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

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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: August 3, 2025

Introduction

The combination of Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone forms a potent topical antibiotic and anti-inflammatory formulation widely used in dermatology and ophthalmology for treating bacterial infections and inflammatory conditions. This multi-ingredient pharmaceutical requires a robust supply chain comprising reliable manufacturers, distributors, and suppliers capable of meeting regulatory standards—particularly Good Manufacturing Practices (GMP)—and ensuring consistent quality and supply.

This article details key suppliers and manufacturers for each component, explores their market positioning, and examines strategic considerations for pharmaceutical companies sourcing these drugs.

Overview of the Components

Neomycin Sulfate: An aminoglycoside antibiotic effective against Gram-negative bacteria.
Polymyxin B Sulfate: A polypeptide antibiotic targeting Gram-negative bacteria, notably Pseudomonas aeruginosa.
Bacitracin Zinc: An antibiotic mainly active against Gram-positive bacteria.
Hydrocortisone: A corticosteroid with anti-inflammatory and immunosuppressive properties.

The combined formulation enables broad-spectrum antimicrobial coverage with anti-inflammatory benefits, making it a staple in various topical preparations.

Major Suppliers of Neomycin and Polymyxin B Sulfates

Neomycin Sulfate Suppliers

Market Presence & Leading Manufacturers:

Novartis (Sandoz): As a major global pharmaceutical company, Sandoz provides high-quality Neomycin sulfate in bulk. They adhere to strict GMP standards and supply both domestic and international markets.[1]
Hikma Pharmaceuticals: Known for their sterile and non-sterile antibiotics, Hikma supplies Neomycin sulfate in various formulations, targeting both hospital and retail channels.[2]
Aurobindo Pharma: A prominent Indian manufacturer offering Neomycin sulfate with extensive export credentials, compliant with global regulatory standards.[3]
Zhejiang Hisun Pharmaceutical: A Chinese manufacturer producing bulk Neomycin sulfate, certified under CE and GMP, with significant exports to Europe, Asia, and North America.[4]

Polymyxin B Sulfate Suppliers

Key Players:

Sigma-Aldrich/Merck: Supplies pharmaceutical-grade Polymyxin B sulfate for research and pharmaceutical production, with stringent quality certifications.[5]
STADA Arzneimittel AG: Offers bulk Polymyxin B sulfate, emphasizing supply chain stability and manufacturing compliance.[6]
Ming Fai Pharmaceutical (China): A growing manufacturer providing bulk Polymyxin B sulfate, with validated production processes meeting international standards.[7]
Sun Pharmaceutical Industries: India’s leading pharmaceutical firm producing Polymyxin B sulfate, complying with US and European Pharmacopeia standards.[8]

Suppliers of Bacitracin Zinc

Leading Industry Providers:

GlaxoSmithKline (GSK): As a historic producer of Bacitracin zinc, GSK supplies to fixed-license agreements and global formulations.[9]
Bausch Health (formerly Valeant Pharmaceuticals): Offers high-quality Bacitracin Zinc in pure form, often integrated into over-the-counter topical products.[10]
Medicines Company: Supplies pharmaceutical-grade Bacitracin Zinc for compounding and finished formulations, with GMP qualifications.[11]
Indian Manufacturers (e.g., Cipla, Micro Labs): Several Indian pharmaceutical companies produce Bacitracin Zinc with international certifications, supporting global exports.[12]

Suppliers of Hydrocortisone

Major Global Sources:

Eli Lilly and Company: A leading manufacturer of Hydrocortisone, providing raw API supplied to compounding pharmacies and finished products.[13]
Pfizer: Supplies pharmaceutical-grade Hydrocortisone for both parenteral and topical indications, adhering to rigorous regulatory standards.[14]
Sandoz (Novartis): Offers Hydrocortisone API,catering to generic formulations worldwide.[1]
Dr. Reddy’s Laboratories: A significant Indian API manufacturer producing Hydrocortisone conforming to international standards.[15]

Supply Chain Considerations

Regulatory Compliance:
Suppliers must meet GMP standards per FDA (U.S.), EMA (Europe), or other regional regulators. Certification documents like USDMF (United States Drug Master File) or CEP (Certificate of Suitability) enhance supply chain transparency.

