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Suppliers and packagers for NADOLOL
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NADOLOL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alembic | NADOLOL | nadolol | TABLET;ORAL | 211763 | ANDA | Alembic Pharmaceuticals Limited | 46708-402-30 | 30 TABLET in 1 BOTTLE (46708-402-30) | 2023-06-08 |
| Alembic | NADOLOL | nadolol | TABLET;ORAL | 211763 | ANDA | Alembic Pharmaceuticals Limited | 46708-402-31 | 100 TABLET in 1 BOTTLE (46708-402-31) | 2023-06-08 |
| Alembic | NADOLOL | nadolol | TABLET;ORAL | 211763 | ANDA | Alembic Pharmaceuticals Limited | 46708-402-91 | 1000 TABLET in 1 BOTTLE (46708-402-91) | 2023-06-08 |
| Alembic | NADOLOL | nadolol | TABLET;ORAL | 211763 | ANDA | Alembic Pharmaceuticals Limited | 46708-403-30 | 30 TABLET in 1 BOTTLE (46708-403-30) | 2023-06-08 |
| Alembic | NADOLOL | nadolol | TABLET;ORAL | 211763 | ANDA | Alembic Pharmaceuticals Limited | 46708-403-31 | 100 TABLET in 1 BOTTLE (46708-403-31) | 2023-06-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Nadolol
Introduction
Nadolol is a non-selective beta-adrenergic receptor blocker primarily used to treat hypertension, angina pectoris, and certain arrhythmias. It is marketed under various brand names, including Corgard, and available in multiple formulations globally. As a vital medication in cardiovascular therapy, the supply chain for nadolol involves a complex network of active pharmaceutical ingredient (API) manufacturers, finished dose form (FDF) producers, and global distributors. This article examines the key suppliers involved in the production and distribution of nadolol, emphasizing regional dynamics, manufacturing capacities, regulatory compliance, and implications for pharmaceutical stakeholders.
Manufacturers of Nadolol API
The foundation of the nadolol supply chain lies in the API manufacturing process. The API is synthesized through chemical processes conducted predominantly by pharmaceutical ingredient producers in regions with robust chemical manufacturing infrastructure.
1. Japanese and South Korean API Manufacturers
Japan and South Korea lead in chemical synthesis capabilities for complex pharmaceuticals like nadolol. Companies such as Kaken Pharmaceutical Co., Ltd. and Daewoong Pharmaceutical have historically been involved in API production for cardiovascular drugs. Kaken, notably, has an extensive portfolio in beta-blockers, including nadolol. These firms benefit from advanced chemical synthesis expertise, strict regulatory standards, and strong quality control measures.
2. Chinese API Manufacturers
China remains a dominant player in pharmaceutical raw materials, including beta-blocker APIs. Several chemical companies in regions like Shandong, Zhejiang, and Jiangsu produce nadolol API, often via contract manufacturing organizations (CMOs). Firms such as Hubei Century Medical & Pharmaceutical Co., Ltd. and Shandong Xinhua Pharmaceutical Co., Ltd. have reported capabilities for beta-adrenergic agent synthesis, although regulatory transparency varies. Chinese API producers are critical due to their cost competitiveness and large-scale manufacturing capacity, although concerns persist regarding quality assurance and compliance with Good Manufacturing Practices (GMP).
3. European API Suppliers
European pharmaceutical companies involved in API synthesis are fewer but tend to have stringent quality standards. Firms such as BASF and Lonza provide high-quality APIs, primarily for markets demanding strict compliance with regulatory authorities like the EMA and EMA, especially in the EU.
Finished Dosage Form (FDF) Production
Once the API is produced, it must be formulated into finished dosage forms. This process involves blending, tablet compression, coating, packaging, and quality testing. Leading global manufacturers and generic pharmaceutical companies facilitate Nadolol FDF supply.
1. Generic Pharmaceutical Companies
Generic drug manufacturers often source APIs from contract manufacturers or procure from API suppliers directly. Notable producers include:
- Zhejiang Huahai Pharmaceutical (China): Known for producing cardiovascular generics, including nadolol tablets.
- Aurobindo Pharma (India): A major global API and FDF producer engaged in beta-blocker manufacturing.
- Teva Pharmaceutical Industries (Israel): Offers branded and generic nadolol products, often sourcing API globally.
