CONTRAVE: Pharmaceutical manufacturers, suppliers, and packagers

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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 27, 2025

Introduction

Contrave, a prescription weight management medication, combines bupropion and naltrexone to target obesity and related metabolic disorders. Marketed primarily for appetite suppression and weight loss, Contrave has become a significant product within the pharmaceutical landscape. Its manufacturing and distribution involve intricate supply chain pathways, layered with licensing agreements, raw material procurement, and regulatory oversight. Understanding the key suppliers behind Contrave provides valuable insights for stakeholders involved in pharmaceutical manufacturing, procurement, and competitive strategy.

Overview of Contrave’s Composition and Manufacturing

Contrave comprises two active pharmaceutical ingredients (APIs): bupropion hydrochloride and naltrexone hydrochloride. These components are synthesized independently and then formulated into the final tablet, which is supplied to healthcare providers and pharmacies. The manufacturing process necessitates sourcing high-quality APIs, excipients, and advanced formulation techniques compliant with regulatory standards (FDA, EMA).

Key Suppliers for Contrave’s Active Pharmaceutical Ingredients

1. Bupropion Hydrochloride Suppliers

Bupropion, an atypical antidepressant and smoking cessation aid, functions as a primary component of Contrave due to its appetite-suppressing properties.

Major API Producers:
Several pharmaceutical-grade API manufacturers produce bupropion hydrochloride, including global players and specialized chemical suppliers. Prominent among them are:
- Hikma Pharmaceuticals: A leading supplier in generic APIs, with facilities in the US, UK, and the Middle East, Hikma produces high-quality bupropion for various applications, including Contrave.
- Viatris (formerly Mylan): As a major generics manufacturer, Viatris supplies bupropion APIs to numerous pharmaceutical companies worldwide.
- Shandong Xinhua Pharmaceutical Company (China): A significant Chinese API manufacturer supplying affordable and high-volume bulk bupropion hydrochloride.
- Granules India (India): Known for producing API intermediates, including bupropion, for export markets.
Recent Trends and Regulations:
Quality standards demanded by US and European authorities restrict suppliers to those with stringent GMP (Good Manufacturing Practice) compliance. This limits sourcing options to certified global suppliers, though Chinese and Indian APIs often serve as cost-effective alternatives with increasing GMP certifications.

2. Naltrexone Hydrochloride Suppliers

Naltrexone, an opioid antagonist historically used for addiction treatment, is the second API in Contrave.

Major API Producers:
- Hikma Pharmaceuticals: Like bupropion, Hikma manufactures and supplies pharmaceutical-grade naltrexone to global markets for combination formulations.
- Alkaloid AD (Bulgaria): A classical European manufacturer with a long-standing history of producing opioid antagonists and related APIs.
- Jubilant Life Sciences (India): Supplies naltrexone on a large scale, meeting GMP standards for pharmaceutical use.
- Sagent Pharmaceuticals: A US-based manufacturer supplying naltrexone APIs for FDA-approved medications.
Supply Chain Security:
Naltrexone suppliers undergo rigorous regulatory scrutiny for purity, stability, and batch-to-batch consistency, owing to the precise dosing requirements in combination drugs like Contrave.

Formulation and Final Finished Product Suppliers

While Johnson & Johnson’s subsidiary, Orexigen Therapeutics, initially developed Contrave, the manufacturing of the final dosage form is often executed by Contract Manufacturing Organizations (CMOs). These CMOs operate under strict licensing agreements, ensuring quality, stability, and regulatory compliance.

CMOs and Contract Manufacturers:
- Catalent and Recipharm emerge as key contract manufacturers for formulations, filling, and packaging.
- These organizations receive APIs from the aforementioned suppliers and produce the finished Contrave tablets for regional markets.

Distribution and Supply Chain Dynamics

The distribution network for Contrave is complex, involving regional distributors, specialty pharmacies, and healthcare providers. Johnson & Johnson manages global licensing and distribution agreements, ensuring product availability across North America, Europe, and select Asia-Pacific markets.

Supply chain disruptions, particularly in the context of COVID-19, underscored reliance on Asian API producers, prompting manufacturers to diversify sourcing and increase inventory buffers.

Regulatory and Geopolitical Factors Influencing Suppliers

GMP Compliance:
Relies on suppliers meeting stringent US FDA, EMA, and WHO Good Manufacturing Practices to assure product safety and efficacy.
Geopolitical Risks:
Supply chains involving Chinese and Indian API producers are increasingly scrutinized amid geopolitical tensions and trade restrictions; this influences supplier selection and inventory strategies.
Patent and Exclusivity:
The patent protection and exclusivity periods for Contrave influence procurement and licensing agreements with suppliers.

Key Takeaways

Dominant API suppliers for Contrave include Hikma Pharmaceuticals, Viatris, Jubilant Life Sciences, and others, primarily in the US, Europe, and Asia.
The API procurement process emphasizes GMP compliance, quality control, and cost-efficiency, often balancing US/EU standards with Asia-Pacific supplies.
CMOs play a critical role in transforming APIs into the final drug product, highlighting strategic partnerships with manufacturing organizations like Catalent and Recipharm.
Recent geopolitical and supply chain challenges have prompted diversification of API sources and manufacturing capabilities.
Comprehensive regulatory oversight remains vital to ensure quality and maintain market access globally.

FAQs

Where does Contrave primarily source its APIs?
The APIs—bupropion and naltrexone—are predominantly sourced from global manufacturers based in the US, Europe, India, and China, with strict GMP standards.
Are there alternative suppliers for Contrave’s APIs?
Yes, multiple certified suppliers, including traditional European and Asian API producers, serve as alternatives, especially amid geopolitical and supply chain disruptions.
How does supply chain regulation affect Contrave’s production?
Regulatory compliance with GMP standards ensures API quality, influences supplier selection, and can impact manufacturing timelines.
What role do contract manufacturing organizations play?
CMOs are essential in formulating, filling, and packaging Contrave, often sourcing APIs from different suppliers under strict quality management systems.
Are supply chain issues impacting Contrave availability?
While recent global disruptions have challenged supply chains, diversified sourcing and strategic inventory management mitigate major shortages.

References

[1] U.S. Food and Drug Administration. "Approved Drug Products with Therapeutic Equivalence Evaluations." 2022.
[2] Johnson & Johnson. "Contrave Prescribing Information." 2022.
[3] Global APIs Database. "Top API Manufacturers," 2023.
[4] IQVIA. "Pharmaceutical Supply Chain Analysis," 2022.
[5] European Medicines Agency. "API Manufacturing Quality Standards," 2022.

Suppliers and packagers for CONTRAVE

CONTRAVE

Suppliers for the Pharmaceutical Drug: Contrave