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 for the Pharmaceutical Drug: QBREXZA

Last updated: August 1, 2025

Introduction

QBREXZA (glycopyrronium cloth) is a topical prescription medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive underarm sweating. As a novel therapeutic option, its market success depends heavily on its supply chain integrity, manufacturing capacity, and the availability of raw materials. This article provides a comprehensive overview of the key suppliers involved in the production of QBREXZA, highlighting the strategic importance of each component in ensuring consistent product quality and supply continuity.

Overview of QBREXZA's Composition and Manufacturing Process

QBREXZA comprises a lyophilized cloth impregnated with glycopyrronium bromide, a muscarinic receptor antagonist. The manufacturing process involves the synthesis of the active pharmaceutical ingredient (API), glycopyrronium bromide, and its subsequent formulation into a topical cloth. Both API production and formulation are critical stages that rely on specialized suppliers and manufacturing facilities.

Active Pharmaceutical Ingredient (API) Suppliers

Glycopyrronium Bromide Production

The core ingredient in QBREXZA, glycopyrronium bromide, is a synthetic quaternary ammonium compound. Its supply chain includes multiple stages:

• Raw Material Suppliers:
  The synthesis of glycopyrronium bromide begins with high-purity starting materials, including brominating agents and specific intermediates. Manufacturers sourcing these raw materials must meet stringent pharmaceutical grade standards, such as API-grade or pharmaceutical-grade purity, to ensure safety and efficacy.

• API Manufacturers:
  Major pharmaceutical companies specializing in small-molecule APIs serve as primary suppliers. Notably, some well-established pharmaceutical firms in Asia, Europe, and North America produce glycopyrronium bromide at scale. For example, suppliers such as Sino Biopharmaceutical Limited (Hong Kong), Sun Pharmaceutical Industries (India), and Fresenius Kabi (Germany) are among firms with capabilities to produce this API (as per industry reports and public filings).

• Quality Certification and Regulatory Compliance:
  To ensure regulatory approval, API suppliers must conform to Good Manufacturing Practices (GMP), provide batch documentation, and meet standards set by the FDA or EMA, depending on the market.

Formulation and Packaging Suppliers

• Cloth and Impregnation Material Suppliers:
  The topical cloth material must be medical-grade, sterile, and capable of maintaining glycopyrronium stability. Suppliers such as 3M or Lohmann & Rauscher are known for medical textiles suitable for drug delivery systems.

• Impregnation and Coating Specialists:
  Companies specializing in pharmaceutical coating and impregnation processes supply the machinery or contract manufacturing services for the precise application of glycopyrronium onto the cloth. Contract manufacturing organizations (CMOs) like Catalent and Famar may be engaged in this phase.

Manufacturers and Contract Development Organizations (CDOs)

The primary manufacturer of QBREXZA is Innoviva, Inc., which collaborates with manufacturing partners for production, quality control, and packaging. The firm leverages global CMO networks to ensure a scalable supply chain. Contract manufacturing ensures flexibility and redundancy, especially amid global supply chain disruptions.

Supply Chain Risks and Contingencies

• Raw Material Scarcity:
  The supply of raw materials for glycopyrronium bromide synthesis can be impacted by geopolitical issues, raw material shortages, or manufacturing delays. Diversification of suppliers and regional manufacturing capabilities mitigate these risks.

• Regulatory and Quality Standards:
  Suppliers must maintain compliance with regulatory standards, complicating sourcing, especially for new vendors.

• Market Dynamics:
  Increased demand for glycopyrronium bromide in other therapeutic areas can strain supply, requiring manufacturers to expand capacity or engage multiple sources.

Emerging and Strategic Suppliers

Given the competitive landscape and the importance of supply chain resilience, pharmaceutical companies are exploring alternative suppliers and regional manufacturing options:

• Regional API Production:
  Companies are investing in North American and European manufacturing facilities to reduce reliance on Asia-based suppliers.

• Innovations in Formulation:
  Suppliers offering nano-coatings or advanced materials are being evaluated to improve stability and efficacy, potentially broadening the supplier base.

Conclusion

The supply chain behind QBREXZA is complex, involving multiple layers of raw material suppliers, API producers, formulation specialists, and contract manufacturers. Ensuring the availability of high-quality glycopyrronium bromide and medical-grade textiles is critical for meeting patient demand and maintaining regulatory compliance. As the product's market expands, diversification and strategic partnerships become essential for mitigating supply disruptions and sustaining production capacity.

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Key Takeaways

• Strategic API sourcing is vital; primary suppliers include global pharmaceutical firms capable of GMP-certified glycopyrronium bromide production.
• Raw material diversification reduces risk; reliance on a single source can jeopardize supply continuity.
• Manufacturing partnerships with CMOs streamline scaling and quality control, bolstering supply chain resilience.
• Regional manufacturing investment is increasingly important to address geopolitical and logistical risks.
• Regulatory compliance remains central; suppliers must adhere to GMP standards and provide thorough documentation.

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FAQs

1. Who are the main API suppliers for glycopyrronium bromide used in QBREXZA?
Major global pharmaceutical firms, including companies like Sun Pharmaceutical Industries and Fresenius Kabi, serve as primary API suppliers, capable of GMP-compliant production of glycopyrronium bromide.

2. What materials are used for the topical cloth in QBREXZA, and who supplies them?
Medical-grade fabrics, often from companies such as 3M or Lohmann & Rauscher, are used. These textiles must meet medical and pharmaceutical standards for stability and safety.

3. How does supply chain disruption impact QBREXZA availability?
Disruptions in raw material supply or manufacturing capacity can delay product availability, potentially affecting patient access and market share.

4. Are there regional suppliers for QBREXZA components?
Yes, companies are increasingly developing regional manufacturing capabilities to reduce reliance on Asian suppliers, aiming for greater supply resilience.

5. How does regulatory compliance influence supplier selection?
Suppliers must comply with GMP standards and provide comprehensive documentation to ensure quality and facilitate regulatory approval processes across markets.

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References

[1] FDA approval documentation for QBREXZA.
[2] Industry reports on glycopyrronium bromide manufacturing.
[3] Public filings of Innoviva, Inc., regarding manufacturing partnerships.
[4] Medical textile supplier profiles.
[5] Supply chain risk analyses for pharmaceutical APIs.