TRAMETINIB DIMETHYL SULFOXIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	MEKINIST	trametinib dimethyl sulfoxide	SOLUTION;ORAL	217513	NDA	Novartis Pharmaceuticals Corporation	0078-1161-47	90 mL in 1 BOTTLE (0078-1161-47)	2023-03-16
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114	NDA	Novartis Pharmaceuticals Corporation	0078-1105-15	30 TABLET, FILM COATED in 1 BOTTLE (0078-1105-15)	2016-03-17
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114	NDA	Novartis Pharmaceuticals Corporation	0078-1112-15	30 TABLET, FILM COATED in 1 BOTTLE (0078-1112-15)	2016-03-17
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114	NDA	Novartis Pharmaceuticals Corporation	0078-1112-94	14 TABLET, FILM COATED in 1 BOTTLE (0078-1112-94)	2016-03-17
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Trametinib Dimethyl Sulfoxide (DMSO) is a specialized chemical compound primarily used as a solvent and formulation aid in the pharmaceutical industry, particularly in the formulation of the targeted cancer therapy, trametinib. Trametinib is marketed under the brand name Mekinist by Novartis and is a selective MEK inhibitor prescribed for treating melanoma and other cancers with BRAF mutations. Given its therapeutic relevance, the procurement of trametinib DMSO involves sourcing highly regulated and high-quality chemical suppliers. This article provides an in-depth analysis of primary suppliers capable of delivering trametinib DMSO, exploring their capabilities, market positioning, quality assurance, and procurement considerations.

Understanding Trametinib DMSO

Trametinib itself is a small-molecule targeted therapy that works by inhibiting MEK1 and MEK2 kinases, disrupting the MAPK signaling pathway involved in cancer cell proliferation. Dimethyl Sulfoxide (DMSO) functions predominantly as a solvent or deep eutectic solvent to facilitate drug stability and delivery in research and development environments. When combined or used for formulation, high-purity trametinib DMSO is indispensable for pharmaceutical research, preclinical studies, and manufacturing processes that require precise solubilization of the active ingredient.

Market Landscape for Trametinib DMSO Suppliers

The procurement of trametinib DMSO involves navigating a niche market characterized by high specificity to pharmaceutical-grade chemicals, strict regulatory standards, and advanced manufacturing capabilities. Suppliers are generally categorized into:

Active Pharmaceutical Ingredient (API) Manufacturers—companies that produce APIs inclusive of trametinib.
Specialty Chemical Suppliers—companies that supply high-purity DMSO optimized for pharmaceutical applications.
Custom Synthesis & Contract Manufacturing Organizations (CMOs)—providers that synthesize or supply bespoke formulations, inclusive of trametinib DMSO, tailored to client specifications.

Given the complexity, most pharmaceutical-grade trametinib DMSO is supplied via direct procurement from API manufacturers or specialized chemical producers with Good Manufacturing Practice (GMP) certification.

Primary Suppliers of Trametinib DMSO

1. Novartis

Market Leader: As the patent holder of trametinib, Novartis is the primary source of the original API and associated formulation components—including trametinib DMSO used internally during drug development and manufacturing. While Novartis primarily supplies to authorized partners and licensees, its manufacturing capabilities make it a key reference point for quality standards and specifications.

Capabilities: End-to-end production from small-scale R&D batches to large-scale GMP manufacturing.
Quality Assurance: Adherence to global pharmaceutical standards (ICH Q7, USP, EP).
Availability: Limited direct sales to third parties; generally, supplies are through licensing agreements or authorized distributors.

Note: Novartis does not typically sell trametinib DMSO as a standalone chemical to external parties outside strategic partnerships.

2. Carbosynth

Overview: Carbosynth is a globally recognized provider specializing in high-purity chemicals, including intermediates, APIs, and solvents with pharmaceutical-grade specifications.

Product Range: Offers high-quality DMSO suitable for pharmaceutical research, preclinical, and manufacturing applications.
API & Specialty Chemicals: Produces a variety of oncology-related APIs, including MEK inhibitors, with potential for custom synthesis.
Certifications: GMP, ISO 9001, and relevant pharmaceutical regulations.
Application: Supplies for research, formulation, and clinical development, including trametinib DMSO upon request.

Reputation: Known for reliable sourcing of high-purity chemicals and custom manufacturing tailored to client demands.

3. Sigma-Aldrich (Merck Group)

Overview: Sigma-Aldrich is one of the world's largest chemical suppliers with extensive catalogues of solvents, reagents, and specialty chemicals across multiple industries, including pharmaceuticals.

