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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	TOBRADEX	dexamethasone; tobramycin	OINTMENT;OPHTHALMIC	050616	NDA	Novartis Pharmaceuticals Corporation	0078-0876-01	3.5 g in 1 TUBE (0078-0876-01)	1988-10-15
Sandoz	TOBRADEX	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050592	NDA AUTHORIZED GENERIC	A-S Medication Solutions	50090-1135-0	2.5 mL in 1 BOTTLE (50090-1135-0)	2009-01-02
Sandoz	TOBRADEX	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050592	NDA AUTHORIZED GENERIC	A-S Medication Solutions	50090-1136-0	5 mL in 1 BOTTLE (50090-1136-0)	2009-01-02
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 28, 2026

TOBRADEX suppliers: Who manufactures Tobramycin-dexamethasone ophthalmic products and what supply chain options exist?

Executive summary: Tobradex (tobramycin + dexamethasone) ophthalmic formulations are supplied through branded and generic manufacturers, with final product availability tied to (1) the specific strength and dosage form (ointment vs suspension), (2) country/regulator labeling, and (3) whether products are marketed under Abbreviated New Drug Application (ANDA) approvals. A complete supplier map requires jurisdiction- and product-form-specific sourcing because “TOBRADEX” is a brand umbrella that covers multiple strengths/dosage forms, and the supply base varies by FDA label, Orange Book listing, and local wholesale distribution.

If you need a jurisdiction-specific supplier roster (US vs EU vs UK vs Canada), the right method is to start from the regulator listing for each specific TOBRADEX trade dress (suspension and/or ointment) and then pull the corresponding approved ANDA/NDA manufacturers, labeled product packagers, and upstream API intermediates.

What companies supply Tobradex (tobramycin and dexamethasone) ophthalmic suspension and ointment?

Direct answer (how TOBRADEX suppliers are determined): suppliers are the NDA/ANDA labelers listed for the specific tobramycin/dexamethasone ophthalmic dosage form and strength in the jurisdiction’s regulator database (FDA Orange Book for the US; EMA national marketing authorizations in Europe; UK MHRA listings; etc.). The branded labeler and each ANDA labeler can differ even when the active ingredients are the same.

Common Tobradex product forms to map

Ophthalmic suspension (tobramycin + dexamethasone)
Ophthalmic ointment (tobramycin + dexamethasone)

Supplier mapping logic (US)

Identify the drug product listing for the exact strength and dosage form.
Extract:
- NDA/ANDA holder (labeler)
- manufacturer/packager (if disclosed in labeling and submissions)
- patent list linkage (Orange Book, when relevant)
- application type (NDA vs ANDA)
Then reconcile those labelers to downstream wholesale distributors used for hospital and retail channels.

What is the Orange Book status of Tobradex and how does it affect supplier availability?

Direct answer: Orange Book status determines whether the US market is anchored by an original NDA supply chain or opened to multiple ANDA suppliers. Where an application is still protected by unexpired patents, fewer suppliers typically hold approvals for substitution with a “same drug, same route, same dosage form, same strength” product.

Why Orange Book status matters for supplier strategy

Patent still in force: fewer ANDA entrants, more reliance on branded or licensed branded supply.
Patents expired or carved out: more ANDA competition, expanding labelers and potentially lowering supply risk.

Data needed for a complete supplier list

Orange Book drug product entry for the exact TOBRADEX strength and dosage form in the relevant market.
The ANDA labelers tied to those drug product codes.

Which generic ANDA suppliers compete with Tobradex in the US?

Direct answer (category): generic Tobramycin-dexamethasone ophthalmic products are supplied by ANDA-approved manufacturers. The supplier roster changes over time as ANDA products launch, discontinue, or rotate labelers and contract manufacturers.

How to structure a supplier competitive set

For each product form and strength:

List each ANDA label holder
Note discontinuations and relaunches using recent FDA/label updates
Identify common contract manufacturing footprints where products are “manufactured for” multiple labelers

Which API and intermediate suppliers support tobramycin and dexamethasone ophthalmic products?

Direct answer: API supply is separated from final drug product supply. Tobradex supply chains normally include:

Tobramycin API suppliers (fermentation and purification chains)
Dexamethasone API suppliers (synthetic and purification chains)
Formulation and sterile ophthalmic fill-finish sites
Packaging providers (unit-dose bottles, multi-dose bottles, tubes)

Practical implication: even if multiple companies market TOBRADEX-equivalents, the sterile ophthalmic fill-finish bottlenecks can concentrate risk in fewer contract manufacturing sites.

What contract manufacturing organizations (CMOs) make ophthalmic tobramycin-dexamethasone products?

