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Suppliers and packagers for generic pharmaceutical drug: DIMETHYL SULFOXIDE
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DIMETHYL SULFOXIDE
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Dimethyl Sulfoxide (DMSO)
Introduction
Dimethyl Sulfoxide (DMSO) is a highly versatile chemical compound extensively used in pharmaceutical and industrial applications. Known for its exceptional ability to penetrate biological membranes, DMSO serves as a solvent, anti-inflammatory agent, and cryoprotectant. Its multifaceted utility has propelled a global demand, necessitating a robust supply chain cultivated by numerous suppliers, ranging from bulk chemical manufacturers to specialized pharmaceutical-grade producers.
This article explores leading suppliers of DMSO, examining their market position, quality assurances, and regulatory compliance. It aims to guide pharmaceutical companies, research institutions, and industrial entities in sourcing reliable and high-quality DMSO.
Overview of DMSO Market Dynamics
The DMSO market is significantly influenced by demand within pharmaceutical development, medical research, and industrial manufacturing. The compound's purity and regulatory compliance are critical factors shaping supplier selection. The global DMSO market was valued at approximately USD 200 million in 2022, with an expected Compound Annual Growth Rate (CAGR) of around 4-6%, driven by expanding medical and biotech sectors [1].
Major Suppliers of DMSO
1. Merck KGaA (Sigma-Aldrich / MilliporeSigma)
Market Position & Product Range:
A global leader in chemical and pharmaceutical manufacturing, Merck (known as Sigma-Aldrich in North America) offers pharmaceutical-grade DMSO for research and therapeutic applications. Their DMSO is renowned for high purity standards, meeting U.S. Pharmacopeia (USP) and European Pharmacopoeia (EP) specifications.
Regulatory Compliance:
Sigma-Aldrich’s DMSO complies with cGMP (current Good Manufacturing Practices), making it suitable for pharmaceutical manufacturing and clinical research.
Supply Capabilities:
Large-scale production facilities ensure steady supply, with options for bulk purchasing, custom grades, and solvent-grade DMSO solutions.
Applications & Quality Assurance:
DMSO supplied is suitable for use as an anti-inflammatory, cryoprotectant, and solvent in drug formulation research. Quality assurance protocols include rigorous testing for residual impurities and endotoxin levels.
2. Covestro (formerly Bayer MaterialScience)
Market Position & Product Range:
Covestro manufactures DMSO primarily for industrial and specialty applications, including pharmaceuticals. Their DMSO solutions align with rigorous quality standards to meet pharmaceutical industry requirements.
Regulatory Compliance:
Covestro emphasizes adherence to ISO standards, with products meeting the specifications necessary for pharmaceutical processing, including USP and EP grades.
Supply Capabilities:
Their global manufacturing facilities and logistics network support consistent availability and timely delivery for large-volume customers.
Research & Development:
Active R&D ensures their DMSO products are optimized for emerging applications in biomedicine and cryopreservation.
3. Nika Group (India)
Market Position & Product Range:
Nika Group supplies pharmaceutical-grade DMSO primarily in the Asian market. They offer various grades, including chemical, pharmaceutical, and technical grades, with tailor-made formulations.
Regulatory Compliance:
Their DMSO products are certified for compliance with international standards, including USP, EP, and JP (Japanese Pharmacopoeia).
Supply Capabilities:
With multiple manufacturing units, Nika Group ensures competitive pricing and reliable supply channels across Asia and beyond.
Quality & Certification:
The company maintains ISO certifications and routinely conducts quality audits for purity, residual solvents, and microbial contamination.
4. Thermo Fisher Scientific
Market Position & Product Range:
Thermo Fisher offers high-purity DMSO suitable for biotech, pharmaceutical, and clinical applications. Their products are employed in drug discovery, cell culture, and cryopreservation.
Regulatory Compliance:
Thermo Fisher's DMSO meets stringent quality standards, including USP and EP grades, with documented batch consistency.
Supply Capabilities:
Their global distribution network facilitates prompt delivery to research facilities and pharmaceutical manufacturers worldwide.
5. Fuso Chemicals
Market Position & Product Range:
Fuso Chemicals specializes in manufacturing industrial and pharmaceutical solvents, including DMSO, with a focus on high purity and customized solutions.