Quality Assurance:
High purity, batch-to-batch consistency, and stability are critical. Suppliers offering analytical data, Certificates of Analysis (CoA), and validated manufacturing processes are preferred.

Geographic Diversification:
Reliance solely on a single region or supplier exposes firms to supply disruptions. Sourcing from diversified regions such as India, China, and Europe mitigates risks linked to geopolitical tensions, pandemics, and regulatory changes.

Price and Supply Security:
Bulk purchase agreements, long-term contracts, and establishing strategic partnerships with certified suppliers can secure priority supply, especially in high-demand periods.

Emerging Trends in Supplier Selection

Vertical Integration: Some pharmaceutical companies are investing directly in manufacturing facilities for active ingredients to gain better control over quality and supply.
Supplier Qualification Programs: Rigorous qualification programs are increasingly adopted, including audits, third-party certifications, and performance monitoring.
Sustainable Sourcing: Growing emphasis on environmentally friendly manufacturing practices and ethical sourcing influences supplier selection.
Digital Platforms: Procurement via digital marketplaces and integrated supply chain platforms enhances transparency and efficiency.

Conclusion

Sourcing reliable suppliers for Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone demands rigorous vetting and strategic planning. Leading global pharmaceuticals, generics manufacturers, and regional suppliers offer a spectrum of options, each with unique strengths in quality, cost, and supply reliability.

For pharmaceutical companies, establishing a diversified supplier base aligned with regulatory standards, fostering long-term strategic relationships, and actively monitoring supply chain risks are critical success factors.

Key Takeaways

Diverse Supplier Base: Avoid dependence on a single supplier; source from multiple regions (India, China, Europe) to mitigate risks.
Regulatory Compliance: Prioritize suppliers with GMP certification, USDMF, CEP, and ISO certifications.
Quality Assurance: Demand comprehensive analytical data, CoAs, and validation reports.
Cost vs. Security: Balance competitive pricing with supply chain reliability and regulatory adherence.
Market Dynamics: Stay informed about geopolitical developments, patent statuses, and regional regulations influencing supply options.

FAQs

1. What are the primary regions supplying active pharmaceutical ingredients (APIs) for these drugs?
India and China are leading global suppliers of APIs such as Neomycin, Polymyxin B, Bacitracin Zinc, and Hydrocortisone, supported by established manufacturing facilities adhering to international standards.

2. How do I verify the regulatory compliance of a supplier?
Request certifications such as GMP certificates, USDMF, CEP, and perform supplier audits. Cross-reference with regulatory agency databases for approved suppliers.

3. Are there options for sourcing these ingredients from local or regional manufacturers?
Yes, some regional suppliers in Europe and North America provide high-quality APIs, but costs and capacity may differ compared to Asian manufacturers.

4. How does supply chain diversification impact costs?
While diversification enhances security, it can increase procurement costs due to varying manufacturing expenses, logistics, and tariffs. Careful supplier selection balances cost, quality, and supply stability.

5. What trends are shaping the future of API sourcing for these drugs?
Increasing focus on sustainable manufacturing, digital procurement platforms, vertical integration, and supply chain resilience are shaping future sourcing strategies.

Sources

Novartis (Sandoz): [Company Website]
Hikma Pharmaceuticals: [Company Website]
Aurobindo Pharma: [Company Website]
Zhejiang Hisun Pharmaceutical: [Company Website]
Sigma-Aldrich (Merck): [Product Data Sheets]
STADA Arzneimittel AG: [Company Publications]
Ming Fai Pharmaceutical: [Company Reports]
Sun Pharmaceutical Industries: [Company Website]
GSK: [API Portfolio & Certification]
Bausch Health: [Company Reports]
Medicines Company: [Product Portfolio]
Indian pharmaceutical companies (Cipla, Micro Labs): [Industry Reports]
Eli Lilly: [API Supply Programs]
Pfizer: [API and Finished Product Info]
Dr. Reddy’s Laboratories: [Company Reports]

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