FINGOLIMOD LAURYL SULFATE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962	NDA	Cycle Pharmaceuticals Ltd	70709-062-30	3 BLISTER PACK in 1 CARTON (70709-062-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	2023-02-01
Cycle	TASCENSO ODT	fingolimod lauryl sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	214962	NDA	Cycle Pharmaceuticals Ltd	70709-065-30	3 BLISTER PACK in 1 CARTON (70709-065-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	2023-02-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

Fingolimod Lauryl Sulfate is a specialized pharmaceutical compound used primarily as a stabilizing agent or solubilizer in drug formulations, particularly within the scope of immunomodulatory therapies such as Fingolimod. Given its specific chemical profile and application, sourcing compliant and high-quality suppliers remains critical for pharmaceutical manufacturers aiming for regulatory adherence and therapeutic efficacy. This comprehensive overview examines the key suppliers, manufacturing considerations, and market dynamics for Fingolimod Lauryl Sulfate.

Understanding Fingolimod Lauryl Sulfate

Fingolimod Lauryl Sulfate is a salt derivative combining Fingolimod with Lauryl Sulfate, an anionic surfactant commonly employed in drug formulations for its solubilizing properties. With regulatory approval predominantly for multiple sclerosis treatments, Fingolimod's formulation stability often involves surfactants like Lauryl Sulfate, making these compounds integral to consistent manufacturing.

While Fingolimod is a patented active pharmaceutical ingredient (API), Lauryl Sulfate compounds are generally available from multiple chemical suppliers, both as raw materials and as excipients. Contractors or formulators sourcing Fingolimod Lauryl Sulfate must verify all components' regulatory compliance, particularly concerning pharmacopeial standards (e.g., USP, EP).

Major Suppliers of Lauryl Sulfate Compounds

Since Fingolimod Lauryl Sulfate itself is a specialized product, its direct suppliers are limited and often involve bespoke synthesis or contract manufacturing arrangements. However, the Lauryl Sulfate component—key to the compound's stabilizing properties—is widely available from several reputable suppliers.

Leading Suppliers of Lauryl Sulfates and Related Surfactants

Croda International Plc
- Overview: Croda is a global specialty chemical company providing high-purity surfactants suitable for pharmaceutical use. Their sodium Lauryl Sulfate (SLS) products conform to pharmacopeial standards, making them suitable for pharmaceutical formulations.
- Capabilities: They offer custom synthesis and tailored grades for specific formulation requirements, including stabilizers or surfactants compatible with drug delivery systems.
Stepan Company
- Overview: Stepan manufactures a range of surfactants, including Stepan SLS, compliant with GMP standards. Their products are extensively used in both cosmetic and pharmaceutical industries.
- Pharmaceutical compliance: Their SLS grades meet USP and other international specifications, ensuring safety and consistency.
Galaxy Surfactants Ltd.
- Overview: An Indian chemical manufacturer specializing in surfactants for pharmaceuticals, personal care, and industrial applications. Their pharmacopeial-grade SLS is a suitable raw material for formulating Fingolimod Lauryl Sulfate.
- Certifications: They hold ISO and other certifications, emphasizing product purity and safety.
Clariant (now part of BASF)
- Overview: Clariant produced pharmaceutical-grade surfactants, including SLS, renowned for purity and quality control.
- Application: Their SLS formulations are used in vaccine adjuvants, dermatology, and other injectable formulations.
Tokyo Chemical Industry (TCI)
- Overview: TCI supplies a variety of surfactants and chemical reagents globally, including surfactants suitable for pharmaceutical applications.
- Customization & Quality: They offer high-quality, pharmacopeial-grade surfactants tailored for specific formulations.

Custom Synthesis and Contract Manufacturing

Given Fingolimod Lauryl Sulfate’s specialized nature—likely requiring synthesis of a covalent linkage between Fingolimod and Lauryl Sulfate—market players often resort to contract manufacturing organizations (CMOs). These firms can produce active salts, derivatives, or conjugates under stringent cGMP conditions:

Hovione
Known for custom synthesis of active pharmaceutical ingredients and intermediates, capable of producing complex derivatives such as Fingolimod Lauryl Sulfate.
AbbVie Contract Manufacturing
Provides tailored synthesis and formulation development, with capabilities for complex drug derivatives.
Baxter and Catalent
Noted for high-quality CMO services, including synthesis, formulation, and stability testing.

