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

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch And Lomb Inc	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	gramicidin; neomycin sulfate; polymyxin b sulfate	SOLUTION/DROPS;OPHTHALMIC	064047	ANDA	Bausch & Lomb Incorporated	24208-790-62	1 BOTTLE, DROPPER in 1 CARTON (24208-790-62) / 10 mL in 1 BOTTLE, DROPPER	1996-01-31
Bausch And Lomb Inc	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	gramicidin; neomycin sulfate; polymyxin b sulfate	SOLUTION/DROPS;OPHTHALMIC	064047	ANDA	A-S Medication Solutions	50090-0247-0	1 BOTTLE, DROPPER in 1 CARTON (50090-0247-0) / 10 mL in 1 BOTTLE, DROPPER	1996-01-31
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: April 25, 2026

Who supplies neomycin, polymyxin B, and gramicidin used in combination products?

The combination “neomycin and polymyxin B sulfates and gramicidin” is sold in topical ophthalmic/otologic formats. Manufacturing supply chains typically source each active ingredient from specialized API producers, then package into finished-dose products (FPP) by branded or contract manufacturers.

Active-ingredient supplier coverage (API):

Neomycin sulfate (API)
Polymyxin B sulfate (API)
Gramicidin (API)

Because this specific combination is used in multiple jurisdictions and dosage forms, suppliers appear across three layers: 1) Fermentation-derived API makers (antibiotic fermentation + purification) 2) API intermediates and finishing (salt formation, specification polishing) 3) FPP manufacturers (fill-finish under license or CMO/contract)

What supplier types support this antibiotic combination?

API fermentation and purification

These antibiotics are produced via microbial fermentation processes, then purified and standardized to tight potency and impurity specs before conversion into the final salt form (where applicable). Typical supplier classes include:

Antibiotic API manufacturers with historical capability in aminoglycosides (neomycin)
Cyclic peptides and polymyxins (polymyxin B)
Gramicidin peptide antibiotic producers

Salt/grade finishing

Neomycin sulfate: salt and assay standardization by API supplier
Polymyxin B sulfate: sulfate salt standardization and potency normalization
Gramicidin: peptide potency and impurity profile control

Finished-dose packagers

FPPs (eye drops/ear drops/ophthalmic or otic solutions or suspensions) are typically produced by branded label holders or CMOs, using qualified API lots from the upstream supplier roster.

Which companies are known suppliers in the neomycin / polymyxin / gramicidin antibiotic supply chain?

The supplier list below reflects companies that are repeatedly active across antibiotic API supply for these drug classes and hold manufacturing capability recognized in global regulatory and industry channels.

Neomycin sulfate and related aminoglycoside antibiotic APIs

Simagchem (API catalog availability and antibiotic raw materials supply across global chemical distribution channels) [1]
TCI Chemicals (supplies research and industrial-grade antibiotic actives through its global catalog network, including neomycin) [2]
BOC Sciences / related catalog distributors (antibiotic raw materials availability in global supply networks; used by downstream formulators for sourcing) [3]

Polymyxin B sulfate antibiotic APIs

Sigma-Aldrich / Merck (polymyxin B sulfate availability in catalog; widely used as an upstream material or reference for formulation supply) [4]
TCI Chemicals (polymyxin B sulfate availability in global catalog) [2]
Simagchem (polymyxin B sulfate catalog sourcing through industrial chemical supply routes) [1]

Gramicidin antibiotic APIs

Sigma-Aldrich / Merck (gramicidin availability in catalog for antibiotic/peptide raw material sourcing) [4]
TCI Chemicals (gramicidin availability in catalog) [2]
Selleckchem (catalog availability for peptide antibiotics including gramicidin) [5]

How to map API suppliers to the finished combination drug

In practice, combination products use:

Neomycin sulfate API supplier qualified by the FPP manufacturer
Polymyxin B sulfate API supplier qualified by the FPP manufacturer
Gramicidin API supplier qualified by the FPP manufacturer

The FPP manufacturer then executes:

Formulation (solubilization and pH/vehicle system selection)
Microbial and physicochemical control strategy
Container closure system and sterilization or aseptic processing strategy (depends on dosage form)
Stability qualification under local conditions

Business implication: The supplier set that matters for procurement is usually not the widest-catalog chemical seller, but the qualified cGMP API manufacturers that can supply commercial lots to an FPP site under established quality agreements.

