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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 |
DIMETHYL SULFOXIDE (DMSO): Supplier Landscape for Pharmaceutical-Grade Material
What are the main types of suppliers for pharmaceutical-grade DMSO?
Pharmaceutical use of dimethyl sulfoxide (DMSO) is typically sourced through three supply channels:
- Specialty chemical manufacturers with pharma-grade DMSO portfolios (they produce or control manufacture of DMSO and sell under controlled quality systems).
- GMP (or pharma-manufacturing) distributors and chemical resellers that provide pharma documentation packages (COA, specification sheets, often CEP/DMF where applicable).
- Bulk logistics suppliers for healthcare supply chains that focus on packaging, traceability, and documentation rather than molecule manufacture.
Which companies supply DMSO used in pharma manufacturing and lab use?
Below is a practical supplier set that is commonly used to source pharmaceutical or pharma-compatible DMSO (typically “USP/FCC/Ph. Eur.” compliant grades, sold with COA and regulatory-supporting documentation). This is a vendor shortlist for procurement and qualification planning.
Core manufacturers and established chemical suppliers
| Supplier | Common DMSO grade labels seen in market | Supply role | Typical procurement footprint |
|---|---|---|---|
| Merck KGaA (MilliporeSigma) | “DMSO” grades for analytical and pharmaceutical/lab use | Manufacturer/brand supplier | Widely used for lab, intermediate, and pharma-adjacent use |
| TCI Chemicals | High-purity DMSO product lines | Manufacturer/supplier | Common for research-grade and controlled spec offerings |
| Honeywell (Sigma-Aldrich legacy brands in some regions) | DMSO product families by purity grade | Supplier | Broad distribution footprint |
| Spectrum Chemical (and similar specialty distributors/manufacturers) | DMSO in multiple purities | Distributor and/or rebrand supplier | Common for EU/US lab supply |
| Fisher Chemical (Thermo Fisher brands) | DMSO lab and specialty grades | Distributor/brand | Strong documentation support for lab procurement |
| VWR / Avantor | DMSO from multiple principals | Distributor | EU lab and pharma supply chain procurement |
What to expect from GMP/distribution-focused suppliers
For drug substance and drug product manufacturing qualification, buyers usually prefer suppliers who can provide:
- Certificate of Analysis (COA) per lot
- Specification sheet tied to a recognized standard (USP/NF, Ph. Eur., or internal pharma spec)
- Quality statements on manufacturing controls, traceability, and change notifications
- Packaging and traceability suitable for controlled manufacturing
- Regulatory support documentation where available (DMF/CEP depends on grade and jurisdiction)
Many branded and distribution channels above can supply these documents, but qualification depends on the exact product code and grade.
What documentation usually matters for pharmaceutical qualification of DMSO?
In procurement and QA onboarding, pharma buyers typically qualify DMSO using:
- Compendial compliance: USP, Ph. Eur., or FCC (depending on intended use)
- Impurity profile: water content, color/clarity limits, acetone/other residuals, acidity/alkalinity, and heavy metals (varies by spec)
- Stability and storage: DMSO is hygroscopic and can change impurity profile if stored improperly
- Lot traceability: unique lot/batch traceability, tamper evidence for shipments
Supplier documentation packages vary by vendor and grade; qualification is based on the final purchase specification and COA.
Which DMSO suppliers are best positioned for pharma documentation packages?
In practice, the suppliers most frequently selected for pharma or pharma-adjacent manufacturing qualification are those with:
- Established pharma/life sciences sales organizations
- Lot-level COA automation
- Long-running quality management systems
- Consistent product codes tied to controlled impurity specs
That typically points to major brand suppliers and their distribution programs, such as:
- Merck (MilliporeSigma)
- Thermo Fisher Scientific (Fisher Chemical)
- Avantor (VWR)
- TCI
- Honeywell/Sigma-Aldrich legacy supply lines (regional product availability depends on local catalog)
Supplier selection matrix for procurement and QA
Use this filtering framework for vendor qualification:
| Qualification driver | What it means for DMSO | Supplier implication |
|---|---|---|
| Compendial compliance | USP/Ph. Eur.-aligned specs | Prefer suppliers with explicit compendial listings per product code |
| Lot documentation | COA and impurity limits per lot | Prefer principals with lot traceability at scale |
| Manufacturing consistency | Impurity control and change control | Prefer established branded suppliers |
| Packaging readiness | Sealed containers, defined transfer controls | Prefer suppliers that support controlled handling and traceability |
| Supply continuity | Ability to hold safety stock | Prefer large distributors or global principals |
How to structure RFQs for DMSO suppliers
A procurement-ready RFQ for DMSO should request:
- The exact grade and standard (USP/Ph. Eur./FCC or internal pharma spec)
- Packaging size and container type
- Lot release expectations (typical acceptance window, if relevant)
- Required documentation set (COA, spec sheet, SDS, and quality statements)
- Change notification policy (if supplier offers it)
- Analytical methods and impurity specs aligned to the intended use
This aligns purchasing with how DMSO is actually qualified in controlled manufacturing.
Key Takeaways
- Pharma-compatible DMSO sourcing typically comes from major branded chemical suppliers and life sciences distribution channels, with qualification driven by grade-specific compendial compliance and lot-level COA documentation.
- The vendor set most often used for pharma-adjacent DMSO includes Merck (MilliporeSigma), Thermo Fisher (Fisher Chemical), Avantor (VWR), TCI, and major branded Honeywell/Sigma-Aldrich supply lines, depending on regional availability and the specific DMSO grade code.
- Procurement qualification hinges on requesting the exact grade standard, impurity limits, and the full documentation package tied to each lot and container.
FAQs
1) Is DMSO supplied for pharma use usually compendial (USP/Ph. Eur.)?
Yes. Pharmaceutical buyers most commonly qualify DMSO grades that explicitly align to compendial standards (USP/Ph. Eur.) or have impurity profiles controlled to match internal pharma specifications.
2) What documentation is typically required for DMSO in GMP purchasing?
At minimum: lot COA, specification sheet, SDS, and traceability/quality statements. Some programs also require change control documentation for ongoing supply.
3) Do pharma suppliers and lab suppliers carry the same DMSO?
They can sell the same chemical, but the grade and impurity specifications usually differ by product code. Qualification depends on the selected grade, not just the molecule name.
4) What storage and handling issues matter for DMSO?
DMSO is hygroscopic, so procurement should align storage practices with supplier guidance to control water and related impurity shifts.
5) Can I source DMSO through distributors?
Yes. Many distributors (life sciences-focused) supply DMSO under branded product codes and can provide COA/spec documentation, but QA should qualify the exact grade and lot release documentation.
Sources
[1] Merck KGaA. “Dimethyl sulfoxide (DMSO) product listings and specifications.” Merck/MilliporeSigma catalog pages.
[2] Thermo Fisher Scientific. “Dimethyl sulfoxide (DMSO) product listings and specifications.” Fisher Chemical catalog pages.
[3] TCI Chemicals. “Dimethyl sulfoxide (DMSO) product listings and specifications.” TCI catalog pages.
[4] Avantor (VWR). “Dimethyl sulfoxide (DMSO) product listings and specifications.” VWR catalog pages.
[5] Honeywell (Sigma-Aldrich legacy). “Dimethyl sulfoxide (DMSO) product listings and specifications.” Honeywell/Sigma-Aldrich catalog pages.
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