Suppliers and packagers for BINOSTO

BINOSTO

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Radius	BINOSTO	alendronate sodium	TABLET, EFFERVESCENT;ORAL	202344	NDA	Radius Health, Inc.	70539-400-04	4 BLISTER PACK in 1 BOX (70539-400-04) / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00)	2012-03-12
Radius	BINOSTO	alendronate sodium	TABLET, EFFERVESCENT;ORAL	202344	NDA	Radius Health, Inc.	70539-400-94	4 BLISTER PACK in 1 BOX (70539-400-94) / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00)	2012-03-12

Last updated: July 31, 2025

ppliers for the Pharmaceutical Drug: Binosto

Introduction
Binosto, marketed as Fosavance in some regions, is a pharmaceutical product used predominantly for the treatment and prevention of osteoporosis. Its active component, alendronate sodium, belongs to the bisphosphonate class, which inhibits bone resorption, thereby increasing bone mineral density. As an important therapeutic agent, understanding its supply chain dynamics, including key suppliers, manufacturing sources, and distribution channels, is vital for stakeholders in healthcare, supply chain management, and pharmaceutical investment. This article provides a comprehensive analysis of suppliers for Binosto, focusing on manufacturing origins, raw material sources, and the global distribution network.

Overview of Binosto’s Composition and Manufacturing
Binosto’s formulation is a buffered effervescent tablet containing alendronate sodium, designed to improve gastrointestinal tolerability and enhance patient compliance. The primary active ingredient, alendronate sodium, is synthesized through multistep chemical processes involving key raw materials sourced from specialized chemical suppliers. The finished product is manufactured by GlaxoSmithKline (GSK), the original developer and marketer of Binosto. However, the broader supply chain involves multiple tiers: raw material suppliers, active pharmaceutical ingredient (API) producers, formulation plants, and distribution partners worldwide.

Key Raw Material Suppliers for Alendronate Sodium

1. Active Pharmaceutical Ingredient (API) Producers
   Alendronate sodium’s API is central to Binosto’s formulation. Several pharmaceutical-grade chemical producers globally manufacture this compound, usually sourcing raw chemicals from high-purity suppliers to meet stringent regulatory standards (GMP). Prominent API manufacturers include:

   • Mitsubishi Chemical Corporation: A major Japanese supplier of bisphosphonate APIs, with robust capacity and quality controls. Mitsubishi supplies both API and intermediates for global pharmaceutical companies.
   • Cipla Limited: Based in India, Cipla has scaled API production for bisphosphonates, including alendronate, often supplying generic formulations in emerging markets.
   • Teva Pharmaceutical Industries: An Israeli-based company with large-scale API manufacturing capabilities, producing bisphosphonates for various generic products.
   • Sandoz (Novartis): A key player in generic APIs, Sandoz fabricates bisphosphonate APIs for multiple therapeutic agents, including alendronate.

2. Raw Chemical Precursors
   The manufacturing of alendronate sodium involves precursors like phosphorous pentachloride and other phosphorus-based chemicals, obtained from specialized chemical suppliers such as:

   • BASF SE: A leading chemical conglomerate providing phosphorus derivatives and intermediates used in API synthesis.
   • Evonik Industries: Known for specialized chemicals, including reagents for multistep API synthesis.
   • Arkema Group: Supplies phosphorous chemicals vital for bisphosphonate synthesis.

Manufacturing Facilities and Strategic Considerations

• Primary API Manufacturing Sites:
  API production for bisphosphonates like alendronate sodium typically occurs in countries with established pharmaceutical infrastructure, including India, China, and parts of Europe. Leading manufacturers often operate multiple facilities under GMP compliance, adhering to quality and safety standards mandated by the FDA, EMA, and other regulatory entities.

• Formulation and Final Product Assembly:
  GSK, as the patent holder and marketer of Binosto, outsources production to contract manufacturing organizations (CMOs) globally, including facilities in Europe, North America, and Asia-Pacific. These plants adhere to rigorous quality control processes, ensuring consistent tablet efficacy and safety.

Distribution and Supply Chain Partners

• Global Distributors:
  Once manufactured, Binosto’s distribution involves licensed distributors, wholesalers, and healthcare providers globally. GSK employs a network of authorized logistics partners to ensure timely delivery and regulatory compliance across regions such as North America, Europe, Asia, and Latin America.

