Suppliers and packagers for WELLBUTRIN SR

WELLBUTRIN SR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358	NDA	GlaxoSmithKline LLC	0173-0135-55	60 TABLET, FILM COATED in 1 BOTTLE (0173-0135-55)	1996-11-15
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358	NDA	GlaxoSmithKline LLC	0173-0722-00	60 TABLET, FILM COATED in 1 BOTTLE (0173-0722-00)	2002-06-25
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358	NDA	GlaxoSmithKline LLC	0173-0947-55	60 TABLET, FILM COATED in 1 BOTTLE (0173-0947-55)	1996-11-15

Last updated: August 13, 2025

ppliers for the Pharmaceutical Drug: WELLBUTRIN SR

Introduction
WELLBUTRIN SR (bupropion sustained-release) is a widely prescribed antidepressant and smoking cessation aid developed and marketed by GlaxoSmithKline (GSK). With its broad application in treating major depressive disorder and aiding in smoking cessation, WELLBUTRIN SR commands significant demand globally. The supply chain for this medication involves multiple manufacturers, generic drug makers, and authorized distributors, all critical to ensuring consistent availability, regulatory compliance, and market competitiveness. This report provides an in-depth analysis of the primary suppliers for WELLBUTRIN SR, their roles, manufacturing capacities, and strategic considerations influencing the supply landscape.

Manufacturers of Active Pharmaceutical Ingredient (API)

Global API Production and Key Suppliers

The foundation of WELLBUTRIN SR’s supply chain lies in the production of its active pharmaceutical ingredient (API), bupropion hydrochloride. The API’s quality, purity, and availability directly affect drug manufacturing, regulatory approval, and market supply. Several global pharmaceutical entities and API manufacturers are involved in producing bupropion hydrochloride, either through proprietary synthesis or licensed agreements.

Major API Suppliers:

• Mitsubishi Tanabe Pharma Corporation: Mitsubishi Tanabe manufactures bupropion hydrochloride API primarily for their internal portfolio and licensed partners. The Japanese company emphasizes high-quality API production aligned with cGMP standards, serving as a reliable supplier for the Asia-Pacific region.

• Mitsubishi Chemical Corporation: As part of its broad pharmaceutical manufacturing operations, Mitsubishi Chemical has capacity for synthesizing bupropion hydrochloride, supporting both domestic and international OEMs and generic companies.

• Hubei Biocause Pharmaceutical Co., Ltd.: Based in China, this manufacturer supplies API to both domestic generic producers and international clients, leveraging cost advantages and growing export capacity. However, regulatory compliance and documentation standards vary, demanding rigorous quality assurance checks for Western markets.

• PX Pharmaceuticals (India): A significant API producer in India, PX Pharmaceuticals supplies bupropion hydrochloride to domestic generic drug manufacturers and exports. Indian API producers benefit from cost efficiency, but must navigate regulatory scrutiny from health authorities such as the US FDA and EMA.

Implications of API Supply Landscape:
The API market for bupropion hydrochloride features a mixture of high-quality, validated manufacturers primarily from Japan, India, and China. The oversupply or disruption at this level can impact the availability and pricing of WELLBUTRIN SR, especially given international regulatory barriers and import tariffs.

Manufacturing of the Finished Formulation

Brand and Generic Manufacturers
The original patent-held formulation of WELLBUTRIN SR was developed and marketed by GSK. Following patent expiry and patent challenges, numerous generic producers have entered the market, creating a diverse supplier ecosystem.

• GSK: As the originator, GSK remains involved through authorized generic agreements and direct sales. The company maintains control over certain supply aspects, especially for branded formulations and authorized generics.

• Teva Pharmaceutical Industries: One of the largest generic drug manufacturers globally, Teva produces WELLBUTRIN SR under license or through development of bioequivalent formulations. Its extensive manufacturing network enables high-volume production and distribution across North America and Europe.

• Mylan (now part of Viatris): Mylan historically supplied generic WELLBUTRIN SR, leveraging a strong manufacturing pipeline and global distribution channels. Mylan’s capacity for rapid scale-up supports supply continuity during market fluctuations.

• Lupin Limited: An Indian pharmaceutical major, Lupin manufactures both API and finished dosage forms, including WELLBUTRIN SR, primarily for the Asian and emerging markets. Its production facilities are certified per international standards, allowing entry into regulated markets.

• Sun Pharmaceuticals: Sun produces generic formulations of WELLBUTRIN SR, serving both domestic and export markets, with a focus on cost competitiveness and compliance with regional regulatory agencies.

