Suppliers and packagers for ZONEGRAN

ZONEGRAN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Advanz Pharma	ZONEGRAN	zonisamide	CAPSULE;ORAL	020789	NDA	Advanz Pharma (US) Corp.	59212-680-10	100 CAPSULE in 1 BOTTLE (59212-680-10)	2000-03-27
Advanz Pharma	ZONEGRAN	zonisamide	CAPSULE;ORAL	020789	NDA	Advanz Pharma (US) Corp.	59212-681-10	100 CAPSULE in 1 BOTTLE (59212-681-10)	2000-03-27

ZONEGRAN (zonisamide) Suppliers: API Makers, Dosage-Form Manufacturers, and Key Component Outsourcing

Last updated: May 26, 2026

Zonegran is zonisamide for epilepsy and is typically produced under a contract manufacturing footprint that separates (i) zonisamide API supply and (ii) solid oral dosage-form manufacturing plus packaging. Public, consistently indexed vendor-level detail is not available in a single authoritative “supplier list” view without specific reference to the Orange Book NDA package insert labeling/manufacturing section for each market, the DMF-linked API holders, and the specific dosage strength/packager. This prevents a complete, accurate supplier roster from being stated.

Zonegran is sold in the US by Eisai Inc. The product is a solid oral drug. From a procurement and IP-risk perspective, supplier identification must be anchored to: (1) the Orange Book “Manufactured for / Distributed by” labeling for each strength, (2) the DMF holder(s) for zonisamide API (if cited), and (3) the contract manufacturing and packaging sites shown in product labeling and FDA inspection disclosures tied to the NDA.

Because a complete, accurate supplier list cannot be produced from verified public data in this format, the only deliverable below is a structured framework of the supplier categories and the specific data fields that must be matched to Zonegran label and regulatory records to identify the actual suppliers by company and site.

Who supplies the ZONEGRAN zonisamide API and is it single- or multi-source?

Answer: Zonegran’s zonisamide API is supplied from one or more API manufacturers referenced through FDA DMFs and/or referenced in NDA/labeling. The exact API holder(s) for Zonegran must be confirmed against the NDA’s DMF cross-references and the product labeling manufacturing section for each strength.

API supplier identification checkpoints

• FDA Drug Master File (DMF) linked to the Zonegran NDA (API chemical entity DMF).
• Orange Book listing that points to the NDA and strength, then label manufacturing details that can be cross-mapped to DMF holders.
• Strength-specific labeling: 25 mg and 100 mg film-coated tablets often have distinct packager/manufacturer entries.

What to extract once the label/Orange Book package is matched

• DMF holder legal entity name
• DMF number and Type (API)
• Manufacturing site address (API plant)
• Evidence of multi-source availability (multiple DMFs or multiple API sites)

Which companies manufacture and package Zonegran tablets in the US?

Answer: The tablet manufacturer and packager are identified in the US product label “Manufactured for” / “Distributed by” and “Manufactured by” sections, which must be matched to each strength’s specific labeling.

Dosage-form and packaging supplier categories

• Tableting and coating CMO (compression, film coating)
• Primary manufacturer (blending, granulation or direct compression, coating, tablet inspection)
• Secondary packaging CMO (bottling, labeling, cartons)
• Clinical vs commercial site split (if shown in label updates)

Label fields that control “supplier” determination

• “Manufactured for” (often the NDA holder or brand owner)
• “Manufactured by” (CMO site)
• NDC packaging configuration (bottle size, carton) mapped to strength
• Any “Distributed by” third-party name that is not a manufacturer

What ZONEGRAN excipients and delivery-system components are typically outsourced?

Answer: As a solid oral product, Zonegran tablet inputs include excipients (binders, disintegrants, fillers, film coat components), lubricants, packaging materials, and tablet coating ingredients. Component suppliers are commonly outsourced through excipient CMOs and distributors, but the actual selected vendor chain is not identifiable from public sources in a single validated list.

Excipients to expect in a zonisamide tablet supply chain

• Tablet core: fillers/diluents, binders, disintegrants, lubricants
• Film coat: polymers, pigments, plasticizers, solvents/water systems
• Packaging: bottles, closures, desiccants (if included), labels, cartons, leaflets

How to convert “typical” into “actual”

• Read excipient composition and manufacturing section in the current US label.
• Match manufacturer/packager sites to FDA inspection records where available.
• Map excipient raw-material approvals to supplier qualification systems (internal only).

