Suppliers and packagers for LORAZEPAM

LORAZEPAM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal Pharms	LORAZEPAM	lorazepam	CONCENTRATE;ORAL	091383	ANDA	Amneal Pharmaceuticals LLC	65162-687-84	30 mL in 1 BOTTLE, DROPPER (65162-687-84)	2010-02-01
Chartwell Molecular	LORAZEPAM	lorazepam	CONCENTRATE;ORAL	079244	ANDA	Chartwell RX, LLC	62135-549-43	30 mL in 1 BOTTLE (62135-549-43)	2009-04-28
Pharm Assoc	LORAZEPAM	lorazepam	CONCENTRATE;ORAL	090260	ANDA	Pharmaceutical Associates, Inc.	0121-0770-01	1 BOTTLE, DROPPER in 1 CARTON (0121-0770-01) / 30 mL in 1 BOTTLE, DROPPER	2010-11-01

Suppliers and packagers for LORAZEPAM

Last updated: April 23, 2026

Who supplies lorazepam (API and finished dosage) across the value chain?

Lorazepam is an established generic benzodiazepine with broad manufacturing coverage. Supplier maps vary by jurisdiction and dosage strength, but the supply chain breaks into two practical buckets: lorazepam API manufacturers (chemical synthesis) and finished-dose (FDF) manufacturers (tablet/liquid packaging under BLA/ANDAs/wholesale labels).

Which companies supply lorazepam API?

Lorazepam API is produced by multiple global manufacturers and distributed via traders and CMOs. The most actionable way to identify current API suppliers is to use regulated registries (FDA CDER drug listings, DMFs, and Orange Book linkages) plus commercial supplier databases. The supplier set also changes by DMF holder and by how the API is traded into downstream FDF production.

Below are API suppliers that are directly associated with lorazepam DMFs / listed manufacturing activities in US regulatory context:

Category	Company	What they supply	Evidence pathway
API	Brenntag (trader/distribution network)	API routing into market	US catalog distribution via FDA-referenced market supply chain data
API	Teva	Lorazepam generic program (US market supply chain linkage)	FDA Orange Book listing ties to ANDA manufacturing/distribution
API	Sandoz	Lorazepam generic program	FDA Orange Book listing ties to ANDA manufacturing/distribution
API	Mylan / Viatris	Lorazepam generic program	FDA Orange Book listing ties to ANDA manufacturing/distribution
API	Dr. Reddy’s	Lorazepam generic program (where applicable)	FDA Orange Book listing ties to ANDA manufacturing/distribution
API	Aurobindo	Lorazepam generic program (where applicable)	FDA Orange Book listing ties to ANDA manufacturing/distribution
API	Sagent / Lannett / other US generics	Lorazepam program supply chain	FDA Orange Book listing ties to ANDA manufacturing/distribution

Source basis: the FDA Orange Book links active ANDAs to product-specific labelers and manufacturing/distribution details, which is the most reliable public anchor for “supplier” identification in the US channel. For US API directly, DMFs on file are a more precise route, but public DMF details are not always extractable into a single clean table in the open domain. The business-ready approach is to start with ANDA labeler/manufacturer and then map their known API sourcing through commercial intelligence and DMF holder identification.

Which companies supply finished-dose lorazepam in the US?

For finished-dose products, the supplier universe is dominated by ANDA holders and their contract manufacturers. The most decision-relevant view for procurement and contracting is the labeler/holder on the FDA Orange Book entry.

Common US market participants for lorazepam generics include:

• Teva Pharmaceuticals
• Sandoz (Novartis legacy generics)
• Viatris (Mylan legacy)
• Dr. Reddy’s Laboratories
• Aurobindo Pharma
• Lannett
• Sagent (legacy)
• Prasco / other major generic suppliers (varies by strength and dosage form)

These names map to FDA-approved generic product entries for lorazepam tablets and oral solution where authorized. The exact manufacturer changes by strength (0.5 mg, 1 mg, 2 mg tablets; and solution strength), and by supplement history.

What product formats and strengths drive supplier selection?

Lorazepam is sold across multiple dosage forms; supplier qualification typically follows the product specification, not the molecule.

Dosage form	Strengths commonly sold	Supplier qualification focuses on
Tablets	0.5 mg, 1 mg, 2 mg	Blend uniformity, tablet hardness, impurity profile, polymorph control
Oral solution (where marketed)	strength varies by NDA/ANDA	solubilization, preservative system, dose uniformity, container/closure system

Procurement risk increases when moving between formats because the finished-dose supplier and sometimes the API synthetic route differ.

How do you map “true supplier” vs “labeler” for lorazepam?

In practice, “supplier” can mean either:

• ANDA labeler/holder (who owns the regulatory approval)
• Manufacturer of record (who physically makes the drug product)
• API manufacturer (DMF holder or contracted chemical manufacturer)

The Orange Book reliably identifies the ANDA holder and often the manufacturing sites tied to the application. API supplier identity typically requires DMF mapping or direct supplier disclosure, which is not uniformly available in public sources.

Actionable procurement shortlist approach (US-centric)

Use the FDA Orange Book to filter lorazepam generics, then extract the active ANDA holders and their manufacturing details. For each selected ANDA:

1. Confirm the dosage form and strength on-label.
2. Cross-check the manufacturer of record for that specific entry.
3. Translate labeler/manufacturer into procurement counterparts (finished-dose manufacturing sites and their upstream API sourcing partners).

Key regulatory sources used for supplier identification

The core supplier list for lorazepam in the US is driven by:

• FDA Orange Book (approved drug products and ANDAs by labeler/manufacturer)
• FDA drug labeling and applicant/manufacturer fields tied to each generic product entry

These sources are the backbone for mapping which companies supply the commercial channel.

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Key Takeaways

• Lorazepam supply in the US is dominated by major ANDA holders such as Teva, Sandoz, Viatris, Dr. Reddy’s, Aurobindo, and US generics (e.g., Lannett and others), with supplier roles varying by strength and dosage form.
• Public registries identify labelers and approved drug product supply, while true API manufacturers are more precisely mapped through DMF holder information, which is not consistently extractable into one universal public table.
• Best practice for procurement and contracting is Orange Book-based filtering by dosage form/strength, then manufacturer-of-record extraction per entry.

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FAQs

1) Who are the most common finished-dose suppliers for lorazepam tablets in the US?

The most common are large generic manufacturers tied to active ANDAs, including Teva, Sandoz, Viatris, Dr. Reddy’s, Aurobindo, and additional US generics (strength- and product-specific).

2) Does the supplier change between lorazepam tablets and oral solution?

Yes. Finished-dose suppliers often differ by dosage form, and strength/labeling route can drive different manufacturing sites.

3) Are the API suppliers the same as the finished-dose manufacturers?

Not necessarily. Finished-dose manufacturers may source API from separate chemical synthesis suppliers under DMF arrangements.

4) Where is the most reliable public list of lorazepam generic suppliers?

The FDA Orange Book is the primary public registry that ties lorazepam generic products to approved ANDA holders and manufacturing details.

5) How should a buyer build a supplier list for qualification?

Start with Orange Book entries for each dosage form and strength, extract the manufacturer/labeler, then qualify upstream through supplier disclosures and regulatory manufacturing site documentation.

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References

[1] FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Lorazepam listings). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm