Suppliers and packagers for generic pharmaceutical drug: VILAZODONE HYDROCHLORIDE

VILAZODONE HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567	NDA	Allergan, Inc.	0456-1110-30	30 TABLET in 1 BOTTLE (0456-1110-30)	2011-04-29
Abbvie	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567	NDA	Allergan, Inc.	0456-1120-30	30 TABLET in 1 BOTTLE (0456-1120-30)	2011-04-29
Abbvie	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567	NDA	Allergan, Inc.	0456-1140-30	30 TABLET in 1 BOTTLE (0456-1140-30)	2011-04-29

VILAZODONE HYDROCHLORIDE API AND KEY INTERMEDIATE SUPPLIERS

Last updated: February 19, 2026

This analysis identifies and profiles key suppliers of Vilazodone Hydrochloride active pharmaceutical ingredient (API) and critical intermediates. It details their manufacturing capabilities, regulatory standing, and geographical distribution.

VILAZODONE HYDROCHLORIDE API MANUFACTURING LANDSCAPE

The production of Vilazodone Hydrochloride API is concentrated among a limited number of manufacturers with established expertise in complex heterocyclic synthesis. These entities possess the necessary Good Manufacturing Practice (GMP) certifications and regulatory filings to supply the global pharmaceutical market.

KEY API SUPPLIERS

Supplier Name	Primary Location	Key Capabilities	Regulatory Approvals	Notes
Sun Pharmaceutical Industries Ltd.	India	Large-scale API synthesis, multiple GMP sites	US FDA, EMA	Established global supplier, extensive regulatory dossier.
Dr. Reddy's Laboratories Ltd.	India	Complex synthesis, high-purity API production	US FDA, EMA	Strong R&D pipeline, broad API portfolio.
Cipla Limited	India	Dedicated synthesis lines, cost-competitive manufacturing	US FDA, EMA	Significant market presence in generics.
Teva Pharmaceutical Industries Ltd.	Israel	Global manufacturing network, robust quality control	US FDA, EMA	Major generic pharmaceutical player.
Aurobindo Pharma Limited	India	Vertical integration, broad therapeutic area coverage	US FDA, EMA	Expanding API manufacturing capacity.

These suppliers operate under stringent quality management systems to ensure API consistency and compliance with pharmacopoeial standards. Their manufacturing processes are designed to control impurities and ensure batch-to-batch reproducibility.

CRITICAL INTERMEDIATE SUPPLY CHAIN DYNAMICS

The synthesis of Vilazodone Hydrochloride involves several key intermediates. Disruptions in the supply of these precursors can impact API production timelines and costs. Identifying reliable intermediate manufacturers is therefore critical.

PRIMARY INTERMEDIATES AND POTENTIAL SUPPLIERS

The synthesis of Vilazodone Hydrochloride typically involves the following key intermediates:

• 5-Cyanoindole: A foundational building block.
• 1-(4-Chlorophenyl)piperazine: A piperazine derivative.
• N-(4-Cyanobutyl)indole-5-carboxamide: A more advanced intermediate.

Identifying specific named suppliers for these intermediates requires detailed market intelligence due to the proprietary nature of some supply chains. However, manufacturers with expertise in indole chemistry and piperazine derivatives are typically involved. These often include:

• Fine chemical manufacturers in India and China: These regions are major hubs for custom synthesis and intermediate production. Companies such as Anachem Laboratories Pvt. Ltd. (India) and Hangzhou Think Chemical Co., Ltd. (China) are representative of the types of entities involved in custom synthesis of such intermediates.
• Specialty chemical divisions of larger pharmaceutical companies: Some integrated pharmaceutical companies may produce key intermediates in-house or through closely affiliated entities.

The sourcing of these intermediates is often characterized by contractual agreements with manufacturers who can demonstrate consistent quality, capacity, and adherence to GMP principles, even if the intermediate itself is not produced under full GMP.

REGULATORY CONSIDERATIONS AND COMPLIANCE

The supply of Vilazodone Hydrochloride API and its intermediates is governed by rigorous regulatory frameworks established by health authorities worldwide.

KEY REGULATORY REQUIREMENTS

• US Food and Drug Administration (FDA): Requires Drug Master Files (DMFs) for APIs. Manufacturers undergo regular facility inspections.
• European Medicines Agency (EMA): Requires Certificates of Suitability to the monographs of the European Pharmacopoeia (CEP) or equivalent documentation.
• Other National Regulatory Bodies: Each country has its own specific requirements for drug substance registration and importation.

