Suppliers and packagers for DIASTAT

DIASTAT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-650-20	2 SYRINGE, PLASTIC in 1 PACKAGE (68682-650-20) / .5 mL in 1 SYRINGE, PLASTIC	1997-07-29
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-652-20	2 SYRINGE, PLASTIC in 1 PACKAGE (68682-652-20) / 2 mL in 1 SYRINGE, PLASTIC	1997-07-29
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-655-20	2 SYRINGE, PLASTIC in 1 PACKAGE (68682-655-20) / 4 mL in 1 SYRINGE, PLASTIC	1997-07-29

DIASTAT suppliers: who manufactures and supplies Diastat (diazepam rectal gel) to the US market

Last updated: May 28, 2026

Executive summary

• Primary US supply is by Pfizer as the current NDA holder and market-facing supplier for Diastat (diazepam) rectal gel products listed under the brand “Diastat” with strengths commonly sold as Diastat AcuDial (10 mg, 15 mg, 20 mg).
• Worsening supply risk is tied to API and gel-pack assembly capacity, because rectal gel products depend on (1) diazepam API procurement, (2) gel formulation compounding and sterilization/asepsis controls appropriate to rectal administration, and (3) controlled filling/assembly of the AcuDial delivery system.
• Competitor supply is structurally constrained: generic “rectal diazepam gel” entrants face formulation and device-specific manufacturing controls that map closely to the Diastat delivery system build.

Who supplies Diastat (diazepam rectal gel) in the US?

Answer (featured snippet): Pfizer supplies Diastat to the US market as the branded product manufacturer/NDA holder.

What entity is on the Diastat label for supply?

• NDA holder / brand supplier: Pfizer (Diastat, diazepam rectal gel; includes Diastat AcuDial configurations).
• Distribution model: branded wholesaler distribution under standard US pharmacy supply chains.

Are there alternative brand-name suppliers?

• No widely used “secondary brand supplier” model applies to Diastat at the brand level. The commercial supply chain is still ultimately anchored to the labeled product’s manufacturing and release through the NDA holder’s quality system.

What manufacturers make the diazepam API used in Diastat?

Answer (featured snippet): The diazepam API supply chain for Diastat is sourced through qualified API manufacturers under Pfizer’s raw material procurement and quality agreements, not through a single public “named” supplier contract list.

Why API supplier names often do not appear publicly

• API procurement is typically controlled via DMF referencing and quality agreements, with supplier qualification handled through Pfizer’s vendor management.
• Public-facing listings often show the finished product rather than the upstream API supplier.

How to evaluate API risk for rectal diazepam gels

• Watch upstream constraints that affect benzodiazepine API availability: capacity cycles, regulatory inspection outcomes for API facilities, and DMF holder changes.
• The rectal gel dosage form also adds dependence on consistent gel rheology and stability windows.

Which companies supply the finished-dose rectal gel manufacturing and filling capacity?

Answer (featured snippet): Diastat’s finished-dose gel and packaging are produced under Pfizer’s manufacturing network; upstream contract manufacturing organizations can fill, package, and assemble components, but the publicly visible “supplier roster” is typically not published as a single list.

What manufacturing steps drive supplier dependence

• Gel compounding and mixing under controlled formulation parameters.
• Filling into the rectal dosing applicator system (AcuDial).
• Sterility and microbiological controls appropriate to the product’s intended handling and administration.
• Final QA release, serialization where applicable, and shipping to US distribution centers.

What to map when tracking supplier changes

• Contract site changes usually show up through:
  • site-specific inspection history
  • changes in product labeling/packaging imprinting
  • manufacturing supplements and annual product reporting patterns to FDA.

What is the role of the AcuDial delivery system in supplier qualification?

Answer (featured snippet): The AcuDial device affects supplier qualification because the product is not only a gel formulation but also a dosing delivery system.

Device-linked supply dependencies

• Applicator materials, tolerances, and assembly steps must match performance specifications for:
  • consistent dosing accuracy
  • leak resistance
  • smooth dosing delivery
• Device and gel are validated together through development and post-approval manufacturing controls.

Why device assembly suppliers matter for continuity of supply

• If applicator components face sourcing interruptions, finished lots can be delayed even when gel compounding capacity exists.
• Conversely, if API or gel formulation capacity is constrained, device assembly inventories still cannot release finished goods without qualifying lots.

How do generics and alternative rectal diazepam products change supplier leverage?

Answer (featured snippet): Alternative manufacturers do not “take over” Diastat supply; they introduce competing finished product supply streams that still depend on rectal gel and device-specific manufacturing.

Generic entry structure for rectal diazepam gels

• Generic rectal diazepam gel products must match:
  • dosage form and strength
  • route of administration
  • dosing performance characteristics
• If device features differ, applicants often address usability and administration performance through formulation and device validation.

What this means for Diastat’s supplier strategy

• Pfizer’s sourcing and manufacturing continuity still hinges on controlling key intermediates:
  • diazepam API supply
  • gel formulation compounding
  • device assembly component chain

What commercial or regulatory events create supplier disruptions for Diastat?

Answer (featured snippet): Supply disruptions are most often driven by FDA compliance events, manufacturing site capacity limits, or component device shortages for the AcuDial system.

Regulatory drivers that can force supplier changes

• cGMP inspection outcomes
• equipment or process validation failures
• product-specific recalls tied to manufacturing deviations

Commercial drivers

• demand spikes for acute use products used in seizure management
• contract manufacturing slot constraints during broader benzodiazepine production cycles

Key suppliers landscape for DIASTAT (structured view)

Answer (featured snippet):

• Finished product supplier (brand-level): Pfizer

Supply tier	What it supplies	Publicly named “supplier” in market-facing listings?	Notes
Brand/NDA holder	Release and distribution of Diastat	Yes	Pfizer is the market-facing supplier/NDA holder for Diastat
Finished dose manufacturing	Gel compounding, filling, QA release	Sometimes (site-level not always transparent)	Often through Pfizer manufacturing network and/or contract manufacturing
Device/applicator assembly	AcuDial assembly components and finished applicators	Rarely as a public single list	Component sourcing can bottleneck release
API tier	Diazepam API for gel	Rarely as a public single list	Typically managed via DMFs and qualification programs

Key Takeaways

• Pfizer is the core supplier for Diastat’s branded finished product in the US.
• Upstream API sourcing and downstream AcuDial applicator component/assembly determine supply continuity.
• Supplier visibility at the component and API tiers is limited publicly; continuity analysis relies on inspection history, manufacturing site reporting patterns, and component-chain risk signals.

FAQs

1. Who makes Diastat rectal gel in the US?
   Pfizer is the market-facing brand supplier/NDA holder for Diastat.

2. Are there named alternative suppliers of the Diastat AcuDial device?
   Public disclosure typically focuses on finished product and not a single named device sub-supplier.

3. Can generic rectal diazepam gels relieve Diastat supply shortages?
   They can add market supply, but they require their own rectal gel and device-qualified manufacturing chains.

4. What parts of Diastat’s supply chain are most failure-prone?
   The diazepam API tier and AcuDial applicator component/assembly tier are the most common constraints.

5. What regulatory actions most directly affect Diastat supply?
   FDA cGMP compliance actions and product recalls tied to manufacturing deviations.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
2. DailyMed. Diastat (diazepam) rectal gel prescribing information. (Accessed via DailyMed).
3. FDA. Drug Approval Package for Diastat (diazepam) rectal gel. (Accessed via Drugs@FDA).