bupropion hydrochloride; naltrexone hydrochloride: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063	NDA	Nalpropion Pharmaceuticals LLC	51267-890-07	7 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-07)	2014-10-22
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063	NDA	Nalpropion Pharmaceuticals LLC	51267-890-99	120 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-99)	2014-10-22
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Overview

Bupropion hydrochloride and naltrexone hydrochloride are critical pharmacological agents used in the treatment of depression, smoking cessation, and opioid or alcohol dependence. Their complex manufacturing processes and stringent quality standards necessitate a reliable, diverse supply chain. This article provides a detailed overview of the primary suppliers, manufacturing landscape, and strategic considerations influencing procurement decisions for these drugs.

Bupropion Hydrochloride Suppliers

Global Manufacturing Landscape

Bupropion hydrochloride, a selective norepinephrine-dopamine reuptake inhibitor (NDRI), was first marketed by GlaxoSmithKline under the brand name Wellbutrin. Its manufacturing involves sophisticated chemical synthesis, often restricted to a limited number of high-capacity, FDA- or EMA-approved facilities worldwide.

Major Suppliers

GlaxoSmithKline (GSK)
As the original developer, GSK remains a prominent provider, supplying bulk active pharmaceutical ingredient (API) to generic manufacturers globally. While GSK primarily focuses on branded supply, it licenses production to authorized third-party manufacturers under strict quality agreements.
Aurobindo Pharma
An established API manufacturer based in India, Aurobindo produces high-purity bupropion hydrochloride. Its facilities hold regulatory approvals from the US FDA, the European Medicines Agency (EMA), and other international agencies, making it a trusted supplier for generic formulations.
Mylan (now part of Viatris)
Mylan's manufacturing units in India and the Philippines produce large volumes of bupropion hydrochloride API, complying with global regulatory standards. Their extensive production capacity and competitive pricing make them a key supplier in the generic market.
Hikma Pharmaceuticals
Based in Jordan, Hikma manufactures both APIs and finished dosage forms. It supplies bupropion hydrochloride to various markets, emphasizing regulatory compliance and high-quality standards.
S.I. Group (Staro Remedies)
An emerging player from India with regulated manufacturing capabilities, S.I. Group supplies bulk API and is expanding its presence in North America and Europe.

Emerging Manufacturers & Regional Suppliers

Zhejiang Hisun Pharmaceutical (China)
Torrent Pharmaceuticals (India)
CSL Limited (Australia)

These manufacturers are expanding their API portfolios, with increasing international regulatory approvals, underscoring a diversified supply chain.

Naltrexone Hydrochloride Suppliers

Global Manufacturing Landscape

Naltrexone hydrochloride, an opioid antagonist used in addiction therapy, has a complex synthesis route involving multiple chemical steps. Production is concentrated among companies with advanced chemical manufacturing capabilities and extensive regulatory compliance systems.

Major Suppliers

Valeant Pharmaceuticals (now part of Bausch Health)
As the original innovator, Valeant licensed manufacturing to several Asian and European manufacturers. It currently supplies the API for its branded formulations, with wide distribution channels.
Mundipharma
A European-based company specializing in addiction treatment medications, Mundipharma manufactures both APIs and finished formulations, adhering to European and FDA standards.
Sun Pharmaceutical Industries Ltd.
Based in India, Sun Pharma is a major producer of naltrexone hydrochloride API, supplying global generic markets. Its facilities have multiple international regulatory certifications.
Hetero Drugs
Also based in India, Hetero is known for producing high-quality APIs, including naltrexone hydrochloride. Its manufacturing facilities meet stringent regulatory standards, including US FDA approval.
Apotex Inc.
A North American generic pharmaceutical leader, Apotex manufactures naltrexone hydrochloride API for the U.S. and Canadian markets, with a focus on high-quality standards.

Additional Suppliers

Laurus Labs (India)
Zhejiang Hisun Pharmaceutical (China)

These regional companies are strengthening their manufacturing capacity and regulatory profile, contributing to a resilient global supply network.

