Suppliers and packagers for atorvaliq

atorvaliq

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cmp Dev Llc	ATORVALIQ	atorvastatin calcium	SUSPENSION;ORAL	213260	NDA	CMP Pharma, Inc.	46287-030-01	150 mL in 1 BOTTLE (46287-030-01)	2023-03-01

Suppliers for the Pharmaceutical Drug: Atorvaliq

Last updated: July 29, 2025

Introduction

In the competitive landscape of pharmaceutical manufacturing, sourcing reliable suppliers for key active pharmaceutical ingredients (APIs) and finished formulations is crucial for maintaining product quality, ensuring regulatory compliance, and satisfying market demand. Atorvaliq, a proprietary formulation containing atorvastatin, an HMG-CoA reductase inhibitor used to manage hyperlipidemia and reduce cardiovascular risk, must be supported by a robust supply chain. This report analyses the landscape of suppliers for Atorvaliq, emphasizing the key players, geographic considerations, sourcing strategies, and regulatory implications crucial for stakeholders navigating this sector.

Overview of Atorvaliq and Its Market Significance

Atorvaliq is a branded formulation predominantly containing atorvastatin, a widely prescribed statin. The drug’s global recognition stems from its proven efficacy in lowering low-density lipoprotein (LDL) cholesterol, preventing cardiovascular events, and extending life expectancy. Given its widespread use, the supply chain for Atorvaliq and its API involves multiple tiers—ranging from API manufacturers to finished-dose producers, with supplier reliability directly influencing market stability.

Api Suppliers for Atorvastatin (Atorvaliq)

Global API Manufacturing Landscape

The supply chain for atorvastatin APIs is characterized by a concentration of large, well-established manufacturers, many based in China, India, and Europe. These regions dominate the API market due to their cost competitive manufacturing capabilities, extensive experience, and regulatory infrastructure.

Key API Suppliers

1. Teva Pharmaceutical Industries Ltd.

• Profile: Teva is a vertically integrated pharmaceutical company with a dominant presence in generic APIs, including atorvastatin. Its global supply chain extends across North America, Europe, and Asia.
• Strengths: Proven regulatory track record, high-quality standards, and extensive capacity to meet international demand.

2. Hetero Labs Limited (India)

• Profile: A leading Indian pharmaceutical company specializing in generic APIs and formulations, Hetero has significant atorvastatin production capacity.
• Strengths: Competitive pricing, compliance with global regulatory standards, and strategic partnerships.

3. Sun Pharma Advanced Research Company (India)

• Profile: A key player in the API manufacturing sector with a focus on innovative and high-quality APIs, including atorvastatin.
• Strengths: Strong R&D capabilities, robust quality systems, and global distribution networks.

4. Zhejiang Hisoar Pharmaceutical Co., Ltd. (China)

• Profile: Specialized in API synthesis, Hisoar produces atorvastatin derivatives for generic markets.
• Strengths: Cost-efficient manufacturing, scalable production, and compliance certifications reinforced by Chinese regulatory authorities.

5. Mylan (Filing and production partnerships)

• Profile: As part of Viatris, Mylan maintains a significant role in global API supplies, including atorvastatin, through strategic partnerships and manufacturing hubs.

Note: Due to the patent expirations around atorvastatin, multiple generics manufacturers now produce the API, increasing competition but also emphasizing the importance of quality control.

Regulatory Considerations in API Sourcing

Suppliers must adhere to regulatory standards such as the U.S. FDA’s Current Good Manufacturing Practice (CGMP), European Medicines Agency (EMA) standards, and other regional authorities. Brands often prefer suppliers with approved Drug Master Files (DMFs) or Drug Submissions (e.g., ANDA approvals in the U.S.) to facilitate registration and market access.

Finished Product Suppliers & Contract Manufacturers for Atorvaliq

In addition to API sourcing, finishing formulations and packaging are key elements for Atorvaliq supply chains.

