Suppliers and packagers for BESIVANCE

BESIVANCE (besifloxacin) Suppliers: Who Makes It, Where Is It Manufactured, and What IP/Regulatory Constraints Shape Supply?

BESIVANCE (besifloxacin ophthalmic suspension) is supplied in the US under Bausch + Lomb’s commercial ownership, with drug substance/drug product supply tied to the manufacturing and labeling referenced in FDA’s drug and listing systems. Based on available FDA listing and product labeling data, the primary US-facing supplier is the marketed-holder, and the regulated manufacturing footprint is governed by the approved NDA packaging/labeling and the listed establishments on FDA records.

Bottom line for sourcing: BESIVANCE supply is centered on Bausch + Lomb’s marketed product (NDA holder), with manufacturing and release occurring at the FDA-identified establishment(s) that cover the marketed dosage form (ophthalmic suspension).

Who supplies BESIVANCE (besifloxacin) in the US today?

US commercial supplier (marketed product): Bausch + Lomb Incorporated.

Drug product configuration:

• Dosage form: ophthalmic suspension
• Route: topical ophthalmic
• Strength: besifloxacin ophthalmic suspension (commonly marketed as 0.6%)

The supply chain for a listed prescription ophthalmic product is constrained by FDA-approved manufacturing sites and the product’s commercial label configuration (container-closure system, strength, and packaging), which determine which establishment(s) can legally produce and release under the NDA/labeling.

What manufacturing sites are listed for BESIVANCE ophthalmic suspension?

FDA manufacturing responsibility for a specific marketed product is reflected in the drug product listing and labeling information tied to the NDA. For prescription ophthalmics, the FDA establishment listing typically identifies the firm(s) authorized for manufacture, packaging, and/or release of the finished ophthalmic suspension.

Practical sourcing implication: procurement of BESIVANCE through distributors typically tracks to Bausch + Lomb’s commercial supply and the finished-product manufacturing sites they control or contract.

Which companies make BESIVANCE drug substance vs finished ophthalmic suspension?

BESIVANCE is an ophthalmic fluoroquinolone. In practice, suppliers for ophthalmic products usually split into:

• API (besifloxacin) manufacturers supplying drug substance, and
• Finished dosage form manufacturers producing the suspension and performing packaging and release under the NDA.

For BESIVANCE, supplier identification at the API level is determined by the NDA chemistry and manufacturing controls (CMC) support and the specific FDA listing records that name the establishment(s) for finished drug product versus drug substance. Those designations govern lawful supply and contractual release.

Business impact: contract manufacturing for ophthalmic suspensions is highly compliance-bound because excipient system, particle attributes, sterilization/aseptic strategy (as applicable), and container-closure compatibility directly affect batch release under the approved quality system.

What is the Orange Book status of BESIVANCE and how does it affect supplier access?

BESIVANCE is a brand ophthalmic prescription product. Orange Book exclusivity and any listed patents affect generic and authorized alternative supply, which can change the competitive supplier landscape over time.

For sourcing, the key operational point is:

• If Orange Book-listed patents or exclusivity block generic entry, Bausch + Lomb and their authorized supply chain remain the dominant lawful channel for US supply of the exact labeled formulation.

When do BESIVANCE patents or exclusivity expire, and when can alternate suppliers enter?

Alternate supplier entry depends on:

• patent expiration on relevant claims (composition, formulation, and method-of-use),
• any pediatric exclusivity, and
• the timing of generic/biosimilar analog actions (for ophthalmics, small-molecule generics via ANDA).

Sourcing planning should treat expiration and any “carve-out” settlements as the gating item that determines when additional manufacturers can launch approved equivalents.

Are there Paragraph IV ANDA challenges for BESIVANCE that change supplier risk?

For small-molecule ophthalmics, Paragraph IV ANDAs can create new generics and change the supplier ecosystem. Supplier risk rises when:

• a first generic is launched in volume,
• settlements shorten entry timelines, or
• the reference product experiences supply interruptions due to reduced demand.

No reliable, complete docket-specific challenge mapping can be stated here without the exact FDA Orange Book listing set and the associated Paragraph IV filings tied to the ANDA(s) for besifloxacin ophthalmic suspension.

What regulatory filings control supply of BESIVANCE (NDA, ANDA, supplements)?

BESIVANCE supply is controlled by:

• the approved NDA under which the product is marketed, and
• CMC supplements that add or modify manufacturing sites, change packaging, or update controls.

Any supplier-switch requires either:

• an FDA-approved change under the NDA, or
• manufacturing controlled under an approved site addition.

How do formulation and packaging requirements constrain BESIVANCE suppliers?

Ophthalmic suspensions face tight constraints:

• particle size and suspension uniformity targets,
• viscosity/rheology specifications,
• preservative system compatibility (if applicable),
• container-closure integrity and extractables/leachables.

A supplier that cannot meet release specs under the approved CMC package cannot supply product for US release.

What generic entry risks exist for BESIVANCE and how would they affect procurement?

Generic entry risks for besifloxacin ophthalmic suspension hinge on:

• whether challengers can obtain FDA approval without violating formulation or method patents, and
• whether the generic can meet identical release specifications for the suspension system.

If an ANDA is approved and launched, it can reduce procurement dependence on the brand supplier and introduce price competition and supply optionality.

Supplier due diligence checklist for BESIVANCE procurement

To qualify BESIVANCE sources in a controlled procurement environment, buyers typically require documentation covering:

• FDA establishment linkage to the approved label configuration (site eligibility for the NDA product),
• COA traceability by batch and expiry,
• evidence of compliance with approved specification release,
• packaging component compatibility (label, bottle, dropper tip, seals),
• change history of manufacturing location and any FDA-approved supplement references.

Key Takeaways

• BESIVANCE’s US commercial supply is anchored to the NDA holder’s marketed product channel (Bausch + Lomb Incorporated).
• Authorized manufacturing sites for drug product release are the controlling supply constraint, governed by FDA-approved CMC and establishment listing for the ophthalmic suspension.
• Generic/alternate supplier availability depends on Orange Book patent and exclusivity timelines, plus any Paragraph IV/settlement-driven entry events.
• For procurement and licensing diligence, the controlling artifacts are FDA-approved manufacturing eligibility and batch release traceability under the approved NDA.

FAQs

Who is the NDA holder for BESIVANCE (besifloxacin ophthalmic suspension)?

Bausch + Lomb Incorporated.

What dosage form and route does BESIVANCE use?

Ophthalmic suspension for topical use in the eye.

Can distributors supply BESIVANCE from alternate manufacturers?

Only if the product is authorized for US release under the NDA framework and the relevant manufacturing and packaging sites are FDA-eligible for the marketed configuration.

Does Orange Book listing impact BESIVANCE availability?

Yes. Patents and exclusivity listed for the reference product determine when approved equivalents can launch without infringement risk.

What typically blocks new suppliers for ophthalmic suspensions like BESIVANCE?

FDA CMC constraints and the need to meet approved specification targets for suspension quality, sterility strategy (as applicable), and container-closure compatibility.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (H1 and database entries for besifloxacin ophthalmic suspension).
2. FDA. Drugs@FDA: BESIVANCE (besifloxacin ophthalmic suspension) product information and labeling.