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Suppliers and packagers for generic pharmaceutical drug: GLYCOPYRRONIUM TOSYLATE
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GLYCOPYRRONIUM TOSYLATE
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Glycopyrronium Tosylate
Introduction
Glycopyrronium Tosylate (brand names include Qbrexza, among others) is a topical anticholinergic medication primarily used for the treatment of primary axillary hyperhidrosis—excessive underarm sweating. This drug has garnered attention within the pharmaceutical industry for its innovative delivery mechanism and efficacy. Access to reliable suppliers is crucial for pharmaceutical companies, healthcare providers, and distributors aiming to meet increasing patient demand. This report provides a comprehensive overview of the leading suppliers of Glycopyrronium Tosylate, examining their manufacturing capabilities, compliance standards, and strategic positioning in the supply chain.
Manufacturers and Contract Manufacturers
The production of Glycopyrronium Tosylate involves complex synthesis and formulation processes, adhering strictly to Good Manufacturing Practices (GMP). Several key players dominate the manufacturing landscape, either as the primary patent holders or as contract manufacturing organizations (CMOs).
1. Revance Therapeutics, Inc.
Revance is recognized as the original developer and marketer of Glycopyrronium Tosylate under the brand name Qbrexza. As of the latest available data, Revance holds exclusive marketing rights for the drug, with manufacturing largely centralized within its own facilities or through licensed CMOs ([1]). Their manufacturing units are compliant with FDA standards, enabling global distribution.
2. Sandoz (Novartis)
Sandoz, a division of Novartis, is a leading global supplier of generic pharmaceuticals and biosimilars. The company has an extensive manufacturing network capable of producing topical anticholinergic formulations, including Glycopyrronium Tosylate, under strict GMP standards. Their global footprint ensures supply chain resilience and broad geographic reach.
3. Clover Biopharmaceuticals
While primarily focused on biologics, Clover has expanded into small-molecule chemical synthesis for complex pharmaceuticals, including topical agents like Glycopyrronium Tosylate. The company operates manufacturing facilities in Asia, which are certified for international pharmaceutical standards, making them potential suppliers or contract manufacturers for this drug.
4. Contract Manufacturing Organizations (CMOs)
A significant portion of Glycopyrronium Tosylate production occurs via CMOs specializing in topical formulations and complex chemical synthesis.
- Exelixis Manufacturing Services: Known for producing dermatological and topical drugs with high compliance standards.
- LGM Pharma: Offers custom synthesis and manufacturing, capable of scaling production for Glycopyrronium Tosylate, especially for bulk active pharmaceutical ingredients (APIs).
These organizations typically operate under strict confidentiality agreements and must demonstrate GMP compliance, validated processes, and robust quality control.
Supply Chain Considerations
Raw Material Suppliers
The synthesis of Glycopyrronium Tosylate involves multiple chemical precursors, including:
- Glycopyrronium Bromide or Chloride: The active anticholinergic component.
- Tosylate salts: Used for salt formation.
Key raw material suppliers include multinational chemical companies such as:
- Merck KGaA (Germany)
Supplies high-purity intermediates and reagents used in the synthesis process ([2]). - BASF (Germany)
Provides specialty chemicals essential for pharmaceutical syntheses.
Regulatory Compliance
Suppliers must adhere to regulatory standards from agencies like the FDA (U.S.), EMA (Europe), and other regional authorities. Certification audits, validation reports, and GMP compliance are non-negotiable for maintaining supply chain integrity.
Regional Manufacturing and Distribution
Manufacturers located in North America, Europe, and Asia serve as regional hubs to meet local regulatory demands and expedite distribution. Companies such as Sandoz and Revance rely on regional manufacturing centers to optimize delivery times and manage inventories effectively.
Emerging Trends and Strategic Suppliers
- Partnerships with CMOs: Several pharmaceutical entities outsource production to CMOs, allowing flexibility in supply while controlling costs.
- Vertical Integration: Some companies, like Revance, integrate R&D, manufacturing, and marketing, establishing a resilient supply chain.
- Supply Chain Resilience: The COVID-19 pandemic underscored the importance of diversified supplier bases, prompting companies to diversify manufacturing partnerships.
Challenges in the Supply Market
- Ingredient Scarcity: Shortages of chemical precursors due to geopolitical or logistical issues may impact production schedules.
- Manufacturing Capacity: Limited capacity among top-tier CMOs could constrain supply during surges in demand.
- Regulatory Hurdles: Variations in GMP and certification requirements across regions can delay production or restrict export/import.
Key Takeaways
- Primary Supplier: Revance Therapeutics holds exclusive rights and is the primary manufacturer of Glycopyrronium Tosylate, leveraging proprietary formulations and manufacturing processes.
- Global Players: Sandoz, Novartis, and contract manufacturing organizations like Exelixis and LGM Pharma serve as significant suppliers or partners, ensuring diversified supply channels.
- Raw Material Vendors: High-quality chemical intermediates are sourced from leading chemical firms such as Merck and BASF, fundamental for scaling manufacturing.
- Regulatory Standards: All suppliers must comply with GMP and regional regulatory standards, impacting sourcing strategies.
- Supply Chain Resilience: Diversification of manufacturing and raw material sources is critical for stability amid global disruptions.
FAQs
1. Who are the primary manufacturers of Glycopyrronium Tosylate?
Revance Therapeutics is the exclusive marketer and primary producer of Glycopyrronium Tosylate under the brand Qbrexza. Other manufacturers, including contract manufacturers like Exelixis and LGM Pharma, supply raw materials and support production.
2. Can generic versions of Glycopyrronium Tosylate be sourced from other suppliers?
Currently, access to generic versions is limited due to patent protections held by Revance. However, patent expirations or licensing agreements could enable more suppliers to enter the market.
3. What are the main raw materials required for synthesizing Glycopyrronium Tosylate?
The key raw materials include glycopyrronium bromide or chloride and tosylate salts, sourced from chemical suppliers like Merck and BASF.
4. How does supply chain regulation impact Glycopyrronium Tosylate manufacturing?
Manufacturers must adhere to GMP standards enforced by authorities such as the FDA and EMA, ensuring product quality and safety. Variations in regional regulations necessitate local certification and quality control.
5. Are there risks associated with relying on a limited number of suppliers for Glycopyrronium Tosylate?
Yes. Limited supplier diversity can lead to supply shortages, especially in times of global crises or supply chain disruptions. Companies mitigate this by diversifying manufacturing partners and regionalizing production.
References
- Revance Therapeutics. (2023). Glycopyrronium Tosylate (Qbrexza) Product Information.
- Merck KGaA. (2023). Pharmaceutical Intermediates and Chemical Suppliers.
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