cozaar: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386	NDA	Organon LLC	78206-121-01	90 TABLET, FILM COATED in 1 BOTTLE (78206-121-01)	2021-06-01
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386	NDA	Organon LLC	78206-122-01	30 TABLET, FILM COATED in 1 BOTTLE (78206-122-01)	2021-06-01
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386	NDA	Organon LLC	78206-122-02	90 TABLET, FILM COATED in 1 BOTTLE (78206-122-02)	2021-06-01
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386	NDA	Organon LLC	78206-123-01	30 TABLET, FILM COATED in 1 BOTTLE (78206-123-01)	2021-06-01
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386	NDA	Organon LLC	78206-123-02	90 TABLET, FILM COATED in 1 BOTTLE (78206-123-02)	2021-06-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Overview of Cozaar and Its Market Presence

Cozaar, the brand name for losartan potassium, is a widely prescribed antihypertensive medication used primarily for managing high blood pressure and reducing the risk of stroke in patients with hypertension and left ventricular hypertrophy. Approved by the U.S. Food and Drug Administration (FDA) in 1995, Cozaar remains a pivotal product within the angiotensin II receptor blocker (ARB) class. The drug’s global demand sustains a complex supply chain involving multiple manufacturers, active pharmaceutical ingredient (API) suppliers, formulators, and distribution channels.

The landscape of Cozaar suppliers encompasses original developers, generic manufacturers, and API suppliers, with diversity driven by patent expirations and regional regulatory variances. Understanding these suppliers offers strategic insights into market stability, pricing dynamics, and supply chain resilience.

Original Manufacturer and Patent Status

Merck & Co. originally developed Cozaar, holding exclusive patents that permitted sole manufacturing and marketing rights until patent expiration. Since patent expiry around 2010 in the United States, an influx of generic producers has entered the market, leading to increased competition and reduced prices.

Patent Expiry and Generic Market Emergence
The expiration of Merck's patent in various jurisdictions catalyzed the entry of numerous generic manufacturers, broadening the supplier base and diversifying the global supply chain. This transition introduced a variety of suppliers, both established and new, into the market.

Active Pharmaceutical Ingredient (API) Suppliers

The foundation of Cozaar's supply chain rests on the procurement of high-quality losartan potassium API. API suppliers are pivotal as they impact drug quality, cost, and regulatory compliance.

Key API Suppliers for Losartan Potassium

Hinan Pharmaceutical Co. Ltd. (China)
As one of the leading API manufacturers, Hinan supplies losartan APIs to generic formulators worldwide. They have achieved certifications such as ISO 9001, ensuring quality standards that meet international requirements.
Ningbo Inno Pharmchem Co., Ltd. (China)
Another prominent Chinese API producer, Ningbo Inno Pharmchem provides large-scale losartan production for global markets. Their integration of high-capacity facilities ensures supply security.
TEVA Pharmaceutical Industries Ltd. (Israel)
TEVA, one of the world's largest generic drug manufacturers, produces their own API and formulates Cozaar equivalents. Their vertically integrated supply chain reduces dependency on external API suppliers.
Sun Pharmaceutical Industries Ltd. (India)
Sun Pharma produces losartan API with robust quality systems, serving markets across Asia, Europe, and North America. They are known for cost-efficiency and high compliance standards.
Aurobindo Pharma Ltd. (India)
Aurobindo supplies losartan API to multiple generic formulations globally, focusing on quality assurance and regulatory compliance, including approvals from the FDA and EMA.

Regional API Suppliers

Chinese API manufacturers dominate the losartan API landscape due to their manufacturing capacities, cost competitiveness, and regulatory approvals in various markets.
Indian API producers, such as Sun Pharma and Aurobindo, leverage advanced technology and rigorous quality management systems.

Quality and Regulatory Considerations
API suppliers must secure Good Manufacturing Practice (GMP) certification, which is critical for compliance in major markets like the U.S., EU, and Japan. Many suppliers have achieved certifications from agencies such as the FDA, EMA, and WHO, ensuring reliability and quality assurance.

Generic Drug Manufacturers and Final Formulation Suppliers

Following patent expiration, multiple pharmaceutical firms produce generic versions of Cozaar. These firms can be categorized into regional and international players.

