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Suppliers and packagers for generic pharmaceutical drug: ROSUVASTATIN CALCIUM
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ROSUVASTATIN 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 |
|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm | EZALLOR SPRINKLE | rosuvastatin calcium | CAPSULE;ORAL | 208647 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-984-64 | 3 BLISTER PACK in 1 CARTON (47335-984-64) / 10 CAPSULE in 1 BLISTER PACK (47335-984-60) | 2019-05-04 |
| Sun Pharm | EZALLOR SPRINKLE | rosuvastatin calcium | CAPSULE;ORAL | 208647 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-984-81 | 90 CAPSULE in 1 BOTTLE (47335-984-81) | 2019-05-04 |
| Sun Pharm | EZALLOR SPRINKLE | rosuvastatin calcium | CAPSULE;ORAL | 208647 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-984-83 | 30 CAPSULE in 1 BOTTLE (47335-984-83) | 2019-05-04 |
| Sun Pharm | EZALLOR SPRINKLE | rosuvastatin calcium | CAPSULE;ORAL | 208647 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-985-64 | 3 BLISTER PACK in 1 CARTON (47335-985-64) / 10 CAPSULE in 1 BLISTER PACK (47335-985-60) | 2019-05-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Rosuvastatin Calcium
Summary
Rosuvastatin Calcium, a potent statin used to lower low-density lipoprotein (LDL) cholesterol and reduce cardiovascular risk, has a broad global supply chain comprising multiple reputable manufacturers and raw material suppliers. Ensuring a reliable and compliant supply chain for rosuvastatin calcium involves navigating multiple regulatory standards, sourcing from qualified suppliers, and understanding regional market dynamics.
This comprehensive analysis provides insight into major suppliers, their manufacturing capacities, regulatory statuses, and supply chain considerations. It also explores alternative sourcing strategies, compares key suppliers, and discusses implications for pharmaceutical companies and healthcare providers.
What Are the Key Suppliers of Rosuvastatin Calcium Globally?
Major Pharmaceutical Manufacturers of Finished Dosage Forms
| Company | Region | Market Share (Est.) | Notable Approvals | Manufacturing Capacity | Key Certifications |
|---|---|---|---|---|---|
| AstraZeneca | Global | Leading producer (original innovator) | NDA & ANDA approvals in US/EU | Extensive global manufacturing network | GMP, FDA, EMA, WHO |
| Mitsubishi Tanabe Pharma | Japan, Asia | Major Asian supplier | Approved in multiple Asian markets | Large-scale facilities | GMP, EU regulations |
| Teva Pharmaceutical Industries | Israel | Largest generic supplier globally | Multiple approvals including FDA, EMA | High-volume production lines | cGMP, ISO certifications |
| Macleods Pharmaceuticals | India | Leading Indian generic manufacturer | Approved in various markets | Robust domestic and international lines | WHO, GMP |
| Zhejiang Huahai Pharmaceutical | China | Noted for API manufacturing | Multiple regulatory approvals | Significant API production capacity | GMP, SFDA certifications |
Leading Raw Material Suppliers: Rosuvastatin Calcium Active Pharmaceutical Ingredient (API)
| Supplier | Region | Estimated Capacity (kg/year) | Regulatory Certifications | Key Notes |
|---|---|---|---|---|
| Zhejiang Huahai Pharmaceutical | China | 2,000–5,000 kg | GMP, SFDA | Major supplier to global pharma companies |
| Cipla Ltd. (API division) | India | 1,000–3,000 kg | WHO-GMP | Widely utilized in generics manufacturing |
| Micro Labs Ltd. | India | ~1,000 kg | WHO-GMP | Increasing export footprint |
| Dr. Reddy’s Laboratories | India | 1,500–2,500 kg | GMP | Supplies to North America and Europe |
| Laurus Labs | India | 1,200–3,000 kg | GMP | Competitive API supplier |
Emerging Suppliers and Regional Variations
- Chinese API manufacturers have increased capacity and export volumes, but face geopolitical and regulatory challenges.
- Indian API producers dominate global exports owing to cost advantages and compliance with international standards.
- European suppliers tend to focus on high-quality standards with fewer capacity constraints.
What Are the Regulatory and Certification Considerations?
Regulatory Certifications for API Suppliers
| Certification | Description | Significance | Examples of Certified Suppliers |
|---|---|---|---|
| GMP (Good Manufacturing Practices) | Ensures manufacturing quality and compliance | Required for market approval | Entire lists above |
| WHO-GMP | Certification for quality standards acceptable internationally | Indian and emerging market suppliers | Cipla, Micro Labs, Laurus Labs |
| FDA Approval (U.S.) | Regulatory approval for API manufacturing | Essential for U.S. marketed drugs | Teva, Canadian and US-based suppliers |
| EMA Certification | European regulatory compliance | Necessary for EU markets | Mitsubishi Tanabe, ZH Pharmaceuticals |
Regulatory Challenges
- Supplier Approval Status: Some suppliers may be certified in certain jurisdictions but lack approvals elsewhere.
- Supply Chain Disruptions: Regulatory inspections, geopolitical tensions, or compliance issues can impede supply.
- Traceability and Transparency: Pharmacopeial standards (USP, EP, BP) require traceability of raw materials.
