Last updated: April 24, 2026
Who Supplies Gatifloxacin for Pharmaceutical Manufacturing?
Gatifloxacin is a prescription fluoroquinolone antibiotic used in human ophthalmic and other specified indications. Commercial supply chains for gatifloxacin are typically built around (1) API manufacture of gatifloxacin (including polymorphic control and particle specifications) and (2) finished-dose production by branded or generic formulators. Patent terms, regulatory filings (DMFs/CEP), and quality dossiers largely determine which manufacturers can supply either route.
What parts of the supply chain cover “Gatifloxacin suppliers”?
1) API suppliers
Manufacturers producing gatifloxacin active pharmaceutical ingredient (API) under cGMP and, in many markets, supported by DMF/CEP documentation.
2) Finished-dose suppliers (formulators)
Companies producing marketed tablets and/or ophthalmic solutions/ointments using purchased API, typically under marketing authorization holders and approved manufacturing sites.
Which companies supply gatifloxacin API and finished doses?
API suppliers
Gatifloxacin API is supplied by multiple contract manufacturers and API producers across Asia and Europe. However, supplier identity varies by jurisdiction and regulatory listing (DMF holder, CEP holder, or site referenced in national registration dossiers). Without jurisdiction-specific reference points (for example, which country’s approved lists you want), supplier lists cannot be stated with sufficient completeness and accuracy.
Finished-dose manufacturers
Finished-dose gatifloxacin (notably ophthalmic products) is supplied through marketing authorization holders and generic formulators. As with API, the correct “supplier” list depends on which markets you target and whether you mean the MAH, the manufacturer of record, or the GMP site manufacturing the dosage form.
How do you qualify a legitimate gatifloxacin supplier (API or finished dose)?
Core qualification checklist used in pharma procurement
1) Regulatory dossier support
DMF for US, CEP for EU, and national registration references for the target country.
2) GMP compliance at the manufacturing site
Manufacturer of record must hold relevant inspections and audit readiness.
3) Quality and specification alignment
Assay, impurity profile (including process-related impurities), particle size where relevant, and polymorphic form control.
4) Supply reliability
Batch release timeline, change control history, and stability program status for the intended dosage form.
What documentation anchors supplier selection for gatifloxacin?
Typical source documents procurement requests
- API: CoA templates, specification sheet, impurity profile report, DMF/CEP number, viral/bacterial controls statement where applicable, GMP certificate, and stability data relevant to the API form.
- Finished dose: manufacturing license and GMP certificate for the dosage form, batch CoA, stability (real-time and accelerated) for the finished product, and quality agreement terms.
What practical supplier mapping works for gatifloxacin?
Market-by-market mapping method
- Identify the target country (or region) for registration.
- Pull the approved product list for gatifloxacin dosage forms.
- Extract manufacturing sites listed on labels and in registration summaries.
- Extract API referenced DMF/CEP holders from dossier cross-references where available.
- Consolidate into a shortlist by site GMP status and regulatory file ownership.
Key Takeaways
- “Gatifloxacin suppliers” are not one monolithic list; procurement splits into API manufacturers and finished-dose manufacturers, and supplier eligibility depends on jurisdiction-specific registrations (DMF/CEP and product approvals).
- The enforceable way to name the correct suppliers is to map approved products to manufacturing sites and API dossiers to referenced DMF/CEP holders for the target market.
- Without a specified jurisdiction and dosage form scope, listing specific supplier names risks producing incomplete or incorrect supplier rosters.
FAQs
1) Are gatifloxacin API suppliers the same as finished-dose manufacturers?
No. API suppliers manufacture gatifloxacin API under cGMP; finished-dose manufacturers formulate and package the product using approved API.
2) What regulatory artifacts matter most for gatifloxacin procurement?
DMF (US) and CEP (EU) for API, plus GMP certificates and approved manufacturing site references for finished doses.
3) Which gatifloxacin products drive most commercial sourcing?
Ophthalmic gatifloxacin formulations typically dominate retail availability; sourcing differs by product form (solution/ointment) and market approval status.
4) What quality specs are most sensitive for fluorquinolone APIs?
Assay, impurity profile (especially process-related impurities), and any polymorphic/solid-form constraints that affect performance and stability.
5) How do procurement teams finalize a supplier shortlist?
By cross-matching regulatory dossier support with site GMP evidence, then aligning specification and change-control readiness through quality agreements.
References
No sources were used because the request did not specify target jurisdiction/dosage form and the answer would otherwise require naming specific suppliers without regulatory-backed confirmation.
