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Last Updated: December 31, 2025

Suppliers and packagers for LUVOX


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LUVOX

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Ani Pharms LUVOX fluvoxamine maleate TABLET;ORAL 021519 NDA AUTHORIZED GENERIC A-S Medication Solutions 50090-5988-0 90 TABLET, COATED in 1 BOTTLE (50090-5988-0) 2011-08-09
Ani Pharms LUVOX fluvoxamine maleate TABLET;ORAL 021519 NDA AUTHORIZED GENERIC ANI Pharmaceuticals, Inc. 62559-158-01 100 TABLET, COATED in 1 BOTTLE (62559-158-01) 2011-08-09
Ani Pharms LUVOX fluvoxamine maleate TABLET;ORAL 021519 NDA AUTHORIZED GENERIC ANI Pharmaceuticals, Inc. 62559-159-01 100 TABLET, COATED in 1 BOTTLE (62559-159-01) 2011-08-09
Ani Pharms LUVOX fluvoxamine maleate TABLET;ORAL 021519 NDA AUTHORIZED GENERIC ANI Pharmaceuticals, Inc. 62559-160-01 100 TABLET, COATED in 1 BOTTLE (62559-160-01) 2011-08-09
Ani Pharms LUVOX fluvoxamine maleate TABLET;ORAL 021519 NDA AUTHORIZED GENERIC Bryant Ranch Prepack 63629-8018-1 30 TABLET, COATED in 1 BOTTLE (63629-8018-1) 2011-08-09
Ani Pharms LUVOX fluvoxamine maleate TABLET;ORAL 021519 NDA AUTHORIZED GENERIC Preferred Pharmaceuticals, Inc. 68788-7219-3 30 TABLET, COATED in 1 BOTTLE (68788-7219-3) 2018-07-27
Ani Pharms LUVOX fluvoxamine maleate TABLET;ORAL 021519 NDA AUTHORIZED GENERIC Preferred Pharmaceuticals, Inc. 68788-7219-6 60 TABLET, COATED in 1 BOTTLE (68788-7219-6) 2018-07-27
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug: Luvox

Last updated: July 30, 2025

Introduction

Luvox, the brand name for fluvoxamine, is an selective serotonin reuptake inhibitor (SSRI) primarily prescribed for obsessive-compulsive disorder (OCD) and other psychiatric conditions. Marketed initially by Laboratory Corporation of America (Lilly), generic formulations are now widely available through multiple suppliers. Ensuring a reliable supply chain for Luvox involves understanding the key manufacturers, generic producers, and distribution channels. This article elucidates the landscape of Luvox suppliers, including brand and generic manufacturers, geographic diversity, and supply chain considerations.

Overview of Luvox (Fluvoxamine)

Luvox is a synthetic compound marketed under multiple brand names globally. It was first approved in the late 1980s and is now available as a generic medication following patent expirations. The active pharmaceutical ingredient (API), fluvoxamine, is produced by several reputable chemical manufacturers, supporting the broader availability of generic formulations.

Key Brand Manufacturer

Eli Lilly and Company

  • Historical Context: Eli Lilly originally developed and marketed Luvox in the United States. Their formulation remains a significant supplier, especially in proprietary markets, although generic versions now predominate globally.
  • Market Presence: Lilly’s supply primarily serves regions where brand loyalty or specific formulations are preferred. However, in recent years, their market share has declined due to patent expiration and increased generic competition.

Major Generic Suppliers of Fluvoxamine

The global landscape for fluvoxamine suppliers is dominated by several generic pharmaceutical manufacturers, which produce both API and finished formulations. These suppliers are critical in meeting worldwide demand and ensuring drug affordability.

North American and European Manufacturers

  1. Sandoz (Novartis Division)

    • One of the largest generic pharmaceutical companies in the world.
    • API Production: Sandoz produces fluvoxamine API in compliance with stringent regulatory standards, including FDA and EMA approvals.
    • Formulations: Offers finished generic tablets, available via various distribution channels.
  2. Teva Pharmaceutical Industries Ltd.

    • Israeli-based multinational with extensive API manufacturing capacity.
    • Supplies fluvoxamine generics to North America and Europe.
    • Known for high-volume production and global distribution.
  3. MannKind Corporation

    • Focused on injectable formulations, but also involved in API supplies for psychiatric medications.
    • Supplies to both proprietary and generic markets, augmenting the global supply chain.
  4. Dr. Reddy’s Laboratories

    • Indian pharmaceutical giant with a significant presence in API manufacturing.
    • Supplies fluvoxamine API and finished dosage forms to multiple markets, including North America and India.

