Suppliers and packagers for generic pharmaceutical drug: POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE

POLYMYXIN B SULFATE; TRIMETHOPRIM 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
Bausch And Lomb	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	polymyxin b sulfate; trimethoprim sulfate	SOLUTION/DROPS;OPHTHALMIC	064120	ANDA	Bausch & Lomb Incorporated	24208-315-10	1 BOTTLE, DROPPER in 1 CARTON (24208-315-10) / 10 mL in 1 BOTTLE, DROPPER	1997-02-14
Bausch And Lomb	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	polymyxin b sulfate; trimethoprim sulfate	SOLUTION/DROPS;OPHTHALMIC	064120	ANDA	Proficient Rx LP	63187-631-10	1 BOTTLE, DROPPER in 1 CARTON (63187-631-10) / 10 mL in 1 BOTTLE, DROPPER	1997-02-14
Bausch And Lomb	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	polymyxin b sulfate; trimethoprim sulfate	SOLUTION/DROPS;OPHTHALMIC	064120	ANDA	NuCare Pharmaceuticals,Inc.	68071-1651-5	10 mL in 1 BOX (68071-1651-5)	1997-02-14
Bausch And Lomb	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	polymyxin b sulfate; trimethoprim sulfate	SOLUTION/DROPS;OPHTHALMIC	064120	ANDA	Preferred Pharmaceuticals Inc.	68788-8152-1	1 BOTTLE, DROPPER in 1 CARTON (68788-8152-1) / 10 mL in 1 BOTTLE, DROPPER	2022-03-14
Bausch And Lomb	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	polymyxin b sulfate; trimethoprim sulfate	SOLUTION/DROPS;OPHTHALMIC	064120	ANDA	Sportpharm LLC	85766-141-10	1 BOTTLE, DROPPER in 1 CARTON (85766-141-10) / 10 mL in 1 BOTTLE, DROPPER	1997-02-14
Epic Pharma Llc	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	polymyxin b sulfate; trimethoprim sulfate	SOLUTION/DROPS;OPHTHALMIC	065006	ANDA	Proficient Rx LP	63187-193-10	1 BOTTLE, DROPPER in 1 CARTON (63187-193-10) / 10 mL in 1 BOTTLE, DROPPER	1998-12-17
Sandoz	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	polymyxin b sulfate; trimethoprim sulfate	SOLUTION/DROPS;OPHTHALMIC	064211	ANDA	A-S Medication Solutions	50090-2925-0	10 mL in 1 BOTTLE, PLASTIC (50090-2925-0)	1998-04-16

Suppliers and packagers for generic pharmaceutical drug: POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE

Last updated: May 25, 2026

Polyymyxin B Sulfate and Trimethoprim Sulfate Suppliers: Who Manufactures and Supplies API and Finished Dosage Options

What companies supply polymyxin B sulfate and trimethoprim sulfate to pharma?

No supplier list can be produced from the information provided. “POLYMYXIN B SULFATE” and “TRIMETHOPRIM SULFATE” can be sourced as APIs or through multiple finished-dosage markets (injectables, ophthalmics, topical combinations), and supplier availability varies by country, customer qualification status, and whether buyers require DMF/CEP support. Without a defined jurisdiction, dosage form, grade (USP/EP/Ph. Eur.), and supply scope (API vs finished product), any named supplier set would be incomplete and potentially wrong.

Which API suppliers are qualified for polymyxin B sulfate and trimethoprim sulfate (DMF/CEP)?

A credible “qualified supplier” answer requires Orange Book or FDA listing linkage for finished drugs, then mapping to API filings (DMFs), plus confirmation of which suppliers hold the relevant drug master files/CEP certificates for the same salt form and strength. This mapping is not available from the current prompt.

How do supply chains differ for polymyxin B sulfate versus trimethoprim sulfate?

Polymyxin B sulfate is a fermentation-derived cyclic peptide antibiotic whose supply can be constrained by manufacturing capacity, purification performance, and regulatory documentation for injection-grade material. Trimethoprim sulfate is a smaller-molecule synthetic antibacterial with a broader global supplier base. Buyers typically face different qualification barriers: polymyxin B sulfate tends to be the tighter bottleneck in validated impurity profiles and sterility-assurance materials, while trimethoprim sulfate is often easier to dual-source.

What finished products use polymyxin B sulfate plus trimethoprim sulfate, and who supplies them?

These actives appear in multiple combination products across geographies, but the exact products (strengths, salt forms, route such as ophthalmic vs topical vs systemic) determine the finished-product supplier. Without the target market and formulation, a supplier list cannot be generated correctly.

What are the main API grades and documentation buyers require for polymyxin B sulfate and trimethoprim sulfate?

Supplier selection depends on whether the buyer needs:

• API for sterile manufacturing (polymyxin B sulfate in particular)
• Compendial grade (USP/EP) vs non-compendial
• DMF type and cross-reference capability
• Impurity specification alignment for regulatory submissions
• Compliance package (GMP certificate, validation, stability protocol)

No document-backed supplier claims are possible from the prompt.

How does polymyxin B sulfate supply risk affect procurement for trimethoprim sulfate combinations?

When a combination product is built on a polymyxin B sulfate API, polymyxin supply constraints can force delays even if trimethoprim sulfate has ample availability. Procurement planning usually hinges on lead times, batch release timelines, and regulatory change control for suppliers. Supplier-level lead time and allocation data are not provided.

What supplier qualification steps should pharma buyers run for these APIs?

Qualification typically includes:

• Audited GMP status
• Regulatory file alignment (DMF/CEP, if applicable)
• Analytical method comparison (impurities, assay, residual solvents, bioburden expectations where relevant)
• Stability program review and out-of-spec (OOS) history review

Supplier names cannot be validated without the missing regulatory and market context.

Key Takeaways

• A precise, business-useful supplier list for polymyxin B sulfate and trimethoprim sulfate cannot be created from the provided inputs alone.
• Supplier availability and “qualification” depend on whether the buyer needs API vs finished dosage, the target country/regulator, and the specific dosage form and strength.

FAQs

1. Are polymyxin B sulfate and trimethoprim sulfate typically sourced from the same suppliers?
2. Do API suppliers for polymyxin B sulfate require additional sterile manufacturing documentation?
3. What determines whether a supplier can support regulatory submissions for polymyxin B sulfate?
4. Is trimethoprim sulfate easier to dual-source than polymyxin B sulfate?
5. How do buyers validate API impurity profiles for antibiotic APIs used in combination products?

References

(No sources cited; none were provided in the prompt.)