Suppliers and packagers for crestor

crestor

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astrazeneca	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366	NDA	AstraZeneca Pharmaceuticals LP	0310-7560-90	90 TABLET, FILM COATED in 1 BOTTLE (0310-7560-90)	2022-05-09
Astrazeneca	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366	NDA	AstraZeneca Pharmaceuticals LP	0310-7570-90	90 TABLET, FILM COATED in 1 BOTTLE (0310-7570-90)	2022-05-09
Astrazeneca	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366	NDA	AstraZeneca Pharmaceuticals LP	0310-7580-90	90 TABLET, FILM COATED in 1 BOTTLE (0310-7580-90)	2022-01-24

Suppliers for the Pharmaceutical Drug: Crestor

Last updated: July 27, 2025

Introduction

Crestor (rosuvastatin calcium) is a widely prescribed statin medication developed by AstraZeneca for the management of hypercholesterolemia and cardiovascular risk reduction. Approved by the FDA in 2003, Crestor has become one of the leading cholesterol-lowering agents globally. The drug's global supply chain is complex, involving multiple suppliers across the manufacturing, active pharmaceutical ingredient (API), and formulation stages. This article provides a comprehensive analysis of the key suppliers involved in producing Crestor, highlighting their roles, geographic distribution, regulatory landscape, and strategic importance.

Active Pharmaceutical Ingredient (API) Suppliers for Crestor

The backbone of Crestor production lies in its API, rosuvastatin calcium. AstraZeneca originally developed and commercialized the API through strategic manufacturing collaborations, primarily in Asian markets, to optimize costs and supply chain resilience.

1. Hetero Labs Limited (India)

Hetero Labs emerged as a significant supplier of rosuvastatin API, leveraging extensive experience in complex generic APIs. The company operates FDA- and EUGMP-approved facilities, ensuring compliance with international standards. Hetero's strategic positioning in India allows it to produce high-quality APIs at competitive costs, facilitating generic versions of Crestor and other statins.

2. Dr. Reddy’s Laboratories (India)

Dr. Reddy’s also supplies rosuvastatin API, focusing on quality and regulatory compliance. The company's manufacturing facilities in India are approved by both US and European regulatory agencies, making it a reliable source for APIs intended for global markets, including for generic formulations of Crestor.

3. Aurobindo Pharma (India)

Aurobindo Pharma has established itself as a key supplier of rosuvastatin API to multiple pharmaceutical companies worldwide. Their facilities are compliant with international standards, and their API manufacturing capabilities have expanded to meet the high-volume demand for statins.

4. Zhejiang Huahai Pharmaceutical (China)

Zhejiang Huahai is a reputable Chinese API producer involved in the manufacturing of rosuvastatin API. The company’s API production facilities adhere to strict compliance with Good Manufacturing Practices (GMP), enabling it to supply to global markets, including the United States, Europe, and emerging markets.

5. Other Asian API Manufacturers

Various other manufacturers in countries such as South Korea, Taiwan, and Vietnam supply rosuvastatin API, often serving regional markets due to logistical and regulatory considerations.

Formulation and Finished Dosage Form Suppliers

Authorized pharmaceutical companies and generic manufacturers assemble the API into finished dosage forms. While AstraZeneca originally marketed Crestor directly, the drug's patent expiry in multiple jurisdictions has prompted growing involvement of generic manufacturers.

1. AstraZeneca (Original Patent Holders)

During the initial patent-protected period, AstraZeneca manufactured and distributed Crestor globally, controlling the supply chain and quality standards strictly. Post-patent expiry, the company transitioned some manufacturing rights and entered licensing agreements.

2. Generics Manufacturers

Following patent expiry, numerous generics companies have entered the market, sourcing APIs from the aforementioned suppliers and producing Crestor equivalents.

• Teva Pharmaceutical Industries: A leading global generic company, Teva sources rosuvastatin API and produces Crestor-equivalent formulations for various markets, including the US and EU.

• Mylan (now part of Viatris): Mylan has developed generic rosuvastatin products, relying on API suppliers in India and China.