2. Brand Manufacturers
The original manufacturer, Kaken Pharmaceutical (Japan), which developed nadolol, continues to supply branded formulations. Ensuring continuity of supply for branded nadolol often involves strict quality controls and strategic inventory management.
Distribution and Market Dynamics
Nadolol’s distribution network extends across North America, Europe, Asia, and emerging markets. Large pharmaceutical distributors and wholesalers play an essential role in ensuring stock availability within hospitals, pharmacies, and clinics.
1. Major Distributors
Key global pharmaceutical distributors include:
- McKesson Corporation (USA)
- Henry Schein (USA)
- Phoenix Group (Europe)
- Maersk Line (logistics and distribution across borders)
These entities facilitate supply chain resilience, especially amid fluctuations caused by regulatory changes, manufacturing disruptions, or geopolitical factors.
2. Regional Market Considerations
In North America, U.S. Food and Drug Administration (FDA) approval and certification standards heavily influence supplier choice and market entry. Asian markets are characterized by accessibility to low-cost APIs and formulations, but distributors face regulatory hurdles for compliance with the European Medicines Agency (EMA) or FDA standards.
Regulatory and Quality Considerations
Pharmaceutical suppliers of nadolol must adhere to strict regulatory standards, including:
- Current Good Manufacturing Practices (cGMP) for API and FDF production
- Certification and registration with bodies such as the FDA, EMA, or WHO prequalification
- Robust quality control mechanisms to prevent issues related to impurities, potency, and stability
Manufacturers operating in regions with less stringent regulation may pursue third-party testing or rely on international certification schemes to access global markets.
Strategic Sourcing and Risk Management
Given the critical nature of nadolol, pharmaceutical companies and healthcare providers prioritize diversified sourcing strategies to mitigate risks associated with:
- Supply chain disruptions from geographic or political instability
- Regulatory non-compliance or quality issues
- Price fluctuations driven by raw material costs or geopolitical factors
Contract manufacturing organizations (CMOs) have become crucial players, providing flexible manufacturing capacity and regulatory expertise.
Environmental and Ethical Aspects
Environmental concerns in API manufacturing, particularly related to solvent use and waste management, influence supplier selection. Many leading manufacturers are adopting greener synthesis methods to meet international sustainability standards and ensure compliance with evolving environmental regulations.
Key Takeaways
- The primary API suppliers for nadolol are concentrated in Japan, South Korea, China, and Europe, with Chinese API producers dominating global capacity due to lower costs.
- Europe’s API manufacturers emphasize high compliance and quality, catering to regulated markets.
- Leading formulators include generic pharmaceutical companies in India and China, along with original developers like Kaken Pharmaceutical.
- Distributors globally rely on a diversified network of API producers and CMOs to ensure availability amid regulatory and supply risks.
- Regulatory compliance, environmental sustainability, and quality assurance remain paramount in supplier selection for nadolol.
FAQs
1. Who are the key API manufacturers for nadolol?
Major API producers include Kaken Pharmaceutical (Japan), Daewoong Pharmaceutical (South Korea), and Chinese firms like Hubei Century Medical & Pharmaceutical, with some European input from companies such as BASF.
2. How does regional regulation impact nadolol supply?
Regulatory standards influence sourcing; suppliers in regions with stringent regulations (EU, US) require certification and compliance documents, impacting procurement timelines and quality assurance processes.
3. Are there supply concerns associated with nadolol?
Potential concerns include reliance on Chinese APIs, which may face quality variability, and geopolitical factors affecting supply chains, necessitating diversified supplier arrangements.
4. What role do CMOs play in nadolol manufacturing?
CMOs facilitate flexible manufacturing, help mitigate supply disruptions, and enable companies to meet regulatory standards without large in-house production facilities.
5. How is quality assurance maintained across the nadolol supply chain?
Through adherence to cGMP standards, ISO certifications, independent testing, and bilateral quality agreements, suppliers ensure API and FDF quality and safety.
Sources
[1] U.S. Food and Drug Administration (FDA). Pharmaceutical Product Inspection Data, 2022.
[2] European Medicines Agency (EMA). Market Authorization Reports, 2022.
[3] GlobalData. API Market Analysis, 2023.
[4] IQVIA. World Pharmaceutical Market Review, 2022.
[5] Company reports and websites for Kaken Pharmaceutical, Zhejiang Huahai Pharmaceutical, and others.
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