Suppliers and packagers for DUREZOL

DUREZOL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sandoz	DUREZOL	difluprednate	EMULSION;OPHTHALMIC	022212	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-6000-78	1 BOTTLE in 1 CARTON (0781-6000-78) / 5 mL in 1 BOTTLE	2013-05-15
Sandoz	DUREZOL	difluprednate	EMULSION;OPHTHALMIC	022212	NDA	Sandoz Inc	66758-086-75	1 BOTTLE in 1 CARTON (66758-086-75) / 5 mL in 1 BOTTLE	2011-01-25

Suppliers and packagers for DUREZOL

Last updated: June 3, 2026

Durezol (difluprednate) Suppliers: What Companies Manufacture, Market, and Supply the U.S. Market?

Durezol is the brand of difluprednate ophthalmic emulsion (0.05%). U.S. supply is tied to Bausch + Lomb as the brand owner, with manufacturing and distribution handled through Bausch + Lomb’s contract manufacturing and distribution networks and, for some product forms and strengths, secondary supply channels.

Who supplies Durezol (difluprednate) in the U.S.?

Primary U.S. brand supplier: Bausch + Lomb (brand owner and primary marketer of Durezol).

What is the product type and labeled strength?

• Drug/active: difluprednate
• Dosage form: ophthalmic emulsion
• Strength: 0.05%
• Typical labeling: ophthalmic use (post-surgical inflammation and pain indications vary by label updates)

How does Bausch + Lomb’s manufacturing network supply Durezol?

Durezol supply is executed through Bausch + Lomb’s manufacturing and packaging operations and, where applicable, contract manufacturing partners used to produce ophthalmic emulsions and fulfill FDA- and distribution-level requirements.

What supply roles exist in ophthalmic branded products?

• Marketing authorization holder / brand supplier: Bausch + Lomb
• Contract manufacturers: typically handle bulk emulsion production, aseptic fill-finish, and packaging under quality systems
• Distribution: wholesaler and specialty distribution channels aligned with U.S. pharmaceutical distribution models
• Labeling and compliance: brand owner manages labeling, lot release, and regulatory reporting

What manufacturers are listed as suppliers on Durezol packaging?

In the branded ophthalmic category, the “supplier” visible to end users (carton/label) most commonly aligns with:

• Bausch + Lomb as the labeled manufacturer/sponsor or labeler (varies by packaging configuration and NDC presentation)

What is the Orange Book status of Durezol that affects supplier competition?

Durezol is the reference brand for difluprednate ophthalmic emulsion. Generic entries depend on the status of listed patents and any exclusivity protections tied to the NDA and post-approval changes. Patent and exclusivity constraints typically limit licensed generic competition, which in turn keeps brand supply more dominant.

How does patent status affect supplier landscape?

• When exclusivity and/or unexpired patents block generic approvals, supply stays concentrated in the brand ecosystem.
• When those barriers ease, additional suppliers can enter via ANDA-approved generics or authorized product distribution.

Which companies supply Durezol equivalents (generics) or authorized difluprednate products?

The supplier set expands only where ANDA-approved generics or authorized equivalents exist for difluprednate ophthalmic emulsion. In markets where no authorized generic is available, supply remains concentrated in the brand supply chain.

What to expect in procurement and sourcing

• If only the branded product is available, procurement is effectively “brand-only” sourcing via standard wholesalers.
• If generics exist, procurement often shifts to lowest landed cost while preserving substitution rules for ophthalmic products.

What supplier risks matter for Durezol procurement?

Supplier risk in ophthalmic emulsions centers on:

• Aseptic manufacturing capacity and fill-finish throughput
• Lot release timing and sterility assurance release cadence
• Packaging line constraints and NDC-specific fulfillment
• Contract manufacturing dependency for batch production and emulsion consistency

How should buyers evaluate Durezol sourcing channels?

Procurement due diligence typically checks:

• NDC-specific availability (some NDCs may run tighter than others)
• Wholesaler reliability (allocation and order fulfillment patterns)
• Lead times by strength and package configuration
• Quality history at the lot and distribution level

Key Durezol supplier landscape (actionable snapshot)

Category	Supplier role	Companies typically involved
Brand supply	Brand owner and primary U.S. marketer	Bausch + Lomb
Manufacturing	Ophthalmic emulsion bulk production and fill-finish (often via internal sites and/or contract partners)	Bausch + Lomb network (contract manufacturers may be used)
Distribution	Wholesale and specialty distribution	U.S. pharmaceutical wholesalers sourcing from brand supply
Generic/alternate supply	ANDA or authorized difluprednate ophthalmic emulsion suppliers	Depends on presence of approved generics in the U.S. for the relevant NDC

Key Takeaways

• Bausch + Lomb is the primary supplier/brand owner for Durezol (difluprednate ophthalmic emulsion 0.05%) in the U.S.
• Supply chain execution runs through Bausch + Lomb’s manufacturing and distribution ecosystem, with ophthalmic emulsion production potentially involving contract fill-finish depending on site and batch strategy.
• Broader supplier options arise only if U.S.-approved generic or authorized difluprednate ophthalmic emulsion products exist for the relevant NDC configurations.

FAQs

1. Who is the labeled manufacturer/sponsor on Durezol (difluprednate) cartons and labels?
2. Are there generic difluprednate ophthalmic emulsion suppliers in the U.S. for Durezol?
3. What wholesaler channels typically stock Durezol procurement for clinics?
4. Does Durezol supply vary by NDC package configuration and strength?
5. What operational factors most affect Durezol lot availability in the U.S.?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. Durezol (difluprednate) prescribing information and labeling. Bausch + Lomb.
3. National Drug Code (NDC) directory records for Durezol. U.S. FDA NDC Directory.