Suppliers and packagers for NEOMYCIN AND POLYMYXIN B SULFATE

NEOMYCIN AND POLYMYXIN B SULFATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Xgen Pharms	NEOMYCIN AND POLYMYXIN B SULFATE	neomycin sulfate; polymyxin b sulfate	SOLUTION;IRRIGATION	065106	ANDA	XGen Pharmaceuticals DJB, Inc.	39822-1201-5	50 AMPULE in 1 CARTON (39822-1201-5) / 1 mL in 1 AMPULE	2006-01-19
Xgen Pharms	NEOMYCIN AND POLYMYXIN B SULFATE	neomycin sulfate; polymyxin b sulfate	SOLUTION;IRRIGATION	065108	ANDA	XGen Pharmaceuticals DJB, Inc.	39822-1220-1	1 VIAL, GLASS in 1 CARTON (39822-1220-1) / 20 mL in 1 VIAL, GLASS	2006-01-31

Suppliers and packagers for NEOMYCIN AND POLYMYXIN B SULFATE

Last updated: May 25, 2026

Neomycin and Polymyxin B Sulfate Supplier Landscape: Who Manufactures Inputs, Finished Dosage Forms, and Private-Label Products

Major points up front: Neomycin and polymyxin B sulfate products are supplied through (1) API and intermediate manufacturers for neomycin sulfate (often as topical/ophthalmic-grade salts), (2) polymyxin B sulfate API suppliers, and (3) finished-goods manufacturers producing branded and generic ophthalmic and otic drops/ointments. Supplier visibility is fragmented by geography, dosage form, and grade (USP/EP compliance, sterility assurance level, and preservative systems). Without a specific listed product (NDC), strength, and dosage form (ophthalmic vs otic, solution vs ointment), the universe of “suppliers” cannot be narrowed to a complete, decision-grade list.

Which companies supply neomycin sulfate and polymyxin B sulfate APIs for pharmaceuticals?

API supply splits by molecule and grade:

Neomycin sulfate API supply considerations

• Neomycin sulfate is typically sourced from manufacturers producing aminoglycoside fermentation-derived materials and then salt-forming to reach regulated specifications.
• Key supply constraints for downstream finished products include:
  • controlled impurity profiles (aminoglycoside co-components),
  • particle size and crystallinity,
  • salt form consistency (sulfate),
  • documentation for USP/EP-style monographs (where applicable).

Polymyxin B sulfate API supply considerations

• Polymyxin B sulfate is produced from fermentation and purified to meet narrow specification windows.
• Downstream sterility and stability requirements for ophthalmic/otic products affect which API suppliers are used.

What supplier evidence matters for licensing and procurement

Procurement-grade evidence usually includes:

• DMF status (where filed) or ASMF equivalents in target markets,
• batch COAs with impurity panels,
• suitability for sterile manufacture (for solutions),
• change control notifications and supply continuity commitments.

What finished-drug manufacturers sell neomycin and polymyxin B sulfate ophthalmic drops or ointments?

Finished-goods supply depends on whether the product is positioned for:

• ophthalmic use (sterile, preservative-defined solution formats),
• otic use (often sterile but with specific formulation and viscosity targets),
• combination products (frequently with other actives depending on market and region).

Ophthalmic vs otic supply chain differences

• Ophthalmic: tighter sterility and particle control expectations; preservative compatibility matters.
• Otic: formulation tolerances for viscosity and excipients differ; packaging and dosing device choices vary.

Which generic and branded NDCs use neomycin plus polymyxin B sulfate, and who manufactures them?

Supplier lists are NDC-specific because the same actives appear in multiple strengths and dosage forms, often with different manufacturing sites and re-packagers.

Why NDC specificity changes the supplier answer

• Labeler and manufacturer are not always the same entity.
• Multiple manufacturing sites can produce the same strength under different labeled products.
• Private label and distributor re-labeling can obscure original finished-goods manufacture.

What is the Orange Book status of neomycin and polymyxin B sulfate combination products?

Orange Book coverage is product-specific and depends on whether the combination is protected by active ingredient, formulation, method-of-use, or packaging claims.

Patent status is not molecule-based

Even if the APIs are common, exclusivity and patent listings are tied to:

• specific NDCs,
• dosage forms (solution vs ointment),
• route-of-administration and labeling.

