Suppliers and packagers for DURYSTA

DURYSTA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911	NDA	Allergan, Inc.	0023-9652-01	1 IMPLANT in 1 POUCH (0023-9652-01)	2020-03-04
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911	NDA	Allergan, Inc.	0023-9652-03	1 IMPLANT in 1 POUCH (0023-9652-03)	2020-03-04

Suppliers and packagers for DURYSTA

Last updated: June 1, 2026

DURYSTA (bimatoprost implant) Suppliers: What companies manufacture and supply the drug product and components?

Durysta (bimatoprost ophthalmic implant, Allergan) is supplied through an integrated manufacturing and packaging network tied to the implant platform and sterile ophthalmic drug product supply chain. The key suppliers are the contract manufacturers and fill-finish/sterile manufacturing partners that produce (1) the biodegradable implant and (2) the drug product container and administration system used for intravitreal delivery.

Who supplies DURYSTA (bimatoprost implant) to pharmacies and health systems?

Durysta’s supply chain is built around sterile ophthalmic drug product manufacturing, packaging, and distribution. The commercial supplier role is typically held by the brand sponsor (Allergan) for commercial distribution, while manufacturing and sterile fill-finish are performed by contract manufacturing organizations (CMOs) under quality agreements and FDA/EMA-appropriate GMP controls.

Brand sponsor and commercial distribution

• Allergan (AbbVie) is the labeled drug sponsor and commercial marketer/distributor for Durysta in the US.

Manufacturing and sterile drug product execution

Durysta is a device-drug combination delivery platform (implant administered by an injector). The operational supplier set typically separates into:

• Implant manufacture (polymer/biodegradable matrix + drug load + implant formation)
• Sterile finished drug product manufacturing (implant incorporation into the final sterile configuration, sterilization/aseptic controls, packaging)
• Administration system / injector supply (components used for in-office intravitreal delivery)

Which companies manufacture the bimatoprost implant used in DURYSTA?

Durysta’s active is bimatoprost, but the protected product is the implant formulation and delivery system. Suppliers therefore map to implant manufacturing know-how, not just bulk API supply.

Drug substance and API supply

• Bimatoprost API is typically sourced from specialized API manufacturers through long-term supply contracts. For Durysta, the specific API supplier identities depend on the approved NDA manufacturing section and commercial supply agreements.

Implant formulation and polymer/drug loading suppliers

• Implant suppliers are the groups with capability for:
  • Controlled bimatoprost loading in a biodegradable polymer matrix
  • Implant geometry and release-rate performance
  • GMP handling of drug-polymer intermediates and final sterile product assembly

Injection system and single-use applicator suppliers

• The injector system is supplied by vendors that meet ophthalmic sterile delivery specifications, since the implant is delivered intravitreally with a pre-set apparatus.

What contract manufacturing sites are used for DURYSTA sterile drug product?

Durysta is manufactured and released as a sterile ophthalmic intravitreal implant product. The contract manufacturing sites are the entities responsible for:

• Sterile assembly and packaging
• Sterility assurance
• Quality control testing and batch release under GMP

Durysta’s supplier list is built from:

• CMOs listed in the drug product’s FDA application manufacturing section
• Packaging and labeling contractors
• Logistics/distribution partners for temperature-controlled and sterile product handling

How many DURYSTA suppliers exist across API, implant, and final pack?

Supplier count varies by stage, but the DURysta supply chain usually divides into 3 supplier tiers:

1. API/drug substance suppliers (bimatoprost)
2. Implant/drug product manufacturing suppliers (implant production, sterile configuration)
3. Packaging, labeling, and injector components suppliers

A typical branded ophthalmic implant supply chain uses multiple qualified vendors but a smaller number for sterile fill-finish and assembly.

Which suppliers matter most for DURYSTA continuity of supply risk?

The highest concentration of supply risk sits with the suppliers controlling:

• Sterile assembly and release testing
• Implant production with validated release kinetics
• Injector system components used for intravitreal delivery

If a CMO or injector-component supplier is disrupted, availability of Durysta is directly affected even when API supply remains intact.

What manufacturing/IP barriers do DURYSTA suppliers face?

Supplier capability is constrained by:

• Process validation for implant characteristics (release rate, drug load uniformity)
• Quality system lock-in to the brand sponsor
• Confidentiality and trade secrets around implant production and assembly
• Regulatory commitments tied to listed manufacturing sites

These barriers typically restrict supplier switching unless a new site is qualified under regulatory requirements and tech transfer is completed.

Key Takeaways

• Durysta is supplied commercially by Allergan (AbbVie), with manufacturing executed through qualified contract manufacturers for implant/sterile drug product and supporting components for the intravitreal delivery system.
• The most operationally critical suppliers are those performing implant manufacture and sterile final assembly/packaging, plus suppliers providing injector components.
• Supplier switching is difficult because of validated implant release specifications, sterile manufacturing controls, and regulatory site commitments.

FAQs

1. Is DURYSTA manufactured by Allergan or by contract manufacturing organizations?
2. Who provides bimatoprost API for implant-based ophthalmic products like DURYSTA?
3. What parts of DURYSTA’s supply chain are most exposed to shortages: API, implant production, or sterile assembly?
4. Do DURYSTA injector systems come from the same suppliers as the implant drug product?
5. How does GMP site qualification affect DURYSTA supplier replacement?

References

1. FDA Orange Book. Durysta (bimatoprost) product listings and patent/approval references. US Food and Drug Administration.
2. FDA Drug Approval Package for Durysta (bimatoprost ophthalmic implant). US Food and Drug Administration.
3. Prescribing Information for Durysta (bimatoprost ophthalmic implant). AbbVie/Allergan.