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Suppliers and packagers for generic pharmaceutical drug: paroxetine hydrochloride
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paroxetine hydrochloride
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Novitium Pharma | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | SUSPENSION;ORAL | 215003 | ANDA | ANI Pharmaceuticals, Inc. | 70954-319-10 | 250 mL in 1 BOTTLE (70954-319-10) | 2021-09-03 |
| Alembic | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 217280 | ANDA | Alembic Pharmaceuticals Limited | 46708-767-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-767-30) | 2025-09-30 |
| Alembic | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 217280 | ANDA | Alembic Pharmaceuticals Limited | 46708-767-91 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-767-91) | 2025-09-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Paroxetine Hydrochloride
Introduction
Paroxetine hydrochloride, a selective serotonin reuptake inhibitor (SSRI), is widely prescribed for depression, anxiety disorders, obsessive-compulsive disorder, and other mental health conditions. As a critical psychopharmacological agent, its global demand necessitates a reliable and compliant supply chain. This article offers an in-depth analysis of key suppliers for paroxetine hydrochloride, focusing on manufacturing capabilities, geographical distribution, regulatory considerations, and market dynamics vital for stakeholders involved in procurement, distribution, and strategic planning.
Manufacturers and Major Suppliers
Global Leaders in Production
The supply of paroxetine hydrochloride is concentrated among several multinational pharmaceutical companies renowned for their API (Active Pharmaceutical Ingredient) manufacturing prowess. These firms operate under stringent Good Manufacturing Practice (GMP) standards, ensuring compliance with international regulatory frameworks.
1. Pfizer Inc.
As the originator of paroxetine, Pfizer historically maintained a robust supply chain through in-house manufacturing and global licensing. Although Pfizer sold its branded portfolio in 2009, including paroxetine products, its residual operations in API production persist through licensed manufacturing agreements with third-party suppliers.
2. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
A leading Chinese pharmaceutical manufacturer, Hisun possesses extensive capabilities in synthesizing paroxetine hydrochloride. Recognized for cost-effective production, it caters to both domestic and international markets, especially in Asia and emerging markets.
3. Dr. Reddy’s Laboratories (India)
A prominent Indian pharma company, Dr. Reddy’s manufactures and supplies paroxetine hydrochloride with adherence to global quality standards. Their vertically integrated manufacturing process enhances supply stability.
4. Hubei Yichang Pharmaceutical Group Co., Ltd. (China)
Specialized in producing SSRIs, Yichang Pharmaceutical contributes significantly to the supply chain with high-volume production capacities, targeting international markets under rigorous quality certifications.
5. GSK (GlaxoSmithKline)
Though GSK is primarily known for its proprietary medications, it has historically engaged in API manufacturing through licensing and partnerships, including production of paroxetine, in line with regulatory compliance.
Emerging and Contract Manufacturers
The global API market exhibits a dynamic landscape, with Contract Manufacturing Organizations (CMOs) increasingly playing pivotal roles. These CMOs offer flexible, scalable, and compliant manufacturing capacities in response to fluctuating market demands.
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Livanova Pharmaceuticals (India)
Specializes in psychiatric drug APIs, including paroxetine hydrochloride, with established GMP compliance. -
VPK Pharmachem Pvt. Ltd. (India)
Provides custom synthesis and manufacturing for SSRIs, augmenting supply flexibility and regional distribution. -
Sandoz (Novartis division)
Through its CMO operations, Sandoz supplies generic APIs, including paroxetine hydrochloride, ensuring consistent quality.
Geographical Distribution and Market Dynamics
Asia-Pacific Region:
China and India dominate the manufacturing landscape owing to cost advantages, vast chemical synthesis expertise, and supportive regulatory environments. Chinese manufacturers such as Hisun and Yichang Pharmaceutical account for a significant portion of global API production, with a focus on export to North America, Europe, and emerging markets.
North America and Europe:
Production in these regions is primarily led by multinational companies like Pfizer and GSK, emphasizing high-quality standards and regulatory compliance to meet stringent FDA and EMA requirements. The API supply here caters to branded formulations and high-value generics.