When does exclusivity expire for neomycin and polymyxin B sulfate generics or branded products?

Exclusivity timelines are NDC and manufacturer specific (application type, listed patents, and any pediatric exclusivity or 505(b)(2) exclusivity overlays).

Practical implication

For procurement or entry planning, the usable exclusivity map is built from:

• NDC-level FDA filings,
• listed patents with expiration dates,
• FDA exclusivity codes and periods.

How strong is the patent estate for neomycin and polymyxin B sulfate combinations?

Patent strength is typically assessed across:

• formulation patents (preservatives, viscosity systems, vehicles),
• method-of-use patents (specific clinical indications),
• manufacturing process patents (sterile filling, lyophilization if applicable),
• polymorph or salt-form claims (less common for widely used APIs like sulfate salts, but can exist for specific intermediates or specific specs).

What typically drives patentability

• packaging and dosing device claims,
• stability and compatibility claims for ophthalmic/otic vehicles,
• labeling-driven method-of-use.

What formulation patents protect neomycin and polymyxin B sulfate ophthalmic/otic products?

Formulation protection often centers on:

• excipient selection and concentrations,
• preservative systems and compatibility with the aminoglycoside matrix,
• viscosity control (especially for ointments and suspensions),
• sterility assurance and fill-finish process parameters.

What Paragraph IV challenges target neomycin and polymyxin B sulfate combination products?

Paragraph IV litigation is NDC-specific and depends on the existence of Orange Book-listed patents tied to a given reference product.

Litigation signals used in sourcing decisions

• settlement terms can determine launch timing,
• consent decrees can restrict generic manufacturing or marketing timelines.

What generic entry risks exist for neomycin and polymyxin B sulfate combination products?

Entry risks come from:

• patent landscape gaps for specific NDCs,
• suitability challenges (bioequivalence requirements for ophthalmic/otic products are product- and formulation-dependent),
• sterility assurance and particulate matter compliance for sterile solution forms.

Manufacturing/IP barriers

• sterile manufacturing line qualification,
• validated cleaning methods for aminoglycoside carryover,
• impurity control and release acceptance criteria.

How do suppliers for neomycin/polymyxin B sulfate differ by geography and regulatory grade?

The supplier set changes based on:

• which markets require specific GMP frameworks,
• whether local registration requires locally validated sterility testing or additional stability studies,
• whether the product is sold as sterile manufactured or terminally sterilized.

Which CDMOs can formulate and fill sterile neomycin plus polymyxin B sulfate ophthalmic products?

For many markets, the “supplier” decision shifts to the CDMO that:

• qualifies the sterile fill-finish,
• holds appropriate licenses for ophthalmic manufacturing,
• manages stability, compatibility, and packaging validation.

What to verify in a CDMO sourcing bid

• sterile processing history,
• experience with aminoglycoside products and impurity management,
• ophthalmic-grade packaging capabilities (sterile droppers, tube formats for ointments),
• regulatory history (inspections, 483/CAPA patterns).

Key Takeaways

• “Suppliers” for neomycin plus polymyxin B sulfate are best mapped at NDC level and dosage-form level, because manufacturing responsibility and grade requirements vary widely.
• API supply differs by salt-grade specs, impurity profiles, and documentation maturity (DMF/ASMF).
• Finished-goods and CDMO participation changes by ophthalmic vs otic format (sterility and fill-finish requirements).
• Patent and exclusivity status is product-specific and cannot be generalized from the active ingredients alone.

FAQs

1. How do I identify the actual manufacturer behind a neomycin plus polymyxin B sulfate NDC label?
2. What documentation should be requested from neomycin sulfate and polymyxin B sulfate API suppliers for sterile ophthalmic formulations?
3. Which manufacturing steps most affect compliance for ophthalmic versus otic neomycin/polymyxin B sulfate products?
4. How do formulation excipients and preservative systems change supplier selection for combination aminoglycoside products?
5. What data points are most useful for screening CDMOs that can fill-finish sterile ophthalmic products containing neomycin and polymyxin B?

References

(No sources cited: the user request does not specify an NDC/dosage form/market, and no decision-grade supplier list can be produced without product-specific FDA, Orange Book, or verified supplier records.)