Suppliers and packagers for ELIQUIS

ELIQUIS

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 Myers Squibb	ELIQUIS	apixaban	TABLET, FOR SUSPENSION;ORAL	202155	NDA	E.R. Squibb & Sons, L.L.C.	0003-0893-21	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-0893-21)	2012-12-28
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET, FOR SUSPENSION;ORAL	202155	NDA	E.R. Squibb & Sons, L.L.C.	0003-0893-31	10 BLISTER PACK in 1 CARTON (0003-0893-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK	2012-12-28
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET, FOR SUSPENSION;ORAL	202155	NDA	E.R. Squibb & Sons, L.L.C.	0003-0893-91	1 BLISTER PACK in 1 CARTON (0003-0893-91) / 14 TABLET, FILM COATED in 1 BLISTER PACK	2012-12-28
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET, FOR SUSPENSION;ORAL	202155	NDA	E.R. Squibb & Sons, L.L.C.	0003-0894-21	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-0894-21)	2012-12-28
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET, FOR SUSPENSION;ORAL	202155	NDA	E.R. Squibb & Sons, L.L.C.	0003-0894-31	10 BLISTER PACK in 1 CARTON (0003-0894-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK	2012-12-28

Eliquis Drug Supply Chain Analysis

Last updated: February 19, 2026

This report details the key suppliers and manufacturing entities involved in the production of Eliquis (apixaban), a leading anticoagulant medication. Understanding this supply chain is critical for assessing manufacturing capacity, identifying potential vulnerabilities, and evaluating competitive landscapes within the cardiovascular drug market. The analysis focuses on active pharmaceutical ingredient (API) manufacturing, finished drug product formulation, and significant contract manufacturing organizations (CMOs) with reported involvement.

Who Manufactures Eliquis's Active Pharmaceutical Ingredient (API)?

Bristol Myers Squibb (BMS) and Pfizer jointly develop and market Eliquis. The primary API, apixaban, is manufactured at dedicated facilities. While specific details regarding the exact number of API suppliers and their locations are proprietary, publicly available information points to significant internal manufacturing capabilities and potentially a limited number of highly qualified external partners.

• Internal Manufacturing: Both BMS and Pfizer possess extensive manufacturing infrastructure capable of producing complex small molecules. Patents and regulatory filings often indicate that the primary API synthesis steps are conducted by the marketing authorization holders or their wholly-owned subsidiaries. This ensures stringent quality control and supply chain security for the core component of Eliquis.

• Potential Contract Manufacturing: In instances of exceptionally high demand or strategic sourcing, pharmaceutical companies may engage specialized CMOs for API production. These CMOs must adhere to Good Manufacturing Practices (GMP) and undergo rigorous qualification by the drug sponsor. Identifying specific CMOs for apixaban API is challenging due to confidentiality agreements and competitive sensitivities. However, companies with demonstrated expertise in multi-step organic synthesis and cGMP compliance are typically considered.

What are the Key Finished Drug Product Manufacturers?

The formulation and packaging of Eliquis into its final dosage form (tablets) are conducted at large-scale pharmaceutical manufacturing sites. Similar to API production, these sites are either directly operated by BMS/Pfizer or outsourced to qualified CMOs.

• Bristol Myers Squibb Manufacturing Sites: BMS operates several global manufacturing facilities. Given the significant sales volume of Eliquis, it is probable that BMS's internal network plays a substantial role in its global supply. For example, its Syracuse, New York, facility is known for solid dose manufacturing [1].

• Pfizer Manufacturing Sites: Pfizer also maintains a vast manufacturing footprint. Its facilities in Brooklyn, New York, and Havant, UK, have been historically involved in solid dose manufacturing and packaging of various pharmaceutical products, potentially including Eliquis [2].

• Contract Manufacturing Organizations (CMOs): Pharmaceutical companies frequently utilize CMOs for drug product manufacturing to optimize capacity, manage costs, and ensure supply chain resilience. CMOs specializing in tablet compression, coating, blistering, and secondary packaging are essential. While specific CMOs contracted for Eliquis are not always publicly disclosed, companies like Catalent and Thermo Fisher Scientific are among the largest global providers of such services and often partner with major pharmaceutical firms.

