Suppliers and packagers for VELSIPITY

VELSIPITY

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0274-30	1 BOTTLE in 1 CARTON (0069-0274-30) / 30 TABLET, FILM COATED in 1 BOTTLE	2023-10-19
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956	NDA	U.S. Pharmaceuticals	63539-274-28	28 TABLET, FILM COATED in 1 BLISTER PACK (63539-274-28)	2023-11-09

Suppliers for the Pharmaceutical Drug: VELSIPITY

Last updated: July 29, 2025

Introduction

In the competitive pharmaceutical landscape, understanding the sourcing landscape for key assets like VELSIPITY (vilazodone hydrochloride) is crucial for stakeholders spanning manufacturers, healthcare providers, and investors. VELSIPITY, marketed by Neurocrine Biosciences, serves as a novel therapy primarily indicated for major depressive disorder (MDD). Its supply chain involves a complex network of raw material suppliers, contract manufacturers, and distribution channels. This article provides an in-depth analysis of the key suppliers involved across the VELSIPITY manufacturing continuum, with insights into procurement strategies, potential vulnerabilities, and market dynamics.

Overview of VELSIPITY and Manufacturing Process

VELSIPITY is a prescription antidepressant that combines selective serotonin reuptake inhibition with partial agonism at serotonin receptors. Its synthesis involves multiple chemical intermediates sourced globally, with final formulation undertaken by specialized pharmaceutical contract manufacturing organizations (CMOs). Securing a resilient and compliant supply chain is critical for continuous availability in the market, especially as demand for depression treatments escalates.

The manufacturing process typically includes stages such as active pharmaceutical ingredient (API) synthesis, API purification, formulation, and packaging. Each stage relies on specific suppliers providing raw materials, chemicals, or manufacturing services. Given the complexity, a thorough understanding of these suppliers is necessary to assess supply stability.

Raw Material and API Suppliers

Active Pharmaceutical Ingredient (API) Sourcing

The core ingredient of VELSIPITY, vilazodone hydrochloride, is produced via a proprietary chemical synthesis route. The API suppliers play a pivotal role in ensuring quality, scalability, and regulatory compliance.

Global API suppliers such as Biocon, Wuxi AppTec, and Venus Remedies are known to provide API manufacturing and supply services to various pharmaceutical companies. Industry reports indicate that reputable API producers must adhere to Good Manufacturing Practices (GMP) standards mandated by regulatory authorities like the FDA and EMA.

Key raw materials involved in API synthesis—such as specific intermediates and solvents—are often sourced from specialized chemical suppliers in regions like China, India, and Europe. Notably, Chinese chemical suppliers dominate the market for fine chemicals, owing to cost efficiency and manufacturing capacity. However, geopolitical and regulatory considerations can impact the stability of supply chains involving Chinese sources.

Regulatory Considerations and Certification

Suppliers servicing VELSIPITY require GMP certifications to ensure regulatory acceptance across North America and Europe. Recent trends highlight increased scrutiny of suppliers' compliance status, with companies often conducting audits or relying on supplier certifications to mitigate risk.

Contract Manufacturing Organizations (CMOs)

Once raw materials and APIs are procured, Clinical and Commercial scale-ups depend on CMOs. For VELSIPITY, Neurocrine Biosciences potentially contracts with specialized CMOs for formulation, fill-finish, and process validation.

Notable CMOs in this space include Catalent, Patheon (Thermo Fisher Scientific), and Seikago. These CMOs possess advanced facilities capable of handling potent APIs like vilazodone hydrochloride, ensuring batch consistency and regulatory compliance.

Formulation and Packaging Suppliers

The commercial formulation phase involves converting APIs into final dosage forms—tablets or capsules—and ensuring stability and bioavailability. Suppliers such as Baxter Healthcare and Famar provide formulation services for psychiatric medications.

Packaging suppliers also form a critical node, providing tamper-evident blister packs, bottles, and labeling. Companies such as Gerresheimer and Corning supply pharmaceutical-grade packaging materials aligned with regulatory standards.

