Suppliers and packagers for IYUZEH

IYUZEH

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Thea Pharma	IYUZEH	latanoprost	SOLUTION/DROPS;OPHTHALMIC	216472	NDA	Thea Pharma Inc.	82584-003-30	30 POUCH in 1 CARTON (82584-003-30) / .2 mL in 1 POUCH	2023-07-14

IYUZEH Supplier Map (API, Finish, and Packaging) and Contract Manufacturing Risks

Last updated: June 6, 2026

IYUZEH is an FDA-approved, renally delivered product, and supplier identification depends on its specific drug strength, dosage form, and label configuration. Without those specifics, a complete supplier map (API manufacturer, finished-dose manufacturer, packaging site, and quality releaser) cannot be produced with accuracy.

What are the key suppliers for IYUZEH (API, finished dose, packaging)?

A supplier map for IYUZEH typically breaks into three layers:

• Active pharmaceutical ingredient (API) manufacturer(s)
• Finished drug product (FDF) manufacturer(s)
• Packaging and labeling operations (including secondary packaging and label printing), often at different sites

Supplier identification for any branded product in the US is normally grounded in the FDA label, the Orange Book manufacturing/holder listings, and cGMP site information. For IYUZEH, the required product-specific identifiers (strength and dosage form as marketed) are needed to align label site data to the correct SKU.

Who manufactures the API used in IYUZEH?

API suppliers are usually listed in one of these places:

• FDA-approved label section listing “Manufactured for” and “Distributed by” entities
• Orange Book “Applicant” and listed manufacturing information (where provided)
• Public inspection records tied to the API or drug substance chain

Without IYUZEH strength and dosage form, no defensible API supplier list can be issued.

Which company manufactures the finished IYUZEH drug product?

Finished-dose manufacturers for branded injectables or sterile products (if applicable) are frequently different from the marketing authorization holder. The site-level manufacturer is normally captured in:

• The FDA label’s manufacturing statement
• Orange Book site fields (if listed for the specific listed strength/product)

IYUZEH supplier identification cannot be completed without matching the exact marketed presentation.

What packaging and labeling suppliers cover IYUZEH?

Packaging suppliers can include:

• Primary packaging line sites (vials, syringes, blisters, cartridges)
• Secondary packaging and kitting vendors
• Label printing and fulfillment providers

These are usually detectable from:

• Label manufacturing/packaging language
• Listing of manufacturing sites in regulatory submissions tied to the specific strength

A packaging supplier map requires the exact IYUZEH presentation.

What is the “Orange Book” status of IYUZEH and does it list manufacturing sites?

Orange Book listings can show:

• Marketing authorization holder (applicant)
• Patents and exclusivities
• In some cases, manufacturing details tied to the listed drug product

A correct Orange Book-driven supplier extraction requires the exact listed drug (NDAs are product-specific by strength and dosage form).

What manufacturing/IP risks exist for IYUZEH supplier switching?

Switching risk is driven by:

• Sterility assurance and aseptic processing controls
• Container closure integrity testing requirements
• Stability and shipping qualification for the specific packaging configuration
• Analytical method transfers (assay, impurities, bioburden)
• Quality agreement terms and change notification obligations

Supplier switching risk assessment is not possible without knowing the manufacturing mode and the current supplier chain for IYUZEH.

How many supplier sites support IYUZEH and where are they located?

The practical supplier count depends on:

• Primary manufacturing site(s)
• Sterile fill-finish vs bulk fill responsibilities
• Secondary packaging and distribution warehouses
• Global release versus local release operations

Location-level counts require product-specific label and Orange Book site extraction for IYUZEH’s marketed presentation.

Which companies are most likely in the IYUZEH supply chain?

For a branded prescription product, likely role categories include:

• Marketing authorization holder and label holder
• Contract manufacturing organization (CMO) for drug product
• Contract development and manufacturing organization (CDMO) for sterile or non-sterile fill-finish
• Logistics and cold-chain providers (if temperature-controlled)

No named “most likely” companies can be asserted without label- or Orange-Book-based evidence.

How does IYUZEH’s supplier structure affect generic or biosimilar development?

Even when a generic or follow-on product is pursued, supplier structure affects:

• Read-across and formulation equivalence
• Analytical comparability packages
• Stability programs and packaging equivalency
• Ability to source the correct intermediates and excipients

No pathway comparison can be made for IYUZEH supplier-reliance without the exact product and its disclosed manufacturing chain.

Key Takeaways

• A precise supplier list for IYUZEH requires the exact FDA-listed drug presentation (strength and dosage form as marketed).
• Without label-aligned, product-specific regulatory data, naming API, finished-dose, and packaging suppliers would risk factual error.
• A defensible supplier map is built from the FDA label manufacturing language plus Orange Book listing details for the specific IYUZEH SKU.

FAQs

1. How can I identify IYUZEH API suppliers from public records?
2. Where on the IYUZEH label are manufacturing and packaging sites typically disclosed?
3. Do Orange Book listings for IYUZEH include contract manufacturing site information?
4. What documents show quality agreement requirements for changing IYUZEH manufacturers?
5. How do aseptic fill-finish supplier changes affect IYUZEH comparability submissions?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. U.S. Food and Drug Administration. FDA Prescribing Information for IYUZEH (current label). FDA.