Suppliers and packagers for zerviate

zerviate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Harrow Eye	ZERVIATE	cetirizine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208694	NDA	Harrow Eye, LLC	82667-015-24	1 POUCH in 1 CARTON (82667-015-24) / 30 VIAL, SINGLE-USE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-USE	2025-04-30

Suppliers and packagers for zerviate

Last updated: May 30, 2026

ZERVIATE (cetirizine hydrochloride) Suppliers: Who Manufactures the Drug Substance and Drug Product?

ZERVIATE is marketed as cetirizine hydrochloride for allergic conjunctivitis. A complete, supplier-grade mapping of active pharmaceutical ingredient (API) manufacturers and finished-dose (drug product) suppliers requires the drug’s FDA facility listings (Drug Establishment Registration and listing), the Orange Book/FDA approval package manufacturing data, and any contract manufacturing disclosures (labeler/manufacturer on the U.S. package insert).

No supplier dataset is provided in the prompt, and no reliable manufacturer list can be produced without those primary FDA/labeling records.

What suppliers manufacture ZERVIATE (cetirizine hydrochloride) drug product in the US?

Featured answer (direct): The drug product manufacturer(s) for ZERVIATE are the labeler(s)/manufacturer(s shown on the U.S. prescribing information and the listed facilities in FDA drug establishment registration tied to the approved NDA.

Key supplier touchpoints

• Labeler/manufacturer on the package insert (drug product site responsible for release)
• FDA Orange Book listings tied to the approved NDA/ANDA/505(b)(2) application
• FDA drug establishment registration for the product’s dosage form and strength
• NDC directory records mapping NDCs to labelers and manufacturing sites

Which labelers or MAHs typically appear for ZERVIATE?

ZERVIATE’s supplier structure depends on whether the U.S. label shows:

• A Marketing Authorization Holder (MAH) plus one or more manufacturing sites, or
• A single company listed as manufacturer for all steps (common in smaller portfolios)

A supplier-grade identification cannot be stated without the actual ZERVIATE labeler/manufacturer and NDC-to-labeler mapping.

Which companies supply the cetirizine hydrochloride API used in ZERVIATE?

Featured answer (direct): ZERVIATE API suppliers are the companies named in the Drug Substance section of the NDA approval package and/or the current CGMP API listing tied to the approved application.

Common API supplier patterns for ophthalmic products

• API made by a contract API manufacturer and supplied to the drug product site
• API sourced through a global procurement chain with one or more alternates

A validated list of API suppliers requires the FDA approval records or the CTD Module 3.2.S/3.2.P manufacturing statements for the specific ZERVIATE NDA.

How can you identify ZERVIATE suppliers via FDA records (Orange Book, label, and establishment registration)?

Featured answer (direct): The most defensible supplier mapping uses a three-step crosswalk:

1. Orange Book / FDA application: identify the approved application and related NDA/labeler.
2. Prescribing information / label: extract the drug product manufacturer and site(s).
3. FDA drug establishment registration: match the dosage form and product listing to registered facilities.

Does ZERVIATE appear in the Orange Book?

If ZERVIATE is listed, it will show:

• Application holder
• Dosage form
• Patent/exclusivity listings
• Manufacturing details indirectly tied to the NDA

A supplier list cannot be produced without Orange Book identification for ZERVIATE.

What are the key supplier constraints for ophthalmic cetirizine (sterility, preservatives, packaging)?

Featured answer (direct): Supplier qualification for ZERVIATE depends on:

• Sterile ophthalmic manufacturing controls (aseptic processing or sterilization method)
• Container-closure system compatibility (ophthalmic dropper/eye drop packaging)
• Preservative system suitability (if present in the formulation)
• Fill-finish capability and batch release testing

Which manufacturing steps determine supplier eligibility?

• API synthesis and impurity profile control
• Drug product compounding
• Sterile filtration and aseptic filling or validated terminal sterilization (as applicable)
• Packaging, labeling, and final QA release

Supplier identification hinges on the actual manufacturing section of the approved application, not general knowledge.

How many suppliers support ZERVIATE drug product and API in practice?

Featured answer (direct): The number of suppliers is the count of:

• Listed manufacturing facility(ies) for drug product release, and
• Listed drug substance manufacturing site(s) for cetirizine hydrochloride

A count cannot be given without the specific FDA labeling and establishment data for ZERVIATE.

Which countries typically host ZERVIATE suppliers (US, EU, India, China)?

Featured answer (direct): For branded ophthalmics in the US market, drug product fill-finish is often performed in US-registered facilities, while API may be sourced globally.

A country-by-country supplier map cannot be stated without the facility registration locations for the specific sites tied to ZERVIATE.

ZERVIATE supplier landscape vs other antihistamine ophthalmics: who typically makes the drug and who supplies API?

Featured answer (direct): The typical landscape for ophthalmic antihistamines is:

• One or more US-registered fill-finish/drug product sites
• One or more contract API sites supplying cetirizine hydrochloride

A direct comparison to other brands requires supplier data from those specific drugs’ labels and FDA records, which is not included.

Key Takeaways

• ZERVIATE supplier identification requires the drug product labeler/manufacturer and the API/drug substance manufacturing statements from FDA approval materials.
• Without the FDA/labeling source data for ZERVIATE, a supplier-grade, company-by-company list of API and drug product manufacturers cannot be produced.

FAQs

1. Where on the ZERVIATE label can I find the drug product manufacturer?
   The manufacturer name and address appear in the U.S. prescribing information and package labeling fields tied to the NDC.

2. How do I find ZERVIATE’s manufacturing site(s) registered with the FDA?
   Crosswalk the ZERVIATE NDC/labeler to FDA drug establishment registration listings for the product.

3. Can the API supplier be different from the drug product manufacturer?
   Yes, ophthalmic products commonly use contract API suppliers feeding a separate drug product fill-finish site.

4. Do supplier changes require FDA notification for ZERVIATE?
   Changes to manufacturing sites are governed by FDA CMC requirements and may require prior approval or notification depending on the change type.

5. How do I verify a claimed supplier is actually used for ZERVIATE batches?
   Use FDA facility registration, the approved application manufacturing section, and labeler/manufacturer references tied to the marketed NDC.

References

No sources were cited because no ZERVIATE FDA labeler/manufacturer or Orange Book/approval package data was provided in the prompt.