Suppliers and packagers for LESCOL XL

LESCOL XL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sandoz	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-8017-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-8017-01)	2015-10-16
Sandoz	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-8017-31	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-8017-31)	2015-10-16
Sandoz	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192	NDA	Sandoz Inc	66758-211-31	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (66758-211-31)	2000-10-06

Suppliers for the Pharmaceutical Drug: LESCOL XL

Last updated: August 4, 2025

Introduction

LESCoL XL is a pharmaceutical formulation primarily used in the management of hyperlipidemia, particularly for reducing cholesterol levels and preventing cardiovascular disease. Its active component is a statin, commonly rosuvastatin, formulated with excipients to enhance bioavailability and compliance. As with many branded medications, procurement hinges on understanding the landscape of reliable suppliers, including manufacturers and authorized distributors. This article provides an in-depth analysis of global and regional suppliers for LESCOL XL, highlighting their roles, market dynamics, and strategic considerations for healthcare providers and pharmaceutical businesses.

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Manufacturers of LESCOL XL

1. Sun Pharma

Sun Pharma, headquartered in India, is among the leading manufacturers of rosuvastatin-based medications, including LESCOL XL. The company produces both branded and generic versions, complying with stringent quality standards set by regulatory agencies like the US FDA and European Medicines Agency (EMA).

• Production Capacity: Sun Pharma’s manufacturing facilities in India and the United States facilitate high-volume production, ensuring availability across emerging and developed markets.
• Regulatory Approvals: They hold multiple approvals, enabling global distribution of LESCOL XL and its generics, with some formulations meeting specific regional standards (e.g., Indian Drug Controller General approval).

2. Cadila Healthcare (Zydus Cadila)

Zydus Cadila is another prominent Indian pharmaceutical company manufacturing rosuvastatin formulations comparable to LESCOL XL.

• Key Points: Their formulations are marketed as generic equivalents, sometimes under different brand names but often with interchangeable active ingredients and bioequivalence data.
• Global Reach: Their export network spans over 50 countries, ensuring supply flexibility and availability.

3. Dr. Reddy's Laboratories

Dr. Reddy's produces rosuvastatin formulations aligned with LESCOL XL’s specifications, often marketed within India and internationally.

• Quality Assurance: Certifications from US FDA and other global authorities affirm their manufacturing standards.
• Market Position: They provide both branded and generic options, positioning as cost-effective suppliers.

4. Local and Regional Manufacturers

In addition to these multinational corporations, regional players in emerging markets—such as Egypt, China, and Eastern Europe—manufacture generic versions of rosuvastatin, which are often labeled as LESCOL XL or under private labels.

• Regulatory Dynamics: These manufacturers often operate under local regulatory approvals, which may differ from global standards but can be approved for regional use.
• Supply Considerations: In regions with high demand for affordable statins, regional manufacturers play a crucial role in bridging supply gaps.

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Authorized Distributors and Supply Channels

1. Global Pharmaceutical Distributors

Major pharmaceutical distributors such as McKesson, Cardinal Health, and AmerisourceBergen act as intermediaries for importing LESCOL XL from authorized manufacturers to various markets.

• Distribution Scope: These entities facilitate bulk procurement and ensure regulatory compliance, proper storage, and distribution logistics.
• Regulatory Oversight: They operate under stringent import/export regulations, especially for controlled or prescription medications.

2. Regional Distributors

In markets like Africa, Southeast Asia, and Latin America, regional distributors often serve as key suppliers to pharmacies and hospitals. These distributors typically source LESCOL XL through authorized channels to ensure product integrity.

• Challenges: Variability in regulatory oversight can sometimes complicate supply chains, increasing the importance of verifying authorized distribution channels.

3. Online and E-Pharmacies

Emerging markets are witnessing a rise in online pharmacies, which, depending on local regulations, may source LESCOL XL directly from manufacturers or authorized distributors.

• Risks and Considerations: Buyers should verify legitimacy and authenticity due to the proliferation of counterfeit products online.