Direct answer: ophthalmic suspension and ointment products are typically filled and packaged by specialized sterile and semi-solid manufacturers. Supplier concentration depends on:

Sterile suspension vs ointment process
Containment and aseptic fill capability
Quality systems (sterility assurance, particulate control)
Batch release geography

How to identify likely ophthalmic CMOs

Use the labeled “manufactured for” and “distributed by” language on the specific product package.
Cross-check manufacturing addresses in regulatory submissions or product labeling.
Map repeat addresses across multiple ANDAs.

What licensing or marketing arrangements affect Tobradex supply?

Direct answer: branded ophthalmic products frequently use a mix of:

internal manufacturing (branded labeler-owned sites)
contract manufacturing under quality agreements
distribution agreements with national wholesalers
licensing of marketed equivalents after ANDA approval

Supplier consequence: multiple “suppliers” can share the same underlying manufacturer/packager, changing pricing and availability but not necessarily manufacturing capacity.

What formulation patents or method-of-use patents restrict supplier entry for Tobradex?

Direct answer: the scope of supplier entry is driven by:

Orange Book-listed patents for the specific drug product code (formulation, manufacturing, and/or method-of-use)
expiration schedules per jurisdiction
any pediatric exclusivity or switching-change-related exclusivity affecting substitutions

Supplier consequence: even with an ANDA, product launch may be delayed by litigation or settlement obligations tied to Paragraph IV challenges.

What patent litigation or settlements affect Tobradex generic launch risk?

Direct answer: for US markets, Paragraph IV challenges to Orange Book listed patents can delay approval and/or launch through statutory stays or litigation timelines. Supplier availability can tighten when:

litigation blocks final approval for launch
settlement triggers launch timing commitments
manufacturing site approvals are suspended due to quality/inspection outcomes

When does Tobradex exclusivity end and when can new suppliers launch?

Direct answer: supplier expansion hinges on:

expiration of relevant Orange Book patents
exclusivity end dates that apply to the NDA/then-to-ANDA landscape
any negotiated “authorized generic” windows

Timing implication: a supplier roster that changes quickly usually follows patent and exclusivity milestones rather than changes in clinical need.

Which countries have the most robust Tobradex supply base?

Direct answer: countries with multiple ANDA/National marketing authorizations and active retail hospital procurement tend to show:

more labelers
broader distributor coverage
lower single-site dependency

Supplier concentration risk increases in jurisdictions where:

fewer ANDAs are approved
procurement relies on one or two wholesalers
ophthalmic sterile capacity is consolidated

Commercial outlook: how supplier count impacts Tobradex pricing and availability

Direct answer: more approved labelers and more fill-finish capacity typically reduce:

backorder risk
distributor allocation frequency
price volatility

Supplier count is a leading indicator of how quickly availability recovers after manufacturing disruptions.

Key Takeaways

TOBRADEX suppliers are jurisdiction- and dosage-form specific. Map the exact ophthalmic suspension or ointment strength first, then pull the labeler/packager from regulator listings.
Supplier competition in the US depends on Orange Book status. Patents and exclusivity shape how many ANDA labelers can market substitutable equivalents.
API suppliers differ from final product suppliers. Even when multiple companies sell TOBRADEX, sterile ophthalmic fill-finish and packaging can concentrate risk in fewer CMOs.
Litigation and settlements can delay market entry. Paragraph IV outcomes and statutory stays affect the timing of new supplier launches.

FAQs

How do I identify the manufacturer of a specific Tobradex lot (not just the brand owner)?
Check the package labeling “manufactured for” and lot trace codes, then cross-map to the drug product listing/labeler.
Do tobramycin-dexamethasone ophthalmic ointment and suspension use the same suppliers?
No. Sterile suspension fill-finish and ointment semi-solid manufacturing often use different facilities and release processes.
Which regulator listing should I use for Tobradex suppliers in the US vs EU?
US: FDA Orange Book for drug product/ANDA labelers. EU: national marketing authorizations and product databases tied to the specific member state.
Can multiple ANDA labelers share the same underlying manufacturer?
Yes. Contract manufacturing and packaging agreements can cause several brand/label products to originate from the same manufacturing sites.
What supply risks matter most for ophthalmic tobramycin-dexamethasone?
Aseptic/sterile capacity, aseptic processing deviations, sterility assurance failures, and packaging component availability.

References (APA)

FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
FDA. Drug Shortages. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-shortages
FDA. ANDA Submissions: Overview. U.S. Food and Drug Administration. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda

Suppliers and packagers for TOBRADEX

TOBRADEX