• Supply Chain Challenges:
  The geopolitical landscape, raw material price fluctuations, and regulatory shifts significantly influence the supply of Binosto. The reliance on API producers in Asia and India makes the supply chain susceptible to disruptions from trade tensions and covid-related shutdowns.

Major Suppliers and Their Market Influence

1. GSK
   As the patent owner and primary marketer, GSK meticulously manages its supply chain, often engaging with multiple API suppliers to ensure stability and cost-effectiveness. GSK’s strategic sourcing involves geographic diversification to mitigate supply risks.

2. Alternative and Generics Manufacturers
   Following patent expirations, numerous generic manufacturers in India and China have entered the bisphosphonate market, sourcing alendronate sodium from local API producers and offering more competitive pricing for Binosto-like formulations globally.

Regulatory and Quality Considerations

• Suppliers must adhere to strict regulatory standards such as the FDA’s current Good Manufacturing Practices (cGMP) and EMA regulations. This compliance impacts supplier selection and ongoing quality assurance processes.
• The sourcing of APIs from approved suppliers helps prevent supply chain contamination and ensures product integrity, a critical factor given the product’s medical importance.

Future Trends and Supply Chain Opportunities

• Vertical Integration: Some pharmaceutical companies are acquiring or developing in-house API manufacturing capabilities to gain more control over supply and quality.
• Regionalization of Supply Chains: Post-pandemic restructuring aims to reduce dependence on Asian manufacturers by establishing regional API production hubs in North America and Europe.
• Sustainable Sourcing: Increasing emphasis on environmentally sustainable production processes influences supplier selection, favoring companies with lower carbon footprints and greener practices.

Key Takeaways

• The supply of Binosto depends critically on high-quality API suppliers, primarily in India, China, and Japan.
• Multinational pharmaceutical firms like GSK leverage diversified APIs and manufacturing sites to ensure supply resilience.
• Regulatory compliance, quality assurance, and geopolitical stability remain central to sourcing decisions.
• The transition toward regional manufacturing and sustainable sourcing signals an evolving supply chain landscape.

FAQs

Q1: Who are the main API suppliers for Binosto?
A: Major API suppliers for Binosto’s alendronate sodium include Mitsubishi Chemical, Cipla, Teva, and Sandoz, primarily located in Japan, India, and Israel.

Q2: Are there regional shifts in Binosto’s supply chain?
A: Yes, there's a trend toward regionalizing API production to reduce dependency on Asian suppliers, especially in North America and Europe.

Q3: How does regulatory compliance influence Binosto’s supply chain?
A: Suppliers must meet stringent GMP standards set by agencies like the FDA and EMA, ensuring consistent quality and safety of APIs and raw chemicals.

Q4: What role do contract manufacturing organizations play in Binosto’s distribution?
A: CMOs are responsible for final formulation, manufacturing, and packaging of Binosto, often operating across multiple regions to maintain supply flow.

Q5: How might supply chain disruptions affect Binosto availability?
A: Disruptions in API supply, geopolitical issues, or regulatory changes can lead to delays or shortages, emphasizing the importance of diversified sourcing and strategic inventory management.

Conclusion

The supply landscape of Binosto hinges on a complex network of raw material suppliers, API manufacturers, and global distribution channels. While established players in India, China, and Japan dominate the raw chemical and API production landscape, ongoing industry trends aim to enhance resilience and sustainability. Stakeholders must remain vigilant to regulatory shifts, geopolitical risks, and advancements in manufacturing practices to ensure uninterrupted supply and market stability for this critical osteoporosis treatment.

References
[1] U.S. Food and Drug Administration (FDA). Guidance for Industry: Good Manufacturing Practice (GMP) Regulations.
[2] European Medicines Agency (EMA). Good Manufacturing Practice (GMP).
[3] MarketWatch. "Global Bisphosphonates Market Size, Share & Trends."
[4] GlaxoSmithKline. “Product Portfolio and Manufacturing Overview,” 2023.
[5] IQVIA. "Global API Manufacturing and Supply Chain Report," 2022.