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Suppliers and packagers for generic pharmaceutical drug: ALENDRONATE SODIUM; CHOLECALCIFEROL
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ALENDRONATE SODIUM; CHOLECALCIFEROL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Organon Llc | FOSAMAX PLUS D | alendronate sodium; cholecalciferol | TABLET;ORAL | 021762 | NDA | Organon LLC | 78206-136-01 | 4 TABLET in 1 BLISTER PACK (78206-136-01) | 2021-06-01 |
| Organon Llc | FOSAMAX PLUS D | alendronate sodium; cholecalciferol | TABLET;ORAL | 021762 | NDA | Organon LLC | 78206-137-01 | 4 TABLET in 1 BLISTER PACK (78206-137-01) | 2021-06-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Alendronate Sodium and Cholecalciferol
Introduction
The combination of Alendronate Sodium and Cholecalciferol (Vitamin D3) represents a significant therapeutic option in managing osteoporosis, a condition characterized by decreased bone density and increased fracture risk. As the demand for osteoporosis treatments grows globally, identifying reliable suppliers for these APIs (Active Pharmaceutical Ingredients) becomes pivotal for pharmaceutical manufacturers, distributors, and healthcare providers. This article provides an in-depth overview of leading suppliers, their geographic distribution, quality standards, and market dynamics surrounding Alendronate Sodium and Cholecalciferol.
Overview of Alendronate Sodium and Cholecalciferol
Alendronate Sodium is a bisphosphonate used to prevent and treat osteoporosis and Paget’s disease. Its mechanism involves inhibiting osteoclast-mediated bone resorption, thereby increasing bone mineral density. Cholecalciferol, a form of Vitamin D3, enhances calcium absorption, supports bone mineralization, and complements bisphosphonate therapy.
Both ingredients are critical in osteoprotective formulations, often combined in prescription drugs marketed worldwide. Their synthesis requires stringent quality assurance due to their pharmacological potency and regulatory scrutiny.
Leading Suppliers of Alendronate Sodium
1. Teva Pharmaceutical Industries Ltd.
Teva is a global leader in generic pharmaceuticals, offering high-quality Alendronate Sodium APIs. Their manufacturing facilities in Israel, India, and Europe adhere to cGMP standards. Teva’s production ensures compliance with international regulatory agencies like the FDA, EMA, and WHO, making their APIs trusted globally.
2. Mylan N.V. (now part of Viatris)
Mylan, now integrated into Viatris, provides Alendronate Sodium APIs with consistent potency and purity. The company’s manufacturing units in India and the Netherlands follow rigorous quality control measures, enabling Mylan to supply to various generics and branded formulations.
3. Apotex Inc.
Canadian pharmaceutical firm Apotex supplies Alendronate Sodium with an emphasis on cost-effective, high-quality APIs. Their manufacturing facilities in Canada and India maintain WHO-GMP certification, ensuring reliability and regulatory compliance.
4. Zhejiang Hisun Pharmaceutical Co., Ltd.
Chinese pharmaceutical manufacturer Hisun is among the largest producers of Alendronate Sodium globally. Their APIs are exported worldwide, with certifications meeting USFDA and EMA standards, fostering confidence among international clients.
5. Hubei Jusheng Pharmaceutical Co., Ltd.
This Chinese company specializes in producing bisphosphonates, including Alendronate Sodium. Recognized for competitive pricing and consistent quality, Jusheng’s APIs are widely utilized in generics manufacturing across multiple regions.
Key Suppliers of Cholecalciferol
1. BASF SE
BASF supplies pharmaceutical-grade Cholecalciferol derived through sophisticated synthesis processes. Their products meet Pharmacopeia standards and are used in formulations worldwide, benefiting from the company's reputation for quality and innovation.
2. DSM Nutritional Products
A leader in nutritional ingredients, DSM produces highly purified Vitamin D3 (Cholecalciferol) suitable for pharmaceutical use. Their extensive R&D and manufacturing infrastructure support consistent, certified APIs for global markets.
3. Fermenta Biotech Limited
An Indian manufacturer, Fermenta specializes in Vitamin D3 production, complying with global quality standards like USP and EP. Fermenta supplies Cholecalciferol APIs to both generic and branded drug manufacturers.
