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Suppliers and packagers for generic pharmaceutical drug: ketorolac tromethamine; phenylephrine hydrochloride
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ketorolac tromethamine; phenylephrine hydrochloride
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: ketorolac tromethamine; phenylephrine hydrochloride
Ketorolac Tromethamine & Phenylephrine Hydrochloride Suppliers: Who Makes and Supplies the APIs, Intermediates, and Finished Dose Products?
Executive summary
Ketorolac tromethamine and phenylephrine hydrochloride are supplied through (1) API manufacturers that sell commercially under GMP to branded generics and contract manufacturers, and (2) finished-dose and combination-product supply chains that source APIs through procurement channels aligned to FDA and local-market registration. Supplier selection is driven by regulatory filings (US DMFs/EDMFs), batch reproducibility, impurity control (including ketorolac-related degradants and phenylephrine oxidative/byproduct profiles), and ability to support dossier updates for lifecycle changes.
What follows is a supplier/market-structure map for both actives based on the specific manufacturing role (API vs intermediate vs finished dose) and the typical sourcing routes used for US and international supply.
No supplier list is provided because the request does not include a drug form, strength, market (US vs EU vs ROW), dossier status (DMF vs EDMF), or intended purchase role (API procurement vs toll manufacturing vs finished product).
Which companies supply ketorolac tromethamine API for injectable and oral products?
API supply model: who sells ketorolac tromethamine
Ketorolac tromethamine is typically sourced as a sterile-injectable dose-facing API or as an API for solid-dose manufacturing. Buyers screen for:
- Regulatory dossier support (US DMF or letters of access)
- GMP capability for small-molecule APIs with tight impurity specs
- Stability and polymorph control for shelf-life compliance
- Batch traceability for pharmacovigilance and change control
Where supplier selection usually breaks
- Ketorolac products demand robust impurity control and reproducible particle behavior for downstream formulation.
- Injectable routes require buyers to ensure API supplier documentation supports aseptic manufacturing controls and endotoxin/bioburden requirements indirectly through drug product controls.
Typical procurement endpoints
- Generic injectables (single-ingredient ketorolac tromethamine)
- Tablets/capsules and solid-dose ketorolac salts (where applicable)
- Combination products that include ketorolac as part of a multi-drug portfolio (less common than monotherapy)
Which companies supply phenylephrine hydrochloride API for nasal, eye, and injection formulations?
API supply model: who sells phenylephrine hydrochloride
Phenylephrine hydrochloride is supplied for multiple therapeutic routes, typically:
- Ophthalmic solutions (mydriasis, diagnostic use)
- Nasal decongestants (OTC and prescription strengths)
- Parenteral pressor use (in hospitals, compounded or commercial)
Supplier qualification is driven by:
- Oxidation and related impurity management under storage and processing
- Salt form consistency and moisture control
- Particle size distribution compatibility with solution or solid formulation methods
- Regulatory dossier readiness (US DMF/EDMF or direct reference)
Where supplier selection usually breaks
- Phenylephrine oxidation and impurity profiles can shift with processing, packaging, and storage conditions.
- Buyers often require validated retest/expiry frameworks and change notifications for upstream synthesis.
What patents control the manufacturing and formulation supply chain for ketorolac tromethamine and phenylephrine?
API manufacturing vs drug product patents
Most competitive “supplier” constraints are practical rather than patent-driven at the API level, unless:
- There are process patents on specific synthetic routes or intermediates used by a constrained manufacturer.
- There are formulation patents for specific dosage forms (extended release, preservative systems, buffering systems, or combination-dose technologies).
How to interpret “supplier risk” from a patent estate
- If a drug product has formulation IP, multiple API suppliers can exist, but finish-dose manufacturers may be restricted.
- If a process patent is active, an API supplier may still sell, but buyers may face litigation or licensing risk only if a particular route is used in the manufactured API and later incorporated into an infringing dosage form.
How do API suppliers get approved into FDA and market supply chains?
FDA dossier pathways
US market entry uses one of:
- US DMF referenced by the finished-dose applicant
- EDMF for Drug Master Files sourced from non-US sites
- ANDA/505(b)(2) reliance or direct filing support (via letters of access or direct ownership alignment)
Qualification artifacts buyers require
- CoA with lot-specific testing
- GMP compliance documentation and inspection history
- Validation package for impurity profiles and stability
- Change control terms aligned to drug product filing maintenance
What supplier categories matter more than “the company name” for ketorolac and phenylephrine?
Category 1: API manufacturers
These suppliers sell ketorolac tromethamine and phenylephrine hydrochloride as APIs to multiple customers.
Category 2: Intermediate manufacturers
When buyers outsource intermediates:
- They screen for process capability and impurity control at intermediate stage
- Finished API manufacturing must still meet final spec and dossier requirements
Category 3: Finished-dose contract manufacturers
These organizations source APIs and run the formulation, fill-finish, and packaging. Supplier choice is often locked into:
- the CMC strategy in the regulatory filing
- quality agreements
- audit readiness
Which combination products include phenylephrine hydrochloride and how does that affect sourcing?
Common combination structures
Phenylephrine appears in:
- multi-ingredient cold/respiratory OTC products (strength and combinations vary by market)
- ophthalmic diagnostic combinations (varies by country and indication)
Sourcing impact
- For combination tablets/liquids, buyers require harmonized impurity profiles across all actives.
- For ophthalmic/sterile products, suppliers are evaluated through sterile manufacturing and preservative compatibility rather than only API purity.
What generic entry risks exist for ketorolac and phenylephrine products based on supplier and IP?
Risk drivers
- Formulation lifecycle IP in finished dosage forms can delay generic entry even when multiple APIs exist.
- Process-linked IP can constrain “allowed” routes for certain API lots if the route falls within a patented method.
How that shows up operationally
- A generic manufacturer may qualify only a subset of API suppliers to meet compatibility and CMC acceptance.
- Multiple suppliers can still be “real,” but only some are used in the filing.
How many suppliers exist for each API and where does capacity concentrate?
Typical market concentration patterns
For widely used small molecules like these, supply is often distributed across:
- several qualified API manufacturers globally
- a narrower subset that maintain strong DMF/EDMF update cadence and audit histories
Capacity tends to concentrate in regions with mature small-molecule API ecosystems, with downstream CMO presence pulling from those upstream networks.
Key Takeaways
- Ketorolac tromethamine and phenylephrine hydrochloride are sourced through multi-step supply chains where regulatory dossier support (DMF/EDMF) and impurity control drive supplier qualification.
- Patent risk usually affects finished-dose formulation/process routes more than it restricts API commercial availability, unless process/formulation IP is actively asserted against specific manufacturing methods.
- Supplier selection for either active is most constrained by the buyer’s regulatory CMC strategy and validated impurity/stability compatibility with the intended dosage form.
FAQs
- Do ketorolac tromethamine APIs require special impurity monitoring for injectable products?
- How do buyers qualify phenylephrine hydrochloride suppliers for ophthalmic solutions?
- What documentation is required to use an API DMF for a US drug product filing?
- Can multiple ketorolac API suppliers be used after a generic product approval without triggering CMC updates?
- What role do intermediate suppliers play in ketorolac and phenylephrine API impurity control?
References
No sources cited.
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