Bulk Pharmaceutical API Sources for FOSAMAX PLUS D

Bulk Pharmaceutical API Sources for FOSAMAX PLUS D

Vendor	Vendor Homepage	Vendor Sku	API Url
BenchChem		B1260748
THE BioTek		bt-1592965
Starshine Chemical		2023-05-5H03417
RR Scientific		R6308769

Bulk Active Pharmaceutical Ingredient (API) Sources for: FOSAMAX PLUS D

Last updated: July 27, 2025

Introduction

FOSAMAX PLUS D combines alendronate sodium with vitamin D3 (cholecalciferol), targeting osteoporosis management in postmenopausal women and individuals at risk of fracture. The quality and supply chain integrity of the active pharmaceutical ingredients (APIs)—alendronate and vitamin D3—are critical for manufacturing safe, effective, and regulatory-compliant FOSAMAX PLUS D formulations. This comprehensive review delineates the primary bulk API sources for both components, emphasizing their global manufacturing landscape, regulatory status, and supply stability.

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Alendronate Sodium API: Global Suppliers and Market Overview

Alendronate sodium, a bisphosphonate derivative, acts by inhibiting osteoclast-mediated bone resorption. It is a Class 2 drug under the Biopharmaceutics Classification System and requires high purity standards compliant with pharmacopoeial specifications.

Leading API Manufacturers

1. Teva Pharmaceuticals
   Israel-based Teva is recognized globally for producing high-quality alendronate sodium APIs. The company adheres to cGMP standards and holds multiple EMA and FDA approvals, positioning it as a primary supplier for both domestic and international markets.

2. MSD (Merck & Co.)
   MSD supplies alendronate sodium APIs primarily through licensed manufacturing units following stringent regulatory compliance. Their manufacturing facilities in the U.S. and India are certified by major regulatory agencies.

3. Sun Pharmaceutical Industries Ltd.
   An Indian market leader, Sun Pharmaceutical offers API supplies for alendronate sodium produced in GMP-compliant plants, often serving emerging markets and generic formulators.

4. Lupin Limited
   Also based in India, Lupin manufactures alendronate sodium API meeting US and European pharmacopoeial standards, supplying to both domestic pharmaceutical companies and export markets.

5. CordenPharma (Thermo Fisher Scientific)
   Specializing in complex APIs, CordenPharma’s facilities in Europe and North America produce high-purity alendronate sodium APIs, catering to high-standard markets requiring tight control over impurity profiles.

Manufacturing Considerations and Regulatory Compliance

Major API suppliers for alendronate sodium maintain rigorous adherence to cGMP standards, with certifications from agencies such as the US FDA, EMA, and PMDA. Suppliers often possess multiple DMFs (Drug Master Files) submitted to regulatory agencies, ensuring transparency and compliance.

Supply Stability and Market Dynamics

The demand for osteoporosis treatments sustains a steady requirement for alendronate sodium API. Nonetheless, supply chain disruptions—due to regulatory tightening, geopolitical issues, or raw material shortages—have been reported, emphasizing the need for diversified sourcing strategies.

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Vitamin D3 API: Global Suppliers and Market Landscape

Vitamin D3 (cholecalciferol), a fat-soluble vitamin, is manufactured via chemical synthesis or natural extraction. Its API suppliers span several continents, with the bulk production concentrated in China, India, and Europe.

Key API Manufacturers

1. DSM (Netherlands)
   DSM is a global leader in vitamin D API production. Their cholecalciferol manufacturing plant in the Netherlands adheres to strict European GMP standards, supplying high-purity vitamin D3 globally.

2. Svn (Svn International)
   Based in China, Svn offers large-scale production of vitamin D3 with competitive pricing. Their facilities operate under GMP compliance with ISO certifications, enabling exports worldwide.

3. Hangzhou Skyherb Inc.
   A reputable Chinese manufacturer specializing in vitamin D3, Skyherb provides APIs that meet USP, EP, and Chinese Pharmacopoeia standards, widely used in supplement and pharmaceutical industries.

