Last updated: May 26, 2026
ZYMAXID suppliers: Who manufactures of ZYMAXID (gatifloxacin ophthalmic solution) in the US?
Zymaxid is the brand for gatifloxacin ophthalmic solution (typically supplied as 0.5% for ocular use). The drug’s “suppliers” in the US market are identified through the FDA’s listing of the finished dosage form and the associated manufacturing sites, plus the Orange Book record tied to the NDA. This analysis is not provided here because the required FDA/Orange Book and listing-level sourcing details (manufacturers, labeler, NDC-to-manufacturer mapping, and site addresses) are not included in the input.
What companies supply Zymaxid (gatifloxacin ophthalmic solution) to pharmacies and hospitals?
Answer: Supplier identification depends on:
- FDA SPL listing for the finished drug product (labeler/supplier, manufacturer of record, and manufacturing site(s))
- Orange Book record for the NDA (to connect product strength/form to the patent and exclusivity record)
- NDC directory mappings (to connect each product NDC to a manufacturing entity)
Without the specific NDC(s) and the FDA listing record(s), complete and accurate supplier names and site-level manufacturers cannot be produced.
H3: What is the FDA “labeler” vs the “manufacturer of record” for Zymaxid?
FDA listings generally separate:
- Labeler (marketing authorization party shown on SPL files)
- Manufacturer of record / applicant
- Manufacturing site(s) for drug substance and drug product
H3: Why do Zymaxid suppliers vary by NDC?
Multiple NDCs can correspond to:
- different presentations (fill size, strength packaging)
- different manufacturing sites over time
- post-approval manufacturing transfers
What is the Orange Book status of Zymaxid, and does it show listed applicants and manufacturing changes?
Answer: Orange Book records show:
- NDA number
- patent list (method-of-use, formulation, device, etc.)
- exclusivity (if any)
- the approved applicant tied to the NDA
But supplier entities beyond the NDA applicant require the FDA SPL product listing. Without the Orange Book/NDA identifier for Zymaxid in the provided input, supplier extraction is not possible.
H3: Does Zymaxid have active exclusivity that affects supply chain entries?
Exclusivity affects generic/ANDA timing, but supplier changes for the brand can still occur via manufacturing transfers. Determining those changes requires the FDA listing history, not provided here.
Which generic or alternative gatifloxacin ophthalmic products compete with Zymaxid, and who supplies them?
Answer: Generic manufacturers and entrants are typically identified by:
- ANDA products in the Orange Book
- FDA SPL listing labeler/manufacturer-of-record for each competing NDC
Because competitor product mapping is not contained in the input, a definitive supplier list cannot be produced.
Which manufacturing sites produce Zymaxid ophthalmic solution (0.5%), and how can you verify them?
Answer: Verification requires:
- the FDA SPL “drug product” section for Zymaxid NDC(s)
- the listed manufacturer name and address for each site
Site-level manufacturer names and addresses are not provided in the input, so a complete supplier dossier cannot be compiled.
How does ZYMAXID supply chain sourcing work for ophthalmic solution products?
Answer: Typical constraints that drive supplier and site qualification for ophthalmic solutions include:
- sterile manufacturing controls
- container-closure system compatibility
- filling and packaging process qualification
- QA release testing for ocular dosage forms
This is general industry context. The specific supplier roster for Zymaxid still requires FDA product listing data tied to Zymaxid’s NDC(s).
What manufacturing or IP barriers affect who can supply Zymaxid?
Answer: For a branded product, barriers include:
- NDA-related regulatory protections (exclusivity, patents listed in Orange Book)
- method-of-manufacture or formulation patents
- ANDA change-of-ownership or facility qualification requirements
But the specific Zymaxid patent estate and which barriers apply are not included in the input.
Key Takeaways
- Supplier identification for Zymaxid must be pulled from FDA SPL/NDC listings and Orange Book-linked NDA records.
- The input does not include the necessary FDA listing identifiers (NDC(s), NDA number, labeler/applicant, or SPL records), so a complete and accurate supplier list cannot be produced.
FAQs
- How do I find the manufacturer of Zymaxid for a specific NDC?
- Does the Zymaxid labeler always match the manufacturer of record in FDA listings?
- What FDA database lists Zymaxid manufacturing sites by NDC?
- Are Zymaxid suppliers different for different pack sizes or fill volumes?
- Do patent listings for Zymaxid predict which suppliers can launch generics?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- U.S. Food and Drug Administration. Drugs@FDA (product label and approval information).
- U.S. Food and Drug Administration. Structured Product Labeling (SPL) and NDC directory resources.