Regulatory & Quality Standards:
Fuso ensures compliance with international norms, offering products suitable for medical research, diagnostics, and therapeutic development.
Supply Chain & Capacity:
Their large-scale manufacturing facilities support continuous supply and bulk procurement.
Emerging & Niche Suppliers
In addition to established players, emerging suppliers in regions such as China and Eastern Europe have increased their market presence. Companies such as Haihang Industry and Shanghai Richest Chemicals offer competitively priced DMSO, often with regulatory documentation suitable for industrial applications or research use.
Regulatory Considerations and Quality Assurance
Choosing the right supplier involves scrutinizing compliance with regulatory standards such as USP, EP, and JP. Purity levels, residual solvent content, endotoxin levels, and microbial contamination are key quality parameters. Suppliers should provide Certificates of Analysis (CoA), and where applicable, Good Manufacturing Practice (GMP) certification.
For pharmaceutical and clinical use, sourcing from suppliers with thorough quality management systems—ISO 9001 and ISO 13485—helps ensure batch-to-batch consistency and compliance with regulatory authorities such as the FDA and EMA.
Conclusion
The supply landscape for DMSO is an interconnected ecosystem comprising global chemical giants, regional manufacturers, and specialized niche producers. Leading suppliers like Merck KGaA, Covestro, Thermo Fisher Scientific, and Nika Group dominate due to their scale, regulatory adherence, and product quality. Emerging suppliers bolster competition, making DMSO more accessible and cost-effective.
Key factors for selecting DMSO suppliers include:
- Regulatory compliance (USP, EP, JP standards)
- Product purity, residual solvents, and endotoxin levels
- Manufacturing capacity and supply reliability
- Certifications and quality assurance protocols
- Compatibility with intended pharmaceutical or research applications
Strategic sourcing from reliable suppliers ensures operational continuity, regulatory compliance, and product efficacy, fostering innovation in pharmaceutical development.
Key Takeaways
- Market Leaders: Merck KGaA, Covestro, Thermo Fisher Scientific, and Nika Group are key DMSO suppliers with extensive product portfolios and global reach.
- Quality Standards: Prioritize suppliers that meet USP, EP, and GMP standards, providing Certificates of Analysis and consistent purity.
- Regulatory Compliance: Sources must align with international drug manufacturing and research regulations if intended for pharmaceutical use.
- Emerging Suppliers: Regional manufacturers in Asia and Eastern Europe offer competitively priced alternatives, especially for industrial applications.
- Supply Chain Security: Due to DMSO’s critical role in biotech, pharmaceuticals, and cryopreservation, reliability and traceability are paramount when selecting suppliers.
FAQs
Q1: What are the primary quality standards to consider for pharmaceutical-grade DMSO?
A1: The main standards include USP (United States Pharmacopeia), EP (European Pharmacopoeia), and JP (Japanese Pharmacopoeia). Suppliers should provide Certificates of Analysis confirming compliance with these standards, including specifications for purity, residual solvents, endotoxin levels, and microbial contamination.
Q2: How does the purity of DMSO influence its application in pharmaceuticals?
A2: Purity impacts safety and efficacy. Impurities, residual solvents, or endotoxins can cause adverse reactions or interfere with drug formulation. Pharmaceutical-grade DMSO typically meets high purity criteria, ensuring suitability for therapeutic use, research, or clinical applications.
Q3: Can regional suppliers meet international regulatory standards?
A3: Yes, many regional manufacturers, especially those in India, China, and Eastern Europe, produce DMSO conforming to international standards like USP, EP, and GMP requirements. Verification through documentation and audits is essential.
Q4: What are the risks of sourcing DMSO from unverified suppliers?
A4: Risks include substandard quality, contamination, inconsistent supply, regulatory non-compliance, and potential legal liabilities. Rigorous qualification processes mitigate these risks.
Q5: How can I verify the regulatory compliance of a DMSO supplier?
A5: Request detailed Certificates of Analysis, GMP certification, and third-party audit reports. Confirm their adherence to relevant pharmacopoeia standards, and where necessary, verify their compliance with local and international regulatory authorities such as the FDA or EMA.
References
- Market Data: Grand View Research. “Dimethyl Sulfoxide Market Size, Share & Trends Analysis Report.” 2022.
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