Suppliers and packagers for MAXIDEX

MAXIDEX

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Harrow Eye	MAXIDEX	dexamethasone	SUSPENSION/DROPS;OPHTHALMIC	013422	NDA	Harrow Eye, LLC	82667-600-05	1 BOTTLE, PLASTIC in 1 CARTON (82667-600-05) / 5 mL in 1 BOTTLE, PLASTIC	2025-04-07

MAXIDEX Supplier Landscape: What Companies Supply the Active Ingredient, Finished Dosage Forms, and Key Components

Last updated: June 3, 2026

Who supplies MAXIDEX (dexamethasone) in the US market?

MAXIDEX is a brand for dexamethasone ophthalmic products. The supply chain typically splits into: (1) active pharmaceutical ingredient (API) producers, (2) contract manufacturers that fill/finish ophthalmic sterile dosage forms, and (3) distributors that sell finished product through wholesalers.

Finished-dose supply (typical structure)

• Brand owner/marketer: controls label, distribution, and regulatory filings (NDC holder of record).
• Sterile ophthalmic manufacturers: produce sterile drug product (fill-finish in ophthalmic bottles/tubes, sterile filtration, terminal sterilization where applicable).
• Wholesalers/distributors: feed retail and hospital channels.

What active ingredient suppliers make dexamethasone for ophthalmic products like MAXIDEX?

For ophthalmic steroids, the API is generally dexamethasone (small-molecule corticosteroid). API supply is usually global and multi-sourced, with commercial availability via Chinese and Indian API manufacturers and a smaller set of US/EU suppliers.

API sourcing characteristics

• API is typically produced in bulk and shipped as intermediate or API powder.
• Ophthalmic steroid drug products require robust controls for particle size, impurities, and microbiological controls for the sterile drug product, even though the API itself is not sterile.

Which contract manufacturers supply sterile ophthalmic filling for MAXIDEX-like products?

Sterile ophthalmic supply usually requires:

• GMP sterile manufacturing suites
• Aseptic processing capability and/or terminal sterilization capability depending on formulation
• Sterile filtration validation
• Visual inspection and microbiological release testing
• Container closure compatibility studies for ophthalmic packaging

Common contract manufacturing roles

• Bulk drug substance to bulk drug product compounding
• Sterile filtration and aseptic fill
• Packaging into bottles (or tubes) with controlled humidity/light handling for corticosteroids

How do FDA drug listing and Orange Book data identify MAXIDEX suppliers?

For brand products, FDA label/NDC listings identify:

• Labeler/NDC holder (who supplies under the label)
• Proprietary name, dosage form, and strength
• Route of administration and packaging size

Orange Book entries (for products that are listed there) typically identify:

• Drug substance and active ingredient(s)
• Patent numbers tied to the approved drug product

Practical implication

• The NDC labeler often maps to the direct supplier/distributor of the finished product in the US, but it does not always disclose the underlying contract manufacturer.

What is the supply role of generic and “authorized” equivalents versus MAXIDEX?

When generics enter, they usually:

• Source dexamethasone API from competing API vendors
• Use different sterile fill-finish plants
• File ANDAs to reference the approved innovator label and manufacturing

Competitive consequence

• MAXIDEX supply risk and pricing pressure rise when generic manufactur­ing capacity increases, independent of API source.

Are there biosimilar or biologic supply issues for MAXIDEX?

No. MAXIDEX is not a biologic. The supply model is small-molecule API plus sterile ophthalmic drug product manufacturing, not biologic fill-finish or biosimilar comparability pathways.

What packaging suppliers and container-closure components are typically used for ophthalmic dexamethasone?

MAXIDEX-like products generally use:

• Ophthalmic bottle formats with sterile closures
• Or ophthalmic tube formats (depending on the specific MAXIDEX presentation)
• Elastomeric components, seals, and tip caps where applicable

Component supply matters because:

• Extractables/leachables can affect corticosteroid stability and preservative systems
• Closure systems affect particulate counts and seal integrity testing during stability programs

How do supply chain disruptions show up for MAXIDEX?

For ophthalmic sterile steroids, disruption signals tend to appear as:

• NDC-level shortages or constrained allocation by wholesalers
• Lead-time increases for sterile fill-finish slots
• Reduced lot availability tied to manufacturing holds or sterility testing backlogs

These show up at the finished product distributor level rather than at API vendor level.

Which companies typically distribute MAXIDEX to wholesalers?

Brand marketers commonly distribute through:

• National wholesalers (buying through distribution networks)
• Hospital pharmacy supply chains
• Specialty distributors for ophthalmology-related procurement channels

The distribution company can differ by geography and contract.

Key Takeaways

• MAXIDEX supply is driven by finished sterile ophthalmic manufacturing and dexamethasone API sourcing, with NDC labeler/marketer determining the direct US “supplier” of record.
• FDA listings can identify the labeler but usually do not disclose the underlying contract manufacturer or API vendor.
• Component and container-closure supply is a material part of risk because sterile ophthalmic stability and extractables control are integral to approval.

FAQs

1. How can I identify the US supplier of record for MAXIDEX by NDC?
2. Do generic ophthalmic dexamethasone products use the same sterile manufacturing plants as MAXIDEX?
3. Which regulatory documents for MAXIDEX list the manufacturing sites and control strategy?
4. What sterility assurance and release testing requirements apply to ophthalmic dexamethasone drug products?
5. How does container-closure selection affect stability for ophthalmic corticosteroids like MAXIDEX?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/ob/
2. FDA. Drug Products (NDC Directory). FDA. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-names-and-labels#ndc