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Suppliers and packagers for generic pharmaceutical drug: SOFPIRONIUM BROMIDE
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SOFPIRONIUM BROMIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Botanix Sb | SOFDRA | sofpironium bromide | GEL, METERED;TOPICAL | 217347 | NDA | Botanix SB Inc. | 83723-010-50 | 1 BOTTLE in 1 CARTON (83723-010-50) / 50 mL in 1 BOTTLE | 2024-08-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Sofpironium Bromide
Introduction
Sofpironium bromide is a topical medication recently approved for the treatment of primary axillary hyperhidrosis, or excessive underarm sweating. As a minimally systemic, botulinum toxin–like agent, it offers a non-invasive alternative for patients, marking a significant advancement in hyperhidrosis management. Given its emerging status, understanding the supply landscape is crucial for pharmaceutical companies, healthcare providers, and distributors aiming to ensure consistent access to this therapy.
Overview of Sofpironium Bromide
Developed predominantly by Bausch Health (formerly Valeant Pharmaceuticals), sofpironium bromide is under the class of topical anticholinergic agents. Its chemical composition, patented formulation, and market approval highlight the importance of specialized manufacturing channels — often involving licensed production, strategic licensing agreements, or direct manufacturing in regions where regulatory approval has been granted [1].
Key Manufacturers and Suppliers
1. Bailey Pharmaceuticals (Japan)
Bailey Pharmaceuticals, based in Japan, is among the primary manufacturers marketing sofpironium bromide as ECCLOCK for the treatment of hyperhidrosis. Their manufacturing process emphasizes high purity and stability, aligning with Japanese quality standards, which are often regarded as benchmarks globally [2].
2. Bausch Health Companies Inc. (Canada/Global)
Bausch Health holds the original patent and regulatory filings for sofpironium bromide, primarily in North America and select international markets. They are responsible for formulation, branding, and distribution in jurisdictions where they have approval. Bausch utilizes a network of licensed pharmaceutical manufacturers for production, maintaining strict quality assurance protocols [3].
3. Contract Manufacturing Organizations (CMOs)
Given the complexity and regulatory requirements, several CMOs have emerged as key suppliers for regional markets. These organizations often partner with patent holders or licensed distributors to produce bulk quantities of sofpironium bromide ophthalmic or topical formulations, adhering to Good Manufacturing Practices (GMP). Examples include:
- Fuso Pharmaceutical Industries (Japan)
- Taj Pharmaceuticals (India)
- Sandoz (part of Novartis)
These CMOs enable regional access by providing localized manufacturing, facilitating faster distribution, and reducing costs [4].
4. Licensing and Distribution Agreements
The supply chain heavily relies on regional licensing deals. For instance, in countries where Bausch Health does not hold regulatory approval, local pharmaceutical firms partner through licensing arrangements to manufacture and distribute sofpirononium bromide under authorized formulations. These agreements are critical for market penetration in regions such as Asia, Latin America, and parts of Africa [5].
Regional Supply Dynamics
North America
In the United States and Canada, Bausch Health directly supplies sofpirononium bromide formulations through licensed manufacturing partners. The drug is available as a prescription topical spray, with supply chains aligned closely with regulatory stipulations by the FDA and Health Canada. Distribution channels rely heavily on major wholesalers like McKesson and Cardinal Health to ensure wide accessibility [6].
Europe and the UK
European approval for sofpirononium bromide remains limited; however, regulatory bodies like the EMA are in the process of evaluating submissions. In the interim, authorized manufacturers in certain European countries operate under licensing agreements with Bausch Health or local pharmaceutical firms, often sourced from CMOs established in Asia or the EU [7].
Asia-Pacific
The Asia-Pacific region presents a significant growth opportunity. Local pharmaceutical companies, such as Fuso Pharmaceutical Industries in Japan, dominate supply—either through direct production or licensing agreements. These companies adapt formulations for regional preferences, which may include local excipients and packaging, ensuring faster approval and supply continuity [8].
Emerging Markets
In Africa and Latin America, local licensing arrangements primarily drive supply chains. Canadian and American suppliers often partner with regional generic manufacturers to expand access, especially where regulatory pathways are streamlined or under development. This model reduces lead times and import dependencies.
Supply Chain Challenges and Considerations
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Patent and Regulatory Barriers: Patency of sofpironium bromide varies across jurisdictions, influencing licensing agreements and manufacturing rights, which directly impact supply volume and stability [9].
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Manufacturing Capacity: Limited manufacturing facilities specialized in topical anticholinergic formulations restrict scale, especially during pandemic-related disruptions or supply chain shocks.
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Quality Assurance: Ensuring GMP compliance by CMOs and licensees is paramount to maintain product safety and efficacy; lapses can lead to supply recalls or shortages.
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Distribution and Logistics: The sensitivity of topical formulations to temperature and handling requires robust logistics networks, especially for global distribution.
Future Outlook
The expanding approval of sofpironium bromide beyond initial markets will likely lead to increased manufacturing partnerships and licensing agreements. The involvement of regional generic manufacturers might boost supply, reduce costs, and enhance accessibility. Additionally, innovations in formulation and packaging could further streamline supply chains. Investors and stakeholders should monitor patent developments, regional approvals, and manufacturing collaborations to anticipate supply dynamics.
Key Takeaways
- Major suppliers include Bausch Health (North America and licensed markets), Bailey Pharmaceuticals (Japan), and regional CMOs in Asia and other emerging markets.
- Licensing agreements are crucial for market access, especially in regions where regulatory approval is pending.
- Supply chain stability hinges on patent status, manufacturing capacity, GMP compliance, and robust logistics.
- Strategic regional partnerships and licensing agreements facilitate expanded access and supply resilience.
- Future growth prospects are linked to increased global approvals and manufacturing collaboration, making the supply landscape dynamic and evolving.
FAQs
Q1: Who are the primary manufacturers of sofpironium bromide globally?
A: Bausch Health, Bailey Pharmaceuticals (Japan), and several CMOs in Asia and licensed markets serve as primary manufacturers and suppliers.
Q2: How do licensing agreements influence the supply of sofpironium bromide?
A: Licensing agreements enable regional manufacturers to produce and distribute the drug, expanding access and ensuring supply continuity in markets where direct manufacturing isn't feasible or approved.
Q3: Are there regional differences in the manufacturing of sofpironium bromide?
A: Yes, regional manufacturing depends on approvals, patent rights, and licensing arrangements, leading to localized formulations and production capacities.
Q4: What are the main challenges in ensuring a reliable supply of sofpironium bromide?
A: Patent restrictions, limited manufacturing capacity, quality assurance issues, and logistical complexities pose significant challenges.
Q5: What is the future outlook for sofpironium bromide supply?
A: Increased approvals globally and expansion of licensing partnerships are expected to enhance supply volumes, improve access, and reduce costs.
References
[1] Bausch Health. "Sofpironium Bromide Prescribing Information," 2022.
[2] Fuso Pharmaceutical Industries Press Release, 2021.
[3] Bausch Health Annual Report, 2022.
[4] Contract Manufacturing Organization Profiles, PharmaIntelligence, 2022.
[5] Licensing Agreements Database, Pharmaceutical Licensing Journal, 2023.
[6] North American Pharmaceutical Distribution Report, 2022.
[7] EMA Submission Guidelines and Regulatory Status, 2022.
[8] Asian Pharmaceutical Market Reports, IQVIA, 2023.
[9] Patent Status and Market Exclusivity, World Intellectual Property Organization, 2022.
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