DIAZEPAM: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chartwell Molecular	DIAZEPAM	diazepam	CONCENTRATE;ORAL	204433	ANDA	Chartwell RX, LLC	62135-768-43	30 mL in 1 BOTTLE (62135-768-43)	2014-04-14
Hikma	DIAZEPAM INTENSOL	diazepam	CONCENTRATE;ORAL	071415	ANDA	Hikma Pharmaceuticals USA Inc.	0054-3185-44	1 BOTTLE in 1 CARTON (0054-3185-44) / 30 mL in 1 BOTTLE	1987-04-03
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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 23, 2026

Diazepam Suppliers: Manufacturers, Key API Sources, and Finished-Dose Contract Manufacturing for US/EU Distribution

Diazepam supply chains split into two tiers: active pharmaceutical ingredient (API) producers and finished-dose manufacturers (tablets, oral solution, injectable). Competitive risk and availability in the US and EU depend on whether a supplier controls both API and finished dosage, and on which marketing authorizations hold the strongest regulatory continuity (FDA drug listings and EU marketing authorizations).

What companies supply diazepam API (active pharmaceutical ingredient) and who manufactures finished doses?

The market for diazepam includes multiple established generics and licensed manufacturers. In practice, “supplier” can mean either: (1) API producers that sell diazepam to generic formulators, or (2) finished-dose manufacturers that hold labeling/marketing authorization responsibility for specific strengths and dosage forms.

Typical supplier map for diazepam

API producers: supply diazepam (and often diazepam intermediates) to generics and contract manufacturers.
Finished-dose manufacturers: supply FDA/EMA-labeled products in one or more dosage forms:
- tablets (common strengths: 2 mg and 5 mg, plus other strengths by jurisdiction)
- oral solution or drops
- injectable formulations (where marketed)
Contract manufacturing organizations (CMOs): produce finished dosage under private label or for branded/generic NDA holders and ANDA sponsors.

How to categorize diazepam “suppliers” for procurement

Regulatory holder: entity responsible for the marketed product listing.
Manufacturing site: site on the regulatory submission for drug product and (if disclosed) API.
Supply continuity: whether the product is continuously marketed and not subject to recurring manufacturing holds or label revisions.

Which suppliers dominate US diazepam availability for tablets, oral solution, and injections?

US supply is driven by the ANDA pipeline and the set of drug products that remain active and continuously supplied. A US “supplier” list is best represented by:

ANDA applicants (often generics sponsors),
Manufacturers of record (drug product manufacturing sites),
Labeler names on commercial distribution.

A procurement-grade supplier list for US diazepam should be built from FDA drug product listing data (Orange Book-linked listings, NDC directories, and FDA labeling), not from marketing webpages.

What Orange Book listings exist for diazepam and what does that imply for supplier selection?

Diazepam is a small-molecule generics landscape where:

many products are older and off-patent,
the “IP” layer is mostly about formulation, polymorph, manufacturing process, and exclusivity rather than active ingredient coverage,
the binding constraint is manufacturing capacity and regulatory compliance.

Practical implication for supplier selection

Choose suppliers with:
- consistent FDA listing history,
- validated manufacturing lines for the target dosage form,
- and documented changes control (CMC comparability) for post-approval changes.

When does diazepam exclusivity end and how does that affect supplier entry risk?

Because diazepam is widely available as a generic, exclusivity windows are not the dominant driver of supply risk for most buyers. Instead, supply risk is more sensitive to:

plant utilization and API availability,
quality incident history,
and the speed of scale-up at approved sites after demand spikes.

For planning purposes, the supplier risk model should treat “entry” as a capacity and regulatory readiness issue rather than an IP-timing issue.

How many manufacturers supply diazepam in major jurisdictions and how concentrated is the supply base?

Supplier concentration varies by dosage form:

Tablets: usually have broader supplier depth due to manufacturing simplicity.
Oral solutions/drops: often face additional formulation stability and packaging constraints.
Injectables: tend to have fewer approved lines and higher compliance burden, raising supply fragility.

High-intent procurement projects typically evaluate concentration by:

NDC count (US) or marketing authorization count (EU),
number of manufacturing sites,
and historical stockout frequency.

What formulations of diazepam are suppliers selling and which supplier capabilities matter?

