Suppliers and packagers for generic pharmaceutical drug: ROSUVASTATIN CALCIUM

ROSUVASTATIN CALCIUM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm	EZALLOR SPRINKLE	rosuvastatin calcium	CAPSULE;ORAL	208647	NDA	Sun Pharmaceutical Industries, Inc.	47335-984-64	3 BLISTER PACK in 1 CARTON (47335-984-64) / 10 CAPSULE in 1 BLISTER PACK (47335-984-60)	2019-05-04
Sun Pharm	EZALLOR SPRINKLE	rosuvastatin calcium	CAPSULE;ORAL	208647	NDA	Sun Pharmaceutical Industries, Inc.	47335-984-81	90 CAPSULE in 1 BOTTLE (47335-984-81)	2019-05-04
Sun Pharm	EZALLOR SPRINKLE	rosuvastatin calcium	CAPSULE;ORAL	208647	NDA	Sun Pharmaceutical Industries, Inc.	47335-984-83	30 CAPSULE in 1 BOTTLE (47335-984-83)	2019-05-04
Sun Pharm	EZALLOR SPRINKLE	rosuvastatin calcium	CAPSULE;ORAL	208647	NDA	Sun Pharmaceutical Industries, Inc.	47335-985-64	3 BLISTER PACK in 1 CARTON (47335-985-64) / 10 CAPSULE in 1 BLISTER PACK (47335-985-60)	2019-05-04

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: Rosuvastatin Calcium

Overview
Rosuvastatin calcium is a widely prescribed statin used to lower cholesterol levels and reduce the risk of cardiovascular disease. As a critical cardiovascular therapeutic, demand for rosuvastatin calcium remains high globally. Its production involves complex synthesis processes, stringent regulatory standards, and a diverse supplier landscape. This article explores the main suppliers of rosuvastatin calcium, analyzing their manufacturing capabilities, geographical distribution, and market positioning to inform stakeholders in procurement, licensing, and strategic partnerships.

Key Manufacturers of Rosuvastatin Calcium

1. AstraZeneca
AstraZeneca pioneered the development of rosuvastatin, branded as Crestor, and holds extensive patent rights. While Pfizer has been a major competitor, AstraZeneca’s early investments established a dominant position in global markets. Post-patent expiration in several regions, AstraZeneca’s manufacturing rights transitioned, with licensed production by other firms. The company’s manufacturing facilities in the United Kingdom and the United States adhere to stringent Good Manufacturing Practices (GMP), ensuring high purity standards. AstraZeneca’s large-scale production capabilities guarantee supply sustainability, especially for branded formulations.

2. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)
One of the leading generic manufacturers, Zhejiang Huahai has achieved the capability to produce rosuvastatin calcium at scale. The company’s manufacturing plant in Linhai, Zhejiang, complies with international GMP standards, making it a prominent supplier for generic markets, particularly in Asia, Europe, and Latin America. Their product quality has been recognized globally, supported by certifications such as EMA (European Medicines Agency) and FDA approvals. Zhejiang Huahai’s strategic focus on cost-effective production has made it a competitive supplier of rosuvastatin calcium in the generic segment.

3. Hetero Labs Ltd. (India)
Hetero Pharmaceuticals ranks among top Indian pharmaceutical companies with significant capacities for statin production, including rosuvastatin calcium. The company’s manufacturing units are GMP-approved, with export licenses to multiple countries. Hetero’s focus on R&D and process innovation ensures high-quality standards and competitive pricing, vital for meeting the demand from emerging markets and generic drug distributors. The company also maintains strategic alliances with global pharmaceutical firms to expand its product reach.

4. Dr. Reddy’s Laboratories (India)
Dr. Reddy’s is a prominent Indian API producer, with a dedicated division for cardiovascular APIs, including rosuvastatin calcium. The company’s manufacturing facilities in India are certified under global regulatory bodies, providing reliable supply to developed and developing nations. Their focus on cost-efficiency and consistent quality makes them a preferred supplier in generic markets, with exports to North America, Europe, and Asia.

5. Teva Pharmaceuticals (Israel)
Teva, one of the world’s largest generic drug manufacturers, also produces rosuvastatin calcium. Their global manufacturing network in Israel, Hungary, and the United States enables diversified production capacity. Teva emphasizes regulatory compliance and supply chain resilience, critical for maintaining global distribution channels for rosuvastatin calcium and related generic formulations.

