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Suppliers and packagers for norvasc
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norvasc
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Viatris | NORVASC | amlodipine besylate | TABLET;ORAL | 019787 | NDA | PFIZER LABORATORIES DIV PFIZER INC | 0069-1520-68 | 90 TABLET in 1 BOTTLE (0069-1520-68) | 1992-07-31 |
| Viatris | NORVASC | amlodipine besylate | TABLET;ORAL | 019787 | NDA | PFIZER LABORATORIES DIV PFIZER INC | 0069-1530-68 | 90 TABLET in 1 BOTTLE (0069-1530-68) | 1992-07-31 |
| Viatris | NORVASC | amlodipine besylate | TABLET;ORAL | 019787 | NDA | PFIZER LABORATORIES DIV PFIZER INC | 0069-1530-72 | 300 TABLET in 1 BOTTLE (0069-1530-72) | 1992-07-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Norvasc
Introduction
Norvasc (amlodipine besylate) is a widely prescribed calcium channel blocker used to treat hypertension and angina pectoris. As a frontline medication, its reliability hinges on a robust supply chain composed of global suppliers spanning active pharmaceutical ingredient (API) producers, excipient suppliers, finished drug manufacturers, and distribution entities. Ensuring an uninterrupted supply chain for Norvasc involves understanding these suppliers' landscape, regulatory dynamics, manufacturing capacities, and the influence of global trade policies.
Active Pharmaceutical Ingredient (API) Suppliers
At the core of Norvasc’s supply chain are API manufacturers responsible for producing amlodipine besylate. A key dynamic influencing the supply landscape is the concentration of API production in specific geographic regions, notably India and China, which dominate the global API manufacturing sector.
Indian pharmaceutical giants like Serum Institute of India, Dr. Reddy’s Laboratories, and Aurobindo Pharma are prominent API suppliers. These entities have extensive experience in synthesizing calcium channel blocker APIs; many produce generic versions compatible with the original Norvasc formulation. Notably, Hetero Labs and Cipla also operate significant API manufacturing facilities, often supplying both domestic and international markets.
Chinese API manufacturers such as Hengyang City Ashland API Co., Ltd. and Qingdao Buxin Pharmaceutical have also entered the sector, primarily catering to Asian markets but increasingly targeting global clients due to cost competitiveness.
The API supply ecosystem is characterized by quality assurance standards aligned with WHO and FDA regulations. Manufacturers frequently seek certifications such as Current Good Manufacturing Practice (cGMP) to qualify for global markets, including the U.S., European Union, and Japan.
Key API Suppliers:
- Serum Institute of India
- Dr. Reddy’s Laboratories
- Aurobindo Pharma
- Hetero Labs
- Cipla
- Chinese API manufacturers (e.g., Hengyang City Ashland API Co., Ltd.)
Finished Dosage Form (FDF) Manufacturers
The transition from API to finished Norvasc tablets involves integrating the active ingredient with excipients and packaging. Several pharmaceutical companies worldwide manufacture generic Norvasc under licensing agreements or through authorized generic programs.
In the United States, Pfizer originally developed Norvasc, but manufacturing rights for generic versions are often conducted by companies like Mylan (now part of Viatris), Aurobindo Pharma, and Lupin. These manufacturers produce licensed generics and authorized generics aligning with regulatory standards from the FDA.
Globally, companies such as Sun Pharmaceutical Industries, Hikma Pharmaceuticals, and Sanofi produce Norvasc formulations tailored for European and Asian markets, adhering to regional regulatory requirements.
Supply Chain Dynamics
The supply of Norvasc exemplifies the integration of API producers with finished drug manufacturers within complex global supply networks. The industry's consolidation trends, patent expiration, and cost pressures have led to increased reliance on Indian and Chinese suppliers for both APIs and formulations. Supply security is achievable through diversified supplier bases, strategic inventory management, and adherence to quality standards.
However, geopolitical factors, trade tariffs, and regulatory scrutiny have periodically disrupted these supply chains, emphasizing the importance of supply chain resilience and supplier qualification processes.
Regulatory and Quality Considerations
Suppliers must meet stringent regulatory standards to ensure drug safety and efficacy. The FDA’s inspektion records, European Medicines Agency (EMA) certifications, and WHO prequalification status serve as critical benchmarks for supplier credibility.
Manufacturers of Norvasc also navigate compliance with international pharmacopoeia monographs (e.g., USP, EP), which specify quality attributes for API and finished formulations.
Emerging Trends and Future Outlook
The industry is witnessing a shift towards diversification of the supplier base through regional manufacturing initiatives, enhancing supply chain resilience. Increasing use of biotechnological processes for API synthesis and the adoption of advanced analytical techniques further improve the quality and consistency of suppliers’ products.
Moreover, patent expiration and the rise of biosimilars and generics promote competition, potentially stabilizing prices and improving supply stability. The COVID-19 pandemic underscored vulnerabilities in global supply chains, prompting pharmaceutical companies to prioritize supply chain transparency and flexibility concerning Norvasc suppliers.
Conclusion
The suppliers for Norvasc comprise a global network of API manufacturers, finished drug producers, and distributors with varying regulatory compliance levels and manufacturing capacities. Indian and Chinese firms dominate the API landscape, with major players such as Serum Institute, Dr. Reddy’s, and Aurobindo leading the market. Finished product manufacturing involves licensed generics from companies like Viatris, Sun Pharma, and Hikma.
Business professionals seeking to secure or analyze the Norvasc supply chain should focus on supplier compliance with regulatory standards, geographical diversification to mitigate risks, and ongoing industry trends favoring supply chain resilience.
Key Takeaways
- The primary API suppliers for Norvasc are Indian and Chinese manufacturers, emphasizing the importance of assessing their regulatory compliance and quality certifications.
- Finished drug manufacturing heavily relies on licensed generics from established global pharmaceutical companies.
- Supply chain disruptions can arise from geopolitical, regulatory, or pandemic-related factors, necessitating diversified supplier strategies.
- Regulatory compliance, including cGMP adherence and certifications like WHO prequalification, is critical for supplier credibility.
- Industry trends toward regional manufacturing and technological advancements are shaping future supply chain stability for Norvasc.
FAQs
1. Who are the main API suppliers for Norvasc?
Major API producers include Serum Institute of India, Dr. Reddy’s Laboratories, and Aurobindo Pharma, primarily based in India, with Chinese manufacturers also contributing.
2. Are there alternative suppliers for Norvasc to mitigate supply risks?
Yes. Companies often diversify sourcing from multiple API and finished drug manufacturers across different regions to enhance supply resilience.
3. How do regulatory standards impact suppliers of Norvasc?
Suppliers must meet stringent standards—such as cGMP certifications from the FDA or EMA—to ensure product safety, quality, and market approval.
4. Is the supply chain for Norvasc vulnerable to geopolitical tensions?
Yes. Dependence on Chinese and Indian suppliers exposes the supply chain to risks from trade disputes, tariffs, and export restrictions, emphasizing the need for diversification.
5. What future industry trends could influence Norvasc's supply chain?
Increased regional manufacturing, technological innovations in API synthesis, and a focus on supply chain transparency are shaping the future landscape of Norvasc supply sources.
References
- U.S. Food and Drug Administration. (2022). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- World Health Organization. (2021). Prequalification of Medicines Program.
- IMS Health (IQVIA). (2022). Global Pharmaceutical Market Analysis.
- Industry reports and company disclosures.
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