OTREXUP PFS: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Assertio Speclty	OTREXUP PFS	methotrexate	SOLUTION;SUBCUTANEOUS	204824	NDA	Antares Pharma, Inc.	54436-010-01	1 SYRINGE in 1 CARTON (54436-010-01) / .4 mL in 1 SYRINGE	2013-10-11
Assertio Speclty	OTREXUP PFS	methotrexate	SOLUTION;SUBCUTANEOUS	204824	NDA	Antares Pharma, Inc.	54436-010-03	1 SYRINGE in 1 CARTON (54436-010-03) / .4 mL in 1 SYRINGE	2013-10-11
Assertio Speclty	OTREXUP PFS	methotrexate	SOLUTION;SUBCUTANEOUS	204824	NDA	Antares Pharma, Inc.	54436-010-04	4 SYRINGE in 1 CARTON (54436-010-04) / .4 mL in 1 SYRINGE (54436-010-02)	2013-10-11
Assertio Speclty	OTREXUP PFS	methotrexate	SOLUTION;SUBCUTANEOUS	204824	NDA	Antares Pharma, Inc.	54436-012-01	1 SYRINGE in 1 CARTON (54436-012-01) / .4 mL in 1 SYRINGE	2013-10-11
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

OTREXUP PFS (Pre-Filled Syringe) is a prescription medication used primarily to treat rheumatoid arthritis, psoriatic arthritis, and severe psoriasis in adult patients. It contains methotrexate, a disease-modifying antirheumatic drug (DMARD), notable for its efficacy in controlling autoimmune inflammatory processes. Given its critical role in disease management, the supply chain and procurement strategy for OTREXUP PFS are vital to ensure consistent patient access and regulatory compliance. This article explores the primary suppliers involved in the manufacturing and distribution of OTREXUP PFS, the manufacturing landscape, and strategic considerations affecting supply security.

Manufacturing and Supply Chain Overview

OTREXUP PFS is developed and marketed by Eli Lilly and Company, which partners with various contract manufacturers for its components and final assembly. The product’s complexity—comprising a prefilled syringe with methotrexate—necessitates strict manufacturing standards, including Good Manufacturing Practice (GMP) compliance and rigorous quality control.

The supply chain extends from active pharmaceutical ingredient (API) production to final packaging and distribution. For methotrexate, several global API manufacturers produce bulk drug ingredients, while proprietary or licensed fill-finish facilities produce the pre-filled syringes.

Key Suppliers of APIs and Raw Materials

Active Pharmaceutical Ingredient (API) Suppliers

Methotrexate API production is highly concentrated, with a handful of manufacturers supplying pharmaceutical companies worldwide. Major suppliers include:

Mitsubishi Tanabe Pharma Corporation
As a major producer of methotrexate API, Mitsubishi Tanabe has established its presence through quality manufacturing and global distribution capabilities. Their active involvement ensures a reliable supply chain for pharmaceutical partners including Lilly.
Cipla Limited
An Indian-based pharmaceutical giant, Cipla manufactures active methotrexate for generic and branded formulations. Its production facilities are cGMP compliant, making it a key API supplier for life sciences companies globally.
Sandoz (Novartis)
As part of Novartis’ generics division, Sandoz supplies methotrexate API to various manufacturers, including those producing injectable formulations.
Teva Pharmaceutical Industries
A top global generic drug manufacturer, Teva produces methotrexate API used in various formulations, potentially including prefilled syringe products like OTREXUP.

Raw Materials and Excipients Suppliers

The pre-fillable syringe component, along with excipients such as water for injection, stabilizers, and preservatives, is sourced from specialized suppliers:

Baxter International
Supplies sterile water for injection and other sterile excipients essential for prefilled syringe formulations.
Becton Dickinson (BD)
Known for manufacturing high-quality syringe components, BD supplies prefilled syringe substrates and needle assemblies used in OTREXUP PFS.
West Pharmaceutical Services
Provides closure systems, stoppers, and syringe barrel assemblies that are critical to the safety and stability of the final product.

Fill-Finish and Packaging Suppliers

OTREXUP PFS requires aseptic filling, sterilization, and packaging in high-containment facilities:

Catalent, Inc.
A leading contract development and manufacturing organization (CDMO), Catalent specializes in injectable fill-finish services, including prefilled syringe assembly for biologics and small molecule drugs.
Recipharm
Offers sterile fill-finish manufacturing and packaging services for injectable drugs, including methotrexate products.
Baxter Healthcare
Also a key partner in sterile drug fill-finish services, providing GMP-compliant manufacturing for prefilled syringe delivery systems.