Regulatory Considerations:
Manufacturers must adhere to cGMP standards mandated by the FDA, EMA, or equivalent agencies. Recent regulations also emphasize environmental impact and supply chain transparency, influencing supplier selection and qualification processes.
Supply Chain Challenges and Considerations
- Regulatory Variability: Differences in regulatory standards across countries can influence the approval and licensing of APIs, affecting supplier viability.
- Quality Assurance: Maintaining GMP compliance is critical to avoid production disruptions, recalls, or regulatory penalties.
- Market Demand Fluctuations: The rising prevalence of mental health conditions has sustained strong demand, but supply chain disruptions—such as those caused by geopolitical issues or pandemics—can lead to shortages.
- Intellectual Property and Licensing: Patent expirations and licensing agreements influence market access and the proliferation of generic suppliers.
Future Outlook and Strategic Implications
The growing global mental health awareness and increased adoption of SSRIs forecast continued steady demand for paroxetine hydrochloride. Diversification of supply sources, especially expanding manufacturing capacities in compliant emerging markets, is crucial for pharmaceutical companies seeking supply resilience. Additionally, ongoing innovation in synthesis routes and process efficiencies can reduce costs and environmental impact, aligning with global regulatory trends.
Key Suppliers Summary
| Supplier | Location | Capabilities | Key Notes |
|---|---|---|---|
| Pfizer Inc. | USA | Historically critical, licensing-based | Transitioned to licensing model |
| Zhejiang Hisun | China | Large-scale synthesis | Cost-effective, expanding global reach |
| Dr. Reddy’s | India | Vertical integration | High-quality, GMP-compliant |
| Hubei Yichang | China | Focused on SSRIs | High-volume, reliable source |
| GSK | UK | API manufacturing via licensing | Emphasizes premium quality |
Key Takeaways
- Diverse Supplier Base: The global supply chain for paroxetine hydrochloride includes major players in China, India, and Western countries, ensuring supply continuity and cost competitiveness.
- Regulatory Compliance Priority: GMP adherence and regulatory approvals are pivotal in supplier qualification, influencing procurement decisions.
- Emerging Markets Significance: India and China continue to expand their role in API manufacturing, driven by cost advantages and regulatory infrastructure improvements.
- Risk Management: Diversification across suppliers and regions mitigates risks associated with geopolitical, environmental, and regulatory disruptions.
- Innovation and Sustainability: Future success depends on advancing green synthesis methods and maintaining supply chain transparency, in line with evolving standards.
FAQs
1. Who are the leading global manufacturers of paroxetine hydrochloride?
Major manufacturers include Zhejiang Hisun Pharmaceutical (China), Dr. Reddy’s Laboratories (India), and historically, Pfizer Inc. through licensing arrangements.
2. What regulatory standards do suppliers for paroxetine hydrochloride need to meet?
Suppliers must comply with cGMP standards regulated by authorities such as the FDA (USA) and EMA (Europe). Certification and audit reports are critical for qualification.
3. How does geographic diversification benefit the supply chain?
Diversification reduces dependency on a single source, minimizes risk from regional disruptions, and enables competitive pricing.
4. Are there emerging manufacturers in the paroxetine hydrochloride API market?
Yes. Indian and Chinese companies are expanding capacities, with CMOs offering flexible manufacturing options to meet rising global demand.
5. What factors influence the choice of suppliers for paroxetine hydrochloride?
Factors include manufacturing capacity, regulatory compliance, quality standards, cost, supply reliability, and environmental sustainability practices.
Sources
[1] Pfizer Inc. Corporate Reports, 2022.
[2] Zhejiang Hisun Pharmaceutical Co., Ltd. Annual Report, 2022.
[3] Dr. Reddy’s Laboratories, API Portfolio Overview, 2022.
[4] Hubei Yichang Pharmaceutical Group Co., Ltd., Regulatory Approvals, 2022.
[5] European Medicines Agency (EMA), API Regulatory Standards, 2022.
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