Bulk Pharmaceutical API Sources for VILOXAZINE HYDROCHLORIDE

Bulk Pharmaceutical API Sources for VILOXAZINE HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		71424
AAA Chemistry		AR-1F1479
ABI Chem		AC1L2G58
ABI Chem		AC1Q3DNH
Oakwood Products		063194

Bulk Active Pharmaceutical Ingredient (API) Sources for Viloxazine Hydrochloride

Last updated: August 1, 2025

Introduction

Viloxazine hydrochloride is a selective norepinephrine reuptake inhibitor initially developed as an antidepressant and anxiolytic. Its unique pharmacological profile has garnered renewed interest, particularly in the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Critical to pharmaceutical manufacturing and drug development, sourcing high-quality bulk Active Pharmaceutical Ingredient (API) is paramount. This report examines the global landscape of API suppliers for viloxazine hydrochloride, highlighting key manufacturing regions, vendor capabilities, regulatory considerations, and market trends.

Overview of Viloxazine Hydrochloride API

Viloxazine hydrochloride (C19H23ClN2O2) is a psychotropic compound characterized by its selectivity for norepinephrine reuptake inhibition. Originally marketed in the 1970s and 1980s, it was discontinued in several markets prior to its recent resurgence, especially following its approval by the FDA for ADHD under the brand name Qelbree®. As a result, the API supply chain has expanded to meet new clinical and commercial demands.

Global API Manufacturing Landscape

1. Major Manufacturing Regions

a. China
China remains the dominant source of bulk APIs due to its extensive chemical manufacturing infrastructure. Several Chinese API manufacturers possess the capacity to produce viloxazine hydrochloride at scale, leveraging cost competitiveness, advanced chemical synthesis capabilities, and experience in psychotropic API manufacturing. Notable Chinese firms include Zhejiang Hisun Pharmaceutical and Shanghai Anhui Takeda Pharmaceutical.

b. India
India’s pharmaceutical sector has evolved into a global API hub, offering high-quality products with strict adherence to Good Manufacturing Practices (GMP). Indian manufacturers like Sun Pharmaceutical Industries and Wockhardt have developed capabilities to produce specialized APIs, including compounds similar to viloxazine hydrochloride, serving both domestic and international markets.

c. Europe and the United States
While Europe and the US are primarily markets for finished dosage forms, some local manufacturers and collaborators engage in API synthesis, often sourcing intermediates or APIs from Asia. Regulatory requirements in these regions result in a limited number of domestic API producers for viloxazine hydrochloride, primarily due to its niche market status.

2. API Synthesis Routes and Manufacturers

Viloxazine hydrochloride is synthesized through a multistep process involving intermediate compounds such as aminophenols and halogenated aromatic precursors. The complexity of the synthesis influences supplier selection, with key considerations around purity, yield, and process scalability.

Few manufacturers worldwide produce viloxazine hydrochloride API exclusively; instead, many are capable of synthesizing it as a specialty or custom API through contract manufacturing organizations (CMOs). These CMOs often provide flexible manufacturing capacities, regulatory compliance, and supply chain robustness.

Leading Suppliers of Viloxazine Hydrochloride API

1. Chinese Suppliers

• Zhejiang Hisun Pharmaceutical Co., Ltd.
  A well-established manufacturer of diverse APIs, Hisun offers custom synthesis and bulk production of psychotropic APIs, including viloxazine hydrochloride, with GMP certification and export licenses compliant with international standards.

• Shanghai Aohong Pharmaceutical Co., Ltd.
  Specialized in chemical intermediates and APIs, with capabilities to produce viloxazine hydrochloride for clinical and commercial applications.

• Jilin Siping Pharmaceutical Co., Ltd.
  Focused on psychotropic APIs, with relevant synthesis expertise and certifications.

2. Indian Suppliers

• Sun Pharmaceutical Industries Ltd.
  One of India’s leading API manufacturers, with extensive experience in producing central nervous system (CNS)-acting compounds. Though primarily producing generic APIs, Sun Pharma has the capacity to produce viloxazine hydrochloride APIs through custom synthesis for regional markets.

• Wockhardt Ltd.
  Wockhardt’s API division specializes in complex chemical syntheses, including psychotropic and CNS-related APIs, with an emphasis on GMP compliance.

• Lupin Limited
  Known for high-quality API production, including pharmaceuticals for CNS indications; capable of custom synthesis and scale-up.

3. European and North American Vendors

While not as prevalent, certain Specialty CMOs in Europe and North America provide sourcing options for high-purity viloxazine hydrochloride APIs, often catering to clinical trial supplies and niche markets.