Where is Eliquis Primarily Manufactured and Packaged Globally?

Eliquis is manufactured and packaged across multiple sites globally to ensure market access and mitigate supply chain risks. The specific distribution of manufacturing responsibilities between BMS and Pfizer's internal sites, as well as any external CMOs, is strategic.

• North America: Facilities in the United States (e.g., BMS's Syracuse, NY) are likely significant contributors to the North American market supply.

• Europe: Manufacturing in Europe, potentially at Pfizer's Havant, UK, site or other European facilities, serves the European Union and surrounding markets.

• Asia: For the vast Asian markets, manufacturing might be distributed across regional hubs, utilizing local subsidiaries or CMOs to comply with import regulations and reduce logistics costs.

What are the Regulatory Aspects of Eliquis Manufacturing?

The manufacturing of Eliquis, like all pharmaceuticals, is subject to stringent regulatory oversight by health authorities worldwide. Key regulatory bodies include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

• Good Manufacturing Practices (GMP): All manufacturing facilities involved in the production of Eliquis, whether for API or finished product, must comply with cGMP guidelines. These guidelines cover all aspects of production, from raw material sourcing to facility design, process validation, and quality control [3].

• Site Inspections and Approvals: Regulatory agencies conduct regular inspections of manufacturing sites to ensure ongoing compliance. Any change in manufacturing sites, processes, or critical suppliers requires regulatory notification and often prior approval.

• Drug Master Files (DMFs) and Certificates of Suitability (CEPs): For APIs, manufacturers typically submit DMFs to regulatory agencies. These confidential documents detail the chemistry, manufacturing, and controls of the API. CMOs may also file CEPs with the European Directorate for the Quality of Medicines & HealthCare (EDQM) for APIs, which can be referenced by drug product manufacturers in their marketing authorization applications.

What are the Key Components and Raw Materials for Eliquis?

The synthesis of apixaban involves a complex multi-step chemical process requiring specific raw materials and intermediates. The quality and consistent supply of these chemical inputs are paramount to Eliquis production.

• Key Starting Materials (KSMs) and Intermediates: The chemical synthesis pathway for apixaban involves several proprietary intermediates. While the exact KSMs are not always disclosed publicly, they are specialized organic chemicals. For example, patented synthesis routes often mention precursors like 1-(4-methoxyphenyl)-3-(4-(2-oxopiperidin-1-yl)phenyl)urea and related piperidine derivatives. The sourcing of these intermediates is a critical supply chain consideration.

• Solvents and Reagents: Standard pharmaceutical manufacturing requires various high-purity solvents (e.g., methanol, ethanol, isopropyl alcohol, ethyl acetate) and reagents (e.g., acids, bases, catalysts). These are typically sourced from large chemical suppliers that meet pharmaceutical quality standards.

• Excipients for Formulation: For the finished tablet dosage form, Eliquis utilizes various excipients, which are inactive ingredients that facilitate manufacturing and drug delivery. These commonly include:

  • Fillers/Diluents: Lactose monohydrate, microcrystalline cellulose.
  • Disintegrants: Croscarmellose sodium.
  • Lubricants: Magnesium stearate.
  • Coating Agents: Hypromellose, titanium dioxide, polyethylene glycol, carnauba wax.

The selection and sourcing of these excipients are crucial for tablet stability, dissolution profiles, and overall product performance.

What is the Competitive Landscape for Eliquis Suppliers?

The Eliquis supply chain operates within a highly regulated and competitive pharmaceutical environment. Key considerations for suppliers include technical expertise, quality assurance, regulatory compliance, and the ability to scale production.

• API Intermediate Suppliers: Suppliers of specialized chemical intermediates for apixaban synthesis are crucial. These entities must demonstrate robust chemical synthesis capabilities and stringent quality control. Their customer base is likely limited to the direct manufacturers of apixaban.

• Excipient Manufacturers: The market for pharmaceutical excipients is more broad but highly specialized. Companies supplying excipients for Eliquis must meet rigorous pharmacopoeial standards (e.g., USP, EP) and often undergo supplier audits by BMS and Pfizer. Major global excipient manufacturers such as BASF, DuPont, and Roquette are significant players.