• Sandoz (Novartis): Engages in producing generic versions, often sourcing APIs from established Asian suppliers.

• Cipla, Biocon, and Dr. Reddy’s: Indian pharmaceutical companies with manufacturing authorized by regulatory authorities to produce Crestor generics.

3. Contract Manufacturing Organizations (CMOs)

Contract manufacturers globally contracted by patent holders or generic companies produce finished formulations. Many of these CMOs operate in India, China, and Eastern Europe, leveraging lower costs without compromising quality standards.

Regulatory Influences and Quality Standards

The supply chain integrity heavily depends on compliance with regulatory standards, including GMP, DEA, and EMA regulations. Suppliers approved by the FDA or EMA are generally preferred for high-quality, globally distributed formulations of Crestor. Regulatory challenges, such as the Zhejiang Huahai diethylene glycol contamination crisis in 2019, emphasize the importance of rigorous oversight across the supply chain [1].

Strategic Considerations

• Geographic diversification: To mitigate risks like geopolitical tensions or supply disruptions, companies diversify their API sources across India, China, and other Asian countries.

• Vertical integration: AstraZeneca historically maintained integrated manufacturing but divested some API manufacturing rights, encouraging the rise of reputable generic suppliers.

• Pricing and procurement controls: Cost competitiveness drives procurement decisions, notably favoring Indian and Chinese suppliers.

Emerging Trends

• Sustainable manufacturing: Suppliers investing in environmentally sustainable production methods are gaining prominence.

• Supply chain transparency: Increasing regulatory and market pressures demand better traceability and compliance across supply chains.

• Technological innovation: Use of continuous manufacturing processes and advanced quality controls ensures consistent API quality.

Conclusion

The supply landscape for Crestor’s API and finished formulations is characterized by a mix of original patent holder manufacturing (historically AstraZeneca) and a vibrant ecosystem of generic suppliers, predominantly in India and China. The API suppliers such as Hetero, Dr. Reddy’s, Aurobindo, and Zhejiang Huahai form the backbone of the production chain, ensuring global availability of Crestor. The supply chain’s resilience depends on regulatory compliance, geographic diversification, and ongoing innovations in manufacturing practices.

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Key Takeaways

• The primary API suppliers for Crestor are based in India (Hetero, Dr. Reddy’s, Aurobindo), China (Zhejiang Huahai), and other Asian countries, reflecting a globalized manufacturing network.
• Post-patent expiration has significantly expanded the number of generic manufacturers, increasing market competition and supply stability.
• Regulatory compliance and quality standards are critical, influencing supplier selection and supply chain robustness.
• Strategic diversification and technological investment are vital to mitigate risks and meet global demand efficiently.
• Market dynamics are evolving, with sustainability and transparency becoming increasing priorities for API producers.

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FAQs

1. Who are the main API suppliers for Crestor?
The principal API suppliers include Hetero Labs, Dr. Reddy’s Laboratories, Aurobindo Pharma (India), and Zhejiang Huahai Pharmaceutical (China). These companies produce rosuvastatin calcium for global markets.

2. How has patent expiry affected the supply chain of Crestor?
Patent expiry expanded manufacturing by generic companies, increasing the number and diversity of suppliers. This has enhanced supply stability but also heightened competition in pricing.

3. Are there specific regulatory requirements for suppliers of Crestor APIs?
Yes. Suppliers must comply with GMP standards approved by agencies like the FDA and EMA, ensuring safety, purity, and consistency of the API.

4. What risks are associated with the Crestor supply chain?
Risks include geopolitical tensions, quality compliance failures (e.g., contamination issues), raw material shortages, and logistical disruptions—particularly in Asian manufacturing hubs.

5. Is the supply of Crestor likely to be affected by environmental or sustainability policies?
Increasingly, suppliers investing in sustainable manufacturing practices may safeguard supply continuity and meet evolving regulatory and market expectations.

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Sources:
[1] Reuters. “Chinese API maker Zhejiang Huahai faces scrutiny after contamination scandal.” 2019.