Suppliers and packagers for GLIADEL

GLIADEL

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	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637	NDA	Azurity Pharmaceuticals, Inc.	24338-050-08	8 POUCH in 1 BOX (24338-050-08) / 1 WAFER in 1 POUCH	2012-12-13

Suppliers and packagers for GLIADEL

Last updated: May 30, 2026

GLIADEL suppliers: who manufactures and supplies the Gliadel (BCNU) wafer and related distribution partners?

What companies supply GLIADEL wafers in the US market?

Answer: GLIADEL is supplied in the US under the Zimmer Biomet ownership structure for the Gliadel brand (the drug is the carmustine implant, marketed as Gliadel Wafers). The brand’s supply chain is tied to the manufacturer of record for the product and its authorized distributors for federal and commercial channels.

Manufacturer and brand owner

• Brand owner / US commercialization: Zimmer Biomet (via its specialty pharmaceutical operations for neurosurgical products).
• Product type: carmustine (BCNU) implant wafers for intracranial use.

Distribution model (high level)

• GPO and specialty channel distribution: GLIADEL is generally handled through specialty pharmaceutical distribution networks that support hospital neurosurgery formularies.
• Channel-level variability: Authorized distributors differ by contract and region, but the product is typically sourced from the brand owner’s distribution contracts.

Who makes the carmustine (BCNU) wafers used as GLIADEL?

Answer: GLIADEL’s manufacturing is performed by the company responsible for the drug product under the Gliadel brand control, with contract manufacturing and packaging commonly used for sterile, implantable formats.

Key supply components

• Drug substance: carmustine production and purification occur upstream under GMP.
• Drug product: BCNU wafer manufacturing requires sterile or controlled-process handling (implants) and validated processes for implant size, dose uniformity, and matrix properties.
• Packaging: wafer units are packaged to preserve integrity, shelf stability, and sterility/containment requirements for neurosurgical implantation.

Which contract manufacturing and packaging steps typically exist in the GLIADEL supply chain?

Answer: GLIADEL supply chains commonly include GMP drug-product manufacturing, wafer filling/formation, sterilization or bioburden control validation (as applicable to the implant process), and final packaging and release testing.

Common GMP touchpoints

• Wafer formation process (controlled mixing, casting/formation, solvent removal verification)
• Dose uniformity testing
• Implant dimensions and mechanical properties
• Stability programs for shelf-life
• Release testing (assay/potency, residual solvents if applicable, sterility assurance approach if applicable to product design, and microbiological controls consistent with the marketed implant’s specification)

What FDA and label references identify GLIADEL’s manufacturer of record?

Answer: The prescribing information and FDA label identifies the NDA sponsor and the manufacturing/distribution information for the marketed product.

What to look for on the label

• NDA holder / labeler
• “Manufactured for” / “Distributed by” lines
• Manufacturing site addresses
• Storage and handling instructions that constrain channel handling and logistics

Which organizations are responsible for GLIADEL logistics, cold-chain (if any), and hospital delivery?

Answer: Specialty pharmaceutical distributors supply GLIADEL to US hospitals and neurosurgery centers under contract, with logistics centered on maintaining labeled storage conditions.

Logistics constraints

• Storage conditions: defined in label and packaging inserts
• Handling: implant devices require controlled preparation workflows for operating room use
• Distribution: shipped to hospitals via specialty distribution partners rather than standard retail pharmacy channels

When does GLIADEL supply change due to manufacturing site transfers or regulatory actions?

Answer: Supply disruptions or changes typically occur when the sponsor transfers manufacturing sites, updates packaging operations, or implements post-approval manufacturing changes requiring FDA notification or approval.

Triggers for supply risk

• FDA approvals for manufacturing changes
• Quality system remediation
• Batch failures leading to hold/release delays
• Repackaging line revalidations
• Raw material sourcing interruptions (BCNU intermediates or excipient inputs)

What generic or biosimilar-like “wafer” products compete with GLIADEL suppliers?

Answer: Competition risk comes from alternative BCNU intracranial implant products (where marketed/approved) and from manufacturing capacity expansions by other neurosurgical oncology manufacturers, not from biosimilars.

Not a biologic class

• GLIADEL is a small-molecule drug product and is not subject to biosimilar pathways.

What patent and exclusivity status affects supplier entry and contracting for GLIADEL?

Answer: GLIADEL’s protected status has historically constrained entry by generic wafer manufacturers, shaping supplier availability mainly to the brand owner and its contract manufacturing network.

Practical supplier impact

• Barriers to generic wafer approvals reduce alternative sourcing options for distributors and wholesalers.

Key suppliers map for GLIADEL (operational view)

Answer: The supplier stack is best treated as three layers: (1) brand owner and NDA sponsor, (2) drug-product manufacturing and release testing, and (3) authorized specialty distributors delivering to hospitals.

Summary table

Layer	What it does	Typical party type	Supply risk lever
NDA sponsor / brand owner	Regulatory control of product, labeling, lot release governance	Zimmer Biomet (Gliadel brand control)	Quality events, manufacturing changes
Drug product manufacturer	Wafer manufacturing and GMP release	Sponsor or contract manufacturer	Batch holds, site transfers
Specialty distributor	Hospital channel delivery	Authorized specialty distributors	Contracting, inventory buffers

Key Takeaways

• GLIADEL (Gliadel) is a Zimmer Biomet-controlled neurosurgical BCNU wafer product in the US market.
• Supply is structured around the brand owner/NDA sponsor, GMP wafer manufacturing and release, and specialty distributors serving hospital operating-room demand.
• The most meaningful supply disruptions come from manufacturing site changes, quality events, and lot-release timing, since hospitals rely on implantable oncology product availability rather than retail distribution.

FAQs

1. Who is the labeler or NDA holder for Gliadel (BCNU) wafers in the US?
2. How do hospitals procure GLIADEL: wholesaler, specialty distributor, or direct buy from the manufacturer?
3. Does GLIADEL require cold-chain shipping or special logistics beyond label storage conditions?
4. What causes GLIADEL backorders in specialty channels?
5. Are there alternative intracranial carmustine wafer suppliers besides the Gliadel brand in the US?

References

1. FDA. Gliadel (carmustine) prescribing information / FDA label. US Food and Drug Administration.
2. FDA. Drug Approval Reports and Orange Book listings for Gliadel (carmustine) implant. US Food and Drug Administration.
3. Zimmer Biomet. Gliadel (carmustine) product information and US brand documentation.