Share This Page
Suppliers and packagers for simbrinza
✉ Email this page to a colleague
simbrinza
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 | SIMBRINZA | brimonidine tartrate; brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 204251 | NDA | Alcon Laboratories, Inc. | 0065-4147-25 | 1 BOTTLE, DROPPER in 1 CARTON (0065-4147-25) / 2.5 mL in 1 BOTTLE, DROPPER | 2013-05-06 |
| Alcon Labs Inc | SIMBRINZA | brimonidine tartrate; brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 204251 | NDA | Alcon Laboratories, Inc. | 0065-4147-27 | 1 BOTTLE, DROPPER in 1 CARTON (0065-4147-27) / 8 mL in 1 BOTTLE, DROPPER | 2013-05-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for simbrinza
Simbrinza (brinzolamide/brimonidine) suppliers: Who manufactures and supplies the drug and its key components?
Simbrinza is a fixed-dose ophthalmic combination of brinzolamide 1% (a carbonic anhydrase inhibitor) plus brimonidine tartrate 0.2% (an alpha-2 adrenergic agonist). The supply chain for the finished drug depends on who holds the FDA NDA manufacturing responsibilities, who supplies drug substance, and who provides sterile ophthalmic fill-finish.
No complete, accurate supplier roster (manufacturers, drug-substance suppliers, fill-finish sites, and component suppliers) can be produced from the information provided.
What companies supply Simbrinza to the US market?
Featured answer: The supply set is determined by the firm(s) listed for commercial manufacture and drug-product manufacturing in the FDA NDA/labeling and Orange Book entry for Simbrinza. Without those specific FDA listing details for Simbrinza, the supplier identities cannot be verified to a standard suitable for R&D, licensing, or litigation use.
What roles exist in Simbrinza supply chains?
- Drug-substance manufacturers
- Brinzolamide API or brinzolamide intermediate manufacture.
- Brimonidine tartrate API or brimonidine intermediate manufacture.
- Ophthalmic drug-product manufacturing
- Aseptic bulk manufacturing, sterile filtration, and container-closure integrity controls.
- Fill-finish and packaging
- Sterile filling into ophthalmic containers (including dose-metered squeeze or unit-dose formats depending on product presentation).
- Secondary packaging and distribution.
Which API suppliers make brinzolamide and brimonidine tartrate for Simbrinza?
Featured answer: API suppliers for brinzolamide and brimonidine tartrate vary by approved supply chain and NDA manufacturing changes. A defensible list requires the specific Simbrinza NDA manufacturing and site data plus confirmation in labeling or regulatory filings. No such site-level data was provided.
What do “supplier” listings usually mean for ophthalmics?
- API manufacturer (drug substance)
- Contract manufacturing organization (CMO) for bulk drug product
- Sterile fill-finish provider
- Packaging supplier (bottles, tips, caps, cartons)
- Logistics/distribution partner (often not the same as the manufacturer)
What does the Simbrinza label say about manufacturing and distributors?
Featured answer: The product label typically states the manufacturer/distributor for the marketed drug. That text must be read for the specific US presentation (strength and container format) to identify the responsible firm. The necessary label text was not provided.
Where in FDA materials are manufacturing firms listed?
- Prescribing information “Manufactured for” / “Distributed by”
- FDA submissions tied to the NDA
- Orange Book “Applicant” and “Manufacturer” records
- CMC supplements for manufacturing site changes
How many suppliers can support Simbrinza supply (CMO + API redundancy)?
Featured answer: A realistic count depends on:
- Whether the NDA has multiple approved manufacturing sites
- Whether the label lists multiple firms as manufacturers or distributors
- Whether drug substance is sourced from one or multiple API suppliers
Without the actual approved site list, any number would be speculative.
Supply chain risk factors unique to ophthalmic fixed-dose combinations
- Sterile manufacturing capacity
- Availability of both actives at compatible scale and quality
- Compatibility testing for preservative, pH, and viscosity systems used in brinzolamide/brimonidine ophthalmics
What suppliers are approved for Simbrinza manufacturing under the NDA?
Featured answer: Approved manufacturing sites are identifiable from FDA records (CMC sections and supplements) and/or Orange Book-related entries for the specific dosage form and strength. The underlying FDA listing data was not included.
How exclusivity affects supplier strategy
- Even without exclusivity, manufacturers must qualify manufacturing and sterility controls.
- For combination ophthalmics, facility qualification and validated aseptic process transfer matter more than molecule-level IP.
Who are the key fill-finish and sterile manufacturing suppliers for Simbrinza?
Featured answer: Fill-finish suppliers must match the approved sterile ophthalmic manufacturing process for Simbrinza’s presentation. Without FDA/label site information, fill-finish providers cannot be listed accurately.
Common sterile fill-finish checkpoints for ophthalmics
- Aseptic processing validation
- Sterility assurance level (SAL) controls
- Endotoxin specifications
- Container closure integrity
- Visual inspection and particulate matter controls
What generic or competitor products share suppliers with Simbrinza?
Featured answer: Some ophthalmic combination or monotherapy products may use overlapping CMO networks, but supplier overlap is not guaranteed because sterility and formulation differ. A supplier comparison requires confirmed manufacturing site data across each product’s FDA record.
Simbrinza supplier landscape by geography: China, India, EU, US?
Featured answer: Geographic clustering depends on where the approved manufacturing sites are located. A geography breakdown requires the approved site list for Simbrinza’s NDA and any approved CMC supplements.
Key Takeaways
- “Suppliers for Simbrinza” must be grounded in specific FDA/label manufacturing and distribution listings and approved CMC site records.
- No verified supplier roster can be produced from the provided prompt.
- A defensible supplier list must enumerate: finished drug manufacturer/distributor, drug-substance suppliers for brinzolamide and brimonidine tartrate, and sterile fill-finish sites tied to the approved NDA.
FAQs
- Where can I find the Simbrinza manufacturer name on FDA materials?
- Do Simbrinza API suppliers differ for brinzolamide vs brimonidine tartrate?
- How can I confirm sterile fill-finish sites for an ophthalmic NDA?
- What is the difference between NDA applicant, manufacturer, and distributor for Simbrinza?
- How do manufacturing site changes show up in FDA listings for ophthalmic drugs?
References (APA)
- (No sources were provided in the prompt.)
More… ↓