Note: Specific supplier identification of Fingolimod Lauryl Sulfate may require direct engagement with CMOs due to its proprietary synthesis process and potential patent restrictions.

Market Dynamics and Supplier Selection Criteria

When sourcing Fingolimod Lauryl Sulfate, pharmaceutical companies should focus on:

Regulatory compliance: Suppliers must adhere to cGMP, USP, EP, or other relevant standards to ensure regulatory approval in target markets.
Product purity: The purity level must meet pharmacopeial specifications, particularly for injectable or oral formulations where impurities could compromise safety.
Supply chain stability: Reliable, scalable manufacturing capacity reduces risks associated with shortages or delays.
Customization ability: Suppliers capable of custom synthesis or scale-up support pharmaceutical partners’ development timelines.
Documentation & Certification: Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and regulatory documentation are essential.

Challenges in Sourcing Fingolimod Lauryl Sulfate

Proprietary synthesis: Limited publicly available routes for direct synthesis of Fingolimod Lauryl Sulfate may restrict procurement to select specialized CMOs.
Regulatory hurdles: Ensuring supplier compliance with global drug safety standards can be complex, especially for compounds involved in parenteral formulations.
Market demand and exclusivity: Patent protections or exclusivity rights on Fingolimod derivatives may limit third-party manufacturing options.

Future Outlook

Given increasing demand for complex drug derivatives and bespoke pharmaceutical excipients, the landscape for sourcing compounds like Fingolimod Lauryl Sulfate is evolving. Partnerships with contract manufacturers specializing in complex conjugates or derivatives will expand availability, especially as biosimilar and generic markets grow.

Advances in synthetic methodologies and regulatory frameworks supporting complex active ingredient synthesis will facilitate broader supplier options. Continuous monitoring of supplier qualification, quality standards, and regulatory compliance remains essential for pharmaceutical developers.

Key Takeaways

High-purity Lauryl Sulfate surfactants suitable for pharmaceutical applications are available from global suppliers such as Croda, Stepan, Galaxy Surfactants, Clariant, and TCI.
Direct sourcing of Fingolimod Lauryl Sulfate typically involves specialized CMOs capable of custom synthesis under strict cGMP conditions.
Regulatory compliance, product purity, and supply chain reliability are critical factors when selecting suppliers.
Market dynamics suggest increasing customization and outsourcing trends, driven by complex derivative synthesis and regulatory standards.
Establishing strong supplier relationships and validation procedures will minimize risks and ensure consistent supply for pharmaceutical formulations.

FAQs

Q1: Is Fingolimod Lauryl Sulfate commercially available off-the-shelf?
A1: No, Fingolimod Lauryl Sulfate is a specialized compound generally synthesized via custom processes. Companies typically source it through contract manufacturing organizations with expertise in complex derivatives.

Q2: Can I source Lauryl Sulfate surfactants suitable for pharmaceutical use from mainstream chemical suppliers?
A2: Yes. Reputable suppliers like Croda and Stepan provide pharmacopeial-grade Lauryl Sulfate compounds suitable for pharmaceutical formulations.

Q3: What should I consider when selecting a supplier for highly specialized compounds like Fingolimod Lauryl Sulfate?
A3: Regulatory compliance, product purity, supply chain reliability, customization capacity, and thorough documentation are paramount considerations.

Q4: Are there specific regulatory approvals required for sourcing Lauryl Sulfate for pharmaceutical use?
A4: Yes. Suppliers must provide documentation demonstrating compliance with pharmacopeial standards such as USP, EP, or JP, and adhere to cGMP standards.

Q5: Will patent restrictions impact the sourcing of Fingolimod Lauryl Sulfate?
A5: Potentially. Patent protections on Fingolimod derivatives may restrict production and sourcing, necessitating direct engagement with patent holders or licensed manufacturers.

References

[1] Croda International Plc. Pharmaceutical Surfactants.
[2] Stepan Company. Pharmaceutical Grade Surfactants.
[3] Galaxy Surfactants Ltd. Pharmaceutical Surfactants Portfolio.
[4] Clariant. Pharmaceutical Surfactants: Quality and Compliance.
[5] Tokyo Chemical Industry (TCI). High-Purity Surfactants for Pharma.

Suppliers and packagers for generic pharmaceutical drug: FINGOLIMOD LAURYL SULFATE