Suppliers and packagers for BROMFENAC SODIUM

BROMFENAC SODIUM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alembic	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	214340	ANDA	Alembic Pharmaceuticals Limited	46708-583-03	1 BOTTLE in 1 CARTON (46708-583-03) / 3 mL in 1 BOTTLE	2024-07-08
Alembic	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	214340	ANDA	Alembic Pharmaceuticals Inc.	62332-583-03	1 BOTTLE in 1 CARTON (62332-583-03) / 3 mL in 1 BOTTLE	2024-07-08
Alembic	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	210560	ANDA	Alembic Pharmaceuticals Limited	46708-508-17	1 BOTTLE in 1 CARTON (46708-508-17) / 1.7 mL in 1 BOTTLE	2022-11-10
Alembic	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	210560	ANDA	Alembic Pharmaceuticals Inc.	62332-508-17	1 BOTTLE in 1 CARTON (62332-508-17) / 1.7 mL in 1 BOTTLE	2019-06-21
Amneal	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	210962	ANDA	Amneal Pharmaceuticals NY LLC	60219-1526-3	1 BOTTLE, DROPPER in 1 CARTON (60219-1526-3) / 3 mL in 1 BOTTLE, DROPPER	2024-07-31
Apotex	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	207334	ANDA	Apotex Corp.	60505-1006-1	1 BOTTLE, DROPPER in 1 CARTON (60505-1006-1) / 1.6 mL in 1 BOTTLE, DROPPER	2024-07-11
Apotex	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	207334	ANDA	Apotex Corp.	60505-1006-2	1 BOTTLE, DROPPER in 1 CARTON (60505-1006-2) / 3 mL in 1 BOTTLE, DROPPER	2024-07-11

Pharmaceutical Supplier Landscape: BROMFENAC SODIUM

Last updated: April 23, 2026

Who supplies bromfenac sodium (API) to pharmaceutical manufacturers?

Bromfenac sodium is supplied through a mix of active pharmaceutical ingredient (API) manufacturers and API distributors. In practice, sourcing splits into two channels:

• API manufacturers (production of bromfenac sodium as the commercial API)
• API traders/distributors (supply and logistics, often multiple manufacturer sources per lot)

Which supplier categories dominate bromfenac sodium availability?

For bromfenac sodium, market access typically comes from:

• Generic API producers in China and India, which supply finished API to contract manufacturers and branded-generic formulation sites.
• Global distributors that broker API inventory across regions and offer documentation packages (typically CoA, spec sheet, DMF linkage where applicable).

What documentation and qualification terms do suppliers typically provide for bromfenac sodium?

Common supplier deliverables for bromfenac sodium lots include:

• Certificate of Analysis (CoA) with assay, impurities, and residuals
• Specification sheet (identity, assay, water content/LOD, related impurities, heavy metals where applicable)
• GMP status and manufacturing site documentation
• Typical regulatory support where available (DMF/CEP linkage)

Where do bromfenac sodium suppliers usually sell: dosage-form vs API?

Supplier offerings typically split into:

• API only (bromfenac sodium bulk material for formulation)
• Finished drug product (ophthalmic solutions are the primary marketed dosage form for bromfenac in many jurisdictions)

What is the most common commercial grade expectation?

Bromfenac sodium is generally supplied as a chemical API with:

• defined assay specification
• defined impurity profile limits
• controlled physical attributes (e.g., particle size where relevant to downstream formulation)

What are the main sourcing risks tied to bromfenac sodium suppliers?

Risk concentrates in:

• Batch-to-batch impurity profile variance
• Documentation gaps (CoA/spec mismatch, unclear DMF/CEP position)
• Regulatory qualification delays due to incomplete quality packages

Key supplier due-diligence checklist for bromfenac sodium

Commercial procurement teams typically validate:

• GMP certification for the manufacturing site
• Quality agreement terms (change control, deviation handling, retesting cadence)
• Analytical method alignment (supplier test methods vs customer acceptance methods)
• Stability/packaging guidance for intended formulation use
• Regulatory documentation (DMF/CEP referencing, where used in customer submissions)

Key Takeaways

• Bromfenac sodium sourcing is dominated by API manufacturer supply complemented by distributor brokerage.
• Supplier qualification hinges on GMP status, CoA/spec integrity, and impurity profile control.
• Procurement risk centers on documentation completeness and batch consistency.

FAQs

1. Is bromfenac sodium usually sourced as API or finished drug product?
   Most upstream sourcing is as API; finished product supply exists but is not the dominant channel for formulation manufacturers.

2. What quality documents should be requested for bromfenac sodium API?
   Typically CoA and a specification sheet tied to the delivered lot, plus GMP and regulatory support where applicable.

3. Do suppliers provide impurity profile data for bromfenac sodium?
   They usually do through the CoA and the supplier specification, which define related impurities and residuals.

4. Which region supply networks dominate bromfenac sodium API availability?
   Availability commonly concentrates in generic API production clusters in China and India, with global distributors covering logistics and brokerage.

5. What typically causes qualification delays for bromfenac sodium?
   Mismatches between customer acceptance criteria and supplier spec/CoA structure, or change control uncertainty across batches.

Sources (APA)
[1] Not provided.