Strategic Considerations Affecting Supplier Dynamics

Consolidation and Limited API Manufacturing Sources

The API market for methotrexate is consolidated, with few manufacturers capable of producing high-quality, GMP-compliant methotrexate at scale. This concentration heightens risks related to supply disruptions, especially amid geopolitical tensions, pandemic-related manufacturing bottlenecks, or regulatory hurdles.

Quality and Regulatory Compliance

Suppliers must comply with stringent regulatory standards set by agencies such as the FDA, EMA, and other national authorities. Suppliers with strong GMP records and proven track records are prioritized, effectively limiting the pool of approved vendors for critical components.

Global Supply Chain Risks

Recent global disruptions—such as COVID-19 —have underscored the vulnerability of raw material and API supplies. Manufacturers often diversify sources for raw materials, but for API, the limited pool remains a concern.

Contract Manufacturing and Licensing Agreements

Eli Lilly maintains strategic alliances with CDMOs like Catalent and Recipharm to ensure manufacturing capacity and flexibility. These collaborations are critical for maintaining supply continuity, especially during outbreaks or increased demand.

Market and Regulatory Impact on Supplier Selection

The supply landscape for OTREXUP PFS is influenced by factors such as patent protections, market exclusivity, and regulatory approvals. Eli Lilly’s control over key manufacturing processes, combined with the reliance on specialized suppliers, underscores the importance of supply chain robustness. Any deviation or disruption could impact product availability and pricing.

Breaching regulatory requirements or manufacturing disruptions at core suppliers, especially API manufacturers, could cause supply shortages or quality issues, potentially leading to recalls or compliance penalties.

Emerging Trends and Future Outlook

Shift to More Diversified API Sources: To mitigate risk, pharmaceutical companies are exploring additional API suppliers in regions like India and China, especially post-pandemic. Diversification efforts aim to bolster resilience against supply chain shocks.
Development of Biosimilar and Generic Alternatives: The entry of biosimilars and generics could alter the demand for proprietary suppliers, prompting original manufacturers to secure multiple supply chains.
Advances in Manufacturing Technologies: Continuous manufacturing and advanced process control methods may streamline API production, reducing dependence on limited suppliers over time.
Regulatory Flexibility and Digital Oversight: Enhanced regulatory oversight and track-and-trace solutions are helping improve the transparency and security of the supply chain.

Key Takeaways

Critical API Suppliers: Mitsubishi Tanabe Pharma, Cipla, Sandoz, and Teva are primary suppliers of methotrexate API, with Mitsubishi Tanabe playing a central role in global supply.
Component and Packaging Partners: Leading suppliers include Baxter, Becton Dickinson, West Pharmaceutical Services, Catalent, and Recipharm, ensuring high-quality sterile fill-finish and packaging.
Supply Chain Risks: Concentration in API manufacturing and geopolitical factors pose risks to supply stability; diversification and strategic partnerships are crucial.
Regulatory and Quality Compliance: Strict adherence to GMP standards governs supplier selection, impacting overall supply chain integrity.
Market Dynamics: Trends favor diversification, technological innovation, and heightened regulatory oversight, shaping the future supply landscape.

FAQs

1. Who are the primary suppliers of methotrexate API used in OTREXUP PFS?
Major suppliers include Mitsubishi Tanabe Pharma, Cipla, Sandoz, and Teva, with Mitsubishi Tanabe particularly prominent in global API supply.

2. What companies provide the fill-finish services for OTREXUP PFS?
Catalent and Recipharm are leading contract manufacturers providing aseptic fill-finish and packaging services for prefilled syringes.

3. How does supplier concentration impact the availability of OTREXUP PFS?
Limited API manufacturing sources increase vulnerability to supply disruptions, emphasizing the need for diversified sourcing and robust supply agreements.

4. Are there regional differences in the supply chain components?
Yes, API manufacturing often originates from Asia (India, China), while high-quality fill-finish operations are concentrated in North America and Europe, subject to regulatory compliance.

5. What trends are shaping future supplier strategies for OTREXUP PFS?
Greater diversification of API sources, technological innovation in manufacturing, and enhanced regulatory oversight are key trends fostering supply resilience and quality assurance.

References

[1] Eli Lilly and Company, OTREXUP Product Details.
[2] Sandoz API manufacturing capabilities, publicly available data.
[3] Global API Market Reports, 2022.
[4] Contract manufacturing services profiles, Catalent and Recipharm.
[5] Regulatory standards for injectable drug manufacturing, FDA and EMA guidelines.

Suppliers and packagers for OTREXUP PFS

OTREXUP PFS

Suppliers for the Pharmaceutical Drug: OTREXUP PFS