Suppliers and packagers for luvox

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

Luvox (Fluvoxamine Maleate) Drug Supply Chain Analysis

Last updated: February 19, 2026

Fluvoxamine maleate, marketed under the brand name Luvox, is a selective serotonin reuptake inhibitor (SSRI) used to treat obsessive-compulsive disorder (OCD) and social anxiety disorder. The drug's active pharmaceutical ingredient (API) is manufactured by several global suppliers, with the final dosage form (tablets) produced by contract manufacturing organizations (CMOs) primarily in North America and Europe. The supply chain involves raw material sourcing, API synthesis, formulation, packaging, and distribution.

Who Are the Key Suppliers of Fluvoxamine Maleate API?

The production of fluvoxamine maleate API is concentrated among a limited number of chemical manufacturers. These entities are critical nodes in the Luvox supply chain, requiring rigorous quality control and adherence to regulatory standards.

• Key API Manufacturers:
  • Gland Pharma Limited: An Indian pharmaceutical company with a significant presence in API manufacturing. Gland Pharma has a broad portfolio of APIs, including those for central nervous system (CNS) drugs.
  • Divi's Laboratories: Another major Indian API producer, known for its backward integration and large-scale manufacturing capabilities. Divi's supplies APIs globally to generic and innovator pharmaceutical companies.
  • Prashanthi Biotech: An Indian API manufacturer that has been identified as a supplier of fluvoxamine maleate.
  • Unichem Laboratories: A prominent Indian pharmaceutical company with API manufacturing facilities. Unichem produces a range of APIs for various therapeutic areas.
  • Other potential suppliers: While specific public data is limited for all suppliers due to commercial confidentiality, other API manufacturers in India, China, and some European countries may also produce fluvoxamine maleate.

The geographical concentration of API manufacturing in India is notable. This region offers advantages in cost-effectiveness and skilled labor, but also presents potential risks related to geopolitical stability, regulatory scrutiny, and supply chain disruptions.

Which Companies Formulate and Manufacture Luvox Tablets?

The formulation of fluvoxamine maleate into finished dosage forms, primarily tablets, is handled by pharmaceutical companies and CMOs. These entities are responsible for blending the API with excipients, manufacturing the tablets, and packaging them for market.

• Primary Formulators/Manufacturers:
  • AbbVie Inc. (through its acquisition of Allergan): AbbVie is the current holder of the New Drug Application (NDA) for Luvox CR (controlled release) in the United States. This indicates their direct involvement or oversight in the manufacturing process.
  • Various Generic Manufacturers: Numerous pharmaceutical companies globally produce generic versions of fluvoxamine maleate tablets. Examples of companies that have marketed or currently market generic fluvoxamine maleate include:
    • Teva Pharmaceutical Industries: A large global generic drug manufacturer.
    • Sun Pharmaceutical Industries: Another major Indian pharmaceutical company with a significant generic drug portfolio.
    • Mylan N.V. (now part of Viatris): A global pharmaceutical company known for its generics business.
    • Par Pharmaceutical Companies (a subsidiary of Endo International plc): Involved in the manufacturing and marketing of generic prescription drugs.
    • Apotex Inc.: A Canadian pharmaceutical company with a global presence in the generic drug market.

The manufacturing of finished dosage forms is often distributed across different regions to ensure market access and mitigate supply risks. North America and Europe are significant manufacturing hubs for finished pharmaceutical products.

What Are the Regulatory Requirements for Luvox Production?

The production of fluvoxamine maleate, like all pharmaceuticals, is subject to stringent regulatory oversight by health authorities worldwide. Compliance with Good Manufacturing Practices (GMP) is paramount.

• Key Regulatory Bodies:

  • U.S. Food and Drug Administration (FDA): Oversees drug manufacturing in the United States.
  • European Medicines Agency (EMA): Regulates medicines in the European Union.
  • Other National Regulatory Agencies: Health Canada, Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and India's Central Drugs Standard Control Organisation (CDSCO) among others.