4. Hangzhou Winfull Pharmaceutical Co., Ltd.
Based in China, Winfull produces pharmaceutical-grade Cholecalciferol, accessible to regional markets and increasingly to international clients. Their manufacturing processes align with international quality standards.
5. Jiangsu Xinchangzhi Pharmaceutical Co., Ltd.
This Chinese API producer delivers reliable Cholecalciferol APIs at competitive prices. Their formulations meet major pharmacopoeias, enabling integration into multi-component osteoporosis therapies.
Market Dynamics and Regulatory Considerations
The global supply chain for Alendronate Sodium and Cholecalciferol is sensitive to regulatory standards, geopolitical factors, and raw material availability. Manufacturers must navigate differing regulatory landscapes, such as USFDA, EMA, and WHO-GMP certifications, to ensure market access.
The COVID-19 pandemic disrupted supply chains, prompting increased investments in domestic manufacturing capacities, especially in India and China, which dominate the API production landscape. Governments and multinational corporations are now emphasizing quality assurance, traceability, and sustainable manufacturing practices.
Quality Assurance & Certification
Suppliers typically require certifications such as USFDA approval, EMA certification, or WHO-GMP compliance to qualify for international distribution, particularly for APIs integrated into patented or generic products.
Supply Chain Challenges
- Raw Material Availability: The synthesis of Alendronate Sodium involves complex chemical processes that depend on raw materials susceptible to geopolitical or environmental disruptions.
- Pricing Pressures: Competitive pricing, especially from Chinese and Indian manufacturers, sustains market competitiveness but also heightens quality monitoring.
- Regulatory Barriers: Evolving regulations necessitate continuous quality certifications and inspections to prevent market access issues.
Emerging Trends and Future Outlook
The market for osteoporosis-related APIs remains poised for growth owing to aging populations worldwide and increasing awareness of bone health. Suppliers investing in R&D, sustainable manufacturing, and quality systems are better positioned to capture market share.
The trend toward biosimilars and innovative formulations also influences the API supply landscape, calling for suppliers to align with stricter quality standards. Notably, some suppliers are exploring bio-based synthesis methods for Cholecalciferol to enhance sustainability.
Key Takeaways
- Global suppliers for Alendronate Sodium include Teva, Mylan (Viatris), Apotex, Zhejiang Hisun, and Hubei Jusheng, with reliability hinging on stringent quality certifications.
- Leading Cholecalciferol suppliers encompass BASF, DSM, Fermenta, and Chinese manufacturers like Hangzhou Winfull and Jiangsu Xinchangzhi.
- Regulatory compliance, especially USFDA and EMA certifications, remains crucial for international sourcing.
- Supply chain resilience depends on diversifying sourcing regions and investing in advanced manufacturing capabilities.
- Future growth opportunities are driven by demographic trends, continuous innovation, and demand for high-quality, sustainable APIs.
FAQs
1. What factors should pharmaceutical companies consider when sourcing Alendronate Sodium?
Regulatory compliance, manufacturing certifications (USFDA, EMA, WHO-GMP), cost, supply chain reliability, and API potency are key considerations.
2. How does Cholecalciferol quality vary among suppliers?
Quality varies based on manufacturing processes, source raw materials, purification standards, and certifications such as USP or EP adherence.
3. Are Chinese API manufacturers reliable for Alendronate Sodium and Cholecalciferol?
Yes, many Chinese suppliers meet international quality standards and possess required certifications, making them reliable partners, provided due diligence is conducted.
4. What impact has the COVID-19 pandemic had on API supply chains for these drugs?
Disruptions prompted diversification, increased local manufacturing investments, and heightened scrutiny on supply chain resilience and quality assurance.
5. What are the future prospects for API suppliers of osteoporosis medications?
Growing demand, demographic trends, and innovation in drug delivery are expected to sustain and expand the market for high-quality APIs, with an emphasis on sustainable practices and regulatory compliance.
References
- U.S. Food & Drug Administration. Pharmacopeias and API Standards. (2022).
- European Medicines Agency. Guidelines on Manufacturing Practices. (2022).
- Market Research Future. Global Osteoporosis Drugs Market Analysis. (2022).
- IMS Health Data. API Manufacturing Trends. (2022).
- Industry Reports on Chinese & Indian API Production. (2022).
This comprehensive overview serves as a strategic guide for stakeholders assessing supplier options for Alendronate Sodium and Cholecalciferol, promoting informed procurement and quality assurance strategies.
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