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Suppliers and packagers for rhopressa
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rhopressa
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alcon Labs Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254 | NDA | Alcon Laboratories, Inc. | 70727-497-25 | 1 BOTTLE in 1 CARTON (70727-497-25) / 2.5 mL in 1 BOTTLE | 2017-12-18 |
| Alcon Labs Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254 | NDA | Alcon Laboratories, Inc. | 70727-497-99 | 1 BOTTLE in 1 CARTON (70727-497-99) / 2.5 mL in 1 BOTTLE | 2017-12-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for rhopressa
RHOPRESSA suppliers (Rhopressa) manufacturing, API, and contract packaging landscape
Rhopressa (netarsudil ophthalmic solution) supply is anchored by the drug’s branded manufacturing chain (finished product and distribution) and a smaller set of upstream specialists for netarsudil API, key intermediates, and sterility-preserving ophthalmic formulation components. Netarsudil is manufactured through a multi-step chemical synthesis and supplied as an API to ophthalmic drug product manufacturers that handle sterile aqueous processing, container closure systems, and end-to-end quality control.
Key supplier buckets for RHOPRESSA
- Finished-dose manufacturer(s): produces sterile ophthalmic solution filled into ophthalmic dispensers.
- API supplier(s): produces netarsudil (and, where vertically integrated, key intermediates).
- Excipients/components: solubilizers, buffers, tonicity agents, and pH adjusters used in the ophthalmic solution; also sterilization-grade and compatibility-tested materials.
- Sterile fill-finish and packaging: sterile filtration, aseptic/terminal processing (as applicable), and packaging for distribution.
- Labeling and distribution (wholesalers/logistics): handles channel supply and cold-chain only if required by product specs (standard ophthalmic solutions typically do not require cold-chain).
Practical implication for sourcing and competitive benchmarking Most near-term supplier risk is concentrated in:
- Netarsudil API availability (single-source or small-number sourcing),
- sterile fill-finish slot capacity for ophthalmic solutions,
- container closure system supply compatible with the dispensing device.
What companies supply Rhopressa (netarsudil) drug product and who are the finished-dose manufacturers?
Featured snippet answer: Rhopressa supply is typically executed through a branded drug product manufacturer (finished-dose producer) and contract sterile fill-finish partners, with netarsudil sourced from API manufacturers. The finished-dose manufacturing and labeling chain is reflected in the drug’s FDA product listings and the current labeling “Manufactured for/By” and “Distributed by” language.
How to map finished-dose suppliers (method used in due diligence)
- Identify the “Manufactured for” entity on the most recent Rhopressa carton/labeling.
- Pull the corresponding FDA listing entry for Rhopressa to confirm:
- labeler name and
- manufacturer role (drug product vs. distributor).
- Cross-check manufacturing sites against:
- facility registrations (FDA),
- inspection history (when available), and
- distribution lead times and supply constraints.
What to look for in the supplier chain
- Sterile manufacturing capability for ophthalmic solutions (aseptic processing and validated sterilization strategy).
- Expertise with ophthalmic compatibility (container material, adsorption, leachables/extractables, preservative interaction).
- Quality system alignment for ophthalmic standards (sterility assurance, particulate controls, stability programs).
Which suppliers provide netarsudil API used in Rhopressa?
Featured snippet answer: Netarsudil API suppliers are the key upstream constraint for Rhopressa. The API supply chain usually includes chemical manufacturers producing netarsudil and, in some cases, vertically integrated suppliers making key intermediates.
API sourcing diligence checklist
- Confirm netarsudil API in vendor qualification dossiers via:
- supplier CoA and DMF linkage (if referenced),
- analytical method congruence (HPLC impurity profile, assay),
- GMP audit results for API site.
- Identify whether API is:
- commercially sourced from multiple vendors, or
- restricted to a limited number of approved suppliers due to impurity specifications.
Upstream chemical supply risks
- Slowdowns in specialty chemical intermediates.
- Limited number of competent sterile-ready formulation partners for ophthalmic solution fill-finish.
- Regulatory and quality documentation burden to qualify additional API suppliers.
What excipient and component suppliers are involved in Rhopressa ophthalmic solution manufacturing?
Featured snippet answer: Ophthalmic formulation supply depends on multiple component suppliers for buffers, tonicity agents, pH adjusters, solubilizing agents, and ophthalmic-grade packaging materials, each qualified for compatibility and extractables/leachables performance.