• Core Regulatory Standards:

  • Current Good Manufacturing Practices (cGMP): Mandated by regulatory bodies to ensure drug products are consistently produced and controlled according to quality standards. This includes requirements for facilities, equipment, personnel, materials, production, laboratory controls, and record-keeping.
  • API Master Files (APIMFs) or Drug Master Files (DMFs): Submitted by API manufacturers to regulatory agencies. These confidential documents contain detailed information about the manufacturing process, facilities, and controls for an API. Pharmaceutical companies using the API can reference these files in their drug applications.
  • Quality Agreements: Formal agreements between the API manufacturer and the drug product manufacturer that define roles, responsibilities, and quality expectations for the entire supply chain.
  • Impurity Profiling and Control: Strict limits on impurities, including genotoxic impurities, are enforced.
  • Stability Testing: Demonstrating that the API and finished drug product remain within acceptable specifications throughout their shelf life.

Regulatory inspections of manufacturing sites, both for API and finished products, are a routine part of ensuring compliance. Any deviations can lead to warning letters, import alerts, or product recalls, impacting supply availability.

What Are the Primary Excipients Used in Luvox Formulations?

Excipients are inactive substances used as carriers for the active ingredient. Their selection is critical for drug product performance, stability, and manufacturability. For fluvoxamine maleate tablets, common excipients include:

• Binders: To hold the tablet ingredients together.

  • Microcrystalline Cellulose
  • Pregelatinized Starch
  • Povidone

• Fillers/Diluents: To add bulk to the formulation.

  • Lactose Monohydrate
  • Mannitol
  • Calcium Phosphate Dibasic

• Disintegrants: To help the tablet break apart after administration.

  • Croscarmellose Sodium
  • Sodium Starch Glycolate

• Lubricants: To prevent sticking to manufacturing equipment.

  • Magnesium Stearate
  • Stearic Acid

• Glidants: To improve powder flow.

  • Colloidal Silicon Dioxide

• Coating Agents (for film-coated tablets): To improve appearance, taste, and ease of swallowing.

  • Hypromellose (HPMC)
  • Titanium Dioxide (as a colorant)
  • Polyethylene Glycol (PEG)

The sourcing of these excipients also falls under regulatory scrutiny, with suppliers expected to adhere to pharmacopoeial standards (e.g., USP, EP) and GMP.

What Are the Risks and Considerations in the Luvox Supply Chain?

The global nature of pharmaceutical supply chains, particularly for generic drugs, introduces several inherent risks that can affect the availability and cost of Luvox.

• Geopolitical and Economic Risks:

  • Supplier Concentration: Heavy reliance on a few API manufacturers, particularly in India, creates vulnerability to political instability, trade disputes, or natural disasters in those regions.
  • Raw Material Price Volatility: Fluctuations in the cost of key starting materials for API synthesis can impact the overall cost of fluvoxamine maleate.
  • Currency Fluctuations: Affect the cost of imported APIs and finished goods.

• Regulatory Risks:

  • GMP Non-Compliance: Enforcement actions by regulatory agencies against API or finished product manufacturers can lead to supply shortages. For example, a warning letter or import ban for a key facility can disrupt the market.
  • Changes in Regulations: Evolving regulatory requirements for impurity control or environmental standards can necessitate costly process changes for manufacturers.

• Operational Risks:

  • Manufacturing Disruptions: Equipment failures, labor strikes, or quality control issues at a manufacturing site can halt production.
  • Logistics and Transportation: Delays or disruptions in shipping, port congestion, or the cold chain (if applicable, though less so for fluvoxamine tablets) can impact timely delivery.
  • Counterfeiting and Diversion: While less common for established generics, risks associated with counterfeit medicines or diversion from legitimate supply channels exist.