Asian and Indian Manufacturers

  1. Sun Pharma

    • One of India’s leading pharmaceutical companies, with API production facilities approved by US FDA.
    • Supplies fluvoxamine to global markets, especially in Asia and Africa.
  2. Cipla

    • Another prominent Indian API and finished dosage form supplier.
    • Provides affordable generics globally, including fluvoxamine.
  3. Lupin Pharmaceuticals

    • Indian-based API and finished product manufacturer.
    • Supplies to US and European markets.
  4. Torrent Pharmaceuticals

    • Supplies APIs and finished formulations, expanding availability in emerging markets.

Regional Distributors and Market-Specific Suppliers

To meet regional demands, numerous distributors and local generic manufacturers source fluvoxamine from primary suppliers, sometimes customizing formulations to regional regulatory standards. These regional suppliers often partner with global API producers to assemble supply chains capable of covering areas with high or emerging demand.

API Manufacturing and Regulatory Considerations

The quality and regulatory compliance of API are paramount. Suppliers producing fluvoxamine must adhere to Good Manufacturing Practices (GMP) and obtain necessary certifications (FDA, EMA, PMDA, etc). This compliance ensures the consistent quality of both APIs and finished drugs, which is vital for approved marketing and supply.

Supply Chain Challenges and Considerations

  • Patent Expirations: The patent on Luvox has expired, significantly increasing generic supply sources.
  • Regulatory Approvals: Some suppliers may face regulatory hurdles, limiting their market access.
  • Pricing Pressures: Market competition has driven prices down, but quality assurance remains critical for suppliers.
  • Supply Disruptions: Factors such as raw material shortages or geopolitical issues can impact API production and availability.

Emerging Trends and Future Outlook

The Luvox market is poised to expand with increased access in emerging markets. The proliferation of Indian and Chinese API producers further supports supply resilience. Additionally, new formulations or delivery mechanisms may influence future supplier engagement.

Conclusion

Luvox’s supply chain comprises a blend of original brand manufacturers, primarily Eli Lilly, and a broad array of generic API producers mainly based in India, China, and Europe. Well-established global players such as Sandoz, Teva, Sun Pharma, and Cipla dominate API production and finished drug supply, ensuring widespread availability. The market’s robustness hinges on regulatory compliance, quality control, and diversified manufacturing capabilities.

Key Takeaways

  • The primary supplier of Luvox in proprietary form is Eli Lilly; however, the global generic market is supplied predominantly by Indian, Chinese, and European manufacturers.
  • Key API producers include Sandoz, Teva, Sun Pharma, Cipla, and Lupin, all adhering to strict GMP standards.
  • Patent expirations have expanded the number of suppliers, leading to increased market competition and affordability.
  • Regional distributors customize supply chains based on regulatory standards and market demands.
  • Maintaining supply chain integrity requires vigilant oversight of regulatory compliance, raw material sourcing, and geopolitical factors.

FAQs

1. Who are the main API manufacturers producing fluvoxamine for Luvox?
Sandoz, Teva, Sun Pharma, Cipla, and Lupin are the leading API producers supplying fluvoxamine for generic Luvox formulations globally.

2. Is the quality of generic Luvox comparable to the brand-name drug?
Yes. Approved generics meet rigorous regulatory standards (FDA, EMA) ensuring bioequivalence and consistent quality.

3. Are there regional differences in Luvox suppliers?
Yes. U.S. and European markets predominantly source from FDA- and EMA-approved manufacturers, while Indian and Chinese firms supply emerging markets.

4. How has patent expiration affected Luvox supply?
Patent expiry has increased the number of available suppliers, enhancing supply security and reducing prices.

5. What factors could disrupt Luvox supply in the future?
Raw material shortages, regulatory changes, geopolitical risks, and manufacturing disruptions can impact supply stability.


Sources:

[1] Sandoz Pharmaceuticals Inc. – Global API supplier information.
[2] Teva Pharmaceutical Industries Ltd. – Product portfolio and GMP compliance.
[3] Indian Pharmaceutical Alliance – API manufacturing standards and regional suppliers.
[4] U.S. Food and Drug Administration (FDA) – API approval databases.
[5] European Medicines Agency (EMA) – Regulatory approvals for generic APIs.

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