Additional Suppliers and Emerging Players

Beyond these key leaders, several regional and niche suppliers provide rosuvastatin calcium, often through licensing or contract manufacturing. These include companies such as Sivananth (India), Mylan (acquired by Viatris), and local regulatory-approved producers in Latin America, Southeast Asia, and Eastern Europe.

Manufacturing Processes and Market Dynamics

Constructing rosuvastatin calcium involves complex synthetic routes, typically starting from advanced intermediates derived through asymmetric catalytic processes. Ensuring chemical purity and bioequivalence demands sophisticated facilities with advanced analytical capabilities. As patents expired in multiple jurisdictions by 2016–2018, generic manufacturers proliferated, increasing market competition and lowering prices.

Supply chain considerations include raw material sourcing, regulatory approvals, quality control, and capacity investments. Suppliers that align with global regulatory standards are preferable; otherwise, distribution may be limited or require additional certification.

Market Dynamics:

• The global rosuvastatin market is projected to grow steadily, driven by increasing prevalence of hypercholesterolemia and cardiovascular diseases.
• Emerging markets in Asia, Africa, and Latin America account for significant growth opportunities due to expanding healthcare infrastructure and lower-cost options.
• Supply security and quality assurance remain critical factors for pharmaceutical companies sourcing rosuvastatin calcium, especially given past quality issues with certain suppliers.

Regulatory Considerations

Suppliers must meet stringent regulatory standards, notably:

• GMP compliance (EMA, FDA, WHO certifications)
• Good Distribution Practices (GDP)
• Effective documentation of manufacturing processes and batch records
• Continuous quality monitoring and stability data

Regulatory registration processes influence supplier selection, with long-standing compliant suppliers favored for their track record and ease of approval.

Supply Chain Risks and Mitigation

Dependence on limited suppliers can pose risks such as shortages, quality lapses, and geopolitical disruptions. To mitigate these risks, pharmaceutical companies diversify their supplier base and verify suppliers’ compliance with global standards. Some firms also develop in-house manufacturing capabilities or enter licensing agreements to secure supply.

Key Takeaways

• Major players in rosuvastatin calcium supply include AstraZeneca (patented), Zhejiang Huahai, Hetero Labs, Dr. Reddy’s, and Teva, each with extensive manufacturing capacity and global regulatory certifications.
• The generic market has become highly competitive post-patent expiry, driven by regional manufacturers who offer cost-effective solutions aligned with strict quality standards.
• Supply chain resilience depends on supplier diversification, regulatory adherence, and quality assurance protocols.
• Emerging markets present significant growth opportunities, though regulatory and quality considerations must be prioritized.
• Strategic partnerships, licensing, and capacity investments are critical for stakeholders seeking reliable supply in a competitive environment.

FAQs

1. Who are the top global suppliers of rosuvastatin calcium?
Major suppliers include AstraZeneca (for branded versions), Zhejiang Huahai, Hetero Labs, Dr. Reddy’s, and Teva, with numerous regional manufacturers serving specific markets.

2. What are the key regulatory requirements for sourcing rosuvastatin calcium?
Suppliers must demonstrate compliance with GMP standards, obtain EMA, FDA, or equivalent certifications, and adhere to Good Distribution Practices for seamless market approval.

3. How has the market for rosuvastatin calcium evolved post-patent expiration?
Patent expirations have led to increased generic manufacturing, intensified competition, and lowered prices, expanding access globally but also amplifying supply chain complexity.

4. What risks are associated with sourcing rosuvastatin calcium from emerging market suppliers?
Risks include variable quality standards, regulatory hurdles, supply disruptions, and counterfeit issues. Due diligence and supplier qualification are essential.

5. What strategies can pharmaceutical companies adopt for reliable rosuvastatin calcium supply?
Diversify suppliers, establish licensing agreements, develop in-house manufacturing, and rigorously verify regulatory compliance to mitigate risks and ensure uninterrupted supply.

Sources
[1] AstraZeneca Official Website, “Crestor (rosuvastatin calcium),” accessed 2023.
[2] European Medicines Agency, “Market authorization of rosuvastatin,” 2022.
[3] Zhejiang Huahai Pharmaceuticals Annual Report, 2022.
[4] Hetero Pharmaceuticals Brochure, 2023.
[5] Teva Pharmaceutical Industries, “Global APIs Portfolio,” 2023.