remeron: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Organon	REMERON	mirtazapine	TABLET;ORAL	020415	NDA	Organon LLC	78206-160-01	30 TABLET, FILM COATED in 1 BOTTLE (78206-160-01)	2021-06-01
Organon	REMERON	mirtazapine	TABLET;ORAL	020415	NDA	Organon LLC	78206-161-01	30 TABLET, FILM COATED in 1 BOTTLE (78206-161-01)	2021-06-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 5, 2025

Introduction

Remeron, the brand name for mirtazapine, is a widely prescribed antidepressant used primarily for major depressive disorder. It's part of the tetracyclic antidepressant class, known for its efficacy and distinct mechanism of action. As a prescription medication, its manufacturing, distribution, and supply chain involve multiple players spanning pharmaceutical companies, generic manufacturers, contract manufacturing organizations (CMOs), and global wholesalers. Ensuring a consistent supply of mirtazapine is critical to meet the ongoing global demand and address the needs of patients with depression.

This article offers a comprehensive overview of key suppliers involved in the production and distribution of Remeron, highlighting the leading brand manufacturer, generic producers, and extractors, along with the implications for health systems, pharmaceutical supply chains, and market dynamics.

1. Brand Manufacturer of REMERON

Organon (a division of Merck & Co.)
Remeron (mirtazapine) was originally developed and marketed by Organon, a pharmaceutical company now owned by Merck & Co. post the merger with Schering-Plough in 2009. Organon historically held the patent rights for Remeron, overseeing its global marketing and distribution. Despite patent expiration, Merck continues to be a key brand supplier by licensing and supply agreements, especially in regions where the patent still holds or where generic competition is limited.

Current Status & Distribution
Merck primarily maintains a supply chain through strategic manufacturing facilities, ensuring the availability of branded Remeron in markets where intellectual property rights persist. The company’s global reach ensures supply continuity, but the focus has now shifted towards generic manufacturing as patents expire.

2. Generic Manufacturers of Mirtazapine

Following patent expiration, multiple pharmaceutical companies have entered the market, producing generic versions of mirtazapine. The availability of generics significantly reduces costs and improves access, especially in low- and middle-income countries.

Key Global Generics Suppliers:

Hetero Drugs Limited (India)
Hetero is among the leading manufacturers of generic mirtazapine, supplying to North America, Europe, and Asia. The company has a robust API (active pharmaceutical ingredient) manufacturing infrastructure, enabling high-volume production and export capacity.
Dr. Reddy’s Laboratories (India)
Dr. Reddy’s produces generic mirtazapine tablets and APIs, operating multiple manufacturing sites compliant with international quality standards (FDA, EMEA). Its extensive distribution network ensures wide access.
Intas Pharmaceuticals (India)
Intas supplies both finished dosage forms and APIs, actively participating in global markets, especially in Europe and Asia. Their manufacturing facilities are certified by various global regulatory agencies.
Sandoz (a Novartis division)
Sandoz is a significant player in global generics, providing affordable mirtazapine options. It has a comprehensive API and formulation manufacturing network designed to meet worldwide demand.
Mylan (now part of Viatris)
Mylan’s portfolio includes mirtazapine as part of its antidepressant offerings. Their global manufacturing facilities cover several continents.

Regional Differentiation and Market Share

The dominant generic suppliers vary by region. In India and Asia, Hetero, Dr. Reddy’s, and Intas are prominent. In Europe and North America, Sandoz and Mylan are preferred due to their regulatory approvals and distribution channels.

3. Active Pharmaceutical Ingredient (API) Suppliers

The API is central to manufacturing mirtazapine tablets. Several companies globally manufacture the API, with India and China leading the production.

Chinese API Manufacturers:
China’s API sector is substantial, with multiple companies supplying high-quality mirtazapine API to global manufacturers. Notable companies include Zhejiang Hisun Pharmaceutical, Jiangsu Hengrui Medicine.
Indian API Producers:
Companies like Synthesis and Aurobindo Pharma produce mirtazapine API for export and domestic markets. Indian API producers adhere increasingly to international standards, facilitating regulatory approval.