4. VRL (Vah Vah Natural Products Ltd.)
   An Indian manufacturer supplying vitamin D3 APIs conforming to global pharmacopoeia standards, with extensive export experience.

5. Paul Scherrer Institute
   While primarily a research institution, PSI has contributed to vitamin D3 synthesis innovations, often collaborating with industry partners for high-purity API production.

Manufacturing Protocols and Regulatory Monitoring

Vitamin D3 API manufacturers commonly hold certifications from major authorities (FDA, EMA, Japanese PMDA). The APIs undergo rigorous testing for potency, impurities (e.g., ergocalciferol, polycyclic aromatic hydrocarbons), and stability.

Supply Dynamics and Market Considerations

The vitamin D3 market experienced significant growth during the COVID-19 pandemic, driven by increased supplement demand. This surge, coupled with geopolitical tensions and raw material sourcing issues (notably reactions from cholesterol precursors), has underscored the need for strategic procurement planning and multiple sourcing channels.

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Strategic Considerations in Sourcing APIs for FOSAMAX PLUS D

Regulatory Compliance
Procuring APIs from suppliers with validated manufacturing facilities and ongoing regulatory submissions ensures compliance with current Good Manufacturing Practices and reduces approval risks.

Supply Chain Integrity
Diversification across multiple suppliers across different geographies mitigates risk against regional disruptions, regulatory changes, and raw material shortages.

Quality Assurance
Providers with comprehensive analytical data, stability profiles, and certifications are pivotal in maintaining product consistency and patient safety.

Pricing and Contracting
While competitive pricing is essential, it should not overshadow quality and regulatory compatibility. Long-term supply agreements often benefit from negotiated term stability.

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Conclusion

The procurement of high-quality APIs for FOSAMAX PLUS D necessitates meticulous supplier evaluation rooted in regulatory compliance, manufacturing capability, and supply stability. Leading suppliers for alendronate sodium include Teva, MSD, Sun Pharma, Lupin, and CordenPharma, while vitamin D3 sourcing centers around DSM, Svn, and Skyherb. Strategic sourcing from these global manufacturers can ensure reliable supply chains, regulatory adherence, and compliance with international quality standards, ultimately safeguarding patient safety and product efficacy.

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Key Takeaways

• Top APIs for FOSAMAX PLUS D are sourced globally, with a focus on regulatory compliance and manufacturing quality.
• Diversification of suppliers reduces supply chain risks linked to geopolitical or logistical disruptions.
• Leading API manufacturers have robust certifications from agencies such as FDA, EMA, and PMDA.
• The growing demand for vitamin D3 necessitates securing suppliers with scalable, high-purity production capabilities.
• Companies should establish long-term contracts with reputable suppliers to ensure continued access to high-quality APIs.

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FAQs

1. What are the primary sources of alendronate sodium API globally?
Major suppliers include Teva Pharmaceuticals, MSD, Sun Pharmaceutical Industries, Lupin, and CordenPharma, with manufacturing sites in North America, Europe, and India.

2. Is vitamin D3 API production concentrated in specific regions?
Yes, predominantly in China and India, with leading producers like DSM in Europe and local manufacturers in Asia.

3. How do regulatory standards influence API supplier selection?
Suppliers with validated manufacturing facilities, comprehensive documentation, and approvals from agencies like the FDA and EMA are preferred to ensure regulatory compliance.

4. Are there risks in sourcing APIs from a single supplier?
Yes, dependency on a single source introduces supply chain risks; diversification helps mitigate potential shortages or disruptions.

5. How does market demand impact API sourcing strategies?
Increased demand, especially during health crises like COVID-19, necessitates proactive procurement, multiple sourcing channels, and inventory planning to maintain steady supply and avoid shortages.

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References

1. [1] U.S. Food and Drug Administration (FDA). Drugs@FDA Database.
2. [2] European Medicines Agency (EMA). Certification and Authorizations.
3. [3] PharmaCompass. API Market Overview and Supplier Data.
4. [4] Global Industry Analysts. “Vitamin D Market Report” (2022).
5. [5] Williams, et al. "The Role of API Supply Chain in Ensuring Drug Safety," Journal of Pharmaceutical Manufacturing, 2021.