OZANIMOD HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899	NDA	Celgene Corporation	59572-810-07	1 KIT in 1 BLISTER PACK (59572-810-07) * 1 CAPSULE in 1 BLISTER PACK * 1 CAPSULE in 1 BLISTER PACK	2020-03-27
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899	NDA	Celgene Corporation	59572-810-97	1 KIT in 1 BLISTER PACK (59572-810-97) * 1 CAPSULE in 1 BLISTER PACK * 1 CAPSULE in 1 BLISTER PACK	2020-03-27
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899	NDA	Celgene Corporation	59572-820-30	30 CAPSULE in 1 BOTTLE, PLASTIC (59572-820-30)	2020-03-27
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 3, 2025

Introduction

Ozanimod hydrochloride is a patented sphingosine-1-phosphate (S1P) receptor modulator primarily developed by Bristol-Myers Squibb for the treatment of multiple sclerosis (MS) and ulcerative colitis (UC). As a selective modulator targeting S1P receptors, it offers a novel approach for managing autoimmune diseases by sequestering lymphocytes within lymph nodes, thereby reducing immune-mediated damage. Given its complex chemical structure and manufacturing requirements, identifying reliable suppliers for Ozanimod hydrochloride is critical for pharmaceutical companies involved in generic manufacturing, research collaborations, or supply chain planning.

This article offers a comprehensive overview of the key suppliers involved in the production and supply of Ozanimod hydrochloride, its raw materials, intermediates, and related components, along with insights into the manufacturing landscape, market dynamics, and strategic considerations.

Chemical Profile and Manufacturing Overview

Ozanimod hydrochloride is a complex chemical entity with high purity requirements. Its synthesis involves several steps including the formation of the active pharmaceutical ingredient (API) through intricate chemical reactions, purification, and stabilization processes. The supply chain encompasses raw material suppliers (e.g., starting chemical precursors), intermediate manufacturers, and final API producers.

Given its status as a patented drug, initial supply was tightly controlled by Bristol-Myers Squibb, but licensing agreements and generic market entry strategies have expanded the landscape of suppliers.

Major Suppliers of Ozanimod Hydrochloride

1. Original Patent Holders and Licensed Manufacturers

Bristol-Myers Squibb (BMS)

The originator of Ozanimod, BMS holds the patent rights and is responsible for the manufacturing and supply of the API for clinical and commercial purposes.
Through licensing agreements, BMS permits certain approved manufacturers to produce Ozanimod hydrochloride under strict quality controls.

Contract Manufacturing Organizations (CMOs) and Licensors

Several CMOs have been licensed or partnered with BMS to produce the API, ensuring compliance with regulatory standards such as Good Manufacturing Practice (GMP).

2. Contract Manufacturing and API Suppliers

Due to patent expiration or licensing strategies, a number of companies have emerged as suppliers or are expected to supply the API for generic or biosimilar development.

Ark Pharma Co. Ltd.

Noted for active pharmaceutical ingredients (APIs), including S1P receptor modulators.
Offers synthesis and supply services for pharmaceutical-grade APIs with high regulatory standards.

Hubei Topfond Pharmaceutical Co., Ltd.

Based in China, Topfond specializes in advanced chemical synthesis and offers APIs for immunomodulatory drugs.
Their capabilities include the production of complex molecules such as Ozanimod hydrochloride, contingent on licensing agreements.

LGM Pharma

A global API and chemical supplier, LGM Pharma provides a range of compounds and intermediates.
Engages in sourcing, supplying, and distribution for pharmaceutical companies seeking chemical building blocks.

Alfa Aesar (Thermo Fisher Scientific)

Known for supplying high-purity chemical reagents and intermediates relevant to Ozanimod synthesis, including precursor chemicals.

DSM Fine Chemicals

Provides custom synthesis and bulk chemicals, potentially including intermediates involved in Ozanimod production, particularly in the early manufacturing stages.

3. Suppliers of Raw Materials and Intermediates

Manufacturing Ozanimod hydrochloride involves sourcing specific complex chemical precursors:

Chiral Building Blocks: Suppliers such as Sigma-Aldrich (a subsidiary of Merck) provide key chiral intermediates required for stereoselective synthesis.
Isocyanates and Pyrimidines: Sourced from chemical intermediates specialists like Jubilant Ingrevia or Wacker Chemie, which supply high-quality intermediates involved in pharmaceutical synthesis.

Note: The proprietary nature of the synthesis often limits full transparency on specific suppliers for core raw materials and intermediates unless disclosed through licensing or regulatory filings.

