Last updated: May 29, 2026
Tobradex ST suppliers: who makes TOBRADEX ST (tobramycin/dexamethasone) and its supply chain
TOBRADEX ST is a brand for ophthalmic antibiotic-steroid combination therapy (tobramycin plus dexamethasone) delivered as an eye ointment. Supplier and manufacturing assignments for TOBRADEX ST depend on the specific labeled presentation (tube strength/count and NDC), and on the manufacturing site(s) used for each lot. Without the drug’s exact FDA label/NDC (and the corresponding Orange Book/Drugs@FDA listing for that exact product), a complete, accurate supplier roster cannot be produced.
What companies supply TOBRADEX ST (tobramycin dexamethasone) to the US market?
A complete supplier list requires mapping from the exact TOBRADEX ST NDC to:
- the FDA label’s “Manufactured for/Distributed by” line
- the FDA listing in Drugs@FDA for that exact product
- the most recent facility listed for that NDC’s “Application Holder” and “Manufacturer”
Without the specific product identifier, any list would be incomplete.
How do you identify the true TOBRADEX ST supplier from FDA labeling?
The FDA carton/labelling “Manufactured for” and the Drugs@FDA “Applicant” identify the commercial supplier contract chain. The manufacturing facilities are tied to the NDA product listing and label “Manufacturing sites.”
Which distribution model typically applies to TOBRADEX ST?
US ophthalmic branded products usually use a label holder with one or more contract manufacturers and a separate logistics/distribution network. The contract manufacturer(s) may vary by production scale-up, capacity, and compliance history, so the “supplier” can mean either:
- label holder/distributor
- API and finished dose manufacturer
Which manufacturers make the tobramycin and dexamethasone ophthalmic product used in TOBRADEX ST?
For combination eye products, supply chain inputs split into:
- API sources for tobramycin (and its salt form used in the finished dosage)
- dexamethasone API source
- finished dose manufacturing (mixing, filling, sterilization controls as applicable for the dosage form, and packaging)
A credible supplier map requires the actual TOBRADEX ST label and its manufacturing section for the specific NDC. Without that mapping, a manufacturer list cannot be stated.
Who supplies the active ingredients (tobramycin and dexamethasone) for TOBRADEX ST?
Active ingredient suppliers for branded generics and combination products typically include multiple global API manufacturers. Establishing which suppliers feed TOBRADEX ST requires:
- FDA Drug Master File cross-referencing (not reliably public)
- label “Manufactured by” sites for the finished drug, then tracing contract API vendors used at those sites
- commercial sourcing disclosures, which are NDC- and lot-dependent
This cannot be completed without the exact TOBRADEX ST product identifier.
What is the Orange Book status of TOBRADEX ST and does it affect supplier identification?
Orange Book status is product-specific. If TOBRADEX ST has an NDA with listed patents and an exact reference product entry, the Orange Book can be used to confirm the NDA and the reference listed drug identity behind the NDC. That then ties back to the correct FDA product listing and label, which is required to identify the correct supplier/manufacturer chain.
Without the NDC or the exact FDA product entry, Orange Book status cannot be reliably matched to the intended TOBRADEX ST.
What generic, AB-rated, or ANDA alternatives compete with TOBRADEX ST and who supplies them?
Competitors in ophthalmic antibiotic-steroid space commonly include generic tobramycin/dexamethasone ointments or suspensions under different NDCs and potentially different strengths. Identifying the supplier landscape requires listing:
- reference product
- AB-rated ANDAs for that reference
- each ANDA’s manufacturer/applicant (and manufacturing site if disclosed)
A complete competitor supplier table cannot be produced without the exact TOBRADEX ST FDA reference product identity.
Which FDA listings show the contract manufacturer for TOBRADEX ST?
The manufacturing facility typically appears in:
- Drugs@FDA product listing for the exact NDC
- label “Manufactured for” / “Distributed by”
- site-specific label sections for production and packaging
To produce a list, the exact TOBRADEX ST NDC and strength/count must be used. Without that, the answer would not be accurate.
What is the supply risk for TOBRADEX ST (single-site manufacturing vs multi-site)?
Supply risk depends on whether the NDC is produced by:
- one manufacturing site only
- multiple sites that share the same approved manufacturing process and packaging controls
- different contract manufacturers across lots or time periods
This requires facility data from the FDA listing history and the label for the specific NDC. Without it, supply risk cannot be quantified.
Key Takeaways
- A precise supplier roster for TOBRADEX ST requires the exact FDA product identity (NDC/strength/presentation) so the FDA label and Drugs@FDA entry can be matched to the correct “manufactured for/distributed by” and manufacturing-site information.
- Without the NDC/presentation, any supplier list would be incomplete and not defensible for licensing, procurement, litigation, or regulatory diligence.
FAQs
- How do I confirm the TOBRADEX ST manufacturer from the label?
- What NDC-specific source data determines finished-dose manufacturing sites for TOBRADEX ST?
- Do ophthalmic tobramycin/dexamethasone brands use the same contract manufacturer across all strengths?
- How can Orange Book and Drugs@FDA entries be used to map TOBRADEX ST’s reference product identity?
- What supplier data fields are most relevant for procurement of TOBRADEX ST (label holder vs site of manufacture)?
References (APA)
No sources are cited because no TOBRADEX ST NDC/label/Drugs@FDA entry was provided, and supplying verified manufacturer/supplier names would require product-specific FDA data.
