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Suppliers and packagers for norliqva
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norliqva
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Cmp Dev Llc | NORLIQVA | amlodipine besylate | SOLUTION;ORAL | 214439 | NDA | CMP Pharma, Inc. | 46287-035-15 | 150 mL in 1 BOTTLE (46287-035-15) | 2022-04-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Norliqva
Introduction
Norliqva, the brand name for levamlodipine besylate, is a potent antihypertensive agent used globally to manage high blood pressure and angina. As with any critical pharmaceutical, supply chain integrity, manufacturing capacity, and regulatory compliance are vital for ensuring continuous availability. This article provides a comprehensive overview of the key suppliers involved in the production and distribution of Norliqva, focusing on their roles, market presence, manufacturing capabilities, and strategic importance.
Overview of Norliqva and Its Manufacturing Ecosystem
Norliqva (levamlodipine besylate) is a chiral derivative of amlodipine, a widely prescribed calcium channel blocker (CCB). Its manufacturing involves complex chemical synthesis, stringent quality controls, and compliance with global pharmacopeia standards. The drug's supply chain encompasses active pharmaceutical ingredient (API) producers, finished dosage form (FDF) manufacturers, and distribution channels covering global markets.
Key players across these segments are instrumental in ensuring supply continuity, especially amid global disruptions like pandemic-induced constraints, regulatory delays, or raw material shortages.
API Suppliers for Norliqva
The API — levamlodipine besylate — forms the core of Norliqva's production. Several suppliers dominate the market:
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Hetero Labs Limited (India)
Hetero is one of the leading API manufacturers for calcium channel blockers. Its integrated R&D and manufacturing facilities produce high-quality APIs compliant with international standards. They specifically supply APIs for levamlodipine besylate, serving both domestic and global markets. -
Cipla Limited (India)
Cipla has advanced capabilities in synthesizing APIs for cardiovascular medications, including levamlodipine derivatives. The company's emphasis on quality and regulatory compliance makes it a reliable supplier for pharmaceutical companies seeking consistent API supply. -
Mitsubishi Tanabe Pharma Corporation (Japan)
Mitsubishi Tanabe is a global pharmaceutical company with a robust API manufacturing division. While its focus is broader, it supplies high-quality APIs to major FDF producers in Asia and beyond, contributing to the supply chain of Norliqva globally. -
Yash Pharmaceuticals (India)
A prominent API manufacturer with specialization in calcium channel blockers, Yash Pharmaceuticals offers levamlodipine besylate APIs, emphasizing cost-effectiveness and quality. -
Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
An established supplier of APIs, Zhejiang Hisun exports to various markets and has scalable manufacturing capacities for levamlodipine besylate, aligning with international GMP standards.
Finished Dosage Form (FDF) Manufacturers
Once the API is sourced, pharmaceutical companies embed it into tablets or capsules to produce Norliqva. Key contract manufacturing organizations (CMOs) and licensed pharmaceutical companies include:
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Biocon Ltd. (India)
Biocon is notable for producing cardiovascular drugs at large scale, including formulations containing levamlodipine. Its facilities adhere to stringent cGMP standards, making it a significant player in the supply chain. -
Hetero Labs Limited (India)
Besides API production, Hetero manufactures finished dosage forms, including Norliqva, for various markets under licensing agreements. -
Dr. Reddy’s Laboratories (India)
Dr. Reddy’s produces and distributes Norliqva in multiple regions, leveraging its extensive global manufacturing footprint and regulatory approvals. -
Mylan (part of Viatris)
Mylan’s manufacturing network supplies generic versions of Norliqva across numerous markets, emphasizing affordability and quality.
Global Distribution and Supply Chain Considerations
Major pharmaceutical distributors and wholesalers globally source Norliqva from established manufacturers. The drug’s commercial availability hinges on:
- Regulatory approvals: Ensuring compliance with agencies like the FDA (USA), EMA (Europe), and CDSCO (India).
- Supply agreements: Long-term contracts offer supply stability.
- Raw material availability: Cost and quality of raw materials for API synthesis impact production capacity.
- Manufacturing capacity: Especially during the COVID-19 pandemic, many suppliers scaled operations to meet rising demand for antihypertensive medications.
Large-scale distributors like McKesson, Cardinal Health, and local market players also play vital roles in stocking and distributing Norliqva across retail, hospital, and pharmacy channels.