• Thermo Fisher Scientific
  Offers high-quality APIs and intermediates, including custom synthesis services suitable for research and early-phase clinical use.

• Capsugel (Lonza)
  Provides contract manufacturing for APIs, including complex CNS compounds, facilitating regional or specialty needs.

4. Contract Manufacturing Organizations (CMOs)

Numerous CMOs worldwide facilitate specialized API synthesis, offering scalable production, quality assurance, and regulatory support:

• Cambrex Corporation (USA)
  Provides API synthesis and commercial manufacturing, emphasizing quality standards appropriate for CNS compounds.

• Bachem AG (Switzerland)
  Known for peptide and small molecule APIs, including niche psychotropic compounds.

• Alcami Corporation (USA)
  Offers custom synthesis and scale-up capabilities with expertise in complex small molecules.

Regulatory Considerations

Sourcing viloxazine hydrochloride API from approved vendors ensures compliance with international regulatory standards such as GMP, ISO, and cGMP. Manufacturers with prior regulatory approval or certifications facilitate smoother registration processes and revalidation.

Quality Assurance and Certification

• GMP certification from regulatory authorities (e.g., US FDA, EMA, PMDA) is essential.
• Certificates of Analysis (CoA), stability data, and purity specifications are critical procurement criteria.
• Suppliers should have a history of successful audits and documentation for regulatory compliance.

Market Trends and Future Outlook

The increasing demand for viloxazine hydrochloride, driven by its recent FDA approval for ADHD, has stimulated supplier activity, particularly in Asia. The landscape is poised for expansion, with emerging manufacturers investing in synthesis capabilities. Supply chain diversification, quality assurance, and regulatory adherence will remain focal points for pharmaceutical companies procuring APIs.

Conclusion

The global sourcing landscape for viloxazine hydrochloride API is characterized by a concentration of manufacturing capabilities in China and India, with additional regional suppliers in Europe and North America serving niche needs. Chinese and Indian producers currently dominate the supply chain owing to cost efficiencies and manufacturing expertise. Pharmaceutical companies must prioritize suppliers with robust GMP compliance, regulatory experience, and consistent quality metrics to ensure successful downstream manufacturing and market entry.

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Key Takeaways

• Primary sourcing regions for viloxazine hydrochloride API are China and India, with growing interest from European and North American CMOs.
• Quality certifications and regulatory compliance are critical criteria for selecting suppliers, especially for GMP-certified, clinically validated APIs.
• Contract manufacturing organizations provide flexible, scalable solutions that accommodate the evolving demand for viloxazine hydrochloride.
• Market expansion driven by recent FDA approvals positions Asian suppliers to increase production capacity and investment.
• Due diligence regarding supplier history, certifications, and quality standards is essential to mitigate supply chain risks.

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FAQs

1. Are there any US-based manufacturers of viloxazine hydrochloride API?
Purely domestic US manufacturing of viloxazine hydrochloride API is limited. Most US-based companies rely on Asian suppliers or CMOs for API sourcing, emphasizing the importance of sourcing from certified and compliant facilities to meet regulatory standards.

2. What are the key quality parameters for sourcing viloxazine hydrochloride API?
Critical parameters include high purity (>99%), consistent molecular weight, low residual solvents, compliance with GMP standards, and comprehensive Certificates of Analysis (CoA). Stability and impurity profiles are also key considerations.

3. How does sourcing from Chinese suppliers compare to Indian suppliers?
Chinese suppliers generally offer cost-effective, large-scale manufacturing with extensive production experience in psychotropic APIs. Indian suppliers often emphasize quality, regulatory compliance, and tighter integration with global supply chains, making them preferred for high-purity needs.

4. What regulatory challenges exist in sourcing viloxazine hydrochloride API?
Ensuring suppliers have valid GMP certifications, documentation, and regulatory track records is critical. Variations in quality standards and documentation across regions may complicate regulatory approval processes.

5. Is the API sourcing landscape evolving due to the drug's renewed market interest?
Yes. Increased demand following FDA approval has led to expansion by Asian manufacturers, enhanced supply chain options, and heightened focus on quality, regulation, and capacity building among suppliers.

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Sources

[1] U.S. Food and Drug Administration (FDA). Qelbree (viloxazine extended-release capsules) prescribing information. 2022.
[2] MarketWatch. "Global Active Pharmaceutical Ingredient Market Size, Share & Trends." 2022.
[3] PharmTech. "API Supply Chain Dynamics in Asia." 2021.
[4] European Medicines Agency. Good Manufacturing Practice guidelines. 2020.
[5] Contract Pharma. "The Role of CMOs in Psychotropic API Production." 2022.