Suppliers and packagers for generic pharmaceutical drug: DESVENLAFAXINE SUCCINATE

DESVENLAFAXINE SUCCINATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Actavis Labs Fl	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204065	ANDA	Actavis Pharma, Inc.	0591-3659-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0591-3659-30)	2017-03-01
Actavis Labs Fl	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204065	ANDA	Actavis Pharma, Inc.	0591-3660-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0591-3660-30)	2017-03-01
Actavis Labs Fl	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204065	ANDA	Actavis Pharma, Inc.	0591-4060-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0591-4060-30)	2017-03-01
Alembic	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204003	ANDA	Alembic Pharmaceuticals Limited	46708-540-10	100 TABLET, EXTENDED RELEASE in 1 CARTON (46708-540-10)	2017-03-01

Suppliers for the Pharmaceutical Drug: Desvenlafaxine Succinate

Last updated: July 30, 2025

Introduction

Desvenlafaxine succinate is an established serotonin-norepinephrine reuptake inhibitor (SNRI) prescribed primarily for Major Depressive Disorder (MDD). As a successor to venlafaxine, desvenlafaxine offers a targeted approach with an improved pharmacokinetic profile. Its global demand hinges on reliable suppliers who meet stringent quality standards, regulatory compliance, and manufacturing capacity. This article provides a comprehensive overview of key suppliers for desvenlafaxine succinate, including manufacturer profiles, sourcing trends, and market dynamics critical for stakeholders and decision-makers involved in procurement and pharmaceutical development.

Pharmaceutical Manufacturing Landscape of Desvenlafaxine Succinate

Desvenlafaxine succinate's synthesis involves complex organic processes, primarily utilizing proprietary chemical routes that require advanced manufacturing infrastructure. The active pharmaceutical ingredient (API) must adhere to strict regulations outlined by bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Consequently, suppliers must demonstrate robust quality controls, Good Manufacturing Practices (GMP) compliance, and consistent supply capabilities.

The primary regions producing desvenlafaxine succinate include India, China, and the United States, with each market showcasing significant manufacturing hubs. India’s pharmaceutical industry is a notable leader in generic active ingredients, offering cost-effective production, while China provides high-volume manufacturing with growing quality assurance measures. The US hosts pharmaceutical giants and contract manufacturing organizations (CMOs) catering to global clients.

Major Suppliers and Manufacturers of Desvenlafaxine Succinate

1. Dr. Reddy's Laboratories

Overview:
Dr. Reddy’s is an Indian multinational company with an extensive portfolio of generic APIs and formulations. It is recognized for its comprehensive R&D capabilities and robust manufacturing network compliant with global quality standards.
API Production:
Dr. Reddy’s supplies desvenlafaxine succinate to various international markets, aligning with FDA and EMA standards. Its manufacturing facilities in India have received pivotal certifications, facilitating global export and license agreements.

Market Position:
As a leading supplier, Dr. Reddy’s has secured several patents and licensing arrangements, making them a preferred partner for pharmaceutical firms seeking reliable API sourcing.

2. Mylan (Now part of Viatris)

Overview:
Viatris, formed after the merger of Mylan and Pfizer’s Upjohn division, is a global pharmaceutical leader with extensive API manufacturing capacity.
API Production:
Viatris produces desvenlafaxine succinate at facilities certified by GMP standards, ensuring adherence to international quality benchmarks. Its global footprint allows for scalable supply chains compatible with high-volume demands.

Market Position:
Viatris’s reputation in generating consistent, affordable APIs makes it a dominant player, especially in North America and Europe.

3. Aurobindo Pharma

Overview:
An Indian pharmaceutical major specializing in generics and APIs, Aurobindo maintains a diverse portfolio, including antidepressants.
API Production:
Aurobindo’s API manufacturing facilities, situated in India and outside, are certified by regulatory agencies, allowing it to serve both domestic and international markets with high-quality desvenlafaxine succinate.

Market Position:
Aurobindo’s strategic focus on cost-efficient production and expanding regulatory approvals bolster its position in the global API supply chain.

4. Zhejiang Huahai Pharmaceutical

Overview:
A prominent Chinese pharmaceutical company with a focus on APIs, Zhejiang Huahai has built a reputation on robust manufacturing practices.
API Production:
Huahai manufactures desvenlafaxine succinate, leveraging advanced synthetic routes and complying with global GMP standards for export. It is an essential supplier serving markets in Asia, Europe, and the Americas.

Market Position:
While facing regulatory scrutiny in certain markets, Zhejiang Huahai remains a key supplier due to its scale and cost competitiveness.