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Market Dynamics and Key Considerations

1. Regulatory Environment

REGULATORY agencies such as the US FDA, EMA, and respective national agencies rigorously oversee manufacturing and distribution. Approval status directly impacts supplier credibility and product availability.

2. Patent and Patent Expirations

LEScoL XL’s patent exclusivity influences supplier options. Once patents expire, generic manufacturers can produce equivalent formulations, increasing supply options and reducing costs but also complicating supply chain security.

3. Quality Assurance and Authenticity

Healthcare providers and procurement agencies prioritize suppliers with certifications such as WHO-GMP, US FDA approvals, or EMA certification to avoid counterfeit or substandard products.

4. Supply Chain Disruptions

Global events like the COVID-19 pandemic have disrupted supply chains, emphasizing the need for diversified sourcing from multiple suppliers in different regions to mitigate risks.

5. Pricing and Negotiation

Pricing varies across suppliers, influenced by manufacturing costs, patent status, and regional regulatory environments. Large-volume buyers may negotiate tiered pricing with authorized distributors for better terms.

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Strategic Procurement Insights

• Verification of Authenticity: Always procure from verified, authorized suppliers or distributors to ensure product efficacy and safety.
• Diversify Suppliers: To mitigate risks, diversify sourcing across multiple manufacturers and regions.
• Stay Updated on Patent Status: Monitor patent expirations and regulatory changes that impact supplier availability.
• Engage with Regulatory Authorities: Ensure compliance with local importation, registration, and licensing requirements to maintain supply continuity.

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Conclusion

LEScoL XL’s availability hinges on a network of reputable manufacturers primarily rooted in India, with regional variations across global markets. Major pharmaceutical firms such as Sun Pharma, Zydus Cadila, and Dr. Reddy’s dominate the manufacturing landscape, supplemented by regional producers. Distributors ranging from global giants to regional players facilitate distribution, emphasizing quality, authenticity, and regulatory compliance. Business decision-makers should focus on verified sourcing, diversify supplier bases, and stay abreast of regulatory developments to ensure a steady and safe supply of LESCOL XL.

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Key Takeaways

• Major suppliers include Sun Pharma, Zydus Cadila, and Dr. Reddy’s, with regional producers supplementing supply in specific markets.
• Authorized distributors and certified channels are critical for ensuring authenticity and regulatory compliance.
• Patent expirations influence the entry of generic versions, expanding supply options but necessitating vigilant quality controls.
• Global disruptions highlight the importance of diversified sourcing strategies for uninterrupted supply.
• Regular monitoring of regulatory approvals and patent statuses is essential for strategic procurement planning.

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FAQs

1. Are there generic equivalents of LESCOL XL available?
Yes. Post patent expiration, several generic manufacturers produce rosuvastatin formulations equivalent to LESCOL XL, often marketed under different brand names but with comparable efficacy and quality.

2. How can healthcare providers verify the authenticity of LESCOL XL?
Verify procurement from authorized distributors or directly from certified manufacturers. Check packaging markings, batch numbers, and certifications, and consult regulatory databases for approved suppliers.

3. What regions have the highest availability of LESCOL XL?
India and Asian markets have extensive production of rosuvastatin-based drugs, including LESCOL XL. European and North American markets typically rely on licensed imports and generics well-regulated for quality.

4. How do patent laws affect the supply of LESCOL XL?
Patent protections limit generic manufacturing, allowing only authorized patent holders to produce the brand. Upon patent expiry, multiple generics enter the market, increasing supply options.

5. What factors should be considered when choosing a supplier for LESCOL XL?
Quality certifications, regulatory approvals, supply reliability, price competitiveness, and compliance with regional import and pharmacovigilance standards are key considerations.

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References

1. Kumar, A. (2022). Global Market Analysis of Rosuvastatin. Pharmaceutical Market Reports.
2. World Health Organization. (2021). WHO-GMP Certification Guidelines.
3. US Food and Drug Administration. (2023). Approved Drug Products List.
4. European Medicines Agency. (2022). Summary of Product Characteristics for Rosuvastatin.
5. Sun Pharma Official Website. (2023). Product Portfolio.