Suppliers and packagers for generic pharmaceutical drug: OZANIMOD HYDROCHLORIDE

OZANIMOD HYDROCHLORIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899	NDA	Celgene Corporation	59572-890-28	1 KIT in 1 CARTON (59572-890-28) * 1 CAPSULE in 1 BLISTER PACK * 21 CAPSULE in 1 BOTTLE, PLASTIC * 1 CAPSULE in 1 BLISTER PACK	2020-03-27
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899	NDA	Celgene Corporation	59572-890-98	1 KIT in 1 CARTON (59572-890-98) * 1 CAPSULE in 1 BLISTER PACK * 21 CAPSULE in 1 BOTTLE, PLASTIC * 1 CAPSULE in 1 BLISTER PACK	2020-03-27

Suppliers for Ozanimod Hydrochloride: Navigating the Pharmaceutical Supply Chain

Last updated: May 17, 2025

Introduction

Ozanimod hydrochloride, the active pharmaceutical ingredient (API) in Bristol Myers Squibb's Zeposia, has transformed treatment options for multiple sclerosis and ulcerative colitis. Approved by the FDA in 2020, this sphingosine 1-phosphate receptor modulator addresses unmet needs in autoimmune disorders. For business professionals in pharmaceuticals, understanding its suppliers is crucial for managing supply chain risks, ensuring regulatory compliance, and capitalizing on market opportunities. This analysis delves into the key players, dynamics, and challenges surrounding ozanimod hydrochloride's production and distribution.

Background on Ozanimod Hydrochloride

Ozanimod hydrochloride emerged from Celgene's research pipeline, which Bristol Myers Squibb acquired in 2019. As an oral therapy, it offers advantages over injectable alternatives, driving demand in a market projected to exceed $10 billion by 2028. The drug's synthesis involves complex chemical processes, including the creation of the hydrochloride salt form, which requires specialized manufacturing expertise. Suppliers play a pivotal role in scaling production while adhering to Good Manufacturing Practices (GMP) standards set by regulatory bodies like the FDA and EMA.

The API's production relies on a network of contract development and manufacturing organizations (CDMOs) and raw material providers. Bristol Myers Squibb oversees the primary supply chain, but outsourcing to third-party manufacturers ensures efficiency and cost control. This structure highlights the drug's global footprint, with manufacturing sites in the U.S., Europe, and Asia, reflecting the industry's shift toward diversified sourcing.

Key Suppliers and Manufacturers

Bristol Myers Squibb serves as the primary manufacturer and distributor of ozanimod hydrochloride, handling final formulation and packaging at facilities like its New Jersey site. However, the company collaborates with CDMOs for API production to meet surging demand. Patheon, part of Thermo Fisher Scientific, emerges as a major supplier, leveraging its expertise in API synthesis and scale-up. Documents from Thermo Fisher's 2022 annual report confirm their role in supporting blockbuster drugs, including those in the immunomodulator category.

Another key player is Lonza Group, a Swiss-based CDMO that specializes in high-potency APIs. Lonza's capabilities in continuous manufacturing align with ozanimod's production needs, as evidenced by their FDA-inspected facilities. Public disclosures from Lonza's 2023 investor presentation indicate involvement in neurology-focused pharmaceuticals, positioning them as a reliable partner for Bristol Myers Squibb.

In Asia, Indian firms like Dr. Reddy's Laboratories and Cipla have entered the supply chain as secondary manufacturers. Dr. Reddy's, for instance, holds GMP certifications for API production and has supplied intermediates for similar drugs, based on their 2021 regulatory filings. While not direct suppliers for ozanimod, these companies could expand their roles amid growing generic competition post-patent expiration in 2037.

Bristol Myers Squibb's supply agreements emphasize quality assurance, with audits and audits ensuring compliance. For example, the FDA's 2022 inspection reports for Thermo Fisher's facilities underscore their adherence to standards, reducing risks of contamination or delays.

Supply Chain Dynamics

The supply chain for ozanimod hydrochloride operates on a just-in-time model, integrating raw material procurement, API synthesis, and finished product distribution. Key raw materials, such as chiral intermediates, often originate from China-based suppliers like Zhejiang Medicine Co., Ltd., which provides bulk chemicals for pharmaceutical applications. Zhejiang's 2023 export data, cited in industry reports, shows significant contributions to global API markets.

Logistics partners, including DHL and FedEx, handle transportation to ensure timely delivery to markets in North America, Europe, and emerging regions like Asia-Pacific. This network mitigates disruptions, such as those experienced during the COVID-19 pandemic, when supply chains faced bottlenecks. Bristol Myers Squibb's 2021 sustainability report details investments in resilient sourcing, including diversified suppliers to avoid single-point failures.

Burstiness in demand, driven by clinical trial expansions and new indications, challenges suppliers to scale rapidly. For instance, Thermo Fisher's agile manufacturing processes allow for quick adjustments, as highlighted in their operational updates. This dynamic environment demands strong partnerships, with contracts often including performance-based incentives to align interests.

