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Suppliers and packagers for generic pharmaceutical drug: PITAVASTATIN CALCIUM
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PITAVASTATIN CALCIUM
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: PITAVASTATIN CALCIUM
Introduction
Pitavastatin calcium stands as a potent lipid-lowering agent, widely prescribed to mitigate hypercholesterolemia and reduce cardiovascular risk. As a member of the statin class, pitavastatin functions by inhibiting HMG-CoA reductase, thereby decreasing hepatic cholesterol synthesis. The demand for this drug has surged globally, driven by increasing cardiovascular disease prevalence and evolving therapeutic guidelines. Understanding the landscape of suppliers for pitavastatin calcium is crucial for pharmaceutical companies, healthcare providers, and regulators intent on securing a reliable supply chain, ensuring drug quality, and optimizing procurement strategies.
Global Market Overview for Pitavastatin Calcium
The commercial production and distribution of pitavastatin calcium are primarily concentrated among pharmaceutical manufacturing giants and generic drug producers. The patent protection landscape, regulatory approvals, and regional market demands shape the supply network. Key markets include Japan, where the drug was initially developed and approved, alongside significant markets in the United States, Europe, and emerging economies in Asia and Latin America.
Major Suppliers and Manufacturers
1. Kowa Company, Ltd. (Japan)
Overview: Kowa developed pitavastatin and was the first to commercialize it globally. Their patent rights and manufacturing facilities primarily cater to Asian markets. As an innovator, Kowa supplies both patented formulations and licensing agreements to regional partners.
Supply Focus: Original research drugs, branded formulations, and regional licensing.
2. Mitsubishi Tanabe Pharma Corporation (Japan)
Overview: Mitsubishi Tanabe has engaged in manufacturing and marketing pitavastatin, leveraging its extensive R&D capabilities. As a key player in Japan, the company supplies both original and generic forms.
Supply Focus: Original and biosimilar formulations for Japanese and select international markets.
3. Dr. Reddy’s Laboratories (India)
Overview: As a prominent generic manufacturer, Dr. Reddy’s produces pitavastatin calcium in multiple strengths, targeting global markets, including North America, Europe, and Asia.
Supply Focus: Competitive generic formulations, meeting rigorous quality standards to obtain international regulatory approvals.
4. Sun Pharmaceutical Industries Ltd. (India)
Overview: Sun Pharma’s global footprint includes manufacturing and marketing pitavastatin calcium. Their focus encompasses high-volume production for both regional and global markets.
Supply Focus: Cost-effective generics with a focus on quality assurance and regulatory compliance.
5. Teva Pharmaceutical Industries Ltd. (Israel)
Overview: Teva offers a range of statins, including pitavastatin, through its extensive global distribution network. Their manufacturing facilities are GMP-certified to meet international standards.
Supply Focus: Generics marketed across multiple regions, including North America and Europe.
6. LC Laboratories (United States)
Overview: Unlike large pharmaceutical firms, LC Laboratories focuses on research chemicals and custom synthesis, sometimes providing high-purity pitavastatin calcium to research institutions and specialty pharmaceutical companies.
Supply Focus: Custom synthesis and specialty-grade pitavastatin for experimental and clinical research.
Regulatory and Licensing Dynamics
Manufacturers generally operate under strict Good Manufacturing Practices (GMP) certifications and obtain approval from regulatory agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and PMDA (Pharmaceuticals and Medical Devices Agency) in Japan. Licensing agreements often exist between original developers like Kowa and regional generic manufacturers, influencing the supply landscape dynamically.
Key Suppliers for Bulk Active Pharmaceutical Ingredient (API)
The supply of pitavastatin calcium as an API hinges primarily on large-scale manufacturers with robust GMP compliance:
- Mitsubishi Tanabe Pharma (Japan) – Original API supplier.
- Dr. Reddy’s Laboratories – Leading generic API manufacturer.
- Sun Pharmaceutical, Teva – Major players providing API for generics.
- LC Laboratories – Specialty API synthesis for research.
