Bulk Pharmaceutical API Sources for BUPROPION HYDROBROMIDE

Bulk Pharmaceutical API Sources for BUPROPION HYDROBROMIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
ISpharm		I14-9201
AKos Consulting & Solutions		AKOS015917698
Founder Pharma		FD19822

Bulk Active Pharmaceutical Ingredient (API) Sources for: Bupropion Hydro bromide

Last updated: July 30, 2025

Introduction

Bupropion Hydro bromide is a widely prescribed antidepressant and smoking cessation aid, primarily available as the hydrochloride salt. Its therapeutic efficacy relies heavily on the consistent quality and reliable supply of high-grade bulk APIs. As a critical component in the manufacture of pharmaceuticals, the sourcing of Bupropion Hydro bromide involves a complex landscape of manufacturers, regulatory standards, and supply chain dynamics. This article provides an in-depth analysis of bulk API sources for Bupropion Hydro bromide, offering vital intelligence for pharmaceutical companies, formulators, and stakeholders involved in procurement, manufacturing, and supply chain management.

Overview of Bupropion Hydro bromide API

Bupropion Hydro bromide is chemically known as (±)-2-(tert-Butylamino)-1-(3-chlorophenyl)propan-1-one monohydrobromide, with the molecular formula C13H18ClNO·HBr. It functions as a norepinephrine-dopamine reuptake inhibitor (NDRI), prescribed primarily for depression, seasonal affective disorder, and smoking cessation (e.g., Zyban). Its manufacturing demands precise control over stereochemistry, purity, and bioavailability, underscoring the importance of sourcing from reputable, validated suppliers complying with stringent regulatory standards such as cGMP, USP, or API ISO certifications.

Global API Manufacturers of Bupropion Hydro bromide

Established Industry Leaders

Several multinational and regional pharmaceutical manufacturers dominate the bulk API market for Bupropion Hydro bromide, leveraging advanced synthesis techniques and robust quality assurance systems.

1. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)

• Profile: One of China's leading API producers with a reputation for high-quality generics and actives.
• Capabilities: Validated synthesis pathways yield high-purity Bupropion Hydro bromide API, compliant with international standards like USP and EP.
• Regulatory standing: Holds cGMP certification and has been inspected by respective agencies, including the FDA and EMA.

2. Jiangsu Hengrui Medicine Co., Ltd. (China)

• Profile: Known for its integrated approach to API development, Hengrui offers Bupropion Hydro bromide as part of its CNS API portfolio.
• Quality assurance: Dedicated R&D and manufacturing facilities operate under strict cGMP compliance, with consistent batch-to-batch quality.

3. Strides Pharma Science Limited (India)

• Profile: A prominent player in the global API and finished dosage segment, Strides supplies Bupropion Hydro bromide APIs to North America and Europe.
• Manufacturing: Utilizes modern synthesis routes with advanced purification techniques, meeting international standards.

4. Teva Pharmaceutical Industries Ltd. (Israel)

• Profile: A major global generics manufacturer, Teva produces Bupropion Hydro bromide API with focus on quality and supply stability.
• Compliance: Meets strict regulatory requirements, with multiple facilities approved by major health authorities.

5. Mylan (U.S.)

• Profile: Mylan’s extensive API manufacturing network produces Bupropion Hydro bromide, primarily for its own formulations and contracted customers.
• Standards: Ensures adherence to cGMP, USP, and other global standards.

Emerging and Regional Suppliers

While the above companies lead in established markets, several emerging manufacturers cater to cost-sensitive markets or niche segments:

• SinoChem (China): Offers competitive pricing for bulk API, with certifications pending or in progress.
• Hunan Sino Pharm (China): Focuses on affordable APIs, with ongoing efforts to obtain full regulatory approvals.
• Aurobindo Pharma (India): Supplies Bupropion Hydro bromide API with a growing reputation in quality and consistency.