Suppliers must maintain comprehensive quality systems that align with ICH Q7 guidelines for API manufacturing. Audits by pharmaceutical companies seeking to qualify suppliers are standard practice and cover process validation, analytical method validation, stability testing, and change control.

GEOGRAPHICAL DISTRIBUTION OF MANUFACTURING CAPABILITIES

The manufacturing base for Vilazodone Hydrochloride API and its key intermediates is geographically concentrated, with India playing a dominant role.

MAJOR MANUFACTURING HUBS

• India: This region hosts a significant number of API manufacturers with extensive experience in complex organic synthesis and a well-established regulatory track record. Its competitive cost structure further supports its prominence.
• China: While not as dominant in finished API manufacturing for regulated markets, China is a significant source for chemical intermediates due to its vast chemical industry.
• Europe and North America: While some high-value or specialized intermediates may be sourced from these regions, large-scale API production for generics is less common compared to India.

This geographical concentration necessitates robust supply chain risk management strategies, including dual sourcing and regular supplier audits.

MARKET TRENDS AND FUTURE PROSPECTS

The market for Vilazodone Hydrochloride is influenced by factors such as patent expiry, generic competition, and advancements in drug formulation.

DRIVING FACTORS

• Generic Entry: As patents for the branded product expire, demand for generic API from qualified manufacturers increases.
• Cost Pressures: Pharmaceutical companies continuously seek cost-effective API sourcing solutions.
• Supply Chain Resilience: Increased focus on supply chain security and diversification following global events.

Manufacturers are investing in expanding capacity and enhancing their regulatory profiles to capture market share in the growing generic Vilazodone Hydrochloride sector.

KEY TAKEAWAYS

• Vilazodone Hydrochloride API manufacturing is dominated by a select group of Indian pharmaceutical companies with strong US FDA and EMA regulatory approvals.
• Key intermediates like 5-cyanoindole and 1-(4-chlorophenyl)piperazine are primarily sourced from custom synthesis providers in India and China.
• Regulatory compliance, including DMF filings and adherence to ICH Q7, is paramount for API suppliers.
• Geographical concentration, particularly in India, necessitates robust supply chain risk management.
• The generic market expansion is the primary driver of demand for Vilazodone Hydrochloride API.

FREQUENTLY ASKED QUESTIONS

What are the primary regulatory hurdles for Vilazodone Hydrochloride API suppliers?

Suppliers must obtain and maintain US FDA Drug Master Files (DMFs) and Certificates of Suitability (CEPs) from the EMA, alongside compliance with ICH Q7 guidelines for API manufacturing and successful site inspections.

How does the sourcing of key intermediates differ from API sourcing?

Intermediate sourcing typically involves custom synthesis providers who may not require full GMP compliance unless specifically stipulated by the API manufacturer. The focus is on consistent chemical purity, reliable capacity, and adherence to agreed-upon quality specifications.

What is the typical lead time for securing a new API supplier for Vilazodone Hydrochloride?

Qualifying a new API supplier typically involves extensive due diligence, including site audits, quality agreement finalization, and batch comparability studies, which can range from six months to over a year.

How do price fluctuations in raw materials affect Vilazodone Hydrochloride API costs?

Prices of key starting materials and reagents, particularly those derived from petrochemicals, can significantly impact the cost of goods sold for Vilazodone Hydrochloride API. Manufacturers often employ hedging strategies or long-term supply contracts to mitigate this volatility.

What are the implications of environmental regulations on API manufacturing locations?

Increasingly stringent environmental regulations, particularly in India and China, can lead to higher operational costs for API manufacturers due to investments in waste treatment and emission control technologies. This can influence pricing and supply chain decisions.

CITATIONS

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from https://www.fda.gov/drugs/guidance-compliance-regulatory-information/drug-master-files [2] European Medicines Agency. (n.d.). Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP). Retrieved from https://www.ema.europa.eu/en/pharmaceuticals/scientific-advice-scientific-guidelines/certificate-suitability-monographs-european-pharmacopoeia-cep [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (1998). ICH Harmonised Tripartite Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (ICH Q7). Retrieved from https://www.ema.europa.eu/en/documents/scientific-guideline/ich-harmonised-tripartite-guideline-good-manufacturing-practice-guide-active-pharmaceutical-ingredients-q7_en.pdf