PAROXETINE MESYLATE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Legacy Pharma	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516	NDA AUTHORIZED GENERIC	Padagis US LLC	0574-0279-30	30 CAPSULE in 1 BOTTLE (0574-0279-30)	2017-10-03
Legacy Pharma	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516	NDA	Legacy Pharma USA, Inc.	83107-027-30	30 CAPSULE in 1 BLISTER PACK (83107-027-30)	2025-02-18
Prinston Inc	PAROXETINE MESYLATE	paroxetine mesylate	CAPSULE;ORAL	207188	ANDA	Solco Healthcare LLC	43547-409-03	30 CAPSULE in 1 BOTTLE (43547-409-03)	2017-08-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Paroxetine mesylate, a selective serotonin reuptake inhibitor (SSRI), is widely prescribed for depression, anxiety disorders, obsessive-compulsive disorder, and other mental health conditions. Its global demand necessitates a robust supply chain comprising numerous manufacturers, distributors, and licensing entities. This comprehensive overview examines key suppliers for paroxetine mesylate, emphasizing their roles, market positions, and strategic relevance in the pharmaceutical supply landscape.

Manufacturers of Paroxetine Mesylate

1. Major Originators and Patent Holders

While the original patent for paroxetine was filed in the late 20th century—by GlaxoSmithKline (GSK)—the landscape has since evolved, with multiple generic manufacturers now supplying the drug following patent expiration.

GlaxoSmithKline (GSK): The initial innovator company, responsible for developing and commercializing paroxetine under brand names such as Paxil globally. Although GSK retains some patent protections in certain jurisdictions, many markets have moved toward generic production.

2. Leading Generic Manufacturers

Post-patent expiry, numerous pharmaceutical companies have begun manufacturing paroxetine mesylate, notably:

Mylan (Now part of Viatris): A major player in generic pharmaceuticals, Mylan has established a comprehensive manufacturing process for paroxetine mesylate, supplying multiple markets worldwide.
Teva Pharmaceutical Industries: A global leader in generics, Teva produces paroxetine mesylate adhering to stringent regulatory standards, including US FDA and EMA compliance.
Apotex Inc.: With manufacturing facilities in North America and globally, Apotex supplies high-volume generic paroxetine mesylate.
Sandoz (Novartis): A significant generic drug manufacturer with extensive production capabilities for SSRIs, including paroxetine mesylate.
Sun Pharmaceutical Industries: India-based Sun Pharma manufactures and markets paroxetine mesylate across various regions, contributing substantially to the global supply.
Lakeland Pharmacal: An established manufacturer in India, known for supplying high-quality generic psychotropic medications.

3. Regional and Specialized Suppliers

Recent years have seen emerging manufacturers, particularly from Asia and Eastern Europe, entering the market with competitive pricing:

Hetero Labs: An Indian pharmaceutical company with a rising presence in the psychotropic drug segment.
Cipla Limited: Based in India, with manufacturing facilities meeting global regulatory standards, producing paroxetine mesylate for multiple markets.

4. Contract Manufacturing Organizations (CMOs)

Some pharmaceutical companies outsource production to CMOs to scale supply rapidly:

Catalent: Provides manufacturing services for paroxetine mesylate formulations and finished dosage forms.
Patheon (Thermo Fisher Scientific): Offers specialized manufacturing solutions for bulk drug substances and APIs.

Distribution Channels and Wholesalers

Efficient distribution ensures uninterrupted supply to pharmacies, hospitals, and clinics.

McKesson and Cardinal Health: U.S.-based pharmaceutical distributors holding substantial inventories of generic paroxetine mesylate.
Aurora Pharma: Distributes in Europe and Asia, with a focus on ISO and GDP standards.
Local Wholesalers: Regional suppliers often source from multiple manufacturers to maintain supply stability and mitigate shortages.

Regulatory and Quality Considerations

Suppliers must comply with international standards:

US FDA: Ensures Good Manufacturing Practices (GMP) for all US-licensed producers.
EMA (European Medicines Agency): Regulates European suppliers, requiring CE marking and batch testing.
Pharmacopoeias (USP, EP, BP): Define purity, potency, and formulation standards for paroxetine mesylate.

Compliance affects supplier selection, especially for multinational pharmaceutical companies and healthcare providers.

Strategic Considerations for Stakeholders

Pricing and Cost Competitiveness: Indian and Chinese suppliers often offer lower production costs, influencing procurement strategies.
Supply Chain Resilience: Diversification among multiple suppliers mitigates risks such as geopolitical disruptions or regulatory actions.
Quality Assurance: Suppliers with validated quality systems reduce the risk of batch recalls and regulatory penalties.
Intellectual Property Rights (IPR): While patents have expired in many jurisdictions, some regions still enforce patent protections, affecting sourcing options.

Emerging Trends and Future Outlook

Bioequivalence and Formulation Innovations: Suppliers investing in alternative formulations (e.g., controlled-release variants) may expand their market share.
Sustainable Manufacturing: Increasing emphasis on environmentally sustainable processes influences supplier selection.
Regulatory Harmonization: Tighter international standards are expected to further scrutinize supplier compliance, favoring established global manufacturers.

Key Takeaways

The wholesale supply of paroxetine mesylate involves a mix of original patent holders, generic manufacturers, CMOs, and regional distributors.
Top global suppliers include Mylan/Viatris, Teva, Sandoz, Sun Pharma, and Apotex, primarily located in North America, Europe, and India.
Supplier selection hinges on regulatory compliance, manufacturing capacity, cost factors, and quality assurance.
Regional suppliers and emerging manufacturers are increasingly important as market demand expands and supply chain resilience becomes critical.
Strategic diversification among multiple suppliers mitigates risks associated with supply disruptions and regulatory variability.

FAQs

1. Are there regional differences in suppliers for paroxetine mesylate?
Yes. North America relies heavily on companies like Mylan and Teva, whereas Indian and Chinese manufacturers, including Sun Pharma and Hetero Labs, dominate the Asian and emerging markets. European suppliers often include Sandoz and local generic companies.

2. How does patent status influence supplier options?
Patent expiration in many jurisdictions opened the market to multiple generics, increasing supplier options. In regions where patents are still enforced, only patent-licensing or authorized producers can legally supply paroxetine mesylate.

3. What quality standards should I consider when sourcing paroxetine mesylate?
Suppliers should adhere to GMP regulations mandated by regulatory authorities like the US FDA, EMA, and WHO. Analytical data on impurity profiles, bioequivalence studies, and batch testing further underpin quality assurance.

4. How does cost impact supplier selection?
Cost competitiveness influences procurement strategies, especially in markets with high generic penetration. Indian manufacturers typically offer lower prices without compromising quality, but regulatory considerations may limit their acceptability in certain regions.

5. Can contract manufacturing organizations impact the supply chain?
Yes. CMOs enable scalable production and may expedite entry into markets with existing manufacturing capacity, but supply agreements must include strict quality and compliance terms to ensure product integrity.

Sources:
[1] U.S. Food and Drug Administration (FDA) Drug Approvals and Guidelines.
[2] European Medicines Agency (EMA) Pharmacovigilance Reports.
[3] Pharmaceutical markets reports from IQVIA and EvaluatePharma.
[4] Company disclosures and regulatory filings (Teva, Mylan, Sun Pharma, etc.).
[5] Industry analyses from GlobalData and Statista.

Suppliers and packagers for generic pharmaceutical drug: PAROXETINE MESYLATE