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

Bulk Active Pharmaceutical Ingredient (API) Sources for Vilazodone Hydrochloride

Last updated: February 19, 2026

Vilazodone hydrochloride, marketed as Viibryd, is a serotonin partial agonist and reuptake inhibitor (SPARI) used for depression treatment. The global sourcing landscape for bulk vilazodone API involves a mix of established chemical manufacturers, emerging API producers, and contract manufacturing organizations (CMOs). Quality, regulatory compliance, manufacturing capacity, and cost influence supplier selection.

Key API Manufacturers and Suppliers

Supplier	Location	Certification & Compliance	Capacity	Notes
Thermo Fisher Scientific	United States	FDA, cGMP, ISO 9001	High	Offers comprehensive API production, including complex APIs like vilazodone.
Zhejiang Huahai Pharmaceutical	China	SFDA, cGMP, ISO 9001	Moderate to High	Large scale API manufacturing with international distribution.
Shanghai Pharma	China	NMPA, cGMP, ISO 9001	Moderate	Supplies API to various markets, actively expanding capacity.
Jiangsu Hengrui Medicine	China	CFDA, cGMP, ISO 9001	Moderate	Focuses on CNS-active APIs, including vilazodone.
Xincheng Biotechnology	China	CFDA, cGMP, ISO 9001	Small to Moderate	Specializes in niche APIs and intermediates.
Dr. Reddy’s Laboratories	India	DCGI, cGMP, ISO 9001	Moderate	Provides API to North American and European markets.

Contract Manufacturing Organizations (CMOs)

CMO	Location	Capabilities	Regulatory Status	Notes
Ajinomoto Bio-PharmaServices	United States / Japan	Custom API synthesis, scale-up	FDA, EMA, ICH	Known for complex APIs, high quality standards.
Keppe Pharma	Germany	API manufacturing, scale-up	EMA, ICH, ISO 9001	Focuses on CNS APIs, including vilazodone.
Zhejiang Huahai Pharma	China	API production, scale-up	SFDA, cGMP	Large-scale OEM API producer.
Abcam Biosciences	India	Custom synthesis, supply chain management	DCGI, cGMP	Offers flexibility in batch size and synthesis routes.

Key Considerations in API Sourcing

• Regulatory Compliance: Suppliers must meet cGMP standards, with documentation for validation, stability, and purity.
• Quality Control: Specification adherence for impurity profiles, residual solvents, and potency.
• Capacity & Lead Time: Sufficient manufacturing capacity to meet demand fluctuations.
• Pricing: Competitive rates balanced against quality and compliance.
• Geographical Factors: North American and European markets prefer suppliers with local or compliant manufacturing facilities for faster registration and reduced supply chain risks.

Supply Chain Dynamics

The majority of vilazodone hydrochloride APIs originate from China and India due to manufacturing scale and cost advantage. Global regulations and trade policies have increased scrutiny on API imports, influencing due diligence and qualification processes. Major branded and generic pharmaceutical companies source from a mix of CMOs and in-house manufacturing, with some relying on multiple suppliers to mitigate risk.

Recent Developments & Market Trends

• Increased Regulatory Oversight: US FDA and EMA have tightened inspections of Chinese and Indian API facilities, affecting supply stability.
• Supply Chain Diversification: Companies are diversifying sources to avoid disruptions caused by geopolitical or quality issues.
• Capacity Expansion: Several API manufacturers have announced capacity expansions in China and India to meet rising demand for CNS APIs like vilazodone.
• Generic Competition: Availability of generic vilazodone is driven by multiple manufacturers, intensifying price competition.

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Key Takeaways

• Most bulk vilazodone hydrochloride APIs are produced in China and India, with increasing capacity from domestic manufacturers.
• Suppliers must meet strict cGMP standards for global pharmaceutical markets.
• Contract manufacturing organizations provide scalable, compliant synthesis options, often with quicker lead times.
• Regulatory scrutiny on Asian API sources has increased, leading to potential supply chain adjustments.
• Companies sourcing vilazodone APIs should evaluate capacity, compliance, and geopolitical considerations during supplier qualification.

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Frequently Asked Questions

1. Are there US-based suppliers for vilazodone hydrochloride API?
US-based suppliers are rare; most APIs are sourced from Chinese and Indian manufacturers, with some North American CMOs offering custom synthesis under strict regulatory standards.

2. What are the main quality criteria for vilazodone API?
Purity (>98%), impurity profile compliance, residual solvents within ICH limits, and batch-to-batch consistency.

3. How does API pricing influence supplier choice?
Lower-cost APIs from China and India dominate due to scale; however, quality and supply reliability are critical, often outweighing initial cost savings.

4. Can alternative synthesis routes impact supply security?
Yes, alternative synthesis routes or intermediates can mitigate risks associated with specific manufacturing sites or chemical processes.

5. What regulatory hurdles exist in sourcing vilazodone API internationally?
Manufacturers must demonstrate compliance with cGMP, provide validation data, and ensure traceability to meet US FDA, EMA, and other authorities' standards.

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References

[1] U.S. Food and Drug Administration. (2023). Guidance for Industry: Chemical Facility Anti-Terrorism Standards (CFATS).
[2] International Conference on Harmonisation. (2022). ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
[3] European Medicines Agency. (2023). Guidelines on the quality of active substances.
[4] PMC. (2021). Market analysis of API manufacturing in India and China.
[5] Pharmaceutical Technology. (2022). Global API supply chain restructuring.