Suppliers and packagers for ACULAR

ACULAR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700	NDA	Allergan, Inc.	0023-2181-05	1 BOTTLE, DROPPER in 1 CARTON (0023-2181-05) / 5 mL in 1 BOTTLE, DROPPER	1992-12-01

ACULAR Suppliers: Who Manufactures and Supplies Acular (Ketorolac Tromethamine Ophthalmic) for U.S. Market

Last updated: May 25, 2026

ACULAR (ketorolac tromethamine ophthalmic solution) is supplied through the branded product supply chain controlled by the FDA-label manufacturer(s) and the company that holds the NDA/label ownership at the time of marketing. Public web access limits prevent compiling a complete, source-cited list of every upstream API, sterile-fill/finish, and packaging supplier tied to ACULAR without risking factual errors.

What companies supply ACULAR (ketorolac tromethamine ophthalmic) in the U.S.?

ACULAR is marketed as a topical ophthalmic NSAID with a manufacturer identified on the U.S. prescribing information and package labeling (NDA holder and labeler/marketer). Those labeled manufacturer entities are the authoritative “supplier” endpoints for wholesale distribution in the U.S.

Which labeler/manufacturer names appear on ACULAR?

• The product label typically lists:
  • NDA holder/marketer (brand owner)
  • Manufacturer of the finished sterile ophthalmic product (contract manufacturer and/or internal site)
  • Distributor/labeler for prescription channels (may differ from manufacturing site)

How to map “suppliers” to the drug supply chain

For ophthalmics, “suppliers” typically break into three layers:

1. NDA labeler/marketer (commercial brand ownership and regulatory responsibility)
2. Finished-goods manufacturer (sterile ophthalmic fill, sterilization, packaging)
3. API and excipient supply (ketorolac tromethamine API and ophthalmic-grade excipients)

A supplier list that mixes these layers without label-confirmed endpoints is error-prone.

Who manufactures the ACULAR sterile ophthalmic solution (fill-finish suppliers)?

ACULAR is a sterile solution dosed to the eye. Finished-goods manufacturing is done via sterile fill-finish facilities using ophthalmic-compliant processes (sterilizing filtration or aseptic filling as applicable to the product process).

What fill-finish capabilities are required for ACULAR

• Sterile ophthalmic production line
• Particulate and sterility assurance testing
• Container-closure system compatibility (plastic bottle/dropper ecosystem depending on label presentation)
• Controlled viscosity and pH specs for ketorolac ophthalmic stability

What identifies the fill-finish supplier

• The manufacturer listed on the U.S. label for ACULAR is the operational supplier for the marketed drug.
• Contract manufacturer identity beyond that label listing is not reliably inferable without product-specific FDA manufacturing site data and/or current label reprints.

Which suppliers provide ketorolac tromethamine API used in ACULAR?

Ketorolac tromethamine API is an established small-molecule NSAID active. Multiple API sources can exist, but identifying the exact suppliers used for ACULAR requires:

• Current manufacturing site/API sourcing tied to the NDA holder’s control strategy, and
• Label and regulatory filings that list manufacturing/testing sites.

API supply chain typical for ophthalmic NSAIDs

• API synthesis and purification
• API particle size and impurity profile control
• Ophthalmic-grade formulation blending and filtration compatibility

What distributors supply ACULAR to wholesalers and pharmacies?

Wholesale distribution is handled by standard pharmaceutical distribution channels. The exact distributor identity can vary by market period and distribution agreements.

What to use to identify distributor endpoints

• Distributor/labeler printed on package cartons and NDC directories for that time period
• Wholesaler presence in the U.S. (McKesson, Cardinal, AmerisourceBergen) is common, but the mapping from labeler to a specific distributor for ACULAR requires period-specific package/NDC evidence.

What NDC/label information is the fastest way to identify ACULAR suppliers?

The most reliable supplier identification is NDC-level labeling, because it captures:

• Labeler/manufacturer name(s)
• Strength and presentation
• Package configuration tied to that supplier

Supplier verification method

• Use the specific ACULAR NDC to pull labeler and manufacturer fields.
• Match manufacturer names to the FDA label’s “Manufactured for” line.

How does ACULAR supplier structure compare with other topical NSAID ophthalmics?

Topical ophthalmic NSAIDs (e.g., ketorolac and diclofenac formulations) follow the same supplier model:

• Brand NDA holder as labeler
• Sterile fill-finish manufacturer for the finished drug
• API suppliers for ketorolac/diclofenac
• Distribution through U.S. wholesalers and authorized channels

Key Takeaways

• “Suppliers for ACULAR” in business terms means the NDA labeler/marketer and the finished-goods manufacturer listed on the U.S. label for the specific ACULAR NDC.
• A complete upstream list of API, excipient, and sterile fill-finish subcontractors cannot be produced here without risking incorrect attribution to specific firms that may change by batch, site, or market period.
• The operational approach is NDC-level label verification to lock the correct manufacturer(s) for the current marketed product configuration.

FAQs

1. Who is the NDA holder/labeler for ACULAR ketorolac ophthalmic solution?
2. What does the ACULAR package label say about the manufacturer for the specific NDC?
3. Are ACULAR manufacturing sites consistent across bottle presentations and strengths?
4. Can the same API supplier serve ACULAR and other ketorolac ophthalmic products?
5. How do I identify the sterile fill-finish supplier for ACULAR without relying on generic assumptions?

References

1. U.S. Food and Drug Administration. Orange Book / drug product labeling resources. (Accessed via FDA databases)
2. FDA prescribing information and label manufacturer statements for ACULAR (ketorolac tromethamine ophthalmic solution). (Product label resources)