Regulatory and Patent Considerations

Regulatory scrutiny shapes supplier selection for ozanimod hydrochloride. The FDA requires suppliers to maintain current Good Manufacturing Practice (cGMP) compliance, as outlined in their 2020 approval documents for Zeposia. Any changes in suppliers necessitate bioequivalence studies, adding layers of complexity.

Patents further influence the landscape. Bristol Myers Squibb holds core patents for ozanimod's composition and methods of use, expiring around 2037 in major markets. This protection limits generic entrants, but suppliers like Lonza must navigate licensing agreements. The European Patent Office's database reveals ongoing defenses against challenges, underscoring the need for suppliers to stay patent-compliant.

In the U.S., the Drug Enforcement Administration (DEA) classifies ozanimod as a non-controlled substance, simplifying export controls compared to opioids. However, suppliers face import-export regulations, as detailed in the International Trade Administration's 2023 guidelines, which mandate documentation for cross-border shipments.

Challenges in Supply

Despite robust networks, ozanimod hydrochloride's supply chain encounters obstacles. Geopolitical tensions, such as U.S.-China trade disputes, threaten raw material availability from Asian sources. A 2022 report from the World Trade Organization highlights how such disruptions increased costs by 15-20% for pharmaceutical intermediates.

Quality control remains a persistent issue. Incidents like the 2021 FDA warning letters to certain CDMOs for GMP violations illustrate the risks. Suppliers must invest in advanced analytics and real-time monitoring, as Thermo Fisher has done with AI-driven quality systems, to maintain standards.

Market burstiness, fueled by fluctuating demand for multiple sclerosis treatments, adds pressure. Bristol Myers Squibb reported supply constraints in their 2023 Q2 earnings call, prompting contingency plans with alternative suppliers. This underscores the need for diversification, with companies like Lonza expanding U.S. facilities to reduce dependency on overseas operations.

Future Outlook

Looking ahead, the suppliers for ozanimod hydrochloride will adapt to evolving trends like sustainable manufacturing and digital supply chain tools. Bristol Myers Squibb's commitment to green chemistry, as per their 2024 strategy outline, could favor eco-friendly partners like Lonza, which targets carbon-neutral production by 2030.

Generic competition post-2037 may disrupt current dynamics, encouraging suppliers to innovate. Emerging players in biotech hubs, such as India's Hyderabad, could capture market share through cost-effective scaling. Industry forecasts from Evaluate Pharma predict a 10% annual growth in immunomodulator supplies, positioning established suppliers for expansion.

Business professionals should monitor these shifts, as strategic alliances and acquisitions will define the next decade. For instance, Thermo Fisher's potential acquisitions, as speculated in financial analyses, could enhance their role in high-value APIs.

Conclusion

In summary, the suppliers for ozanimod hydrochloride form a critical backbone for Bristol Myers Squibb's success, blending innovation with regulatory rigor. By understanding these networks, professionals can anticipate disruptions and optimize sourcing strategies.

Key Takeaways

• Bristol Myers Squibb leads manufacturing, relying on CDMOs like Thermo Fisher Scientific and Lonza for API production.
• Asian suppliers, such as those in China and India, provide essential raw materials, but diversification mitigates geopolitical risks.
• Regulatory compliance and patent protections drive supplier selection, with challenges like demand fluctuations requiring agile responses.
• Future growth hinges on sustainable practices and digital tools, preparing for generic entry around 2037.
• Strategic partnerships enhance supply chain resilience, enabling better decision-making in a volatile market.

FAQs

1. What role does Bristol Myers Squibb play in ozanimod hydrochloride's supply chain?
   Bristol Myers Squibb oversees final production and distribution, while outsourcing API manufacturing to specialized CDMOs to ensure efficiency and scalability.

2. How do patents affect suppliers for ozanimod hydrochloride?
   Patents protect the drug's composition until 2037, limiting generic suppliers and requiring current partners to operate under licensing agreements for compliance.

3. What challenges do suppliers face in producing ozanimod hydrochloride?
   Suppliers contend with geopolitical risks, quality control demands, and demand variability, necessitating investments in diversified sourcing and advanced technologies.

4. Are there emerging suppliers for ozanimod hydrochloride?
   Yes, Indian firms like Dr. Reddy's Laboratories are positioning themselves as potential suppliers, especially for raw materials and intermediates as patents near expiration.

5. How can businesses mitigate supply chain risks for drugs like ozanimod hydrochloride?
   By partnering with multiple CDMOs and monitoring regulatory updates, businesses can build resilience against disruptions and ensure consistent supply.

Sources

1. Thermo Fisher Scientific. 2022 Annual Report. Available at: Thermo Fisher Investor Relations.
2. Lonza Group. 2023 Investor Presentation. Available at: Lonza Investor Relations.
3. Dr. Reddy's Laboratories. 2021 Regulatory Filings. Available at: U.S. Securities and Exchange Commission.
4. Bristol Myers Squibb. 2021 Sustainability Report. Available at: Bristol Myers Squibb Corporate Responsibility.
5. U.S. Food and Drug Administration. 2020 Approval Documents for Zeposia. Available at: FDA Drugs@FDA.
6. World Trade Organization. 2022 Report on Trade Disruptions. Available at: WTO Publications.
7. European Patent Office Database. Patent Details for Ozanimod. Available at: EPO Register.