OSIMERTINIB MESYLATE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065	NDA	AstraZeneca Pharmaceuticals LP	0310-1248-30	30 TABLET, FILM COATED in 1 BOTTLE (0310-1248-30)	2015-11-13
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065	NDA	AstraZeneca Pharmaceuticals LP	0310-1251-30	30 TABLET, FILM COATED in 1 BOTTLE (0310-1251-30)	2015-11-13
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065	NDA	AstraZeneca Pharmaceuticals LP	0310-1349-30	30 TABLET, FILM COATED in 1 BOTTLE (0310-1349-30)	2015-11-13
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Osimertinib mesylate, marketed as Tagrisso by AstraZeneca, is a targeted therapy used primarily in the treatment of non-small cell lung cancer (NSCLC) with specific epidermal growth factor receptor (EGFR) mutations. As an oral, third-generation EGFR tyrosine kinase inhibitor (TKI), osimertinib’s manufacturing and supply chain are critical to ensuring global availability, especially given its status as a first-line treatment for particular lung cancer indications. This article provides a comprehensive analysis of suppliers involved in the production of osimertinib mesylate, focusing on key manufacturers, raw material sources, contract manufacturing organizations (CMOs), and supply chain considerations.

Manufacturers of Osimertinib Mesylate

Original Equipment Manufacturers (OEMs) and Patent Holders

AstraZeneca holds the original patent rights for osimertinib. The company manages the drug’s development, clinical trials, and commercialization. While AstraZeneca is responsible for marketing and distribution, the manufacturing process itself involves multiple suppliers, including active pharmaceutical ingredient (API) producers and formulation facilities.

Active Pharmaceutical Ingredient (API) Suppliers

The core of osimertinib supply hinges on the API manufacturing. Due to the compound's complex synthesis and stringent quality requirements, a limited number of specialized suppliers produce the API at commercial scale.

WuXi AppTec (China): One of the prominent companies involved in the synthesis of osimertinib active pharmaceutical ingredient. WuXi is known for robust API manufacturing capabilities aligned with Good Manufacturing Practices (GMP).
Hikal Ltd. (India): Reportedly involved in the synthesis of osimertinib intermediates and API, leveraging India’s burgeoning pharmaceutical manufacturing sector.
Thermo Fisher Scientific (United States): Provides critical reagents and intermediates that could be utilized in the synthesis process, although direct API manufacturing by them is less documented.

While AstraZeneca’s specific supply chain arrangements remain proprietary, it is inferred that multiple API suppliers across Asia, especially China and India, contribute to the global supply chain of osimertinib mesylate.

Raw Material and Intermediate Suppliers

The synthesis of osimertinib involves complex organic reactions requiring high-purity raw materials and intermediates.

Specialty Chemical Suppliers: Companies like Sigma-Aldrich (part of Merck Group) and TCI Chemicals supply raw materials such as heteroaryl compounds, amines, and other intermediates crucial for the multi-step synthesis process.
Custom Chemical Synthesis Firms: Several CMO firms specialize in custom synthesis, providing building blocks and intermediates tailored to the specific process required for osimertinib production.

Contract Manufacturing Organizations (CMOs) and Packaging

Given the precision required, many pharmaceutical companies outsource the final formulation, packaging, and even sterile processing of osimertinib to specialized CMOs:

PATHEON (U.S.): Known for high-containment cytotoxic drug manufacturing, which may be involved in sterile formulation or packaging.
Catalent Pharma Solutions: A global provider for formulation, filling, and packaging, including oral solid dosage forms like tablets.
TA-Industries (India): Known for solid dosage manufacturing and packaging capabilities, especially for generic or branded products in Asia.

The production of osimertinib tablets requires stringent quality control, including stability testing, labelling, and distribution logistics, all managed through a network of CMOs and logistics providers.

Supply Chain Dynamics and Risks

Consolidation and Geopolitical Factors: The limited number of API producers, mainly in China and India, heightens supply chain vulnerabilities. Recent geopolitical tensions and supply chain disruptions have prompted pharmaceutical companies to diversify sources.
Regulatory and Quality Assurance: Regulatory agencies like the FDA and EMA impose strict quality standards, influencing supplier qualification and continuous monitoring.
Patent and Licensing Arrangements: AstraZeneca’s licensing agreements with generic manufacturers, particularly in emerging markets, extend osimertinib access but also complicate supply chains.

Emerging Trends and Future Suppliers

Vertical Integration: Some pharmaceutical companies are investing in in-house API production to mitigate supply risks.
New Market Entrants: As demand grows, new suppliers in Southeast Asia, South Korea, and even Europe are entering the market to meet increasing global needs.
Sustainable Manufacturing: Growing emphasis on sustainable and environmentally friendly processes influences supplier selection.

Conclusion

The supply of osimertinib mesylate involves a tightly coordinated network of specialized API producers, raw material suppliers, CMOs, and logistics providers. The primary API manufacturers are based primarily in China and India, supported by suppliers of chemical intermediates across Asia and Europe. While AstraZeneca retains oversight of manufacturing standards and intellectual property, supply chain resilience hinges on diversifying sourcing strategies, maintaining quality assurance, and managing geopolitical risks.

Key Takeaways

Limited but Critical API Producers: Osimertinib's complex synthesis restricts its API production to a small pool of specialized manufacturers, mainly in Asia.
Supply Chain Vulnerabilities: Dependence on a limited number of API suppliers, particularly in China and India, exposes the supply chain to geopolitical and logistical risks.
Diversification and Vertical Integration: Pharmaceutical firms are increasingly seeking to diversify sources or internalize manufacturing to mitigate vulnerabilities.
Quality and Regulatory Oversight: Strict compliance with GMP ensures safety and efficacy but increases dependence on qualified suppliers who meet high standards.
Emerging Suppliers and Trends: New players in Southeast Asia and investments in sustainable manufacturing practices are poised to influence future supply dynamics.

FAQs

Who are the main API suppliers for osimertinib mesylate?
The leading API suppliers include WuXi AppTec in China and Hikal Ltd. in India, among others, due to their advanced synthesis capabilities and GMP compliance.
What factors influence the choice of suppliers for osimertinib?
Factors include quality standards, manufacturing capacity, regulatory compliance, cost, proximity to markets, and geopolitical stability.
Are there risks associated with the limited number of API manufacturers?
Yes. Dependence on few suppliers increases vulnerability to supply disruptions, regulatory issues, or geopolitical tensions.
How are pharmaceutical companies addressing supply chain risks for osimertinib?
Strategies include diversifying sources, investing in in-house manufacturing, establishing strategic inventories, and engaging multiple CMOs.
What is the outlook for new suppliers in the osimertinib supply chain?
As demand grows, new suppliers in regions like Southeast Asia and Europe are entering the market, supported by advancements in synthesis technology and regulatory approvals.

References

[1] AstraZeneca. (2022). Tagrisso (osimertinib) Summary of Product Characteristics.
[2] WuXi AppTec. Corporate website and API manufacturing capabilities.
[3] Hikal Ltd. Annual Reports and API synthesis data.
[4] Market analysis reports on EGFR inhibitors and supply chain dynamics, IQVIA.
[5] Regulatory filings and manufacturing disclosures from EMA and FDA databases.

This document aims to assist industry professionals, procurement officers, and strategic planners in understanding the supply landscape of osimertinib mesylate, facilitating data-driven decisions in sourcing, inventory management, and risk mitigation.

Suppliers and packagers for generic pharmaceutical drug: OSIMERTINIB MESYLATE