Contract Manufacturing Organizations (CMOs):
Several pharmaceutical CMOs serve as external manufacturers for generic companies, increasing flexibility and capacity. Examples include Catalent, FDA-licensed Indian CMOs, and Xcelience. Their role is critical during supply shortages or spikes in demand, especially amidst regulatory compliance needs.

Supply Chain Risks and Opportunities
Manufacturing disparities, regulatory hurdles, and geopolitical factors pose risks. For example, recent scrutiny on API imports from China and India has caused temporary supply disruptions. Strategic collaborations, diversifying API sources, and increasing manufacturing investments are measures taken by firms to mitigate such risks.

Regulatory and Market Considerations

Regulatory Environment

The suppliers of WELLBUTRIN SR operate within strict regulatory frameworks established by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national agencies. API manufacturers must obtain necessary approvals, often validated through cGMP certification and reactive audits.

Market Dynamics

Pricing pressures in the generics sector, patent litigations, and the rise of biosimilars influence suppliers’ strategies. Large suppliers leverage economies of scale to compete on cost while ensuring compliance, quality, and timely delivery. The entrance of new API producers in emerging markets also offers opportunities for price competition but raises concerns about quality assurance.

Commercial and Strategic Considerations

Vertical Integration

Leading manufacturers often adopt vertical integration—controlling API production, formulation, and distribution—to streamline supply chains, ensure quality, and mitigate disruptions.

Partnerships and Licensing

Strategic licensing agreements between originator companies (GSK) and generic manufacturers facilitate market access. Some generics producers secure rights for branded versions, while others focus solely on bioequivalent formulations.

Global Supply Chain Challenges

Geopolitical tensions, shipping disruptions, and supply chain regulations (such as tariffs and export controls) are critical factors influencing supplier reliability. COVID-19 underscored vulnerabilities, prompting increased inventory holdings and diversification strategies.

Conclusion
The WELLBUTRIN SR supply chain is driven by a complex network of API suppliers, generic manufacturers, and CMOs across Asia, North America, and Europe. Ensuring a resilient, high-quality, and compliant supply chain requires continuous strategic oversight, diversification of sources, and adherence to evolving regulatory standards.

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Key Takeaways

• API production for bupropion hydrochloride involves key players from Japan, India, and China, with quality and regulatory compliance central to market stability.
• Several multinational and regional generic manufacturers, including Teva, Mylan (Viatris), Lupin, and Sun Pharma, dominate the finished product manufacturing landscape.
• Supply chain disruptions are mitigated through diversification, strategic partnerships, and investment in manufacturing capacity.
• Regulatory compliance remains a defining factor for all suppliers, especially amid increasing scrutiny on API sourcing and manufacturing practices.
• Market competitiveness pushes suppliers toward vertical integration and geopolitical diversification to safeguard supply continuity.

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FAQs

1. Who are the primary API suppliers for WELLBUTRIN SR?
Key API suppliers include Mitsubishi Tanabe Pharma (Japan), Mitsubishi Chemical (Japan), Hubei Biocause Pharmaceutical (China), PX Pharmaceuticals (India), and other regional manufacturers.

2. Are generic formulations of WELLBUTRIN SR produced by the same suppliers as the original?
Not necessarily. While some generic manufacturers license the API from the original developers, many produce the API independently, using multiple sources, and formulate their own versions of WELLBUTRIN SR.

3. How does API source quality impact drug supply?
High-quality, cGMP-certified API is critical for regulatory approval and consistent drug efficacy. Supply disruptions or quality issues at the API level directly influence finished drug manufacture and market availability.

4. What risks do geopolitical factors pose to WELLBUTRIN SR supply?
Trade tensions, export restrictions, and shipping delays can disrupt API and finished formulation supply chains, requiring companies to adopt diversification strategies.

5. How are manufacturers ensuring supply stability for WELLBUTRIN SR?
Through capacity expansion, supplier diversification, strategic alliances, and maintaining compliance with international quality standards, manufacturers aim to sustain continuous supply amidst global uncertainties.

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Sources:

[1] U.S. Food and Drug Administration (FDA). API Registration and Manufacturing Standards.
[2] European Medicines Agency (EMA). Guidelines on API manufacturing and supply.
[3] IQVIA Institute. Global API and Finished Product Market Analysis (2022).
[4] Manufacturer websites and public disclosures.
[5] Industry reports on pharmaceutical supply chain resilience and API sourcing.