How many suppliers support ZONEGRAN commercial supply and how do you assess redundancy risk?

Answer: Zonegran’s supply risk depends on whether the API is single-sourced and whether the finished tablets are made by one or multiple CMO sites. A verified supplier count requires label-based mapping plus DMF holder mapping.

Redundancy scoring model (procurement view)

• API single-source vs multi-source (multiple DMFs, multiple API sites)
• Finished dose site count (multiple NDA manufacturing sites)
• Packaging site count (multiple NDC packagers)
• Known tech transfer history (if indicated by label/manufacturing changes over time)

What generic entry risks exist for ZONEGRAN suppliers if API is constrained?

Answer: Supplier constraints affect generic launch schedules when zonisamide API supply is bottlenecked. Generic entry risk is driven by:

• availability of qualified zonisamide API
• ability to source film-coating materials and match dissolution performance
• CMO capacity for solid oral tablets at scale

Paragraph IV and litigation angle (supplier-impact)

When generics pursue FDA approval pathways, the ability to procure API and execute formulation manufacturing becomes critical. Supplier outages often translate into delayed launches, even when IP position is favorable.

What is the Orange Book status of ZONEGRAN relevant to supplier selection?

Answer: Zonegran is an innovator NDA with Orange Book-listed patents that can constrain generic entry but do not directly list suppliers. Orange Book status matters for procurement only insofar as it affects:

• expected competitive generics/authorized generics timing
• demand volatility across the supplier base

Supplier relevance of Orange Book milestones

• Patent-expiration-driven demand shifts
• Generic readiness schedules that pressure API CMOs and finished-dose CMOs

Which supply-chain documents typically list ZONEGRAN suppliers by site?

Answer: The highest-signal public documents are the product label and FDA Orange Book listing entries. For deeper supplier discovery, you must use FDA facility inspection disclosures and DMF-linked API references.

Procurement-ready sources to anchor supplier identification

• US prescribing information and label manufacturing section
• Orange Book NDA listing tied to ZONEGRAN strengths and dosage forms
• FDA inspection reports (establishment name matching label manufacturers)
• DMF references for API (linked to the NDA)

ZONEGRAN supplier map template (to populate from label + Orange Book + DMF)

Use this table structure to capture the actual suppliers once the NDA labeling and DMF references are matched.

Category	Item	Supplier role	Jurisdiction	Entity (legal name)	Site address	Evidence in public record
API	Zonisamide API	API manufacturer	US			DMF holder linked to NDA
Drug product	Tablets (25 mg, 100 mg)	Tableting/Coating CMO or primary manufacturer	US			Label “Manufactured by” section
Packaging	Bottling/cartoning	Packager	US			Label “Packaged by” or listing tied to NDC
Release testing	QC/QA testing	QC lab	US			Manufacturing section and CMO certifications
Raw materials	Excipients, coating polymers	Excipients supplier chain	Global			Only indirectly from label/manufacturer disclosures

Key Takeaways

• “Supplier list” for Zonegran cannot be stated accurately from a single public index without tying the US label manufacturing section to the Orange Book NDA listing and DMF cross-references.
• Procurement-grade identification requires matching: DMF-linked API holder(s) plus label-specified drug product manufacturer/packager for each strength and NDC.
• The supplier count (API and finished-dose sites) determines redundancy risk and affects generic launch feasibility if API is constrained.

FAQs

1. Does Zonegran use a single zonisamide API source or multiple DMFs for API supply?
2. Which company is the “Manufactured by” site for Zonegran tablets for 25 mg vs 100 mg?
3. How do DMF-linked zonisamide API holders affect supplier qualification for generic manufacturers?
4. Do Zonegran packaging and bottling sites differ by NDC and strength?
5. What documents should procurement teams review to identify Zonegran suppliers by site and role?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (U.S. FDA).
2. US Prescribing Information / Medication Guide and Product Label for Zonegran (zonisamide). (Eisai Inc., US).
3. FDA Drug Master File (DMF) database and NDA-DMF linkages. (U.S. FDA).