Suppliers and packagers for DIAZEPAM INTENSOL

DIAZEPAM INTENSOL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
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

DIAZEPAM INTENSOL Suppliers: Who Makes the Brand, API, and Key Supply-Chain Inputs

Last updated: June 1, 2026

Diazepam Intensol supply originates with the brand holder and its contracted manufacturers for drug product, plus upstream suppliers for diazepam active pharmaceutical ingredient (API), excipients, and packaging. The definitive list of “suppliers” depends on the specific market (US vs ex-US), the dosage strength, and whether the reference is for manufacturing sites, API vendors, or component excipient/closure suppliers.

Who supplies DIAZEPAM INTENSOL (drug product) in the US?

Answer: Diazepam Intensol is marketed in the US by Axsome Therapeutics, Inc.
The drug product is manufactured under contract by one or more FDA-registered manufacturers associated with the approved NDA/labeling. The exact contract manufacturer(s) are determinable from the FDA label “Manufactured for” and from the FDA registration database tied to the specific listed drug.

What does the US label say about the “manufactured for” entity?

Actionable source for the drug-product supplier: the US package insert labeling page that lists “Manufactured for [label holder]” and “Manufactured by” (if present).

Typical label patterns for Intensol products:

• Label holder listed as the NDA holder/marketer
• “Manufactured for” line reflecting the contract manufacturer identity
• Packaging/labeling supplier sometimes shown separately (bottle/closure)

How to map the manufacturing supplier to FDA registrations

Drug product manufacturing sites can be mapped by:

• FDA Establishment Registration and Listing (may show the specific site used for the label’s “manufactured for” line)
• FDA drug inspection records tied to the specific facility name

Who supplies the diazepam API used in DIAZEPAM INTENSOL?

Answer: The diazepam API is supplied by one or more API manufacturers that hold DMF/ASMF filings referenced in the NDA.
In the US, the API supplier identity can be pulled from:

• FDA’s Orange Book listing details and associated regulatory documents
• The Drug Master File (DMF) references listed with the application (where publicly retrievable)

What to look for in the NDA/DMF footprint

API supplier tracing typically uses:

• DMF holder name and filing number (when disclosed in publicly accessible FDA documentation)
• Inactivity or changes in DMF cross-references over time
• Updates to manufacturing site and process controls

What common supply-chain constraint affects benzodiazepine liquids

For benzodiazepine oral solutions, supply sensitivity can come from:

• API batch availability and DMF-based qualification
• solvent/reagent supply for synthesis steps
• nitrogen/controlled atmosphere needs for certain intermediates
• metrology and particle control for low-dose uniformity

Which excipient suppliers matter for DIAZEPAM INTENSOL?

Answer: Diazepam Intensol uses a liquid oral dosage formulation, so excipients are critical supply-chain inputs for solubilization, stability, viscosity, and preservative system.
While the exact excipient list depends on the current approved formulation in the US label, typical oral solution components include:

• solubilizer/co-solvent system
• sweetener or flavor component
• viscosity adjuster
• pH adjusters and buffers
• preservatives (if used)
• purified water meeting compendial specifications

How excipient supplier identity is determined

Excipients are often sourced from qualified vendors but may not be named publicly in label text. The reliable path is:

• NDA comparability supplements and CMC documentation (when made public)
• FDA inspection observations and facility listings for excipient manufacturing sites when inspectors cite them
• supplier qualification and vendor change notifications in CMC filings

What packaging suppliers are used for DIAZEPAM INTENSOL?

Answer: Packaging suppliers are tied to the bottle, closure, and child-resistant components used for the Intensol dispensing system.
For oral solutions, packaging supplier choices impact:

• material compatibility with the solution
• extractables and leachables (closure liners)
• dosing accuracy and shelf-life stability

Where to find closure/bottle configuration

The label and carton labeling generally indicate:

• bottle type (size, counts, dispensing format)
• closure style (sometimes only by description)
• storage conditions

Closure materials and dosing caps are typically confirmed through:

• CMC packaging section in the NDA
• extractables/leachables reports in the public assessment record (where available)

How many supplier tiers exist for DIAZEPAM INTENSOL?

Answer: At least three tiers apply in practice.

1. Drug product contract manufacturing (NDA product manufacturing site)
2. API manufacturing (diazepam API producer(s) referenced by DMF/ASMF)
3. Component suppliers (major excipient system and packaging)

A fourth tier often exists:

• logistics and warehousing providers that handle controlled substance distribution requirements, including temperature monitoring and chain-of-custody for DEA-regulated distribution.

What generic-entry or shortage risks affect DIAZEPAM INTENSOL supply?

Answer: The main supply risks for benzodiazepine liquid products are constrained by:

• API availability through DMF-registered supply chains
• stability-driven hold times and bottle/closure compatibility
• limited number of qualified facilities capable of scaling oral solution manufacturing to USP-compliant specifications

What changes trigger supply disruptions

• DMF holder change or upstream batch availability constraints
• manufacturing site transfer and process revalidation timelines
• preservative/pH system adjustments that alter stability windows
• packaging component substitutions (closure liner reformulation) requiring comparability studies

Key Takeaways

• DIAZEPAM INTENSOL drug product supply is contract-manufactured under the US label holder’s NDA and is reflected in “manufactured for” labeling and FDA facility registrations.
• Diazepam API supply is typically DMF/ASMF-referenced in the NDA and is determined from the regulatory references rather than from label text.
• Excipients and packaging are essential supply-chain inputs for oral solution stability and dosing accuracy; supplier names are usually found in CMC documentation, not consumer-facing labeling.
• Supply-chain risk for benzodiazepine oral solutions concentrates at API availability, CMC stability, and packaging/closure compatibility.

FAQs

1) How can I identify the contract manufacturer for DIAZEPAM INTENSOL from public records?
Use the US package insert “Manufactured for/Manufactured by” lines and match the facility name to FDA Establishment Registration entries.

2) Does the Orange Book list the diazepam API supplier for DIAZEPAM INTENSOL?
Orange Book listings typically do not name the API supplier; they list the listed drug and patents exclusivity. API supplier mapping uses NDA DMF/ASMF references.

3) Are packaging suppliers listed on DIAZEPAM INTENSOL labeling?
Usually not by vendor name. Packaging type and configuration appear, while vendor identity is generally in CMC documentation.

4) What is the fastest path to find component suppliers for the oral solution formulation?
The fastest path is the NDA CMC package and DMF/ASMF references for excipients and API, then match to FDA-registered manufacturing sites where publicly available.

5) What typically causes DIAZEPAM Intensol supply shortages?
Upstream diazepam API availability, liquid formulation stability hold-time limits, and packaging/closure qualification changes.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US FDA.
2. FDA. Drugs@FDA. Label and application information for diazepam formulations. US FDA.
3. FDA. Establishment Registration and Listing (EURL/Edu). US FDA.
4. FDA. DMF/ASMF reference framework and NDA technical sections (public framework for regulatory references). US FDA.