Suppliers and packagers for OPTISON

OPTISON

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899	NDA	GE Healthcare Inc.	0407-2707-03	5 VIAL, SINGLE-USE in 1 CARTON (0407-2707-03) / 3 mL in 1 VIAL, SINGLE-USE	2002-01-02
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899	NDA	GE Healthcare Inc.	0407-2707-18	18 VIAL, SINGLE-USE in 1 CARTON (0407-2707-18) / 3 mL in 1 VIAL, SINGLE-USE	2002-01-02

Suppliers for the Pharmaceutical Drug: OPTISON

Last updated: July 29, 2025

Introduction

OPTISON (perflutren lipid microsphere) is a well-established ultrasonic contrast agent used primarily to enhance echocardiography imaging. Approved by the U.S. Food and Drug Administration (FDA) in 2001, it plays a critical role in cardiac imaging, facilitating clearer visualization of cardiac chambers and pathology. As a specialized medical product, OPTISON’s supply chain involves a limited set of recognized manufacturers and suppliers, primarily due to stringent quality controls, regulatory compliance, and proprietary manufacturing processes. This article explores the key suppliers involved in the production and distribution of OPTISON, market dynamics, and regulatory considerations influencing its supply chain stability.

Manufacturers of OPTISON

1. Lantheus Medical Imaging Inc.

Lantheus Medical Imaging Inc. is the sole licensee and manufacturer of OPTISON for the US market, holding exclusive rights to produce and distribute the contrast agent [1]. The company's facilities in North Billerica, Massachusetts, are GMP-compliant and equipped to manufacture high-quality microsphere-based contrast agents for diagnostic purposes.

Lantheus has invested heavily in the manufacturing infrastructure to ensure supply continuity, compliance with FDA regulations, and high product purity standards. Their manufacturing protocol includes complex processes such as lipid microsphere formulation, sterilization, and quality control testing, which require specialized equipment and expertise.

2. General Electric Healthcare (GE Healthcare)

While GE Healthcare historically played a role in ultrasound imaging and contrast agents, it does not currently manufacture OPTISON. However, GE’s extensive distribution network and experience in contrast agent delivery systems influence the broader supply chain landscape through compatibility and integration with imaging platforms.

3. Other Potential Suppliers and Generics

To date, there are no known generic or alternative manufacturers producing OPTISON under authorized licensing in the United States or globally. The proprietary nature of the formulation, particularly the lipid microsphere technology, restricts unlicensed manufacturing or production by unauthorized entities. In markets outside the US, licensing agreements with regional pharmaceutical entities may vary.

Global Supply Chain Considerations

Regulatory Approval and Licensing

Since OPTISON is proprietary and licensed exclusively to Lantheus, its production is bound by regulatory approvals obtained from agencies such as the FDA (US), the European Medicines Agency (EMA), and others. These agencies impose strict manufacturing standards, which limit the number of approved suppliers.

Manufacturing Capacity and Innovation

The limited number of suppliers results in potential supply vulnerabilities, especially during global disruptions like the COVID-19 pandemic. Lantheus has expanded manufacturing capacity in recent years, aiming to meet rising demand and regional expansion, including markets in Europe, Asia, and Latin America.

Distribution Channels

Distribution of OPTISON involves a network of specialty pharmaceutical distributors, healthcare providers, and hospitals. The product’s shelf life (~24 months when stored properly) and storage requirements (refrigeration at 2–8°C) also impact supply logistics, necessitating cold chain management expertise from suppliers.

Regulatory and Market Dynamics

Patent and Market Exclusivity

Lantheus’s patent protection for OPTISON provides a period of market exclusivity. Once patents expire, potential for biosimilar or generic competition may emerge, but as of 2023, no such alternatives are available.

Supply Chain Risks

Dependence on a single manufacturer (Lantheus) inherently introduces risks related to manufacturing disruptions, regulatory delays, or capacity constraints. Strategic stockpiling and regional manufacturing expansion are strategies employed to mitigate these risks.

Emerging Technologies and Future Supply Considerations

Research into alternative ultrasound contrast agents aims to develop safer, more efficient, or cost-effective options. Advances in nanotechnology and biodegradable microspheres could, in the future, challenge or complement OPTISON’s position and supply chain dynamics.

Key Suppliers Summary

Supplier	Role	Location	Notes
Lantheus Medical Imaging Inc.	Sole licensed manufacturer for US	North Billerica, MA	Proprietary production of OPTISON
Regional Distributors	Distribution and supply logistics	Global	Cold chain expertise required
Potential future entrants	Biosimilars / Generics	Unknown	Limited due to patent protections

Conclusion

The global supply of OPTISON is largely centered around Lantheus Medical Imaging Inc., which maintains exclusive manufacturing rights in key markets such as the US. Its role as the primary supplier is supported by stringent quality standards and regulatory approvals, but reliance on a single manufacturer introduces supply chain risks. Expanding manufacturing capacity, regional licensing, and technological innovation are vital to ensuring supply resilience amid growing demand and potential market evolutions.

Key Takeaways

• Lantheus Medical Imaging Inc. is the exclusive supplier of OPTISON in the US and many other regions, controlling its production and distribution.
• The proprietary manufacturing process and regulatory protections limit the emergence of authorized generic competitors.
• Supply chain risks are mitigated through capacity expansion, regional licensing, and strict cold chain logistics.
• Future market developments, including biosimilar competition and technological innovations, could influence the supply landscape.
• Stakeholders should monitor regulatory changes and manufacturing capacity updates to ensure ongoing access to OPTISON.

---

FAQs

1. Who are the primary suppliers of OPTISON globally?
Lantheus Medical Imaging Inc. is the primary and often the sole licensed manufacturer of OPTISON in the US and many other markets, with regional distributors handling logistics.

2. Are there any generic versions of OPTISON available?
Currently, no generic or biosimilar versions of OPTISON are authorized for use in the US, owing to patent protections and proprietary formulations.

3. How does supply chain disruption impact OPTISON availability?
Disruptions at the manufacturing site, regulatory delays, or logistical challenges can cause shortages, impacting hospital and diagnostic center accessibility.

4. What strategies are in place to ensure OPTISON’s supply stability?
Lantheus is investing in manufacturing capacity expansion, maintaining inventory reserves, and working with regional partners for distribution to prevent shortages.

5. Could new contrast agents replace OPTISON in the future?
Yes, ongoing research into alternative contrast agents, including nanotechnology-based microspheres and biodegradable options, might offer substitutes or complements in the future.

---

References

[1] Lantheus Medical Imaging Inc. Official Website. “Product Information for OPTISON.” Accessed 2023.