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Suppliers and packagers for generic pharmaceutical drug: NEPAFENAC
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NEPAFENAC
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Harrow Eye | ILEVRO | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 203491 | NDA | Harrow Eye, LLC | 82667-400-03 | 1 BOTTLE, PLASTIC in 1 CARTON (82667-400-03) / 3 mL in 1 BOTTLE, PLASTIC | 2024-05-01 |
| Harrow Eye | NEVANAC | nepafenac | SUSPENSION/DROPS;OPHTHALMIC | 021862 | NDA | Harrow Eye, LLC | 82667-500-03 | 1 BOTTLE, PLASTIC in 1 CARTON (82667-500-03) / 3 mL in 1 BOTTLE, PLASTIC | 2025-01-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: NEPAFENAC
Nepafenac API and finished-dose suppliers: who makes it for global markets?
Nepafenac (CAS 136-42-9) is most commonly supplied as an active pharmaceutical ingredient (API) for ophthalmic use, typically for aqueous eye drop products used in ophthalmology (eg, cataract surgery indications). At market level, sourcing usually splits into (1) API manufacturers that produce nepafenac to drug-substance specifications and (2) contract manufacturers that formulate and package nepafenac ophthalmic solutions.
No definitive, comprehensive supplier roster can be produced from the information provided.
What companies supply nepafenac API worldwide?
Featured snippet answer: Nepafenac API suppliers are identified through Drug Master File (DMF) ownership, CEP/DMF correspondence to regulators, and commercial B2B catalogs tied to specific strengths and jurisdictions.
Common supplier identification channels for nepafenac API
- DMF holders linked to ophthalmic application dossiers
- CEP holders (where applicable) linked to EU registrations
- Authorized distributors listing nepafenac API grade for pharmaceutical customers
- Specific API listings in market procurement systems used by CMOs and formulators
Nepafenac grade and spec dependencies that affect supplier choice
- Ophthalmic-grade particle size and impurity profile
- Solubility and stability requirements for aqueous formulation
- Compliance with ICH Q3A/Q3B impurity limits and regional pharmacopeia expectations
- Packaging compatibility for API transfer to ophthalmic formulators
Which contract manufacturers formulate and package nepafenac eye drops?
Featured snippet answer: Ophthalmic CMOs that support sterile compounding, aseptic filling, and ophthalmic packaging are the typical route for finished-dose supply.
Formulation and packaging constraints that narrow the supplier base
- Sterile manufacturing environment (aseptic processing)
- Container closure system compatibility with nepafenac
- Drop-size and viscosity targets for patient dosing consistency
- Labeling and device integration if bundled with other ophthalmic products
Finished-dose strengths that influence CMO selection
- Common ophthalmic concentrations for nepafenac products determine tank batching and analytical validation scope
- Preservative system and container material selections can require additional qualification
What patents protect nepafenac ophthalmic products and constrain supply?
Featured snippet answer: Patent estates for nepafenac ophthalmic products can constrain who can commercialize finished doses, even if API supply exists.
Patent estate components that typically matter
- Composition-of-matter (drug substance) patents
- Formulation patents (concentration, buffer, stabilizers, preservative system)
- Method-of-use patents (post-cataract inflammation/pain dosing regimens)
- Process patents (manufacturing route, impurity control)
When do nepafenac products lose exclusivity, and how does that affect suppliers?
Featured snippet answer: Exclusivity loss typically increases availability of finished-dose manufacturers and triggers market entry by generics, but API suppliers are often unchanged.
Practical impact on the supplier landscape
- Pre-exclusivity: sourcing concentrates around branded product supply chains and verified ophthalmic CMOs
- Post-exclusivity: more CMOs qualify and more labeled generics source nepafenac API in parallel
What is the Orange Book status of nepafenac ophthalmic drugs?
Featured snippet answer: Orange Book status depends on the specific listed product (drug, dosage form, applicant). “Nepafenac” alone is not sufficient to produce a single Orange Book answer.
Why status is product-specific
- Multiple applicants can list different NDA/BLA entries for different strengths
- Each listing has its own patent and exclusivity set
How many patents cover nepafenac formulations and method-of-use?
Featured snippet answer: Coverage is not uniform across all nepafenac ophthalmic brands and generics; counts depend on the specific NDA and product family.
Typical patent family breadth
- Formulation IP can cover buffer systems and stabilizer combinations
- Use patents can cover dosing schedules and post-surgical endpoints
Which companies challenge nepafenac generics via Paragraph IV?
Featured snippet answer: Paragraph IV activity is product- and jurisdiction-specific and depends on identified NDA challengers and the associated patent list.
How Paragraph IV affects supplier availability
- Filing reduces legal risk for generic launchers but does not directly change API supplier qualification
- Finished-dose CMOs may become preferred partners once litigation risk for a given application is resolved
How does nepafenac API sourcing compare with alternative NSAID ophthalmics?
Featured snippet answer: Sourcing competitiveness depends on API impurity profiles, sterile processing know-how, and container closure qualification, not just molecule availability.
Comparison axes used by buyers
- API supply continuity and lead times
- Impurity control capability
- Ability to support ophthalmic formulation qualification
- Regulatory history of the chosen API supplier and CMO
Commercial sourcing risks for nepafenac: what bottlenecks matter most?
Featured snippet answer: The main bottlenecks are typically sterile manufacturing capacity, ophthalmic container qualification, and regulatory/quality documentation tied to the API.
Key risk points in procurement
- Single-source API dependencies for specific impurity specifications
- Aseptic fill-finish capacity constraints
- Delays tied to analytical method validation and stability protocols
- Change control burdens if switching API supplier late in development or scale-up
Key Takeaways
- Nepafenac sourcing splits into nepafenac API suppliers and ophthalmic sterile CMO/finishers.
- Exact supplier lists require product-specific regulatory anchoring (API DMF/CEP holders and finished-dose NDA holders).
- Patent and exclusivity status affects which finished-dose applicants can launch but often does not change the underlying API market.
- Procurement bottlenecks tend to be sterile manufacturing capacity, container closure qualification, and impurity/spec compliance.
FAQs
- How do API DMF holders influence nepafenac ophthalmic supply qualification?
- What sterile manufacturing capabilities are required for nepafenac eye drops?
- Do nepafenac generic launches require switching API suppliers or only formulation/CMC changes?
- How do container closure systems affect stability of nepafenac ophthalmic solutions?
- What documentation do buyers typically require when sourcing nepafenac API for ophthalmology?
References
(No sources were cited because no supplier or regulatory records were provided in the prompt.)
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