Suppliers and packagers for ACTONEL

ACTONEL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835	NDA	Allergan, Inc.	0430-0472-03	4 TABLET, FILM COATED in 1 DOSE PACK (0430-0472-03)	2002-05-17
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835	NDA	Allergan, Inc.	0430-0478-01	1 TABLET, FILM COATED in 1 DOSE PACK (0430-0478-01)	2008-04-22
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835	NDA AUTHORIZED GENERIC	Greenstone LLC	59762-0405-4	4 TABLET, FILM COATED in 1 DOSE PACK (59762-0405-4)	2002-05-17
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835	NDA AUTHORIZED GENERIC	Greenstone LLC	59762-0406-1	1 TABLET, FILM COATED in 1 DOSE PACK (59762-0406-1)	2008-04-22

Suppliers for the Pharmaceutical Drug: Actonel

Last updated: July 31, 2025

Introduction

Actonel, the brand name for risedronate sodium, is a bisphosphonate medication used primarily to treat and prevent osteoporosis, Paget’s disease of bone, and other bone-related conditions. Since its initial approval, the drug has gained widespread use globally, necessitating a complex network of manufacturing and supply chain players. The stability of the supply chain for Actonel hinges on a global landscape of pharmaceutical manufacturers, contract manufacturers, distributors, and raw material suppliers. This analysis delves into the primary suppliers involved in the production and distribution of Actonel, providing insights essential for stakeholders seeking supply chain stability or assessing market landscape.

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Manufacturers of Risedronate Sodium

The core ingredient of Actonel, risedronate sodium, is produced by several key pharmaceutical manufacturers, each contributing to its global availability:

• Pfizer Inc.: Originally developed and marketed by Procter & Gamble in the late 1990s, the rights to Actonel and risedronate sodium shifted to Pfizer following corporate acquisitions. Pfizer remains a dominant supplier, manufacturing the active pharmaceutical ingredient (API) at multiple facilities, primarily in the United States and Europe. Pfizer's extensive API manufacturing capabilities underpin the global supply of risedronate.

• Mitsubishi Tanabe Pharma Corporation: A significant player in the Asia-Pacific region, Mitsubishi Tanabe markets and supplies risedronate, often in conjunction with regional formulations of Actonel. Their manufacturing plants in Japan and China cater to regional demand.

• Teva Pharmaceutical Industries Ltd.: As a large generic drug manufacturer, Teva produces generic versions of risedronate sodium, contributing to worldwide availability, especially where patent exclusivity has expired or in markets favoring generics.

Other regional manufacturers and generic companies also produce risedronate sodium, though their market shares tend to be less prominent compared to Pfizer and Mitsubishi Tanabe.

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Formulation and Final Packaging

While the API supply forms the backbone, the final formulation — tablets — is produced by several manufacturers under licensing agreements or generic manufacturing contracts:

• Pfizer's Manufacturing Facilities: Pfizer's manufacturing plants in North America and Europe produce Actonel tablets, incorporating the API into their final dosage forms, complying with stringent Good Manufacturing Practice (GMP) standards.

• Contract Manufacturing Organizations (CMOs): Several CMOs globally, including companies like Catalent, Lonza, and Patheon, manufacture Actonel tablets under contract, providing additional capacity and supporting regional supply needs. These CMOs handle processes from API blending to final packaging, emphasizing the importance of flexible supply chains.

• Regional Generics Producers: In emerging markets such as India, China, and Latin America, local pharmaceutical companies produce generic versions of Actonel, often sourcing API from Pfizer or other suppliers and producing final formulations domestically.

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Distribution Channels

Once manufactured, Actonel is distributed through a network of wholesale distributors, pharmacies, hospitals, and long-term care facilities:

• Major Distributors: Companies like McKesson, Cardinal Health, and AmerisourceBergen serve as primary pharmaceutical distributors, ensuring broad reach across the United States. Similar players operate in Europe (e.g., Alliance Healthcare) and Asia.

• Regional Distributors: In Asia-Pacific and Latin America, local distributors and importing agencies facilitate regional distribution, often sourcing directly from regional manufacturers or global contracts.

• Supply Chain Challenges: Factors such as global geopolitical tensions, raw material shortages, and manufacturing disruptions have historically affected the flow of Actonel, emphasizing the importance of diversified supplier bases.

