Suppliers and packagers for RIMSO-50

RIMSO-50

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan Institutional	RIMSO-50	dimethyl sulfoxide	SOLUTION;INTRAVESICAL	017788	NDA	Mylan Institutional LLC	67457-177-50	1 VIAL, GLASS in 1 CARTON (67457-177-50) / 50 mL in 1 VIAL, GLASS	1978-04-04

Suppliers for the Pharmaceutical Drug: RIMSO-50

Last updated: August 4, 2025

Introduction

RIMSO-50, the trademarked name for dimethyl sulfoxide (DMSO) 50% solution, is a pharmaceutical product primarily indicated for the relief of pain and inflammation associated with interstitial cystitis. Its unique chemical properties, including high tissue penetration and anti-inflammatory effects, have made RIMSO-50 an important drug in urology. As a critical therapeutic, understanding the suppliers of RIMSO-50 is vital for healthcare providers, distributors, investors, and regulatory bodies aiming for reliable access and supply chain stability.

Overview of RIMSO-50 Supply Chain

RIMSO-50’s manufacturing and distribution involve a multistep process: raw material procurement, formulation, packaging, and distribution. The drug’s active ingredient, DMSO, is produced globally but requires strict quality controls for pharmaceutical use. The final product is usually supplied by a limited number of licensed manufacturers, owing to regulatory restrictions, patent protections, and the specialized nature of pharmaceutical-grade DMSO.

Manufacturers of RIMSO-50

1. Paladin Labs / Alora Pharmaceuticals

Historically, Paladin Labs, acquired by Endo International in 2014, was the primary manufacturer of RIMSO-50 in North America. The company held the original license and manufacturing rights under the brand RIMSO-50, ensuring quality and regulatory compliance through Health Canada and FDA approvals.

Following the acquisition, Endo Pharmaceuticals has maintained manufacturing and distribution, positioning itself as a dominant supplier within major markets. Endo's extensive manufacturing facilities comply with Good Manufacturing Practice (GMP) standards, ensuring consistent drug quality.

2. International Suppliers of DMSO (Raw Material)

While Endo is the primary supplier of the finished product, several pharmaceutical-grade DMSO raw materials are sourced globally from specialized chemical manufacturers. Some notable suppliers include:

• Sigma-Aldrich (Merck Group): Offers pharmaceutical-grade DMSO for research and manufacturing purposes. Although primarily a raw material provider, Sigma-Aldrich supplies DMSO used in the formulation of RIMSO-50 by licensed manufacturers.
• BASF: A global chemical giant supplying high-purity DMSO suitable for pharmaceutical applications, often serving as a raw material source.
• DAISO SSI: Provides GMP-grade DMSO for pharmaceutical and medical applications, supporting manufacturing of finished drugs like RIMSO-50.

The raw material suppliers are critical to manufacturing, but the actual finished product's supply chain remains concentrated within proprietary manufacturing licenses.

Regulatory and Licensing Landscape

A select few companies hold rights to produce RIMSO-50 due to patent protections and regulatory approvals, with Endo Pharmaceuticals being the primary license holder in many regions. The licensing agreements restrict the number of manufacturers, thus creating a limited but reliable supply chain.

Regulatory agencies such as the FDA (U.S. Food and Drug Administration) and Health Canada rigorously monitor manufacturing processes, ensuring safety and efficacy standards. These authorizations serve to limit alternate suppliers, making the licensing agreements pivotal in supply chain stability.

Distribution Channels

Distribution of RIMSO-50 is centralized through authorized distributors linked directly to the manufacturing licensees. These entities ensure that the product reaches hospitals, specialty clinics, and pharmacies adhering to strict cold chain and storage requirements.

In emerging markets, local distributors may procure RIMSO-50 through authorized global suppliers, but the overall supply remains tightly controlled for quality assurance.

Emerging Trends and Challenges

• Limited Supplier Base: The consolidation of manufacturing rights has created a relatively small supplier network, raising concerns over supply disruptions.
• Manufacturing Capacity Constraints: Capacity limitations at licensed manufacturers could impact global availability, especially amid increased demand or manufacturing disruptions.
• Regulatory Barriers: Stringent regulations can impede the entry of new suppliers, maintaining high barriers to market entry.
• Supply Chain Disruptions: Factors such as geopolitical issues, pandemics, or raw material shortages may impact the continuity of supply.

Future Outlook

To mitigate risks, some stakeholders are exploring alternative sources of pharmaceutical-grade DMSO and potential licensing negotiations for additional manufacturers. Advances in chemical synthesis and potential patent expiries could create opportunities for new entrants.

However, given the high regulatory restrictions, the supply chain for RIMSO-50 remains concentrated among a few licensed producers, primarily in North America and Europe. Careful supply chain management and supplier diversification are critical for ensuring continuous access.

Key Takeaways

• Dominant Suppliers: Endo Pharmaceuticals currently holds the primary role as the manufacturer and distributor of RIMSO-50 in major markets.
• Raw Material Sources: High-purity DMSO sourced from global chemical giants like Sigma-Aldrich, BASF, and Daiso SSI supplies the raw ingredients for finished RIMSO-50.
• Supply Chain Risks: Limited manufacturer licensing and capacity constraints heighten the risk of supply disruptions, necessitating strategic planning.
• Regulatory Constraints: Stringent GMP compliance and licensing restrictions shape the supplier landscape, hindering rapid market entry for new suppliers.
• Emerging Opportunities: Growing demand and technological advances in DMSO synthesis could present opportunities for diversification of suppliers in the future.

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Key Takeaways

• The supply of RIMSO-50 is primarily controlled by licensed manufacturers, notably Endo Pharmaceuticals.
• Raw material DMSO supplies are globally sourced from reputable chemical producers, but finished product manufacturing remains tightly regulated.
• Supply chain vulnerabilities arise from limited manufacturer numbers and capacity constraints, emphasizing the importance of strategic procurement planning.
• Regulatory compliance underpins supplier selection, maintaining high standards but restricting rapid market entry for new suppliers.
• Future supply chain stability may benefit from technological innovation and potential regulatory relaxations, provided safety and quality are maintained.

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FAQs

1. Who are the main suppliers of RIMSO-50 globally?
Endo Pharmaceuticals is the primary licensed manufacturer of RIMSO-50 in North America and other regions, with raw DMSO supplied by global chemical producers like Sigma-Aldrich and BASF.

2. Are there alternative suppliers for RIMSO-50?
Currently, the supply is limited due to licensing restrictions. While raw DMSO can be sourced from multiple global suppliers, the finished product’s manufacturing rights are tightly controlled.

3. What challenges exist in the supply chain for RIMSO-50?
Limited manufacturing licenses, capacity constraints, and regulatory compliance pose risks to consistent supply. Geopolitical and pandemic-related disruptions further threaten supply continuity.

4. Can new manufacturers enter the RIMSO-50 market?
Entry is challenging due to strict licensing, high regulatory standards, and the need for GMP-compliant manufacturing facilities. Future opportunities may arise from technological advances or patent expirations.

5. How can healthcare providers ensure a stable supply of RIMSO-50?
Establishing relationships with multiple authorized distributors, maintaining inventory buffers, and monitoring supply chain developments are key strategies.

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Sources
[1] Endo Pharmaceuticals official website and product documentation.
[2] Healthcare regulatory agencies (FDA, Health Canada) drug approval and licensing databases.
[3] Chemical suppliers' product catalogs (Sigma-Aldrich, BASF).