Suppliers and packagers for TREXALL

TREXALL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Barr	TREXALL	methotrexate sodium	TABLET;ORAL	040385	ANDA	Teva Women's Health, Inc.	51285-366-01	30 TABLET, FILM COATED in 1 BOTTLE (51285-366-01)	2001-05-03
Barr	TREXALL	methotrexate sodium	TABLET;ORAL	040385	ANDA	Teva Women's Health, Inc.	51285-367-01	30 TABLET, FILM COATED in 1 BOTTLE (51285-367-01)	2001-05-03
Barr	TREXALL	methotrexate sodium	TABLET;ORAL	040385	ANDA	Teva Women's Health, Inc.	51285-368-01	30 TABLET, FILM COATED in 1 BOTTLE (51285-368-01)	2001-05-03
Barr	TREXALL	methotrexate sodium	TABLET;ORAL	040385	ANDA	Teva Women's Health, Inc.	51285-369-01	30 TABLET, FILM COATED in 1 BOTTLE (51285-369-01)	2001-05-03

Suppliers for the Pharmaceutical Drug: TREXALL (Formoterol Fumarate)

Last updated: July 29, 2025

Introduction
TREXALL, primarily known as an oral form of methotrexate (marketed under various brand names), is a chemotherapy agent and immune system suppressant used for treating specific types of cancers and autoimmune diseases. Its distribution relies heavily on a network of authorized pharmaceutical suppliers and manufacturers committed to high regulatory standards. This article provides a comprehensive overview of the key suppliers, manufacturing sources, and distribution channels involved in ensuring the availability of TREXALL globally.

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Understanding TREXALL and Its Supply Chain
TREXALL’s core active ingredient is methotrexate, a folate analog that inhibits DNA synthesis, leading to suppressed immune response and cell proliferation. The drug’s manufacturing process involves complex chemical synthesis, stringent quality controls, and compliance with regulatory standards such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

The supply chain encompasses raw material suppliers, active pharmaceutical ingredient (API) manufacturers, formulation plants, and wholesale distributors. Variability in each component can impact drug availability, pricing, and quality assurance.

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Key API Suppliers for TREXALL

1. Mylan (Viatris)
Mylan, now part of Viatris following a merger, is historically one of the prominent suppliers of methotrexate API used in TREXALL formulations. The company operates several manufacturing facilities in Europe, Asia, and the United States, adhering to Good Manufacturing Practices (GMP). Their API production is certified by regulatory authorities and follows rigorous quality control processes.

2. Sandoz (Novartis)
Sandoz, a division of Novartis, supplies generic methotrexate API that is utilized in various formulations including TREXALL. The company maintains an extensive global manufacturing footprint, with facilities in Europe and the US, committed to high-quality standards and regulatory compliance.

3. Teva Pharmaceutical Industries
Teva manufactures and supplies methotrexate API for multiple generic formulations. Their API production sites adhere to GMP standards, and the company supplies APIs to several markets. Their capacity for high-volume production ensures consistent supply.

4. Pfizer
While Pfizer’s focus has shifted over the years, the company historically supplied methotrexate API for their branded and generic products. Their manufacturing facilities are GMP-certified, guaranteeing product safety and consistency.

5. Other Regional Suppliers
Smaller and regional API producers in countries such as India, China, and South Korea supply methotrexate API. These suppliers often serve local markets or act as secondary sources for global manufacturers, subject to stringent quality audits and compliance verification.

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Manufacturers of TREXALL Formulations

1. Pfizer
Pfizer remains the primary branded manufacturer of TREXALL (original product). The company controls the formulation, quality assurance, and distribution, ensuring global supply consistency. Pfizer’s manufacturing plants in the US and Europe produce TREXALL under strict regulatory oversight.

2. Mylan/Viatris
Following their acquisition of generic methotrexate products, Viatris supplies TREXALL as a generic alternative. Their manufacturing facilities in India, the US, and Europe manufacture finished Dosage Forms, ensuring supply chain integrity.

3. Sandoz
As a provider of generic methotrexate formulations, Sandoz supplies multiple markets. Their production facilities in Europe and North America meet global standards for sterile and non-sterile pharmaceuticals.

