Suppliers and packagers for generic pharmaceutical drug: naltrexone

naltrexone

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897	NDA	Alkermes, Inc.	65757-300-01	1 KIT in 1 CARTON (65757-300-01) * 4 mL in 1 VIAL, GLASS (65757-302-02) * 4 mL in 1 VIAL, GLASS (65757-304-03)	2006-06-13
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897	NDA	Alkermes, Inc.	65757-301-01	1 KIT in 1 CARTON (65757-301-01) * 4 mL in 1 VIAL, GLASS (65757-303-02) * 4 mL in 1 VIAL, GLASS (65757-305-03)	2006-06-13

Suppliers for the Pharmaceutical Drug: Naltrexone

Last updated: November 7, 2025

Introduction

Naltrexone, an opioid antagonist primarily used to manage alcohol and opioid dependence, has gained increased attention in both clinical and research settings. As demand surges globally, a comprehensive understanding of suppliers distributing pharmaceutical-grade Naltrexone becomes vital for healthcare providers, pharmaceutical companies, and investors. This article provides an in-depth analysis of the key suppliers, sourcing channels, regulatory considerations, and market dynamics influencing Naltrexone supply chains.

Overview of Naltrexone

Naltrexone is marketed primarily under brand names such as Revia and Vivitrol. It functions by blocking opioid receptors, thus inhibiting the effects of opioids and reducing cravings in alcohol dependence. The global market for Naltrexone is driven by rising awareness of addiction treatments and expanding healthcare infrastructure, especially across North America, Europe, and parts of Asia.

The drug is available in oral and injectable forms, with distinctions in manufacturing sources and supplier networks depending on regional regulations and clinical needs.

Major Pharmaceutical Suppliers of Naltrexone

1. Global Manufacturers of Pharmaceutical Naltrexone

a. Mallinckrodt Pharmaceuticals

Mallinckrodt is among the leading providers of Naltrexone globally, offering both oral and injectable formulations. Their supply chain encompasses active pharmaceutical ingredient (API) production, finished dosage forms, and distribution channels. The company complies with stringent regulatory standards like FDA approval and EMA certification, ensuring high-quality standards in their products ([1]).

b. Sun Pharmaceutical Industries Ltd.

An Indian-based pharmaceutical giant, Sun Pharma manufactures generic Naltrexone formulations for multiple markets, especially in Asia and emerging markets. Their API production capabilities include sourcing high-purity Naltrexone for both domestic use and export ([2]).

c. Teva Pharmaceutical Industries

Teva supplies generic Naltrexone for global markets, leveraging its extensive manufacturing facilities and distribution network. The company offers oral tablets primarily, with a focus on affordable access ([3]).

d. Orexo AB

Specializing in prescription solutions for addiction, Orexo supplies both Naltrexone tablets and extended-release formulations like Vivitrol, developed through proprietary drug delivery systems. Their supply chain emphasizes quality control and regulatory compliance ([4]).

2. Contract Manufacturers and Custom API Suppliers

Several smaller firms and contract manufacturing organizations (CMOs) serve as API suppliers to large pharmaceutical companies. These firms often operate under strict cGMP standards to produce Naltrexone API, which is then formulated into finished products by pharmaceutical partners.

Key API Suppliers Include:

• Hikal Ltd. (India): Provides active ingredients including Naltrexone API, catering to global pharmaceutical companies ([5]).

• Aurobindo Pharma: Offers both finished formulations and APIs, with manufacturing facilities approved by regulatory authorities like the US FDA ([6]).

Source of Raw Materials and Manufacturing Challenges

The primary raw material for Naltrexone synthesis involves complex chemical processes, often demanding high-purity intermediates. The key challenges for suppliers include:

• Quality assurance: Ensuring traceability and compliance with international standards remains critical.

• Regulatory tooling: API manufacturing is heavily regulated; supplier approval hinges on FDA, EMA, and other relevant authorities’ audits.

• Sourcing raw chemicals: Many intermediates are sourced globally, with stability and geopolitical factors impacting supply reliability.