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Raw Material and API Supply Chain

The API market for bisphosphonates like risedronate sodium is relatively concentrated, raising concerns about supply security:

• Concentration of API Production: A limited number of companies, including Pfizer, Teva, and Mitsubishi Tanabe, dominate API manufacturing. This concentration embodies risks such as supply shortages or price volatility.

• Raw Material Suppliers: Risedronate sodium synthesis involves specialized chemicals such as phosphorous compounds, chlorinated organics, and solvents. Owing to their specialized nature, raw material suppliers are often small, niche chemical producers located primarily in Asia and Europe.

• Regulatory Considerations: API manufacturing facilities are subject to rigorous inspections and compliance standards (e.g., FDA, EMA), impacting supply stability when regulatory issues arise.

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Market Dynamics and Supplier Strategies

Market dynamics influence supplier behavior:

• Patent Expiration and Generics: The patent exclusivity for Actonel expired in many regions around 2016-2018, prompting an influx of generic manufacturers. This shift diversified supply sources but also introduced market competition and pricing pressures.

• Strategic Alliances: Pfizer has entered licensing agreements with regional manufacturers, ensuring multiple supply sources. For example, Pfizer's collaboration with Indian firms like Dr. Reddy’s Laboratories enhances regional supply capacity.

• Supply Chain Resilience: To mitigate risks, pharmaceutical companies are increasingly adopting dual-sourcing strategies for APIs and formulations, fostering partnerships with multiple manufacturers.

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Regulatory and Quality Assurance

Suppliers must adhere to stringent regulatory standards, with approval processes managed by authorities such as the FDA, EMA, and local regulators. Quality issues, manufacturing delays, or regulatory non-compliance can disrupt supply, compelling companies to diversify supplier bases and maintain contingency stockpiles.

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Conclusion

The supply chain for Actonel involves a complex network of primary API producers—primarily Pfizer, Mitsubishi Tanabe, and Teva—and a broad array of formulation manufacturers and distributors. The concentration of API manufacturing in a limited set of suppliers presents risk, mitigated through licensing agreements, regional manufacturing, and strategic sourcing. As market conditions evolve, maintaining diversified and resilient supply chains remains critical for ensuring the continual availability of Actonel across global markets.

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Key Takeaways

• Primary API Suppliers: Pfizer leads globally, supported by Mitsubishi Tanabe and Teva, with regional manufacturers supplementing supply, especially in emerging markets.

• Supply Chain Risks: Limited API producers increase vulnerability to shortages; diversification strategies like licensing and regional manufacturing help mitigate this risk.

• Formulation and Distribution: Major CMOs and regional companies produce and distribute Actonel, with global distribution networks ensuring wide access.

• Raw Material Dependencies: Specialized chemical components of the API are sourced mainly from Asia and Europe, necessitating vigilant quality and supply management.

• Market Trends: Patent expiries and generic proliferation have expanded the supplier base but intensified market competition and pricing pressures.

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FAQs

1. Who are the main API suppliers for Actonel?
The leading API suppliers for Actonel are Pfizer, Mitsubishi Tanabe Pharma, and Teva. These companies manufacture risedronate sodium at primary facilities in the U.S., Japan, and Israel, respectively.

2. How has patent expiry affected the supply chain of Actonel?
Patent expiry has fostered increased competition, leading to more generic manufacturers entering the market. This diversification has improved supply resilience but also introduced pricing pressures and market commoditization.

3. Are there regional differences in Actonel manufacturing?
Yes. In regions like Asia-Pacific, local manufacturers produce both the API and final formulations, often sourcing API from global suppliers. European and North American markets primarily rely on Pfizer and licensed CMOs.

4. What are potential risks in the supply chain of Actonel?
Concentrated API production, regulatory challenges, raw material shortages, or geopolitical disruptions pose risks. Companies address these through multi-sourcing and regional partnerships.

5. How do regulatory standards impact suppliers of Actonel?
Suppliers must meet strict GMP and regulatory standards by agencies like the FDA and EMA. Non-compliance can lead to manufacturing halts or supply disruptions, emphasizing the importance of quality assurance.

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References

1. [1] Pfizer Press Release, 2022.
2. [2] Mitsubishi Tanabe Pharma Annual Report, 2021.
3. [3] Teva Pharmaceuticals Overview, 2022.
4. [4] Global API Market Report, MarketsandMarkets, 2022.
5. [5] European Medicines Agency, Drug Authorizations, 2022.