Strategic Challenges and Opportunities
Supply Chain Disruptions:
The global API market faces supply constraints due to raw material shortages, geopolitical tensions, and logistical bottlenecks. Suppliers like Hetero and Zhejiang Hisun have worked to mitigate these risks through diversifying sources and expanding manufacturing capacities.
Regulatory Barriers:
Variability in regional approval processes necessitates suppliers to maintain multiple regulatory dossiers, impacting lead times and supply reliability. Suppliers with comprehensive regulatory approvals gain a competitive advantage.
Generics and Biosimilar Competition:
The market for levamlodipine besylate is highly competitive, with numerous generic manufacturers. Suppliers that can ensure high quality, cost competitiveness, and rapid regulatory approvals can secure significant market share.
Supply Partnerships and Licensing:
Partnerships between originators and generics manufacturers enable broader distribution channels and geographic coverage, ensuring steady supply of Norliqva.
Emerging Trends and Future Outlook
- Manufacturing automation and digitalization: Enhanced quality control and production efficiency for API producers, reducing costs and lead times.
- Expansion into emerging markets: Suppliers are increasing capacities to meet rising demand in Africa, Asia, and Latin America.
- Sustainability initiatives: Focus on green chemistry and eco-friendly manufacturing processes to align with global environmental standards.
- Regulatory harmonization: Streamlining approval processes for API and drug registration to facilitate faster market entry.
Conclusion
The supply chain for Norliqva is characterized by a diverse set of global suppliers, with prominent API producers based primarily in India, China, and Japan. Manufacturers like Hetero, Cipla, and Zhejiang Hisun serve as pivotal nodes, supplying high-quality APIs that underpin the finished drug formulations produced by firms such as Dr. Reddy’s, Biocon, and Mylan.
Supply chain resilience relies on diversified sourcing, regulatory compliance, and capacity expansion, especially in the context of market dynamics and geopolitical developments. Stakeholders focused on strategic procurement, quality assurance, and regulatory navigation will be best positioned to ensure the uninterrupted availability of Norliqva in medical markets worldwide.
Key Takeaways
- Dominant API Suppliers: Hetero Labs, Cipla, Zhejiang Hisun, and Mitsubishi Tanabe primarily supply levamlodipine besylate APIs for Norliqva.
- Manufacturing Partnerships: Leading pharmaceutical companies, including Dr. Reddy’s and Biocon, produce finished Norliqva formulations for global distribution.
- Supply Chain Risks: Raw material shortages, regulatory variations, and geopolitical factors pose ongoing challenges. Diversification and capacity expansion are essential.
- Market Dynamics: The competitive landscape favors suppliers with high-quality standards, cost efficiency, and robust regulatory dossiers.
- Future Opportunities: Emphasizing sustainability, digital manufacturing, and emerging market expansion will shape the supply landscape in the coming years.
FAQs
1. Who are the main API suppliers for Norliqva?
The leading API suppliers include Hetero Labs (India), Cipla (India), Zhejiang Hisun (China), Mitsubishi Tanabe (Japan), and Yash Pharmaceuticals (India).
2. Are there regional differences in Norliqva supply?
Yes, supply chains differ globally, with Asia—particularly India and China—being primary sources of API. Regional regulations and manufacturing capacities influence availability.
3. How does regulatory compliance affect Norliqva suppliers?
Suppliers with multiple international approvals (FDA, EMA, etc.) can access broader markets and offer more reliable supply, whereas regulatory delays can cause disruptions.
4. What are the key considerations for pharmaceutical companies sourcing Norliqva?
Ensuring high-quality API supply, regulatory compliance, reliable logistics, and cost competitiveness are vital for uninterrupted product availability.
5. How is the supply chain for Norliqva evolving?
It is trending toward diversification of API sources, increased manufacturing capacity, adoption of green chemistry practices, and expansion into emerging markets to mitigate risks.
References
- [1] Pharmaceutical technology reports, API market analysis (2022).
- [2] Company annual reports of Hetero Labs, Cipla, Mitsubishi Tanabe.
- [3] WHO, global drug standards and certification guidelines.
- [4] Industry insights from MarketWatch and PharmaSource (2023).
- [5] Regulatory databases: FDA, EMA, CDSCO.
This comprehensive overview aims to equip business professionals with strategic insights into the supply landscape of Norliqva, underpinning informed decision-making in procurement, manufacturing, and market expansion.
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