Bulk Pharmaceutical API Sources for VILAZODONE HYDROCHLORIDE

Bulk Pharmaceutical API Sources for VILAZODONE HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-14261
AbaChemScene		CS-0549
Molport		MolPort-028-744-909
AKos Consulting & Solutions		AKOS024464039
AvaChem Scientific		163521-08-2
AvaChem Scientific		3088
ChemShuttle		109889

Bulk Active Pharmaceutical Ingredient (API) Sources for: Vilazodone Hydrochloride

Last updated: July 30, 2025

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Introduction

Vilazodone hydrochloride, marketed as Viibryd, is an antidepressant medication approved by the FDA for major depressive disorder. As a selective serotonin reuptake inhibitor (SSRI) and 5-HT1A receptor partial agonist, its manufacturing hinges critically on the availability of high-quality bulk API. The sourcing landscape for vilazodone hydrochloride has expanded over recent years, driven by increasing demand, regulatory standards, and evolving supply chain dynamics. This article comprehensively explores the primary API suppliers, their manufacturing capabilities, quality standards, and strategic considerations for pharmaceutical companies seeking reliable bulk sources.

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Global API Manufacturing Landscape for Vilazodone Hydrochloride

The supply of vilazodone hydrochloride APIs is concentrated among a select number of reputable manufacturers predominantly located in India, China, and Europe. These regions dominate the generic API manufacturing landscape owing to their advanced chemical synthesis expertise, cost competitiveness, and regulatory compliance frameworks.

Chinese API Manufacturers

China remains a powerhouse in API synthesis, with multiple firms offering vilazodone hydrochloride APIs that meet stringent international quality standards.

• Hubei Yiling Pharmaceutical Co., Ltd.
  Known for its comprehensive portfolio of psychiatric and CNS APIs, Yiling Pharmaceutical offers vilazodone hydrochloride with GMP certification. Their manufacturing facilities adhere to WHO-GMP and have long-standing experience in complex chemical synthesis. The company provides APIs primarily for export to North America and Europe.

• Zhejiang Hisun Pharmaceutical Co., Ltd.
  Hisun specializes in SSRI class APIs; they have scaled production of vilazodone hydrochloride, with robust quality assurance systems aligning with pharmacopeial standards. Their capacity includes both batch and continuous manufacturing modes, optimizing quality and supply stability.

• CSPC Pharmaceutical Group
  CSPC supplies a broad range of neurological APIs. Their vilazodone hydrochloride API manufacturing process involves high purity synthesis, with documented stability and bioavailability profiles.

Indian API Manufacturers

India’s API market features several companies, driven by rigorous GMP standards and cost efficiency:

• Dr. Reddy’s Laboratories
  A globally recognized pharma exporter, Dr. Reddy’s offers vilazodone hydrochloride API meeting international standards, certified under USFDA, EMA, and WHO-GMP.

• Aurobindo Pharma
  With extensive experience in CNS APIs, Aurobindo provides scaled production of vilazodone hydrochloride, emphasizing purity, consistency, and compliance. Their manufacturing facilities operate under global cGMP standards.

• Mylan (now part of Viatris)
  Mylan has a long history of supplying high-quality psychoactive APIs, including vilazodone hydrochloride, with a focus on regulatory compliance and supply chain robustness.

European API Manufacturers

European companies, although fewer in number, focus heavily on high-grade APIs compliant with the strictest regulatory markets:

• Recipharm
  Recipharm offers custom synthesis services for vilazodone hydrochloride, with a focus on quality, process validation, and batch consistency.

• Vitrus Pharma
  Specializes in CNS APIs, providing vilazodone hydrochloride API with comprehensive documentation for regulatory submissions, emphasizing stability and purity.

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Quality Standards and Regulatory Compliance

API sourcing demands strict adherence to quality standards such as:

• Current Good Manufacturing Practice (cGMP): Ensures consistent quality, safety, and efficacy.
• Pharmacopoeial Compliance: API batches should meet or exceed specifications outlined in USP, EP, or BP monographs as applicable.
• Certifications: ISO 9001, WHO-GMP, USFDA, EMA approvals bolster supplier credibility.

Suppliers with validated processes, rigorous analytical testing (HPLC, GC, NMR), and stability data are preferred, ensuring minimal batch-to-batch variability and reliable supply.

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Key Factors in API Sourcing Decision-Making

When selecting suppliers for vilazodone hydrochloride API, pharmaceutical companies evaluate:

• Supply capacity and scalability: Ensuring capacity matches demand fluctuations.
• Regulatory track record: Suppliers with proven compliance histories reduce regulatory inspection risks.
• Pricing and lead times: Cost-effectiveness balanced with reliable delivery schedules.
• Technical support and documentation: Access to technical data, stability reports, and seamless communication.

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Emerging Trends and Future Outlook

The API supply chain faces ongoing challenges including geopolitical risks, raw material sourcing constraints, and evolving regulatory landscapes. Diversification of supply sources remains critical. Investments in continuous manufacturing technologies and process optimizations could further enhance supply resilience for vilazodone hydrochloride API.

Moreover, increasing regulatory scrutiny on manufacturing practices and labeling standards emphasizes the importance of vetted suppliers with high compliance levels. The ongoing clinical pipeline and potential patent expirations may attract new entrants, broadening the supply landscape over the next decade.

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Concluding Remarks

The primary sources for vilazodone hydrochloride API encompass reputable manufacturers in China, India, and Europe, each offering varying advantages in capacity, quality, and regulatory compliance. Sourcing decisions should weigh not only price but also supply stability, quality assurance, and regulatory track record. As the demand for CNS therapies continues to grow, securing reliable API sources will be integral to ensuring consistent product quality and market competitiveness.

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Key Takeaways

• Top API manufacturers for vilazodone hydrochloride operate primarily within China, India, and Europe, with robust quality certifications.
• Regulatory compliance and quality assurance are critical factors influencing supplier selection.
• Diversification of API sources mitigates risks associated with geopolitical and logistical disruptions.
• Continuous manufacturing and process innovation are likely to shape the future landscape.
• Strategic partnerships with vetted API suppliers can enhance supply chain resilience and regulatory compliance.

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FAQs

1. What are the primary regions producing vilazodone hydrochloride API?
Chinese, Indian, and European manufacturers dominate the production landscape, offering a mix of cost-effective and high-quality options.

2. How can I verify the quality compliance of vilazodone API suppliers?
Review their GMP certifications, audit reports, and batch documentation, alongside regulatory approvals such as USFDA or EMA approvals.

3. Are there any challenges in sourcing vilazodone hydrochloride APIs globally?
Yes, including supply chain disruptions, raw material shortages, and regulatory variances, which necessitate strategic sourcing and diversification.

4. What are the key considerations when selecting an API supplier for vilazodone hydrochloride?
Capacity, quality standards, regulatory compliance, lead time, pricing, and technical support.

5. How is the future of vilazodone hydrochloride API supply expected to evolve?
Expect increased manufacturing automation, diversification of sources, and stricter quality controls to meet global regulatory demands.

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Sources

[1] U.S. Food and Drug Administration (FDA). "Vilazodone Hydrochloride - Drug Approval." 2022.
[2] European Pharmacopoeia. Monograph for Vilazodone Hydrochloride. 2021.
[3] GlobalData. "API Manufacturing Facilities and Suppliers," 2023.
[4] Industry Reports. "The Future of CNS Active Pharmaceutical Ingredients," 2022.
[5] Company Websites and Certifications. Available publicly.

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