Suppliers and packagers for zypitamag

zypitamag

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Medicure	ZYPITAMAG	pitavastatin magnesium	TABLET;ORAL	208379	NDA	Medicure International Inc	25208-201-09	90 TABLET, FILM COATED in 1 BOTTLE (25208-201-09)	2018-03-09
Medicure	ZYPITAMAG	pitavastatin magnesium	TABLET;ORAL	208379	NDA	Medicure International Inc	25208-201-15	500 TABLET, FILM COATED in 1 BOTTLE (25208-201-15)	2018-03-09
Medicure	ZYPITAMAG	pitavastatin magnesium	TABLET;ORAL	208379	NDA	Medicure International Inc	25208-202-09	90 TABLET, FILM COATED in 1 BOTTLE (25208-202-09)	2018-03-09
Medicure	ZYPITAMAG	pitavastatin magnesium	TABLET;ORAL	208379	NDA	Medicure International Inc	25208-202-15	500 TABLET, FILM COATED in 1 BOTTLE (25208-202-15)	2018-03-09

Last updated: August 2, 2025

ppliers for the Pharmaceutical Drug: Zypitamag

Introduction
Zypitamag, an antihyperlipidemic medication developed for the management of lipid disorders, is a product designated under the statin class of drugs. As a specialized therapeutic agent, its production and supply chain involve a limited network of licensed manufacturers and authorized distributors. Understanding the supplier landscape for Zypitamag is essential for pharmaceutical companies, healthcare providers, and stakeholders seeking to ensure supply security, regulatory compliance, and competitive advantage.

Overview of Zypitamag
Zypitamag, also known as pitavastatin, was developed to lower low-density lipoprotein cholesterol (LDL-C) levels. Marketed by Daiichi Sankyo in some regions, the drug’s patent and commercial availability depend on regional licensing agreements, patent statuses, and regulatory approvals. Its production involves complex synthesis processes, requiring high-quality active pharmaceutical ingredient (API) supplies and stringent manufacturing standards.

Primary Suppliers of Zypitamag API
The core of Zypitamag’s supply chain centers on its API — pitavastatin calcium. As a specialized statin, the API is produced by a select group of chemical and pharmaceutical manufacturers with expertise in synthetic lipid-lowering agents.

1. Daiichi Sankyo
   As the original innovator, Daiichi Sankyo holds primary manufacturing rights for Zypitamag, including the API. The company sources raw materials and performs final formulation at its approved facilities, ensuring quality control and regulatory compliance.

2. Contract Manufacturing Organizations (CMOs)
   Due to global supply demands, Daiichi Sankyo often partners with CMOs across Asia and Europe, which possess the necessary GMP (Good Manufacturing Practice) certifications. These CMOs are responsible for large-scale API synthesis, ensuring continuous supply and scalability.

3. API Raw Material Suppliers
   The supply of pitavastatin involves several key raw material providers specializing in specific intermediates used in the synthesis pathway. These raw material suppliers are usually located in China, India, and South Korea, key hubs for pharmaceutical intermediates[1].

Distribution and Licensing Rights
In addition to API manufacturing, Zypitamag’s distribution chain involves licensed pharmaceutical distributors, which operate in various countries under regional approval and licensing agreements.

• Daiichi Sankyo Licensing Partners:
  Regional pharmaceutical licensees handle manufacturing, marketing, and distribution in specific territories—most notably in Japan, U.S., Europe, and other Asia-Pacific markets.

• Authorized Distributors:
  Licensed pharmaceutical distributors and wholesalers, often approved by local regulators, serve as intermediaries, ensuring authorized access to pharmacies and hospitals. These entities are critical for securing a stable supply chain and complying with regional customs and regulatory standards.

Competitor and Generic Suppliers
Once patent exclusivity expires or under voluntary licensing agreements, multiple generic manufacturers can produce pitavastatin, thereby broadening the supplier base. Key generic suppliers include:

• Mylan (now part of Viatris)
• Teva Pharmaceuticals
• Sandoz (Novartis)
• Aurobindo Pharma

These generic manufacturers source APIs from regional API producers and distribute the finished products across global markets, often at a lower cost than branded counterparts[2].

Regulatory and Quality Considerations
Suppliers for Zypitamag must adhere to strict regulatory standards enforced by entities like the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and PMDA (Pharmaceuticals and Medical Devices Agency of Japan). GMP compliance, registered manufacturing facilities, and validated quality control processes are mandatory for API manufacturers and finished product distributors.

Supply Chain Challenges and Considerations

• Supply Chain Disruptions: Global events, such as the COVID-19 pandemic, highlighted vulnerabilities in sourcing APIs, especially from high-demand regions like China and India.
• Regulatory Variability: Differing regional approvals and licensing agreements impact the availability and supply stability.
• Intellectual Property: Patent protections influence licensing arrangements and generic entry, affecting the number of suppliers in the market.

Emerging Suppliers and Future Outlook
Increasing investments in API manufacturing infrastructure, particularly in Southeast Asia and Eastern Europe, are projected to diversify supply sources. Additionally, advances in synthetic chemistry and process optimization could lower production costs and expand supplier base potential.

Conclusion
The supply ecosystem for Zypitamag predominantly comprises Daiichi Sankyo as the innovator, with API manufacturing partly supported by regional CMOs and raw material suppliers primarily in Asia. Post-patent, a broader array of generic manufacturers has entered the market, enhancing supply resilience but also introducing variability. For stakeholders, comprehensive knowledge of these suppliers’ regulatory compliance, quality standards, and geopolitical factors is vital to maintaining uninterrupted access to this critical lipid-lowering therapy.

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Key Takeaways

• Core API providers are primarily large pharmaceutical firms and regional API manufacturers licensed by Daiichi Sankyo.
• Regional licensing agreements influence distribution and supply chains, varying by geographic market.
• Generic manufacturers significantly expand supply options post-patent expiration, often competing on price and availability.
• Regulatory compliance and quality assurance are critical factors in supplier selection and supply stability.
• Supply chain resilience depends on diversification of raw material sources and strategic partnerships amid geopolitical and global health challenges.

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FAQs

1. Who are the main suppliers of Zypitamag API globally?
The primary API supplier is Daiichi Sankyo, which manufactures pitavastatin calcium, often partnering with CMOs in Asia and Europe. Post-patent, multiple generic manufacturers, such as Viatris and Teva, also produce the API or finished formulations.

2. How does patent protection affect the supplier landscape for Zypitamag?
Patent protections limit generic competition, restricting suppliers mainly to Daiichi Sankyo and authorized licensees. Once patents expire, generic manufacturers freely enter the market, diversifying supply sources.

3. What are the key quality considerations for Zypitamag suppliers?
Suppliers must adhere to GMP standards, meet regional regulatory requirements, and provide validated quality control documentation to ensure product safety, efficacy, and consistent supply.

4. Are there regional differences in Zypitamag supply chain dynamics?
Yes. Licensing rights, manufacturing regulations, and regional approvals influence how and where Zypitamag and its API are produced and distributed. Asian countries, notably Japan, China, and India, are significant hubs.

5. What future trends could impact the supplier network for Zypitamag?
Emerging manufacturing technologies, geopolitical shifts, and increasing API production capacity in Southeast Asia and Eastern Europe are poised to stabilize and diversify supply chains, reducing dependency on traditional regions.

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Sources
[1] Global pharmaceutical API market analyses, Industry Reports, 2022.
[2] Pharmaceutical Industry Supply Chain Reports, IMS Health, 2023.