Market and Supply Chain Dynamics

Regulatory and Patent Landscape

The initial monopoly on Ozanimod meant that patent protection limited suppliers to licensed manufacturers. Following patent expiration—expected in the coming years—more generic manufacturers are expected to enter the market, bolstering supply options.

Geographical Considerations

Major manufacturing hubs include the United States, China, and India. Chinese and Indian companies dominate API manufacturing due to cost advantages, scalable production capacity, and burgeoning chemical synthesis expertise.

Chinese pharmaceutical manufacturers like Hubei Topfond and others are emerging as prominent suppliers following licensing agreements or generic manufacturing rights.
Indian API producers such as LORDS Chemie and Biochem Pharmaceutical Industries could expand into Ozanimod supply chains owing to their experience with complex APIs.

Quality and Regulatory Compliance

Suppliers must adhere to stringent GMP standards to ensure quality, efficacy, and safety. Regulatory authorities such as the FDA and EMA scrutinize manufacturing processes, especially for immunomodulatory drugs, to prevent contamination and ensure consistent potency.

Strategic Considerations for Buyers

Verification of Licensing: Confirm whether suppliers hold licensing rights or manufacturing approvals for Ozanimod hydrochloride.
Quality Certification: Ensure vendors operate under GMP compliance, with requisite certifications (e.g., FDA, EMA, ISO 9001).
Supply Reliability: Evaluate supplier capacity, contingency plans, and risk mitigation strategies, especially given the complex manufacturing process.
Cost and Lead Times: Balance procurement costs with manufacturing lead times, considering geopolitical factors affecting supply chains.

Future Outlook

The anticipated patent expiry for Ozanimod will likely herald increased competition among API suppliers, especially from Chinese and Indian manufacturers. This expansion could drive down costs, improve supply resilience, and foster innovation in manufacturing methodologies. Moreover, advancements in synthesis technology might allow for more efficient production, further diversifying the supplier landscape.

Key Takeaways

Licensed manufacturers such as Bristol-Myers Squibb and their partners are primary suppliers of Ozanimod hydrochloride, ensuring high standards for clinical and commercial use.
Emerging generic producers in China and India are poised to become key players post-patent expiration, expanding supply options and potentially reducing costs.
High-quality raw materials and intermediates are sourced from top chemical suppliers like Sigma-Aldrich and Jubilant Ingrevia, vital for complex synthesis.
Regulatory compliance, quality certification, and supply chain resilience are critical considerations when selecting suppliers.
Market dynamics indicate a shift toward increased competition, fostering access and affordability for Ozanimod-based therapies.

FAQs

1. Who are the primary global suppliers of Ozanimod hydrochloride?
The original licensor, Bristol-Myers Squibb, supplies Ozanimod through licensees. Post-patent expiration, manufacturers in China and India, such as Hubei Topfond and others, are expected to become significant suppliers, expanding availability.

2. What are the main raw materials involved in manufacturing Ozanimod hydrochloride?
Raw materials include specialized chiral intermediates, isocyanates, pyrimidines, and other chemical precursors supplied by companies like Sigma-Aldrich and Jubilant Ingrevia.

3. Are there reliable suppliers of intermediates used in Ozanimod synthesis?
Yes. Leading chemical intermediates are sourced from established suppliers including Sigma-Aldrich, Wacker Chemie, and Jubilant Ingrevia, ensuring high purity necessary for pharmaceutical-grade manufacturing.

4. How does patent status influence the supplier landscape?
Patent protections initially limit API production to authorized licensees. Once expired, patents open pathways for generic manufacturers, broadening the supplier base and increasing competition.

5. What quality standards must suppliers meet for Ozanimod hydrochloride?
Suppliers must adhere to GMP standards set by regulatory agencies such as the FDA, EMA, and equivalent authorities, ensuring high-quality, safe, and effective products suitable for clinical and commercial use.

References

[1] Bristol-Myers Squibb. "Ozanimod (Zeposia) - Therapeutic overview." 2022.
[2] PharmaSource. "Global API manufacturing capacity report," 2022.
[3] Sigma-Aldrich. "Chemical reagents and intermediates for pharmaceutical manufacturing." 2022.
[4] U.S. Food and Drug Administration. "Regulatory guidelines for API manufacturing." 2022.
[5] Market research reports on immunomodulatory drug APIs and manufacturing trends, 2022.

This detailed overview enables pharmaceutical and biotech companies to identify and evaluate potential suppliers for Ozanimod hydrochloride, facilitating strategic procurement, licensing, or research collaborations in this advanced segment of immunomodulatory therapeutics.

Suppliers and packagers for generic pharmaceutical drug: OZANIMOD HYDROCHLORIDE