Suppliers differentiate by dosage form and formulation requirements:

Tablets

key capability: compression and uniformity validation
packaging: blister vs bottle requirements by channel

Oral solution / drops

key capability: solubilization strategy, preservative system compatibility, and stability profile
key constraint: viscosity and droplet dosing accuracy controls

Injectables

key capability: sterile manufacturing, filtration validation, and container closure integrity
key constraint: sterility assurance, endotoxin controls, and line qualification

Which injectable diazepam suppliers have the lowest regulatory and supply disruption risk?

Injectables have the tightest quality system expectations. A defensible supplier short list in injectable diazepam should prioritize:

verified sterile manufacturing capability at the approved site,
stable batch release history,
and low frequency of manufacturing-related supplements or refusals.

What patent estate affects diazepam supplier decisions in 2026?

For diazepam generics, the patent estate generally does not block most standard supplier entry because the active ingredient is off-patent in most markets. The remaining barriers tend to be:

manufacturing process claims,
formulation claims for specific dosage forms,
and method-of-use claims where they exist in local jurisdiction filings.

For supplier contracting, these factors are managed via:

freedom-to-operate screening at the product and manufacturing-process level,
and license coverage where a product-specific formulation or process is claimed.

What generic entry risks exist for diazepam: Paragraph IV, biosimilars, or manufacturing approvals?

Paragraph IV: often less relevant for diazepam because most ANDA challenges target more current exclusivity or later-expiring patents, which is less common in an established generics base.
Biosimilars: not applicable to diazepam because it is a small molecule.
Manufacturing approvals: the real entry risk is whether a new supplier can demonstrate regulatory-grade CMC and batch reproducibility.

How do diazepam API sourcing risks affect finished-dose suppliers?

Diazepam API availability is exposed to:

capacity constraints at API plants,
quality systems maturity,
and cross-border logistics and customs lead times for controlled substances and precursors.

For contract negotiation, buyers typically manage this through:

dual-sourcing API agreements,
committed safety stock,
and contractual lead times tied to forecast.

Which countries supply the diazepam API ecosystem for generics?

Diazepam API and intermediates are commonly produced in regions with established pharmaceutical manufacturing infrastructure. For procurement planning, country-of-origin risk is usually assessed via:

known regulatory inspection history at the specific facility,
recall and quality incident records,
and responsiveness to CAPA timelines.

A facility-level screen beats a country-level screen for actionable risk.

Supplier comparison matrix for diazepam: tablets vs solution vs injection

Supplier type	What they provide	Best-fit dosage forms	Key due diligence points
API supplier	Diazepam API (and potentially intermediates)	All dosage forms	DMF linkage (if used), CoA consistency, impurity profile controls, lead times
Finished-dose generic manufacturer	Marketed diazepam product	Tablets, solution, injection	Labeling compliance, batch release track record, site inspection outcomes
CMO/private label	Contract manufacturing under sponsor control	Tablets, solution, sometimes injection	CMC comparability capability, tech transfer execution, line capacity

Key takeaways

Diazepam supply in the US and EU is overwhelmingly generic-driven; the meaningful supplier differentiation is manufacturing reliability and regulatory continuity by dosage form.
For procurement, separate API sourcing from finished-dose manufacturing and evaluate facility-level quality systems, not just brand or catalog claims.
Tablets usually have the widest supplier depth; injectables concentrate fewer approved lines and therefore carry higher supply disruption risk.

FAQs

1) What information should I check on labels or FDA listings to identify the real diazepam manufacturer?

Look for the “manufactured for” or “labeled by” entity plus the listed manufacturing site information in labeling and FDA listing records; then map that to the drug product manufacturing site for batch release continuity.

2) Do diazepam tablets and oral solutions use the same manufacturing suppliers?

Often they do not. Tablet lines and liquid lines are typically different capabilities with different stability and packaging validation requirements.

3) How do I reduce supplier stockout risk for diazepam injection?

Use dual-sourcing for sterile manufacture when available, lock committed lead times, and track historical batch release timing and any manufacturing change supplements.

4) Is diazepam supply constrained by API availability?

Yes at times. Finished-dose availability depends on timely API delivery, impurity control within specification, and the ability to scale validated commercial batches.

5) Are there any biosimilar risks for diazepam suppliers?

No. Diazepam is a small-molecule drug, so biosimilars are not part of the competition set.

References

FDA Orange Book. Drug Products (Diazepam listings). U.S. Food and Drug Administration.
FDA Drug Product Databases (NDC and product listing information). U.S. Food and Drug Administration.

Suppliers and packagers for generic pharmaceutical drug: DIAZEPAM

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