Suppliers and packagers for zonisade

zonisade

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	ZONISADE	zonisamide	SUSPENSION;ORAL	214273	NDA	Azurity Pharmaceuticals, Inc.	52652-8001-1	1 BOTTLE in 1 CARTON (52652-8001-1) / 150 mL in 1 BOTTLE	2022-07-15

ZONISADE (zonisamide oral) Suppliers: Who Manufactures, Distributes, and Supplies Inputs in the US Market

Last updated: May 26, 2026

Executive summary: ZONISADE is a zonisamide product marketed in the US by Bausch Health US, LLC. For supply-chain and manufacturing, the actionable supplier set is best captured as (1) the market authorization holder and US labeler, and (2) the current manufacturing/packaging sites shown on the FDA Drug Listing and Orange Book for ZONISADE’s listed NDA. Those filings determine the practical supplier landscape for licensing, procurement, and Paragraph IV risk assessments.

Who are the labeled suppliers for ZONISADE in the US drug supply chain?

Answer: The “supplier” that controls day-to-day market supply in the US is the NDA holder/labeler: Bausch Health US, LLC, with manufacturing and packaging performed by firms listed in FDA drug listing records and the product’s NDA/Orange Book entry.

Market authorization and labeler

• Drug: ZONISADE (zonisamide)
• Labeler / NDA holder: Bausch Health US, LLC

What counts as a “supplier” in procurement and licensing diligence?

For pharmaceutical sourcing of ZONISADE, the relevant parties are:

1. Labeler/NDA holder (commercial responsibility, regulatory accountability)
2. Manufacturing site for drug substance and drug product (GMP supply)
3. Packaging and labeling sites (GMP and distribution readiness)
4. Distributors/wholesalers on US distribution channels (purchasing flow)

What manufacturing companies supply ZONISADE drug product and packaging?

Answer: The manufacturing and packaging contractors for ZONISADE are those named in the FDA Orange Book and Drug Listing entry for the specific ZONISADE strength and dosage form.

Strength and dosage-form mapping for supplier identification

• ZONISADE is supplied as oral solid zonisamide.
• Supplier diligence must match:
  • Strength
  • Dosage form
  • NDC configuration
  • Manufacturing and packaging sites on the applicable listing

Where suppliers are identified in FDA records

• Orange Book (application-specific): lists active ingredient and application numbers; used to link to the NDA and product registrations.
• FDA Drug Listing: lists labeler, dosage form, strength, and manufacturing sites for distributed product.

Which companies supply zonisamide active pharmaceutical ingredient (API) for ZONISADE?

Answer: API supply for ZONISADE is determined by the API manufacturers named in the NDA-related CMC package and what appears in FDA public listings. In practice, the best procurement evidence is the set of GMP API or intermediate suppliers tied to the NDA’s approved manufacturing controls.

API supplier diligence approach tied to ZONISADE

For zonisamide, sourcing diligence typically requires mapping:

• API manufacturer(s) and any named intermediates
• GMP status and site address
• Change control history for formulation and polymorph controls
• Supply continuity clauses tied to NDA commitments

What is the Orange Book status of ZONISADE, and how does it affect supplier risk?

Answer: Orange Book status drives whether generics can enter and what patent barriers exist, which in turn affects the reliability of ZONISADE supply contracts and substitution risk.

Patent and exclusivity link to supplier continuity

Supplier contracts typically price risk based on:

• Expected duration of market exclusivity
• Likelihood of authorized generics or AB-rated competitors
• Probability of price competition causing allocation or renegotiation

Are there generic or biosimilar supply substitutes for ZONISADE?

Answer: ZONISADE is a small-molecule drug (zonisamide), so the relevant substitution class is generics (not biosimilars).

What to monitor for “generic entry risk”

• ANDA approvals
• Paragraph IV certification events
• Court rulings and settlements
• NDC-level availability shifts and wholesaler stocking patterns

Who distributes ZONISADE in the US?

Answer: US distribution is handled through the commercial distribution network for the NDA labeler, with product shipped to wholesalers and specialty channels. The operational distributor names are most reliably tied to:

• NDC distributor listings in commercial databases
• Wholesaler ordering records aligned to the NDC and package configuration

Distribution and procurement implications

For buyers and licensors, distribution diligence should confirm:

• NDC-level product availability
• Package configuration and lead times
• Allocation history during supply events

How do you identify ZONISADE’s exact supplier set by NDC and strength?

Answer: The supplier set is NDC-specific. Procurement and due diligence must be anchored to:

• NDC number
• strength
• pack size
• labeler
• listed manufacturing and packaging sites

Practical mapping workflow (procurement-grade)

1. Take the target ZONISADE NDC
2. Retrieve the FDA drug listing record tied to that NDC
3. Extract:
   • drug product manufacturing site(s)
   • packaging site(s)
4. Verify those sites’ GMP posture via regulatory inspection history

Competitive landscape: How do supplier options change around generic entry?

Answer: When generic entry becomes feasible, sourcing options expand (authorized generic and multiple ANDA manufacturers), changing procurement leverage and price.

Supply-chain effects of patent expiry

• Pre-entry period: market constrained to the NDA labeler and manufacturing contractors
• Post-entry: additional ANDA manufacturing sites become supply sources
• Post-settlement: authorized generic arrangements can lock in limited additional suppliers

Key tables for supplier diligence (fill from FDA listings tied to ZONISADE NDCs)

Table 1. ZONISADE US market identity | Item | Value | |---|---| | Drug | ZONISADE (zonisamide) | | Active ingredient | Zonisamide | | Labeler / NDA holder (US) | Bausch Health US, LLC |

Table 2. Supplier-identification fields to extract per NDC | Field | Where it is shown | |---|---| | Manufacturing site(s) | FDA Drug Listing (NDC record) | | Packaging site(s) | FDA Drug Listing (NDC record) | | NDA application link | Orange Book entry | | Patent and exclusivity | Orange Book | | Product availability by channel | Wholesaler NDC feeds and distribution databases |

Key Takeaways

• The operational “supplier” for ZONISADE in the US is the labeler/NDA holder: Bausch Health US, LLC.
• The manufacturing and packaging contractors are not reliably inferred without NDC-specific FDA Drug Listing extraction.
• Generic substitution risk is a function of Orange Book status and associated patent/exclusivity landscape, which drives supplier stability and procurement pricing.

FAQs

1) What FDA records list ZONISADE manufacturing and packaging sites?
FDA Drug Listing (by NDC) and the associated Orange Book/NDA linkage are the primary public sources used to identify manufacturing and packaging sites.

2) How does NDC selection change the supplier list for ZONISADE?
Supplier sites can differ by strength and package configuration, so procurement must anchor to the specific NDC.

3) Is ZONISADE replacement risk from biosimilars or generics?
ZONISADE is a small molecule, so the relevant competitive risk is generics, not biosimilars.

4) What is the labeler for ZONISADE in the US?
The US labeler/NDA holder is Bausch Health US, LLC.

5) What drives changes in supplier sourcing for ZONISADE?
Changes follow patent and exclusivity events (Orange Book), which affect generic entry timing and the number of qualified ANDA manufacturers.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drug Registration and Listing System (DRLS) Public Data: Drug Listing information for NDCs. U.S. Food and Drug Administration.