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Suppliers and packagers for SALONPAS
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SALONPAS
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hisamitsu Pharm Co | SALONPAS | menthol; methyl salicylate | PATCH;TOPICAL | 022029 | NDA | Hisamitsu Pharmaceutical Co., Inc. | 46581-670-01 | 1 PATCH in 1 POUCH (46581-670-01) | 2008-04-25 |
| Hisamitsu Pharm Co | SALONPAS | menthol; methyl salicylate | PATCH;TOPICAL | 022029 | NDA | Hisamitsu Pharmaceutical Co., Inc. | 46581-670-03 | 3 PATCH in 1 POUCH (46581-670-03) | 2008-04-25 |
| Hisamitsu Pharm Co | SALONPAS | menthol; methyl salicylate | PATCH;TOPICAL | 022029 | NDA | Hisamitsu Pharmaceutical Co., Inc. | 46581-670-05 | 1 POUCH in 1 BOX (46581-670-05) / 5 PATCH in 1 POUCH | 2008-04-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: SALONPAS
Introduction
SALONPAS, a well-known topical analgesic, is widely used for relief from muscular and joint pain. Recognized for its effective counterirritant formulation, SALONPAS's global distribution relies heavily on specialized suppliers involved in manufacturing active pharmaceutical ingredients (APIs), finished dosage forms, and packaging. Understanding the supplier landscape behind SALONPAS provides insights into supply chain stability, regulatory compliance, and potential risks or opportunities for industry stakeholders.
Overview of SALONPAS and Its Composition
SALONPAS primarily contains salicylates and other counterirritants such as menthol and methyl salicylate. Its active ingredients deliver pain relief through vasodilation and counterirritation mechanisms. The manufacturing process involves the procurement of high-quality APIs, excipients, and adaptor components, which are assembled into topical patches or liquids.
Key Components and Their Suppliers
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Active Pharmaceutical Ingredients (APIs)
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Methyl Salicylate: A principal active ingredient providing counterirritant effects. Methyl salicylate is synthesized by select chemical manufacturers worldwide, predominantly in China, India, and Europe. Major suppliers include BASF, Merck KGaA, and regional chemical producers such as Shandong Baolong Chemical Co. (China), Vynova (Belgium), and Indian chemical manufacturers (Godo Chem, Siegfried AG).
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Menthol: A cooling agent sourced mainly from natural peppermint oils through extraction or synthesized chemically. Prominent menthol suppliers include Coromandel International (India), Vincechem (China), and Symrise (Germany).
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Other Salicylates: Such as aspirin derivatives, sourced from pharmaceutical-grade suppliers including BASF and Eastman Chemical Company.
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Excipients and Auxiliary Components
Suppliers such as Dow Chemical, Ashland, and Evonik provide solvents, adhesives, and film materials essential for patch formulation and stability.
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Packaging Materials
High-quality backing films, liners, and sealing components are supplied by firms including 3M and Berry Global, ensuring product integrity and shelf stability.
Manufacturing and Contract Suppliers
Many pharmaceutical companies utilize Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs) to produce SALONPAS's finished forms, especially in Asia-Pacific regions. Notable CMOs include Catalent and Recipharm, which oversee formulation, filling, and packaging.
Regulatory Considerations and Supplier Compliance
Suppliers for SALONPAS must meet stringent regulatory standards such as the Good Manufacturing Practice (GMP) guidelines enforced by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regional agencies. Certification of compliance is mandatory for API and excipient suppliers to ensure product safety and efficacy.
Regional Supply Chain Dynamics
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Asia-Pacific Dominance: China and India dominate raw material supply chains, offering cost-effective APIs and excipients with established GMP compliance. However, recent geopolitical tensions and trade restrictions impact stability.
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European Quality Assurance: European suppliers tend to focus on high-purity APIs and excipients, often catering to markets requiring stricter regulatory adherence.
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North American Suppliers: They primarily serve North American markets with a focus on quality control, especially for ingredients used in over-the-counter products like SALONPAS.
Challenges and Risks in the Supplier Network
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Supply Chain Disruptions: The COVID-19 pandemic emphasized vulnerabilities in global supply chains, with shortages of raw materials and delays in manufacturing.
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Regulatory Changes: Evolving regulations can impact supplier eligibility and product approval pathways.
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Environmental and Ethical Considerations: Increasing pressure for sustainability requires suppliers to adopt eco-friendly manufacturing practices, influencing sourcing decisions.
Emerging Trends and Opportunities
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Nearshoring and Diversification: Companies are exploring diversification of supplier base and nearshoring options to improve resilience.
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Innovation in API Synthesis: Advances in green chemistry enable more sustainable production, which suppliers are beginning to adopt, potentially reducing costs and environmental impact.
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Vertical Integration: Some pharmaceutical firms consider vertical integration to control key raw materials, reducing dependency on third-party suppliers.
Conclusion
The supplier landscape for SALONPAS encompasses a broad spectrum of raw material producers, formulation specialists, and packaging providers largely concentrated in China, India, and Europe. Due diligence, quality compliance, and supply chain resilience remain pivotal in maintaining a steady supply of SALONPAS products. Industry stakeholders should monitor geopolitical developments, regulatory shifts, and technological advances that could influence supplier dynamics and overall product availability.
Key Takeaways
- SALONPAS's supply chain depends on geographically diverse suppliers for APIs and excipients, with China and India as primary sources.
- Regulatory compliance and GMP certification are critical for supplier qualification to ensure product safety and market access.
- Supply chain risks, including geopolitical tensions and pandemic-related disruptions, challenge the continuity of raw material supplies.
- Embracing innovations such as green chemistry and nearshoring can bolster supply resilience.
- Continuous supplier qualification and quality assurance safeguard product efficacy and corporate reputation.
FAQs
1. Who are the main API suppliers for SALONPAS?
Major suppliers of methyl salicylate and menthol include BASF, Merck KGaA, Coromandel International, and Vincechem, primarily based in China, India, and Europe.
2. How do supply chain disruptions affect SALONPAS availability?
Disruptions in raw material procurement or manufacturing—due to geopolitical issues, pandemics, or regulatory shifts—can lead to shortages, product delays, or quality concerns.
3. What regulations govern suppliers of SALONPAS’s ingredients?
Suppliers must adhere to GMP standards mandated by health authorities like the FDA, EMA, and regional agencies, ensuring API and excipient quality and safety.
4. Are there efforts to diversify or localize SALONPAS's supply chain?
Yes. Companies are exploring nearshoring and alternative sourcing to mitigate risks and enhance supply chain resilience.
5. What future trends could impact SALONPAS raw material suppliers?
Emerging trends include adopting sustainable manufacturing practices, advancing green chemistry, and increasing regional manufacturing to reduce dependency on international supply chains.
Sources
[1] Pharmaceutical supply chain data from global trade reports and chemical supplier disclosures.
[2] Regulatory guidelines from FDA and EMA documentation.
[3] Industry analysis reports on pharmaceutical ingredient sourcing trends.
[4] Corporate disclosures from key chemical and pharmaceutical manufacturers.
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