Major Generic Manufacturers

Mylan (now part of Viatris)
Mylan’s Cozaar equivalents leverage APIs from certified suppliers, ensuring compliance with global standards. They dominate markets in the U.S. and parts of Europe.
Sandoz (Novartis)
Specializing in generics, Sandoz manufactures losartan-based formulations with high regulatory standards, ensuring broad access in North America and Europe.
Hetero Drugs Ltd. (India)
A significant producer for Indian and emerging markets, Hetero offers low-cost generic losartan formulations.
Cadila Healthcare (India)
Known for affordable medications, Cadila supplies losartan formulations primarily within Asia.
Sun Pharmaceutical Industries
As a key player in formulations, Sun Pharma also manufactures in-house APIs, which allows tighter control over supply and quality.

Distribution Channels and Market Share
The availability of Cozaar generics has led to competitive pricing and widespread accessibility. The supply chain is influenced by regional regulatory approvals, manufacturing capacity, and strategic partnerships.

Supply Chain Challenges and Opportunities

The supply chain for Cozaar involves sourcing high-quality API from API manufacturers, formulation from licensed pharmaceutical companies, and distribution through global networks.

Key Challenges:

Regulatory Compliance: Ensuring API and formulation compliance with evolving international standards remains a barrier for emerging suppliers.
Quality Assurance: Maintaining consistent API quality and batch-to-batch uniformity affects market trust and regulatory approvals.
Geopolitical Risks: Trade tensions between China, India, and Western markets influence sourcing stability.
Supply Security: Manufacturing disruptions, such as shortages of raw materials or geopolitical issues, can impact supply continuity.

Strategic Opportunities:

Diversifying API sourcing from multiple certified suppliers decreases dependency on single regions.
Investing in API development and manufacturing capacity enhances supply resilience.
Strengthening regulatory compliance across markets expedites approval processes and ensures access.

Impact of Patent Expiry on Supplier Dynamics

The expiration of Merck’s patents catalyzed an expansion in supplier diversity, notably increasing the presence of Indian and Chinese API producers. This shift has led to decreased drug prices and improved market access but emphasizes the importance of quality assurance.

Emergence of Contract Manufacturing Organizations (CMOs)
Many drug companies now depend on CMOs for API synthesis and formulation, offering scalable, cost-effective production while adhering to stringent quality standards.

Future Outlook and Competitive Landscape

As patent protections continue to decline globally, the market for Cozaar and its generics will remain highly competitive. Suppliers investing in technological innovation, quality systems, and regulatory pathways will command a greater share of the market.

The rise of biosimilars and alternative antihypertensive drugs could also influence demand, urging suppliers to diversify their portfolios.

Key Takeaways

The supply chain for Cozaar involves a broad network of API manufacturers, formulators, and distributors, with Chinese and Indian companies dominating API production.
API quality, GMP compliance, and regulatory approvals are critical determinants of supplier credibility and market stability.
Patent expirations have democratized the market, increasing competition and lowering drug prices.
Suppliers should focus on diversifying sourcing, enhancing quality assurance, and navigating geopolitical risks to ensure supply chain resilience.
The evolving landscape demands proactive investment in manufacturing capabilities and regulatory compliance to maintain competitiveness.

FAQs

Who are the primary API suppliers for Cozaar globally?
Chinese companies such as Hinan Pharmaceutical and Ningbo Inno Pharmchem, along with Indian firms like Sun Pharma and Aurobindo, are the main API suppliers.
How does patent expiration affect supplier diversity for Cozaar?
Patent expiry enables a multitude of generic manufacturers to produce Cozaar, expanding the supplier base and fostering competition, which can improve supply stability and reduce prices.
What quality standards must API suppliers meet for Cozaar?
API suppliers require GMP certifications from recognized agencies such as the FDA and EMA, along with adherence to international quality management systems.
Are there regional differences in Cozaar suppliers?
Yes, Chinese and Indian manufacturers dominate API supply globally, with regional formulators adapting to local regulatory environments to produce generics.
What risks exist in the current Cozaar supply chain?
Risks include geopolitical tensions, raw material shortages, regulatory compliance lapses, and manufacturing disruptions.

References

Suppliers and packagers for cozaar

cozaar

Suppliers for the Pharmaceutical Drug: Cozaar (Losartan Potassium)