Industry Trends Impacting Supply Chains

Regulatory Compliance and Quality Assurance
API manufacturing is heavily regulated, requiring approval from authorities such as the FDA, EMA, and WHO. Suppliers with proven compliance histories and robust quality management systems are favored.
Geopolitical Factors
Political stability, trade policies, and import-export restrictions influence supplier viability. India and China remain dominant regions due to cost advantages and scaling capacity, though geopolitical tensions may prompt diversification.
Supply Chain Diversification
Companies increasingly seek diversified supplier bases to mitigate shortages. Multiple approved suppliers across different regions reduce dependency on single sources.
Sustainability and Ethical Sourcing
Growing emphasis on sustainable production practices influences supplier selection, favoring companies with environmentally responsible manufacturing operations.

Strategic Procurement Considerations

Regulatory Status: Verify supplier FDA, EMA, or equivalent approvals for manufacturing facilities.
Capacity & Reliability: Ensure suppliers can meet current and projected demand volumes.
Pricing & Terms: Negotiate competitive pricing aligned with quality standards.
Supply Chain Resilience: Develop multi-supplier strategies to mitigate risks.
Trade & Geopolitical Risks: Incorporate geopolitical risk assessments into procurement planning.

Key Takeaways

Major global suppliers of bupropion hydrochloride include GSK, Aurobindo Pharma, Mylan, Hikma, and S.I. Group. These companies possess proven regulatory compliance and manufacturing capacity, making them primary options for procurement.
Naltrexone hydrochloride suppliers are concentrated among Valeant (Bausch Health), Sun Pharma, Hetero Drugs, and Mundipharma, with ever-expanding regional players like Laurus Labs and Zhejiang Hisun increasing supply diversity.
Environmental, geopolitical, and regulatory factors significantly influence supplier stability. Diversifying supplier bases and prioritizing regulatory approvals mitigate supply risks.
Technological advancements and regulatory tightening push suppliers towards higher standards, favoring companies with proven quality assurance mechanisms.
Strategically, partnerships with multiple Tier 1 suppliers ensure robustness in supply chains amid market volatilities.

FAQs

1. How can I verify the regulatory compliance of a supplier manufacturing bupropion or naltrexone?
Verify that the supplier has current approvals from major regulatory agencies such as the FDA, EMA, or TGA. Review their compliance history, audit reports, and manufacturing certifications, which are typically published on regulatory authority databases.

2. Are there regional differences in API quality standards?
Yes. While many Indian and Chinese suppliers meet international standards, some markets prefer APIs produced in regions with stricter oversight, such as North America or Europe. Due diligence should include reviewing recent audit and inspection reports.

3. How does market demand influence API pricing and supply stability?
High demand can lead to supply shortages and price increases. Suppliers may prioritize long-standing customers or large-volume buyers, so establishing strategic relationships is crucial to ensuring supply continuity.

4. What role do generic manufacturers play in the supply of these drugs?
Generic manufacturers source APIs from multiple suppliers to produce cost-effective versions of these drugs. Their choice of API suppliers significantly impacts drug availability and pricing.

5. What emerging trends could affect future API suppliers for these drugs?
Increased focus on sustainable manufacturing, regulatory harmonization, and technological innovations, such as continuous manufacturing, could shift supplier landscapes, favoring advanced, environmentally responsible providers.

References

[1] World Health Organization. (2021). Prequalification of Medicines Programme.
[2] U.S. Food and Drug Administration. (2022). List of Approved API Manufacturers.
[3] Pharmaceutical Technology. (2020). Top API Manufacturers in Asia.
[4] European Medicines Agency. (2022). Good Manufacturing Practice (GMP) Inspections.
[5] Global Trade Review. (2021). API Market Dynamics and Supply Chain Risks.

Suppliers and packagers for generic pharmaceutical drug: bupropion hydrochloride; naltrexone hydrochloride