BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch And Lomb	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate	OINTMENT;OPHTHALMIC	064068	ANDA	Bausch & Lomb Incorporated	24208-785-55	1 TUBE in 1 CARTON (24208-785-55) / 3.5 g in 1 TUBE	1995-10-30
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

The combination of Bacitracin Zinc, Hydrocortisone, Neomycin Sulfate, and Polymyxin B Sulfate forms a potent topical pharmaceutical used primarily to treat bacterial skin infections, inflammation, and dermatitis. Ensuring a reliable supply chain for these active pharmaceutical ingredients (APIs) and finished products is critical for pharmaceutical manufacturers and healthcare providers. This analysis identifies the key suppliers for each component, explores the global landscape, and provides insights into sourcing strategies for industry stakeholders.

Overview of the Components and Their Market Significance

Bacitracin Zinc: An antibiotic effective against gram-positive bacteria; widely used in topical formulations due to its safety profile and efficacy.
Hydrocortisone: A corticosteroid that reduces inflammation and immune response; a staple in anti-inflammatory dermatological products.
Neomycin Sulfate: An aminoglycoside antibiotic targeting gram-negative bacteria, often combined with other agents to broaden antimicrobial coverage.
Polymyxin B Sulfate: A polymyxin-class antibiotic effective against multidrug-resistant gram-negative bacteria; critical in topical formulations.

Each component's market demand has surged in response to increasing antibiotic resistance and the global emphasis on topical therapies for skin infections.

Global Suppliers and Manufacturing Landscape

Bacitracin Zinc Suppliers

Sandoz (Novartis Group)
- As one of the prominent producers, Sandoz supplies Bacitracin Zinc in various forms globally, maintaining quality standards compliant with regulatory agencies like the FDA and EMA.
Yunnan Baiyao Group (China)
- A leading Chinese manufacturer known for producing pharmaceutical-grade Bacitracin Zinc, with expanding presence in international markets.
HUBEI TOPSON PHARMACEUTICAL
- Based in China, TOPSON manufactures and exports Bacitracin Zinc suitable for pharmaceutical use, with a focus on quality control.
Sigma-Aldrich (Merck Group)
- Offers laboratory-grade Bacitracin Zinc, primarily for research, but also supplies pharmaceutical-grade APIs through its custom manufacturing services.

Hydrocortisone Suppliers

Sandoz (Novartis)
- A dominant global producer of Hydrocortisone APIs, offering various formulations including injectable, topical, and oral.
Pfizer
- Supplies Hydrocortisone for broad pharmaceutical applications, with stringent quality certifications suitable for topical formulations.
Mingfeng (China)
- Focuses on producing pharmaceutical-grade Hydrocortisone, serving both domestic and export markets.
Hubei Huida Pharmaceutical Co.
- Chinese manufacturer with capacity to supply Hydrocortisone API for topical applications worldwide.

Neomycin Sulfate Suppliers

Jiangsu Hengrui Medicine Co., Ltd.
- A leading Chinese API manufacturer providing Neomycin Sulfate at pharmaceutical-grade standards.
Hindustan Antibiotics Ltd. (India)
- A longstanding producer of antibiotics, including Neomycin Sulfate, with exports to multiple regions.
Yuwang Pharmaceutical Group
- Chinese exporter supplying high-quality Neomycin Sulfate to the international pharmaceutical industry.
Capot Chemical
- Specializes in antibiotic APIs, including Neomycin Sulfate, with a strong reputation for quality control.

Polymyxin B Sulfate Suppliers

Xianju Pharmaceutical Co., Ltd.
- Major Chinese producer of Polymyxin B Sulfate, complying with international quality standards.
Hubei Huida Pharmaceutical Co.
- Provides pharmaceutical-grade Polymyxin B Sulfate, focusing on global exports.
Sigma-Aldrich (Merck Group)
- Offers research-grade Polymyxin B Sulfate; for pharmaceutical-grade APIs, more specialized suppliers are required.
Bachem AG (Switzerland)
- Supplies specialized peptide APIs, including Polymyxin B, with a high focus on pharmaceutical-grade production.

Key Considerations for Sourcing

Regulatory Compliance: Suppliers must meet regulatory standards such as cGMP (current Good Manufacturing Practices), ISO certifications, and FDA approvals to ensure product quality and safety.
Supply Chain Stability: Given geopolitical factors and manufacturing capacity constraints, diversification of suppliers across regions—predominantly China, India, and Europe—is advised.
Cost and Lead Times: Chinese manufacturers often offer competitive pricing and substantial capacity but may involve longer lead times due to export logistics and regulatory clearances.
Quality Assurance: Verify certificates of analysis (CoA), batch records, and third-party testing to ensure API purity and consistency.

Regional Manufacturing Hotspots

Asia: Dominant source for API production, with China accounting for over 50% of global API manufacturing capacity.
India: Significant provider of antibiotics and corticosteroids, with a robust API manufacturing sector that emphasizes quality and affordability.
Europe: Focused on high-quality, cGMP-compliant production, often catering to markets with stringent regulatory requirements.

Strategic Sourcing Recommendations

Establish dual or multiple supplier agreements to mitigate supply risks.
Prioritize suppliers with proven compliance and quality certifications.
Consider upstream agreements with suppliers for raw materials to streamline supply chains.
Integrate local Chinese and Indian suppliers for cost advantages, supplemented by European suppliers for high-regulatory-demand markets.

Conclusion

Sourcing the APIs—Bacitracin Zinc, Hydrocortisone, Neomycin Sulfate, and Polymyxin B Sulfate—requires a strategic approach aligning quality, cost, and supply reliability. Major global suppliers predominantly reside in China, India, and select European countries, each offering distinct advantages. Healthcare companies and manufacturers should conduct comprehensive due diligence, including regulatory compliance verification, to secure a resilient supply chain for topical pharmaceutical formulations containing these ingredients.

Key Takeaways

Diversify supplier base geographically to reduce dependency risk.
Prioritize suppliers with GMP certification and proven regulatory track records.
Consider cost, quality, and lead times in vendor evaluation.
Engage in long-term partnerships to ensure stable supply.
Stay abreast of regulatory developments influencing API manufacturing standards.

FAQs

1. What factors should I consider when choosing a supplier for these APIs?
Focus on regulatory compliance (e.g., GMP standards), product quality (certificates of analysis), production capacity, reputation, and supply stability.

2. Are Chinese API manufacturers reliable for pharmaceutical-grade APIs?
Yes, many Chinese manufacturers meet international standards, but due diligence regarding certifications, audits, and compliance history remains essential.

3. How do geopolitical factors influence API sourcing?
Trade restrictions, tariffs, and diplomatic relations can impact availability and cost, making supplier diversification critical.

4. Can I source these APIs directly from manufacturers or through distributors?
Both options are available; direct sourcing offers better pricing but requires rigorous qualification, while distributors simplify procurement with validated products.

5. What is the typical lead time for API procurement?
Lead times vary from 4 to 12 weeks, depending on supplier location, order volume, and regulatory clearance requirements.

Sources

[1] Market research reports on pharmaceutical APIs, 2022.
[2] International Pharmaceutical Regulators Forum (IPRF).
[3] Major suppliers’ official websites and certification disclosures.
[4] Global Data, API manufacturing industry analysis, 2022.

Suppliers and packagers for generic pharmaceutical drug: BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE