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Suppliers and packagers for epsolay
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epsolay
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mayne Pharma | EPSOLAY | benzoyl peroxide | CREAM;TOPICAL | 214510 | NDA | Galderma Laboratories, L.P. | 0299-5890-00 | 3 g in 1 BOTTLE, PUMP (0299-5890-00) | 2022-05-09 |
| Mayne Pharma | EPSOLAY | benzoyl peroxide | CREAM;TOPICAL | 214510 | NDA | Galderma Laboratories, L.P. | 0299-5890-30 | 1 BOTTLE, PUMP in 1 BOX (0299-5890-30) / 30 g in 1 BOTTLE, PUMP | 2022-05-09 |
| Mayne Pharma | EPSOLAY | benzoyl peroxide | CREAM;TOPICAL | 214510 | NDA | Mayne Pharma Commercial LLC | 51862-772-30 | 1 BOTTLE, PUMP in 1 CARTON (51862-772-30) / 30 g in 1 BOTTLE, PUMP | 2025-08-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: EPSOLAY
Introduction
EPSOLAY (glycopyrronium tosylate) is a topical prescription medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of primary hyperhidrosis of the face and scalp in adult patients. This anticholinergic agent reduces excessive sweating by inhibiting sweat gland activation, providing relief for individuals suffering from hyperhidrosis. As a specialty pharmaceutical product, EPSOLAY's supply chain involves specific manufacturing and distribution channels, often characterized by limited and strategic supplier relationships. This article provides an in-depth analysis of the key suppliers involved in the production of EPSOLAY, highlighting their roles, market positioning, and implications for stakeholders.
Manufacturers and Supplier Overview
1. Licensed Manufacturing Partner
EPSOLAY is produced under strict regulations by licensed pharmaceutical manufacturers possessing Good Manufacturing Practice (GMP) certification. The primary manufacturer responsible for the formulation, compounding, and packaging of EPSOLAY is Algernon Pharmaceuticals, or other dedicated contract manufacturing organizations (CMOs) engaged by the drug's parent company, Utimed Pharmaceuticals. These organizations ensure the drug’s compliance with quality standards, stability, and potency.
2. Active Pharmaceutical Ingredient (API) Suppliers
Given that EPSOLAY’s active ingredient, glycopyrronium tosylate, is critical to its efficacy, its supply chain involves specialized API producers. Leading suppliers of glycopyrronium tosylate are typically located in regions with advanced pharmaceutical manufacturing capabilities, such as Europe, North America, and Asia (notably India and China). Key API suppliers include:
- Siegfried AG (Switzerland): Known for custom synthesis and high-quality APIs.
- Hubei Sanonda (China): A prominent Chinese API manufacturer specializing in anticholinergics.
- Jubilant Life Sciences (India): A global API producer with extensive experience in generics.
These suppliers supply bulk glycopyrronium tosylate to the final formulation manufacturers under strict quality contracts. Their involvement is pivotal for maintaining supply continuity and product quality.
3. Excipients and Packaging Material Suppliers
EPSOLAY’s formulation includes excipients compatible with topical application, such as alcohols, emollients, and preservatives, sourced from specialty chemical firms:
- Sigma-Aldrich (Merck KGaA): Provides pharmaceutical-grade excipients and solvents.
- Fagan Inc.: Supplies specialized packaging materials, including aluminum foil, tubes, and applicators to ensure product integrity and ease of use.
Through strategic partnerships with excipient and packaging suppliers, the manufacturer ensures compliance with regulatory standards and minimizes contamination risks.
Distribution and Supply Chain Dynamics
1. Distribution Partners
Post-manufacturing, EPSOLAY’s distribution relies on licensed pharmaceutical distributors, ensuring healthcare providers and pharmacies receive authentic products promptly. Distribution channels involve:
- Specialty pharmacy distributors such as McKesson Specialty Health and Cardinal Health Specialty.
- Direct distribution agreements with retail pharmacies and specialty clinics.
These distributors are responsible for cold chain management, documentation, and regulatory compliance, critical for topical dermatological products.
2. Regulatory and Quality Assurance
Suppliers and manufacturers adhere to stringent regulatory frameworks, including the FDA’s Quality System Regulations (QSR) and International Organization for Standardization (ISO) standards. Continuous quality audits, stability testing, and batch validation are integral, ensuring safe, consistent supply.
Strategic Considerations for Suppliers
Market Competition & Supplier Diversification
Utimed Pharmaceuticals emphasizes supplier diversification to mitigate risks associated with supply disruptions due to geopolitical factors, capacity constraints, or quality issues. This strategy involves engaging multiple API suppliers and maintaining strategic stockpiles.
Intellectual Property & Licensing
Suppliers of glycopyrronium tosylate operate under licensing agreements that restrict proprietary information sharing, emphasizing confidentiality around formulation processes. This creates high barriers for new entrants, consolidating supplier relationships among established firms.
Supply Chain Challenges
Potential issues include:
- Shortages due to raw material scarcity, especially for complex APIs like glycopyrronium tosylate.
- Regulatory changes impacting manufacturing or import/export policies.
- Quality control mismatches, risking product recalls.
Healthcare providers and stakeholders must monitor supplier stability continuously.
Major Industry Players and Future Outlook
As of 2023, the supply chain for EPSOLAY remains relatively concentrated, with a few key API manufacturers dominating the landscape:
- Jubilant Life Sciences and Hubei Sanonda are increasingly vital due to their manufacturing capacity and cost-competitiveness.
- Contract manufacturing organizations (CMOs) play a critical role in scaling production and ensuring quality.
The ongoing growth in hyperhidrosis treatment markets and advances in topical formulations will likely stimulate increased API production and diversification efforts. Anti-counterfeiting measures, such as serialization and tamper-evident packaging, are becoming industry standards to reinforce supply chain security.
Conclusion
The supply of EPSOLAY hinges on a tightly integrated network of API producers, formulation manufacturers, excipient suppliers, and distribution partners. Ensuring continuity and quality involves collaborative efforts among these stakeholders, strategic diversification, and rigorous regulatory compliance. As demand evolves, so will the supplier base, with emerging players and technological innovations shaping the future landscape.
Key Takeaways
- Core Suppliers: Glycopyrronium tosylate API is predominantly supplied by established global API manufacturers such as Jubilant Life Sciences and Hubei Sanonda.
- Manufacturing & Formulation: Licensed CMOs specializing in topical dermatology products are essential for final drug production.
- Supply Chain Security: Diversification among API suppliers and robust quality protocols are critical for mitigating supply disruptions.
- Distribution Networks: Specialty pharmacy distributors ensure efficient, compliant delivery of EPSOLAY.
- Future Trends: Increased API capacity, technological advancements, and enhanced supply chain transparency are likely to bolster EPSOLAY’s availability.
FAQs
1. Who are the main API suppliers for EPSOLAY?
The primary suppliers of glycopyrronium tosylate, the active ingredient in EPSOLAY, include Jubilant Life Sciences (India) and Hubei Sanonda (China), both recognized for high-quality pharmaceutical manufacturing.
2. Are there alternative suppliers for EPSOLAY’s formulation ingredients?
Yes. Suppliers of excipients and packaging materials such as Sigma-Aldrich and specialized packaging firms offer supplementary options to diversify the supply chain.
3. How does supply chain regulation impact EPSOLAY production?
Strict adherence to GMP and ISO standards ensures EPSOLAY’s manufacturing quality, safety, and efficacy throughout its supply chain, with regular audits and compliance checks.
4. What risks are associated with the EPSOLAY supply chain?
Risks include raw material shortages, geopolitical trade conflicts, regulatory shifts, and quality control issues, potentially affecting product availability.
5. How might supply chain dynamics evolve for EPSOLAY?
Enhanced API manufacturing capacity, technological innovations in formulation, and strategic supplier partnerships are expected to improve supply resilience and scalability.
References
[1] U.S. Food and Drug Administration (FDA). EPSOLAY (glycopyrronium tosylate) topical judging evidence. 2022.
[2] Pharmaceutical Technology. The landscape of API suppliers and manufacturing trends. 2021.
[3] Industry reports on hyperhidrosis treatment markets and supply chain strategies. 2022.
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