Product Line: Offers pharmaceutical-grade DMSO with high purity (>99.9%), certified for cell culture, drug formulation, and analytical applications.
Custom Solutions: Provides contract manufacturing and custom synthesis services, including APIs and solvents like trametinib DMSO when requested.
Certifications: Includes GMP, ISO, and other regulatory standards.

Strengths: Global distribution network and robust quality assurance systems.

4. Toronto Research Chemicals (TRC)

Overview: TRC supplies research chemicals for scientific and pharmaceutical applications, including DMSO grades suitable for biological research and formulation.

Product Range: Provides high-purity DMSO, with specifications fitting pharmaceutical research requirements.
API Capabilities: Offers custom synthesis services and compounds relevant to oncology, including targeted inhibitors.
Regulatory compliance: Meets necessary certifications for research-grade materials.

Limitations: Primarily research-grade; for GMP-grade trametinib DMSO, clients may need dedicated suppliers like Carbosynth or Sigma-Aldrich.

5. WuXi AppTec & ChemPartner

Overview: As leading Contract Research and Manufacturing Organizations (CROs), these companies offer custom chemical synthesis, including complex APIs and formulations.

Capabilities: Custom synthesis of trametinib DMSO, scaling from R&D to clinical quantities.
Compliance: Adheres rigorously to GMP standards for pharmaceutical manufacturing.
Market Position: Trusted partners for pharmaceutical companies seeking reliable, compliant suppliers.

Procurement Considerations

Procurement of trametinib DMSO should prioritize suppliers with:

GMP Certification: Essential for pharmaceutical applications to meet regulatory standards.
High Purity & Consistency: Purity levels exceeding 99.9% are typically required.
Regulatory Documentation: Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and compliance reports.
Supply Chain Stability: Reliable delivery schedules and capacity to meet clinical and production demands.
Custom Synthesis Capabilities: For formulations requiring tailored specifications or intermediates.

Quality Assurance and Regulatory Compliance

Strict adherence to pharmacopeial standards (USP, EP, JP) and ICH guidelines is critical. Suppliers should provide comprehensive documentation, including stability data, validation reports, and batch records. Validation of chemical purity and absence of contaminants ensures drug safety and efficacy.

Conclusion

The procurement of trametinib dimethyl sulfoxide demands strategic sourcing from reputable, compliant suppliers capable of delivering pharmaceutical-grade materials at scale. Key industry players include Carbosynth, Sigma-Aldrich, and specialized CMOs with GMP accreditation. While Novartis remains the primary API producer, third-party suppliers support research and formulation needs, especially when sourcing high-purity DMSO for laboratory and clinical applications.

Key Takeaways

Primary suppliers include Carbosynth, Sigma-Aldrich, and CMOs like WuXi AppTec, all capable of providing GMP-grade trametinib DMSO.
Quality and compliance are non-negotiable; suppliers must meet international pharmaceutical standards.
Cost considerations should factor in purity, certification, and supply chain reliability.
Custom synthesis services are essential for tailored formulations and scaling from research to manufacturing.
Due diligence involves reviewing supplier certifications, validation data, and regulatory documentation to ensure compliance.

Frequently Asked Questions (FAQs)

1. Can I purchase trametinib DMSO directly from Novartis?

Generally, no. Novartis predominantly supplies trametinib APIs to authorized partners and licensees. External procurement of trametinib DMSO is typically through third-party chemical suppliers with pharmaceutical-grade products.

2. What purity level is required for pharmaceutical-grade trametinib DMSO?

Purity levels above 99.9% are standard, with certification from suppliers including Certificates of Analysis certifying compliance with pharmacopeial standards.

3. Are there any risks associated with sourcing trametinib DMSO from non-GMP suppliers?

Yes. Non-GMP sources may not meet strict regulatory or purity standards, risking contamination, batch inconsistency, and regulatory non-compliance, which can impact drug safety and efficacy.

4. What regulatory certifications should suppliers possess?

Suppliers should hold GMP, ISO 9001, and relevant pharmacopeial certifications, with comprehensive documentation to support quality assurance.

5. Is custom synthesis necessary for procuring trametinib DMSO?

In some cases, yes. Custom synthesis is required to obtain specific formulations, purity levels, or quantities suited to research, clinical trials, or manufacturing needs.

Sources:
[1] Novartis Pharmaceuticals. "Mekinist (trametinib) product information."
[2] Carbosynth. "High Purity Chemicals and APIs."
[3] Sigma-Aldrich. "Pharmaceutical Grade DMSO Specifications."
[4] ICH Guidelines. "Q7 Good Manufacturing Practice Guide for APIs."

Suppliers and packagers for generic pharmaceutical drug: TRAMETINIB DIMETHYL SULFOXIDE