ltd.

Overview: An Indian producer specializing in antibiotics, Biochimpharm supplies Polymyxin B Sulfates with an emphasis on export markets and quality compliance.

Capabilities: They produce high-purity API formulations, aligned with pharmacopeial standards, offering flexible batch sizes.

Market Presence: Their primary markets include Asia, Africa, and Europe.

Leading Suppliers of Bacitracin Zinc

1. Huajin Pharmaceutical Co., Ltd.

Overview: A prominent Chinese manufacturer, Huajin produces Bacitracin Zinc with a focus on pharmaceutical-grade API and intermediates.

Capabilities: Their manufacturing process ensures high purity, low endotoxin levels, and compliance with international standards.

Market Presence: Huajin supplies to North America, Europe, and Asia, with strong OEM partnerships.

2. Glentham Life Sciences

Overview: Based in the UK, Glentham is recognized for their pharmaceutical-grade Bacitracin Zinc, catering mainly to the North American and European markets.

Capabilities: They provide Bacitracin Zinc with detailed documentation, quality certificates, and solutions tailored for topical formulations.

Market Presence: Their strategic focus on high-quality standards bolsters their reputation among premium pharmaceutical companies.

3. Zhejiang Hisoar Pharmaceutical Co., Ltd.

Overview: An industry leader in China, Hisoar offers Bacitracin Zinc with consistent quality and extensive regulatory support.

Capabilities: They provide APIs compliant with USP, EP, and Chinese pharmacopeias, supporting a range of formulation needs.

Market Presence: Export markets include Southeast Asia, Africa, and South America.

Manufacturing and Regulatory Considerations

Suppliers must demonstrate adherence to GMP standards, possess relevant certifications such as ISO, FDA approvals, or EMA compliance, and maintain robust quality assurance systems. The complexity of fermentation-based APIs like Neomycin and Polymyxin B underscores the importance of process validation and traceability. Strategic sourcing also requires evaluating supplier capacity, lead times, and adaptability to regulatory changes, including environmental standards and quality documentation.

Market Dynamics and Supply Chain Risks

Global supply chains for these antibiotics face challenges from geopolitical tensions, regulatory shifts, and pandemic-induced disruptions. Asian manufacturers, primarily from China and India, dominate API production—highlighting the importance of diversified sourcing strategies. The necessity for supply chain resilience underscores the need for long-term partnerships with verified suppliers offering consistent quality and capacity.

Conclusion

Securing quality suppliers for Neomycin, Polymyxin B Sulfates, and Bacitracin Zinc is vital for pharmaceutical companies manufacturing topical antibiotics. Leading manufacturers like Siegfried, HIKAL, Jiangxi Bolai, Chongqing Chuandong, and Huajin offer reliable, compliant APIs tailored to different market needs. Strategic evaluation should involve considerations around quality certifications, manufacturing capacity, regulatory compliance, and supply chain robustness to mitigate risks and ensure uninterrupted supply for healthcare applications.

Key Takeaways

Diversify sources: Engage multiple suppliers across regions to mitigate geopolitical and supply chain risks.
Verify certifications: Prioritize suppliers with GMP, ISO, and relevant pharmacopeial compliance.
Assess capacity: Ensure suppliers have sufficient production capacity to meet demand fluctuations.
Focus on transparency: Select partners with comprehensive quality documentation and traceability.
Stay compliant: Monitor evolving regulatory standards in target markets to maintain ongoing product approval.

FAQs

1. Are there any emerging suppliers for Neomycin or Polymyxin B Sulfates?
Yes. Emerging companies in India and China are increasingly investing in fermentation technology and quality systems, expanding their market share as demand grows and supply chains diversify.

2. What are the key regulatory standards to consider when sourcing these APIs?
Relevant standards include USP, EP, JP, and Chinese pharmacopeias, alongside certifications like GMP, ISO, and FDA approvals, ensuring compliance with regional regulatory requirements.

3. How can manufacturers evaluate the quality of API suppliers?
Manufacturers should assess certifications, conduct audits, review quality documentation, analyze batch consistency, and verify compliance through third-party testing or regulatory submissions.

4. What supply chain risks are associated with sourcing these antibiotics?
Risks include geopolitical tensions, export restrictions, pandemics, and raw material shortages. Establishing diversified supplier relationships and maintaining strategic inventories mitigate these risks.

5. Is there a trend toward regional manufacturing hubs for these APIs?
Yes. Countries like India and China are strengthening regional capacities due to cost advantages, regulatory investments, and existing manufacturing expertise, fostering more localized supply chains.

Sources:
[1] European Pharmacopoeia and United States Pharmacopeia standards.
[2] Company websites and press releases of Siegfried AG, HIKAL Ltd., Chongqing Chuandong, and others.
[3] Industry reports on antibiotic API manufacturing and global supply chains.

Suppliers and packagers for NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC