Suppliers and packagers for PAXIL CR

PAXIL CR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936	NDA AUTHORIZED GENERIC	Apotex Corp	60505-1316-3	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-1316-3)	2019-08-09
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936	NDA AUTHORIZED GENERIC	Apotex Corp	60505-1317-3	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-1317-3)	2019-08-09
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936	NDA AUTHORIZED GENERIC	Apotex Corp	60505-1318-3	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-1318-3)	2019-08-09
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936	NDA	Apotex Corp	60505-4377-3	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-4377-3)	2011-01-01

Suppliers for the Pharmaceutical Drug: PAXIL CR

Last updated: July 31, 2025

Introduction

PAXIL CR, marketed as paroxetine controlled-release tablets, is a prescription antidepressant developed by GlaxoSmithKline (GSK). As a selective serotonin reuptake inhibitor (SSRI), PAXIL CR addresses conditions such as major depressive disorder, obsessive-compulsive disorder, and generalized anxiety disorder. Given its widespread use, supply chain integrity and the diversity of suppliers are crucial for ensuring manufacturing continuity, regulatory compliance, and market stability. This article provides an in-depth analysis of primary suppliers involved in the manufacturing and distribution of PAXIL CR, encompassing active pharmaceutical ingredient (API) providers, formulation manufacturers, and distribution channels, with insights into regulatory and market dynamics.

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1. Overview of PAXIL CR Supply Chain

The supply chain for PAXIL CR involves multiple tiers:

• API Suppliers: The providers of paroxetine, the active pharmaceutical ingredient.
• Formulation Manufacturers: Companies that process APIs into controlled-release tablet forms.
• Packaging and Distribution: Entities responsible for packaging, logistics, and regulatory compliance.
• Distribution Channels: Wholesalers, pharmacies, and healthcare providers.

Understanding each component's suppliers helps gauge vulnerabilities, geopolitical influences, and patent or patent expirations that shape the competitive landscape.

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2. Active Pharmaceutical Ingredient (API) Suppliers

2.1. Key API Manufacturers

Paroxetine hydrochloride, the API in PAXIL CR, was initially synthesized by GSK, which maintained in-house manufacturing. However, patent exclusivity, market expiration, and subsequent generic entries have diversified the supplier base.

• GSK’s API Manufacturing: Historically, GSK produced the API in-house, particularly during the drug's patent life, ensuring quality and security of supply.
• Generic API Suppliers: Post-patent expiry in most markets, several manufacturers have emerged, including:
  • Hikma Pharmaceuticals: Known for their pharmaceutical generics portfolio, including paroxetine APIs.
  • Mitsubishi Chemical: A Japanese firm involved in chemical synthesis for APIs.
  • Apisero (previously Aurobindo, Teva, Sandoz): Large Indian and European manufacturers have scaled API production for generic versions.

2.2. Regional API Suppliers

API manufacturing is geographically concentrated, with key suppliers located in:

• India: Major hub due to cost advantages, with firms like Aurobindo, Cadila, Sun Pharma, and Lupin producing high-quality paroxetine APIs.
• China: An expanding source of raw chemicals and intermediates that support the production of APIs.
• Europe and North America: Limited API manufacturing; primarily involved in quality testing, regulatory compliance, and some production for niche markets.

2.3. Quality and Regulatory Standards

APIs supplied globally must comply with Good Manufacturing Practices (GMP) mandated by agencies like the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other regulators. Suppliers with GMP-certified facilities are preferred, reducing supply risks associated with non-compliance.

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3. Formulation and Finished Dosage Form Suppliers

3.1. Original Manufacturer

• GSK: The original developer of PAXIL CR, responsible for manufacturing, branding, and distribution during patent protection. Their facilities across Europe and North America ensured high-quality product supply.

3.2. Generic Manufacturers

Following patent expiry, multiple generic firms began manufacturing PAXIL CR formulations—often by acquiring licensing agreements or through direct API supply:

• Mylan (now Viatris): Historically involved in generic antidepressants, including controlled-release formulations.
• Teva Pharmaceuticals: Known for extensive generic drug portfolios, including paroxetine CR formulations.
• Sandoz (Novartis): Supplies generic paroxetine formulations globally.
• Sun Pharma, Lupin, and Aurobindo: India-based firms with significant market share in paroxetine CR formulations.

3.3. Contract Manufacturing Organizations (CMOs)

Numerous CMOs specialize in formulation, blending API with excipients, tablet compression, and coating. They often serve as critical nodes in the supply chain, providing flexibility and scalability, especially during market surges.

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4. Regulatory and Market Dynamics Impacting Suppliers

4.1. Patent Expiry and Generic Entry

The key patent protecting PAXIL CR in various markets expired between 2011 and 2014, catalyzing a surge in generic manufacturers. Patent expirations typically lead to increased supplier diversity but also intensify competition and price erosion.

4.2. Regulatory Approvals and Quality Assurance

Suppliers worldwide must navigate stringent regulatory requirements. The US FDA’s approval of API facilities as Acceptable Quality Systems (AQS) and equivalent European agencies expedites market entry but also elevates standards to avoid shortages or recalls.

4.3. Supply Chain Risks

Consolidation among API suppliers, geopolitical tensions, and global disruptions like the COVID-19 pandemic pose risks to consistent PAXIL CR supply. Diversified sourcing strategies mitigate dependency on single-region suppliers.

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5. Distribution and Logistics

Manufacturers and distributors utilize logistic firms specializing in pharmaceutical freight—DHL, FedEx, and other specialized logistics providers—ensuring the integrity of transportation, temperature control, and compliance with regulatory documentation.

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6. Market and Future Outlook

The increasing trend toward generic and biosimilar drugs suggests a robust supplier ecosystem for PAXIL CR. Ongoing quality improvements and diversified sourcing will likely stabilize supply chains, though regulatory changes, patent litigations, or market fluctuations could induce shifts.

6.1. Impact of Patent Expiry and Generics

The entry of generics led to multiple suppliers, lowering prices and broadening the supplier base. As patents for other formulations expire, similar dynamics are expected for PAXIL CR.

6.2. Emerging Suppliers and Innovation

Enhanced manufacturing techniques, such as continuous manufacturing and innovative delivery systems, may influence future supplier landscapes. Companies investing in manufacturing efficiency and quality standards will command competitive advantages.

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Key Takeaways

• The supply chain for PAXIL CR is highly diversified post-patent expiry, involving multiple global API suppliers primarily based in India and China.
• Quality compliance with GMP standards remains a hallmark requirement for sustained supplier relationships and regulatory approval.
• Original manufacturer GSK's role has diminished with the proliferation of generic manufacturers, which now dominate the formulation and distribution landscape.
• Supply chain resilience depends on geographic diversification, regulatory vigilance, and the agility of manufacturers to adapt to market and geopolitical dynamics.
• Future stability will hinge on continued patent expirations, new manufacturing innovations, and regulatory environments supporting quality and access.

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FAQs

Q1: Who are the primary API suppliers for PAXIL CR?
A1: Post-patent expiry, major API suppliers include Indian companies like Aurobindo, Sun Pharma, Lupin, and Teva, with some Chinese firms contributing intermediates. GSK historically produced the API in-house during patent protection.

Q2: How has patent expiration impacted the supply chain for PAXIL CR?
A2: Patent expiration led to a surge in generic manufacturers, increasing supplier diversity, reducing costs, and creating a more resilient but competitive supply environment.

Q3: What regulatory standards do suppliers of PAXIL CR need to meet?
A3: Suppliers must adhere to GMP standards set by agencies such as the FDA and EMA, ensuring quality, safety, and efficacy of both APIs and finished formulations.

Q4: Are there risks associated with the current supplier landscape for PAXIL CR?
A4: Yes. Risks include geopolitical tensions, manufacturing disruptions, quality non-compliance, and regulatory changes, which could impact consistent supply.

Q5: What is the future outlook for suppliers of PAXIL CR?
A5: The continuation of patent expirations and market competition suggests a stable and diversified supplier base, with innovation and regulatory compliance being key to maintaining supply security.

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References

1. GlaxoSmithKline. (2022). PAXIL (paroxetine) Product Information.
2. U.S. Food and Drug Administration (FDA). (2022). Approved Drug Products.
3. MarketWatch. (2023). Status of Paxil (paroxetine) patent and generic entries.
4. IQVIA. (2022). Global API Manufacturing Data Report.
5. European Medicines Agency (EMA). (2022). GMP Inspection Reports for API Manufacturers.