ELIQUIS SPRINKLE: Pharmaceutical manufacturers, suppliers, and distributors

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bristol	ELIQUIS SPRINKLE	apixaban	FOR SUSPENSION;ORAL	220073	NDA	E.R. Squibb & Sons, L.L.C.	0003-0898-28	28 CAPSULE in 1 BOTTLE (0003-0898-28)	2025-09-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: September 16, 2025

Introduction

ELIQUIS (apixaban) is a widely prescribed anticoagulant developed by Bristol-Myers Squibb, used primarily to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment and secondary prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE). In recent years, the approval of ELIQUIS ES (sprinkle capsules) has expanded its usability for patients with swallowing difficulties, requiring specialized supplier infrastructure to meet global demand. Understanding the primary suppliers behind the manufacturing and distribution of ELIQUIS SPRINKLE is crucial for stakeholders across the pharmaceutical supply chain.

Manufacturing and Supply Chain Overview

ELIQUIS SPRINKLE capsules are designed for ease of administration by sprinkling contents onto soft foods or liquids, facilitating patient compliance, especially among pediatric and geriatric populations. Manufacturing these specialized capsules involves intricate processes, including formulation, encapsulation, and packaging, which are predominantly managed by Bristol-Myers Squibb and its contractual manufacturing organizations (CMOs).

Key to ensuring stable supply is an extensive, diversified supply chain involving active pharmaceutical ingredient (API) production, excipient sourcing, capsule manufacturing, and distribution networks. The supply chain’s robustness depends on reliable suppliers for each component, adherence to quality standards, and geopolitical stability.

Primary Suppliers

1. Active Pharmaceutical Ingredient (API) Suppliers

The core of ELIQUIS manufacturing hinges on high-quality apixaban API existing from multiple global sources, primarily supplied by:

Bristol-Myers Squibb’s In-house API Production:
Bristol-Myers Squibb (BMS) maintains control over its API production through its own facilities or closely vetted CMOs, ensuring supply security and quality assurance.
Contract Manufacturers and API Suppliers:
To diversify supply vulnerability, BMS partners with third-party API manufacturers, including companies based in China, India, and Europe, which meet stringent cGMP (current Good Manufacturing Practices) standards. Some major API manufacturers involved include:
- Shanghai Sunshine Pharmaceutical Co., Ltd.
  A leading Chinese API producer supplying apixaban intermediates and bulk API, compliant with international regulatory standards.
- Sun Pharma Advanced Research Co., Ltd. (India)
  Known for its API manufacturing capabilities and supply commitments for various anticoagulants.
- AbbVie Manufacturing Facilities (for certain APIs)
  Although primarily focused on other products, collaborations for API supply are possible within the industry’s network.

2. Excipients and Capsule Components

The sprinkle capsules require specialized excipients and capsule shells, primarily sourced from:

Catalent, Inc.:
A global leader in softgel and hard capsule manufacturing, providing the gelatin capsules, along with excipients like fillers and stabilizers.
Dow Chemical and BASF:
Leading suppliers of excipients, including disintegrants and lubricants used in the capsule formulation.

3. Contract Manufacturing Organizations (CMOs)

The complex process of capsule filling, sterilization, and packaging often occurs at dedicated CMO facilities, including:

Catalent (USA and Europe):
Responsible for capsule filling, especially for specialized formulations like ELIQUIS SPRINKLE.
Recipharm (Sweden):
Offers highly validated manufacturing and packaging services for oral solid dose pharmaceuticals, including sprinkle capsules.
Recro Pharma and Patheon (Thermo Fisher Scientific):
Additional partners involved in manufacturing stages to secure supply chain resilience.

Distribution and Logistics Suppliers

Ensuring timely delivery involves shipping via licensed logistics providers:

DHL Pharmaceutical & Healthcare Logistics:
Offers temperature-controlled shipments across borders, aligned with pharmaceutical regulations.
FedEx Custom Critical:
Specializes in expedited healthcare logistics for sensitive products like ELIQUIS SPRINKLE.
Local Distributors:
Regional distributors in North America, Europe, and Asia ensure product availability in pharmacies and hospitals.

Regulatory and Quality Assurance

Suppliers are evaluated based on compliance with:

FDA cGMP standards
EMA standards
ICH-GMP guidelines

Regular audits by BMS and regulatory bodies verify the quality and reliability of each supplier, preventing disruptions.

Emerging Trends and Supplier Dynamics

The pharmaceutical industry is witnessing an increased focus on supply chain diversification, especially for critical drugs like ELIQUIS SPRINKLE. Recent geopolitical tensions and global crises have prompted manufacturers to source from multiple regions, including North America, Europe, and Asia, to mitigate risks. The ongoing development of biopharmaceutical manufacturing techniques may also influence future supplier relationships.

Conclusion

The supply of ELIQUIS SPRINKLE hinges on a network of specialized suppliers spanning API manufacturers, excipient providers, capsule producers, and logistics providers. Bristol-Myers Squibb’s strategic partnerships with CMOs and raw material suppliers across continents ensure drug availability, compliance, and responsiveness to demand fluctuations. A well-integrated and compliant supply chain remains vital for maintaining ELIQUIS SPRINKLE’s market position and meeting global patient needs.

Key Takeaways

Diverse API sources from China (Shanghai Sunshine), India (Sun Pharma), and internal manufacturing secure API supply.
Established partnerships with CMOs like Catalent and Recipharm facilitate capsule formulation, filling, and packaging.
Reliable logistics providers, such as DHL and FedEx, uphold temperature-controlled distribution critical for maintaining drug efficacy.
Regulatory compliance and ongoing quality audits are vital for supplier reliability.
Supply chain diversification minimizes risks associated with geopolitical or pandemic-related disruptions.

FAQs

1. Who are the primary active pharmaceutical ingredient (API) suppliers for ELIQUIS SPRINKLE?
Major API suppliers include Shanghai Sunshine Pharmaceutical (China), Sun Pharma (India), and in-house Bristol-Myers Squibb manufacturing facilities, all adhering to strict cGMP standards.

2. Which companies manufacture the capsules used for ELIQUIS SPRINKLE?
Catalent and Recipharm are the leading CMO partners responsible for capsule production and filling processes.

3. What logistics providers are involved in distributing ELIQUIS SPRINKLE?
DHL and FedEx provide temperature-controlled, expedited shipping services for global distribution.

4. How does Bristol-Myers Squibb ensure the quality and consistency of its ELIQUIS supply chain?
Through rigorous supplier qualification, regulatory compliance audits, and ongoing quality assessments aligned with FDA and EMA standards.

5. Are there regional differences in supplier networks for ELIQUIS SPRINKLE?
Yes, regional suppliers and distributors are employed based on geographic demand, supply chain security, and regulatory considerations to ensure global access.

Sources:
[1] Bristol-Myers Squibb official website and product information.
[2] Global Supply Chain Reports on Pharmaceutical API manufacturing.
[3] Regulatory guidelines from FDA, EMA, and ICH.
[4] Industry reports on contract manufacturing organizations.
[5] Logistics service providers' official documentation.

Suppliers and packagers for ELIQUIS SPRINKLE