Supply Chain Dynamics and Considerations
Factors Impacting Supply Reliability
| Factor | Impact | Mitigation Strategies |
|---|---|---|
| Regulatory Approvals | Limits sourcing options | Partner with certified suppliers; maintain regulatory dossiers |
| Manufacturing Capacity | Can cause shortages | Establish multiple sourcing relationships |
| Geopolitical Risks | Trade restrictions, tariffs | Diversify supplier base across regions |
| Quality Assurance | Risk of non-compliance | Frequent audits, quality agreements |
Regional Market Considerations
| Region | Key Suppliers | Regulatory Requirements | Pricing Trends |
|---|---|---|---|
| North America | Teva, Apotex | FDA regulations | Premium pricing for branded products |
| Europe | ZH Pharma, Stada | EMA standards | Competitive generic pricing |
| Asia-Pacific | Cipla, Micro Labs | WHO-GMP, local standards | Cost-effective sourcing |
| Africa & LATAM | Local manufacturers, Indian exporters | Local regulatory agencies | Lower-cost options, variable quality |
Comparison of Key Suppliers for Rosuvastatin Calcium API
| Supplier | Capacity (kg/year) | Certifications | Pricing Competitiveness | Supply Reliability | Regulatory Approvals |
|---|---|---|---|---|---|
| Zhejiang Huahai | 2,000–5,000 | GMP, SFDA | Moderate | High | Multiple markets |
| Cipla Ltd. | 1,000–3,000 | WHO-GMP | High | High | Global |
| Micro Labs | ~1,000 | WHO-GMP | Competitive | Moderate | Several jurisdictions |
| Dr. Reddy’s | 1,500–2,500 | GMP | Competitive | Reliable | US, EU, India |
| Laurus Labs | 1,200–3,000 | GMP | Competitive | Good | Global |
How Do Suppliers Impact Market Dynamics for Rosuvastatin Calcium?
- Pricing Fluctuations: API supply constraints from top suppliers can increase prices.
- Quality Standards: Suppliers with rigorous certification mitigate regulatory compliance risks.
- Supply Chain Flexibility: Multi-sourcing minimizes shortages and ensures steady production.
- Market Entry: New entrants often leverage regional suppliers with lower costs.
Deep Dive: How Do Regulatory Policies Affect Supplier Selection?
- US FDA Enforcement: Intensified inspections restrict non-compliant suppliers.
- EU Regulations: Emphasis on Quality by Design (QbD) influences supplier qualification.
- India’s Favouring of WHO-GMP: Facilitates export but may restrict some markets.
- China’s Rapid API Expansion: Boosts capacity but raises concerns over quality and IP rights.
Implications for Stakeholders
- Pharmaceutical Companies: Need to establish diversified, certified supplier networks; consider strategic stockpiling.
- Regulators: Enhance oversight to ensure API quality, adapt policies for emerging suppliers.
- Healthcare Providers: Rely on consistent supply for affordability and availability.
- Investors: Focus on suppliers with robust certifications and capacity expansion plans.
Key Takeaways
- The global market for rosuvastatin calcium API and finished forms is dominated by India, China, and some European suppliers.
- Regulatory certification, capacity, and supply reliability are critical when selecting suppliers.
- Geopolitical risks necessitate supplier diversification to mitigate shortages.
- Quality assurance and compliance remain non-negotiable for market access.
- The ongoing expansion of API manufacturing capacities across Asia suggests sustained supply but requires diligent regulatory oversight.
FAQs
1. What are the top suppliers of rosuvastatin calcium API globally?
Major API suppliers include Zhejiang Huahai Pharmaceutical (China), Cipla Ltd. (India), Micro Labs Ltd. (India), Dr. Reddy’s Laboratories (India), and Laurus Labs (India), with capacities ranging from 1,000 to over 5,000 kg/year and certifications like GMP and WHO-GMP.
2. How do regulatory standards impact sourcing decisions for rosuvastatin calcium?
Regulatory standards like GMP, WHO-GMP, and approvals from FDA or EMA determine supplier eligibility. Suppliers lacking these certifications may face restrictions, making compliance a key criterion for procurement.
3. What regional differences influence supplier choices?
North America and Europe favor suppliers with rigorous certifications and robust quality management. Asia-Pacific offers cost advantages and ample capacity but calls for careful validation due to variable regulatory oversight.
4. Could geopolitical tensions disrupt the supply chain for rosuvastatin calcium?
Yes, geopolitical factors such as trade restrictions, tariffs, or diplomatic tensions can impede API supply, particularly from China and other emerging markets, emphasizing the importance of a diversified supply chain.
5. Are new suppliers emerging in the rosuvastatin calcium market?
While no major new entrants currently threaten established leaders, regional API producers in India and China are expanding capacity, potentially increasing supply diversity and competition.
References
- U.S. Food and Drug Administration (FDA). "API Inspection and Certification Policies," 2022.
- European Medicines Agency (EMA). "Guidelines for Manufacturing and Regulatory Compliance," 2023.
- Zhejiang Huahai Pharmaceutical Annual Report, 2022.
- Cipla Ltd. Corporate Brochure, 2022.
- Micro Labs Ltd. Annual Corporate Responsibility Report, 2022.
- Industry Analysis, "Global API Market Trends," IQVIA, 2022.
- WHO, "Guidelines on Good Manufacturing Practices," 2021.
This analysis offers a detailed landscape of suppliers for rosuvastatin calcium, highlighting critical aspects affecting supply chain stability, regulatory compliance, and market competitiveness. Stakeholders should consider multi-layered sourcing strategies aligned with regulatory standards and geopolitical risks to ensure consistent availability of this vital drug.
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