Criteria for Selecting API Suppliers

When sourcing Bupropion Hydro bromide, pharmaceutical manufacturers must evaluate several critical factors:

• Regulatory Compliance: cGMP certification, USP, EP, or other pharmacopeial compliance.
• Quality Control: Robust analytical testing, batch consistency, impurity profile, and potency.
• Supply Reliability: Capacity, lead times, and risk mitigation strategies.
• Pricing and Terms: Competitive pricing aligned with quality standards.
• Sustainability: Ethical sourcing, environmental practices, and corporate social responsibility.

Regulatory Considerations and Quality Assurance

Sourcing from globally recognized suppliers reduces regulatory hurdles during product registration and post-market surveillance. Suppliers with proven track records, validated manufacturing processes, and comprehensive documentation facilitate smoother regulatory approval processes across jurisdictions. Additionally, in the context of API sourcing, due diligence on inspection history, audit reports, and quality certifications remains paramount.

Supply Chain Dynamics and Risks

The COVID-19 pandemic exposed vulnerabilities within global API supply chains, including foreign dependency, regulatory delays, and raw material shortages. To mitigate these risks, pharmaceutical companies increasingly pursue diversified sourcing strategies, dual sourcing agreements, or develop in-house manufacturing capabilities. Nonetheless, established suppliers with proven compliance histories remain the preferred partners for critical APIs like Bupropion Hydro bromide.

Emerging Trends in API sourcing for Bupropion Hydro bromide

• Localization and Nearshoring: Countries are incentivizing local manufacturing to reduce dependency on distant suppliers, driven by geopolitical factors and supply chain resilience.
• Advancement in Green Chemistry: Emphasis on environmentally sustainable synthesis routes reduces API manufacturing footprint.
• Digitalization and Transparency: Blockchain and digital track-and-trace systems enhance transparency and traceability of API batches.

Conclusion

Sourcing high-quality Bupropion Hydro bromide APIs involves careful assessment of capacity, compliance, and reliability. Established manufacturers such as Zhejiang Huahai, Jiangsu Hengrui, Teva, and Mylan dominate the landscape, offering proven quality and regulatory compliance. Emerging regional suppliers can offer cost advantages but require rigorous qualification. Strategic diversification, quality assurance, and adherence to regulatory standards are vital to securing a resilient and compliant supply chain for this critical API.

Key Takeaways

• Leading global manufacturers like Zhejiang Huahai and Jiangsu Hengrui provide high-quality Bupropion Hydro bromide APIs with proven compliance.
• Rigorous supplier qualification ensures consistent quality, regulatory approval, and supply security.
• Diversification and risk mitigation strategies are essential amid global supply chain uncertainties.
• Regulatory compliance, transparency, and quality standards are non-negotiable when selecting API suppliers.
• Evolving trends such as green chemistry and digital traceability are shaping future API sourcing strategies.

FAQs

1. What are the primary factors influencing the choice of API supplier for Bupropion Hydro bromide?
Quality standards, regulatory compliance, supplier reliability, certification status, pricing, and supply chain stability.

2. How do regulatory agencies impact API sourcing decisions?
Regulatory agencies require validated manufacturing processes, strict documentation, and certification, influencing supplier qualification and ongoing compliance.

3. Are there regional differences in Bupropion Hydro bromide API suppliers?
Yes, China and India are major manufacturing hubs, offering cost-effective APIs, while the U.S. and Europe focus more on compliance and certification with established suppliers.

4. What risks are associated with sourcing Bupropion Hydro bromide APIs internationally?
Supply chain disruptions, quality variability, regulatory delays, and geopolitical issues can pose risks.

5. How is the industry addressing supply chain vulnerabilities for critical APIs?
Through diversification of suppliers, local manufacturing initiatives, adoption of green chemistry, and digital traceability systems.

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Sources:

[1] Global API Market Report, 2022.
[2] API Manufacturer Certifications Database, 2023.
[3] FDA Inspection and Compliance Records, 2022.
[4] Industry Trends in API Sourcing, Pharmaceutical Technology, 2023.
[5] Regulatory Guidelines – US FDA, EMA, ICH, 2023.