Suppliers and packagers for OMIDRIA

OMIDRIA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388	NDA	Rayner Surgical Inc.	82604-600-00	1 VIAL in 1 CARTON (82604-600-00) / 4 mL in 1 VIAL	2023-07-01
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388	NDA	Rayner Surgical Inc.	82604-600-04	4 VIAL in 1 CARTON (82604-600-04) / 4 mL in 1 VIAL	2023-07-01
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388	NDA	Rayner Surgical Inc.	82604-600-99	4 VIAL in 1 CARTON (82604-600-99) / 4 mL in 1 VIAL	2023-07-01

Suppliers and packagers for OMIDRIA

Last updated: May 29, 2026

Omidria (phenylephrine 1% and ketorolac 0.3%) suppliers: Who manufactures the FDA product, APIs, and key components?

Omidria is a fixed-dose intraoperative irrigation solution used to prevent postoperative mydriasis and reduce pain after cataract surgery with intraocular lens implantation. The product is marketed in the US as phenylephrine hydrochloride 1% and ketorolac tromethamine 0.3% in an irrigation fluid.

Core supply chain question: identify (1) the FDA-listed drug product manufacturer(s) for Omidria, (2) the labeled supplier roles for the drug substance and excipients when disclosed in FDA labeling/registration summaries, and (3) contract manufacturing or API sources for phenylephrine HCl and ketorolac tromethamine that are compatible with sterile ophthalmic/intraocular irrigation requirements.

Who are the FDA-listed manufacturers and suppliers for Omidria in the US?

Short answer: A supplier map requires Omidria’s specific FDA labeling/registration listings (NDC-to-manufacturer mapping) and Orange Book listing details for product and listed patents. Without those discrete FDA fields and the exact NDC(s) tied to current US presentation(s), the supplier set cannot be stated accurately.

Which roles matter in “supplier” for Omidria

For procurement and regulatory diligence, “supplier” typically splits into:

• Drug product manufacturer: sterile, single-use vial/bottle filling and packaging under cGMP
• NDA holder/labeler: the entity responsible for labeling and regulatory submissions
• Drug substance supplier(s):
  • Phenylephrine hydrochloride (API)
  • Ketorolac tromethamine (API)
• Critical excipient suppliers: buffers, tonicity agents, surfactants (if any), and sterilization-compatible components

Why NDC matters

Omidria can have multiple presentations and NDC configurations. Supplier entities can change by NDC due to site changes, labeler changes, or distribution arrangements. The only defensible supplier identification is NDC-anchored to current FDA listings.

What APIs are used in Omidria and who typically supplies phenylephrine HCl and ketorolac tromethamine?

Short answer: Omidria’s active ingredients are:

• Phenylephrine hydrochloride 1%
• Ketorolac tromethamine 0.3%

Supplier identification for the APIs requires confirmation from:

• FDA drug substance manufacturer disclosures (if provided in labeling or in registration files)
• Certificate of Analysis procurement records
• DMF holders or cross-referenced DMFs tied to the NDA
• Orange Book and FDA “listed drug” manufacturing site details (when available)

Without NDC-specific FDA submissions and the NDA’s DMF cross-references, API supplier names cannot be listed without risking factual error.

API sourcing risks specific to ophthalmic irrigation

• Particle control and endotoxin/sterility alignment with intraoperative administration
• Salt form and assay specifications (phenylephrine HCl; ketorolac tromethamine)
• Solubility and compatibility in the fixed-dose irrigation matrix

Which companies produce Omidria drug product (sterile irrigation solution) under contract manufacturing?

Short answer: Contract manufacturing and filling sites must be determined from FDA listing data for the exact Omidria presentations. Generic “sterile ophthalmic solutions” manufacturer lists are not reliable because sterile manufacturing is site-specific and NDC-specific.

Site-change sensitivity

For sterile injectable/irrigation products, supplier changes can occur due to:

• revalidation of aseptic filling lines
• sterilization method changes
• packaging component changes (vial/bottle, stoppers)
• NDA supplements tied to new manufacturing sites

Supplier due diligence therefore requires the current manufacturing site(s) tied to each NDC.

What does the Orange Book list for Omidria manufacturing and patent-protected product characteristics?

Short answer: Orange Book listings link to patent coverage and listed drug identity, but they do not consistently disclose raw material supplier names. They can identify the listed drug and the application/labeler, which is the backbone needed to trace manufacturing sites.

Patent estate relevance to supply chain

Even when supplier names are the goal, the patent estate can affect:

• availability of authorized generics
• whether FDA substitutes exist
• the feasibility of contract manufacturing for would-be entrants

How do you map Omidria suppliers to DMFs for phenylephrine HCl and ketorolac tromethamine?

A defensible mapping approach is:

1. Use the NDA’s DMF references for each API (phenylephrine HCl; ketorolac tromethamine)
2. Identify DMF holders and the associated manufacturing sites
3. Confirm which DMF(s) are used for the current marketed product presentations

This mapping cannot be executed reliably without the NDA-specific DMF cross-reference data for Omidria.

What generic or biosimilar entry risks affect Omidria’s supply landscape?

Omidria is a small-molecule ophthalmic irrigation product (not a biologic), so the primary competitive risk is ANDA/generics and authorized supply arrangements, not biosimilar-style risk.

Supplier landscape changes typically track:

• patent expirations and exclusivity timelines
• ANDA approvals and potential settlement-driven launch timing
• whether challengers can secure sterile manufacturing capacity quickly

Without Orange Book and litigation/timing specifics for Omidria, launch-driven supplier shifts cannot be quantified.

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Key Takeaways

• Omidria’s active ingredients are phenylephrine hydrochloride 1% and ketorolac tromethamine 0.3% in a sterile intraoperative irrigation solution.
• “Suppliers for Omidria” must be NDC-anchored to FDA drug product manufacturing listings to name specific manufacturers for the marketed product.
• API supplier names for phenylephrine HCl and ketorolac tromethamine require NDA-specific DMF cross-references or FDA registration disclosures tied to the marketed presentations.
• Patent and regulatory status can shift supply chain dynamics through authorized generics, ANDA entry timing, and contract manufacturing availability.

FAQs

1. What are the active ingredients in Omidria and what are their concentrations?
   Phenylephrine hydrochloride 1% and ketorolac tromethamine 0.3%.

2. Is Omidria manufactured as a sterile ophthalmic irrigation solution, and what does that imply for suppliers?
   Yes. It requires aseptic manufacturing controls suitable for intraoperative administration.

3. Do Orange Book listings identify Omidria API or excipient suppliers?
   They typically focus on patent coverage and listed drug identity, not raw material supplier names.

4. How do NDAs and DMFs determine the API suppliers used for Omidria?
   The NDA’s DMF references for the APIs identify DMF holders and the relevant manufacturing sources for the drug substances.

5. What competitive pathways could change Omidria’s supply chain in the US?
   ANDA-driven competition and authorized supply arrangements tied to Orange Book patent timelines.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Database).
2. U.S. Food and Drug Administration. Drug Registration and Listing System (DRLS) and NDC directory. (Database).