Suppliers and packagers for XALATAN

XALATAN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597	NDA	Viatris Specialty LLC	58151-419-35	1 BOTTLE, DROPPER in 1 CARTON (58151-419-35) / 2.5 mL in 1 BOTTLE, DROPPER	2024-10-22
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-0333-2	1 BOTTLE, DROPPER in 1 CARTON (59762-0333-2) / 2.5 mL in 1 BOTTLE, DROPPER	2010-11-15

Suppliers and packagers for XALATAN

Last updated: May 31, 2026

Xalatan (latanoprost) suppliers: who manufactures the drug, APIs, and key outsourced inputs?

Xalatan is the brand-name formulation of latanoprost, supplied through a mix of primary manufacturers, contract manufacturing organizations (CMOs), and ingredient suppliers tied to each market’s regulatory approvals. The supplier landscape is product- and jurisdiction-specific, and the set of “suppliers” you care about typically breaks into: (1) finished-dose manufacturers, (2) API (latanoprost) producers, and (3) ophthalmic sterile formulation component suppliers (buffers, preservatives, packaging).

Important constraint for this request: no dataset was provided (and none is available in the prompt) identifying which country/market, dosage form (typically 0.005% ophthalmic solution), strength, packaging configuration, or specific authorized label listing you mean. Without that, a complete, accurate supplier list cannot be produced.

Who are the manufacturers of Xalatan 0.005% ophthalmic solution by country?

Featured snippet answer: Xalatan suppliers differ by NDC/market because the finished drug is commercialized through different MAH/distributors and finished-dose manufacturing sites tied to country-specific approvals and labeling.

Finished-dose suppliers: what determines the “manufacturer” on Xalatan packaging?

• Labeler/marketing authorization holder (MAH) in the country
• Finished-dose release site (GMP site listed for the product)
• NDC and packager (US), or equivalent local product registries (EU/UK, etc.)
• Sterile ophthalmic manufacturing format (vial vs unit-dose, presence of preservative)

Which companies supply latanoprost API for Xalatan and generic latanoprost?

Featured snippet answer: API suppliers for latanoprost include producers of ophthalmic-grade prostaglandin analog active substance used across both branded and generic equivalents. The exact roster depends on the regulatory registration and supplier-of-record for the specific market.

API sourcing risk points for ophthalmic prostaglandin analogs

• Controlled impurity profiles (EP/USP compliance for latanoprost)
• Stereochemistry and impurity limits
• Chiral purity controls during synthesis
• Scale capability for sterile-fill supply chains (even if the API is non-sterile)

What suppliers provide key ophthalmic sterile formulation inputs for latanoprost drops?

Featured snippet answer: The “supplier” set for Xalatan-like ophthalmic solutions typically includes vendors for:

• Preservatives (commonly benzalkonium chloride in many multidose ophthalmics, depending on the exact labeled product)
• Buffers and tonicity agents (to meet pH and osmolality specs)
• Sterile filtration and filling consumables (filters, tubing, process aids)
• Packaging (dropper bottles, unit-dose systems, closures, labeling systems)

Typical component categories that drive supplier onboarding

• Sterile filtration membranes compatible with latanoprost
• Container-closure systems validated for extractables/leachables
• Compatibility with preservatives and pH targets

How does Xalatan’s supply chain differ between US and EU/UK markets?

Featured snippet answer: Supply chain structure changes because regulatory dossiers and release testing sites differ by region, and unit-dose vs multidose packaging variants can be region-dependent.

Market drivers that change the supplier list

• Different regulatory submissions and manufacturing authorizations
• Different contract terms for sterile filling and labeling
• Local distribution partners and warehousing requirements

What is the Orange Book status of Xalatan, and how does that affect supplier sourcing?

Featured snippet answer: Xalatan is listed in the US Orange Book for patent and exclusivity status. That status affects generic entry timing, not the core set of API and fill suppliers directly, but it does change which firms compete for supply once multiples enter.

Supplier impact of generic entry

• Increased competition for API and fill-finish
• More bidders for sterile manufacturing capacity
• Pressure on ingredient costs and packaging availability

How many suppliers typically support Xalatan commercialization, and what are the usual outsourcing steps?

Featured snippet answer: A typical ophthalmic branded supply chain uses multiple vendors across the value chain:

• API manufacture
• Drug substance purification and characterization
• Sterile fill-finish (CMO)
• QC release testing and stability program support
• Packaging and distribution logistics

What supplier bottlenecks exist for latanoprost ophthalmic solutions?

Featured snippet answer: Bottlenecks usually concentrate in:

• High-spec API impurity control capacity
• Sterile fill-finish slots
• Container-closure availability that meets extractables/leachables requirements

Bottleneck scenarios that affect supply reliability

• Sterile manufacturing disruptions (cleanroom capacity)
• Packaging component shortages
• API batch rejection due to impurity excursions

Which contract manufacturers and fill-finish providers work on latanoprost ophthalmic products?

Featured snippet answer: Contract manufacturers for latanoprost exist in sterile ophthalmic fill-finish networks, but the exact names require linking to the specific product registration and manufacturing site list for the labeled Xalatan in each market.

What to look for in regulatory manufacturing site listings

• GMP site addresses tied to the labeled product
• Sterile ophthalmic manufacturing classification and aseptic processing license
• Release-testing locations for finished product

Key Takeaways

• “Suppliers for Xalatan” is not a single list; it splits into API producers, finished-dose manufacturers, and sterile formulation and packaging vendors.
• Supplier rosters vary by jurisdiction, NDC/packaging configuration, and regulatory registration.
• The bottlenecks most likely to impact supply reliability are sterile fill-finish capacity, packaging component availability, and API impurity-control capability.

FAQs

1. Who is the marketing authorization holder (MAH) for Xalatan in the US?
2. Are Xalatan and latanoprost generic products sourced from the same API suppliers?
3. Which packaging formats are used for Xalatan (multidose vs unit-dose) and who supplies them?
4. Do sterile fill-finish providers differ for preserved vs preservative-free latanoprost formulations?
5. What regulatory documents list the actual manufacturing sites for Xalatan, and where are they published?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. EMA. European public assessment reports (EPAR) and product information for latanoprost-containing ophthalmic products.
3. FDA. Drugs@FDA database.