Distribution and Supply Chain Dynamics

The supply chain for Naltrexone involves upstream raw material sourcing, API production, formulation, and finally, distribution through licensed pharmacies and healthcare institutions. Disruptions can arise due to:

• Regulatory shifts, such as patent expirations or generic approvals, affecting market competition.
• Supply chain bottlenecks caused by raw material shortages, geopolitical tensions, or manufacturing issues.
• Quality compliance concerns, leading to recalls or market withdrawal.

Regulatory Landscape and Supply Reliability

The regulatory status influences the availability of Naltrexone by dictating manufacturing standards and approval processes. For example, in the U.S., the FDA’s approval of both brand and generic versions ensures multiple suppliers. Conversely, in markets with less regulatory oversight, supply stability may depend on fewer regional manufacturers.

Emerging Markets and Local Suppliers

In developing regions, local pharmaceutical companies tend to source Naltrexone API from international suppliers, often leading to variable quality and supply consistency. Regional regulatory agencies are increasingly scrutinizing imports, emphasizing the need for transparent sourcing and manufacturing documentation.

Implications for Stakeholders

• Healthcare providers should verify supplier accreditation and API quality through regulatory certifications.
• Pharmaceutical companies should diversify their supplier base to mitigate risks associated with supply chain disruptions.
• Investors must monitor patent statuses, regional regulatory changes, and manufacturing capacity expansions affecting Naltrexone supply stability.

Market Trends and Future Outlook

The ongoing development of long-acting injectable formulations by companies like Orexo and the potential for new indications (e.g., desistant for obesity or COVID-19 related research) are likely to influence supplier dynamics. Additionally, increased manufacturing capacity and technological advances in API synthesis will enhance global supply resilience.

Conclusion

The supply landscape for Naltrexone is characterized by a mix of established pharmaceutical companies, contract manufacturers, and regional players. Ensuring a stable supply requires vigilance over regulatory compliance, raw material sourcing, and manufacturing quality. As global demand grows, diversification and quality assurance will remain critical to maintaining market stability in this vital addiction management medication.

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Key Takeaways

• Leading suppliers include global pharmaceutical giants such as Mallinckrodt, Sun Pharma, Teva, and Orexo.
• API sourcing relies heavily on high-purity manufacturing, often outsourced to specialized CMOs in India and other regions.
• Supply chain stability hinges on regulatory compliance, raw material availability, and geopolitical factors.
• Diversification of suppliers and adherence to quality standards mitigate risks of shortages or recalls.
• Emerging formulations and applications are poised to expand supply chain complexity, emphasizing the need for robust manufacturing and regulatory strategies.

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FAQs

1. Who are the primary global suppliers of pharmaceutical-grade Naltrexone?
Major suppliers include Mallinckrodt, Sun Pharma, Teva, and Orexo, offering both APIs and finished dosage formulations across global markets ([1], [2], [3], [4]).

2. How does the sourcing of raw materials impact Naltrexone supply?
Raw material availability and quality directly influence API production capacity, with supply disruptions arising from geopolitical issues, regulatory challenges, or shortages of intermediates.

3. Are there regional differences in Naltrexone supplier access?
Yes. Developed markets typically have multiple approved suppliers, ensuring supply stability, whereas emerging markets may rely on fewer regional or international sources, affecting availability.

4. What role do contract manufacturing organizations play in the Naltrexone supply chain?
CMOs manufacture the API and sometimes finished products for larger pharmaceutical companies, expanding global production capacity and supporting market demand.

5. What are the key considerations for stakeholders to ensure a reliable Naltrexone supply?
Quality assurance, supplier diversification, compliance with regulatory standards, and proactive management of raw material sourcing are essential for supply stability.

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References

1. Mallinckrodt Pharmaceuticals. (2022). Company overview. [Online] Available at: https://www.mallinckrodt.com
2. Sun Pharmaceutical Industries Ltd. (2022). Product portfolio. [Online] Available at: https://www.sunpharma.com
3. Teva Pharmaceutical Industries Ltd. (2022). Company profile. [Online] Available at: https://www.tevapharm.com
4. Orexo AB. (2022). Innovation in addiction treatment. [Online] Available at: https://www.orexo.com
5. Hikal Ltd. (2022). API manufacturing capabilities. [Online] Available at: https://www.hikal.com
6. Aurobindo Pharma. (2022). Quality and compliance. [Online] Available at: https://www.aurobindo.com