Suppliers and packagers for combigan

combigan

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	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398	NDA	Allergan, Inc.	0023-9211-03	1 BOTTLE, DROPPER in 1 CARTON (0023-9211-03) / 2.5 mL in 1 BOTTLE, DROPPER	2007-11-14
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398	NDA	Allergan, Inc.	0023-9211-05	1 BOTTLE, DROPPER in 1 CARTON (0023-9211-05) / 5 mL in 1 BOTTLE, DROPPER	2007-11-14
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398	NDA	Allergan, Inc.	0023-9211-10	1 BOTTLE, DROPPER in 1 CARTON (0023-9211-10) / 10 mL in 1 BOTTLE, DROPPER	2007-11-14

COMBIGAN (brimonidine tartrate + timolol) suppliers: who manufactures, supplies, and sources the active ingredients and finished drug products

Last updated: May 26, 2026

COMBIGAN is a fixed-dose ophthalmic solution using brimonidine tartrate (0.2%) and timolol (as timolol maleate, 0.5%) for lowering intraocular pressure in glaucoma and ocular hypertension. Supplier visibility splits into three layers: (1) active pharmaceutical ingredient (API) makers, (2) finished-dose ophthalmic solution manufacturing sites for branded COMBIGAN, and (3) commercially relevant supply chains feeding FDA-approved product strength, labeling, and distribution channels.

Who supplies the COMBIGAN active ingredients (API) and the finished ophthalmic solution?

Answer: Identify suppliers by (a) the Orange Book/approved product listing for COMBIGAN to determine the FDA applicant/manufacturer for the finished dosage form, then (b) map the API suppliers through third-party procurement records, DMF holdings, and API sourcing documents tied to the FDA-listed manufacturing and packaging sites. Without that dataset, only the finished-product manufacturer/applicant can be stated from FDA product records and the API supplier list cannot be completed to a “named companies” standard.

What company is listed as the COMBIGAN drug product manufacturer in the FDA Orange Book?

Answer: COMBIGAN is an FDA-approved branded ophthalmic product. The FDA Orange Book listing for COMBIGAN identifies the applicant/holder and the finished drug manufacturing/labeler entries associated with the approved dosage form.

Where in the regulatory record are COMBIGAN manufacturing and labeling details located?

• Orange Book “Drug Product” record: labeler/applicant/manufacturer for the finished ophthalmic solution
• FDA SPL (Structured Product Labeling): labeler and distributor data for the marketed NDC
• CMC section of the NDA: manufacturing site roster (often via site supplements)
• DMF cross-references: API supplier identification only where DMFs are public and cross-referenced to the NDA’s component list

Which API suppliers make brimonidine tartrate for ophthalmic use?

Answer: Brimonidine tartrate supply is typically sourced from specialty API producers and firms making controlled stereochemistry salts. A complete supplier roster requires DMF-linked identification or corroborated commercial supply chain records tied to COMBIGAN’s NDA components.

What brimonidine tartrate supply characteristics drive supplier selection?

• Stereochemical control for brimonidine (chiral identity and impurity profile)
• Salt form consistency with the ophthalmic formulation
• Regulatory history for ophthalmic concentration and impurity acceptance criteria
• Availability of analytical method validation packages to support change control

Which API suppliers make timolol maleate (timolol) for ophthalmic use?

Answer: Timolol maleate is widely manufactured globally. A complete supplier roster for COMBIGAN still requires NDA component mapping or DMF cross-references tied to the COMBIGAN product record.

What timolol maleate supply characteristics matter for ophthalmic solutions?

• Impurity profile control for ophthalmic tolerability
• Particle and solid-state characteristics that influence dissolution and stability
• Compatibility with ophthalmic excipients and container closure systems
• Supply continuity for branded-volume production cycles

What manufacturing sites produce COMBIGAN ophthalmic solution?

Answer: COMBIGAN’s finished product is produced at FDA-inspected manufacturing sites associated with the NDA and listed in FDA records. Exact site names are determinable from the Orange Book and SPL for the NDC.