Regulatory and quality gating that limits “catalog” suppliers

Even when many chemical suppliers advertise neomycin/polymyxin/gramicidin, the combination product supply chain is constrained by:

cGMP manufacturing of APIs with batch traceability
Compliance with pharmacopeial monographs (USP/EP) for assay, impurities, and identification
Residuals and microbial quality controls
Salt form controls (neomycin sulfate, polymyxin B sulfate)
Peptide-specific characterization for gramicidin

Practical procurement lens: many catalog suppliers sell for laboratory or non-commercial use. FPP manufacturers typically qualify only suppliers with a documented regulatory and quality history for commercial antibiotic APIs.

Procurement-ready supplier short list by “sourcing channel”

Because “supplier” can mean either chemical distributor or cGMP API manufacturer, the channel determines which list is actionable.

Channel A: Global catalog distributors (fast access, not always cGMP-grade)

Sigma-Aldrich / Merck (neomycin-class antibiotic raw materials, polymyxin B sulfate, gramicidin) [4]
TCI Chemicals (neomycin/polymyxin B/gramicidin in catalog networks) [2]
Selleckchem (gramicidin peptide antibiotic in catalog network) [5]
Simagchem (antibiotic raw materials catalog supply) [1]

Channel B: Chemical sourcing platforms for industrial trade

Simagchem (API/antibiotic raw materials catalog) [1]
Global chemical marketplaces are often used for initial supplier discovery but do not guarantee cGMP qualification.

What matters most for selecting a supplier for this specific combination

For a manufacturer or procurement team, the selection criteria typically collapse into a small checklist:

Assay/potency matched to pharmacopeial and internal release limits
Impurity profile consistent across lots (critical for polymyxins and aminoglycosides)
Salt form verification for neomycin sulfate and polymyxin B sulfate
Peptide identity and related substances for gramicidin
Stability data compatibility with the final dosage form
Regulatory history (DMFs, CEPs, inspections where applicable)
Supply continuity for a multi-antibiotic combo (qualification requires continuity)

Key Takeaways

The combination “neomycin and polymyxin B sulfates and gramicidin” depends on three upstream API streams: neomycin sulfate, polymyxin B sulfate, and gramicidin.
Many vendors offer these actives via catalog distribution, including Sigma-Aldrich/Merck, TCI, Simagchem, Selleckchem, and others, but FPP qualification usually limits procurement to cGMP-capable suppliers with documented batch quality and regulatory acceptability. [1][2][4][5]
The procurement target is not “availability,” but qualification readiness: potency/impurities, salt/identity controls, and supply continuity for antibiotic multi-API formulations.
Supplier selection should be made through the FPP manufacturer’s qualified vendor list at the site, because the final product quality depends on upstream API variability controls.

FAQs

Which API is typically the most difficult to qualify in this combination?

Gramicidin can be operationally challenging because it is a peptide antibiotic where identity and related-substance profiling drive tighter specification adherence than many small-molecule APIs.

Do common catalog chemical sellers supply commercial-grade API for finished drug products?

Some do, but catalog listings usually do not guarantee the cGMP grade, impurity limits, or documentation required for commercial FPP supply. Qualification depends on the supplier’s regulatory-quality package.

Are neomycin sulfate and polymyxin B sulfate sold interchangeably across suppliers?

No. Even within the same named salt, potency and impurity profiles differ by manufacturer process and control strategy, so suppliers must match the FPP’s release specification.

What documentation is commonly required to qualify an antibiotic API supplier?

Qualification typically relies on assay and impurity data packages, CoA trends, stability-relevant information, and regulatory-quality documentation tied to the manufacturing site.

How many suppliers should a manufacturer keep for this combination?

At minimum, the FPP typically maintains a qualified single-source baseline for each API, then adds alternates through tech transfer and stability compatibility if business continuity demands it.

References

[1] Simagchem. (n.d.). Neomycin / polymyxin B sulfate / gramicidin product listings. https://www.simagchem.com/
[2] TCI Chemicals. (n.d.). Product catalog listings for neomycin, polymyxin B sulfate, and gramicidin. https://www.tcichemicals.com/
[3] BOC Sciences. (n.d.). Antibiotic raw material listings including neomycin. https://www.bocsci.com/
[4] Merck/Sigma-Aldrich. (n.d.). Product catalog for polymyxin B sulfate and gramicidin. https://www.sigmaaldrich.com/
[5] Selleckchem. (n.d.). Gramicidin product listing. https://www.selleckchem.com/

Suppliers and packagers for NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN