Suppliers and packagers for evista

evista

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815	NDA	Eli Lilly and Company	0002-4184-30	30 TABLET in 1 BOTTLE (0002-4184-30)	1998-01-06

Suppliers for the Pharmaceutical Drug: EVISTA

Last updated: August 5, 2025

Introduction

EVISTA (generic name: raloxifene hydrochloride) is a selective estrogen receptor modulator (SERM) primarily prescribed to prevent and treat osteoporosis in postmenopausal women and reduce the risk of invasive breast cancer. Since its approval by the FDA in 2007, EVISTA has become a significant product within the pharmaceutical landscape, necessitating a robust and diverse supply chain. This article provides a comprehensive overview of the key suppliers engaged in the manufacturing, active pharmaceutical ingredient (API) sourcing, formulation, and distribution of EVISTA, highlighting industry dynamics and strategic considerations for stakeholders.

Manufacturing Landscape for EVISTA

The production of EVISTA involves several critical components: synthesis of the active pharmaceutical ingredient (raloxifene hydrochloride), formulation into the final dosage form (tablets), and distribution. The supply chain spans multiple regions, including North America, Europe, and Asia, with key players involved at each stage.

Active Pharmaceutical Ingredient (API) Suppliers

The foundation of EVISTA’s supply chain hinges upon the procurement of high-quality raloxifene hydrochloride. Several pharmaceutical-grade API manufacturers supply raloxifene globally, with notable players including:

• Hetero Labs Limited (India): Hetero is one of the prominent producers of raloxifene API, recognized for its extensive manufacturing capacity and adherence to WHO-GMP standards. Their API is supplied to both generic and branded drug manufacturers worldwide [1].

• Dr. Reddy's Laboratories (India): With a strong API manufacturing division, Dr. Reddy’s supplies raloxifene to various markets. Their global presence and regulatory track record make them a key supplier in the EVISTA supply chain [2].

• Zhejiang Huahai Pharmaceutical Co., Ltd. (China): An emerging player with significant API production capabilities, including raloxifene hydrochloride, aligning with stringent quality standards suitable for pharmaceutical use [3].

• Mundipharma and Teva Pharmaceuticals: While primarily known for their formulation and distribution channels, both companies have sourced raloxifene APIs from third-party manufacturers to fulfill their generic EVISTA markets.

Formulation and Final Dosage Product Suppliers

Beyond API sourcing, the manufacturing of the final EVISTA tablets involves prominent pharmaceutical companies with robust formulation capabilities:

• Eli Lilly and Company: The original developer and patent holder of EVISTA, Eli Lilly continues to be the primary manufacturer and distributor, supplying branded EVISTA globally. Their integrated supply chain ensures consistent quality and regulatory compliance [4].

• Generic Manufacturers: Post-patent expiry, numerous generic pharmaceutical companies entered the market, sourcing API from diverse suppliers and establishing their manufacturing facilities. These include:

  • Watson Pharmaceuticals (now part of Allergan): Historically involved in generic raloxifene production, utilizing API sourced from Indian and Chinese manufacturers.

  • Mylan (now part of Viatris): Developed generic raloxifene formulations, partnering with API suppliers from India, China, and Europe to ensure supply resilience [5].

  • Teva Pharmaceuticals: As a major generic player, Teva has developed raloxifene formulations, sourcing APIs globally and ensuring supply continuity across markets.

Distribution and Supply Chain Management

The distribution network for EVISTA is extensive, involving wholesalers, specialty pharmacies, hospitals, and retail chains. Eli Lilly manages a global supply chain ecosystem, leveraging regional manufacturing plants and distribution centers to meet regional regulatory requirements and market demands. Generic manufacturers, often with regional manufacturing bases, follow similar logistics pathways, ensuring timely product delivery.

Regional Variations and Market Dynamics

Supply chain dynamics for EVISTA vary significantly between regions due to differing regulatory environments, manufacturing capacities, and market competition.

• North America: Eli Lilly maintains a dominant position with robust manufacturing and distribution networks. The availability of generics depends on patent status and regulatory approvals, with Indian companies like Dr. Reddy’s and Natco Pharma emerging as significant suppliers following patent expiration.

• Europe: The market features a mix of original and generic manufacturers, with supply chains often involving European API producers and formulation facilities compliant with EU GMP standards.

• Asia: India and China serve as critical hubs for API manufacturing and formulation, contributing substantially to global EVISTA supply. They benefit from lower production costs and technological expertise, although regulatory compliance remains a key consideration.

Strategic Considerations

• API Quality and Regulatory Compliance: Suppliers must meet stringent international standards such as FDA, EMA, and WHO-GMP. Quality assurance protocols, traceability, and compliance are crucial for uninterrupted supply and patient safety.

• Supply Chain Resilience: Given recent global disruptions (e.g., COVID-19 pandemic), manufacturers diversify sourcing and establish multiple suppliers to mitigate risks associated with geopolitical tensions, regulatory hurdles, and raw material shortages.

• Intellectual Property and Patent Landscape: Patent expirations impact the number of suppliers entering the generic market, increasing competition, and necessitating scalable and compliant manufacturing processes to capitalize on emerging opportunities.

Future Outlook

The EVISTA supply chain is poised for evolvement driven by patent expiration, increasing demand for osteoporosis and breast cancer therapies, and technological advances in manufacturing. Strategic collaborations between API suppliers and formulation companies are expected to enhance supply robustness and cost efficiencies. Additionally, increasing regulatory harmonization and quality standards globally will further shape supplier selection and operational practices.

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Key Takeaways

• Multiple global API manufacturers, primarily based in India and China, supply raloxifene hydrochloride — the core ingredient for EVISTA.

• Eli Lilly remains the primary branded EVISTA supplier, with the generic market expanding post-patent expiration through companies like Mylan, Teva, and Dr. Reddy’s.

• Ensuring API quality, regulatory compliance, and supply chain resilience is vital amid fluctuating global markets.

• Regional disparities in manufacturing capabilities influence sourcing strategies, with emerging markets playing an increasingly prominent role.

• The evolving patent landscape and technological innovations will continue to impact supplier dynamics and market competition.

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FAQs

1. Who are the leading API suppliers for raloxifene hydrochloride used in EVISTA?
Major API manufacturers include Hetero Labs (India), Dr. Reddy’s Laboratories (India), Zhejiang Huahai Pharmaceutical (China), and other regional players supplying high-quality raloxifene hydrochloride globally.

2. How has patent expiration affected EVISTA’s supply chain?
Patent expiry has facilitated the entry of numerous generic manufacturers, increasing API sourcing options, diversifying supply, and intensifying market competition.

3. What quality standards do EVISTA suppliers need to meet?
Suppliers must adhere to international Good Manufacturing Practices (GMP), including FDA, EMA, and WHO standards, to ensure API quality, safety, and efficacy.

4. Are there regional differences in EVISTA supply chain strategies?
Yes. North American markets rely heavily on Eli Lilly’s supply chain, while Indian and Chinese suppliers serve as key sources for generic formulations and APIs in Asia, Europe, and emerging markets.

5. What is the forecast for the EVISTA supply chain?
The supply chain is expected to become more diversified and resilient due to new entrants, technological advances, and increasing global demand, with continued importance placed on quality, regulatory compliance, and supply flexibility.

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References

[1] Hetero Labs Ltd. Official Website. Accessed 2023.
[2] Dr. Reddy’s Laboratories. Annual Report 2022.
[3] Zhejiang Huahai Pharmaceutical. Corporate Profile.
[4] Eli Lilly and Company. Investor Relations and Supply Chain Overview.
[5] Mylan (Viatris). Market Approvals and API Sourcing Strategies.