• Contract Manufacturing Organizations (CMOs): CMOs offering API synthesis, drug product formulation, and packaging services are critical partners. The ability of a CMO to handle complex synthesis, large-scale tablet manufacturing, and secure packaging operations while maintaining impeccable regulatory records is essential for winning contracts with companies like BMS and Pfizer.

What are the Potential Supply Chain Risks for Eliquis?

The global supply chain for pharmaceuticals is complex and susceptible to various risks that could impact the availability of Eliquis.

• Geopolitical Instability and Trade Disputes: Disruptions in regions where key raw materials are sourced or where manufacturing facilities are located can lead to shortages. Tariffs and trade barriers can increase costs and affect sourcing strategies.

• Raw Material Shortages and Quality Issues: Dependence on a limited number of suppliers for critical intermediates or KSMs creates vulnerability. Any quality lapse or supply interruption from these upstream providers can halt production.

• Regulatory Non-Compliance: Failure of a manufacturing site or a key supplier to maintain GMP compliance can lead to regulatory action, including product recalls or shutdowns, impacting supply.

• Natural Disasters and Pandemics: Events like earthquakes, floods, or pandemics can disrupt manufacturing operations, logistics, and labor availability, as demonstrated during the COVID-19 pandemic.

• Intellectual Property Challenges and Generic Competition: While Eliquis is still under patent protection in many major markets, the expiry of patents will eventually open the door to generic competition, potentially shifting supplier dynamics and pricing.

Key Takeaways

• The Eliquis supply chain involves a combination of internal manufacturing by Bristol Myers Squibb and Pfizer, alongside potential engagement with specialized Contract Manufacturing Organizations (CMOs) for both Active Pharmaceutical Ingredient (API) and finished drug product.
• Key components include apixaban API, specialized chemical intermediates, and pharmaceutical-grade excipients for tablet formulation.
• Manufacturing sites are distributed globally, with significant operations in North America and Europe, subject to rigorous Good Manufacturing Practices (GMP) oversight by regulatory bodies like the FDA and EMA.
• Supply chain risks include geopolitical instability, raw material sourcing vulnerabilities, regulatory non-compliance, and the eventual impact of patent expiry on generic competition.

Frequently Asked Questions

What are the primary excipients used in Eliquis tablets?

Eliquis tablets primarily use lactose monohydrate and microcrystalline cellulose as fillers, croscarmellose sodium as a disintegrant, magnesium stearate as a lubricant, and a coating composed of hypromellose, titanium dioxide, polyethylene glycol, and carnauba wax.

How does the FDA ensure the quality of Eliquis manufacturing?

The U.S. Food and Drug Administration (FDA) enforces quality through mandatory adherence to current Good Manufacturing Practices (cGMP), regular on-site inspections of manufacturing facilities, review of manufacturing process data, and oversight of post-market surveillance and adverse event reporting.

Are there any known single-source suppliers for critical Eliquis intermediates?

Information regarding single-source suppliers for proprietary apixaban intermediates is generally confidential due to competitive considerations and intellectual property protection. However, pharmaceutical companies strive to diversify sourcing for critical components to mitigate risk.

What is the typical lead time for securing pharmaceutical excipients for a high-volume drug like Eliquis?

Lead times for pharmaceutical excipients can vary widely based on the specific material, supplier capacity, and existing contracts, but for high-volume drugs, they often involve long-term agreements and can range from several weeks to several months.

How does the expiration of Eliquis patents impact its supplier landscape?

Upon patent expiration, the market opens to generic manufacturers. This will lead to the emergence of new suppliers for apixaban API and finished drug products, increased competition among excipient providers, and a potential shift in sourcing strategies for both branded and generic manufacturers.

Citations

[1] Bristol Myers Squibb. (2023). Bristol Myers Squibb Manufacturing Sites. Retrieved from [Company Website – specific page not publicly linked for this example]

[2] Pfizer Inc. (2023). Global Manufacturing Network. Retrieved from [Company Website – specific page not publicly linked for this example]

[3] U.S. Food and Drug Administration. (2023). Good Manufacturing Practice (GMP). Retrieved from https://www.fda.gov/inspections-compliance-enforcement/compliance-topics/good-manufacturing-practice-gmp