Supply Chain Considerations
The reliance on Chinese and Indian API suppliers presents supply chain risks and opportunities. Disruptions due to geopolitics, trade restrictions, or quality concerns impact global availability.

4. Contract Manufacturing Organizations (CMOs)

CMOs play a pivotal role in scaling manufacturing capacity for both brand-name and generic mirtazapine.

TRPharm (India)
Known for compliant API production and formulation services, TRPharm works with several generic firms.
Catalent and Patheon (Global)
These organizations provide formulation, filling, and packaging services for finished dosage forms to generic manufacturers.
Alvogen and XEco (India)
Emerging players offering manufacturing and formulation expertise OEMs expand capacity via CMOs.

5. Distribution and Wholesale Suppliers

The distribution network for mirtazapine involves major pharmaceutical wholesalers, pharmacy chains, and online suppliers.

McKesson and Cardinal Health (North America)
These distributors supply pharmacies and hospitals with generic mirtazapine, ensuring steady availability.
Phoenix Pharma (Europe, Asia)
Prominent in European markets, distributing both branded and generic mirtazapine.
Regional Distributors and Online Pharmacies
Increasing reliance on online pharmacy networks allows for broader access but raises concerns about regulatory compliance and drug authenticity.

6. Market Dynamics and Supply Chain Risks

The supply landscape for mirtazapine is shaped by patent statuses, regulatory approvals, geopolitical factors, and manufacturing capacities. Patent expiration in many jurisdictions has spurred a proliferation of generic suppliers, promoting affordability but intensifying competition.

Supply chain risks include:

API shortages from Chinese or Indian manufacturers
Regulatory delays or bans
Disruptions from geopolitical tensions
Quality control issues, leading to recalls

These challenges necessitate diversified supplier relationships and strategic stockpiling to mitigate shortages.

7. Regulatory Considerations

Manufacturers must comply with stringent quality and regulatory standards set by agencies like the FDA, EMA, and others. For API producers, adherence to Good Manufacturing Practices (GMP) ensures product quality, influencing supplier choices globally.

Key Takeaways

The original patent holder, Merck, continues to supply Remeron in select markets, but generic manufacturers dominate global supply.
Indian firms like Hetero, Dr. Reddy's, and Intas are primary API and finished product suppliers, ensuring affordability and accessibility.
Global giants such as Sandoz and Mylan maintain significant market shares, especially in Western markets.
API supply chain risks originate mainly from Chinese and Indian manufacturing sectors, requiring diversified sourcing strategies.
Regulatory compliance and quality control remain critical to maintaining supply chain integrity for mirtazapine.

FAQs

1. Who are the leading manufacturers of generic mirtazapine?
Hetero Drugs Limited, Dr. Reddy’s Laboratories, Intas Pharmaceuticals, Sandoz, and Mylan are predominant global generic mirtazapine producers.

2. Is Remeron still under patent protection?
Patent protection varies by country. In many regions, patent expiration has led to increased generic competition, though Merck retains exclusive rights in some markets.

3. Where is the API for mirtazapine primarily manufactured?
Mainly in China and India, with several companies complying with international GMP standards.

4. How do supply chain disruptions impact the availability of Remeron?
Disruptions in API supply, regulatory issues, or geopolitical tensions can lead to shortages, affecting the availability of both branded and generic mirtazapine.

5. How do regulatory agencies influence the supply chain?
They enforce GMP standards and approve manufacturing facilities, dictating quality parameters and influencing supplier accreditation and market access.

References

[1] Merck & Co. Official website. Patent and product information on Remeron.
[2] IQVIA. Global Pharmaceutical Market Reports.
[3] U.S. Food and Drug Administration (FDA). ORA Inspection Reports.
[4] Global Data. Pharmaceutical API Manufacturer Profiles.
[5] Indian Pharmaceutical Industry Reports. API and Formulation Market Overview.

Suppliers and packagers for remeron

remeron

Suppliers for the Pharmaceutical Drug: REMERON (Mirtazapine)