Common component categories that require supplier qualification
- Buffer system for pH control and stability.
- Tonicity agent for eye tolerance and isotonicity.
- Preservative system (if present in the formulation) and its supplier chain.
- Solubilization aids to keep netarsudil in solution.
- Dilution and purification consumables for sterile filtration and bulk holding.
Packaging and container closure suppliers
- Ophthalmic dispenser components (bottle/dispenser materials) must be:
- compatible with netarsudil and solution chemistry,
- proven for leachables/extractables and adsorption,
- able to meet dose uniformity and closure integrity requirements.
Who performs sterile fill-finish and packaging for Rhopressa?
Featured snippet answer: Rhopressa is filled as a sterile ophthalmic solution by finished-dose manufacturers and/or contract sterile fill-finish facilities that handle aseptic processing, sterilizing filtration, and ophthalmic-specific packaging assembly.
Fill-finish supplier qualification drivers
- Sterile processing capability and validated sterilization method (process-dependent).
- Extractables/leachables controls for the specific container closure system.
- Environmental monitoring and aseptic controls aligned with sterile ophthalmic product requirements.
- Scale capacity for ophthalmic packaging runs (often constrained by line availability and changeover time).
How can you verify Rhopressa suppliers using FDA labeling, Orange Book, and facility registrations?
Featured snippet answer: Use a three-step verification framework: label text (carton and package insert), FDA product listing/labeler information, and FDA facility registration for manufacturing sites.
Where supplier information is typically captured
- Package label / prescribing information
- identifies “Manufactured for” and the entity name.
- FDA drug listing / SPL
- identifies labeler and often manufacturing sites for drug product.
- Facility registrations (NDC-linked sites)
- confirms where sterile manufacturing occurs.
Why this matters
- The “brand owner” is not the same as the “drug product manufacturer.”
- Contract sterile fill-finish can shift supply risk even when the API source stays constant.
When does Rhopressa face supply risk based on supplier concentration or sterile manufacturing capacity?
Featured snippet answer: Supply risk rises when netarsudil API is sourced from a small number of qualified vendors and when ophthalmic sterile fill-finish line capacity is tight, causing lead-time extensions or batch release delays.
Supply risk signals to monitor
- API lead time changes from qualified vendors.
- Batch release timing shifts tied to sterility testing turnaround or stability program updates.
- Backorders that correlate with line capacity constraints at sterile fill-finish sites.
What are the generic or biosimilar entry implications for Rhopressa sourcing?
Featured snippet answer: Generics and authorized alternatives do not typically change Rhopressa’s immediate supply chain. They can, however, introduce new competition for netarsudil API and ophthalmic sterile fill-finish capacity, potentially affecting procurement costs and availability.
Competitive sourcing pressure points
- API demand increases across multiple manufacturers.
- Shared packaging component supply (ophthalmic dispensers) can tighten.
- Sterile fill-finish slots for ophthalmic solutions become more contested.
Key Takeaways
- Rhopressa supply is best analyzed by splitting the chain into finished-dose manufacturers, netarsudil API suppliers, and sterile fill-finish/ophthalmic packaging providers.
- The highest leverage supplier risk sits in netarsudil API sourcing and the sterile fill-finish capacity for ophthalmic solutions.
- Supplier verification should rely on labeling manufacturer/distributor language, FDA product listings, and FDA facility registrations tied to Rhopressa NDCs.
- Future generic entrants can increase demand for API and sterile fill-finish capacity, impacting pricing and availability.
FAQs
- Which NDCs should be used to map Rhopressa suppliers in FDA listings?
- What documents confirm netarsudil API supplier qualification for ophthalmic use?
- How do container closure system suppliers affect stability and compatibility for Rhopressa?
- What sterile fill-finish capabilities are required for ophthalmic solution batch release?
- How do API batch release specifications influence vendor switching for netarsudil?
References (APA)
- U.S. Food and Drug Administration. Drugs@FDA. Rhopressa (netarsudil) product information and labeling. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
- U.S. Food and Drug Administration. FDA Product and Labeling (SPL) and drug listing records. https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files
- U.S. Food and Drug Administration. FDA Facility Registration and Drug Establishment Registration (FEI) database. https://www.fda.gov/drugs/drug-establishment-and-facility-registration-and-listing
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