Regional API producers are often complemented by international traders and brokers, especially in markets like China and India, where high-volume manufacturing capitalizes on lower production costs.
Regional Market Considerations
North America and Europe
In these markets, supply is predominantly sourced from established generic manufacturers like Dr. Reddy’s, Teva, and Sun Pharma, driven by stringent regulatory standards. Their API quality assurance aligns with FDA and EMA requirements, ensuring market access and compliance.
Asia-Pacific
In Japan, original manufacturers like Kowa and Mitsubishi Tanabe dominate. Meanwhile, India’s generics sector, including Dr. Reddy’s and Sun Pharma, supplies APIs and finished formulations to domestic and export markets.
Emerging Economies
Manufacturers in China and India increasingly serve as API suppliers due to cost advantages, with many obtaining WHO-GMP certification to ensure quality standards support global exports.
Challenges in Supplier Selection
- Regulatory Compliance: Ensuring suppliers meet quality standards mandated by target markets’ regulatory authorities.
- Supply Chain Stability: Supplier reliability and capacity to meet demand fluctuations.
- Cost Competitiveness: Balancing quality with procurement cost, especially for generics.
- Intellectual Property Rights: Navigating patent landscapes and licensing agreements.
- Quality Assurance: Consistent GMP compliance, extensive analytical validation, and release testing.
Future Outlook
The landscape for pitavastatin calcium suppliers is expected to evolve with patent expirations and increased approval of biosimilars and generics. Regional manufacturers in India and China are poised to expand their market shares, driven by cost advantages and increasing global demand. Additionally, supply chain diversification and advanced manufacturing technologies will play vital roles in securing consistent quality and availability.
Key Takeaways
- The primary manufacturers of pitavastatin calcium include original developers like Kowa and Mitsubishi Tanabe, as well as global generic producers such as Dr. Reddy’s, Sun Pharma, and Teva.
- The API supply chain is concentrated in Asia, with certified GMP facilities ensuring compliance for international markets.
- Regulatory standards significantly influence supplier qualification and procurement decisions.
- Cost, quality, and supply reliability remain critical factors in supplier selection for pharmaceutical companies.
- Market dynamics will shift with patent expiries, increasing generic competition, and regional manufacturing capacity expansion.
FAQs
1. Who are the leading producers of pitavastatin calcium API globally?
Major API producers include Mitsubishi Tanabe Pharma (Japan), Dr. Reddy’s Laboratories (India), Sun Pharmaceutical Industries (India), and Teva Pharmaceuticals (Israel), all maintaining GMP-certified manufacturing facilities for global markets.
2. Are there regional differences in suppliers for pitavastatin calcium?
Yes. Japan's market primarily relies on original manufacturers like Kowa and Mitsubishi Tanabe, whereas India and China supply a significant portion of generic APIs. Regulatory standards influence sourcing decisions across regions.
3. What factors should be considered when selecting a pitavastatin calcium supplier?
Quality compliance (GMP certification), regulatory approval, manufacturing capacity, supply stability, cost, and intellectual property considerations.
4. How might patent expiries affect the supplier landscape?
Patent expirations will open markets for additional generics, increasing competition among manufacturers, particularly in India and China, and potentially lowering prices and expanding supply options.
5. Are there specialized suppliers for research-grade pitavastatin?
Yes, companies like LC Laboratories provide high-purity, research-grade pitavastatin calcium for experimental use, further diversifying the supply chain beyond pharmaceutical-grade APIs.
References
- [1] Kowa Company, Ltd.: Official website and product portfolio.
- [2] Mitsubishi Tanabe Pharma: Regulatory filings and global manufacturing data.
- [3] Dr. Reddy’s Laboratories: API manufacturing and global markets.
- [4] Sun Pharmaceutical Industries: Global API production overview.
- [5] Teva Pharmaceutical Industries: Supply chain and compliance standards.
- [6] World Health Organization (WHO): API manufacturing standards and certification data.
Note: Specific citations pertain to publicly available corporate disclosures and regulatory filings as of 2023.
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