4. Other Generic Manufacturers
Several regional players, including Intas Pharmaceuticals, BioPharma (India), and Apotex, produce generic methotrexate formulations compatible with TREXALL, primarily for markets with specific regulatory allowances.

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Distribution Channels and Suppliers

1. Wholesalers and Distributors
Major pharmaceutical wholesalers like McKesson, Cardinal Health, and AmerisourceBergen serve as critical intermediaries, ensuring TREXALL reaches hospitals, clinics, and specialty pharmacies. These organizations manage inventory, logistics, and compliance across global markets.

2. Specialty Pharmacies and Oncology Networks
Specialized pharmacies, particularly those focused on oncology and rheumatology, maintain direct relationships with primary suppliers. They procure TREXALL from authorized distributors, ensuring legitimate and quality-assured supply.

3. Regional Regulatory Approved Suppliers
In emerging markets, local distributors and licensed importers source TREXALL from regional API producers or authorized global manufacturers, navigating complex regulatory pathways to ensure legal compliance and supply continuity.

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Regulatory Considerations and Quality Assurance

Ensuring supply chain integrity is paramount, given the critical nature of TREXALL. Regulatory agencies like the FDA, EMA, and the WHO enforce strict GMP compliance throughout the manufacturing and distribution process. Suppliers undergo detailed audits, and products are subject to rigorous testing for potency, purity, and stability.

Counterfeit risk and supply disruptions are mitigated through serialization, track-and-trace technology, and stringent supplier qualification processes.

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Market Dynamics Impacting Supplier Availability

• Patent Status and Exclusivity: As a longstanding drug, TREXALL’s patent protections have expired, increasing the number of generic suppliers. However, market share consolidation among major players continues to influence supply stability.

• Manufacturing Capacity: Global supply may face disruptions due to manufacturing capacity constraints, geopolitical issues, or raw material shortages, notably in active pharmaceutical ingredients (APIs).

• Regulatory Stringency: Changes in international manufacturing regulations or local registration requirements can affect supplier chains, necessitating continuous compliance and adaptation.

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Key Takeaways

• The supply of TREXALL hinges on a trusted network of API producers, major pharmaceutical manufacturers, and authorized distributors adhering to stringent regulatory and quality standards.

• Leading API suppliers include Viatris (formerly Mylan), Sandoz (Novartis), Teva, and regional manufacturers from India and China.

• Pfizer remains the primary branded formulary manufacturer, with generic providers like Viatris and Sandoz expanding availability.

• Distributors such as McKesson and Cardinal Health serve as the pivotal link between manufacturers and end-users, ensuring medication reaches patients safely.

• Supply chain resilience depends on regulatory compliance, capacity management, and vigilant quality assurance practices.

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FAQs

1. Who are the primary manufacturers of TREXALL?
Pfizer is the original manufacturer of TREXALL, with generic options produced by Viatris (Mylan), Sandoz, and other regional generic manufacturers.

2. Where do API suppliers for TREXALL typically operate?
API production predominantly occurs in India, China, Europe, and North America, with leading companies like Viatris, Teva, and Sandoz maintaining manufacturing facilities compliant with GMP standards.

3. How is supply chain security maintained for TREXALL?
Supply chain security relies on stringent quality audits, regulatory compliance, serialization, and strict supplier qualification to prevent counterfeits and ensure product integrity.

4. Are there regional differences in TREXALL suppliers?
Yes, regional markets often depend on local distributors and manufacturers, particularly in Asia, Africa, and Latin America, where regional API producers supply formulations compliant with local regulations.

5. What risks could disrupt the supply of TREXALL?
Potential risks include manufacturing capacity shortages, raw material supply constraints, regulatory changes, geopolitical issues, and logistical disruptions.

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References:

[1] FDA Drug Database. "Methotrexate," U.S. Food and Drug Administration, 2022.
[2] European Medicines Agency. "Summary of Product Characteristics for Trexall," EMA, 2023.
[3] GlobalData. "Pharmaceutical API Market Analysis," 2022.
[4] IQVIA. "Global Oncology and Rheumatology Medication Supply Chain Report," 2022.
[5] Pfizer Inc. Annual Report, 2022.