• Quality Risks:

  • API Purity: Ensuring consistent high purity of the API is critical. Batch-to-batch variability or the emergence of new impurities can pose significant challenges.
  • Excipient Quality: Inconsistent quality or supply of critical excipients can affect tablet manufacturing and performance.

Companies involved in the Luvox supply chain, including brand holders and generic manufacturers, must implement robust risk management strategies. This includes qualifying multiple suppliers for critical raw materials and APIs, conducting regular audits of manufacturing partners, maintaining strong relationships with regulatory bodies, and developing contingency plans for supply disruptions. Diversification of manufacturing sites, where feasible, can also enhance supply chain resilience.

Key Takeaways

The supply chain for fluvoxamine maleate (Luvox) is characterized by a concentrated API manufacturing base, predominantly in India, supplying global formulators and contract manufacturers responsible for producing finished dosage forms. Regulatory compliance, particularly adherence to cGMP, is paramount across all stages. Key risks include geopolitical instability in API production regions, potential for regulatory enforcement actions affecting manufacturing sites, and operational disruptions. Robust risk management, including supplier diversification and stringent quality oversight, is essential for ensuring consistent product availability.

FAQs

1. What is the primary risk associated with the current geographical concentration of fluvoxamine maleate API manufacturing? The primary risk is vulnerability to supply chain disruptions stemming from geopolitical events, natural disasters, or regulatory actions in the regions where API production is concentrated.

2. How do regulatory bodies ensure the quality and safety of fluvoxamine maleate? Regulatory bodies like the FDA and EMA ensure quality and safety through the mandatory adherence to Current Good Manufacturing Practices (cGMP), regular inspections of manufacturing facilities, and the review of detailed Drug Master Files (DMFs) for APIs.

3. Can a single API manufacturer's failure to comply with regulations halt the entire Luvox supply? While not guaranteed, a significant regulatory failure by a key API manufacturer, particularly if few alternatives exist or if other suppliers are at capacity, can lead to substantial drug shortages. This is why pharmaceutical companies often qualify multiple suppliers.

4. What role do contract manufacturing organizations (CMOs) play in the Luvox supply chain? CMOs are essential for the formulation and manufacturing of the finished Luvox tablets. They provide the specialized facilities, expertise, and capacity for converting the API into the final drug product according to strict quality standards.

5. Beyond API and finished product manufacturing, what other critical supply chain elements require attention for Luvox? Attention is also required for the supply of critical excipients, packaging materials, and the logistics infrastructure that ensures the timely and secure transport of both the API and the finished drug product to market.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice (CGMP) Regulations. Retrieved from https://www.fda.gov/drugs/pharmaceutical-manufacturing/current-good-manufacturing-practice-cgmp-regulations

[2] European Medicines Agency. (n.d.). Good manufacturing practice. Retrieved from https://www.ema.europa.eu/en/human-regulatory-information/research-and-development/compliance-regulatory-affairs/good-manufacturing-practice

[3] Gland Pharma Limited. (n.d.). API Business. Retrieved from https://www.glandpharma.com/api-business

[4] Divi's Laboratories. (n.d.). Products. Retrieved from https://www.divis.com/products

[5] Unichem Laboratories. (n.d.). API Division. Retrieved from https://www.unichem.com/api-division/

[6] Drug Master Files (DMFs). (n.d.). U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/drugs/drug-master-files/drug-master-files

[7] Allergan. (n.d.). Product Information for Luvox CR. (Note: Specific public disclosures on current manufacturing partners may be proprietary and not publicly detailed by the brand holder).

[8] Teva Pharmaceutical Industries. (n.d.). Product Portfolio. (Generic product availability varies by region and is often listed on national regulatory agency databases).

[9] Sun Pharmaceutical Industries. (n.d.). Generics. Retrieved from https://www.sunpharma.com/business/generics

[10] Viatris Inc. (n.d.). Product Information. (Formerly Mylan N.V.)