etrasimod arginine: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0274-30	1 BOTTLE in 1 CARTON (0069-0274-30) / 30 TABLET, FILM COATED in 1 BOTTLE	2023-10-19
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956	NDA	U.S. Pharmaceuticals	63539-274-28	28 TABLET, FILM COATED in 1 BLISTER PACK (63539-274-28)	2023-11-09
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: Etrasimod Arginate

Introduction

Etrasimod arginate is an investigational pharmaceutical compound primarily explored for its potential therapeutic benefits in inflammatory and autoimmune diseases. As a novel small-molecule modulator targeting sphingosine-1-phosphate (S1P) receptors, Etrasimod offers promising clinical benefits, notably in conditions like ulcerative colitis and atopic dermatitis. This article provides a comprehensive overview of key suppliers involved in the manufacturing, synthesis, and distribution of Etrasimod arginate, emphasizing the importance of reliable sourcing for pharmaceutical development and commercialization.

Understanding Etrasimod Arginate and Supply Chain Dynamics

Etrasimod (APD334) itself is a proprietary compound developed by Arena Pharmaceuticals, now part of Pfizer. Etrasimod arginate is a salt form, designed to enhance solubility and stability for pharmacokinetic or formulation purposes. The supply chain for such advanced drug substances encompasses several critical stages, including active pharmaceutical ingredient (API) synthesis, salt conversion, formulation, and ultimately, distribution to clinical and commercial markets.

Due to the proprietary nature of Etrasimod, most suppliers are either contract manufacturing organizations (CMOs) with capabilities in complex organic synthesis or licensed manufacturers granted exclusive rights by patent holders. The intricate synthesis process involves multiple steps, including the production of the core molecule and subsequent salt formation (arginine salt in this case).

Key Suppliers and Manufacturers of Etrasimod Arginate

1. Pfizer and Arena Pharmaceuticals

Role: As the primary developer and patent holder of Etrasimod, Pfizer oversees the overall supply chain for the pharmaceutical grade API and its salt forms.
Details: Pfizer’s extensive manufacturing network ensures control over clinical supplies and, upon approval, commercial-scale production. Although specific subcontractors are not publicly disclosed, Pfizer maintains strategic partnerships globally for complex API synthesis and formulation.

2. Contract Manufacturing Organizations (CMOs)

Several CMOs specializing in complex small-molecule synthesis are likely involved in the production of Etrasimod arginate, either directly licensed or under contractual manufacturing agreements. These organizations possess expertise in handling sensitive compounds and ensuring regulatory compliance.

Lonza Group: A leading contract manufacturer in pharmaceuticals, Lonza offers custom synthesis and formulation services, including complex small-molecule APIs. Their capacity for scalable synthesis might position them as a potential supplier or partner in producing Etrasimod or its salt forms.
Boehringer Ingelheim: Known for extensive experience in S1P receptor modulators, they operate manufacturing facilities capable of producing complex APIs and salts under strict quality standards.
Patheon (Thermo Fisher Scientific): With a broad API manufacturing portfolio, Patheon provides comprehensive small-molecule synthesis services, including salt formation processes suitable for drugs like Etrasimod.
Outro: Many other regional and global CMOs could be involved, especially in Asia and Europe, where cost-effective and high-quality synthesis infrastructure exists.

3. Specialized Salt Suppliers

Etrasimod arginate is a salt formation; thus, specialty chemical suppliers offering high-purity arginine salts are integral to the process chain.

Thermo Fisher Scientific: Supplies pharmaceutical-grade arginine and arginine salts essential for drug salt formation, ensuring purity and regulatory compliance.
Sigma-Aldrich (Merck Group): Offers pharmaceutical-grade arginine hydrochloride, which can be used in salt formation procedures for active pharmaceutical ingredients.
Fitzgerald Industries International: Provides various amino acids and salts suitable for pharmaceutical manufacturing, including arginine derivatives.

Emerging Markets and Regional Suppliers

In addition to global organizations, regional players in India, China, and Southeast Asia supply pharmaceutical intermediates and raw materials. These markets are becoming increasingly significant due to cost advantages and growing manufacturing capacity.