5. Contract Manufacturing Organizations (CMOs)

Several CMOs operate globally, offering custom manufacturing, scaling, and packaging services. Notable players include BASF, Patheon (a Thermo Fisher Scientific company), and Fresenius Kabi, providing high-quality APIs on a contract basis to pharmaceutical companies worldwide. These organizations offer flexibility and rapid scaling, crucial during supply disruptions or capacity expansion.

Emerging and Niche Suppliers

Given the high regulation and quality requirements, emerging suppliers often focus on niche markets or specific regulatory approvals. These include smaller Indian and Chinese manufacturers with rapidly developing GMP standards, aiming to expand their global footprint. Additionally, some suppliers specialize in advanced synthetic processes to improve yield and reduce costs, attracting interest from large pharmaceutical firms seeking alternative or secondary sources.

Supply Chain Factors Influencing Supplier Selection

Several factors influence procurement decisions regarding desvenlafaxine succinate suppliers:

• Regulatory Compliance: Suppliers must meet international standards (e.g., FDA, EMA, PMDA).
• Manufacturing Capacity: High-volume capacity with scalable ramp-up options.
• Quality Assurance: Consistent quality with rigorous testing and validation.
• Cost Competitiveness: Cost-effective production without compromising standards.
• Delivery Reliability: On-time delivery and supply chain resilience.
• Intellectual Property Rights: Assurance of licensing or non-IP-infringing production.

Market Dynamics and Trends

The global demand for desvenlafaxine succinate continues to grow driven by increasing prevalence of depression, expanding mental health awareness, and the shift towards generic medications. This trend fuels competition among suppliers, leading to price reductions and intensified investments in manufacturing efficiencies. Moreover, geopolitical factors and supply chain disruptions—such as those experienced during the COVID-19 pandemic—highlight the importance of diversified sourcing strategies and dual-sourcing arrangements.

Regulatory evolution, especially in China and India, with stricter GMP enforcement, aims to enhance global manufacturers’ reputation and compliance, thereby modifying supplier landscapes. The rise of Contract Manufacturing Organizations providing API synthesis as a service further diversifies the supply sources.

Conclusion

Supply of desvenlafaxine succinate hinges on a blend of well-established pharmaceutical manufacturers primarily based in India, China, and North America, along with flexible contract manufacturing services. Leading entities like Dr. Reddy's Laboratories, Viatris, and Aurobindo Pharma remain at the forefront, with emerging players expanding capacity and compliance standards. Strategic sourcing, compliance assurance, and supply chain resilience are paramount for pharma companies seeking reliable, cost-effective desvenlafaxine succinate supplies.

Key Takeaways

• Indian and Chinese manufacturers dominate the desvenlafaxine succinate supply landscape, driven by cost efficiencies and manufacturing capacity.
• Regulatory compliance with global standards (FDA, EMA) remains a decisive factor in supplier selection.
• Diversifying suppliers and leveraging contract manufacturing organizations enhance supply chain robustness.
• Evolving quality standards in emerging markets offer opportunities but necessitate rigorous validation.
• Strategic procurement must balance cost, quality, capacity, and compliance to ensure uninterrupted supply in a competitive global market.

FAQs

1. What are the key regulatory requirements for suppliers of desvenlafaxine succinate?
Suppliers must comply with GMP standards mandated by agencies like the FDA, EMA, and PMDA. Certification, rigorous testing protocols, traceability, and validation documents are essential for international acceptance.

2. Which countries are the leading producers of desvenlafaxine succinate?
India, China, and the United States are primary producers, with India and China leading in manufacturing capacity and cost advantages, while the US emphasizes high regulatory compliance.

3. How do supply chain disruptions impact desvenlafaxine succinate procurement?
Disruptions can cause shortages, price escalations, and quality concerns. Diversified sourcing and strategic inventory management are vital to mitigate risks.

4. Are there patented or proprietary elements related to desvenlafaxine succinate manufacturing?
The synthesis processes are protected under patents in some jurisdictions. However, many manufacturers produce generic versions under licensing agreements or through patent expirations, increasing supply competition.

5. What are the future prospects for desvenlafaxine succinate suppliers?
Growth driven by expanding mental health treatments, regulatory tightening, and the shift to generics will likely elevate supplier capacity, improve quality standards, and foster innovation in synthetic processes.

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Sources:
[1] IQVIA. Global API Market Analysis, 2022.
[2] Pharmeuropa. GMP Standards and Compliance for APIs, 2023.
[3] Indian Pharmaceutical Industry Report, 2022.
[4] Chinese Pharmaceutical Regulatory Overview, NMPA, 2022.
[5] MarketWatch. Trends in Antidepressant API Supplies, 2023.