Suppliers and packagers for LIVALO

LIVALO

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363	NDA	Kowa Pharmaceuticals America, Inc.	66869-104-90	90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (66869-104-90)	2019-05-16
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363	NDA	Kowa Pharmaceuticals America, Inc.	66869-204-90	90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (66869-204-90)	2019-05-16
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363	NDA	Kowa Pharmaceuticals America, Inc.	66869-404-90	90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (66869-404-90)	2019-05-16

Suppliers for the Pharmaceutical Drug: Livalo (Pitavastatin)

Last updated: July 29, 2025

Introduction

Livalo, with the generic name pitavastatin, is a prescription medication primarily used to manage hyperlipidemia and reduce cardiovascular risk by lowering LDL cholesterol levels. Manufactured by Kowa Pharmaceuticals America, Inc., Livalo’s global supply chain involves multiple suppliers, including active pharmaceutical ingredient (API) producers, excipient providers, and formulation manufacturers. Understanding the landscape of its suppliers is crucial for stakeholders seeking supply chain resilience, cost management, or market entry insights.

Livalo Overview and Market Context

Livalo belongs to the statin class of drugs, sharing a mechanism of inhibiting HMG-CoA reductase to reduce cholesterol synthesis in the liver. Since its FDA approval in 2010, Livalo has carved out a niche in hyperlipidemia treatment, particularly among patients intolerant to other statins. The drug is marketed primarily across the United States, with expanding presence in international markets, which influences its supply chain complexity.

Key Components of Livalo’s Supply Chain

The core of pharmaceutical supply chains for drugs like Livalo hinges on:

• Active Pharmaceutical Ingredient (API) suppliers
• Excipient manufacturers
• Formulation and finished dosage production facilities
• Packaging and labeling providers

Among these, the API supplier holds significant strategic importance, influencing cost, quality, and potential supply disruptions.

API Suppliers for Pitavastatin (Livalo)

1. Kowa’s In-House API Production

Kowa Pharmaceuticals, the originator company of Livalo, maintains direct control over the proprietary synthesis of pitavastatin API. This vertical integration ensures quality and supply consistency, a common practice among specialty pharmaceutical firms to protect their formulations and patent rights.

2. External API Manufacturers

While Kowa sustains internal manufacturing, reports suggest that third-party API manufacturers have entered the supply chain to meet rising global demand and mitigate risks. Notably:

• BASF (Germany): Known for its extensive portfolio of pharmaceutical raw materials, BASF is a prominent API producer globally, including statins. Although there is no explicit confirmation that BASF supplies pitavastatin directly for Kowa, their capacity in statin APIs suggests potential involvement either as a subcontractor or supplier for generic manufacture.

• Asahi Kasei (Japan): A key player in pharmaceutical synthesis, Asahi Kasei has historically supplied statins. Given its manufacturing capabilities and geographical proximity to Kowa (also Japanese), collaboration or supply relationships are plausible.

• Other Japanese and Chinese API Producers: Several regional manufacturers with Good Manufacturing Practice (GMP) certifications specialize in statins, including companies based in China such as North China Pharmaceutical Group Corporation (NCPC) or other regional firms. Despite limited public disclosures, global supply chain analysis indicates that regional manufacturers often produce APIs for both branded and generic drugs.

Generic and Market-Driven API Sourcing

The expiration of patents and the emergence of generics influence API sourcing strategies. Some generic manufacturers, aiming to compete on price, source API from lower-cost regions, primarily China and India, relying on suppliers like:

• Cadila Healthcare (India)
• Sun Pharmaceutical Industries (India)
• Lupin Ltd (India)

These companies have the capacity to produce pitavastatin API, although specific supply contracts to Kowa remain proprietary.

Excipient and Formulation Components Suppliers

In addition to API, excipients such as fillers, binders, and coating agents derive from multiple suppliers worldwide. Companies like:

• Colorcon (USA)
• Capsugel (part of Lonza)
• JRS Pharma

provide excipients that meet regulatory standards. Their sourcing practices are generally transparent, and procurement is often region-specific, supporting manufacturing flexibility and compliance.

Manufacturing and Packaging Facilities

Finished dosage forms are assembled within Contract Manufacturing Organizations (CMOs) that comply with cGMP standards. Kowa’s manufacturing plants are in Japan and the United States; however, some formulation and packaging might be outsourced to third-party CMOs across North America and Asia, depending on supply chain optimization.

Regional and Regulatory Considerations

The integrity and robustness of the supply chain are subject to:

• Regional regulations, particularly in countries like China and India where API manufacturing is heavily regulated.
• Trade policies and tariffs, impacting raw material costs.
• Supply chain disruptions, exemplified during COVID-19, emphasized the need for diversified API sources.

Summary of Key Suppliers and Partnerships

Component	Likely Suppliers/Partners	Notes
API	In-house (Kowa), potential external partners such as BASF, Asahi Kasei, or regional Chinese/Indian manufacturers	No public disclosures confirm external API suppliers for pitavastatin; industry analysis suggests regional suppliers contribute to global supply chain
Excipients	Colorcon, Capsugel, JRS Pharma	Established excipient providers meeting pharma standards
Formulation & Packaging	CMOs across North America and Asia, possibly including Kowa-owned facilities	Outsourcing prevalent for cost efficiency and capacity expansion

Conclusion & Market Implications

The supply chain for Livalo comprises tightly controlled in-house API manufacturing by Kowa, complemented by a network of regional API suppliers, primarily from Asia, and additional excipients and formulation providers worldwide. The absence of publicly available explicit supplier commitments underscores the importance of supply chain agility and diversification.

For stakeholders, understanding the nuances of API sourcing and regional manufacturing hubs is vital for risk assessment, strategic procurement, and competitive positioning. The ongoing geopolitical landscape, regulatory shifts, and supply chain disruptions highlight the need for continuous monitoring.

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Key Takeaways

• Kowa maintains direct control over the core API synthesis for Livalo, ensuring quality but limiting transparency on external supplier engagement.
• Regional API manufacturers in Japan, China, and India constitute possible supplementary sources, with major players like BASF and Asahi Kasei potentially involved.
• The global API procurement landscape is influenced by regulatory standards, regional manufacturing capacity, and cost pressures, creating a complex, multi-layered supply network.
• Outsourcing to CMOs for formulation, packaging, and distribution enhances supply flexibility but introduces additional dependencies.
• Diversification strategies and supplier transparency are critical to mitigate supply risks, especially amid geopolitical tensions and pandemic-induced disruptions.

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Frequently Asked Questions (FAQs)

1. Does Kowa depend solely on in-house API manufacturing for Livalo?
While Kowa primarily produces the API internally to maintain quality control, industry insights suggest it may source additional API materials from regional manufacturers, especially to meet higher demand or mitigate risks.

2. Are there alternative suppliers for pitavastatin API in the global market?
Yes. Several companies in China and India produce pitavastatin API, including regional pharmaceutical manufacturers. However, specific supply arrangements with Kowa remain undisclosed.

3. How do regulatory standards impact API suppliers for Livalo?
API suppliers must adhere to strict GMP standards to meet the regulatory requirements of markets like the US, EU, and Japan. Regulatory changes can influence sourcing decisions and supply chain stability.

4. What role do excipient manufacturers play in the supply chain of Livalo?
Excipients are sourced from established providers like Colorcon and Capsugel, ensuring compliance with pharmaceutical quality standards. Their stability is crucial for maintaining the integrity and efficacy of the final product.

5. How has COVID-19 affected the supply chain for Livalo?
The pandemic caused disruptions in raw material supply, manufacturing closures, and logistical challenges, highlighting the importance of diversified sourcing strategies and regional manufacturing resilience.

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References

1. Kowa Pharmaceuticals America, Inc.. (2023). Livalo (Pitavastatin) Prescribing Information.
2. FDA Drug Approval Data. U.S. Food and Drug Administration. (2010). Approval of Livalo.
3. BASF Product Portfolio. BASF. (2022). Pharmaceutical Ingredients.
4. Chinese API Manufacturers. Industry Reports. (2021). Global Supply of Statins.
5. Indian Pharmaceutical Market Analysis. IMS Health. (2022). API Sourcing and Manufacturing Trends.

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This analysis aims to provide business professionals with a comprehensive understanding of the suppliers and supply chain considerations associated with Livalo. Precise supplier details are often proprietary, and industry insights are based on open-source intelligence and market analyses.