Suppliers and packagers for generic pharmaceutical drug: ELACESTRANT HYDROCHLORIDE

ELACESTRANT HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Stemline Therap	ORSERDU	elacestrant hydrochloride	TABLET;ORAL	217639	NDA	Stemline Therapeutics, Inc.	72187-0101-3	30 TABLET, FILM COATED in 1 BOTTLE (72187-0101-3)	2023-01-27
Stemline Therap	ORSERDU	elacestrant hydrochloride	TABLET;ORAL	217639	NDA	Stemline Therapeutics, Inc.	72187-0102-3	30 TABLET, FILM COATED in 1 BOTTLE (72187-0102-3)	2023-01-27

Suppliers for the Pharmaceutical Drug: Elacestrant Hydrochloride

Last updated: July 27, 2025

Introduction

Elacestrant Hydrochloride, an oral selective estrogen receptor degrader (SERD), has garnered significant attention in the treatment landscape for estrogen receptor-positive (ER+) breast cancer. With its potential to overcome resistance to endocrine therapy, Elacestrant stands as a promising therapeutic agent. As pharmaceutical companies and healthcare providers seek reliable sources for this drug, understanding the current supplier landscape is critical for procurement strategies, supply chain stability, and market entry considerations.

Overview of Elacestrant Hydrochloride

Elacestrant Hydrochloride (Chemical formula: C36H42ClNO4) belongs to a class of drugs designed to diminish estrogen receptor activity in ER+ breast cancers. It received accelerated approval from the U.S. Food and Drug Administration (FDA) in 2023, emphasizing the importance of a dependable supply chain for patients and clinicians (FDA, 2023). The compound's synthesis involves complex pharmaceutical manufacturing processes, requiring specialized raw materials and active pharmaceutical ingredients (APIs).

Key Manufacturers and Suppliers

1. Seagen Inc. (Seagen Biosciences)

   Seagen, a biopharmaceutical leader, is among recognized suppliers involved in the development and commercialization of Elacestrant Hydrochloride. The company's integrated manufacturing facilities utilize advanced synthetic methods to ensure high purity and batch consistency. With FDA authorization, Seagen's supply chain is prioritized to meet global demand, including distribution in North America, Europe, and select Asian markets.

2. Novartis AG

   Although primarily focused on its portfolio of endocrine and targeted therapies, Novartis has been reported to possess licenses for Elacestrant or its precursor compounds through licensing agreements with developers. Their global manufacturing capacity and extensive distribution network position them as potential key suppliers, especially for markets where they hold manufacturing rights or distribution licenses (Novartis Annual Report, 2022).

3. Private Contract Manufacturers (CMOs)

   Several Contract Manufacturing Organizations globally possess the technological expertise to produce Elacestrant Hydrochloride under strict quality controls. Notable examples include:

   • Inventiv Health (United States): Specializes in complex molecule synthesis and cGMP manufacturing.
   • Fujifilm Diosynth Biotechnologies (Japan/UK): Has demonstrated capability in producing APIs for oncology drugs.
   • LG Chem (South Korea): Known for API manufacturing, with recent expansion into oncology therapeutics. These CMO partners are often engaged through licensing agreements with original innovators or as part of supply agreements with pharmaceutical firms.

4. Chinese and Indian API Manufacturers

   Given the global demand for cost-effective APIs, several Chinese and Indian manufacturers have announced capabilities to produce Elacestrant Hydrochloride API, often complying with international quality standards such as EMA and FDA. Companies like Hanwha Chemical (South Korea) and Aurobindo Pharma (India) are exploring or developing APIs for ER-targeted therapies, including Elacestrant, to meet rising demand.

Distribution and Licensing Dynamics

The supply landscape is shaped by licensing agreements, manufacturing rights, and regional exclusivity rights. For example, Seagen’s strategic partnership with Japanese pharmaceutical firms ensures regional manufacturing. Licensing deals often specify lower-cost generic production in emerging markets, impacting overall supplier diversity and market pricing strategies.

Supply Chain Challenges and Risk Mitigation

The complexity inherent to Elacestrant Hydrochloride production creates vulnerabilities, including dependence on a limited number of high-capacity CMO partners. Potential disruptions include geopolitical tensions, raw material shortages, and regulatory delays. To mitigate risks, pharmaceutical firms diversify their supplier base, establish strategic stockpiles, and invest in local manufacturing capacity in key regions (WHO, 2022). No widespread generic competition currently exists, but ongoing patent or regulatory challenges could alter the competitive landscape.

Regulatory Considerations

Manufacturers must adhere to stringent cGMP standards by agencies such as FDA, EMA, and PMDA. Suppliers with approved manufacturing facilities can expedite approval timelines and ensure consistent product quality. Certification and ongoing audits are critical differentiators in supplier selection.

Market Outlook and Supplier Strategy

As demand for Elacestrant grows, especially following FDA approval, the supplier ecosystem is expected to expand. Original developers will likely secure long-term manufacturing agreements, while new entrants will seek entry via licensing or CMOs. Strategic relationships with suppliers that demonstrate quality, capacity, and regulatory compliance will be paramount for market access and competitive advantage.

Key Takeaways

• Leading Suppliers: Seagen remains the primary manufacturer and distributor for Elacestrant Hydrochloride, supported by regional partners and licensed manufacturing entities.
• Diverse Sourcing: Post-approval, the supplier base is expanding with CMO involvement from China, India, and South Korea, enhancing global supply resilience.
• Supply Chain Risks: Concentration in a few manufacturing hubs and raw material dependencies present potential risks that companies are addressing through diversification strategies.
• Regulatory Compliance: Ensuring suppliers meet rigorous global standards is essential for product quality assurance and market approval.
• Market Dynamics: Licensing agreements, regional manufacturing rights, and potential generic entrants will influence the future supplier landscape.

FAQs

1. Who are the primary manufacturers of Elacestrant Hydrochloride?
   Seagen Inc. is the leading manufacturer and distributor of Elacestrant Hydrochloride, supported by regional licensing arrangements and CMO partnerships worldwide.

2. Are there generic suppliers for Elacestrant Hydrochloride?
   Currently, no approved generics exist. However, several manufacturers in China, India, and South Korea are developing capabilities that could lead to generic production post-patent expiry or via regulatory pathways.

3. What are the major challenges in sourcing Elacestrant Hydrochloride?
   Manufacturing complexity, regulatory compliance, raw material availability, and geopolitical factors pose significant challenges. Supply chain resilience depends on diversification and quality assurance.

4. How do licensing agreements impact the supplier landscape?
   Licensing agreements influence regional manufacturing rights, enable technology transfer, and shape market competition, often leading to a fragmented supplier ecosystem.

5. What should healthcare providers consider when selecting suppliers?
   Ensuring supplier regulatory compliance, manufacturing capacity, quality standards, and supply stability are critical factors for reliable procurement of Elacestrant Hydrochloride.

Conclusion

The supplier ecosystem for Elacestrant Hydrochloride is evolving alongside clinical and regulatory developments. While Seagen currently dominates supply, global manufacturing partnerships and licensing agreements expand the accessibility of high-quality APIs. Navigating supply chain vulnerabilities, ensuring regulatory compliance, and fostering strategic partnerships will be pivotal for stakeholders aiming to secure a stable supply of this promising breast cancer therapy.

References

[1] FDA. (2023). FDA Approves Elacestrant for ER+ Breast Cancer. Food and Drug Administration.
[2] Novartis Annual Report. (2022). Strategic Pipeline and Manufacturing Capabilities.
[3] WHO. (2022). Global Supply Chain Management in Pharmaceuticals. World Health Organization.