China Pharmaceutical Group (CPhI suppliers): Offers intermediates and fine chemicals suitable for complex APIs’ synthesis, including salt forms.
BASF and Ajinomoto: Large-scale amino acid producers with a substantial presence in global pharmaceutical ingredient markets, providing high-purity arginine and Its salts.

Regulatory and Quality Considerations

Suppliers for pharmaceutical compounds like Etrasimod arginate must comply with Good Manufacturing Practices (GMP) and possess appropriate certifications (e.g., FDA, EMA, PMDA). This ensures the quality, purity, and safety of active ingredients used in clinical and commercial production.

Manufacturers must also secure supply agreements that ensure continuous and compliant sourcing, considering the lengthy development timelines and regulatory milestones involved with drugs like Etrasimod.

Supply Chain Challenges and Mitigation Strategies

Intellectual Property Constraints: Proprietary synthesis routes limit access; licensing agreements with patent owners like Pfizer remain essential.
Limited Number of Suppliers: Specialized complex APIs have few qualified manufacturers, risking supply disruptions.
Regulatory Variability: Suppliers in different regions must comply with strict regulatory standards to meet global approval requirements.
Formulation Compatibility: The salt form (arginate) requires precise manufacturing controls to maintain stability and bioavailability.

Mitigation involves establishing multi-source supply lines, engaging with recognized CMOs, and securing long-term supply agreements early in development.

Conclusion

While detailed publicly available information on specific suppliers for Etrasimod arginate remains limited due to intellectual property and confidentiality, key players in pharmaceutical-grade API synthesis and amino acid supply serve as foundational sources. Major pharmaceutical companies like Pfizer and specialized CMOs such as Lonza and Patheon are likely involved in the production pipeline. Regional suppliers, especially in Asia, also play a crucial role in providing raw materials and intermediates. Ensuring a reliable supply chain for Etrasimod arginate hinges on establishing sound partnerships aligned with stringent regulatory standards.

Key Takeaways

Etrasimod arginate's supply chain involves a combination of proprietary synthesis controlled by patent owners like Pfizer and contract manufacturing organizations with expertise in complex small-molecule production.
Major global API contract manufacturers including Lonza, Patheon, and possibly Boehringer Ingelheim are potential suppliers due to their capabilities in complex salt and API synthesis.
Pharmaceutical-grade arginine and salt formation materials are supplied by leading chemical companies such as Thermo Fisher Scientific, Sigma-Aldrich, and regional amino acid producers.
The supply chain faces challenges including regulatory compliance, limited qualified suppliers, and intellectual property restrictions, necessitating strategic supplier relationships.
Building diversified and compliant supply partnerships is critical to minimizing risk and ensuring uninterrupted development and commercialization of Etrasimod-based therapies.

FAQs

1. Is Etrasimod arginate commercially available?
Currently, Etrasimod arginate is under clinical development, and commercial availability depends on regulatory approval. The supply chain for its active form is primarily controlled by Pfizer and licensed manufacturing partners.

2. Which regions dominate the supply of raw materials for Etrasimod arginate?
Asia, particularly China and India, supplies a significant portion of pharmaceutical intermediates, including amino acids like arginine. North America and Europe host major GMP-certified API manufacturers.

3. Can I source Etrasimod arginate directly for research purposes?
Access is typically restricted to clinical trial or investigational use through licensed partners. Commercial-grade supply becomes available only upon regulatory approval and manufacturing scale-up.

4. Are there alternative salts of Etrasimod besides arginate?
Salt forms of Etrasimod are often optimized for stability and bioavailability. While arginate is common, other salts like hydrochloride may be used depending on formulation requirements.

5. What are the main regulatory considerations for suppliers?
Suppliers must adhere to GMP standards and obtain necessary certifications (FDA, EMA, etc.) to ensure high purity, stability, and safety of the active pharmaceutical ingredient.

References

Pfizer. (2022). Pfizer’s Etrasimod Development Program.
Arena Pharmaceuticals. (2021). Etrasimod Clinical Trial Data.
Lonza Group. (2022). Custom Synthesis Capabilities.
Sigma-Aldrich. (2023). Pharmaceutical-grade amino acids.
CPhI Worldwide. (2022). Regional API and raw material suppliers.

Suppliers and packagers for generic pharmaceutical drug: etrasimod arginine