How to map COMBIGAN supply chain to specific sites

• Pull COMBIGAN NDC product record
• Use Orange Book manufacturing/labeler fields tied to that NDC
• Cross-check with SPL for labeler/distributor alignment
• Verify site changes through supplements and annual reports where public

What packaging and sterile ophthalmic solution suppliers are involved?

Answer: Ophthalmic solution finished goods require:

• sterile manufacturing environment
• container closure and dispensing unit sourcing (bottle, dropper mechanism, cap)
• secondary packaging and distribution labeling

A named list of packaging suppliers requires access to the specific NDA CMC packaging component list and/or procurement records for COMBIGAN.

How do COMBIGAN supplier risks change as generics and authorized alternatives expand?

Answer: Supplier concentration risk increases when APIs and ophthalmic sterile fill-finish capacity are limited in a small number of qualified plants. When a brand faces increased generic competition, supply chain continuity remains critical because market share losses can reduce production economics for high-cost sterile sites, increasing reliance on alternate qualified lines or contract manufacturers.

What supply-chain bottlenecks affect ophthalmic fixed-dose products?

• Sterile fill-finish capacity at FDA-inspected plants
• Low-visibility ophthalmic excipient supply (buffer systems, viscosity agents, preservatives)
• Container closure component lead times
• Stability and compatibility requirements that narrow excipient substitutions

What sourcing model does COMBIGAN use: in-house vs contract manufacturing?

Answer: COMBIGAN is typically produced through an NDA-aligned manufacturing network, which may include contract manufacturing organizations (CMOs) and/or contract sterile fill-finish (CSF) providers. Determining whether each step is in-house requires the site list tied to the NDA and site-specific inspection history.

How many suppliers typically exist for brimonidine tartrate + timolol ophthalmic products?

Answer: API supplier counts for these actives tend to be higher than finished ophthalmic sterile fill-finish suppliers because APIs are more globally distributed. Without Orange Book-linked component mapping to named DMF holders, the exact “number of suppliers” for COMBIGAN cannot be stated at a “named company” level.

Which suppliers are active in the COMBIGAN market for distribution and contracting?

Answer: Distribution suppliers are generally “labeler/distributor” parties in the SPL plus any wholesale distributors tied to NDC distribution channels. Contracting suppliers at the CMO level are identified by site records tied to the NDA for COMBIGAN’s NDC.

What competitor generics increase supplier leverage against COMBIGAN?

Answer: Generic entry can change supplier leverage by shifting procurement toward companies producing multiple ophthalmic products on shared sterile platforms. Still, supplier leverage is determined by (1) qualified sterile capacity, (2) API availability, and (3) customer qualification cycles, not just market demand.

Key Takeaways

• COMBIGAN supply chain separates into API sourcing (brimonidine tartrate, timolol maleate) and finished sterile ophthalmic solution manufacturing/packaging.
• A named supplier list for COMBIGAN requires FDA product record linkage (Orange Book + SPL) and DMF cross-referenced API supplier identification.
• Without those dataset-derived linkages, only a high-level supplier taxonomy can be established without accuracy guarantees on named companies.

FAQs

1. How do I identify COMBIGAN’s finished-goods manufacturer from FDA records? Use the COMBIGAN NDC in the FDA Orange Book and SPL to extract the labeler/applicant and listed manufacturing site(s).
2. What’s the difference between API suppliers and sterile fill-finish suppliers for COMBIGAN? APIs (brimonidine tartrate, timolol maleate) are sourced from API manufacturers, while sterile ophthalmic solution production is done at FDA-inspected sterile fill-finish plants.
3. Do COMBIGAN generics source the same APIs from the same suppliers? Often not. Generics may use different API suppliers as long as they meet DMF/compendial specs and bioequivalence requirements and pass FDA CMC controls.
4. What regulatory artifacts reveal API supplier identity for COMBIGAN? DMF holdings, DMF cross-references in the NDA/CMC, and component supplier declarations associated with the approved product record.
5. What supplier risks are most material for ophthalmic combination products? Sterile fill-finish capacity constraints, container closure lead times, and tight impurity specifications for APIs used at ophthalmic concentrations.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. FDA.
2. FDA. SPL (Structured Product Labeling) database. U.S. FDA.
3. FDA. Drug Master Files (DMF) program overview and regulatory framework. U.S. FDA.