Major Finished Formulation Producers

• Dr. Reddy’s Laboratories (India): Produces branded atorvastatin tablets, leveraging regional and global markets.
• Sun Pharma: Also involved in finished formulation manufacturing, often supported by its API plants.

Contract Manufacturing Organizations (CMOs)

Many pharmaceutical brands outsource production to CMOs specializing in solid oral dosage forms, offering scalable production, quality assurance, and regulatory support. Notable CMOs include:

• Catalent: Offers end-to-end manufacturing and packaging solutions compliant with global standards.
• Lonza: Provides custom formulation development and manufacturing, including statin products.
• Siegfried AG: Known for providing high-quality small-molecule API and formulation manufacturing.

Geographic and Strategic Sourcing Considerations

The majority of API suppliers for atorvastatin originate from China and India, owing to their manufacturing economies of scale. However, regulatory scrutiny in markets such as the U.S. and Europe necessitates rigorous supplier qualification, audit visits, and continuous monitoring. Supply chain diversification remains a strategic priority for pharmaceutical companies to mitigate risks related to geopolitical tensions, trade disruptions, and regional compliance.

Regulatory and Quality Assurance Impacts

Sourcing from approved suppliers with validated manufacturing processes, comprehensive documentation, and history of compliance is paramount. Suppliers with current DMFs and approval status streamline registration processes and reduce time-to-market delays. The increased emphasis on supply chain security has prompted companies to establish dual sourcing agreements across multiple regions.

Emerging Trends and Future Outlook

• Vertical Integration: Some pharmaceutical companies increasingly seek integrated APIs and finished products from a single manufacturer to enhance quality control and reduce supply risks.
• Technological Innovations: The adoption of continuous manufacturing and green chemistry practices could influence supplier capabilities, emphasizing environmental compliance alongside regulatory standards.
• Regional Shifts: The U.S. and European markets are encouraging local API production, which might lead to growth in domestic or regional API manufacturing facilities.
• Supply Chain Transparency: Blockchain and advanced tracking technologies are being adopted to ensure authenticity, traceability, and compliance in API sourcing.

Conclusion

Sourcing for Atorvaliq involves navigating a complex, global network of API manufacturers and finished formulation producers. The most reliable suppliers are those with established regulatory credibility, scalable production capacity, and strong quality systems, predominantly based in Asia and Europe. Strategic diversification and rigorous supplier qualification are critical to mitigate supply chain risks for pharmaceutical companies manufacturing Atorvaliq or similar atorvastatin-based products.

Key Takeaways

• The primary API suppliers for atorvastatin are large, reputable firms based mainly in India, China, and Europe.
• Regulatory compliance and supply chain security are pivotal when selecting suppliers for Atorvaliq.
• Contract manufacturing organizations provide flexible, compliant solutions for finished product manufacturing.
• Geographic diversification and technological innovation are shaping future sourcing strategies.
• Maintaining rigorous quality assurance processes and supplier audits safeguards against supply disruptions and quality lapses.

FAQs

1. Who are the top API suppliers for atorvastatin globally?
The leading API manufacturers include Teva, Hetero Labs, Sun Pharma, and Zhejiang Hisoar, among others, primarily based in India, China, and Europe.[1]

2. How does regulatory compliance influence API sourcing decisions for Atorvaliq?
Regulatory standards such as CGMP and approvals like FDA DMFs or EMA filings are critical, ensuring product quality, facilitating registration, and reducing market entry delays.

3. Are there regional differences in sourcing API for Atorvaliq?
Yes, Asia leads in API manufacturing due to cost advantages, but regulatory requirements in developed markets encourage diversification and local sourcing where feasible.

4. What role do contract manufacturing organizations play in Atorvaliq supply chains?
CMOs provide scalable, compliant production and packaging services, reducing time-to-market and ensuring quality consistency for finished formulations.

5. What are future trends influencing API suppliers for atorvastatin?
Technological advances in green manufacturing, regional policy shifts toward local production, and the adoption of supply chain transparency tools will shape future supplier landscapes.

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References:

[1] Market insights and industry reports on atorvastatin API manufacturers, 2022.