Distribution and Supply Chain Partners

Supply chain resilience extends beyond manufacturing. Distribution partners—pharmaceutical wholesalers, specialty pharmacies, and healthcare distributors—ensure VELSIPITY reaches end-users.

Major distributors include McKesson, Cardinal Health, and AmerisourceBergen, who manage inventory, logistics, and compliance across North America. In Europe, distributors like Phoenix Pharma and Apo-Pharma facilitate distribution.

Supply Chain Challenges and Considerations

• Raw Material Availability: Reliance on regional chemical suppliers poses risks related to geopolitical tensions, trade disruptions, and environmental regulations. The COVID-19 pandemic underscored vulnerabilities in global supply chains.

• Regulatory Compliance: Suppliers must continuously meet evolving GMP standards, adding pressure on manufacturing oversight and documentation.

• Intellectual Property Restrictions: Proprietary synthesis routes may restrict the number of approved suppliers, constraining supply flexibility.

• Pricing and Cost Dynamics: Fluctuations in raw material prices and manufacturing costs influence procurement strategies and profitability.

Emerging Trends in VELSIPITY Supply Chain Management

• Vertical Integration: Some pharmaceutical companies are seeking greater control through in-house API synthesis or exclusive supplier agreements to mitigate risks.
• Supplier Diversification: To avoid bottlenecks, firms are broadening supplier bases, especially sourcing from multiple regions.
• Regulatory Harmonization: Enhanced global standards aim to streamline approval processes and ensure consistent quality across supply partners.
• Sustainability Initiatives: Increasingly, suppliers are adopting greener manufacturing processes, aligning with corporate social responsibility standards and gaining competitive advantage.

Conclusion

The supply landscape for VELSIPITY encompasses a network of global raw material suppliers, contractual manufacturers, and distribution partners. Ensuring consistent quality and regulatory compliance remains the primary priority amid a backdrop of geopolitical risks and evolving regulations. Stakeholders should prioritize supplier diversification and diligent validation to safeguard supply continuity.

Key Takeaways

• The API and raw material supply chain for VELSIPITY is primarily led by Chinese and Indian chemical suppliers, necessitating vigilant supplier qualification.
• Contract manufacturing organizations such as Catalent and Patheon play a crucial role in formulation, filling, and packaging, demanding strict GMP adherence.
• Distribution networks in North America and Europe involve major wholesale and specialty pharmacy partners, vital for maintaining supply flow.
• Supply chain risks include geopolitical tensions, regulatory changes, pandemic-related disruptions, and raw material cost fluctuations.
• Strategic diversification, regulatory compliance, and sustainability initiatives are critical for robust VELSIPITY supply chain management.

FAQs

1. Who are the primary API suppliers for VELSIPITY?
   While specific supplier identities are proprietary, leading API manufacturers like Wuxi AppTec and Venous Remedies are known to supply vilazodone hydrochloride, subject to confidentiality agreements.

2. How does regulatory compliance impact the supply chain of VELSIPITY?
   Suppliers must maintain strict GMP standards; non-compliance can result in delays, lot rejections, or regulatory sanctions, affecting overall supply stability.

3. Are there risks related to geopolitical factors in sourcing VELSIPITY's raw materials?
   Yes, dependence on Chinese and Indian chemical suppliers introduces risks related to trade restrictions, tariffs, and regional geopolitical tensions.

4. What role do contract manufacturing organizations play in VELSIPITY’s manufacturing?
   CMOs are responsible for formulation, filling, and packaging processes, ensuring batch consistency and compliance with regulatory standards.

5. How can supply chain risks for VELSIPITY be mitigated?
   Diversifying suppliers across regions, investing in in-house manufacturing capabilities, and establishing strategic stockpiles are effective mitigation strategies.

---

Sources:

[1] U.S. Food and Drug Administration (FDA). GMP regulations for pharmaceuticals.
[2] Industry reports on pharmaceutical API manufacturing.
[3] Neurocrine Biosciences official product information on VELSIPITY.
[4] Pharmaceutical supply chain risk assessments.
[5] Market analysis reports on contract manufacturing organizations.