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

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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

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

Last updated: May 30, 2026

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc suppliers: who manufactures the combo product and components?

Executive summary

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC is a fixed-dose, topical antibiotic combination typically supplied as branded and generic ointments/creams under multiple ANDAs. Supplier mapping depends on (1) the specific US product’s NDA/ANDA holder that files to the FDA Orange Book, (2) the labeled manufacturer (finished dosage form) and the firm listed as the primary manufacturer, and (3) whether you are sourcing finished product or API and excipients. Without the specific labeled product(s) or dosage form(s) you mean (ointment vs other), a complete supplier list cannot be produced accurately.

Which companies supply NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (US marketed ointment/cream)?

Finished-goods suppliers for this combination are the FDA-registered manufacturers behind each listed US marketing application. In practice, the supply chain splits across:

• ANDA/NDA holders (applicant of record)
• Labeler and manufacturing site(s) (cGMP release sites)
• Contract manufacturers (CMOs) producing the finished ointment
• API and intermediate suppliers for neomycin sulfate, polymyxin B sulfate, and bacitracin zinc

Key actionable point: If you are evaluating sourcing risk, you need the manufacturer name(s) tied to the exact NDC for your target strength and dosage form, then trace whether the site is captive or CMO.

How do you identify the true supplier for each NDC of neomycin/polymyxin/bacitracin zinc?

A reliable supplier build follows this workflow:

1. Pull the Orange Book listing for the exact combination and dosage form.
2. Extract:
   • Applicant/holder
   • Dosage form
   • Strength
   • Corresponding NDC(s)
3. Use the NDC to connect to:
   • FDA labeler/manufacturer information
   • GMP site(s) tied to the marketed finished dosage form
4. Where relevant, cross-check:
   • site names appear on FDA inspection records
   • DMF holders for any components (API-related filings)

This yields “supplier” as a defensible set of firms, not a broad guess.

Who supplies the active pharmaceutical ingredients for the topical triple-antibiotic combination?

At the API level, sourcing typically includes separate supply chains for:

• Neomycin sulfate (often produced/derived via fermentation and purification)
• Polymyxin B sulfate (fermentation-based production)
• Bacitracin zinc (bacitracin produced and complexed into zinc salt form)

Many manufacturers and distributors handle:

• fermentation-derived APIs
• purification and salt formation
• excipient-grade materials (hydrocarbons, petrolatum components, etc.)

Key actionable point: “API supplier” should be treated as distinct from “finished dosage manufacturer.” A firm can distribute APIs without making them, and a finished-goods supplier can rely on multiple API sources to manage supply continuity.

What formulation manufacturers supply the ointment dosage form for this antibiotic triple combo?

The ointment base commonly uses:

• petrolatum/mineral oil blends and/or other semi-solid carriers
• emulsifiers or viscosity modifiers depending on product type
• preservatives and stability modifiers where applicable

Topical antibiotics are often produced by specialized topical-gels/ointments CDMOs that also handle:

• aseptic constraints are typically not the same as injectables, but microbial control in compounding and filling remains critical
• tight blending and uniformity controls for multi-antibiotic systems
• packaging line clearance validation to avoid cross-contamination

Supplier identification requires the finished dosage form manufacturer(s) for each NDC, not a generic list.

Does supplier availability differ by strength, dosage form, or package size?

Yes. Supply continuity often varies by:

• strength and label claims (different concentrations)
• ointment vs alternative semisolid format
• tube vs jar vs multi-pack presentation
• whether the site is a single-API-source operation or multi-source operation

A firm may supply one NDC and not another, even within the same combination.

What manufacturing and IP constraints affect supplier onboarding for this triple-antibiotic topical?

Commercial supplier onboarding for generics/topicals is constrained by:

• regulatory filings (the ANDA supports the approved formulation and manufacturing process)
• comparability of impurity profiles for antibiotic APIs
• specification alignment for potency and assay method validation
• packaging, shelf life, and stability protocol compatibility

For new entrants, the limiting factor usually becomes:

• process development to match impurity and dissolution/uniformity specs
• scale-up and validation of blending and filling for semi-solids

Orange Book status: does it change who can supply?

Orange Book status affects eligibility for generic competition and Para IV/III frameworks for systematized IP, but for supplier mapping, the practical effect is:

• existing ANDA holders with approval already supply the market
• newer approvals can create incremental supply as long as manufacturing capacity is available

If you are assessing current supplier landscape, Orange Book is not sufficient alone. You need NDC-level manufacturer data tied to marketed inventory.

When do exclusivity and patent expirations affect supplier switching?

Supplier switching is driven less by exclusivity alone and more by:

• new ANDA approvals
• transfer of manufacturing lines
• CMO capacity availability
• market share shifts after entry

A full exclusivity-driven timeline requires the exact Orange Book record(s) for the specific labeled product and strength. Without the exact product identifier, a correct expiration calendar cannot be produced.

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Key Takeaways

• “Supplier” for NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC must be defined as either finished dosage manufacturer (by NDC) or API source (by DMF/API relationships).
• A defensible supplier list requires tying firms to specific marketed NDC(s) and associated FDA-registered manufacturing sites.
• Without the exact product/dosage form/strength (and NDCs or application numbers), any supplier enumeration would risk being inaccurate.

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FAQs

1. How can I confirm the finished dosage manufacturer for a specific neomycin/polymyxin/bacitracin zinc ointment NDC?
2. What is the difference between an ANDA applicant and the actual cGMP manufacturer of neomycin/polymyxin/bacitracin zinc ointment?
3. Which API manufacturers typically supply neomycin sulfate, polymyxin B sulfate, and bacitracin zinc for topical antibiotics?
4. Do suppliers change when a generic topical triple-antibiotic switches packaging formats (tube vs jar)?
5. How do impurities and potency specs for fermentation-derived antibiotic APIs affect qualified supplier onboarding?

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References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. Food and Drug Administration. NDC Directory (Drugs@FDA and labeler/manufacturer information). FDA. https://www.fda.gov/drugs/drug-approvals-and-databases/ndc-directory