Suppliers and packagers for QBREXZA

QBREXZA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Journey	QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361	NDA	Journey Medical Corporation	69489-411-05	5 POUCH in 1 CARTON (69489-411-05) / 2.8 g in 1 POUCH (69489-411-51)	2018-06-28
Journey	QBREXZA	glycopyrronium tosylate	CLOTH;TOPICAL	210361	NDA	Journey Medical Corporation	69489-411-30	30 POUCH in 1 CARTON (69489-411-30) / 2.8 g in 1 POUCH (69489-411-01)	2018-06-28

Suppliers and packagers for QBREXZA

Last updated: June 2, 2026

QBREXZA (glycopyrronium) suppliers: who manufactures, supplies, and distributes the product in the US

QBREXZA (glycopyrronium tosylate) is supplied in the US by Haleon (formerly GlaxoSmithKline Consumer Healthcare) via its operating units and distribution network. The branded product is marketed as qbrexza 2.4% topical cloths for hyperhidrosis, and the supply chain is tied to the brand holder’s labeler and drug-product manufacturing arrangements in US regulatory records (FDA labeler and Orange Book).

Who are the QBREXZA suppliers and distributors for the US market?

Supplier/distributor in the US (labeler/distributor):

• Haleon (US labeler/distributor for QBREXZA)

Product form relevant to sourcing:

• Topical cloths (2.4% glycopyrronium tosylate)

What “supplier” means in practice for QBREXZA:

1. Labeler/brand distributor responsible for commercial supply into the US channel.
2. Drug-product manufacturing site(s) producing the finished cloth dosage form.
3. API sourcing of glycopyrronium tosylate.
4. Packaging and cloth-impregnation line converting drug into single-use wipes.

What company supplies QBREXZA to pharmacies and wholesalers?

Featured answer: QBREXZA is supplied to the US channel under Haleon as the labeler/distributor.

What is the Orange Book labeler for QBREXZA?

• Orange Book listing mechanics tie the marketed drug to the labeler and the associated drug product entries.
• For QBREXZA, the marketed product is aligned with Haleon in US FDA labeling and disposition records.

How are QBREXZA cloth products typically distributed operationally?

• Single-use cloth dosage forms generally require tight control of:
  • impregnation uniformity
  • solvent/vehicle hold-up time
  • pouch integrity and moisture barrier performance
  • distribution temperature excursions (label-dependent)

Which companies make the QBREXZA drug substance (glycopyrronium tosylate)?

QBREXZA uses glycopyrronium tosylate as the active ingredient. Supplier identification for the drug substance depends on:

• the DMF (Drug Master File) referenced in FDA submissions
• the API manufacturing site name(s) disclosed through DMF linkages and inspection outcomes
• public disclosures tied to regulatory correspondence

Public, direct supplier naming for glycopyrronium tosylate for QBREXZA is not present in the same way as the labeler/distributor identity. The commercial supplier list for the API requires cross-referencing DMF and manufacturing site disclosures.

Which finished-dose manufacturers supply the QBREXZA cloths?

The finished-dose manufacturer(s) for QBREXZA cloths are tied to:

• the NDC product labeler chain
• the manufacturing site names used on the US prescribing information and FDA product listing components
• inspection records and contract manufacturing arrangements disclosed in regulatory submissions

For cloth products, the finished-dose manufacturing typically includes:

• drug solution preparation (or dispersion, depending on vehicle)
• cloth impregnation and controlled drying
• cutting and pouch packing
• QA release for uniformity and microbiological specs where applicable

How can QBREXZA suppliers be verified using FDA sources (Orange Book / labeling)?

High-reliability verification approach used in practice:

1. Check the FDA labeler/distributor information for the QBREXZA NDC(s).
2. Confirm active ingredient strength and dosage form for the specific listed product entry.
3. Use the Orange Book to identify the drug product and associated listing metadata for the marketed formulation.
4. For manufacturing sites and API suppliers, use:
   • referenced DMF details in the underlying FDA submission history
   • inspection databases (where site-level disclosure is available)
   • published manufacturing sections in the label and compliance documents

What supplier relationships matter for QBREXZA continuity of supply?

For hyperhidrosis topical cloths, key continuity drivers include:

• cloth substrate supply and coating compatibility
• impregnation equipment capacity and validation state
• pouch packaging availability (barrier films and sealing components)
• API glycopyrronium tosylate availability and grade/traceability requirements

QBREXZA generic or competitor supply: do they change supplier risk?

Brand supply risk is primarily driven by:

• the finished-dose manufacturer capacity
• the API chain for glycopyrronium tosylate
• packaging component constraints

Generic entry (if any) would introduce:

• new NDCs and potentially new contract manufacturing and packaging suppliers
• potential reliance on different API suppliers

Key Takeaways

• Haleon is the US labeler/distributor supplier for QBREXZA.
• QBREXZA is a 2.4% glycopyrronium tosylate topical cloth product, so the supply chain includes cloth impregnation and moisture-barrier packaging.
• Detailed API and finished-dose manufacturer site naming requires cross-linking FDA references (DMF/labeler/manufacturing sections and inspection disclosures).

FAQs

1) Who is the labeler for QBREXZA in the US?
QBREXZA is labeled and distributed in the US under Haleon.

2) What is the active ingredient in QBREXZA?
QBREXZA active ingredient is glycopyrronium tosylate.

3) Is QBREXZA supplied as a cream or a wipe?
QBREXZA is supplied as single-use topical cloths.

4) Do QBREXZA suppliers differ by NDC strength or pack size?
The supplier relationship is typically anchored by the labeler/distributor for the NDC; manufacturing and packaging sites can vary by product code even when labeler remains the same.

5) How are QBREXZA supply and sourcing risks assessed for procurement?
Procurement due diligence focuses on cloth substrate availability, impregnation line capacity, barrier pouch components, and glycopyrronium tosylate continuity.

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References (APA)

1. U.S. Food and Drug Administration. (n.d.). QBREXZA prescribing information and product labeling. FDA. https://www.accessdata.fda.gov
2. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/